44 results on '"De Jaegere P"'
Search Results
2. Short- and long-term outcomes in octogenarians undergoing percutaneous coronary intervention with stenting.
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Marcolino MS, Simsek C, de Boer SP, van Domburg RT, van Geuns RJ, de Jaegere P, Akkerhuis KM, Daemen J, Serruys PW, and Boersma E
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- Acute Coronary Syndrome mortality, Age Factors, Aged, Aged, 80 and over, Antibiotics, Antineoplastic therapeutic use, Antineoplastic Agents, Phytogenic therapeutic use, Cohort Studies, Coronary Artery Disease mortality, Coronary Thrombosis epidemiology, Equipment Failure statistics & numerical data, Female, Humans, Longitudinal Studies, Male, Middle Aged, Netherlands, Paclitaxel therapeutic use, Percutaneous Coronary Intervention mortality, Proportional Hazards Models, Prospective Studies, Risk Factors, Sirolimus therapeutic use, Treatment Outcome, Acute Coronary Syndrome therapy, Coronary Artery Disease therapy, Drug-Eluting Stents statistics & numerical data, Percutaneous Coronary Intervention statistics & numerical data, Stents statistics & numerical data
- Abstract
Aims: To investigate the incidence of cardiac events in octogenarians who underwent percutaneous coronary intervention (PCI) with stenting, as well as to evaluate the efficacy and safety of drug-eluting stents (DES) in this population., Methods and Results: The study included 6,129 consecutive patients who underwent PCI with stenting from 2000 to 2005 in our centre, of whom 291 (4.7%) were octogenarians. After adjusting for confounders, age ≥80 years appeared a significant predictor of high mortality at 30 days (adjusted hazard ratio [aHR] 1.92, 95% CI 1.23-3.01), and four years (aHR 2.25, 95% CI 1.77-2.85). No differences were seen with respect to incident myocardial infarction (MI), but target lesion (63.2 vs. 32.6 per 1,000 person-years at one year and 27.9 vs. 16.6 per 1,000 person-years at four years) and vessel (83.1 vs. 52.9 per 1,000 person-years at one year and 37.7 vs. 25.0 per 1,000 person-years at four years) revascularisation rates were lower in octogenarians. When comparing DES with bare metal stents (BMS) in octogenarians, mortality and MI rates were comparable, but there was a significantly lower incidence of target lesion revascularisation at one- (9.5 vs. 0.6 per 1,000 person-years, aHR 0.07, 95% CI 0.01-0.57) and four-year (3.4 vs. 0.7 per 1,000 person-years, aHR 0.16, 95% CI 0.04-0.59) follow-up in patients who received a DES., Conclusions: Octogenarians undergoing PCI with stenting have an increased mortality risk, whereas the rates of repeat revascularisation in octogenarians are lower. This study suggests that the benefit of DES in reducing revascularisation rates is extended to elderly patients.
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- 2012
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3. Plaque sealing and passivation with a mechanical self-expanding low outward force nitinol vShield device for the treatment of IVUS and OCT-derived thin cap fibroatheromas (TCFAs) in native coronary arteries: report of the pilot study vShield Evaluated at Cardiac hospital in Rotterdam for Investigation and Treatment of TCFA (SECRITT).
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Wykrzykowska JJ, Diletti R, Gutierrez-Chico JL, van Geuns RJ, van der Giessen WJ, Ramcharitar S, Duckers HE, Schultz C, de Feyter P, van der Ent M, Regar E, de Jaegere P, Garcia-Garcia HM, Pawar R, Gonzalo N, Ligthart J, de Schepper J, van den Berg N, Milewski K, Granada JF, and Serruys PW
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- Aged, Aged, 80 and over, Coronary Angiography, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease pathology, Coronary Stenosis diagnostic imaging, Coronary Stenosis pathology, Feasibility Studies, Female, Fractional Flow Reserve, Myocardial, Humans, Longitudinal Studies, Male, Middle Aged, Pilot Projects, Plaque, Atherosclerotic diagnostic imaging, Plaque, Atherosclerotic pathology, Tomography, Optical Coherence, Ultrasonography, Interventional, Alloys therapeutic use, Coronary Artery Disease therapy, Coronary Stenosis therapy, Percutaneous Coronary Intervention instrumentation, Plaque, Atherosclerotic therapy, Stents
- Abstract
Aims: The aim of the pilot SECRITT trial was to evaluate the safety and feasibility of sealing the high risk IVUS and optical coherence tomography-derived thin cap fibroatheroma (TCFA), with a dedicated nitinol self-expanding vShield device., Methods and Results: After screening with angiography, fractional flow reserve (FFR), intravascular ultrasound virtual histology (IVUS-VH) and optical coherence tomography (OCT), 23 patients met enrolment criteria (presence of non-obstructive VH-derived TCFA lesion with thin cap on OCT) and were randomised to vShield (n=13) versus medical therapy (n=10). In the shielded group, baseline percent diameter stenosis was 33.2±13.5%, FFR was 0.93±0.06. At six-month follow-up in shielded patients percent diameter stenosis further decreased to 18.7±16.9% and FFR remained the same 0.93±0.05. Average late loss was 0.24±0.13 mm. Average baseline fibrous cap thickness was 48±12 µm. After shield placement at six-month follow-up neo-cap formation was observed with average cap thickness of 201±168 µm. There were no dissections after shield placement and no plaque ruptures. In addition, mean stent area of 8.76±2.16 mm2 increased to 9.45±2.30 mm2, that is by 9% at six-month follow-up. The number of malapposed struts decreased from 10.7% to 7.6% and the number of uncovered struts at six months was 8.1%. There were no device-related major adverse cardiovascular events (MACE) events at six-month follow-up., Conclusions: High risk plaque passivation and sealing with a vShield self-expanding nitinol device appears feasible and safe. A long-term larger randomised study with streamlined screening criteria is needed to evaluate the efficacy of this approach over medical therapy.
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- 2012
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4. Seven-year safety and efficacy of the unrestricted use of drug-eluting stents in saphenous vein bypass grafts.
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Nauta ST, Van Mieghem NM, Magro M, Deckers JW, Simsek C, Van Geuns RJ, Van Der Giessen WJ, De Jaegere P, Regar E, Van Domburg RT, and Serruys PW
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- Aged, Angioplasty, Balloon, Coronary adverse effects, Angioplasty, Balloon, Coronary mortality, Cardiovascular Agents administration & dosage, Chi-Square Distribution, Constriction, Pathologic, Coronary Angiography, Coronary Artery Bypass mortality, Female, Graft Occlusion, Vascular diagnostic imaging, Graft Occlusion, Vascular etiology, Graft Occlusion, Vascular mortality, Humans, Kaplan-Meier Estimate, Male, Metals, Middle Aged, Myocardial Infarction etiology, Netherlands, Paclitaxel administration & dosage, Predictive Value of Tests, Proportional Hazards Models, Prosthesis Design, Risk Assessment, Risk Factors, Saphenous Vein diagnostic imaging, Sirolimus administration & dosage, Time Factors, Treatment Outcome, Angioplasty, Balloon, Coronary instrumentation, Coronary Artery Bypass adverse effects, Drug-Eluting Stents, Graft Occlusion, Vascular therapy, Saphenous Vein transplantation, Stents
- Abstract
Objectives: The aim was to investigate the 7-year clinical outcomes of patients treated with either drug-eluting stents (DES) or bare-metal stents (BMS) for saphenous vein graft disease (SVG)., Background: Atherosclerotic disease in SVG has several peculiarities which make it difficult to extrapolate outcomes of the use of DES as compared to BMS, from outcomes observed in native coronary arteries. To date no long-term safety and efficacy results for DES in SVG have been published., Methods: Between January, 2000 and December, 2005 a total of 250 consecutive patients with saphenous vein graft disease were sequentially treated with DES (either sirolimus- or paclitaxel-eluting stents) or with BMS. Yearly follow-up was performed., Results: At 87 months (7.25 years), a total of 101 patients died (58 [46%] in the BMS group and 43 [42%] in the DES group, P-value= 0.4). There was no significant difference in the combined endpoint mortality or myocardial infarction. Cumulative target vessel revascularisation (TVR) was higher in the BMS group compared to the DES group (41% vs. 29%, respectively; adjusted hazard ratio [HR] 0.63, 95% confidence interval [CI]: 0.39-1.0). The cumulative incidence of major adverse cardiac events was 73% vs. 68% in the BMS and DES groups, respectively (adjusted HR 0.93, 95% CI: 0.67-1.3)., Conclusions: In the present study, the unrestricted use of DES for SVG lesions appeared safe and effective up to 7.25 years- and the use of DES resulted in a clinically relevant lower rate of TVR., (Copyright © 2011 Wiley Periodicals, Inc.)
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- 2012
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5. Short- and long-term major adverse cardiac events in patients undergoing percutaneous coronary intervention with stenting for acute myocardial infarction complicated by cardiogenic shock.
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Marcolino MS, Simsek C, de Boer SP, van Domburg RT, van Geuns RJ, de Jaegere P, Akkerhuis KM, Daemen J, Serruys PW, and Boersma E
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- Aged, Angioplasty, Balloon, Coronary mortality, Coronary Artery Bypass mortality, Drug-Eluting Stents, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction complications, Myocardial Infarction mortality, Myocardial Revascularization mortality, Paclitaxel administration & dosage, Prognosis, Shock, Cardiogenic mortality, Sirolimus administration & dosage, Tubulin Modulators administration & dosage, Angioplasty, Balloon, Coronary adverse effects, Myocardial Infarction therapy, Shock, Cardiogenic complications, Stents
- Abstract
Objectives: To determine the risk of short- and long-term mortality and major adverse cardiac events (MACE) in acute myocardial infarction (AMI) patients complicated by cardiogenic shock (CS) in the contemporary practice of primary percutaneous coronary intervention with stenting., Methods: Of the 1,755 consecutive AMI patients undergoing percutaneous coronary intervention with stenting enrolled, 103 had CS at admission. Primary endpoints were early mortality (within 30 days after the index event) and late mortality (from day 31 up to 4 years). Secondary endpoints included MACE [all-cause death, myocardial infarction or target vessel revascularization (TVR)], myocardial infarction, TVR and stent thrombosis., Results: Thirty-day mortality was higher among CS patients, and CS was a strong independent predictor of a higher risk of early death (adjusted HR 3.64, 95% CI 2.44-5.44). The late mortality rate was significantly higher in CS patients, and CS was also a predictor of higher risk of death at a 4-year follow-up (adjusted HR 1.95, 95% CI 1.11-3.45). Recurrent AMI, TVR and stent thrombosis rates were similar among patients with and without CS., Conclusion: CS complicating AMI is still a severe clinical event, mainly with regard to a significant higher risk of early mortality, but also associated with a worse prognosis in 30-day survivors., (Copyright © 2012 S. Karger AG, Basel.)
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- 2012
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6. Intravascular ultrasound radiofrequency analysis after optimal coronary stenting with initial quantitative coronary angiography guidance: an ATHEROREMO sub-study.
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Sarno G, Garg S, Gomez-Lara J, Garcia Garcia HM, Ligthart J, Bruining N, Onuma Y, Witberg K, van Geuns RJ, de Boer S, Wykrzykowska J, Schultz C, Duckers HJ, Regar E, de Jaegere P, de Feyter P, van Es GA, Boersma E, van der Giessen W, and Serruys PW
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- Aged, Angioplasty, Balloon, Coronary methods, Coronary Vessels diagnostic imaging, Female, Humans, Male, Middle Aged, Prospective Studies, Reproducibility of Results, Ultrasonography, Interventional methods, Angioplasty, Balloon, Coronary standards, Coronary Angiography, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease therapy, Stents standards, Ultrasonography, Interventional standards
- Abstract
Aims: To investigate whether the use of intravascular ultrasound virtual histology (IVUS-VH) leads to any improvements in stent deployment, when performed in patients considered to have had an optimal percutaneous coronary intervention (PCI) by quantitative coronary angiography (QCA)., Methods and Results: After optimal PCI result (residual stenosis by QCA<30%), IVUS-VH was performed in 100 patients by protocol, with the option to use the information left to the discretion of the operators. Patients were categorised as: Group1 (n=54), where the IVUS-VH findings were used to evaluate the need for further optimisation of the stent deployment; and Group2 (n=46), where the IVUS-VH was documentary such that the stenting results were considered optimal according to QCA. Optimal stent deployment on IVUS-VH was defined as: normal stent expansion, absence of stent malapposition, complete lesion coverage as indicated by a plaque burden (PB%) between 30-40% and necrotic core confluent to the lumen<10% or PB%<30% at the 5 mm proximal and distal to the stent. The first IVUS-VH in all patients demonstrated the achievement of optimal stent deployment, incomplete lesion coverage, stent under-expansion and stent-edge dissection in 60%, 31%, 20% and 8% of patients, respectively. There was no stent malapposition. In Group 1, 25 patients had optimal stent deployment and did not require further intervention, whilst in 29 patients further intervention was needed (additional stent, n=18; post-dilatation, n=29). Overall optimal stent deployment was finally achieved in 52/54 patients (96%) in Group 1 and 35/46 (76%) of Group 2, p<0.05., Conclusions: IVUS-VH may have a role in facilitating optimal stent implantation and complete lesion coverage.
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- 2011
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7. The relative safety and efficacy of bare-metal and drug-eluting stents in low and high-risk patient subsets. An epidemiological analysis of three sequential cohorts of consecutive all comers (n = 6129).
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Daemen J, van Twisk PH, Kukreja N, van Domburg RT, Boersma E, de Jaegere P, and Serruys PW
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- Aged, Angioplasty, Balloon, Coronary adverse effects, Angioplasty, Balloon, Coronary mortality, Cardiovascular Diseases etiology, Cardiovascular Diseases mortality, Cohort Studies, Coronary Artery Disease mortality, Diabetes Complications therapy, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Netherlands epidemiology, Platelet Aggregation Inhibitors therapeutic use, Proportional Hazards Models, Registries, Risk Assessment, Time Factors, Treatment Outcome, Angioplasty, Balloon, Coronary instrumentation, Cardiovascular Agents administration & dosage, Cardiovascular Diseases prevention & control, Coronary Artery Disease therapy, Drug-Eluting Stents, Metals, Paclitaxel administration & dosage, Sirolimus administration & dosage, Stents
- Abstract
Aims: Sirolimus- and paclitaxel- eluting stents (SES and PES respectively) have been shown to produce a sustained reduction in restenosis and repeat revascularisations as compared to bare-metal stents (BMS) up to four years. There is still limited data about the long-term safety and efficacy of DES in high-risk subgroups., Methods and Results: A total of 6,129 consecutive patients were treated during three sequential periods with BMS (n = 2,428; January, 2000 to April, 2002), SES (n = 866; April 2002 to February 2003) or PES (n = 2,835; February 2003 to December 2005). A stratified analysis (including age, gender, diabetes, clinical presentation, treated vessel, multivessel disease, AHA lesion class, bifurcation, in-stent restenosis, average stent diameter < or = 2.5 mm and total stented length < or = 30 mm) was performed to evaluate possible heterogeneities in treatment effect. At four years, all-cause mortality was identical between the drug-eluting stent (DES) and BMS cohorts (13.5% vs. 13.4%, respectively; Adjusted HR 1.10, 95% CI 0.90 - 1.34) without evidence of heterogeneity in the high-risk patient subsets. Both DES significantly reduced the risk for target vessel revascularisation (TVR) as compared to BMS (TVR: 11.9% vs. 15.7% respectively; Adjusted HR 0.69, 95% CI 0.58 - 0.82) along with a reduced risk for post-operative MI (adjusted HR 0.75, 95% CI 0.57 - 0.98), but counterbalanced by a non-significantly higher risk for stent thrombosis (3.1% vs. 1.6%; adjusted HR 1.26, 95% CI 0.82 - 1.95). DES failed to show superiority to BMS in patients with acute myocardial infarction (TVR 10.5% vs. 9.2% respectively; Adjusted HR 1.26, 95% CI 0.82 - 1.93)., Conclusions: In a real world patient population, after four years, the overall use of DES was associated with similar all-cause mortality rates and a significantly reduced risk for post-operative MI and TVR as compared to BMS.
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- 2009
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8. A clinical randomized trial to evaluate the safety of a noninvasive approach in high-risk patients undergoing major vascular surgery: the DECREASE-V Pilot Study.
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Poldermans D, Schouten O, Vidakovic R, Bax JJ, Thomson IR, Hoeks SE, Feringa HH, Dunkelgrün M, de Jaegere P, Maat A, van Sambeek MR, Kertai MD, and Boersma E
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- Aged, Exercise Test, Feasibility Studies, Female, Follow-Up Studies, Humans, Male, Middle Aged, Myocardial Ischemia etiology, Myocardial Ischemia surgery, Pilot Projects, Risk Factors, Treatment Outcome, Angioplasty, Balloon, Coronary, Coronary Artery Bypass, Myocardial Ischemia prevention & control, Stents, Vascular Surgical Procedures
- Abstract
Objectives: The purpose of this research was to perform a feasibility study of prophylactic coronary revascularization in patients with preoperative extensive stress-induced ischemia., Background: Prophylactic coronary revascularization in vascular surgery patients with coronary artery disease does not improve postoperative outcome. If a beneficial effect is to be expected, then at least those with extensive coronary artery disease should benefit from this strategy., Methods: One thousand eight hundred eighty patients were screened, and those with > or =3 risk factors underwent cardiac testing using dobutamine echocardiography (17-segment model) or stress nuclear imaging (6-wall model). Those with extensive stress-induced ischemia (> or =5 segments or > or =3 walls) were randomly assigned for additional revascularization. All received beta-blockers aiming at a heart rate of 60 to 65 beats/min, and antiplatelet therapy was continued during surgery. The end points were the composite of all-cause death or myocardial infarction at 30 days and during 1-year follow-up., Results: Of 430 high-risk patients, 101 (23%) showed extensive ischemia and were randomly assigned to revascularization (n = 49) or no revascularization. Coronary angiography showed 2-vessel disease in 12 (24%), 3-vessel disease in 33 (67%), and left main in 4 (8%). Two patients died after revascularization, but before operation, because of a ruptured aneurysm. Revascularization did not improve 30-day outcome; the incidence of the composite end point was 43% versus 33% (odds ratio 1.4, 95% confidence interval 0.7 to 2.8; p = 0.30). Also, no benefit during 1-year follow-up was observed after coronary revascularization (49% vs. 44%, odds ratio 1.2, 95% confidence interval 0.7 to 2.3; p = 0.48)., Conclusions: In this randomized pilot study, designed to obtain efficacy and safety estimates, preoperative coronary revascularization in high-risk patients was not associated with an improved outcome.
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- 2007
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9. Two-year clinical outcome after coronary stenting of small vessels using 2.25-mm sirolimus- and paclitaxel-eluting stents: insight into the RESEARCH and T-SEARCH registries.
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Tanimoto S, Daemen J, Tsuchida K, García-García HM, de Jaegere P, van Domburg RT, and Serruys PW
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- Aged, Chi-Square Distribution, Coronary Angiography, Coronary Restenosis epidemiology, Coronary Restenosis prevention & control, Coronary Stenosis drug therapy, Drug Delivery Systems, Female, Follow-Up Studies, Humans, Male, Middle Aged, Netherlands epidemiology, Paclitaxel administration & dosage, Proportional Hazards Models, Prospective Studies, Registries, Sirolimus administration & dosage, Treatment Outcome, Coronary Stenosis therapy, Stents
- Abstract
Objectives: To evaluate long-term outcomes after drug-eluting stents (DES) implantation in small coronary vessels., Background: Sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) have been reported to improve both the angiographic and clinical outcomes compared with bare metal stents even in 'real world' settings. Currently, no data is available on long-term outcomes after DES implantation in small vessels., Methods: Since April 2002, our institution has implanted DES, either SES or PES, as a default strategy in all patients irrespective of their clinical presentation. Between October 2002 and September 2003, 197 consecutive patients were enrolled: 107 consecutive patients received at least one 2.25-mm SES (SES group) and 90 consecutive patients received at least one 2.25-mm PES (PES group)., Results: The two cohorts presented with high-risk characteristics. At 2 years, the cumulative incidence of major adverse cardiac events (MACE) in the SES group was significantly lower than that in the PES group (10.3% vs. 23.3%, P=0.02). There were two subacute angiographic stent thromboses in the PES group and none in the SES group. By multivariate analysis, PES utilization (HR 2.37, 95% CI 1.07-5.26), presentation with acute coronary syndromes (ACS) (HR 3.34, 95% CI 1.44-7.70) and multi-vessel disease (MVD) (HR 3.91, 95% CI 1.27-12.0) were identified as independent predictors of MACE., Conclusions: In an unselected population treated for small vessel disease, SES were associated with significantly better 2-year clinical outcomes than PES. The use of PES and the presentation with ACS and MVD were identified as independent predictors of MACE., (Copyright (c) 2006 Wiley-Liss, Inc.)
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- 2007
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10. Single-vessel versus bifurcation stenting for the treatment of distal left main coronary artery disease in the drug-eluting stenting era. Clinical and angiographic insights into the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) and Taxus-Stent Evaluated at Rotterdam Cardiology Hospital (T-SEARCH) registries.
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Valgimigli M, Malagutti P, Rodriguez Granillo GA, Tsuchida K, Garcia-Garcia HM, van Mieghem CA, Van der Giessen WJ, De Feyter P, de Jaegere P, Van Domburg RT, and Serruys PW
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- Aged, Drug Delivery Systems, Female, Humans, Male, Middle Aged, Registries, Angioplasty, Balloon, Coronary, Coronary Stenosis therapy, Immunosuppressive Agents administration & dosage, Paclitaxel administration & dosage, Sirolimus administration & dosage, Stents
- Abstract
Background: Routine drug-eluting stent (DES) implantation has recently improved outcome in patients undergoing percutaneous treatment of left main (LM) coronary artery. However, even in the DES era, distal LM treatment remains an independent predictor of poor outcome. Whether single-vessel stenting (SVS) or bifurcation stenting (BS) should be performed to optimize treatment of such a lesion is unclear., Methods: From April 2002 to June 2004, 94 patients affected by distal LM disease underwent percutaneous intervention at our institution either with SVS (n = 48) or BS (n = 46). The 2 groups were well balanced for all baseline characteristics but the extension of disease in the LM carina., Results: After a median follow-up of 587 days (range, 328-1179), the cumulative incidence of MACE was similar between the 2 groups (31% in the BS vs 28% in SVS group, HR 0.96, 95% CI 0.46-1.49, P = .92), with no difference for the composite death/myocardial infarction or target vessel revascularization. After adjustment for confounders, the technique of stenting was not a predictor of either major adverse cardiac events or target vessel revascularization. Angiographic analysis--performed in 81% of eligible patients in SVS and 87% in the BS group--confirmed the equivalency between SVS versus BS., Conclusions: In consecutive patients undergoing catheter-based distal LM intervention, SVS or BS may perform equally under both clinical and angiographic perspective in current DES era.
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- 2006
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11. Multislice spiral computed tomography for the evaluation of stent patency after left main coronary artery stenting: a comparison with conventional coronary angiography and intravascular ultrasound.
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Van Mieghem CA, Cademartiri F, Mollet NR, Malagutti P, Valgimigli M, Meijboom WB, Pugliese F, McFadden EP, Ligthart J, Runza G, Bruining N, Smits PC, Regar E, van der Giessen WJ, Sianos G, van Domburg R, de Jaegere P, Krestin GP, Serruys PW, and de Feyter PJ
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- Adrenergic beta-Antagonists pharmacology, Aged, Coronary Artery Disease physiopathology, Coronary Artery Disease therapy, Coronary Restenosis physiopathology, Coronary Vessels diagnostic imaging, Coronary Vessels physiopathology, Female, Heart Rate drug effects, Heart Rate physiology, Humans, Male, Middle Aged, Predictive Value of Tests, Prospective Studies, Risk Factors, Sensitivity and Specificity, Ultrasonography, Interventional, Coronary Angiography methods, Coronary Restenosis diagnostic imaging, Myocardial Revascularization methods, Stents, Tomography, Spiral Computed methods
- Abstract
Background: Surveillance conventional coronary angiography (CCA) is recommended 2 to 6 months after stent-supported left main coronary artery (LMCA) percutaneous coronary intervention due to the unpredictable occurrence of in-stent restenosis (ISR), with its attendant risks. Multislice computed tomography (MSCT) is a promising technique for noninvasive coronary evaluation. We evaluated the diagnostic performance of high-resolution MSCT to detect ISR after stenting of the LMCA., Methods and Results: Seventy-four patients were prospectively identified from a consecutive patient population scheduled for follow-up CCA after LMCA stenting and underwent MSCT before CCA. Until August 2004, a 16-slice scanner was used (n = 27), but we switched to the 64-slice scanner after that period (n = 43). Patients with initial heart rates > 65 bpm received beta-blockers, which resulted in a mean periscan heart rate of 57 +/- 7 bpm. Among patients with technically adequate scans (n = 70), MSCT correctly identified all patients with ISR (10 of 70) but misclassified 5 patients without ISR (false-positives). Overall, the accuracy of MSCT for detection of angiographic ISR was 93%. The sensitivity, specificity, and positive and negative predictive values were 100%, 91%, 67%, and 100%, respectively. When analysis was restricted to patients with stenting of the LMCA with or without extension into a single major side branch, accuracy was 98%. When both branches of the LMCA bifurcation were stented, accuracy was 83%. For the assessment of stent diameter and area, MSCT showed good correlation with intravascular ultrasound (r = 0.78 and 0.73, respectively). An intravascular ultrasound threshold value > or = 1 mm was identified to reliably detect in-stent neointima hyperplasia with MSCT., Conclusions: Current MSCT technology, in combination with optimal heart rate control, allows reliable noninvasive evaluation of selected patients after LMCA stenting. MSCT is safe to exclude left main ISR and may therefore be an acceptable first-line alternative to CCA.
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- 2006
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12. Distal left main coronary disease is a major predictor of outcome in patients undergoing percutaneous intervention in the drug-eluting stent era: an integrated clinical and angiographic analysis based on the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) and Taxus-Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) registries.
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Valgimigli M, Malagutti P, Rodriguez-Granillo GA, Garcia-Garcia HM, Polad J, Tsuchida K, Regar E, Van der Giessen WJ, de Jaegere P, De Feyter P, and Serruys PW
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- Aged, Female, Humans, Male, Middle Aged, Multivariate Analysis, Paclitaxel therapeutic use, Predictive Value of Tests, Sirolimus therapeutic use, Treatment Outcome, Angioplasty, Balloon, Coronary, Coronary Angiography, Coronary Disease diagnostic imaging, Coronary Disease therapy, Paclitaxel administration & dosage, Sirolimus administration & dosage, Stents
- Abstract
Objectives: This study sought to investigate whether the anatomical location of the disease carries prognostic implications in patients undergoing drug-eluting stent (DES) implantation for the left main coronary artery (LMCA) stenosis., Background: Liberal use of DES, compared with a bare metal stent (BMS), has resulted in an improved outcome in patients undergoing LMCA intervention. However, the overall event rate in this subset of patients remains high, and alternative tools to risk-stratify this population beyond conventional surgical risk status would be desirable., Methods: From April 2002 to June 2004, 130 patients received DES as part of the percutaneous intervention for LMCA stenoses in our institution. Distal LMCA disease (DLMD) was present in 94 patients. They were at higher surgical risk and presented with a greater coronary disease extent compared with patients without DLMD., Results: After a median of 587 days (range 368 to 1,179 days), the cumulative incidence of major adverse cardiac events (MACE) was significantly higher in patients with DLMD at 30% versus 11% in those without DLMD (hazard ratio [HR] 3.42, 95% confidence interval [CI] 1.34 to 9.7; p = 0.007), mainly driven by the different rate of target vessel revascularization (13% and 3%; HR 6, 95% CI 1.2 to 29; p = 0.02). After adjustment for confounders, DLMD (HR 2.79,95% CI 1.17 to 8.9; p = 0.032) and surgical risk status (HR 2.18,95% CI 1.06 to 4.5; p = 0.038) remained independent and complementary predictors of MACE., Conclusions: Distal LMCA disease carries independent prognostic implications, and it may help in selecting the most appropriate patient subset for LMCA intervention beyond the conventional surgical risk status in the DES era.
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- 2006
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13. Sirolimus-eluting versus paclitaxel-eluting stent implantation for the percutaneous treatment of left main coronary artery disease: a combined RESEARCH and T-SEARCH long-term analysis.
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Valgimigli M, Malagutti P, Aoki J, Garcia-Garcia HM, Rodriguez Granillo GA, van Mieghem CA, Ligthart JM, Ong AT, Sianos G, Regar E, Van Domburg RT, De Feyter P, de Jaegere P, and Serruys PW
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- Coated Materials, Biocompatible, Coronary Angiography, Follow-Up Studies, Humans, Angioplasty, Balloon, Coronary, Coronary Artery Disease therapy, Paclitaxel administration & dosage, Sirolimus administration & dosage, Stents
- Abstract
Objectives: The purpose of this study was to investigate the long-term clinical and angiographic profile of sirolimus-eluting stent (SES) versus paclitaxel-eluting stent (PES) in patients undergoing percutaneous intervention for left main (LM) coronary disease., Background: The long-term clinical and angiographic impact of SES as opposed to PES implantation in this subset of patients is unknown., Methods: From April 2002 to March 2004, 110 patients underwent percutaneous intervention for LM stenosis at our institution; 55 patients were treated with SES and 55 with PES. The two groups were well balanced for all baseline characteristics., Results: At a median follow-up of 660 days (range 428 to 885), the cumulative incidence of major adverse cardiovascular events was similar (25% in the SES group vs. 29%, in the PES group; hazard ratio 0.88 [95% confidence interval 0.43 to 1.82]; p = 0.74), reflecting similarities in both the composite death/myocardial infarction (16% in the SES group and 18% in the PES group) and target vessel revascularization (9% in the SES group and 11% in the PES group). Angiographic in-stent late loss (mm), evaluated in 73% of the SES group and in 77% of the PES group, was 0.32 +/- 74 in the main and 0.36 +/- 0.59 in the side branch in the SES group vs. 0.46 +/- 0.57 (p = 0.36) and 0.52 +/- 0.42 (p = 0.41) in the PES group, respectively., Conclusions: In consecutive patients undergoing percutaneous LM intervention, PES may perform closely to SES both in terms of angiographic and long-term clinical outcome.
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- 2006
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14. One year clinical follow up of paclitaxel eluting stents for acute myocardial infarction compared with sirolimus eluting stents.
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Hofma SH, Ong AT, Aoki J, van Mieghem CA, Rodriguez Granillo GA, Valgimigli M, Regar E, de Jaegere PP, McFadden EP, Sianos G, van der Giessen WJ, de Feyter PJ, Van Domburg RT, and Serruys PW
- Subjects
- Adult, Aged, Coated Materials, Biocompatible, Coronary Restenosis prevention & control, Drug Delivery Systems, Epidemiologic Methods, Female, Humans, Male, Middle Aged, Treatment Outcome, Angioplasty, Balloon, Coronary methods, Cardiovascular Agents therapeutic use, Myocardial Infarction therapy, Paclitaxel therapeutic use, Sirolimus therapeutic use, Stents
- Abstract
Objective: To compare clinical outcome of paclitaxel eluting stents (PES) versus sirolimus eluting stents (SES) for the treatment of acute ST elevation myocardial infarction., Design and Patients: The first 136 consecutive patients treated exclusively with PES in the setting of primary percutaneous coronary intervention for acute myocardial infarction in this single centre registry were prospectively clinically assessed at 30 days and one year. They were compared with 186 consecutive patients treated exclusively with SES in the preceding period., Setting: Academic tertiary referral centre., Results: At 30 days, the rate of all cause mortality and reinfarction was similar between groups (6.5% v 6.6% for SES and PES, respectively, p = 1.0). A significant difference in target vessel revascularisation (TVR) was seen in favour of SES (1.1% v 5.1% for PES, p = 0.04). This was driven by stent thrombosis (n = 4), especially in the bifurcation stenting (n = 2). At one year, no significant differences were seen between groups, with no late thrombosis and 1.5% in-stent restenosis (needing TVR) in PES versus no reinterventions in SES (p = 0.2). One year survival free of major adverse cardiac events (MACE) was 90.2% for SES and 85% for PES (p = 0.16)., Conclusions: No significant differences were seen in MACE-free survival at one year between SES and PES for the treatment of acute myocardial infarction with very low rates of reintervention for restenosis. Bifurcation stenting in acute myocardial infarction should, if possible, be avoided because of the increased risk of stent thrombosis.
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- 2005
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15. Short- and long-term clinical outcome after drug-eluting stent implantation for the percutaneous treatment of left main coronary artery disease: insights from the Rapamycin-Eluting and Taxus Stent Evaluated At Rotterdam Cardiology Hospital registries (RESEARCH and T-SEARCH).
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Valgimigli M, van Mieghem CA, Ong AT, Aoki J, Granillo GA, McFadden EP, Kappetein AP, de Feyter PJ, Smits PC, Regar E, Van der Giessen WJ, Sianos G, de Jaegere P, Van Domburg RT, and Serruys PW
- Subjects
- Aged, Cohort Studies, Coronary Angiography, Coronary Disease diagnostic imaging, Coronary Disease drug therapy, Coronary Restenosis diagnostic imaging, Coronary Restenosis epidemiology, Drug Implants, Female, Follow-Up Studies, Humans, Incidence, Male, Middle Aged, Myocardial Infarction epidemiology, Myocardial Infarction prevention & control, Registries, Risk Factors, Sirolimus administration & dosage, Time Factors, Treatment Outcome, Angioplasty, Balloon, Coronary, Coronary Disease therapy, Coronary Restenosis prevention & control, Sirolimus therapeutic use, Stents
- Abstract
Background: The impact of drug-eluting stent (DES) implantation on the incidence of major adverse cardiovascular events in patients undergoing percutaneous intervention for left main (LM) coronary disease is largely unknown., Methods and Results: From April 2001 to December 2003, 181 patients underwent percutaneous coronary intervention for LM stenosis at our institution. The first cohort consisted of 86 patients (19 protected LM) treated with bare metal stents (pre-DES group); the second cohort comprised 95 patients (15 protected LM) treated exclusively with DES. The 2 cohorts were well balanced for all baseline characteristics. At a median follow-up of 503 days (range, 331 to 873 days), the cumulative incidence of major adverse cardiovascular events was lower in the DES cohort than in patients in the pre-DES group (24% versus 45%, respectively; hazard ratio [HR], 0.52 [95% CI, 0.31 to 0.88]; P=0.01). Total mortality did not differ between cohorts; however, there were significantly lower rates of both myocardial infarction (4% versus 12%, respectively; HR, 0.22 [95% CI, 0.07 to 0.65]; P=0.006) and target vessel revascularization (6% versus 23%, respectively; HR, 0.26 [95% CI, 0.10 to 0.65]; P=0.004) in the DES group. On multivariate analysis, use of DES, Parsonnet classification, troponin elevation at entry, distal LM location, and reference vessel diameter were independent predictors of major adverse cardiovascular events., Conclusions: When percutaneous coronary intervention is undertaken at LM lesions, routine DES implantation, which reduces the cumulative incidence of myocardial infarction and the need for target vessel revascularization compared with bare metal stents, should currently be the preferred strategy.
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- 2005
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16. Comparison of early outcome of percutaneous coronary intervention for unprotected left main coronary artery disease in the drug-eluting stent era with versus without intravascular ultrasonic guidance.
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Agostoni P, Valgimigli M, Van Mieghem CA, Rodriguez-Granillo GA, Aoki J, Ong AT, Tsuchida K, McFadden EP, Ligthart JM, Smits PC, de Jaegere P, Sianos G, Van der Giessen WJ, De Feyter P, and Serruys PW
- Subjects
- Chi-Square Distribution, Coronary Angiography, Coronary Disease diagnostic imaging, Female, Humans, Male, Middle Aged, Proportional Hazards Models, Risk Factors, Survival Analysis, Treatment Outcome, Angioplasty, Balloon, Coronary, Coronary Disease therapy, Stents, Ultrasonography, Interventional
- Abstract
The aim of this study was to assess the short- and mid-term clinical impact of intravascular ultrasound guidance in 58 patients referred for elective percutaneous treatment of unprotected left main coronary artery disease with drug-eluting stents. The use of intravascular ultrasound, used in 41% of the procedures, was not associated with additional clinical benefit with respect to angiographic-assisted stent deployment.
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- 2005
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17. Randomized comparison between stenting and off-pump bypass surgery in patients referred for angioplasty.
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Eefting F, Nathoe H, van Dijk D, Jansen E, Lahpor J, Stella P, Suyker W, Diephuis J, Suryapranata H, Ernst S, Borst C, Buskens E, Grobbee D, and de Jaegere P
- Subjects
- Aged, Angina Pectoris therapy, Angioplasty, Balloon, Cost-Benefit Analysis, Female, Follow-Up Studies, Humans, Life Tables, Male, Middle Aged, Myocardial Infarction epidemiology, Netherlands, Quality-Adjusted Life Years, Recurrence, Stroke epidemiology, Surveys and Questionnaires, Treatment Outcome, Angina Pectoris surgery, Coronary Artery Bypass economics, Stents economics
- Abstract
Background: Stenting improves cardiac outcome in comparison with balloon angioplasty. Compared with conventional surgery, off-pump bypass surgery on the beating heart without cardiopulmonary bypass may reduce morbidity, hospital stay, and costs. The purpose, therefore, was to compare cardiac outcome, quality of life, and cost-effectiveness 1 year after stenting and after off-pump surgery., Methods and Results: Patients referred for angioplasty (n=280) were randomly assigned to stenting (n=138) or off-pump bypass surgery. At 1 year, survival free from stroke, myocardial infarction, and repeat revascularization was 85.5% after stenting and 91.5% after off-pump surgery (relative risk, 0.93; 95% CI, 0.86 to 1.02). Freedom from angina was 78.3% after stenting and 87.0% after off-pump surgery (P=0.06). Quality-adjusted lifetime was 0.82 year after stenting and 0.79 year after off-pump surgery (P=0.09). Hospital stay after the initial procedure was 1.43 and 5.77 days, respectively (P<0.01). Stenting reduced overall costs by 2933 dollars (26.2%) per patient (8276 dollars versus 11 209 dollars; P<0.01). Stenting was more cost-effective in 95% of the bootstrap estimates., Conclusions: At 1 year, stenting was more cost-effective than off-pump surgery while maintaining comparable cardiac outcome and quality of life. Stenting rather than off-pump surgery, therefore, can be recommended as a first-choice revascularization strategy in selected patients.
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- 2003
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18. Angiotensin-converting enzyme insertion/deletion polymorphism does not influence the restenosis rate after coronary stent implantation.
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Ferrari M, Mudra H, Grip L, Voudris V, Schächinger V, de Jaegere P, Rieber J, Hausmann D, Rothman M, Koschyk DH, and Figulla HR
- Subjects
- Aged, Coronary Angiography, Coronary Restenosis blood, Coronary Restenosis diagnostic imaging, Coronary Stenosis blood, Coronary Stenosis diagnostic imaging, Double-Blind Method, Female, Graft Occlusion, Vascular blood, Graft Occlusion, Vascular diagnostic imaging, Humans, Male, Middle Aged, Peptidyl-Dipeptidase A blood, Predictive Value of Tests, Blood Vessel Prosthesis Implantation, Coronary Restenosis genetics, Coronary Stenosis surgery, Gene Deletion, Graft Occlusion, Vascular genetics, Peptidyl-Dipeptidase A genetics, Polymorphism, Genetic genetics, Stents
- Abstract
Background: Experimental studies have shown an activation of the angiotensin-converting enzyme (ACE) system as a response to endothelial injury. Recent publications have elucidated the hypothesis that the ACE gene polymorphism may influence the level of late luminal loss after coronary stent implantation. It is still unclear whether the polymorphism of the angiotensin gene is a major predictor of the extent of neointimal hyperplasia. In this multicenter study, we therefore tested the relationship between the ACE gene polymorphism and the restenosis rate after coronary stent implantation., Methods: As a substudy of the optimization with intracoronary ultrasound (ICUS) to reduce stent restenosis (OPTICUS) study, we analyzed ACE serum levels and the ACE gene polymorphism in 154 patients at 9 different centers. All patients underwent elective coronary stent implantation in a stenosis of a major coronary vessel. Balloon inflations were repeated until a satisfactory result was achieved in on-line quantitative coronary angiography or ICUS fulfilling the OPTICUS study criteria. After follow-up of 6 months, all patients underwent reangiography under identical projections as the baseline procedure. A blinded quantitative analysis of the initial procedure as well as the follow-up examinations were performed by an independent core laboratory. ACE gene polymorphism and ACE serum activity were measured at the 6-month follow-up in a double-blinded setting., Results: With respect to the ACE gene polymorphism, there were three subgroups: DD genotype (48 patients), ID (83 patients) and II (23 patients). The subgroups did not differ in regard to age, gender, extent of coronary artery disease, stenosis length, initial degree of stenosis or degree of stenosis after stent implantation. In all, 39 patients (25.3%) had significant restenosis: 12 DD patients (25.0%), 18 ID patients (21.7%) and 9 II patients (39.1%) (odds ratio 2.164, 95% confidence interval 0.853-5.493). We obtained the following results for ACE serum levels: 0.53 micromol/l/s in the DD subgroup, 0.29 micromol/l/s in the ID subgroup and 0.09 micromol/l/s in the II subgroup (p < 0.001). Multivariate logistic regression analysis of the influence of ACE gene polymorphism on the restenosis rate after coronary stent implantation adjusted for lesion length (>12 mm), ACE inhibitor or hydroxymethylglutaryl coenzyme A reductase (CSE) inhibitor treatment, age, male gender, diabetes mellitus, hypertension, high cholesterol, family history, smoking and three-vessel disease did not uncover any statistic significance., Conclusions: In contrast to other study groups, we were unable to disclose that the DD polymorphism of the ACE gene was associated with a higher rate of restenosis after coronary stent implantation in this multicenter study. In addition, patients with higher ACE serum levels did not show a higher restenosis rate in this trial. We conclude that the pathogenesis of restenosis is a multifactorial process involving various genetic and nongenetic factors., (Copyright 2002 S. Karger AG, Basel)
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- 2002
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19. The Octopus Study: rationale and design of two randomized trials on medical effectiveness, safety, and cost-effectiveness of bypass surgery on the beating heart.
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van Dijk D, Nierich AP, Eefting FD, Buskens E, Nathoe HM, Jansen EW, Borst C, Knape JT, Bredée JJ, Robles de Medina EO, Grobbee DE, Diephuis JC, and de Jaegere PP
- Subjects
- Coronary Artery Bypass economics, Cost-Benefit Analysis, Humans, Multicenter Studies as Topic, Quality of Life, Research Design, Risk, Stroke, Angioplasty, Balloon, Coronary, Cardiopulmonary Bypass, Coronary Artery Bypass methods, Randomized Controlled Trials as Topic, Stents
- Abstract
The Octopus Study consists of two multicenter randomized clinical trials in which coronary artery bypass grafting on the beating heart (off-pump CABG) using the Utrecht Octopus Method is compared to intracoronary stent implantation and conventional CABG. The primary endpoint in the comparison of off-pump CABG versus stent implantation (OctoStent Trial) is medical effectiveness (i.e., absence of reintervention and major adverse cardiac and cerebrovascular events at 1 year after treatment). The primary endpoint in the comparison of off-pump CABG versus conventional CABG (OctoPump Trial) is cerebral safety (i.e., absence of cognitive deficits and cerebrovascular events at 3 months after treatment). Secondary endpoints in both trials include presence and severity of angina, quality of life, exercise capacity, and cost-effectiveness. A total of 560 patients will be enrolled. A random sample of 210 patients will undergo repeat angiography at 1 year to assess angiographic restenosis rate and graft patency. Including 1-year follow-up, the study will last for 3 years. Control Clin Trials 2000;21:595-609
- Published
- 2000
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20. Long term outcome after coronary stent implantation: a 10 year single centre experience of 1000 patients.
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van Domburg RT, Foley DP, de Jaegere PP, de Feyter P, van den Brand M, van der Giessen W, Hamburger J, and Serruys PW
- Subjects
- Adult, Aged, Aged, 80 and over, Anticoagulants therapeutic use, Coronary Disease drug therapy, Female, Follow-Up Studies, Graft Occlusion, Vascular surgery, Humans, Male, Middle Aged, Multivariate Analysis, Platelet Aggregation Inhibitors therapeutic use, Treatment Outcome, Coronary Disease surgery, Stents
- Abstract
Objective: To describe the long term clinical outcome (up to 11 years) after coronary stenting., Design: A single centre observational study encompassing 1000 consecutive patients with a first stent implantation (1560 stents) between 1986 and 1996, who were followed for at least one year with a median follow up of 29 months (range 12-132 months)., Results: Up to July 1997 the cumulative incidence of the major adverse cardiac events (MACE) of death, non-fatal acute myocardial infarction, coronary artery bypass grafting, and repeat percutaneous transluminal coronary angioplasty was 8.2%, 12.8%, 13.1%, and 22.4%, respectively. Survival at one, three, and five years was 95%, 91%, and 86%, respectively. Comparison of MACE incidence during the "anticoagulant era" and the "ticlopidine era" revealed significantly improved event free survival with ticlopidine (27% v 13%; p < 0.005). Multivariable analyses showed that ejection fraction < 50% (relative risk (RR) 4. 1), multivessel disease (RR 3.0), diabetes (RR 2.9), implantation in saphenous vein graft (RR 2.1), indication for unstable angina (RR 1. 9), and female sex (RR 1.7) were independent predictors of increased mortality after stenting. Independent predictors of any MACE were multivessel stenting (RR 2.0), implantation in saphenous bypass graft (RR 1.6), diabetes (RR 1.5), anticoagulant treatment (versus ticlopidine and aspirin) (RR 1.5), bailout stenting (RR 1.5), multivessel disease (RR 1.4), and multiple stent implantation (RR 1. 5)., Conclusions: Long term survival and infarct free survival was good, particularly in non-diabetic men with single vessel disease and good ventricular function, who had a single stent implanted in a native coronary artery. A dramatic improvement was observed in event free survival, both early and late, with the replacement of anticoagulation by ticlopidine. This, of course, cannot be separated from improved stent implantation techniques between 1986 and 1995. Ultimately, almost 40% of the patients experienced an adverse cardiac event (mainly repeat intervention) in the long term. New advances in restenosis treatments and in secondary prevention must be directed at this aspect of patient management after stenting.
- Published
- 1999
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21. Coronary-artery stenting compared with balloon angioplasty for restenosis after initial balloon angioplasty. Restenosis Stent Study Group.
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Erbel R, Haude M, Höpp HW, Franzen D, Rupprecht HJ, Heublein B, Fischer K, de Jaegere P, Serruys P, Rutsch W, and Probst P
- Subjects
- Aged, Coronary Angiography, Coronary Artery Bypass, Coronary Disease diagnostic imaging, Coronary Disease mortality, Coronary Vessels pathology, Disease-Free Survival, Female, Humans, Male, Middle Aged, Myocardial Infarction, Prospective Studies, Recurrence, Thrombosis etiology, Angioplasty, Balloon, Coronary, Coronary Disease therapy, Stents adverse effects
- Abstract
Background: Intracoronary stenting reduces the rate of restenosis after angioplasty in patients with new coronary lesions. We conducted a prospective, randomized, multicenter study to determine whether intracoronary stenting, as compared with standard balloon angioplasty, reduces the recurrence of luminal narrowing in restenotic lesions., Methods: A total of 383 patients who had undergone at least one balloon angioplasty and who had clinical and angiographic evidence of restenosis after the procedure were randomly assigned to undergo standard balloon angioplasty (192 patients) or intracoronary stenting with a Palmaz-Schatz stent (191 patients). The primary end point was angiographic evidence of restenosis (defined as stenosis of more than 50 percent of the luminal diameter) at six months. The secondary end points were death, Q-wave myocardial infarction, bypass surgery, and revascularization of the target vessel., Results: The rate of restenosis was significantly higher in the angioplasty group than in the stent group (32 percent as compared with 18 percent, P= 0.03). Revascularization of the target vessel at six months was required in 27 percent of the angioplasty group but in only 10 percent of the stent group (P=0.001). This difference resulted from a smaller mean (+/-SD) minimal luminal diameter in the angioplasty group (1.85+/-0.56 mm) than in the stent group (2.04+/-0.66 mm), with a mean difference of 0.19 mm (P=0.01) at follow-up. Subacute thrombosis occurred in 0.6 percent of the angioplasty group and in 3.9 percent of the stent group. The rate of event-free survival at 250 days was 72 percent in the angioplasty group and 84 percent in the stent group (P=0.04)., Conclusions: Elective coronary stenting was effective in the treatment of restenosis after balloon angioplasty. Stenting resulted in a lower rate of recurrent stenosis despite a higher incidence of subacute thrombosis.
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- 1998
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22. Intravascular ultrasound-guided optimized stent deployment. Immediate and 6 months clinical and angiographic results from the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study)
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de Jaegere P, Mudra H, Figulla H, Almagor Y, Doucet S, Penn I, Colombo A, Hamm C, Bartorelli A, Rothman M, Nobuyoshi M, Yamaguchi T, Voudris V, DiMario C, Makovski S, Hausmann D, Rowe S, Rabinovich S, Sunamura M, and van Es GA
- Subjects
- Aged, Angina Pectoris diagnostic imaging, Coronary Angiography, Feasibility Studies, Female, Humans, Male, Middle Aged, Prospective Studies, Recurrence, Angina Pectoris therapy, Stents, Ultrasonography, Interventional
- Abstract
Objectives: A study was set up to validate the safety and feasibility of intravascular ultrasound-guided stenting without subsequent anticoagulation, and its impact on the 6 months restenosis rate., Methods: The study was designed to be multicentred, prospective, and observational., Results: One hundred and sixty-one patients with stable angina and a de novo coronary artery lesion were enrolled. In four patients, the implantation of a Palmaz-Schatz (with spiral bridge) stent had failed. One of these four patients died 3 days following bypass surgery. In two other patients, intravascular ultrasound assessment was not performed. One hundred and twenty-five of the remaining 155 patients (81%) were treated with aspirin (100 mg x day(-1)), because all three criteria for optimized stent expansion were met. Twenty-two of the remaining 38 patients (25%), in whom at least one criterion was not met were treated with aspirin and acenocoumarol (3 months, INR 2.5-3.5), while 16 patients only received aspirin. Stent thrombosis was documented in two patients (1.3%) for which repeat angioplasty was performed. During the hospital stay, there were no deaths or Q-wave myocardial infarctions. Five patients (3.2%) sustained a non-Q-wave myocardial infarction. During the follow-up period (198+/-38 days, complete for all patients, except one), one patient (0.6%) sustained a Q-wave myocardial infarction, one (0.6%) underwent bypass surgery, and repeat angioplasty was performed in nine patients (5.7%). In two of the nine patients, repeat angioplasty involved another lesion. Therefore, the target lesion revascularization rate during follow-up was 4.5% (seven patients). At quantitative coronary angiography, the minimal lumen diameter (mean+/-SD) increased from 1.12+/-0.34 mm before to 2.89+/-0.35 mm after stenting. Repeat angiography at 6 months was performed in 144 patients (92%). The minimal lumen diameter at follow-up was 2.12+/-0.67 mm. Restenosis (diameter stenosis of 50% or more) was documented in 12 patients or 8.3%. When the two patients with documented stent thrombosis are included, the restenosis rate amounts to 97%., Conclusions: These data confirm that, in selected patients, stents can safely be implanted without the use of systemic anticoagulation, provided optimal stent expansion is achieved. The exact role of intravascular ultrasound in the achievement of these results needs to be established by appropriately designed studies. In the meantime, intravascular ultrasound coupled with the Palmaz-Schatz stent incorporating a spiral bridge, may have contributed considerably to the immediate angiographic outcome, which in turn may explain the favourable clinical and angiographic outcome at 6 months.
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- 1998
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23. Clinical and angiographic outcome of elective stent implantation in small coronary vessels: an analysis of the BENESTENT trial.
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Keane D, Azar AJ, de Jaegere P, Rutsch W, de Bruyne B, Legrand V, Kiemeneij F, de Feyter P, van de Heuvel P, Ozaki Y, Morel MA, and Serruys PW
- Subjects
- Angioplasty, Balloon, Coronary, Coronary Angiography, Coronary Disease etiology, Female, Follow-Up Studies, Humans, Male, Middle Aged, Recurrence, Treatment Outcome, Blood Vessel Prosthesis Implantation, Coronary Disease surgery, Coronary Vessels pathology, Stents
- Abstract
We examined the influence of vessel size using an intention-to-treat approach in 259 patients who underwent stent implantation and in 257 patients who underwent balloon angioplasty alone in the BENESTENT trial. In the stented population, smaller vessel size was associated with a higher stent:vessel ratio, a greater relative gain and a greater subsequent loss index, and a higher risk of adverse cardiac events. In the balloon angioplasty population small vessel size conveyed an increased requirement for revascularization but did not increase the risk of procedural failure or myocardial infarction during follow-up. Logistic regression indicated that decreasing vessel size (as a continous variable) was associated with an increasing risk of a cardiac event for both the stent and balloon angioplasty populations.
- Published
- 1996
24. Clinical trials on intracoronary stenting.
- Author
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de Jaegere PP, Eefting FD, Popma JJ, and Serruys PW
- Subjects
- Biocompatible Materials, Blood Vessel Prosthesis Implantation, Clinical Trials as Topic, Coronary Disease diagnostic imaging, Humans, Safety, Treatment Outcome, Ultrasonography, Interventional, Coronary Disease surgery, Stents
- Abstract
The stent is currently taking the lead in the treatment of obstructive coronary artery disease. The interest in this device is not only reflected by the relative number of patients referred for angioplasty and treated with a stent but also by the large number of clinical trials. These can be divided into trials assessing the safety and feasibility of the implantation of second generation or new stents, studies assessing novel treatment strategies and randomized clinical trials. With respect to the latter, they all compare stent implantation with balloon angioplasty. Of major importance will be the comparison of stent implantation with surgical revascularization of obstructive coronary artery disease. The increasing number of therapeutic options, however, confront the physician with the difficult choice and responsibility of selecting the most appropriate treatment. Therefore, systematic and objective evaluation of the available therapeutic approaches by means of appropriately designed trials is imperative. The purpose of this paper is to summarize and to put into perspective the various studies on intracoronary stenting. Distinction is made between observational studies testing a device or evaluating a new concept in intracoronary stenting and randomized clinical trials.
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- 1996
25. Cost effectiveness of stent implantation versus PTCA: the BENESTENT experience.
- Author
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Van Hout BA, van der Woude T, de Jaegere PP, van den Brand M, van Es GA, Serruys PW, and Morel MA
- Subjects
- Coronary Disease surgery, Cost-Benefit Analysis, Disease-Free Survival, Follow-Up Studies, Humans, Pilot Projects, Quality of Life, Angioplasty, Balloon, Coronary economics, Blood Vessel Prosthesis Implantation economics, Coronary Disease economics, Stents economics
- Abstract
The aim of this paper is to assess the costs and effects of stent implantation versus percutaneous transluminal coronary angioplasty (PTCA). Data have been taken from both the BENESTENT-I and BENESTENT-II pilot study. Effects are expressed in terms of event-free survival and costs include those of the initial hospitalization and those during follow-up. The costs per additional event-free survivor after 7 months are estimated at Dfl 88,315, Dfl 28,127 and Dfl 6747 using respectively the results from the BENSTENT-I study, the BENESTENT-II pilot study and phase IV of the BENESTENT-II pilot study. Significant decreases in complications and ischaemic events have made stent implantation not only the most favourable in terms of event-free survival but also in terms of cost effectiveness.
- Published
- 1996
26. Long-term clinical outcome after stent implantation in saphenous vein grafts.
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de Jaegere PP, van Domburg RT, Feyter PJ, Ruygrok PN, van der Giessen WJ, van den Brand MJ, and Serruys PW
- Subjects
- Aged, Angina Pectoris epidemiology, Angioplasty, Balloon, Coronary, Coronary Angiography, Coronary Artery Bypass, Disease-Free Survival, Female, Follow-Up Studies, Graft Occlusion, Vascular diagnostic imaging, Graft Occlusion, Vascular epidemiology, Humans, Male, Recurrence, Risk Factors, Time Factors, Treatment Outcome, Angina Pectoris therapy, Graft Occlusion, Vascular therapy, Saphenous Vein transplantation, Stents
- Abstract
Objectives: We sought to determine the role of stent implantation in vein grafts by evaluating the long-term clinical outcome and estimated event-free survival at 5 years in 62 patients and by comparing our data with those of other treatment modalities previously reported., Background: Patients with recurrent angina after coronary artery bypass graft surgery pose a problem. Stent implantation has been advocated in an effort to avoid repeat operation and to address the limitations of balloon angioplasty., Methods: Patients undergoing stenting of a vein graft were entered into a dedicated data base. They were screened for death, infarction, bypass surgery and repeat angioplasty. Procedure-related events were included in the follow-up analysis. Survival and event-free survival curves were constructed by the Kaplan Meier method., Results: A total of 93 stents (84 Wallstent and 9 Palmaz-Shatz) were implanted in 62 patients. During the in-hospital period seven patients (11%) sustained a major cardiac event: two deaths (3%), two myocardial infarctions (3%) and three urgent bypass surgeries (5%). The clinical success rate, therefore, was 89%. During the follow-up period (median 2.5 years, range 0 to 5.9), another five patients (8%) died, 14 (23%) sustained a myocardial infarction, 12 (20%) underwent bypass surgery, and 14 (23%) underwent angioplasty. The estimated 5-year survival and event-free survival rates (free from infarction, repeat surgery and repeat angioplasty) were (mean +/- SD) 83 +/- 5% (95% confidence interval [CI] 73% to 93%) and 30 +/- 7% (95% CI 16% to 44%), respectively., Conclusions: The in-hospital outcome of patients who underwent stent implantation in a vein graft is acceptable, but the long-term clinical outcome is poor. It is unlikely that mechanical intervention alone will provide a satisfactory or definite answer for the patient with graft sclerosis over the long term.
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- 1996
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27. Heparin-coated Palmaz-Schatz stents in human coronary arteries. Early outcome of the Benestent-II Pilot Study.
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Serruys PW, Emanuelsson H, van der Giessen W, Lunn AC, Kiemeney F, Macaya C, Rutsch W, Heyndrickx G, Suryapranata H, Legrand V, Goy JJ, Materne P, Bonnier H, Morice MC, Fajadet J, Belardi J, Colombo A, Garcia E, Ruygrok P, de Jaegere P, and Morel MA
- Subjects
- Aspirin administration & dosage, Coronary Angiography, Coronary Disease mortality, Disease-Free Survival, Equipment Design, Exercise Test, Female, Follow-Up Studies, Humans, Length of Stay, Male, Middle Aged, Pilot Projects, Safety, Ticlopidine administration & dosage, Treatment Outcome, Warfarin administration & dosage, Coronary Disease therapy, Coronary Vessels, Heparin administration & dosage, Stents adverse effects
- Abstract
Background: The purpose of the Benestent-II Pilot Study was to evaluate the safety of delaying and eliminating anticoagulant therapy in patients receiving a heparin-coated stent in conjunction with antiplatelet drugs., Methods and Results: The study consisted of three initial phases (I, II, III) during which resumption of heparin therapy after sheath removal was progressively deferred by 6, 12, and 36 hours. In phase IV, coumadin and heparin were replaced by 250 mg ticlopidine and 100 mg aspirin. Of the 207 patients with stable angina pectoris and a de novo lesion in whom heparin-coated stent implantation was attempted, implantation was successful in 202 patients (98%). Stent thrombosis did not occur during all four phases, and the overall clinical success rate at discharge was 99%. Bleeding complications requiring blood transfusion or surgery fell from 7.9% in phase I to 5.9%, 4%, and 0% in the three following phases. Hospital stay was 7.4, 6.1, 7.2, and 3.1 days for the consecutive phases. The restenosis rate for the combined four phases was 13% (15% in phase I, 20% in phase II, 11% in phase III, and 6% in phase IV). The overall rate of reintervention for the four phases was 8.9%. At 6 months, 84%, 75%, 94%, and 92% of the patients of phases I to IV, respectively, were event free. For the four phases, the event-free rate was 86%, which compares favorably with the rate observed in the Benestent-I study (80%; relative risk, 0.68 [0.45 to 1.04])., Conclusions: The implantation of stents coated with polyamine and end-point-attached heparin in stable patients with one significant de novo coronary lesion is well tolerated, is associated with no (sub)acute stent thrombosis, and results in a favorable event-free survival after 6 months.
- Published
- 1996
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28. Differences in restenosis propensity of devices for transluminal coronary intervention. A quantitative angiographic comparison of balloon angioplasty, directional atherectomy, stent implantation and excimer laser angioplasty. CARPORT, MERCATOR, MARCATOR, PARK, and BENESTENT Trial Groups.
- Author
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Foley DP, Melkert R, Umans VA, de Jaegere PP, Strikwerda S, de Feyter PJ, and Serruys PW
- Subjects
- Adult, Aged, Coronary Disease diagnostic imaging, Female, Follow-Up Studies, Humans, Male, Middle Aged, Multicenter Studies as Topic, Multivariate Analysis, Randomized Controlled Trials as Topic, Recurrence, Regression Analysis, Treatment Outcome, Angioplasty, Balloon, Coronary instrumentation, Angioplasty, Laser instrumentation, Atherectomy, Coronary instrumentation, Coronary Angiography, Coronary Disease therapy, Stents
- Abstract
With the increasing clinical application of new devices for percutaneous coronary revascularization, maximization of the acute angiographic result has become widely recognized as a key factor in maintained clinical and angiographic success. What is unclear, however, is whether the specific mode of action of different devices might exert an additional independent effect on late luminal renarrowing. The purpose of this study was to investigate such a difference in the degree of provocation of luminal renarrowing (or 'restenosis propensity') by different devices, among 3660 patients, who had 4342 lesions successfully treated by balloon angioplasty (n = 3797), directional coronary atherectomy (n = 200), Palmaz-Schatz stent implantation (n = 229) or excimer laser coronary angioplasty (n = 116) and who also underwent quantitative angiographic analysis pre- and post-intervention and at 6-month follow-up. To allow valid comparisons between the groups, because of significant differences in coronary vessel size (balloon angioplasty = 2.62 +/- 0.55 mm, directional coronary atherectomy = 3.28 +/- 0.62 mm, excimer laser coronary angioplasty = 2.51 +/- 0.47 mm, Palmaz-Schatz = 3.01 +/- 0.44 mm; P < 0.0001), the comparative measurements of interest selected were the 'relative loss' in luminal diameter (RLoss = loss/vessel size) to denote the restenosis process, and the 'relative lumen at follow-up' (RLfup = minimal luminal diameter at follow up/vessel size) to represent the angiographic outcome. For consistency, lesion severity pre-intervention was represented by the 'relative lumen pre' (RLpre = minimal luminal diameter pre/vessel size) and the luminal increase at intervention was measured as 'relative gain' (relative gain = gain/ vessel size). Differences in restenosis propensity between devices was evaluated by univariate and multivariate analysis. Multivariate models were constructed to determine relative loss and relative lumen at follow-up, taking account of relative lumen pre-intervention, lesion location, relative gain, vessel size and the device used. In addition, model-estimated relative loss and relative lumen at follow-up at given relative lumen pre-intervention relative gain and vessel size, were compared among the four groups. Significant differences were detected among the groups both with respect to these estimates, as well as in the degree of influence of progressively increasing relative gain, on the extent of renarrowing (relative loss) and angiographic outcome (relative lumen at follow-up), particularly at higher levels of luminal increase (relative gain). Specifically, lesions treated by balloon angioplasty or Palmaz-Schatz stent implantation (the predominantly 'dilating' interventions) were associated with more favourable angiographic profiles than directional atherectomy or excimer laser (the mainly 'debulking' interventions). Significant effects of lesion severity and location, as well as the well known influence of luminal increase on both luminal renarrowing and late angiographic outcome were also noted. These findings indicate that propensity to restenosis after apparently successful intervention is influenced not only by the degree of luminal enlargement achieved at intervention, but by the device used to achieve it. In view of the clinical implications of such findings, further evaluation in larger randomized patient populations is warranted.
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- 1995
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29. Designing of trials: power calculations based on matching as a surrogate for randomization.
- Author
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de Jaegere PP, Ruygrok PN, de Feyter PJ, and Serruys PW
- Subjects
- Case-Control Studies, Coronary Disease epidemiology, Data Interpretation, Statistical, Equipment Design, Humans, Random Allocation, Sample Size, Angioplasty, Balloon, Coronary, Coronary Disease therapy, Randomized Controlled Trials as Topic, Research Design, Stents
- Abstract
In the design of clinical trials we strive to extract the maximum amount of information from a minimum number of patients and yet retain statistical validity. Matching has become acknowledged as a useful and valid surrogate for the randomized trial. By using data from matched trials along with power calculations we can accurately predict the number of patients required to achieve statistical significance in a related randomized trial.
- Published
- 1994
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30. Clinical and angiographic outcome following implantation of the new Less Shortening Wallstent in aortocoronary vein grafts: introduction of a second generation stent in the clinical arena.
- Author
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Keane D, Buis B, Reifart N, Plokker TH, Ernst JM, Mast EG, Renkin J, Heyndrickx G, Morel M, and de Jaegere P
- Subjects
- Angioplasty, Balloon, Coronary, Anticoagulants therapeutic use, Combined Modality Therapy, Coronary Angiography, Equipment Design, Female, Graft Occlusion, Vascular diagnostic imaging, Humans, Male, Middle Aged, Recurrence, Stainless Steel, Treatment Outcome, Coronary Artery Bypass, Graft Occlusion, Vascular therapy, Saphenous Vein transplantation, Stents
- Abstract
One of the factors felt to have contributed to the high rate of stent occlusion in the European registry of the coronary Wallstent in the 1980s was the frequent deployment of more than one stent to cover the target lesion. This resulted from a high degree of shortening of the Wallstent upon expansion. To overcome this limitation the design of the Wallstent was modified to reduce the degree of shortening. We report the results of a study of the first patients to undergo implantation of the new Less Shortening Wallstent. Thirty-five Wallstents were electively deployed in aortocoronary vein grafts in 29 patients. Stent deployment was successful in 35 of 36 attempts in 30 lesions. In five of the 30 lesions, a second stent was required to cover the proximal portion of the lesion. Angiographic success (< 50% residual diameter stenosis as determined by off-line quantitative coronary angiography) was achieved in all 29 patients. During the in-hospital phase, no major adverse cardiac event occurred (reintervention, re-CABG, myocardial infarction, or death) and five patients had hemorrhagic complications. Following hospital discharge, one patient had a subacute stent occlusion associated with symptoms and elevated cardiac enzymes at 11 days, another patient had symptoms and elevated cardiac enzymes (CK 300 U/I) at 22 days with a patent stent, five patients required balloon angioplasty within the 6 month follow-up period (four for restenosis and one for stent occlusion), one patient underwent re-CABG for a native artery stenosis distal to the anastomosis of the patent stented vein graft.(ABSTRACT TRUNCATED AT 250 WORDS)
- Published
- 1994
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31. Structural design, clinical experience, and current indications of the coronary Wallstent.
- Author
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Keane D, de Jaegere P, and Serruys PW
- Subjects
- Clinical Trials as Topic, Coronary Artery Bypass, Coronary Vessels, Equipment Design, Graft Occlusion, Vascular therapy, Humans, Multicenter Studies as Topic, Polymers, Randomized Controlled Trials as Topic, Saphenous Vein transplantation, Stainless Steel, Coronary Disease therapy, Stents
- Abstract
Based on data described previously, the wallstent is a versatile stent that, by virtue of its longitudinal flexibility and low profile, can be deployed with a high degree of success in complex lesions of both native coronary arteries and bypass vein grafts. This article discusses its structural design, the experimental studies of thrombogenicity and polymeric coating, early and late clinical experience with the wallstent, clinical evaluation of the less shortening wallstent, and the current indications of the coronary wallstent
- Published
- 1994
32. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group.
- Author
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Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, and Materne P
- Subjects
- Angina Pectoris therapy, Confidence Intervals, Female, Follow-Up Studies, Humans, Male, Middle Aged, Reoperation, Risk, Thrombolytic Therapy, Treatment Outcome, Vascular Patency, Angioplasty, Balloon, Coronary, Coronary Disease surgery, Coronary Disease therapy, Stents
- Abstract
Background: Balloon-expandable coronary-artery stents were developed to prevent coronary restenosis after coronary angioplasty. These devices hold coronary vessels open at sites that have been dilated. However, it is unknown whether stenting improves long-term angiographic and clinical outcomes as compared with standard balloon angioplasty., Methods: A total of 520 patients with stable angina and a single coronary-artery lesion were randomly assigned to either stent implantation (262 patients) or standard balloon angioplasty (258 patients). The primary clinical end points were death, the occurrence of a cerebrovascular accident, myocardial infarction, the need for coronary-artery bypass surgery, or a second percutaneous intervention involving the previously treated lesion, either at the time of the initial procedure or during the subsequent seven months. The primary angiographic end point was the minimal luminal diameter at follow-up, as determined by quantitative coronary angiography., Results: After exclusions, 52 patients in the stent group (20 percent) and 76 patients in the angioplasty group (30 percent) reached a primary clinical end point (relative risk, 0.68; 95 percent confidence interval, 0.50 to 0.92; P = 0.02). The difference in clinical-event rates was explained mainly by a reduced need for a second coronary angioplasty in the stent group (relative risk, 0.58; 95 percent confidence interval, 0.40 to 0.85; P = 0.005). The mean (+/- SD) minimal luminal diameters immediately after the procedure were 2.48 +/- 0.39 mm in the stent group and 2.05 +/- 0.33 mm in the angioplasty group; at follow-up, the diameters were 1.82 +/- 0.64 mm in the stent group and 1.73 +/- 0.55 mm in the angioplasty group (P = 0.09), which correspond to rates of restenosis (diameter of stenosis, > or = 50 percent) of 22 and 32 percent, respectively (P = 0.02). Peripheral vascular complications necessitating surgery, blood transfusion, or both were more frequent after stenting than after balloon angioplasty (13.5 vs. 3.1 percent, P < 0.001). The mean hospital stay was significantly longer in the stent group than in the angioplasty group (8.5 vs. 3.1 days, P < 0.001)., Conclusions: Over seven months of follow-up, the clinical and angiographic outcomes were better in patients who received a stent than in those who received standard coronary angioplasty. However, this benefit was achieved at the cost of a significantly higher risk of vascular complications at the access site and a longer hospital stay.
- Published
- 1994
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33. Recoil following Wiktor stent implantation for restenotic lesions of coronary arteries.
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de Jaegere P, Serruys PW, van Es GA, Bertrand M, Wiegand V, Marquis JF, Vrolicx M, Piessens J, Valeix B, and Kober G
- Subjects
- Aged, Coronary Angiography, Coronary Disease pathology, Coronary Vessels pathology, Female, Follow-Up Studies, Humans, Male, Middle Aged, Coronary Disease therapy, Stents
- Abstract
The purpose of this study was to determine acute recoil of the vessel wall immediately after Wiktor stent implantation in native coronary arteries of 77 consecutive patients and to assess whether there was compression or "late recoil" of the stent itself at long-term follow-up. Furthermore, the relationship between recoil and a number of clinical, angiographic, and procedural variables was studied in addition to the relation between acute recoil renarrowing or restenosis was assessed. All angiograms were analyzed with the Cardiovascular Angiography Analysis System using automated edge detection. Acute recoil was defined by the difference between the mean diameter of the fully expanded balloon on which the stent was mounted and the mean diameter of the stented segment. Late recoil was calculated by comparing the mean diameter of the stent itself immediately after implantation and at follow-up without opacification of the vessel. Acute recoil amounted to 0.25 +/- 0.32 mm or 8.2%. Multivariate analysis identified sex (coefficient = -0.20, p = 0.04) and stent/artery ratio (coefficient = 0.99, p = 0.0001) as the only independent predictors of acute recoil. "Late recoil" of the stent itself was not observed. The overall difference between the mean diameter of the stent itself immediately after implantation and at follow-up was -0.15 +/- 0.33 mm, suggesting an overall increase in diameter of 5.0%. There was no relation between acute recoil and late restenosis. On the contrary, there was a trend towards a greater degree of recoil in patients without restenosis. Moreover, linear regression analysis disclosed a weak but negative correlation between acute recoil and a loss in minimal luminal diameter (coefficient: -0.55, p = 0.04). The Wiktor stent effectively scaffolds the instrumented vessel. Only a minimal amount of acute recoil was noted, which did not contribute to late luminal renarrowing or restenosis. In addition, no late compression of the stent itself was observed. These data suggest that tissue ingrowth into the lumen of the stented segment is the main cause of late luminal renarrowing after stent implantation.
- Published
- 1994
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34. Intracoronary stents: a review of the experience with five different devices in clinical use.
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De Jaegere PP, De Feyter PJ, Van der Giessen WJ, and Serruys PW
- Subjects
- Equipment Design, Forecasting, Humans, Recurrence, Treatment Outcome, Coronary Artery Disease therapy, Stents adverse effects, Stents trends
- Abstract
Atherosclerotic cardiovascular disease remains one of the most important causes of morbidity and mortality in the industrialized world. Treatment is basically aimed at palliation and consists of either pharmacological intervention or revascularization. The first significant advances in the latter were largely surgical. However, the pressing need for treatment with less invasive and potentially less expensive techniques, have stimulated the development of nonsurgical revascularization techniques. Percutaneous transluminal coronary balloon angioplasty, which was first performed by Andreas Gruentzig in 1977, is one of the most successful examples and provided the stimulus for a rapid technological growth of interventional cardiology. It is now widely accepted as a safe and effective treatment of obstructive coronary artery disease. However, the risk of abrupt vessel closure during or immediately after the intervention and the risk of late luminal renarrowing or restenosis continue to compromise its overall safety and efficacy. To improve the immediate and long-term results of balloon angioplasty, a number of new technologies such as intracoronary stenting, directional or rotational atherectomy, and laser therapy have been developed and represent the leading edge in the battle against atherosclerosis. The purpose of this paper is to review the experience and results of the various types of stents in clinical use.
- Published
- 1994
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35. Angiographic predictors of recurrence of restenosis after Wiktor stent implantation in native coronary arteries.
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de Jaegere P, Serruys PW, Bertrand M, Wiegand V, Marquis JF, Vrolicx M, Piessens J, Valeix B, Kober G, and Bonnier H
- Subjects
- Aged, Confidence Intervals, Coronary Disease epidemiology, Coronary Disease therapy, Female, Follow-Up Studies, Humans, Incidence, Male, Middle Aged, Prognosis, Recurrence, Regression Analysis, Risk, Angioplasty, Balloon, Coronary, Coronary Angiography, Coronary Disease diagnostic imaging, Stents
- Abstract
Intracoronary stenting has been proposed as an adjunct to balloon angioplasty to improve the immediate and long-term results. However, late luminal narrowing has been reported following the implantation of a variety of stents. One of the studies conducted with the Wiktor stent is a prospective registry designed to evaluate the feasibility, safety and efficacy of elective stent implantation in patients with documented restenosis of a native coronary artery. To identify angiographic variables predicting recurrence of restenosis, the angiograms of the first 91 patients with successful stent implantation and without clinical evidence of (sub)acute thrombotic stent occlusion were analyzed with the Computer Assisted Angiographic Analysis System using automated edge detection. The incidence of restenosis was 44% by patient and 45% by stent according to the 0.72 mm criterion, and 30% by patient and 29% by stent according to the 50% diameter stenosis criterion. The risk for restenosis for several angiographic variables was determined using an univariate analysis and is expressed as odds ratio with corresponding confidence interval. The only statistically significant predictor of restenosis was the relative gain when it exceeded 0.48 using the 0.72 mm criterion (odds ratio 2.7, 95% confidence interval 1.1-6.4). Furthermore, the relation between the relative gain (increase in minimal luminal diameter normalized to vessel size) as angiographic index of vessel wall injury and relative loss (decrease in minimal luminal diameter normalized to vessel size) as index of neointimal thickening was analyzed using a linear regression analysis. When using the categorical approach to address restenosis, there is an increased risk for recurrent restenosis when the relative gain exceeds 0.48. The continuous approach underscores this concept by indicating a weak but positive relation between the relative gain and relative loss.
- Published
- 1993
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36. Endovascular stents: preliminary clinical results and future developments.
- Author
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de Jaegere PP, de Feyter PJ, van der Giessen WJ, and Serruys PW
- Subjects
- Angioplasty, Balloon, Coronary, Forecasting, Humans, Vascular Patency, Coronary Disease therapy, Coronary Vessels, Stents adverse effects
- Abstract
At present, there is an exponential use of new interventional techniques whose proper role and value have not yet been defined. The intracoronary stent is just one example. There is no doubt that stents can be implanted with a high technical success rate associated with highly predictable immediate angiographic results and that they appear to be superior to all other interventional techniques. However, the intrinsic thrombogenicity of all devices currently available for clinical use warrants a vigorous anticoagulation, exposing the patient either to the risk of (sub)acute stent thrombosis or to the risk of hemorrhage and vascular complications. It remains to be determined whether stent implantation will reduce the incidence of restenosis and whether this results in an improved long-term event and symptom-free survival. Experimental studies indicate that the thrombogenic nature of stents may be controlled by coating the struts with endothelial cells or polymers. With respect to restenosis, it is evident that as long as mechanical injury is applied to the vessel wall, the vessel wall will respond with neointimal thickening. The intracoronary stent has the potential to control this tissue response by serving as a carrier for local antiproliferative drug delivery or eventually for genetic manipulation. The intensive research which is now going on in combination with experimental animal data, human postmortem pathologic observations, and angiographic studies is yielding clear insights and future directions to address these issues.
- Published
- 1993
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37. Matching based on quantitative coronary angiography as a surrogate for randomized studies: comparison between stent implantation and balloon angioplasty of native coronary artery lesions.
- Author
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de Jaegere PP, Hermans WR, Rensing BJ, Strauss BH, de Feyter PJ, and Serruys PW
- Subjects
- Cineangiography methods, Clinical Trials as Topic methods, Constriction, Pathologic therapy, Coronary Disease pathology, Coronary Vessels pathology, Humans, Radiographic Image Interpretation, Computer-Assisted, Randomized Controlled Trials as Topic, Recurrence, Treatment Outcome, Angioplasty, Balloon, Coronary, Coronary Angiography methods, Coronary Disease therapy, Research Design, Stents
- Abstract
Although intracoronary stenting has been advocated as an adjunct to balloon angioplasty to circumvent late restenosis, its effectiveness has not yet been verified. Therefore the aim of this study was to determine the differences in the immediate and long-term changes in stenosis geometry between Wallstent implantation and balloon angioplasty in native coronary artery lesions. To obtain two study populations with identical baseline stenosis characteristics, patients were matched for lesion site, vessel size, and minimal luminal diameter. Only patients undergoing elective and successful coronary intervention of a native coronary artery, in whom a control angiographic study had been performed, were included. A total of 186 patients (93 in each group) were selected. The coronary angiograms were analyzed with the computer-assisted cardiovascular angiographic analysis system. Matching was considered adequate, since there was an equal number of lesion sites in each study population and there were no differences in baseline reference diameter and minimal luminal diameter. Wallstent implantation resulted in a significantly greater increase in minimal luminal diameter (from 1.22 +/- 0.34 mm to 2.49 +/- 0.40 mm, p < 0.00001) compared with balloon angioplasty (from 1.21 +/- 0.29 mm to 1.92 +/- 0.35 mm, p < 0.00001). Despite a greater decrease in minimal luminal diameter after Wallstent implantation (0.48 +/- 0.74 mm) than after balloon angioplasty (0.20 +/- 0.46 mm), the minimal luminal diameter at follow-up was significantly greater after stent implantation (2.01 +/- 0.75 mm vs 1.72 +/- 0.54, p < 0.0001). It was concluded that Wallstent implantation results in a superior immediate and long-term increase in minimal luminal diameter compared with balloon angioplasty. The larger initial gain after stent implantation compensates for the late loss, and thus an improved initial result and not lessened neointimal hyperplasia is responsible for a reduced incidence of restenosis. Studies based on matching of angiographic variables are a surrogate for randomized studies, forecasting their results and offering insight into the effects of different interventional techniques. Moreover, these studies yield statistical information that may be helpful for the proper design of a randomized study (sample size, type II error).
- Published
- 1993
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38. Immediate changes in stenosis geometry following stent implantation: comparison between a self-expanding and a balloon-expandable stent.
- Author
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de Jaegere PP, Strauss BH, van der Giessen WJ, de Feyter PJ, and Serruys PW
- Subjects
- Angioplasty, Balloon, Coronary methods, Coronary Angiography methods, Equipment Design, Evaluation Studies as Topic, Humans, Recurrence, Coronary Artery Disease therapy, Stents
- Abstract
The immediate changes in stenosis geometry following Wallstent and Wiktor stent implantation in native coronary arteries were compared in 92 patients (46 in each group) using automated edge detection. Patients with comparable baseline stenosis characteristics were selected. Lesions were matched for lesion site, reference diameter, and minimal luminal diameter. In both groups, the stented coronary artery was the left anterior descending artery in 27 patients (59%), the left circumflex artery in four patients (9%), and the right coronary artery in 15 patients (33%). The baseline reference diameter was 2.86 +/- 0.39 mm and 2.87 +/- 0.42 mm in the Wallstent and Wiktor stent study group, respectively (NS). The baseline minimal luminal diameter was identical in both groups (1.13 +/- 0.24 mm). The nominal size (mean +/- SD) of the unconstrained Wallstent was 3.5 +/- 0.3 mm and 3.3 +/- 0.3 mm for the Wiktor stent (P less than 0.05). Both types of stents resulted in a similar increase in minimal luminal diameter immediately following implantation (Wallstent: 2.34 +/- 0.38 mm, Wiktor stent: 2.43 +/- 0.27 mm, NS). Furthermore, there was a similar decrease in diameter stenosis and increase in minimal luminal cross-section area following implantation of both stents. These morphological changes were associated with a normalization of the hemodynamic parameters in both groups. It is concluded that, although the Wallstent and Wiktor stent are different in design and mechanical characteristics, there is a similar immediate improvement in stenosis geometry following implantation of both devices.
- Published
- 1992
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39. Wiktor stent implantation in patients with restenosis following balloon angioplasty of a native coronary artery.
- Author
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de Jaegere PP, Serruys PW, Bertrand M, Wiegand V, Kober G, Marquis JF, Valeix B, Uebis R, and Piessens J
- Subjects
- Coronary Angiography, Coronary Disease diagnostic imaging, Female, Humans, Male, Middle Aged, Recurrence, Angioplasty, Balloon, Coronary, Coronary Disease therapy, Stents
- Abstract
Intracoronary stenting has been introduced as an adjunct to balloon angioplasty aimed at overcoming its limitations, namely acute vessel closure and late restenosis. This study reports the first experience with the Wiktor stent implanted in the first 50 consecutive patients. All patients had restenosis of a native coronary artery lesion after prior balloon angioplasty. The target coronary artery was the left anterior descending artery in 26 patients, the circumflex artery in 7 patients and the right coronary artery in 17 patients. The implantation success rate was 98% (49 of 50 patients). There were no procedural deaths. Acute or subacute thrombotic stent occlusion occurred in 5 patients (10%). All 5 patients sustained a nonfatal acute myocardial infarction. Four of these patients underwent recanalization by means of balloon angioplasty; the remaining patient was referred for bypass surgery. A major bleeding complication occurred in 11 patients (22%): groin bleeding necessitating blood transfusion in 6, gastrointestinal bleeding in 3 and hematuria in 2. Repeat angiography was performed at a mean of 5.6 +/- 1.1 months in all but 1 patient undergoing implantation. Restenosis, defined by a reduction of greater than or equal to 0.72 mm in the minimal luminal diameter or a change in diameter stenosis from less than to greater than or equal to 50%, occurred in 20 (45%) and 13 (29%) patients, respectively. In this first experience, the easiness and high technical success rate of Wiktor stent implantation are overshadowed by a high incidence of subacute stent occlusion and bleeding complications.(ABSTRACT TRUNCATED AT 250 WORDS)
- Published
- 1992
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40. Morphologic change in coronary artery stenosis with the Medtronic Wiktor stent: initial results from the core laboratory for quantitative angiography.
- Author
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Serruys P, De Jaegere P, Bertrand M, Kober G, Marquis JF, Piessens J, Uebis R, Valeix B, and Wiegand V
- Subjects
- Adult, Aged, Angioplasty, Balloon, Coronary, Blood Flow Velocity, Coronary Disease diagnostic imaging, Coronary Disease physiopathology, Female, Humans, Male, Middle Aged, Coronary Angiography, Coronary Disease therapy, Coronary Vessels physiopathology, Stents
- Abstract
The purpose of this study was to assess the early changes in stenosis geometry after implantation of the Medtronic Wiktor stent in human coronary arteries. Morphologic changes were evaluated by quantitative coronary angiography using automated edge detection. The hemodynamic significance of the morphologic changes were assessed by the calculation of the theoretical pressure drop across the dilated and stented stenosis derived from the Poiseuile and turbulent resistances assuming a coronary blood flow of either 0.5, 1, or 3 ml/sec. Fifty patients were studied before and immediately after stent implantation. The stented coronary artery was the left anterior descending artery in 26 patients, the circumflex artery in eight patients, and the right coronary artery in 16 patients. Stent implantation resulted in an additional increase in the minimal luminal cross-sectional area and minimal luminal diameter of the dilated vessel without changing the curvature of the stenosis. Furthermore, there was a significant reduction of the "plaque area." This was associated with a normalization of the calculated resistances to flow and pressure drop across the stenosis. To a minimal extent, recoil (0.1 +/- 0.36 mm) was observed after stent implantation.
- Published
- 1991
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41. Comparative angiographic quantitative analysis of the immediate efficacy of coronary atherectomy with balloon angioplasty, stenting, and rotational ablation.
- Author
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Umans VA, Strauss BH, Rensing BJ, de Jaegere P, de Feyter PJ, and Serruys PW
- Subjects
- Coronary Artery Disease diagnostic imaging, Female, Hemodynamics physiology, Humans, Male, Middle Aged, Angioplasty, Laser, Coronary Angiography, Coronary Artery Disease therapy, Endarterectomy, Stents
- Abstract
Interventional cardiology has branched in two directions: devices that primarily dilate coronary stenoses and those that debulk coronary tissue. Presently the optimum coronary intervention has not been found. While patients are awaiting randomized trials, a comparison based on matched quantitative coronary analysis may be useful to evaluate results of new interventional techniques. Therefore we compared 51 patients undergoing atherectomy with individually matched patients who were undergoing balloon angioplasty and stenting. The lesions were matched according to location of stenosis and reference diameter. Atherectomy and stenting resulted in larger gains in minimal luminal diameter compared with conventional balloon angioplasty. The minimal luminal diameter was increased from 1.2 +/- 0.4 mm to 2.6 +/- 0.4 mm in the atherectomy group and from 1.2 +/- 0.3 mm to 1.9 +/- 0.4 mm in the angioplasty group (p less than 0.00001). Atherectomy and stenting resulted in similar gains in minimum luminal diameter (1.4 mm vs 1.3 mm, p = NS). In addition, atherectomy and stenting appear to be more effective in resisting elastic recoil because of tissue removal and an intrinsic dilating effect, respectively. In matched populations directional atherectomy and stenting appear to be more effective intracoronary interventional devices than balloon angioplasty based on the immediate results. However, atherectomy is limited in smaller coronary vessels because of its larger size.
- Published
- 1991
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42. Management and outcome of patients with established coronary artery disease: the Euro Heart Survey on coronary revascularization
- Author
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Lenzen, M. J., Boersma, E., Bertrand, M. E., Maier, W., Moris, C., Piscione, F., Sechtem, U., Stahle, E., Widimsky, P., De Jaegere, P., Scholte Op Reimer, W. J. M., Mercado, N., Wijns, W., Meier, B., Sergeant, P., Vos, J., Unger, F., Manini, Malika, Bramley, Claire, Laforest, Valérie, Taylor, Charles, Del Gaiso, Susan, Huber, Kurt, De Backer, Guy, Sirakova, Vera, Cerbak, Roman, Thayssen, Per, Lehto, Seppo, Blanc, Jean-Jacques, Delahaye, François, Kobulia, Bondo, Zeymer, Uwe, Cokkinos, Dennis, Karlocai, Kristof, Graham, Ian, Shelley, Emer, Behar, Shlomo, Maggioni, Aldo, Grabauskiene, Virginija, Deckers, Jaap, Asmussen, Inger, Stepinska, Janina, Gonçalves, Lino, Mareev, Vyacheslav, Riecansky, Igor, Kenda, Miran F., Alonso, Angeles, Lopez-Sendon, José Luis, Rosengren, Annika, Buser, Peter, Okay, Tugrul, Sychov, Oleg, Fox, Kevin, Wood, David, Boersma, Eric, Crijns, Harry, Fox, Kim, McGregor, Keith, Mulder, Barbara, Priori, Sylvia, Rydén, Lars, Tavazzi, Luigi, Vahanian, Alec, Vardas, Panos, Wijns, William, Sarkisyan, Karine, Glogar, H. D., Derntl, Michael, Frick, Matthias, Pachinger, O., Zwick, Ralf, Vrints, Christiaan, Van Hertbruggen, Els, Vercammen, Marc, Sysmans, Tineke, Schroeder, E., Domange, Juliette, De Pril, Hilde, De Vriese, Johan, Van Hecke, Tonny, Legrand, V., Gillon, Marie-France, Richardy, Michel, Doneux, P., Petrov, Ivo, Jorgova, J., Starcevic, Boris, Eeckhout, Eric, Berger, Alexandre, Prudent, Veronique, Camenzind, E., Masson, Nicolas, Zambartas, Costas, Kleanthous, Helen, Widimsky, Petr, Stellova, Blanka, Aschermann, Michael, Simek, Stanislav, Kautzner, J., Karmazin, Vladimir, Svab, P., Indrak, Jan, Branny, M., Hladilova, Kveta, Kala, P., Thayssen, P., Cappelen, Helle, Jensen, Lisette Okkels, Gitt, A., Gehrke, Konstanze, Erbel, R., Gutersohn, Achim, Eggebrecht, Holger, Al Khani, Murad, Sechtem, Udo, Rosenberger, Antje, Vogelsberg, Holger, Klepzig, H., Schmidt, Arnold, Silber, Sigmund, Mau, Birgit, Leuner, Christian, Czyborra, Karen, Reuschling, Christina, Muno, Eva, Kleber, F., Rux, Sascha, Zeymer, U., Saad, Aly, Ibrahim, B. S. S., Elabady, Maged, Castro Beiras, A., Fernandez, Jorge Salgado, Navarro Del Arno, Felipe, Iniguez Romo, A., Cruz Fernandez, J. M., Mayoreal, Alejandro Recio, Rebanal, Franciso Javier Rivero, De La Borbolla, Mariano Garcia, Chaparro, Marinela, Brotons, C., Permanyer Miralda, C., Vilai Perez, Srta Irma, Moris, Cesar, Fernandez Aviles, F., De La Fuente Galan, Luis, Vinuela, Paula Tejedor, Malpartida De Torres, F., Mora, Javier, Rodriguez, Ignacio Santos, Bustamante, Itziar Piedra, Sanchez Fernandez, Pedro L., Diago Torrent, J. L., Diez Gil, Jose L., Perpinan, Javier, Palacios Motilla, V., Soledad Alcasena Juango, M., Berjon-Reyero, Jesus, Melgares Moreno, R., Guerrero, Juan Carlos Fernandez, Lehto, S., Savolainen, Kirsti, Nieminen, M. S., Syvanne, Mikko, Cohen-Solal, A., Oboa, Antoine-Sylvain, Bassand, J. P., Espinosa, Denis Pales, Jouet, Veronique, Montalescot, G., Gallois, Vanessa, Daubert, J. C., Clerc, Jean Michel, Machecourt, Jacques, Cottin, Y., Walker, D., Holland, Fhiona, Wood, D., Prosser, Jenni, Muir, Lis, Barber, Kate, Cleland, J. G. F., Cook, Jocelyn, Chapichadze, Zaza, Christos, Ioannis Skoularigisn Athanasiou, Tsiavou, Nastasia, Chrysohoou, Christina, Manginas, Athanassios, Terrovitis, John, Kanakakis, John, Vavuranakis, Manolis, Drakos, Stavros, Farmakis, Thomas, Samara, C., Papakosta, Christina, Bourantas, Christos, Michalis, L. K., Christos, Mpourantas, Foussas, Stefanos, Adamopoulou, Evdokia, Vardas, P. E., Marketou, Mary, Alotti, N., Basa, Anna Maria, Vigh, Andras, Preda, Istvan, Csoti, Eva, Keltai, M., Kerkovits, G., Hendler, Alberto, Blatt, Alex, Beyar, R., Shefer, Arie, Halon, David, Bentzvi, Margalait, Avramovitch, Naomi, Bakst, Avinoam, Cafri, Carlos, Grosbard, Aviva, Margolis, Bella, Suleiman, Khalid, Banai, Shmuel, Meerkin, David, Mosseri, Morris, Guita, Pnina, Jabara, Rifat, Jafari, Jamal, Ben Shitrit, Debi, Ghasan, null, Salameh, null, Brezins, Marc, Van Den Akker-Berman, Lily, Guetta, Victor, Rozenman, Yoseph, Biagini, A., Berti, Sergio, Ferrero, Massimo, Colombo, A., Roccaforte, R., Milici, Caterina, Scarpino, L., Salvi, A., Desideri, Alessandro, Sabbadin, Daniela, Galassi, Alfredo, Giuffrida, Giuseppe, Rognoni, Andrea, Vassanelli, Corrado, Paffoni, Paola, Cioppa, Angelo, Rubino, Paolo, De Carlo, Marco, Petronio, Anna Sonia, Naccarella, F., Saia, Francesco, Marzocchi, Antonio, Maranga, Stefano Sdringola, Presbitero, P., Valsecchi, Fazya, Piscione, Federico, Esposito, Giovanni, Santini, Napoli M., Tubaro, Marco, Erglis, A., Narbute, Inga, Kavoliuniene, Ausra, Zaliunas, R., Navickas, Ramunas, Grabauskiene, V., Luckute, Davia, Subkovas, Eduardas, Wagner, Daniel, Vermeer, F., Lousberg, Aimee, Fransen, Heidi, Breeman, Arno, Tebbe, Henriette, De Boer, M. J., Van Der Wal, Metske, Deckers, J., Vos, Jeroen, Leenders, C. M., Veerhoek, M. J., Jansen, Chris, Bijl, M., Koppelaar, Colinda, Van Den Linden, null, Brons, R., Widdershofen, J. W. M. G., Broers, Herman, Kontny, F., Jonzon, Marianne, Wodniecki, Jan, Tomasik, Andrzej, Trusz-Gluza, M., Nowak, Seweryn, Ruzyllo, Witold, Deptuch, Tomasz, Marques, Jorge, Matias, F., Madeira, H., Oliveira, Joaquim, Sargento, Luis, Ionac, Adina, Dragulescu, Iosif Stefan, Mut-Vitcu, Bogdan, Maximov, Daniela, Dorobantu, M., Apetrei, E., Niculescu, Rodica, Petrescu, Virgil, Bucsa, Adrian, Deleanu, Dan, Benedek, I. S., Hintea, Theodora, Aronov, D., Tikhomirova, Elena, Kranjec, I., Prokselj, Katja, Kanic, Vojko, Sepetoglu, Ahmet, Aytekin, S., Aytekin, V., Catakoglu, Alp Burak, Parlar, Hayri, Tufekcioglu, Suavi, Ozyedek, Zeki, Baltali, Mehmet, Kiziltan, null, Vukovic, Milan, Neskovic, A. N., Lenzen, M. J, Boersma, E, Bertrand, Me, Maier, W, Moris, C, Esposito, Giovanni, Piscione, Federico, Sechtem, U, Stahle, E, Widimsky, P, de Jaegere, P, Scholte op Reimer, W. J. M, Mercado, N, Wijns, W., University of Zurich, Wijns, W, Lenzen, M. J., Boersma, E., Bertrand, M. E., Maier, W., Moris, C., Piscione, F., Sechtem, U., Stahle, E., Widimsky, P., De Jaegere, P., Scholte Op Reimer, W. J. M., Mercado, N., Meier, B., Sergeant, P., Vos, J., Unger, F., Manini, Malika, Bramley, Claire, Laforest, Valérie, Taylor, Charle, Del Gaiso, Susan, Huber, Kurt, De Backer, Guy, Sirakova, Vera, Cerbak, Roman, Thayssen, Per, Lehto, Seppo, Blanc, Jean-Jacque, Delahaye, Françoi, Kobulia, Bondo, Zeymer, Uwe, Cokkinos, Denni, Karlocai, Kristof, Graham, Ian, Shelley, Emer, Behar, Shlomo, Maggioni, Aldo, Grabauskiene, Virginija, Deckers, Jaap, Asmussen, Inger, Stepinska, Janina, Gonçalves, Lino, Mareev, Vyacheslav, Riecansky, Igor, Kenda, Miran F., Alonso, Angele, Lopez-Sendon, José Lui, Rosengren, Annika, Buser, Peter, Okay, Tugrul, Sychov, Oleg, Fox, Kevin, Wood, David, Boersma, Eric, Crijns, Harry, Fox, Kim, Mcgregor, Keith, Mulder, Barbara, Priori, Sylvia, Rydén, Lar, Tavazzi, Luigi, Vahanian, Alec, Vardas, Pano, Wijns, William, Sarkisyan, Karine, Glogar, H. D., Derntl, Michael, Frick, Matthia, Pachinger, O., Zwick, Ralf, Vrints, Christiaan, Van Hertbruggen, El, Vercammen, Marc, Sysmans, Tineke, Schroeder, E., Domange, Juliette, De Pril, Hilde, De Vriese, Johan, Van Hecke, Tonny, Legrand, V., Gillon, Marie-France, Richardy, Michel, Doneux, P., Petrov, Ivo, Jorgova, J., Starcevic, Bori, Eeckhout, Eric, Berger, Alexandre, Prudent, Veronique, Camenzind, E., Masson, Nicola, Zambartas, Costa, Kleanthous, Helen, Widimsky, Petr, Stellova, Blanka, Aschermann, Michael, Simek, Stanislav, Kautzner, J., Karmazin, Vladimir, Svab, P., Indrak, Jan, Branny, M., Hladilova, Kveta, Kala, P., Thayssen, P., Cappelen, Helle, Jensen, Lisette Okkel, Gitt, A., Gehrke, Konstanze, Erbel, R., Gutersohn, Achim, Eggebrecht, Holger, Al Khani, Murad, Sechtem, Udo, Rosenberger, Antje, Vogelsberg, Holger, Klepzig, H., Schmidt, Arnold, Silber, Sigmund, Mau, Birgit, Leuner, Christian, Czyborra, Karen, Reuschling, Christina, Muno, Eva, Kleber, F., Rux, Sascha, Zeymer, U., Saad, Aly, Ibrahim, B. S. S., Elabady, Maged, Castro Beiras, A., Fernandez, Jorge Salgado, Navarro Del Arno, Felipe, Iniguez Romo, A., Cruz Fernandez, J. M., Mayoreal, Alejandro Recio, Rebanal, Franciso Javier Rivero, De La Borbolla, Mariano Garcia, Chaparro, Marinela, Brotons, C., Permanyer Miralda, C., Vilai Perez, Srta Irma, Moris, Cesar, Fernandez Aviles, F., De La Fuente Galan, Lui, Vinuela, Paula Tejedor, Malpartida De Torres, F., Mora, Javier, Rodriguez, Ignacio Santo, Bustamante, Itziar Piedra, Sanchez Fernandez, Pedro L., Diago Torrent, J. L., Diez Gil, Jose L., Perpinan, Javier, Palacios Motilla, V., Soledad Alcasena Juango, M., Berjon-Reyero, Jesu, Melgares Moreno, R., Guerrero, Juan Carlos Fernandez, Lehto, S., Savolainen, Kirsti, Nieminen, M. S., Syvanne, Mikko, Cohen-Solal, A., Oboa, Antoine-Sylvain, Bassand, J. P., Espinosa, Denis Pale, Jouet, Veronique, Montalescot, G., Gallois, Vanessa, Daubert, J. C., Clerc, Jean Michel, Machecourt, Jacque, Cottin, Y., Walker, D., Holland, Fhiona, Wood, D., Prosser, Jenni, Muir, Li, Barber, Kate, Cleland, J. G. F., Cook, Jocelyn, Chapichadze, Zaza, Christos, Ioannis Skoularigisn Athanasiou, Tsiavou, Nastasia, Chrysohoou, Christina, Manginas, Athanassio, Terrovitis, John, Kanakakis, John, Vavuranakis, Manoli, Drakos, Stavro, Farmakis, Thoma, Samara, C., Papakosta, Christina, Bourantas, Christo, Michalis, L. K., Christos, Mpouranta, Foussas, Stefano, Adamopoulou, Evdokia, Vardas, P. E., Marketou, Mary, Alotti, N., Basa, Anna Maria, Vigh, Andra, Preda, Istvan, Csoti, Eva, Keltai, M., Kerkovits, G., Hendler, Alberto, Blatt, Alex, Beyar, R., Shefer, Arie, Halon, David, Bentzvi, Margalait, Avramovitch, Naomi, Bakst, Avinoam, Cafri, Carlo, Grosbard, Aviva, Margolis, Bella, Suleiman, Khalid, Banai, Shmuel, Meerkin, David, Mosseri, Morri, Guita, Pnina, Jabara, Rifat, Jafari, Jamal, Ben Shitrit, Debi, Ghasan, Null, Salameh, Null, Brezins, Marc, Van Den Akker-Berman, Lily, Guetta, Victor, Rozenman, Yoseph, Biagini, A., Berti, Sergio, Ferrero, Massimo, Colombo, A., Roccaforte, R., Milici, Caterina, Scarpino, L., Salvi, A., Desideri, Alessandro, Sabbadin, Daniela, Galassi, Alfredo, Giuffrida, Giuseppe, Rognoni, Andrea, Vassanelli, Corrado, Paffoni, Paola, Cioppa, Angelo, Rubino, Paolo, De Carlo, Marco, Petronio, Anna Sonia, Naccarella, F., Saia, Francesco, Marzocchi, Antonio, Maranga, Stefano Sdringola, Presbitero, P., Valsecchi, Fazya, Santini, Napoli M., Tubaro, Marco, Erglis, A., Narbute, Inga, Kavoliuniene, Ausra, Zaliunas, R., Navickas, Ramuna, Grabauskiene, V., Luckute, Davia, Subkovas, Eduarda, Wagner, Daniel, Vermeer, F., Lousberg, Aimee, Fransen, Heidi, Breeman, Arno, Tebbe, Henriette, De Boer, M. J., Van Der Wal, Metske, Deckers, J., Vos, Jeroen, Leenders, C. M., Veerhoek, M. J., Jansen, Chri, Bijl, M., Koppelaar, Colinda, Van Den Linden, Null, Brons, R., Widdershofen, J. W. M. G., Broers, Herman, Kontny, F., Jonzon, Marianne, Wodniecki, Jan, Tomasik, Andrzej, Trusz-Gluza, M., Nowak, Seweryn, Ruzyllo, Witold, Deptuch, Tomasz, Marques, Jorge, Matias, F., Madeira, H., Oliveira, Joaquim, Sargento, Lui, Ionac, Adina, Dragulescu, Iosif Stefan, Mut-Vitcu, Bogdan, Maximov, Daniela, Dorobantu, M., Apetrei, E., Niculescu, Rodica, Petrescu, Virgil, Bucsa, Adrian, Deleanu, Dan, Benedek, I. S., Hintea, Theodora, Aronov, D., Tikhomirova, Elena, Kranjec, I., Prokselj, Katja, Kanic, Vojko, Sepetoglu, Ahmet, Aytekin, S., Aytekin, V., Catakoglu, Alp Burak, Parlar, Hayri, Tufekcioglu, Suavi, Ozyedek, Zeki, Baltali, Mehmet, Kiziltan, Null, Vukovic, Milan, Neskovic, A. N., Cardiology, Lenzen, Mj, and Scholte op Reimer, Wj
- Subjects
Practice survey ,Male ,Coronary Stenosi ,Coronary angiography ,medicine.medical_treatment ,Myocardial Infarction ,Coronary Artery Disease ,Angina ,Coronary artery disease ,Myocardial Revascularization ,Stent ,Myocardial infarction ,Coronary Artery Bypass ,Angioplasty, Balloon, Coronary ,CABG ,PCI ,Professional Practice ,Health Survey ,Middle Aged ,Europe ,Treatment Outcome ,Epidemiologic Method ,Practice Guidelines as Topic ,Cardiology ,Stents ,Female ,Guideline Adherence ,Cardiology and Cardiovascular Medicine ,Human ,medicine.medical_specialty ,outcome ,Euro Heart Survey ,610 Medicine & health ,Platelet Glycoprotein GPIIb-IIIa Complex ,142-005 142-005 ,2705 Cardiology and Cardiovascular Medicine ,Angioplasty ,Internal medicine ,medicine ,Humans ,Angina, Unstable ,cardiovascular diseases ,Interventional cardiology ,Unstable angina ,business.industry ,Coronary Artery Bypa ,Coronary Stenosis ,Percutaneous coronary intervention ,Length of Stay ,medicine.disease ,Health Surveys ,Conventional PCI ,570 Life sciences ,biology ,Epidemiologic Methods ,business - Abstract
AIMS: The purpose of the Euro Heart Survey Programme of the European Society of Cardiology is to evaluate to which extent clinical practice endorses existing guidelines as well as to identify differences in population profiles, patient management, and outcome across Europe. The current survey focuses on the invasive diagnosis and treatment of patients with established coronary artery disease (CAD). METHODS AND RESULTS: Between November 2001 and March 2002, 7769 consecutive patients undergoing invasive evaluation at 130 hospitals (31 countries) were screened for the presence of one or more coronary stenosis >50% in diameter. Patient demographics and comorbidity, clinical presentation, invasive parameters, treatment options, and procedural techniques were prospectively entered in an electronic database (550 variables+29 per diseased coronary segment). Major adverse cardiac events (MACE) were evaluated at 30 days and 1 year. Out of 5619 patients with angiographically proven coronary stenosis (72% of screened population), 53% presented with stable angina while ST elevation myocardial infarction (STEMI) was the indication for coronary angiography in 16% and non-ST segment elevation myocardial infarction or unstable angina in 30%. Only medical therapy was continued in 21%, whereas mechanical revascularization was performed in the remainder [percutaneous coronary intervention (PCI) in 58% and coronary artery bypass grafting (CABG) in 21%]. Patients referred for PCI were younger, were more active, had a lower risk profile, and had less comorbid conditions. CABG was performed mostly in patients with left main lesions (21%), two- (25%), or three-vessel disease (67%) with 4.1 diseased segments, on average. Single-vessel PCI was performed in 82% of patients with either single- (45%), two- (33%), or three-vessel disease (21%). Stents were used in 75% of attempted lesions, with a large variation between sites. Direct PCI for STEMI was performed in 410 cases, representing 7% of the entire workload in the participating catheterization laboratories. Time delay was within 90 min in 76% of direct PCI cases. In keeping with the recommendations of practice guidelines, the survey identified under-use of adjunctive medication (GP IIb/IIIa receptor blockers, statins, and angiotensin-converting enzyme-inhibitors). Mortality rates at 30 days and 1 year were low in all subgroups. MACE primarily consisted of repeat PCI (12%). CONCLUSION: The current Euro Heart Survey on coronary revascularization was performed in the era of bare metal stenting and provides a global European picture of the invasive approach to patients with CAD. These data will serve as a benchmark for the future evaluation of the impact of drug-eluting stents on the practice of interventional cardiology and bypass surgery.
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- 2005
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43. Routine Fractional Flow Reserve Measurement After Percutaneous Coronary Intervention: The FFR-SEARCH Study.
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van Bommel, Rutger J., Masdjedi, Kaneshka, Diletti, Roberto, Lemmert, Miguel E., van Zandvoort, Laurens, Wilschut, Jeroen, Zijlstra, Felix, de Jaegere, Peter, Daemen, Joost, and van Mieghem, Nicolas M.
- Abstract
Background: Fractional flow reserve (FFR) is the current gold standard to determine hemodynamic severity of angiographically intermediate coronary lesions. Much less is known about the prognostic effects of FFR measured directly after percutaneous coronary intervention (PCI). The aims of this study were to evaluate post-PCI FFR values, identify predictors for a low post-PCI FFR, and to investigate whether a relationship between postprocedural FFR and outcome during 30-day follow-up exists. Methods and Results: The FFR-SEARCH (Fractional Flow Reserve—Stent Evaluated at Rotterdam Cardiology Hospital) is a prospective registry in which FFR measurements were performed after PCI in 1000 consecutive patients. All FFR measurements were performed under maximum hyperemia with intravenous adenosine with the Navvus RXi system (ACIST Medical Systems, Eden Prairie, MN). The clinical end point was defined as a composite of death, target vessel revascularization, or nonfatal myocardial infarction at 30-day follow-up. Measurement of post-PCI FFR was successful in 959 patients (96%), and a total of 1165 lesions were assessed. There were no complications related to the microcatheter. A total of 322 ST-segment–elevation myocardial infarction patients with 371 measured lesions were excluded leaving 637 patients with 794 measured lesions for the final analysis. Overall post-PCI FFR was 0.90±0.07. In 396 lesions (50%), post-PCI FFR was >0.90. A total of 357 patients (56%) had ≥1 lesion(s) with a post-PCI FFR ≤0.90, and 73 patients (11%) had ≥1 lesion(s) with a post-PCI FFR ≤0.80 with post-PCI FFR ≤0.80 in 78 lesions (9.8%). Complex lesion characteristics, use of multiple stents and smaller reference vessel diameter was associated with post-PCI FFR ≤0.90. During follow-up, 11 patients (1.8%) reached the clinical end point. There was no significant relationship between post-PCI FFR and the clinical end point at 30-day follow-up (P =0.636). Conclusions: Routine measurement of post-PCI FFR using a monorail microcatheter is safe and feasible. Several lesion and patient characteristics were associated with a low post-PCI FFR. Post-PCI FFR did not correlate with clinical events at 30 days. [ABSTRACT FROM AUTHOR]
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- 2019
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44. Explanation of Postprocedural Fractional Flow Reserve Below 0.85: A Comprehensive Ultrasound Analysis of the FFR SEARCH Registry.
- Author
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van Zandvoort, Laurens J.C., Masdjedi, Kaneshka, Witberg, Karen, Ligthart, Jurgen, Tovar Forero, Maria Natalia, Diletti, Roberto, Lemmert, Miguel E., Wilschut, Jeroen, de Jaegere, Peter P.T., Boersma, Eric, Zijlstra, Felix, Van Mieghem, Nicolas M., and Daemen, Joost
- Abstract
Supplemental Digital Content is available in the text. Background: Fractional flow reserve (FFR) after percutaneous coronary intervention is a predictor of adverse cardiovascular events during follow-up. However, the rationale for low post procedural FFR values remains often elusive based on angiographic findings alone. Methods and Results: FFR SEARCH (Stent Evaluated at Rotterdam Cardiology Hospital) is a prospective single-center registry in which post-percutaneous coronary intervention FFR was assessed in 1000 consecutive all-comer patients. FFR measurements were performed with a microcatheter ±20 mm distal to the most distal stent edge. In 100 vessels with a post procedural FFR ≤0.85, and 20 vessels >0.85 high definition intravascular ultrasound analysis was performed. In 100 vessels with a post-percutaneous coronary intervention FFR ≤0.85, mean post procedural FFR was 0.79±0.05. Minimal lumen area was 2.19 (1.81–3.19) mm
2 , mean lumen area was 5.95 (5.01–7.03) mm2 , and minimal stent area was 4.01 (3.09–5.21) mm2 . Significant residual focal proximal lesions were found in 29% of the assessed vessels whereas, focal distal lesions were found in 30% of the vessels. Stent underexpansion and malapposition were found in 74% and 22% of vessels, respectively. Clear focal signs of luminal narrowing were found in 54% of the vessels analyzed. Although incidences of focal lesions, underexpansion, and malapposition were similar between both cohorts, minimal stent area was significantly smaller in vessels with a post-percutaneous coronary intervention FFR ≤0.85 as compared with those with an FFR >0.85. Conclusions: In patients with a post procedural FFR ≤0.85, intravascular ultrasound revealed focal signs of luminal narrowing in a significant number of cases. [ABSTRACT FROM AUTHOR]- Published
- 2019
- Full Text
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