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Objectives: This study assessed the ability of the dual-antiplatelet therapy (DAPT) score in stratifying ischemic and bleeding risk in a contemporary percutaneous coronary intervention (PCI) population., Background: The DAPT score is recommended by guidelines as a tool to stratify ischemic and bleeding risk. Its utility in contemporary PCI is unknown., Methods: The study studied patients in GLOBAL LEADERS (A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) who were free of major ischemic and bleeding events and adhered to antiplatelet strategy during the first year after PCI. The primary ischemic endpoint was the composite of myocardial infarction or stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium type 3 or 5. Outcomes from 12 to 24 months after PCI were compared according to the DAPT score., Results: Of 11,289 patients that were event-free after the first year, 6,882 and 4,407 patients had low (<2) and high (≥2) DAPT scores, respectively. Compared with a low DAPT score, patients with a high DAPT score had a higher rate of the composites of myocardial infarction or stent thrombosis (0.70% vs. 1.55%; p < 0.0001). The rate of Bleeding Academic Research Consortium type 3 or 5 bleeding was 0.54% and 0.30% in the low and high DAPT score groups, respectively (p = 0.058). The effect of ticagrelor versus aspirin monotherapy on primary ischemic and bleeding endpoints during the second year were no different among the 2 groups., Conclusions: The DAPT score can stratify ischemic but not bleeding risk in a contemporary PCI population during the second year. The score did not provide additional value for selection of antiplatelet strategy beyond the first year., (Copyright © 2020 American College of Cardiology Foundation. All rights reserved.)

Introduction and Objectives: Stenting of coronary bifurcation lesions carries an increased risk of stent deformation and malapposition. Anatomical and pathological observations indicate that the high stent thrombosis rate in bifurcations is due to malapposition of stent struts., Methods: Strut apposition was assessed with optical coherence tomography (OCT) in bifurcation lesions treated either using the simple technique of stent implantation in the main vessel only or a complex technique (i.e. Culotte's). A strut was regarded as malapposed if the gap between its endoluminal surface and the vessel wall was greater than its thickness plus an OCT resolution error margin of 15 microm., Results: Simple and complex (i.e. Culotte's) approaches were used in 17 and 14 patients, respectively. Strut malapposition was significantly more frequent for the half of the bifurcation on same side as the vessel side branch (median, 46.1%; interquartile range [IQR], 35.3-62.5%) than for the half opposite the side branch (9.1%; IQR, 2.2-21.6%), the distal segment (7.5%; IQR, 2.3-20.2%) or the proximal segment (12.6%; IQR, 7.8-23.1%; P< .0001); the gap between strut and vessel wall in malapposed struts was significantly greater in the first segment than the others: 98 microm (IQR, 37-297 microm) vs. 31 microm (IQR, 13-74 microm), 49 microm (IQR, 20-100 microm) and 38 microm (IQR, 17-90 microm), respectively (P< .0001). Using the complex technique had no effect on the prevalence of strut malapposition in the four segments relative to the simple technique (P=.31) but was associated with a smaller gap in the proximal segment (47 microm vs. 60 microm; P=.0008)., Conclusions: In coronary bifurcation lesions, strut malapposition occurred most frequently and was most significant close to the side branch ostium. The use of Culotte's technique did not significantly increase the prevalence of strut malapposition compared with a simple technique.

Objectives: We investigated the long-term clinical outcomes and independent predictors of major cardiac events in unprotected left main coronary artery disease (ULMCA) patients treated by percutaneous coronary intervention with drug-eluting stent (DES)., Background: There is limited information on long-term (>3 years) outcomes after DES implantation for ULMCA. Furthermore, bifurcation angle and SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) score are emerging as parameters for patient risk stratification, and their prognostic implications have still to be elucidated., Methods: One hundred forty-eight patients with ULMCA treated with DES were analyzed and compared with a historical cohort of 79 patients who received bare-metal stents for the treatment of ULMCA. Patient-oriented composite end point was defined as the occurrence of all-cause death, any myocardial infarction, or any revascularization., Results: The 4-year cumulative incidence of all-cause death, any myocardial infarction, any revascularization, and patient-oriented composite were 35.6%, 3.8%, 25.2%, and 54.4%, respectively. These end points had relatively increased from 1 year to 4 years by Delta70%, Delta5%, Delta50%, and Delta68%, respectively. When compared with a historical cohort who received bare-metal stents for ULMCA treatment, landmark analysis performed after the first 2 years of follow-up demonstrated that the DES cohort had significantly higher patient-oriented composite end point over the last 2 years of follow-up (26% vs. 8%, p = 0.02). EuroSCORE (European System for Cardiac Operative Risk Evaluation), cardiogenic shock, and SYNTAX score were identified as independent predictors for the 4-year patient-oriented composite, whereas bifurcation angle was not., Conclusions: Late increase in patient-oriented composite end points after DES implantation for ULMCA warrants careful and long-term follow-up. SYNTAX score and EuroSCORE appear to have a significant prognostic value in long-term patient risk., (Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Pre- and post-interventional optical coherence tomography (OCT) assessment of degenerated saphenous vein grafts (SVG) treated with implantation of pericardium covered stents. Percutaneous treatment of SVG represents one of the major challenges of current percutaneous coronary interventions (PCI). Artificial membrane-covered stents have failed to show additional benefit over conventional stents., Methods and Results: Six cases of PCI of de novo lesions in degenerated SVGs were successfully treated with a novel pericardium covered stent (PCS). Successful deployment was achieved in all cases. Large emboli were retrieved in a distal filter in one case with a long degenerated lesion. Pre- and postinterventional OCT was performed to assess the lesion characteristics and vessel diameter before stenting and the pericardium layer integrity, strut apposition and presence of plaque prolapse after stenting. In order to better understand the OCT images, three PCS of different diameters were deployed in silicone tubes of 700 microm thickness wall with inner tube diameter matching the stent diameter. OCT was repeated after spreading a thin layer of gel inside the tube, mimicking the toothpaste-like plaque observed in SVG. In vivo and in vitro OCT images excluded the presence of plaque prolapse in all but one case and detected a characteristic pattern with bulging of the pericardium between struts, possibly due to trapping of soft intraluminal plaque (or gel) behind the pericardial layer., Conclusions: These cases offer insight into the mechanism of protection against distal embolisation, elucidated by the appearance of these stents after deployment in vivo and in vitro.

Objective: The The Arterial Revascularization Therapies Study (ARTS)-II trial found no differences in survival or overall adverse events between sirolimus-eluting stents (SES) and the surgical arm of ARTS-I. Nevertheless, existing data suggest that patients with disease of the proximal left anterior descending artery (LAD) may derive particular benefit from coronary artery bypass grafting (CABG). We therefore analysed the clinical outcome of patients in ARTS-I and ARTS-II with proximal LAD involvement., Design: Multicentre observational study., Setting: Forty-five European academic hospitals., Patients: Patients with multivessel coronary artery disease., Interventions: Patients in ARTS-II with proximal LAD disease treated with SES (289/607, 48%) were compared with 187/600 (31%) bare metal stent patients (ARTS-I BMS) and 206/605 (34%) surgical patients (ARTS-I CABG) with proximal LAD involvement from ARTS-I., Main Outcome Measures: Major adverse cardiac and cerebrovascular events after 3 years., Results: The Arterial Revascularization Therapies study part 2 (ARTS-II) subgroup had better survival than both ARTS-I groups (ARTS-II 98.6% vs ARTS-I BMS 95.7%, p = 0.05 and vs ARTS-I CABG 94.7%, p = 0.01) and lower rates of the hard clinical composite endpoint of death or non-fatal myocardial infarction (ARTS-II 3.1% vs ARTS-I BMS 9.6%, p = 0.002 and vs ARTS-I CABG 9.7%, p = 0.002). Although the ARTS-I CABG patients had a lower need for repeat revascularisation than ARTS-II (5.3% vs 13.1%, p = 0.002), the overall composite adverse event rates (death, myocardial infarction, stroke or any repeat revascularisation) were not significantly different between the ARTS-I CABG and ARTS-II patients (15.0% vs 18.0%, p = 0.4)., Conclusions: SES are not inferior to CABG or bare metal stents for the treatment of patients with multivessel coronary disease including involvement of the proximal LAD.

Objectives: We investigated the impact of sex on outcomes after percutaneous coronary intervention (PCI) with drug-eluting stent (DES)., Background: Women have a higher risk of adverse outcomes after PCI than do men. However, long-term outcomes of women after contemporary PCI with DES have not been fully investigated., Methods: We performed a retrospective cohort study of 4,936 consecutive patients (28.2% women) who underwent PCIs between 2000 and 2004, before and after introduction of DES (bare-metal stent [BMS] group: n = 2,131, DES group: n = 2,805), to assess the impact of sex on long-term PCI outcomes and to compare outcome after PCI of women between the DES and BMS eras., Results: Compared with men, women undergoing PCIs were 5 years older and more frequently have comorbidities such as diabetes mellitus and hypertension. In patients treated throughout the BMS and DES eras, there were no differences by sex for risk of all-cause death, myocardial infarction, or target vessel revascularization 3 years after procedure. The procedural complexity was higher in the DES era, nevertheless, risk for target vessel revascularization and major adverse cardiac event at 3 years were significantly lower in women treated with DES than in women treated with BMS (adjusted hazard ratio [HR] for target vessel revascularization: 0.52 [95% confidence interval (CI): 0.36 to 0.75], adjusted HR for major adverse cardiac event: 0.63 [95% CI: 0.48 to 0.83])., Conclusions: Although women had worse baseline characteristics, no differences in 3-year outcomes were observed between men and women. Compared with BMS use, DES use has decreased revascularization rate equally in women and men.

Aims: Previous randomised studies have shown a significant reduction in restenosis when oral rapamycin (OR) is administered to patients undergoing bare metal stent (BMS) implantation. How this regimen compares to drug eluting stents (DES) is unknown., Methods and Results: Two-hundred patients with de novo coronary lesions were randomised to treatment with OR plus BMS (100 pts) or with DES (100 pts). OR was given as a bolus of 10 mg per day before PCI followed by daily doses of 3 mg during following 13 days. Primary endpoints were to compare hospital, follow-up and overall cost at one, two, three and five years of follow-up. The secondary endpoints included death, myocardial infarction (MI) and stroke and were analysed as major adverse cardiovascular events (MACCE). Target vessel (TVR) and target lesion revascularisation (TLR) were independently analysed. Costs included procedural resources, hospitalisation, medications, repeat revascularisation procedures and professional fees. Baseline demographic, clinical and angiographic characteristics were similar. At 18.3 +/- 7 months of follow-up, the initial strategy of OR plus BMS resulted in significant cost saving when compared to DES (p=0.0001). TLR rate was 8.2% with DES and 7.0% with OR plus BMS (p=0.84), similarly no differences in TVR rate in both groups was seen (10.6% and 10.5% in OR and DES group respectively, p=0.86). Non-inferiority testing, determined that DES therapy failed to be cost saving compared to OR in all possible cost scenarios., Conclusions: A strategy of OR plus BMS is cost saving compared to DES in patients undergoing PCI for de novo coronary lesions.

Objectives: We aimed to evaluate the risk of definite stent thrombosis with bare-metal stents (BMS) and drug-eluting stents (DES) in patients treated for acute coronary syndromes., Background: Acute coronary syndromes (ACS) have been reported as increasing the risk for stent thrombosis., Methods: Between January 2000 and December 2005, 5,816 consecutive patients underwent percutaneous coronary intervention for de novo lesions with a single stent type. These patients consisted of 3 sequential groups of BMS (n = 2,248), sirolimus-eluting stents (n = 822) and paclitaxel-eluting stents (n = 2,746). In total, 3,485 patients presented with an ACS., Results: After a median follow-up of 1,394 days, patients with ACS had a definite stent thrombosis rate of 2.5% versus 1.0% in patients with stable angina (propensity score-adjusted hazard ratio [HR]: 2.80, 95% confidence interval [CI]: 1.72 to 4.56). ACS patients had a higher risk of early and late stent thrombosis, although the increased risk of very late stent thrombosis was only present in ACS patients treated with DES. In stable patients, any stent thrombosis resulted in a significant increase in mortality (adjusted HR: 4.0, 95% CI: 1.7 to 9.3), although this was particularly evident for late or very late stent thrombosis; in contrast only early stent thrombosis significantly increased mortality in patients with acute coronary syndrome patients (adjusted HR: 2.0, 95% CI: 1.0 to 4.1)., Conclusions: Patients with acute coronary syndromes are at higher risk of early and late stent thrombosis with either BMS or DES, although very late stent thrombosis seems to be uniquely associated with DES. The clinical sequelae of late and very late stent thrombosis are more pronounced in stable patients.

Drug-eluting stents (DESs) have been shown to reduce the rate of repeat revascularization compared with bare-metal stents (BMSs) after multivessel percutaneous coronary intervention in carefully selected patients. However, the long-term safety and efficacy of DESs in patients with multivessel disease outside the setting of randomized trials was unknown. Therefore, all patients undergoing multivessel percutaneous coronary intervention with BMSs, sirolimus-eluting stents (SESs), or paclitaxel-eluting stents (PESs) from January 2000 to December 2005 were investigated. The primary end point was all-cause mortality. A total of 1,720 patients were recruited in 3 consecutive sequential groups of BMS (n=701; January 2000 to April 2002), SES (n=293; April 2002 to February 2003), and PES (n=726; February 2003 to December 2005). Overall median follow-up was 1,440 days. There was improved 3-year survival in the SES group (93.7%) compared with both the BMS (86.1%) and PES groups (87.3%), which remained significant after propensity score adjustment for differences in baseline and procedural characteristics (SES vs BMS, adjusted hazard ratio 0.53, 95% confidence interval 0.30 to 0.94; SES vs PES, adjusted hazard ratio 0.49, 95% confidence interval 0.28 to 0.87). There was no difference in mortality between the PES and BMS groups. Both DES types significantly reduced the need for clinically driven target-vessel and target-lesion revascularization without an excess in myocardial infarction or stent thrombosis. In conclusion, both SESs and PESs significantly reduced the need for repeated revascularization in these patients with no excess in mortality. SESs might reduce mortality in patients undergoing multivessel percutaneous coronary intervention.

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.

Background: We previously reported that the 1-year survival-free from target lesion revascularization was 97.4% in patients with chronic total occlusion (CTO) treated with sirolimus-eluting stents (SES). There are currently no long-term results of the efficacy of SES in this subset of lesions. We assessed the 3-year clinical outcomes of 147 patients with CTO treated with either SES or bare metal stents (BMS)., Methods and Results: A total of 147 (BMS = 71, SES = 76) patients were included. Four patients died in the BMS group while five patients died in the SES group, P = 0.8; two myocardial infarctions occurred in both groups, P = 0.9; and target vessel revascularization was performed in nine patients in the BMS and seven in the SES group, P = 0.5. The cumulative event-free survival of MACE was 81.7% in BMS group and 84.2% in SES group, P = 0.7. Two patients of the SES group had a coronary aneurism at 3-year angiographic follow-up., Conclusions: The use of SES was no longer associated with significantly lower rates of target vessel revascularization and major adverse cardiac events in patients with CTOs after 3 years of follow-up compared with BMSs., ((c) 2007 Wiley-Liss, Inc.)

Objective: To compare the postprocedural and long-term clinical outcomes of two groups of patients, all presenting with chronic saphenous vein graft (SVG) occlusion, who underwent either SVG or native vessel reopening., Background: Chronic total occlusions (CTO) treatment in patients who underwent previous surgical revascularization is a dilemma and the choice of performing native vessel or SVG recanalization is not always easy., Methods: Between July 2002 and October 2004, a total of 260 patients were successfully treated for a CTO. Of them, we selected all patients (n = 24) who had previous bypass surgery with graft occlusion. Of this final group, 13 patients underwent a percutaneous graft recanalization while 11 underwent native vessel reopening., Results: Primary end points were in-hospital and 3-year rates of death, myocardial infarction, target lesion revascularization, and target vessel revascularization. No events occurred in either group during the in-hospital period. Cumulative 3-year event-free survival in the native vessel and SVG group was 81.8% and 83.9% respectively (P = NS). One death and one TVR occurred in each group., Conclusion: In selected cases, SVG reopening instead of the native vessel is feasible. In such a high-risk population, drug-eluting stent implantation in both SVG and native CTO lesions is associated with good long-term outcomes., ((c) 2007 Wiley-Liss, Inc.)

Sirolimus-eluting stents (SESs) recently proved to be superior to bare metal stents (BMSs) in decreasing the need for repeat revascularization in patients with ST-segment elevation myocardial infarction (STEMI) at 1 year. Whether this also holds for paclitaxel-eluting stents (PESs) is currently unclear and the long-term relatively efficacy of the 2 drug-eluting stents is currently unknown. We investigated the 3-year efficacy of SESs and PESs versus BMSs in patients with STEMI. Primary angioplasty was performed in a consecutive group of 505 patients (BMSs in 183, SESs in 186, PESs in 136). At 3 years, the cumulative mortality rate was comparable in the 3 groups: 13.3% in the BMS group, 11.5% in the SES group, and 12.4% in the PES group (nonsignificant for all). The rate of target vessel revascularization (TVR) was 12.0% in the BMS group compared with 8.0% and 7.7% in the SES and PES groups, respectively (p = 0.12 for BMS vs SES, 0.30 for BMS vs PES, 0.62 for SES vs PES). The cumulative incidence of death, MI, or TVR was 25.5% in the BMS group compared with 17.9% and 20.6% in the SES and PES groups, respectively (p = 0.06 for BMS vs SES, 0.32 for BMS vs PES, 0.45 for SES vs PES). Angiographic stent thrombosis occurred in 2.4% of all patients (BMS 1.6%, SES 2.7%, PES 2.9%). In conclusion, in this relatively small consecutive patient cohort, the use of SESs and PESs was no longer associated with significantly lower rates of TVR and major adverse cardiace events in patients with STEMI after 3 years of follow-up. A high frequency of stent thrombosis was observed in the 2 drug-eluting stent groups.

Background: Stent thrombosis is a safety concern associated with use of drug-eluting stents. Little is known about occurrence of stent thrombosis more than 1 year after implantation of such stents., Methods: Between April, 2002, and Dec, 2005, 8146 patients underwent percutaneous coronary intervention with sirolimus-eluting stents (SES; n=3823) or paclitaxel-eluting stents (PES; n=4323) at two academic hospitals. We assessed data from this group to ascertain the incidence, time course, and correlates of stent thrombosis, and the differences between early (0-30 days) and late (>30 days) stent thrombosis and between SES and PES., Findings: Angiographically documented stent thrombosis occurred in 152 patients (incidence density 1.3 per 100 person-years; cumulative incidence at 3 years 2.9%). Early stent thrombosis was noted in 91 (60%) patients, and late stent thrombosis in 61 (40%) patients. Late stent thrombosis occurred steadily at a constant rate of 0.6% per year up to 3 years after stent implantation. Incidence of early stent thrombosis was similar for SES (1.1%) and PES (1.3%), but late stent thrombosis was more frequent with PES (1.8%) than with SES (1.4%; p=0.031). At the time of stent thrombosis, dual antiplatelet therapy was being taken by 87% (early) and 23% (late) of patients (p<0.0001). Independent predictors of overall stent thrombosis were acute coronary syndrome at presentation (hazard ratio 2.28, 95% CI 1.29-4.03) and diabetes (2.03, 1.07-3.83)., Interpretation: Late stent thrombosis was encountered steadily with no evidence of diminution up to 3 years of follow-up. Early and late stent thrombosis were observed with SES and with PES. Acute coronary syndrome at presentation and diabetes were independent predictors of stent thrombosis.

Aims: To investigate the outcome of a real world diabetic patient cohort treated with bare metal stents (BMS), sirolimus-, or paclitaxel-eluting stents (SES and PES, respectively). Due to the different mechanisms of action of both drugs it is currently unknown which device is the best option to treat these high-risk patients., Methods and Results: The study compares the 2-year clinical outcome of 708 consecutive diabetic patients (25% insulin treated) treated with either a BMS (n = 252), a SES (n = 206), or a PES (n = 250), as part of the RESEARCH and T-SEARCH registries. Target vessel revascularization was 19.5% in the BMS group, vs. 15.3% in the SES group and 9.7% in the PES group. PES (21.2%), but not SES (28.9%), were superior to BMS (29.7%) in reducing major adverse cardiac events. After propensity analyses, none of the differences remained significant. The incidence of stent thrombosis (ST) was high in both DES groups., Conclusion: There was a trend towards a more favourable outcome associated with the use of PES over BMS. There was no significant difference between SES and PES in each of the clinical endpoints, and neither in the NIDDM patients, which are hypothesized to be better-off with PES.