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The present study reports on the clinical outcome of 31 consecutive patients with left main coronary artery disease treated with a sirolimus-eluting stent. The implantation of this stent was associated with abolition of post-discharge fatal events and percutaneous reintervention. [ABSTRACT FROM AUTHOR]

The long-term efficacy of percutaneous coronary intervention for mildly obstructive coronary narrowings is limited by the occurrence of restenosis, limiting the applicability of this therapy for these lesions. The present study reports on a consecutive series of 20 patients treated with sirolimus-eluting stent implantation for 23 angiographically mild de novo lesions (defined as a diameter stenosis <50% by quantitative coronary angiography). At a mean follow-up of 399 +/- 120 days, the survival-free of major adverse events was 95%, with no patient requiring target lesion revascularization. [ABSTRACT FROM AUTHOR]

Objectives: This study evaluated the early outcomes of patients with acute coronary syndromes (ACS) treated with sirolimus-eluting stents (SES).Background: The safety of SES implantation in patients with a high risk for early thrombotic complications is currently unknown.Methods: Sirolimus-eluting stents have been utilized as the device of choice for all percutaneous procedures in our institution, as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. After four months of enrollment, 198 patients with ACS had been treated exclusively with SES (64% of those treated in the period) and were compared with a control group composed of 301 consecutive patients treated with bare stents in the same time period immediately before this study. The incidence of major adverse cardiac events (MACE) during the first month was evaluated (death, nonfatal myocardial infarction [MI], or re-intervention).Results: Compared with control patients, patients treated with SES had more primary angioplasty (95% vs. 77%; p < 0.01), more bifurcation stenting (13% vs. 5%; p < 0.01), less previous MI (28% vs. 45%; p < 0.01), and less glycoprotein IIb/IIIa inhibitor utilization (27% vs. 42%; p < 0.01). The 30-day MACE rate was similar between both groups (SES 6.1% vs. control patients 6.6%; p = 0.8), with most complications occurring during the first week. Stent thrombosis occurred in 0.5% of SES patients and in 1.7% of control patients (p = 0.4). In multivariate analysis, SES utilization did not influence the incidence of MACE (odds ratio 1.0 [95% confidence interval: 0.4 to 2.2]; p = 0.97).Conclusions: Sirolimus-eluting stent implantation for patients with ACS is safe, with early outcomes comparable with bare metal stents. [ABSTRACT FROM AUTHOR]

Introduction: Mitral annulus assessment is of utmost importance for the management of patients with mitral valve (MV) abnormalities, as it helps to determine the decision for surgical or transcatheter treatment. Three-dimensional (3D) transesophageal echocardiography (TOE) has been the only reliable echocardiographic method for the evaluation of the mitral annulus by now. However, newer transthoracic echocardiography (TTE) 3D probes have enabled to provide accurate measurements as well and become a valuable tool when TOE is contraindicated. The aim of this study is to assess the feasibility of 3D TTE analysis of mitral annulus and the level of agreement with 3D TOE measurements., Methods: A total of 121 consecutive patients were assessed with 3D TTE and TOE. All mitral annulus parameters were retrospectively analyzed with the dedicated 4D autoMVQ application. Bland-Altman analysis and intraclass correlation coefficient were used for the comparison and agreement between the two methods. Half of our patients had normal mitral valves and served as control group, while the other half had various mitral valve pathologies., Results: AutoMVQ analysis was not feasible in 11 out of 121 TTE examinations (91% feasibility) and in 4 out of 121 TOE examinations (96% feasibility). Mitral annular area and perimeter were slightly larger in TTE than those measured by TOE (12.7 ± 3.6 vs. 12.4 ± 3.2 cm 2 for area and 12.7 ± 1.7 vs. 12.5 ± 1.6 cm for perimeter), however still showing strong correlation (r = .942 and r = .922, respectively). The majority of mitral valve measurements (anterior-posterior, medial-lateral and commissural diameter, aorto-mitral angle and anterior leaflet length) were similar among the two methods with strong correlation (r > .80). Inter-trigonal distance, posterior leaflet length and tenting height showed weaker agreement between TTE and TOE (r = .687, r = .687, r = .634, respectively). Mitral annular dimensions (by 3D area) were found to be significantly larger in patients with MV pathology (13.5 ± 3.5 vs. 11 ± 2.3 cm 2 ), atrial fibrillation (14.4 ± 3 vs. 11.4 ± 2.8 cm 2 ), left ventricular (13.8 ± 3.1 vs. 11.7 ± 3.1cm 2 ) and left atrial dilatation (13 ± 3.3 vs. 10.6 ± 2.3cm 2 ) compared to the individuals in the control group (p < .001 for all comparisons)., Conclusions: Assessment of the MV with 3D TTE with dedicated MVQ software is feasible and accurate, showing strong correlation and agreement with TOE measurements., (© 2022 Wiley Periodicals LLC.)

Aims: The purpose of this study was to assess the incidence and predictors of graft failure prior to discharge. Multi-slice computed tomography has the ability to evaluate graft patency in a non-invasive way., Methods and Results: Of 145 consecutive patients who were screened, 73 were included in the study (78% male, mean age 65 years). A total of 206 grafts were analysed (2.8±0.9 grafts/patient). Of the 206 grafts, 126 were venous, 72 were left internal mammary, five were right internal mammary and three were radial grafts. We evaluated 100% of proximal anastomoses sites and 92% (190/206) of the distal anastomoses. We identified five patients (6.8%) who had at least one occluded graft. A total of seven out of 206 (3.4%) grafts were occluded. Independent predictors of successful graft outcome were left anterior descending artery as a recipient artery, good distal run-off as assessed by a surgeon and vessel size larger than 2 mm., Conclusions: The results demonstrate that the in-hospital acute graft failure rate is 3.4% (6.8% of patients). Multi-slice computed tomography is a robust technique to assess novel therapies to reduce the rate of graft attrition further, and might be clinically useful in patients with persistent or early recurrence of symptoms after CABG.

Introduction: The Hellenic Heart Registry on Percutaneous Coronary Interventions (HHR-PCI) was a prospective, observational registry of patients with stable angina or acute coronary syndromes who underwent percutaneous coronary intervention (PCI) between January 2008 and October 2010., Methods: HHR-PCI was a database that used a secure web-based interface for data entry by individual users. All PCI centers and operators were invited to participate. The participating PCI centers were geographically divided into three main regions: Athens Metro Area, Thessaloniki Metro Area, and Rest of Greece. Indications, demographics, procedural characteristics, and in-hospital outcomes (death, myocardial infarction, cerebrovascular accidents) were recorded., Results: Eighteen (18) centers participated in the registry (2008-2010) in a systematic fashion, entering complete data for 3441 patients (males 83.1%, mean age 64.1 years, 5521 lesions). PCI was elective in 47.1% of patients and was used to treat an acute coronary syndrome in 52.5%. There were 742 (21.6%) patients treated for ST-segment elevation myocardial infarction, with 225 (30.3%) receiving primary PCI (mean door-to-balloon time 140 minutes). The mean numbers of stents per lesion and per patient were 1.14 and 1.74, respectively, with drug eluting stents being used in 74.2% of coronary lesions. Periprocedural complications were observed in 105 patients (3.1%), while the incidence of in-hospital death, myocardial infarction, and cerebrovascular event were 0.5%, 1%, and 0.6%, respectively., Conclusions: HHR-PCI was the first web-based national PCI registry in Greece and has provided useful insights regarding the practice of interventional cardiology in this country. Efforts should be made to maintain and extend this type of PCI registry, with a view to improving quality and outcomes research in the field of interventional cardiology.

Aims: We sought to explore whether global and regional scientific output in cardiovascular medicine is associated with economic variables and follows the same trend as medicine and as science overall., Methods and Results: We registered the number of documents, number of citations, citations per document and the h-index for the first 50 countries according to the h-index (a measure to evaluate both the productivity and impact of the publications) in cardiovascular medicine. Economic variables (gross domestic product [GDP] per capita, % expenditure of the GDP in research and development [R&D] and health) were obtained from the World Bank, the UNESCO, and the World Health Organization. In total, the scientific output in cardiology showed the same position as in medicine and science overall (mean difference vs. medicine -0.9±5.3º, p=0.25 vs. science -0.7±5.3º, p=0.39). We found significant correlations between the h-index and the % GDP expenditure in R&D (r=0.67, p<0.001), and the % GDP expenditure in health (r=0.71, p<0.0001). Overall, there was a 21.4% (interquartile range 3.7; 55.0) increase in the % GDP expenditure in R&D between 1996 and 2007. Emerging economies showed the larger growth in % GDP expenditure in health and R&D., Conclusions: The global situation of scientific output in cardiovascular medicine is highly polarised and closely related to economic indicators. Emergent economies, with higher rates of GDP growth and increasingly larger expenditures for R&D and healthcare, are expected to show a visible escalation in the scientific global picture in the near future.

Percutaneous pulmonary valve implantation into dysfunctional right ventricular (RV) to pulmonary artery conduits is being increasingly performed in many European and North American centers with satisfactory results and low-complication rates. We report the first application of this elaborate technique in the native RV outflow tract of a young patient who developed severe supravalvular pulmonary stenosis following an arterial switch operation for transposition of the great arteries. The procedure may be used as an alternative to surgical repair for the treatment of selected patients with supravalvular pulmonary stenosis complicating congenital heart surgery., (Copyright © 2011 Wiley Periodicals, Inc.)

Aims: Sirolimus-eluting stents (SES) have recently been shown to reduce restenosis in selected patients. The impact of this new stent on the use of coronary bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) in clinical practice is yet unknown. Therefore, we investigated the impact of SES on the clinical practice of CABG and PCI in a series of unselected consecutive patients., Methods and Results: Between April and October 2002, a policy of SES implantation for all procedures has been instituted in our hospital. In total, 798 patients were referred to PCI and 275 to CABG (SES group). A control group was composed of all interventions (806 PCI and 314 CABG) performed during the preceding 6 months (pre-SES). The main outcome was the occurrence of major adverse cardiac events (MACE) at 15 months. In the SES era, a significant shift was noted in the PCI group towards more multi-vessel stenting (28 vs. 24%; P<0.05), more bifurcation stenting (18 vs. 7%; P<0.0001), and the use of more stents (1.9 vs. 1.5; P<0.05). In the PCI elective patients, a shift was noted towards more three-vessel disease (pre-SES: 16% vs. SES: 23%; P=0.02). Furthermore, we observed a shift in the CABG group towards more impaired LV function (pre-SES: 34% vs. SES: 41%; P=0.02) and towards more three-vessel disease (pre-SES: 67% vs. SES: 75%; P=0.03). Overall, the cumulative MACE percentages at 1 year after coronary revascularization (PCI and CABG combined) decreased from 16.8 to 13.8% (P=0.03). The cumulative MACE percentages in the pure SES group and the pre-SES bare metal stent group at 12 months were 15.6 and 19.8%, respectively (P<0.01)., Conclusion: The introduction of the SES has certainly had an impact on the treatment strategy of coronary artery disease (CAD). Increased use of these stents allows more complex coronary anatomy to be treated by PCI, and results in lower repeat revascularization rates.

Background: To evaluate the impact of the extent of coronary disease (single- or multivessel) and of fluvastatin treatment on the incidence of long-term cardiac atherosclerotic complications in the Lescol Intervention Prevention Study (LIPS)., Methods: A total of 1063 patients with single-vessel disease and 614 patients with multivessel disease were randomized to receive fluvastatin (40 mg bid) or placebo for at least 3 years following a first successful percutaneous coronary intervention. The incidence of cardiac atherosclerotic events (cardiac death, non-fatal myocardial infarction, and coronary re-interventions not related to restenosis) was evaluated., Results: Patients with multivessel disease tended to be older and presented a higher prevalence of associated risk factors and cardiovascular antecedents. The presence of multivessel disease markedly increased the risk of cardiac atherosclerotic events compared with single-vessel disease among patients allocated to placebo (RR 1.67 [95% CI: 1.24-2.25]; p<0.001). In patients treated with fluvastatin, however, no significant differences in long-term outcomes were observed between patients with multivessel disease and patients single-vessel disease (RR 1.28 [95% CI: 0.90-1.81]; p=0.2)., Conclusions: Multivessel coronary disease impaired the 4-year outcomes after percutaneous intervention. However, the hazardous effect of multivessel disease was significantly reduced by long-term fluvastatin treatment.

Background: Diabetes increases the risk of developing cardiovascular disease. Patients with diabetes undergoing percutaneous coronary intervention (PCI) show poorer outcomes compared with nondiabetic patients. The aim of this study was to determine the clinical benefit of long-term fluvastatin in patients with diabetes who had undergone a successful PCI., Methods: This subanalysis of a prospective, multicenter, randomized, double-blind, placebo-controlled trial of patients who had undergone PCI and were treated with fluvastatin determined the impact of fluvastatin on the survival-free period of major adverse cardiac events (MACE) (defined as cardiac death, nonfatal myocardial infarction, and reintervention procedure [coronary artery bypass grafting, repeat PCI, PCI for a new lesion]). Patients with baseline total cholesterol levels of 135 to 270 mg/dL (3.5-7.0 mmol/L) and triglyceride levels of 400 mg/dL (4.5 mmol/L) were randomized at discharge either to fluvastatin (n = 844) or to placebo (n = 833); follow-up was 3 to 4 years. Among these patients, there were 202 with diabetes (120 on fluvastatin, 82 placebo) and 1475 without diabetes (724 on fluvastatin, 751 on placebo). The primary clinical outcome was survival time free of MACE and MACE excluding restenosis., Results: The presence of diabetes increased the risk of MACE by almost 2-fold in placebo-treated patients (RR 1.78, 95% CI 1.20-2,64, P = .0045). In contrast, in diabetic patients treated with fluvastatin, the risk of MACE was not significantly different from that in patients without diabetes. Fluvastatin reduced the risk of MACE in diabetic patients by 51% (P = .0088)., Conclusions: Diabetes is a consistent clinical predictor of cardiovascular complications and fluvastatin reduces the increased incidence of long-term adverse complications associated with the presence of diabetes.

Renal impairment is an important predictor of mortality after percutaneous coronary intervention and may increase the restenosis rate. However, the relation between restenosis and the risk of death in patients who have renal impairment remains unclear. We evaluated the incidences of repeat revascularization and mortality in patients who had renal impairment and those who did not and who received sirolimus-eluting stents or bare stents. A total of 1,080 consecutive patients treated for 1 year had available data to calculate baseline creatinine clearance. Patients received bare stents (first 6 months, n = 543) or sirolimus-eluting stents (last 6 months, n = 537) and were grouped according to the presence or absence of renal impairment (creatinine clearance <60 ml/min). Patients who had renal impairment had a higher mortality rate at 1 year (7.6% vs 2.5%, hazard ratio 3.14, 95% confidence interval 1.68 to 5.88, p <0.01), with no differences in mortality between patients who received bare stents and those who received sirolimus-eluting stents (hazard ratio 0.91, 95% confidence interval 0.49 to 1.68, p = 0.8). The incidence of target vessel revascularization decreased significantly in patients who were treated with sirolimus-eluting stents and did not have renal impairment (hazard ratio 0.59, 95% confidence interval 0.39 to 0.90, p = 0.01) and in those who had decreased renal function (hazard ratio 0.37, 95% confidence interval 0.15 to 0.90, p = 0.03). Thus, sirolimus-eluting stents compared with conventional stents decreased clinical restenosis in patients who had renal impairment. However, this benefit was not paralleled by a decrease in the risk of death in this population. It seems unlikely that restenosis could be a contributing factor that influenced the increased mortality of patients who had impaired renal function.

Objectives: We sought to compare the diagnostic value of multi-slice computed tomography (MSCT) coronary angiography (CA) to detect significant stenoses (> or =50% lumen diameter reduction) with that of invasive CA., Background: The latest 16-row MSCT scanner has a faster rotation time (375 ms) and permits scanning with a higher X-ray tube current (500 to 600 mA) during MSCT CA when compared with previous scanners., Methods: We studied 51 patients (37 men, mean age 58.9 +/- 10.0 years) with stable angina or atypical chest pain. Patients with pre-scan heart rates > or =70 beats/min received oral beta-blockade. The heart was scanned after intravenous injection of 100 ml contrast (iodine content, 400 mg/ml). Mean scan time was 18.9 +/- 1.0 s. The MSCT scans were analyzed by two observers unaware of the results of invasive angiography, and all available coronary branches > or =2 mm were included., Results: Invasive CA demonstrated normal arteries in 16% (8 of 51), non-significant disease in 21% (11 of 51), single-vessel disease in 37% (19 of 51), and multi-vessel disease in 26% (13 of 51) of patients. There were 64 significant lesions. Sensitivity, specificity, and positive and negative predictive values for detection of significant lesions on a segment-based analysis were 95% (61 of 64, 95% confidence interval [CI] 86 to 99), 98% (537 of 546, 95% CI 96 to 99), 87% (61 of 70, 95% CI 76 to 98), and 99% (537 of 540, 95% CI 98 to 99), respectively. All patients with angiographically normal coronary arteries or significant lesions were correctly identified. Three of 11 patients with <50% lesions were incorrectly classified as having single-vessel disease., Conclusions: The 16-row MSCT CA reliably detects significant coronary stenoses in patients with atypical chest pain or stable angina pectoris.

Objective: To assess the effectiveness of routine sirolimus eluting stent (SES) implantation for unselected patients with in-stent restenosis and to provide preliminary information about the angiographic outcome for lesion subgroups and for different in-stent restenosis patterns., Design: Prospective, single centre registry., Setting: Tertiary referral centre., Patients: 44 consecutive patients (53 lesions) without previous brachytherapy who were treated with SES for in-stent restenosis were evaluated. Routine angiographic follow up was obtained at six months and the incidence of major adverse cardiovascular events was evaluated., Results: At baseline, 42% of the lesions were focal, 21% diffuse, 26% proliferative, and 11% total occlusions. Small vessel size (reference diameter < or = 2.5 mm) was present in 49%, long lesions (> 20 mm) in 30%, treatment of bypass grafts in 13%, and bifurcation stenting in 18%. At follow up, post-SES restenosis was observed in 14.6%. No restenosis was observed in focal lesions. For more complex lesions, restenosis rates ranged from 20-25%. At the one year follow up, the incidence of death was 0, myocardial infarction 4.7% (n = 2), and target lesion revascularisation 16.3% (n = 7). The target lesion was revascularised because of restenosis in 11.6% (n = 5)., Conclusions: Routine SES implantation is highly effective for focal in-stent restenosis and appears to be a promising strategy for more complex patterns of restenosis.

The aim of this study was to evaluate the effectiveness of sirolimus-eluting stent (SES) implantation for patients with multivessel disease, which included left anterior descending artery (LAD) treatment. Since April 2002, SES has been utilized as the device of choice for all interventions in our institution as part of the Rapamycin-Eluting Stent Evaluated at Rotterdam Hospital (RESEARCH) registry. In the first 6 months of enrollment, 99 consecutive patients (17.6% of the total population) were treated for multivessel disease involving the LAD. The impact of SES implantation on major adverse cardiac events (MACE) was evaluated. All the patients received SES in the LAD. Additional stent implantation in the right coronary artery, the left circumflex, or in all three major vessels was attempted successfully in 32 (32%), 51 (52%), and 16 (16%) of the treated patients respectively. During a mean follow-up of 360 +/- 59 days (range, 297-472 days), we had one death, one non-Q-wave myocardial infarction, and eight patients required subsequent intervention. The event-free survival of MACE at 1 year was 85.6%. SES implantation for multivessel disease in a consecutive series of patients is associated with low incidence of adverse events. The reported results are related predominantly to the reduction in repeat revascularization.

The percutaneous treatment of coronary bifurcation stenoses is hampered by an increased rate of subsequent restenosis. The present study reports on the outcomes of a consecutive series of 58 patients with 65 de novo bifurcation stenoses treated with sirolimus-eluting stent implantation in both the main vessel and side branch. At 6 months, the incidence of major adverse cardiac events was 10.3% (1 death and 5 target lesion revascularizations) with no episodes of acute myocardial infarction or stent thrombosis.

The purpose of this study was to compare the mid-term clinical outcome of sirolimus-eluting stent (SES) implantation and vascular brachytherapy (VBT) for in-stent restenosis (ISR). We assessed the 9-month occurrence of major adverse cardiac events (MACE) in 44 consecutive patients with ISR treated with SES implantation and 43 consecutive patients treated with VBT in the period immediately prior. Baseline clinical and angiographic characteristics of the two groups were similar. During follow-up, three patients (7%) died in the VBT group and none in the SES group. The incidence of myocardial infarction was 2.3% in both groups. Target lesion revascularization was performed in 11.6% of the VBT patients and 16.3% of the SES patients (P = NS). The 9-month MACE-free survival was similar in both groups (79.1% VBT vs. 81.5% SES; P = 0.8 by log rank). The result of this nonrandomized study suggests that sirolimus-eluting stent implantation is at least as effective as vascular brachytherapy in the treatment of in-stent restenosis., (Copyright 2004 Wiley-Liss, Inc.)

The effectiveness of sirolimus-eluting stent (SES) implantation in patients treated electively for left main (LM) stenoses has not been yet ascertained. The present study reports on the clinical and angiographic outcome of 16 consecutive patients treated electively for de novo stenoses in the LM. The impact of SES implantation on major adverse cardiac events was evaluated. Mean age was 65 +/- 11 years. Unprotected LM was present in nine (56%), and eight patients (50%) received stents extending into both the left anterior descending and circumflex arteries for stenoses of the distal left main bifurcation. In-house mortality and reintervention rate was zero. One patient developed a non-Q-wave myocardial infarction related to the index procedure. At 1-year clinical follow-up, there were no deaths or further myocardial infarctions; one (6%) patient required target lesion revascularization. A total of 12 patients (75%) underwent 6-month angiographic follow-up with a late lumen loss of 0.04 +/- 0.65 mm and one focal restenosis (8% of patients). Elective SES implantation for LM disease was associated with zero mortality and a very low incidence of additional major adverse events at 1 year.

Sirolimus-eluting stents have been used in our institution for all percutaneous interventions, without clinical or anatomic exclusion criteria, as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital registry. We analyzed the incidence of (sub)acute stent thrombosis after sirolimus-eluting stent implantation in an unselected population of 510 consecutive patients. At 3-month follow-up, (sub)acute stent thrombosis was diagnosed in 2 patients (0.4%) 6 hours and 11 days after the procedure, respectively. These cases occurred in diabetic women with complex coronary lesions. Intravascular ultrasound examination showed inadequate stent expansion and uncovered distal dissection as possible mechanical explanations for the thrombosis.

The use of bare stents for the percutaneous intervention of saphenous vein bypass grafts (SVGs) is associated with a high subsequent rate of restenosis. To assess the impact of the sirolimus-eluting stent (SES), we studied 19 consecutive patients who underwent de novo SVG intervention treated solely with SES. Mean graft age was 10 years. Clinical presentation was an acute coronary syndrome in 68%. In total, twenty-two de novo lesions were treated with 35 SESs (mean=1.6 stents per lesion). Use of glycoprotein IIb/IIIa inhibitor therapy and distal embolization protection device were at operator discretion and were 42% and 32%, respectively. The rate of in-hospital major adverse cardiac events (MACE) was 11%, related to 2 patients with a creatine kinase rise consistent with peri-procedural acute myocardial infarction (AMI); a distal protection device was not utilized in either. Over a mean 12.5+/-2.6 month follow-up, one patient died from a non-cardiac cause, and there were no further AMIs. Target lesion revascularization was undertaken in 1 patient (5%); survival free of MACE was 84%. In conclusion, utilizing SESs for percutaneous intervention of degenerate SVGs is associated with a low rate of target vessel revascularization. Increased utilization of distal protection devices might reduce the peri-procedural rate of AMI.

The purpose of this study was to assess the safety and effectiveness of sirolimus-eluting stent (SES) postdilatation with largely oversized balloons. We evaluated the clinical outcome of 68 consecutive patients enrolled in the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry who underwent percutaneous coronary intervention with SES implantation and further postdilatation with balloons > 1 mm larger than the stent nominal size. Angiographic follow-up was either scheduled for selected subgroups or clinically driven. Overall, 75 lesions were treated. The procedure was successful in 98.5% of the cases. One patient (1.5%) underwent emergency coronary bypass surgery for acute vessel occlusion. During 10.1 +/- 1.7 months of follow-up, three patients (4.5%) died, one (1.5%) had acute myocardial infarction, and four (6%) had target vessel revascularization. At angiographic follow-up, loss index was 0.13 +/- 0.34 and restenosis rate was 7.7%. Although not routinely recommended in every patient, SES postdilatation with largely oversized balloons appears a safe and effective strategy for selected patients., (Copyright 2004 Wiley-Liss, Inc.)

Long-length stenting has a poor outcome when bare metal stents are used. The safety and efficacy of the sirolimus-eluting stent (SES) in long lesions has not been evaluated. Therefore, the aim of the present study was to evaluate the clinical and angiographic outcomes of SES implantation over a very long coronary artery segment. Since April 2002, all patients treated percutaneously at our institution received a SES as the device of choice as part of the Rapamycin Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. During the RESEARCH registry, stents were available in lengths of 8, 18, and 33 mm. The present report includes a predefined study population consisting of patients treated with >36-mm-long stented segments. Patients had a combination of >or=2 overlapping stents at a minimum length of 41 mm (i.e., one 33-mm SES overlapping an 8-mm SES) to treat native de novo coronary lesions. The incidence of major cardiac adverse events (death, nonfatal myocardial infarction, and target lesion revascularization) was evaluated. The study group comprised 96 consecutive patients (102 lesions). Clinical follow-up was available for all patients at a mean of 320 days (range 265 to 442). In all, 20% of long-stented lesions were chronic total occlusions, and mean stented length per lesion was 61.2 +/- 21.4 mm (range 41 to 134). Angiographic follow-up at 6 months was obtained in 67 patients (71%). Binary restenosis rate was 11.9% and in-stent late loss was 0.13 +/- 0.47 mm. At long-term follow-up (mean 320 days), there were 2 deaths (2.1%), and the overall incidence of major cardiac events was 8.3%. Thus, SES implantation appears safe and effective for de novo coronary lesions requiring multiple stent placement over a very long vessel segment.

Objectives: This study investigated the clinical outcomes of patients with ST-segment elevation myocardial infarction (MI) treated with sirolimus-eluting stents (SESs) or with conventional bare stents., Background: The clinical impact of SES implantation for patients with ST-segment elevation MI is currently unknown., Methods: Primary angioplasty was performed with SESs in 186 consecutive patients with acute MI who were compared with 183 patients treated with bare stents. The incidence of death, reinfarction, and repeat revascularization was assessed at 30 and 300 days., Results: Postprocedure vessel patency, enzymatic release, and the incidence of short-term adverse events were similar in both the sirolimus and the bare stents (30-day rate of death, reinfarction, or repeat revascularization: 7.5% vs. 10.4%, respectively; p = 0.4). Stent thrombosis was not diagnosed in any patient in the sirolimus group and occurred in 1.6% of patients treated with bare stents (p = 0.1). At 300 days, treatment with SESs significantly reduced the incidence of combined adverse events (9.4% vs. 17%; hazard ratio [HR] 0.52 [95% confidence interval (CI) 0.30 to 0.92]; p = 0.02), mainly due to a marked reduction in the risk of repeat intervention (1.1% vs. 8.2%; HR 0.21 [95% CI 0.06 to 0.74]; p = 0.01)., Conclusions: Compared to conventional bare stents, the SESs were not associated with an increased risk of stent thrombosis and were effective in reducing the incidence of adverse events at 300 days in unselected patients with ST-segment elevation acute MI referred for primary angioplasty.

We assessed the impact of long-term fluvastatin treatment on adverse atherosclerotic cardiac events (cardiac death, myocardial infarction, and revascularization excluding repeat interventions due to restenosis in the first 6 months) in 847 patients (fluvastatin [n = 417] or placebo [n = 430]) with average cholesterol levels treated with stents in the Lescol Intervention Prevention Study (LIPS). During the 4-year follow-up period, fluvastatin significantly decreased total cholesterol and low-density lipoprotein cholesterol levels and decreased the risk of first adverse atherosclerotic cardiac events by 30% compared with placebo (95% confidence interval -49 to -3.4, p = 0.03).

The treatment of in-stent restenosis (ISR) remains one of the major therapeutic challenge for the interventional cardiologist. All percutaneous mechanical approaches have shown disappointing results and the recurrence of ISR was reported to be unacceptably high. Currently, the only proven effective therapy available for the treatment of ISR, at least for the most complex lesions, is vascular brachytherapy. However, this therapy is limited by potential side effects and logistic requirements. The introduction of drug-eluting stents, that carry and release antiproliferative agents, have demonstrated to virtually eliminate ISR in de novo lesions. In the light of this promising results for de novo lesions, sirolimus-eluting stents (SES) were recently used for the treatment of ISR in 2 pilot studies. In Sao Paulo, 25 patients with ISR treated with SES (1.4 stent per lesion) presented 4% ISR and no clinical events at 1 year. In Rotterdam, 16 patients with severe ISR were treated with 26 SES. Intravascular ultrasound evaluation demonstrated successful inhibition of neointimal hyperplasia with 1.1% volume obstruction of the stent, which is similar to the Sao Paulo series (0.8%). At 9 months clinical follow-up, 3 patients had experienced 4 major adverse cardiac events (2 deaths and 1 acute myocardial infarction necessitating repeat target vessel angioplasty). With the results presently available, SES implantation can be considered safe and potentially efficacious in the treatment of ISR. However, multicenter, long-term randomized studies are warranted in order to evaluate this new treatment concept.