Left Main Stenting in Comparison With Surgical Revascularization: 10-Year Outcomes of the (Left Main Coronary Artery Stenting) LE MANS Trial.

OBJECTIVES: This study has reported 10-year clinical follow-up of patients enrolled in the prospective, randomized LE MANS (Left Main Stenting) trial. BACKGROUND: The very long-term outcome after left main stenting in comparison with surgical revascularization remains unknown. METHODS: In this prospective, multicenter trial, we randomly assigned 105 patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease according to SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score to percutaneous coronary intervention (PCI) with stenting (n = 52) or coronary artery bypass grafting (CABG) (n = 53). Drug-eluting stents were implanted in 35%, whereas arterial grafts to the left anterior descending artery were utilized in 81%. Currently, the mean long-term follow-up was collected at 9.8 ± 1.0 years. Follow up for all-cause mortality is complete, whereas the incidence of major adverse cardiovascular and cerebral events (MACCE) was reported from 90% of patients. Ambulatory follow-up was completed in 46 (43.9%) patients. RESULTS: At 10 years, there was a trend toward higher ejection fraction in stenting when compared with surgery (54.9 ± 8.3% vs. 49.8 ± 10.3%; p = 0.07). The mortality (21.6% vs. 30.2%; p = 0.41) and MACCE (51.1% vs. 64.4%; p = 0.28) were statistically not different between groups; however, numerically the difference was in favor of stenting. Similarly, there was no difference in the occurrence of myocardial infarction (8.7 vs. 10.4%; p = 0.62), stroke (4.3 vs. 6.3%; p = 0.68), and repeated revascularization rates (26.1% vs. 31.3%; p = 0.64). The probability of very long-term survival up to 14 years was comparable between PCI and CABG (74.2% vs. 67.5%; p = 0.34; hazard ratio: 1.45, 95% confidence interval: 0.67 to 3.13); however, there was a trend toward higher MACCE-free survival in the PCI group (34.7% vs. 22.1%; p = 0.06; hazard ratio: 1.71, 95% confidence interval: 0.97 to 2.99). CONCLUSIONS: In patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease, stenting offers numerically, but statistically nonsignificant, favorable long-term outcome up to 10 years in terms of safety and efficacy outcome measures, therefore, constitutes an alternative therapy for CABG.

Treatment of symptomatic coronary artery disease in patients with end-stage renal disease on hemodialysis with paclitaxel-eluting TAXUS stent.

Percutaneous coronary intervention (PCI) utilizing drug-eluting stents is becoming a very common revascularization technique in the dialysis cohort; therefore, we sought to identify the impact of dialysis on outcomes in this group of patients. This is a multicenter registry comparing results of 290 patients (186 with normal kidney function, 104 on dialysis) who underwent PCI with exclusive use of paclitaxel-eluting TAXUS stent. The primary endpoint was an assessment of major adverse cardiac events (MACE) at 1- and 2-year observation. Mean follow-up was 23.3 ± 6.1 months. Results at 12 months showed: MACE 11.8% vs. 7.7% (P = not significant [ns]), composite major adverse cardiac and cerebrovascular events (MACCE) 12.4% vs. 11.5% (P = ns), all-cause death 2.7% vs. 8.6% (P < 0.05), cardiac death 2.7% vs. 1.9% (P = ns), target vessel revascularization (TVR) 9.1% vs. 6.7% (P = ns), acute myocardial infarction (AMI) 3.8% vs. 2.9% (P = ns), cerebrovascular events (CVA) 0.5% vs. 1.0% (P = ns); and results at 24 months showed: MACE 17.7% vs. 18.3% (P = ns), MACCE 21.5% vs. 26.0% (P = ns), all-cause death 4.3% vs. 14.4% (P < 0.01), cardiac death 3.2% vs. 1.9% (P = ns), TVR 14.0% vs. 16.3% (P = ns), AMI 5.4% vs. 5.8% (P = ns), CVA 3.2% vs. 2.9% (P = ns) for non-end-stage renal disease (ESRD) and dialysis group, respectively. Prior coronary artery bypass graft (CABG) was found to be single risk factor for MACE, TVR, and MACCE in patients with ESRD, while dialysis and prior CABG were found to be single risk factors for death in the entire population. PCI with TAXUS is a feasible procedure and presents promising results in dialysis-dependent patients.

Comparable clinical safety and efficacy of biodegradable versus durable polymer paclitaxel eluting stents despite shorter dual antiplatelet therapy: insights from a multicenter, propensity score-matched registry.

BACKGROUND: The biodegradable polymer drug-eluting stents have been proposed as an alternative to durable polymer DES, theoretically improving vessel healing and reducing the need for prolonged double anti platelet therapy (DAPT), however clinical significance of this technology is under debate. Therefore, we sought to compare the clinical outcomes of two Paclitaxel eluting stents (PES) containing different polymer-based eluting matrices. METHODS: In this multicenter registry of 392 consecutive patients who underwent PCI between June 2006 and September 2008, we included patients with stable angina or NSTE-ACS displaying at least one significant lesion (>50% diameter stenosis) in native coronary arteries. RESULTS: Biodegradable polymer PES (BP-PES, LUC Chopin(2) , Balton, Poland) was implanted in 206 patients, whereas durable polymer PES (DP-PES, Taxus, Boston Scientific, USA) was implanted in 186 patients. There were no significant differences in baseline characteristics between groups with the exception of increased diabetes and number of lesions for BP-PES. In risk-unadjusted analysis at 1-year follow-up, there were no significant differences in TLR (BP-PES: 8.4% vs. DP-PES: 6%; P = 0.36), TVR (BP-PES: 11.1% vs. DP-PES: 8.4%; P = 0.36) and incidence of stent thromboses (BP-PES: 2.15% vs. DP-PES: 3.4%; P = 0.42) between groups. There was also no difference in MACCE between groups (17.6% vs. 14.4%, P = 0.49). The mean dual antiplatelet therapy (DAPT) compliance at 1 year was 77% for BP-PES versus 92% for DP-PES (P = 0.03). Kaplan-Meier analysis showed a significantly higher long-term stroke free survival in BP-PES (P = 0.04). After adjustment, this was sustained with an additional tendency toward higher MI free survival for BP-PES (P = 0.059). CONCLUSIONS: In this observational analysis, BP-PES were comparable to DP-PES, with regard to incidence of repeated revascularizations, stent thromboses and MACCE despite earlier DAPT discontinuation.

Early and long-term outcomes after surgical and percutaneous myocardial revascularization in patients with non-ST-elevation acute coronary syndromes and unprotected left main disease.

UNLABELLED: Surgical myocardial revascularization (CABG) in patients with unprotected left main coronary artery disease (ULMCA) is a Class I recommendation in the AHA/ACC guidelines, however it is associated with increased perioperative risk in non-ST elevation acute coronary syndromes (NSTE-ACS). The aim of this study was to compare early and late results after percutaneous coronary intervention (PCI) and CABG in this cohort of patients. METHODS: A multicenter prospective registry included 138 patients with patent but severely narrowed (> 50%) ULMCA disease and NSTE-ACS diagnosed between January 2005 and April 2007. After emergent coronary angiography, 63 patients underwent PCI, whiles 75 were assigned for CABG. RESULTS: Groups were comparable with regard to sex, age and prevalence of diabetes mellitus (DM). They had similar left ventricular ejection fraction, SYNTAX Score and incidence of distal LM stenosis. However, PCI patients were at higher surgical risk (Euroscore 8.7 +/- 3.7 vs. 7.4 +/- 3.0; p = 0.02) and myocardial infarction incidence (28% vs. 14%; p = 0.07). The 30-day mortality was 1.5% after PCI vs. 12% after CABG (p = 0.043) and major adverse cardiovascular and cerebrovascular events (MACCE) were 3.2% vs. 14.7%, respectively (p = 0.04). After 12 months, there were 4 deaths in the PCI group and 12 deaths in the CABG group (6.3% vs. 16%; p = 0.14). There was no difference in MACCE (9.5% vs. 9.3% p = ns). Kaplan-Meier analysis revealed a trend toward better survival after PCI (p = 0.07). Revascularization with CABG and a Euroscore > 5 were the independent risk factors influencing early survival, while a Euroscore > 6 was the independent predictor of late mortality. CONCLUSIONS: PCI is a reasonable alternative to CABG in patients with NSTE-ACS and ULMCA stenosis.

Early and long-term results of unprotected left main coronary artery stenting: the LE MANS (Left Main Coronary Artery Stenting) registry.

OBJECTIVES: The aim of the study was to evaluate early and late outcomes after percutaneous coronary intervention (PCI) of unprotected left main coronary artery disease (ULMCA) and to compare bare-metal stent (BMS) and drug-eluting stent (DES) subgroups. BACKGROUND: PCI is an increasingly utilized method of revascularization in patients with ULMCA. METHODS: This multicenter prospective registry included 252 patients after ULMCA stenting enrolled between March 1997 and February 2008. Non-ST-segment elevation acute coronary syndrome was diagnosed in 58% of patients; ST-segment elevation myocardial infarction cases were excluded. Drug-eluting stents were implanted in 36.2% of patients. RESULTS: Major adverse cardiovascular and cerebral events (MACCE) occurred in 12 (4.8%) patients during the 30-day period, which included 4 (1.5%) deaths. After 12 months there were 17 (12.1%) angiographically confirmed cases of restenosis. During long-term follow-up (1 to 11 years, mean 3.8 years) there were 64 (25.4%) MACCE and 35 (13.9%) deaths. The 5- and 10-year survival rates were 78.1% and 68.9%, respectively. Despite differences in demographical and clinical data in favor of BMS patients, unmatched analysis showed a significantly lower MACCE rate in DES patients (25.9% vs. 14.9%, p = 0.039). This difference was strengthened after propensity score matching. The DES lowered both mortality and MACCE for distal ULMCA lesions when compared with BMS. Ejection fraction <50% was the only independent risk factor influencing long-term survival. CONCLUSIONS: Stenting of ULMCA is feasible and offers good long-term outcome. Implantation of DES for ULMCA decreased the risk of long-term MACCE, and particularly improved survival in patients with distal ULMCA disease.