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Age-Related Characteristics and Outcomes of Patients With Heart Failure With Preserved Ejection Fraction Effect of Intravascular Ultrasound-Guided vs Angiography-Guided Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial Long-Term Durability of Transcatheter Heart Valves: Insights From Bench Testing to 25 Years Comprehensive intravascular ultrasound assessment of stent area and its impact on restenosis and adverse cardiac events in 403 patients with unprotected left main disease Rationale and design of a randomized clinical trial comparing safety and efficacy of Myval transcatheter heart valve versus contemporary transcatheter heart valves in patients with severe symptomatic aortic valve stenosis: the LANDMARK trial Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI Clinical applications of machine learning in the diagnosis, classification, and prediction of heart failure Association Between Functional Impairment and Medication Burden in Adults with Heart Failure Suture- or Plug-Based Large-Bore Arteriotomy Closure: A Pilot Randomized Controlled Trial

Clinical Trial2012 Jul;5(7):708-17.

JOURNAL:JACC Cardiovasc Interv. Article Link

Everolimus-eluting stent implantation for unprotected left main coronary artery stenosis. The PRECOMBAT-2 (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) study

Kim YH, Park DW, PRECOMBAT-2 Investigators. Keywords: bypass surgery; coronary disease; left main coronary disease; stents

ABSTRACT


OBJECTIVES - This study sought to evaluate the safety and efficacy of second-generation drug-eluting stents (DES) for patients with unprotected left main coronary artery (ULMCA) stenosis.


BACKGROUND - The clinical benefit of second-generation DES for ULMCA stenosis has not been determined.

METHODS - The authors assessed 334 consecutive patients who received everolimus-eluting stents (EES) for ULMCA stenosis between 2009 and 2010. The 18-month incidence rates of major adverse cardiac or cerebrovascular events (MACCE), including death, myocardial infarction (MI), stroke, or ischemia-driven target vessel revascularization (TVR), were compared with those of a randomized study comparing patients who received sirolimus-eluting stents (SES) (n = 327) or coronary artery bypass grafts (CABG) (n = 272).

RESULTS - EES (8.9%) showed a comparable incidence of MACCE as SES (10.8%; adjusted hazard ratio [aHR] of EES: 0.84; 95% confidence interval [CI]: 0.51 to 1.40; p = 0.51) and CABG (6.7%, aHR of EES: 1.40; 95% CI: 0.78 to 2.54; p = 0.26). The composite incidence of death, MI, or stroke also did not differ among patients receiving EES (3.3%), SES (3.7%; aHR of EES: 0.63; 95% CI: 0.27 to 1.47; p = 0.29), and CABG (4.8%; aHR of EES: 0.67; 95% CI: 0.29 to 1.54; p = 0.34). However, the incidence of ischemia-driven TVR in the EES group (6.5%) was higher than in the CABG group (2.6%, aHR of EES: 2.77; 95% CI: 1.17 to 6.58; p = 0.02), but comparable to SES (8.2%, aHR of EES: 1.14; 95% CI: 0.64 to 2.06; p = 0.65). Angiographic restenosis rates were similar in the SES and EES groups (13.8% vs. 9.2%, p = 0.16).

CONCLUSIONS - Second-generation EES had a similar 18-month risk of MACCE for ULMCA stenosis as first-generation SES or CABG.

TRIAL REGISTRATION - ClinicalTrials.gov NCT01348022.

Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.