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

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. (Evaluation of Outcomes of EES Implantation for Unprotected Left Main Coronary Artery Stenosis [PRECOMBAT-2]; NCT01348022)