Long-Term Outcomes after Drug-Eluting Stents versus Coronary Artery Bypass Grafting for Left Main Coronary Disease: 10-Year Follow-Up of the Multicenter Randomized Controlled PRECOMBAT Trial

Background: Long-term comparative outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents and coronary-artery bypass grafting (CABG) in patients with left main coronary artery disease are still limited.Methods: From April 2004 to August 2009, a total of 600 patients with unprotected left main coronary artery disease were randomly assigned to undergo either PCI with sirolimus-eluting stents (PCI group, 300 patients) or CABG (CABG group, 300 patients). The primary outcome was a major adverse cardiac or cerebrovascular event (death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization). The follow-up was extended to at least 10 years for all patients (median, 11.3 years). This report provides descriptive information on end-point events.Findings: At 10 years, a primary outcome event occurred in 29.8% of the PCI group and in 24.7% of the CABG group (hazard ratio with PCI vs. CABG, 1.25; 95% confidence interval [CI], 0.93 to 1.69; P=0.14). The 10-year incidences of a composite of death, myocardial infarction, or stroke (18.2 vs. 17.5%; hazard ratio, 1.00; 95% CI, 0.70 to 1.44; P=0.98) and death from any cause (14.5% vs. 13.8%; hazard ratio, 1.13; 95% CI, 0.75 to 1.70; P=0.57) were not significantly different between the PCI and CABG groups. Ischemia-driven target-vessel revascularization was more frequent after PCI than after CABG (16.1% vs. 8.0%; hazard ratio, 1.98; 95% CI, 1.21 to 3.21; P=0.006).Interpretation: In this randomized cohort of patients with left main coronary artery disease who underwent PCI or CABG, we did not detect significant differences in the rates of major adverse cardiac or cerebrovascular events, serious composite outcome, and mortality at 10 years.Trial Registration: PRECOMBAT 10-year follow-up study [ClinicalTrials.gov number, NCT03871127] and PRECOMBAT [ClinicalTrials.gov number, NCT00422968].Funding Statement: This study was funded by the Cardiovascular Research Foundation, Seoul, Korea.Declaration of Interests: DWP reports grants from Daiichi-Sankyo, grants from ChongKunDang Pharm, grants from Daewoong Pharm, personal fees from Edwards, grants and personal fees from Abott Vascular , personal fees from Medtronic, outside the submitted work. GMP reports grants from Yuhan Pharm, outside the submitted work. SJP reports grants and personal fees from Abott Vascular , grants from Daiichi-Sankyo, grants from ChongKunDang Pharm, grants from Daewoong Pharm, grants and personal fees from Edwards, outside the submitted work. All other authors declare no competing interests.Ethics Approval Statement: The institutional review board at each hospital approved the protocol, and informed consent to obtain information on 10-year outcomes was waived. Follow-up was performed in accordance with the local law and regulations of each participating site and complied with the Declaration of Helsinki.