Ten-year Outcomes After Drug-Eluting Stents or Bypass Surgery for Left Main Coronary Disease in Patients With and Without Diabetes Mellitus: The PRECOMBAT Extended Follow-Up Study

Abstract

Background Several trials reported differential outcomes after percutaneous coronary intervention with drug-eluting stents (DES) and coronary-artery bypass grafting (CABG) for multivessel coronary disease according to the presence of diabetes mellitus (DM). However, it is not well recognized how DM status affects very-long-term (10-year) outcomes after DES and CABG for left main coronary artery disease. Methods and Results In the PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) trial, patients with LMCA were randomly assigned to undergo PCI with sirolimus-eluting stents (n=300) or CABG (n=300). The primary outcome was the incidence of major adverse cardiac or cerebrovascular events (MACCE; a composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization). Outcomes were examined in patients with (n=192) and without (n=408) medically treated diabetes. The follow-up was extended to at least 10 years for all patients (median, 11.3 years). The 10-year rates of MACCE were not significantly different between DES and CABG in patients with DM (36.3% versus 26.7%, respectively; hazard ratio [HR], 1.35; 95% CI, 0.83-2.19; P=0.23) and without DM (25.3% versus 22.9%, respectively; HR, 1.15; 95% CI, 0.79-1.67; P=0.48) (P-for-interaction=0.48). There were no significant between-group differences in composite of death, MI, or stroke, and all-cause mortality, regardless of DM status. TVR rates were consistently higher after DES than CABG. Conclusions In this 10-year extended follow-up of PRECOMBAT, we found no significant difference between DES and CABG with respect to the incidences of MACCE, serious composite outcome, and all-cause mortality in patients with and without DM with LMCA disease. However, owing to the limited number of patients and no adjustment for multiple testing, overall findings should be considered hypothesis-generating, highlighting the need for further research. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03871127 and NCT00422968.

Keywords: coronary artery bypass grafting; drug‐eluting stents; left main coronary artery disease; percutaneous coronary intervention.

Conflict of interest statement

Dr D.‐W. Park reports grants from Daiichi‐Sankyo, Chong Kun Dang Pharm, and Daewoong Pharm, personal fees from Edwards, grants and personal fees from Abott Vascular, and personal fees from Medtronic, all outside the submitted work. Dr S.‐J. Park reports grants and personal fees from Abott Vascular, grants from Daiichi‐Sankyo, grants from Chong Kun Dang Pharm and Daewoong Pharm, grants and personal fees from Edwards, all outside the submitted work. The remaining authors have no disclosures to report.

Figures

Figure 1. Kaplan‐Meier curves for the 10‐year primary composite outcome, according to the presence or absence of diabetes mellitus.

The 10‐y event curves after percutaneous coronary intervention and coronary artery bypass grafting are shown for primary composite outcome of death from any cause, myocardial infarction, stroke, or ischemic‐driven target‐vessel revascularization.

Figure 2. Cumulative incidences of primary composite outcome, according to diabetes mellitus status and treatment assignment.

The 10‐y event curves after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) are shown for primary composite outcome of death from any cause, myocardial infarction, stroke, or ischemic‐driven target‐vessel revascularization. Hazard ratios are for the PCI group, as compared with the CABG group. DM indicates diabetes mellitus; and HR, hazard ratio.