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.

Long‐term outcomes of percutaneous versus surgical revascularization in patients with diabetes and left main coronary artery disease: A meta‐analysis of randomized controlled trials

“…After the removal of duplicate records and studies based on title/abstract review, 30 remained and were fully reviewed for the inclusion and exclusion criteria. Four RCTs met all inclusion criteria (EXCEL, NOBLE, PRECOMBAT, and SYNTAX) 7,16–19 . A nonoverlapping population of 1080 patients was included, of whom 553 (51.2%) underwent PCI.…”

“…Four RCTs met all inclusion criteria (EXCEL, NOBLE, PRECOMBAT, and SYNTAX). 7,[16][17][18][19] A nonoverlapping population of 1080 patients was included, of whom 553 (51.2%) underwent PCI. 1.…”

Surgical and percutaneous coronary revascularization in patients with multivessel or left main disease; what happens beyond five years? A systematic review and study level meta-analysis of randomized trials

“…The literature search identified 475 records and 13 studies were considered relevant and then retrieved. Among them, 4 RCTs [BEST (NCT05125367 and NCT00997828) FREEDOM (NCT00086450), PRECOMBAT (NCT03871127 and NCT00422968) and SYNTAX (NCT03417050) (20)(21)(22)(23)] met the eligibility criteria and were included in the final analysis. The PRISMA Flow Chart of study selection is shown in Supplemental Figure 1.…”

Coronary artery bypass grafting is superior to percutaneous coronary intervention in patients with left ventricular dysfunction

“…This is still controversial despite recent data. Looking at specific subsets of patients like those with the left main disease, some very recent data from Jeong et al 14 suggest that there are no significant differences between DES and CABG with respect to the incidences of MACCE, serious composite outcome, and all‐cause mortality in patients with and without diabetes mellitus with LMCA disease although authors state that their sample size could be a limitation. Furthermore, Ono et al 15 just a few days ago highlight in this extended follow‐up of the SYNTAX trial 16 that there were no significant differences at 10 years in all‐cause death and estimated life expectancy between PCI and CABG in the elderly (>70 years).…”