Key Points:
- Previous studies have demonstrated the superiority of CABG over PCI in the treatment of multivessel disease; however, most studies were performed without the use of newer second-generation stents.
- The two-year outcomes of the BEST trial demonstrated superiority of CABG compared to PCI with second-generation everolimus-eluting DES; however, the authors then pursued an extended outcome analysis up to a median follow-up of 11.8 years.
- There was no difference between PCI and CABG at extended follow-up in the primary outcome composite of all-cause death, MI, and total revascularization. However, the rate of spontaneous MI and repeat revascularization was higher in the PCI arm.
- IVUS use reduced the incidence of the primary composite amongst patients undergoing PCI.
Previous trials examining the use of PCI vs CABG in multivessel CAD, including SYNTAXES-3VD, FREEDOM, and FAME3, have demonstrated the superiority of CABG. However, these studies were generally performed with first generation drug eluting stents (DES). The BEST trial was conducted in order to compare CABG with PCI using second-generation (everolimus-eluting) DES in multivessel disease. The two-year results were published in 2015 and demonstrated higher MACE in patients with PCI compared to CABG. However, the long-term results of the BEST study have not yet been published. In a breaking presentation at the 2022 TCT Conference today, Dr. Jung-Min Ahn (Asan Medical Center, Korea) and his team presented their study: “EES or CABG for Multivessel CAD,” or the extended follow-up outcomes of the BEST study.
The BEST study (NCT00997828) was a prospective, open-label, randomized trial conducted across 27 sites in East Asia which assessed the safety and effectiveness of coronary stenting with the Everolimus-Eluting Coronary Stent System compared to CABG. The inclusion criteria comprised adults with angiographic multivessel CAD, defined as critical (>70%) lesions in at least two major epicardial vessels in at least two coronary territories with indication for revascularization based on angina or objective evidence of myocardial ischemia; relevant exclusions included class III-IV heart failure, prior CABG, recent PCI < 1 year, acute STEMI, or any in-stent restenosis of a target vessel. The trial was designed to assign 1776 patients, but after 880 were included, the study was terminated early due to slow enrollment. The mean age was 64 and 41% had diabetes; the average SYNTAX score was 24.4, and 12.5% of patients were deemed to have high operative risk. For those undergoing PCI, 71.8% utilized IVUS guidance, 50.9% achieved complete revascularization, and the average number of stents placed was 3.4. For those undergoing CABG, the average number of grafted vessels was 3.1 (2.1 arterial grafts), 99.3% received a LIMA, and 71.5% achieved complete revascularization.
In this extended follow-up analysis, patients were followed for a median of 11.8 years (up to 13.7 years) after initial enrollment. The primary outcome was a composite of major adverse cardiovascular events (MACE) including all-cause death, myocardial infarction, and target vessel revascularization (TVR). At median follow-up, there was no difference in the primary endpoint between the PCI and CABG arms (HR 1.18, 95% CI 0.88-1.56, p = 0.26). There was similarly no difference in the secondary composite of death, MI, or stroke or the individual secondary outcome of death from any cause. Repeat revascularization was higher in the PCI arm (HR 1.92, 95% CI 1.58-2.32, p <0.001). While the overall rate of myocardial infarction did not differ between groups, the stratified outcome of spontaneous myocardial infarction was higher in the PCI group (HR 1.86, 95% CI 1.06-3.27, p =0.03). In a secondary analysis of the primary outcome, among patients treated with PCI, IVUS use resulted in lower MACE (HR 0.45, 95% CI 0.33-0.61, p <0.001).
When discussing the clinical implications of the study at TCT, Dr. Ahn stated: “In the BEST trial, during a median follow-up of 11.8 years, there were no significant differences between PCI and CABG in the incidence of the composite of death from any cause, MI, or TVR, or in mortality alone….however, the incidence of spontaneous MI and repeat revascularization was higher in the PCI group…this extended follow-up provides important long-term insights that could aid in decision-making for the optimal revascularization strategy in patients with MVD.”