Summary
Percutaneous coronary intervention with second-generation everolimus-eluting stents was inferior to coronary artery bypass graft surgery in patients with multivessel coronary artery disease in the open-label prospective randomized BEST trial. The composite primary outcome (all-cause death, myocardial infarction, target vessel revascularization) occurred more frequently in patients randomized to percutaneous coronary intervention.
- NCT00997828
- PCI
- CABG
- bypass surgery
- BEST
- CAD
- drug-eluting stent
- everolimus
- cardiology & cardiovascular medicine clinical trials
- interventional techniques & devices
Long-term data from the prospective open-label BEST trial found percutaneous coronary intervention (PCI) with a second-generation drug-eluting stent to be inferior to coronary artery bypass graft (CABG) surgery in patients with multivessel coronary artery disease (CAD), according to Seung-Jung Park, MD, PhD, Asan Medical Center, Seoul, Korea [Park SJ et al. N Engl J Med. 2015].
Recent studies have found that CABG surgery is associated with lower rates of adverse outcomes in patients with multivessel CAD when compared with PCI. The BEST trial was designed as a randomized noninferiority trial that compared optimal revascularization with PCI using everolimus-eluting stents to CABG in patients with multivessel CAD.
A total of 880 patients from 4 countries in East Asia with angina and/or objective evidence of a myocardial ischemia and multivessel CAD confirmed by angiography were enrolled in the trial. The study was terminated early because of slow enrollment.
Patients were randomly assigned to PCI (n = 438) or CABG (n = 442), although crossovers and other treatment changes occurred. The primary end point was the composite of major adverse cardiac events (all-cause death, myocardial infarction [MI], and target vessel revascularization) at 2 years. Key secondary end points included stroke, new lesion revascularization, and TIMI major bleeding.
Follow-up was performed with either a clinic visit or phone interview at 30 days; 6, 9, and 12 months; and then annually. Medications for secondary prevention (aspirin, statins) were strongly recommended, and routine angiography in the absence of ischemia was discouraged.
The composite primary end point occurred in 11.0% of PCI patients and 7.9% of CABG patients at 2 years with an absolute risk difference of 3.1 percentage points (95% CI, –0.8 to 6.9; PNoninferiority = .32). The incidence of the primary outcome was significantly higher in the PCI group vs the CABG group at 5 years (Table 1). CABG performed better for the primary end point in all of the prespecified subgroups. As shown in Table 1, some secondary outcomes were increased at 5 years in the PCI group vs the CABG group, while TIMI major bleeding was significantly lower.
In conclusion, the BEST trial found that PCI with the second-generation everolimus-eluting stent was inferior to CABG for the primary end point of all-cause death, MI, or target vessel revascularization at 2 years. Patients randomized to PCI had an increased risk of all-cause death, MI, and target vessel revascularization that remained present at 5 years.
- © 2015 SAGE Publications