BEST: Due to Less TVR, CABG Still Favored Over PCI in Patients with Multivessel Disease
SAN DIEGO, CA—Even with the availability of newer-generation DES, patients with multivessel coronary artery disease still have better outcomes with surgery, according to a randomized study presented March 16, 2015, at the American College of Cardiology/i2 Scientific Session and published simultaneously online ahead of print in The New England Journal of Medicine.
Seung-Jung Park, MD, PhD, of Asan Medical Center (Seoul, South Korea), presented results from the Bypass Surgery Versus Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease (BEST) trial, which randomized 880 patients from 27 hospitals in 4 East Asian countries to PCI with an everolimus-eluting stent (n = 438) or CABG (n = 442) for treatment of multivessel disease.
The trial, which screened patients from July 2008 through September 2013, had a planned enrollment of 1,776 patients but was terminated early as a result of slow recruitment. Dr. Park explained that this was thought to be a consequence of the rapid spread of fractional flow reserve (FFR) measurement in clinical practice.
All patients were considered candidates for stenting or surgery, and demographic, clinical, and angiographic characteristics were well matched between the 2 groups at baseline. In the PCI group, patients received an average of 3.4 stents and IVUS use was 71.8%. Complete revascularization was more common with CABG than with PCI (71.5% vs 50.9%; P < .001). Compared with CABG patients, PCI patients were more likely to receive certain types of medical therapy including antiplatelet agents, beta blockers, ACE inhibitors or ARBs, and calcium channel blockers.
At 2 years, DES did not show noninferiority to CABG for the primary endpoint of death, MI, or TVR (P for inferiority = .32).
However, at a median follow up of 4 years, the rate of the primary endpoint was higher in the PCI group than in the CABG group, driven by greater rates of TVR with PCI. No differences were seen between treatment groups for the composite safety endpoint of death, MI, or stroke, but rates of any repeat revascularization, spontaneous MI, TVR, and new-lesion revascularization were higher in the PCI group (table 1).
Mortality rates were similar at 6.6% in the PCI group and 5.0% in the CABG group (P = .30). TIMI major bleeding was less frequent in the PCI group vs CABG (6.8% vs 29.9%; P < .001), but rates of fatal bleeding did not differ. ARC-defined stent thrombosis occurred in 7 PCI patients (1.6%) and consisted of 4 definite and 3 probable cases.
Registry Offers Additional Perspective
In a related registry study published in the same journal, mortality rates at approximately 3 years were similar for patients with multivessel disease irrespective of whether they received CABG or PCI using everolimus-eluting stents.
Researchers led by Sripal Bangalore, MD, MHA, of New York University School of Medicine (New York, NY), assessed the outcomes of 9,223 patients treated from 2008 through 2011 at centers in New York State. Mortality with CABG was 2.9% per year compared with 3.1% per year for PCI (P = .50). While the risks of MI and repeat revascularization each were higher with PCI compared with CABG, the risk of stroke was lower (0.7% per year vs 1.0% per year; HR 0.62, 95% CI 0.50-0.76). However, the heightened MI risk only reached significance among patients with incomplete revascularization (P for interaction = .02).
In an editorial accompanying both studies, Robert A. Harrington, MD, of Stanford University School of Medicine (Stanford, CA), says together they demonstrate that “there are clearly trade-offs between the 2 revascularization strategies that need to be discussed with patients as part of the shared decision-making process.”
While the early stroke risk with CABG may be unacceptable for some patients, others may elect to avoid the later hazards of PCI such as greater risk of repeat procedures or MI, he notes. These decisions, Dr. Harrington adds, should also take into account angiographic results, “with particular focus on whether complete revascularization with PCI appears to be feasible—a factor that would make PCI more attractive than CABG.”
During a press conference following Dr. Park’s presentation, moderator John Jarcho, MD, of Brigham & Women’s Hospital (Boston, MA), said the BEST findings are “likely to be generalizable to Western populations, but there’s always a little bit of asterisk over that because it was an entirely Asian population.”
It is “relatively surprising,” Dr. Jarcho noted, how closely the registry study by Dr. Bangalore mirrors BEST—with the exception of stroke outcomes—despite limitations inherent to a non-randomized design. Asian patients in general have less calcification of the ascending aortic arch, Dr. Jarcho reported, noting that there may be genetic differences as well that could be potentially important when looking at comparison studies.
1. Park S-J, Ahn J-M, Kim Y-H, et al. Trial of everolimus-eluting stents or bypass surgery for coronary disease. N Engl J Med. 2015;Epub ahead of print.
2. Bangalore S, Guo Y, Samadashvili Z, et al. Everolimus-eluting stents or bypass surgery for multivessel coronary disease. N Engl J Med. 2015;Epub ahead of print.
3. Harrington RA. Selecting revascularization strategies in patients with coronary disease [editorial]. N Engl J Med. 2015;Epub ahead of print.
- BEST was supported by Abbott Vascular, the Cardiovascular Research Foundation (Seoul, South Korea), and a grant from the Ministry of Health and Welfare Affairs, South Korea.
- Dr. Park reports consultant fees/honoraria as well as research support/grants from Abbott, Boston Scientific, Cordis, and Medtronic; and ownership interest/partnership/principal in the Cardiovascular Research Foundation (Seoul, South Korea).
- The registry study was supported by Abbott Vascular.
- Dr. Bangalore reports receiving consultant fees/honoraria from Abbott Vascular, Boerhringer Ingelheim, Daiichi Sankyo, Gilead Sciences, Pfizer, and Unique Pharmaceuticals as well as research support or grants from Abbott.
- Dr. Harrington reports relationships with multiple pharmaceutical and device companies.
- Dr. Jarcho reports no relevant conflicts of interest.
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