AT ACC 15
SAN DIEGO (FRONTLINE MEDICAL NEWS) – Percutaneous coronary intervention with everolimus-eluting stents is associated with significantly higher major adverse cardiovascular events than is coronary artery bypass grafting in patients with multivessel coronary artery disease, according to results of the BEST trial.
In the randomized noninferiority trial of 880 patients, there was a 47% higher rate of the primary endpoint of death, myocardial infarction, or target vessel revascularization among patients randomized to percutaneous coronary intervention (PCI) with the new-generation drug-eluting stent than among those randomized to coronary artery bypass grafting (CABG), after a median of 4.6 years follow-up.
However, the differences in primary endpoint were not significant for noninferiority between the two groups at the 2-year follow-up mark, Dr. Seung-Jung Park said at the annual meeting of the American College of Cardiology.
The Xience everolimus-eluting stent used in BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) is one of several bioabsorbable vascular scaffolds that have caught on in recent years. The working hypothesis behind the device is that by dissolving during a period of 12-24 months, the scaffold provides temporary bracing against restenosis but then disappears, allowing improved endovascular healing.
Patients were randomized after diagnostic coronary angiography to PCI (438 patients) or to CABG (442).
The study, which was terminated early because of slow enrollment, also found a significantly greater rate of the composite secondary endpoint of death, myocardial infarction, stroke, or repeat revascularization in the PCI group compared to the CABG group (19.9% vs. 13.3%, P = .01).
There were no significant differences between the two groups in the rate of the other secondary safety endpoint: a composite of death, MI, and stroke.
In total, 29 patients assigned to PCI died, compared with 22 assigned to CABG (6.6% vs. 5%, P = .30).
The rate of spontaneous myocardial infarction was significantly higher in the PCI group (4.3% vs. 1.6%, P = .02), as was the rate of repeat revascularization (11% vs. 5.4%, P = .003).
There were fewer incidences of major bleeding in the PCI group compared to the CABG group, although the rate of fatal major bleeding was similar for both arms of the study.
Diabetes status had a major negative impact on outcome for patients undergoing PCI, increasing the rate of the primary endpoint to 19.2%, compared to 9.1% in patients undergoing CABG (P = .007).
“In the BEST trial, PCI with everolimus-eluting stents was not shown to be noninferior to CABG with respect to the primary endpoint of death, myocardial infarction, or target vessel revascularization at 2 years,” wrote Dr. Park of the University of Ulsan College of Medicine, and his coauthors. The article was published online simultaneously with his presentation (N. Engl. J. Med. 2015 March 15 [ doi:10.1056/NEJMoa1415447 ]).
“At longer-term follow-up (median 4.6 years), PCI was associated with a significant increase in the incidence of the primary endpoint, as compared to the incidence with CABG.”
The authors suggested this difference was largely attributable to the higher rate of repeat target-vessel revascularization in patients who had undergone PCI, as well as the spontaneous myocardial infarction and new lesion revascularization.
In contrast to previous studies, the researchers did not find a significant difference in the rate of stroke between the two groups.
“The reason for this discrepancy is not clear, but the use of off-pump CABG can avoid excessive manipulation of the aorta, and may have contributed to a reduced rate of stroke in the CABG group in our study,” the authors noted.
The researchers acknowledged that the trial was not powered to detect differences in individual endpoints and that they did experience enrollment difficulties.
The CardioVascular Research Foundation, Abbott Vascular, and the Korea Healthcare Technology Research and Development Project supported the study. Dr. Park disclosed ties with Abbott, Cordis, Boston Scientific, and Medtronic, and has an ownership interest in the Cardiovascular Research Foundation.