Long-term Follow Up Finds No Significant Safety or Major Adverse Event Differences Between PCI with an Everolimus-Eluting Stent and Surgery

News Archive

Results from the BEST Trial Presented at TCT and Published Simultaneously in Circulation

BOSTON – September 19, 2022 – Ten-year outcomes after percutaneous coronary intervention (PCI) with an everolimus-eluting stent and coronary-artery bypass grafting (CABG) found no significant difference between the two treatments in terms of safety and major adverse cardiac events. Spontaneous myocardial infarction and repeat revascularizations occurred more frequently with PCI compared to CABG.

Findings were reported today at TCT 2022, the 34th annual scientific symposium of the Cardiovascular Research Foundation (CRF). TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.

Long-term comparative outcomes data after PCI utilizing an everolimus-eluting stent and CABG in patients with multivessel coronary artery disease is limited. The prospective, multicenter, randomized, controlled trial was conducted in 27 international heart centers. Between July 2008 and September 2013, a total of 880 patients with angiographic multivessel coronary artery disease amenable to either PCI or CABG were randomly assigned to PCI with an everolimus-eluting stent (n= 438) or CABG (n=442).

Follow-up was originally scheduled at 30 days and six, nine, and 12 months, and annually

for up to five years. The study was terminated early due to slow enrollment in October 2013 and reported findings with a median clinical follow-up of 4.6 years. In February 2022, the principal investigator invited participation from all 27 heart centers for an extended follow-up study with a minimum and maximum follow-up of eight years and 14 years, respectively.

The primary endpoint was the composite of death from any cause, myocardial infarction, or target-vessel revascularization. During a median follow-up of 11.8 years (interquartile range, 10.6 to 12.5 years), the primary endpoint occurred in 151 patients (34.5%) in the PCI group and 134 patients (30.3%) in the CABG group (HR 1.18; 95% CI, 0.88 to 1.56; p=0.26). No significant differences were seen in the occurrence of a safety composite of death, myocardial infarction, or stroke between groups (28.8% and 27.1%, HR 1.07; 95% CI 0.75 to 1.53; p=0.70) as well as death from any cause (20.5% and 19.9%, HR 1.04; 95% CI 0.65 to 1.67; p=0.86). Spontaneous myocardial infarction (7.1% and 3.8%, HR 1.86; 95% CI 1.06 to 3.27; p=0.031) and repeat revascularization (22.6% and 12.7%, HR 1.92; 95% CI 1.58 to 2.32; p<0.001) occurred more frequently after PCI than after CABG.

“Over an extended follow-up of up to 14 years, there were no significant differences in the rates of major adverse cardiac events, serious composite outcomes, and mortality for PCI compared to CABG,” said Jung-Min Ahn, MD, Asan Medical Center. “Having this specific type of very long-term data could aid in making treatment decisions for patients with multivessel coronary artery disease.”

The study was supported by funds from the CardioVascular Research Foundation (Seoul, Korea) and Abbott Vascular. Dr. Ahn had no disclosures to report.

About CRF and TCT

The Cardiovascular Research Foundation (CRF) is one of the world’s leading nonprofit organizations specializing in interventional cardiology innovation, research, and education. CRF is dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 30 years, CRF has helped accelerate medical breakthroughs and educated doctors on the latest treatments for heart disease. CRF’s centers of excellence include the CRF Skirball Center for Innovation, CRF Clinical Trials Center, CRF Center for Education, CRF Digital, TCTMD, and Structural Heart: The Journal of the Heart Team.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the premier educational meeting specializing in interventional cardiovascular medicine. Now in its 34th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.

For more information, visit www.crf.org and www.tctconference.com.

###