• Extended Follow-Up Study Reports No Difference in Safety and Adverse Events Between PCI and CABG

    There were no significant differences in the rates of major adverse cardiac events, safety composite endpoint, and mortality between percutaneous coronary intervention (PCI) and coronary-artery bypass grafting (CABG), according to new extended-follow-up of up to 14 years from the BEST study.

    However, the incidence of spontaneous myocardial infarction (MI) and repeat revascularization was higher in the PCI group than in the CABG group, noted the authors, led by Jung-Min Ahn, MD, PhD, from Ulsan University College of Medicine, Seoul, South Korea.

    Findings from the extended-outcomes study were reported Monday at Transcatheter Cardiovascular Therapeutics (TCT) 2022 in Boston and published simultaneously online in Circulation.

    Speaking at TCT 2022, Ahn noted that long-term comparative outcomes after PCI with everolimus-eluting stents and CABG in patients with multivessel coronary artery disease (CAD) have been “limited,” but noted that  the extended follow-up of the BEST trial provides important long-term insights that could help decision-making for the optimal revascularization strategy in patients with multivessel coronary artery disease.

    “The current study reports very long-term clinical outcomes in patients with multivessel coronary artery disease who underwent PCI with everolimus-eluting stents and those who underwent CABG,” noted the authors.

    “There were no significant differences between PCI and CABG in the rates of the composite of death from any cause, myocardial infarction, or target vessel revascularization as well as the mortality during an extended follow-up period of up to 14 years,” they said, noting, however, that spontaneous MI and repeat revascularization more frequently occurred in patients after PCI than after CABG.

    Study setup

    Ahn and colleagues performed an extended clinical follow-up to evaluate longer-term comparative outcomes between PCI with everolimus-eluting stents and CABG among patients with multivessel CAD, who were followed for up to 13.7 years after initial enrollment in the BEST trial.

    The BEST trial was a prospective, multicenter, randomized controlled trial conducted in 27 international heart centers, in which 1,776 patients with angiographic multivessel CAD were randomly assigned to receive PCI with everolimus-eluting stents or CABG. Follow-up for BEST was originally scheduled at 30 days and 6, 9 and 12 months, and annually thereafter for up to 5 years. However, Ahn and colleagues reported that the trial was terminated early due to slow patient enrollment – after recruiting 880 patients – and reported findings with a median clinical follow-up of 4.6 years.

    However, in February 2022, the Ahn and colleagues invited participation from all 27 heart centers in an extended follow-up study with a minimum follow-up of 8 years and maximum follow-up of 14 years. Clinical follow-up was performed via clinical visit, telephone interview, medical records or national health insurance service database.

    The primary endpoint for both the initial trial and the extended follow-up study was a major adverse cardiac event composite of death from any cause, myocardial infarction or target-vessel revascularization. The major secondary endpoints were a safety composite of death, myocardial infarction or stroke and a composite of death, myocardial infarction, stroke or any repeat revascularization, while additional secondary endpoints included the individual components of the composite endpoints.

    Ahn reported that the baseline demographic, clinical and angiographic characteristics of the patients were well-matched, with a mean age of 64.5 years, while 41% had diabetes and 77% had triple-vessel CAD. They reported that SYNTAX score was 24.4 (low in 42.2% of the patients, intermediate in 41.4%, and high in 16.5%), and 12.5% were at high operative risk with the European System for Cardiac Operative Risk Evaluation ≥6.

    Complete revascularization was achieved in 50.9% and 71.5% of the patients in the PCI group and CABG groups, respectively (p<0.001), the investigators said, noting that patients in the PCI group received an average of 3.4 stents at 85.3 mm in length per patient, with intravascular ultrasound used in 71.8% of patients during PCI. In the CABG group, 64.3% of patients underwent off-pump surgery, and 99.3% underwent revascularization of the left anterior descending artery with the left internal thoracic artery.

    Long-term follow-up

    Ahn and colleagues reported that during a median follow-up of 11.8 years (interquartile range [IQR]: 10.6 to 12.5 years; maximum: 13.7 years), the primary endpoint occurred in 151 patients (34.5%) in the PCI group and 134 patients (30.3%) in the CABG group (hazard ratio [HR] 1.18; 95% confidence interval [CI], 0.88 to 1.56; P=0.26).

    They added that no significant differences were seen in the occurrence of the safety composite of death, myocardial infarction or stroke between groups (28.8% vs. 27.1%, HR 1.07; 95% CI 0.75 to 1.53; P=0.70) as well as the occurrence of death from any cause (20.5% vs. 19.9%, HR 1.04; 95% CI 0.65 to 1.67; P=0.86).

    The rate of stroke was not significantly different between groups (5.3% vs. 5.7%; HR, 0.94; 95% CI, 0.62 to 1.42; p=0.92), they said. However, spontaneous myocardial infarction (7.1% vs. 3.8%, HR 1.86; 95% CI 1.06 to 3.27; P=0.031) and any repeat revascularization (22.6% vs. 12.7%, HR 1.92; 95% CI 1.58 to 2.32; P<0.001) were more frequent after PCI than after CABG, reported Ahn.

    “The extended follow-up of the BEST trial provides important long-term insights that could aid in decision-making for the optimal revascularization strategy in patients with multivessel coronary artery disease,” said Ahn.

    The BEST Extended Outcome Study was an investigator-initiated trial and was funded by the CardioVascular Research Foundation (Seoul) and Abbott Vascular, Santa Clara, California.

    Source:

    Ahn JM, Kang DY, Yun SC, et al. Everolimus-Eluting Stents or Bypass Surgery for Multivessel Coronary Artery Disease: Extended Follow-up Outcomes of Multicenter Randomized Controlled BEST Trial. Circulation 2022 Sep 19 (Article in press).

    Image Credit: Jason Wermers/CRTonline.org

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