Arrhythmia and Death Following Percutaneous Revascularization in Ischemic Left Ventricular Dysfunction: Prespecified Analyses From the REVIVED-BCIS2 Trial

Abstract

Background: Ventricular arrhythmia is an important cause of mortality in patients with ischemic left ventricular dysfunction. Revascularization with coronary artery bypass graft or percutaneous coronary intervention is often recommended for these patients before implantation of a cardiac defibrillator because it is assumed that this may reduce the incidence of fatal and potentially fatal ventricular arrhythmias, although this premise has not been evaluated in a randomized trial to date.

Methods: Patients with severe left ventricular dysfunction, extensive coronary disease, and viable myocardium were randomly assigned to receive either percutaneous coronary intervention (PCI) plus optimal medical and device therapy (OMT) or OMT alone. The composite primary outcome was all-cause death or aborted sudden death (defined as an appropriate implantable cardioverter defibrillator therapy or a resuscitated cardiac arrest) at a minimum of 24 months, analyzed as time to first event on an intention-to-treat basis. Secondary outcomes included cardiovascular death or aborted sudden death, appropriate implantable cardioverter defibrillator (ICD) therapy or sustained ventricular arrhythmia, and number of appropriate ICD therapies.

Results: Between August 28, 2013, and March 19, 2020, 700 patients were enrolled across 40 centers in the United Kingdom. A total of 347 patients were assigned to the PCI+OMT group and 353 to the OMT alone group. The mean age of participants was 69 years; 88% were male; 56% had hypertension; 41% had diabetes; and 53% had a clinical history of myocardial infarction. The median left ventricular ejection fraction was 28%; 53.1% had an implantable defibrillator inserted before randomization or during follow-up. All-cause death or aborted sudden death occurred in 144 patients (41.6%) in the PCI group and 142 patients (40.2%) in the OMT group (hazard ratio, 1.03 [95% CI, 0.82-1.30]; P=0.80). There was no between-group difference in the occurrence of any of the secondary outcomes.

Conclusions: PCI was not associated with a reduction in all-cause mortality or aborted sudden death. In patients with ischemic cardiomyopathy, PCI is not beneficial solely for the purpose of reducing potentially fatal ventricular arrhythmias.

Registration: URL: https://www.

Clinicaltrials: gov; Unique identifier: NCT01920048.

Keywords: arrhythmias, cardiac; cardiomyopathies; death, sudden, cardiac; defibrillators, implantable; heart failure; myocardial revascularization; percutaneous coronary intervention.

Figure 1.

CONSORT diagram. CAD indicates coronary artery disease; CONSORT, Consolidated Standards of Reporting Trials; CM, cardiomyopathy; LVSD, left ventricular systolic dysfunction; OMT, optimal medical therapy; and PCI, percutaneous coronary intervention. *Number screened and numbers excluded have been extrapolated from interval screening logs that were conducted during the trial at multiple centers.

Figure 2.

Primary outcome of all-cause death or aborted sudden death over all follow-up. Kaplan-Meier estimates of the cumulative incidence of death from any cause or aborted sudden death in a time-to-first event analysis. Incidence includes total events over the entire follow-up period in each group in the intention-to-treat population, censored at death, withdrawal from the trial, or date of final follow-up encounter. HR indicates hazard ratio; OMT, optimal medical therapy; and PCI, percutaneous coronary intervention.

Figure 3.

Primary outcome by prespecified subgroups. Forest plot showing hazard ratios for the primary outcome according to prespecified subgroups. Dashed line represents the null hypothesis of no treatment effect. The British Cardiovascular Intervention Society Jeopardy Score ranges from 0 to 12, with higher scores indicating a greater volume of myocardium subtended by diseased arteries. Implantable cardioverter defibrillator (ICD) indication (primary or secondary) includes both ICD and cardiac resynchronization therapy defibrillator implantations. Left ventricular ejection fraction (LVEF) change is from baseline to 6 months from core laboratory analyses; improved LVEF was defined as an improvement above the median change (>4.2%); unchanged or deteriorated LVEF was defined as below the median (≤4.2%). Recruiting center type defined by frequency of device implantation in the REVIVED-BCIS2 trial (Revascularisation for Ischaemic Ventricular Dysfunction): frequent if >50% of patients received a device, and infrequent if ≤50% received a device. NYHA indicates New York Heart Association heart failure class; OMT, optimal medical therapy; and PCI, percutaneous coronary intervention.

Figure 4.

Cumulative device implantation by treatment group. The proportional hazards assumption seems to be violated (demonstrated by early separation of the curves, followed by gradual convergence over time); hence, a hazard ratio has not been calculated. OMT indicates optimal medical therapy; and PCI, percutaneous coronary intervention.