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Arrhythmia and Death Following Percutaneous Revascularization in Ischemic Left Ventricular Dysfunction: Prespecified
Divaka Perera1,2, Holly P Morgan1, Matthew Ryan1
1National Institute for Health Research Biomedical Research Center and British Heart Foundation Center of Research Excellence at the School of Cardiovascular Medicine and Sciences, King's College London, United Kingdom (D.P., H.P.M., M.R.).
Insights
Percutaneous coronary intervention (PCI) did not reduce mortality or sudden death in patients with ischemic cardiomyopathy. Revascularization is not recommended solely to prevent ventricular arrhythmias in this population.
Area of Science:
- Cardiology
- Interventional Cardiology
- Electrophysiology
Background:
- Ventricular arrhythmias are a major cause of mortality in patients with ischemic left ventricular dysfunction.
- Revascularization (PCI or CABG) is often recommended for these patients before ICD implantation, but its efficacy in reducing arrhythmias is unproven.
Purpose of the Study:
- To evaluate whether percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) reduces all-cause death or aborted sudden death compared to OMT alone in patients with ischemic cardiomyopathy.
- To assess the impact of PCI on secondary outcomes, including cardiovascular death, appropriate ICD therapy, and ventricular arrhythmias.
Main Methods:
- Randomized trial of 700 patients with severe left ventricular dysfunction, extensive coronary disease, and viable myocardium.
- Patients were assigned to PCI + OMT or OMT alone.
- Primary outcome: composite of all-cause death or aborted sudden death over a minimum of 24 months.
Main Results:
- No significant difference in the primary outcome between PCI+OMT and OMT alone groups (41.6% vs. 40.2%, HR 1.03; P=0.80).
- No significant differences observed in any secondary outcomes, including cardiovascular death, aborted sudden death, or appropriate ICD therapy.
- The study enrolled 700 patients across 40 UK centers between 2013 and 2020.
Conclusions:
- PCI is 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 in this patient group.
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.
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