Overall and Cause-Specific Mortality in Randomized Clinical Trials Comparing Percutaneous Interventions With Coronary
Mario Gaudino1, Irbaz Hameed1,2, Michael E Farkouh3
1Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, New York.
JAMA Internal Medicine
|October 12, 2020
Summary
Percutaneous coronary intervention (PCI) showed higher all-cause and cardiac mortality versus coronary artery bypass grafting (CABG). Even non-cardiac deaths were higher with PCI, supporting all-cause mortality as a key trial endpoint.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Clinical Trials Methodology
Background:
- Mortality rates are a critical endpoint in trials comparing percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG).
- Debate exists on whether all-cause or cardiac mortality is the preferred endpoint, as non-cardiac mortality is presumed unrelated to treatment.
Purpose of the Study:
- To compare all-cause and cause-specific mortality between PCI and CABG in patients with coronary artery disease using randomized clinical trials (RCTs).
Main Methods:
- Systematic search of MEDLINE, Embase, and Cochrane Library databases up to November 2019.
- Inclusion of RCTs comparing PCI (with drug-eluting or bare-metal stents) to CABG, focusing on trials reporting mortality outcomes.
- Data extraction and synthesis followed PRISMA guidelines, with pooled analysis using fixed- and random-effects models.
Main Results:
- Twenty-three RCTs with 13,620 patients were analyzed, with a mean follow-up of 5.3 years.
- PCI was associated with significantly higher all-cause mortality (IRR, 1.17) and cardiac mortality (IRR, 1.24) compared to CABG.
- Notably, PCI also showed higher non-cardiac mortality (IRR, 1.19) compared to CABG.
Conclusions:
- PCI demonstrated higher rates of all-cause, cardiac, and non-cardiac mortality compared to CABG at 5-year follow-up.
- The increased non-cardiac mortality with PCI suggests potential procedure-related causes, reinforcing the utility of all-cause mortality as a primary endpoint in myocardial revascularization studies.
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