REVIVED-BCIS2
Trial question
What is the role of PCI in patients with severe ischemic LV systolic dysfunction?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
12.0% female
88.0% male
N = 700
700 patients (86 female, 614 male)
Inclusion criteria: patients with a LVEF ≤ 35%, extensive coronary artery disease amenable to PCI and demonstrable myocardial viability
Key exclusion criteria: acute myocardial infarction in the 4 weeks before randomization; acute decompensated HF or sustained ventricular arrhythmias within 72 hours before randomization
Interventions
N=347 PCI (coronary angioplasty or stents plus optimal medical therapy)
N=353 medical therapy alone (optimal medical therapy alone)
Primary outcome
Death from any cause or hospitalization for heart failure
37.2
38
38.0 %
28.5 %
19.0 %
9.5 %
0.0 %
Percutaneous coronary
intervention
Medical therapy
alone
No significant
difference ↔
No significant difference in death from any cause or hospitalization for HF (37.2% vs. 38%; HR 0.99, 99% CI 0.78 to 1.27)
Secondary outcomes
No significant difference in improvement in LVEF at 6 months (1.8% vs. 3.4%; ARD -1.6, 95% CI -3.7 to 0.5)
No significant difference in improvement in LVEF at 12 months (2% vs. 1.1%; AD 0.9%, 95% CI -1.7 to 3.4)
No significant difference in death from cardiovascular causes (21.9% vs. 24.9%; HR 0.88, 95% CI 0.65 to 1.2)
Safety outcomes
No significant differences in serious adverse event, bleeding at 2 years.
Significant difference in major bleeding at year 1 (3.1% vs. 0.6%).
Conclusion
In patients with a LVEF ≤ 35%, extensive coronary artery disease amenable to PCI and demonstrable myocardial viability, PCI was not superior to medical therapy alone with respect to death from any cause or hospitalization for HF.
Reference
Divaka Perera, Tim Clayton, Peter D O'Kane et al. Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction. N Engl J Med. 2022 Oct 13;387(15):1351-1360.
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