Percutaneous coronary intervention in the very elderly with NSTE-ACS: the randomized 80+ study.

Abstract

Objective: The treatment strategy in the very elderly with NSTE-ACS is debated, as they are often under-represented in clinical trials. The aim of this multicenter randomized controlled trial was to compare invasive and conservative strategies in the very elderly with NSTE-ACS.Methods: We randomly assigned patients ≥ 80 years of age with NSTE-ACS to an invasive strategy with coronary angiography and optimal medical treatment or a conservative strategy with only optimal medical treatment. The primary outcome was the combined endpoint of major adverse cardiac and cerebrovascular events (MACCE). Sample size was powered for a 50% reduction of event rate in MACCE with an invasive strategy. We used intention-to-treat analysis.Results: Altogether, 186 patients were included between 2009 and 2017. The study was terminated prematurely due to slow enrollment. At 12-month follow-up, the primary outcome occurred in 31 (33.3%) of the invasive treatment group and 34 (36.6%) of the conservative treatment group, with a hazard ratio (HR) of 0.90 (95% CI 0.55‒1.46; p = 0.66) for the invasive group relative to the conservative group. The corresponding HR value for urgent revascularization was 0.29 (95% CI 0.10‒0.85; p = 0.02), 0.56 (95% CI 0.27‒1.18; p = 0.13) for myocardial infarction, 0.70 (95% CI 0.31‒1.58; p = 0.40) for all-cause mortality, 1.35 (95% CI 0.23‒7.98; p = 0.74) for stroke, and 1.62 (95% CI 0.67‒3.90; p = 0.28) for recurrent hospitalization for cardiac reasons.Conclusion: In the very elderly with NSTE-ACS, we did not find any significant difference in MACCE between invasive and conservative treatment groups at 12-month follow-up, possibly due to small sample size. ClinicalTrials.gov: NCT02126202.