Complete revascularization across PRECISE-HBR bleeding risk strata in older patients with myocardial infarction and multivessel coronary artery disease: a FIRE trial subanalysis
A Sarti, A Erriquez, J Farina, S Caglioni, M Cocco, F M Verardi, A Cantone, R Pavasini, F Marchini, G Campo, S BiscagliaAbstract
Background
High bleeding risk (HBR) is common among elderly patients presenting with myocardial infarction (MI) undergoing percutaneous coronary intervention (PCI). In the FIRE trial, HBR status defined according to the Academic Research Consortium–HBR (ARC-HBR) criteria was highly prevalent and associated with a significantly increased risk of adverse events at 1 year. Data on the long-term prognostic implications of HBR and on the performance of newer bleeding risk stratification tools in this population remain limited. The PRECISE-HBR score is a novel risk model developed to provide comprehensive bleeding risk assessment across the spectrum of patients undergoing PCI, demonstrating improved discrimination for bleeding events compared with previous scores, including ARC-HBR and PRECISE-DAPT. Its role in elderly MI patients with multivessel disease and its long-term prognostic impact have not been investigated.
Purpose
To assess whether the long-term benefits of complete revascularization are consistent across bleeding risk strata defined by the PRECISE-HBR score in older MI patients enrolled in the FIRE trial.
Methods
In the FIRE trial, 1,445 patients aged ≥75 years with MI and multivessel disease were randomized to complete or culprit-only revascularization. Patients were stratified according to PRECISE-HBR score into three categories: ≤22 (no HBR), 23–26 (HBR), and ≥27 (very HBR). The primary endpoint was a 3-year composite of death, MI, stroke, or ischemia-driven revascularization. The key secondary endpoint was cardiovascular death or MI at 3 years. The safety endpoint was a composite of contrast-associated acute kidney injury, stroke, or Bleeding Academic Research Consortium type 3–5 bleeding.
Results
682 patients were classified as no HBR, 197 as HBR, and 566 as very HBR. Compared with no HBR, HBR and very HBR patients had a higher risk of the primary endpoint (HR 1.72, 95% CI 1.27–2.33; HR 1.91, 95% CI 1.53–2.39) and of the secondary endpoint (HR 1.87, 95% CI 1.23–2.85; HR 2.23, 95% CI 1.63–3.04). Very HBR patients were also at increased risk of the safety endpoint (HR 1.44, 95% CI 1.10–1.88). No significant differences in bleeding events were observed across PRECISE-HBR strata at 3 years. Complete revascularization reduced the primary outcome in no HBR, HBR and very HBR patients, with negative interaction testing (p for interactions 0.739). No heterogeneity according to bleeding risk was observed for secondary or safety endpoints.
Conclusions
In elderly MI patients, complete revascularization provided sustained ischemic and safety benefit at 3 years irrespective of PRECISE-HBR–defined bleeding risk. These findings support the use of physiology-guided complete revascularization regardless HBR status. The absence of long-term bleeding differences may be explained by discontinuation of dual antiplatelet therapy beyond 12 months, attenuating late bleeding risk.Outcomes PRECISE HBR FIREFor image description, please refer to the figure legend and surrounding text.KM PRECISE HBR FIREFor image description, please refer to the figure legend and surrounding text.