Prognosis of Claims‐ Versus Trial‐Based Ischemic and Bleeding Events Beyond 1 Year After Coronary Stenting

Abstract

Background It is unknown whether clinical events identified with administrative claims have similar prognosis compared with trial‐adjudicated events in cardiovascular clinical trials. We compared the prognostic significance of claims‐based end points in context of trial‐adjudicated end points in the DAPT (Dual Antiplatelet Therapy) study. Methods and Results We matched 1336 patients aged ≥65 years who received percutaneous coronary intervention in the DAPT study with the CathPCI registry linked to Medicare claims. We compared death at 21 months post‐randomization using Cox proportional hazards models among patients with ischemic events (myocardial infarction or stroke) and bleeding events identified by: (1) both trial adjudication and claims; (2) trial adjudication only; and (3) claims only. A total of 47 patients (3.5%) had ischemic events identified by both trial adjudication and claims, 24 (1.8%) in trial adjudication only, 15 (1.1%) in claims only, and 1250 (93.6%) had no ischemic events, with annualized unadjusted mortality rates of 12.8, 5.5, 14.9, and 1.26 per 100 person‐years, respectively. A total of 44 patients (3.3%) had bleeding events identified with both trial adjudication and claims, 13 (1.0%) in trial adjudication only, 65 (4.9%) in claims only, and 1214 (90.9%) had no bleeding events, with annualized unadjusted mortality rates of 11.0, 16.8, 10.7, and 0.95 per 100 person‐years, respectively. Among patients with no trial‐adjudicated events, patients with events in claims only had a high subsequent adjusted mortality risk (hazard ratio (HR) ischemic events: 31.5; 95% CI, 8.9‒111.9; HR bleeding events 23.9; 95% CI, 10.7‒53.2). Conclusions In addition to trial‐adjudicated events, claims identified additional clinically meaningful ischemic and bleeding events that were prognostically significant for death.

Keywords

• claims
• clinical trials
• DAPT
• end points
• prognosis