Abstract 17714: Randomized Clinical Trial Comparing Bare Metal Stents Plus Oral Colchicine versus Drug-Eluting Stents for the Prevention of Hard Clinical Outcomes. Two Years Follow-Up Results

Abstract

Introduction: Percutaneous coronary intervention (PCI) for ischemic heart disease is common and stent selection. Bare metal stents (BMS) or drug-eluting stents (DES) impact outcomes. Colchicine has been shown to reduce cardiac events. The long-term efficacy of BMS plus colchicine (BMS+C) vs DES in terms of major adverse cardiovascular events (MACE) is unknown. We presented preliminary results at AHA 2022, we are reporting extended follow-up. Hypothesis: PCI with BMS+C have similar MACE compared to DES-treated patients (pts). Methods: Multicenter, randomized clinical trial (RCT) enrolled PCI pts from February 2020 to April 2022, randomly assigned to BMS+C or DES and followed at 1, 6, 12 months, and then annually until 5 years. BMS+C received 0.5 mg oral colchicine BID for 3 months. Primary endpoint (EP) compared cost and incidence of MACE, a composite of death, myocardial infarction, stroke, or ischemic-driven target vessel revascularization. Due to the cost difference between devices a non-inferiority 15% threshold level was estimated. Secondary EP included individual components of primary EP and overall costs. Drug tolerance was analyzed. Baseline and 1-month C-Reactive Protein (CRP) levels were assessed and a delta difference was compared. An IRB and local authorities approved the protocol (NCT04382443). Results: We included 205 pts in each arm. Baseline characteristics were similar, Acute Coronary Syndromes was 78% vs 74.6% (p=0.24). Syntax Score was 22.2+/-11.4 vs 21.1+/- 9.4, respectively (p=0.49). Follow-up was 25 +/- 5 months. Primary and secondary EP are presented in the table. 5% of BMS+C pts withdraw from the drug due to side effects. Delta CRP between groups showed 5.4 +/- 6.4 vs 1.6 +/- 1.7, BMS vs DES, p<0.001. Conclusions: In this RCT of pts with ACS and low Syntax score, a strategy with BMS+C was non-inferior to DES in terms of long-term clinical outcomes. Colchicine diminished inflammation markers. Cumulative costs were lower in the BMS+C group. cost.