Two-Year Results of the OPTIMIZE IDE Trial: A Randomized Evaluation of Sirolimus-Eluting Coronary Stents With Fixed-Wire and Rapid-Exchange Delivery Systems and a Novel Bioresorbable Drug Carrier

Abstract

Background The ultra-low profile Slender integrated delivery system (IDS) (Svelte Medical System) fixed-wire and rapid-exchange (Direct RX) drug-eluting stent (DES) systems, specifically designed to facilitate transradial (TR) access and direct stenting (DS), were evaluated for safety and efficacy in the prospective, randomized, controlled, multicenter OPTIMZE IDE trial. Methods OPTIMIZE compared Slender IDS or Direct RX with Xience (Abbott Laboratories) or Promus EES (1:1 randomization) (Boston Scientific) in subjects with ischemic heart disease and ≤ 3 de novo stenotic lesions ≤ 34 mm in length in ≤2 native coronary arteries with renovascular disease (RV 2.25 mm to 4.00mm. Randomization was stratified by planned stent strategy (DS or pre-dilation) following diagnostic angiography. DS was limited to 30% of subjects. TR access was encouraged but not required. The study primary endpoint, 1-year target lesion failure (TLF), was powered for noninferiority using a creatine kinase (CK)-MB–based definition of target- vessel myocardial infarction (TVMI). Results Subjects (N = 1,639) were randomized at 74 investigative sites in the United States, Europe, and Japan; 79% were treated via TR approach. DS was successful in 94% of lesions attempted with a DS strategy. TLF at 1 year was similar across groups (10.3% vs 9.5% for treatment and control; perineural noninferiority [PNI] = 0.034); however, noninferiority (PNI ≤ 0.025) was not met as high troponin use and subsequent protocol-defined TVMI rates effectively underpowered the study. At 1-year follow-up, rates of target lesion revascularization (1.5% vs 1.9%), TVMI (9.4% vs 8.2%), cardiac death (0.3% vs 0.3%), and any stent thrombosis (0.4% vs 0.5%) were similar across the treatment and control groups (all P > 0.05). Two-year outcomes, analysis of specific biomarkers, and protocol definition impact on TVMI rates will be presented for the first time. Conclusion OPTIMIZE is the first IDE trial to evaluate a novel fixed-wire DES, DS, and TR access between randomized DES. Two-year clinical outcomes and the influence of MI definitions, cardiac biomarkers, and biomarker sensitivity on clinical trial design and outcomes will be presented.