The OPTIMIZE randomized trial to assess safety and efficacy of the Svelte IDS and RX Sirolimus-eluting coronary stent Systems for the Treatment of atherosclerotic lesions: Trial design and rationale

Am Heart J. 2019 Oct;216:82-90. doi: 10.1016/j.ahj.2019.07.003. Epub 2019 Jul 13.

Abstract

Coronary stenting without angioplasty pretreatment (direct stenting) may simplify procedures in appropriate lesions. Direct stenting is facilitated by smaller profile coronary stent platforms. The present study was designed for regulatory approval of a novel drug-eluting coronary stent and incorporates both randomized comparison for non-inferiority to an approved predicate device as well as a nested evaluation of subjects eligible for direct stenting. STUDY DESIGN AND OBJECTIVES: Prospective, single-blind, randomized, active-control, multi-center study designed to assess the safety and efficacy of the novel Svelte sirolimus-eluting stent (SES) systems. A total of 1630 subjects with up to 3 target lesions will be randomized 1:1 to the Svelte SES versus either the Xience or Promus everolimus-eluting stents (control). Randomization will be stratified by whether or not a direct stenting strategy is planned by the investigator. The primary endpoint is target lesion failure (TLF) at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a non-inferiority test with a non-inferiority margin of 3.58%. Secondary clinical endpoints include individual components of TLF, stent thrombosis and measures of procedural resource utilization including contrast administration, fluoroscopy exposure and procedural resource utilization as well as costs. CONCLUSION: The OPTMIZE Trial will evaluate the safety, efficacy and clinical value of the novel Svelte SES in subjects with up to 3 lesions, and will provide a comparison of direct stenting between randomized devices.

Trial registration: ClinicalTrials.gov NCT03190473.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Coronary Artery Disease / pathology
  • Coronary Artery Disease / therapy*
  • Dilatation / methods
  • Drug-Eluting Stents* / adverse effects
  • Equivalence Trials as Topic
  • Everolimus / administration & dosage*
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Multicenter Studies as Topic
  • Percutaneous Coronary Intervention / methods*
  • Platelet Aggregation Inhibitors / therapeutic use
  • Prospective Studies
  • Prosthesis Design
  • Randomized Controlled Trials as Topic*
  • Single-Blind Method
  • Sirolimus / administration & dosage*
  • Treatment Outcome

Substances

  • Immunosuppressive Agents
  • Platelet Aggregation Inhibitors
  • Everolimus
  • Sirolimus

Associated data

  • ClinicalTrials.gov/NCT03190473