MedStar Authors catalog › Details for: Rationale of a novel study design for the BIOFLOW V study, a prospective, randomized multicenter study to assess the safety and efficacy of the Orsiro sirolimus-eluting coronary stent system using a Bayesian approach.
Rationale of a novel study design for the BIOFLOW V study, a prospective, randomized multicenter study to assess the safety and efficacy of the Orsiro sirolimus-eluting coronary stent system using a Bayesian approach.
Citation: American Heart Journal. 193:35-45, 2017 Nov.Journal: American heart journal.Published: 2017ISSN: 0002-8703.Full author list: Doros G; Massaro JM; Kandzari DE; Waksman R; Koolen JJ; Cutlip DE; Mauri L.UI/PMID: 29129253.Subject(s): *Absorbable Implants | *Bayes Theorem | Coronary Angiography | Coronary Stenosis/di [Diagnosis] | *Coronary Stenosis/su [Surgery] | *Drug-Eluting Stents | Follow-Up Studies | Humans | Immunosuppressive Agents/pd [Pharmacology] | *Myocardial Revascularization/mt [Methods] | Prospective Studies | Prosthesis Design | *Sirolimus/pd [Pharmacology] | Treatment OutcomeInstitution(s): MedStar Heart & Vascular InstituteonActivity type: Journal Article.Medline article type(s): Journal ArticleOnline resources: Click here to access onlineDigital Object Identifier: https://dx.doi.org/10.1016/j.ahj.2017.08.001 (Click here)Abbreviated citation: Am Heart J. 193:35-45, 2017 Nov.Local Holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006through MWHC library: 1999 - 2006.Abstract: BACKGROUND: Traditional study design submitted to the Food and Drug Administration to test newer drug-eluting stents (DES) for marketing approval is the prospective randomized controlled trial. However, several DES have extensive clinical data from trials conducted outside the United States that have led to utilization of a novel design using the Bayesian approach. This design was proposed for testing DES with bioresorbable polymer compared with DES most commonly in use today that use durable polymers for drug elution.Abstract: STUDY DESIGN AND OBJECTIVES: This prospective, multicenter, randomized, controlled trial is designed to assess the safety and efficacy of the Orsiro bioresorbable polymer sirolimus-eluting stent (BP SES). Up to 1,334 subjects with up to 3 de novo or restenotic coronary artery lesions who qualify for percutaneous coronary intervention with stenting will be randomized 2:1 to the BP SES versus the Xience durable polymer everolimus-eluting stent (DP EES). Data from this trial will be combined with data from 2 similarly designed trials that also randomize subjects to BP SES and DP EES (BIOFLOW II, N=452 and BIOFLOW IV, N=579) by using a Bayesian approach. The primary end point is target lesion failure 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 test of noninferiority of the BP SES versus DP EES on the primary end point according to a noninferiority delta of 3.85%. Secondary end points include stent thrombosis and the individual components of target lesion failure. Subjects will be followed for 5 years after randomization.Abstract: CONCLUSIONS: The BIOFLOW V trial offers an opportunity to assess clinical outcomes in patients treated with coronary revascularization using the Orsiro BP SES relative to a commonly used DP EES. The use of a Bayesian analysis combines a large randomized cohort of patients 2 two smaller contributing randomized trials to augment the efficiency of the comparison. Copyright (c) 2017 Elsevier Inc. All rights reserved.
