BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) In Coronary Stenosis Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Stenosis
- Sponsor
- Medinol Ltd.
- Enrollment
- 1919
- Locations
- 8
- Primary Endpoint
- Target Lesion Failure (TLF)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The BioNIR study aims to show that the BioNIR ridaforolimus eluting stent is non-inferior to the Resolute zotarolimus-eluting stent for the primary clinical endpoint of target lesion failure (TLF) at 12 months; that it is non-inferior to the Resolute for the secondary endpoint of angiographic in-stent late loss at 13 months; and that it is more cost-effective.
Detailed Description
The BioNIR is a prospective, multi-center, single-blind, two-arm, randomized clinical trial. The population will consist of subjects undergoing PCI for angina (stable or unstable), silent ischemia, NSTEMI, and recent STEMI. Complex lesions are allowed. There is no limit to the number of lesions per vessel or individual lesion length; however, the total planned stenting in the coronary tree cannot exceed 100mm. Randomization will be stratified by the presence of medically treated diabetes vs. no medically treated diabetes, acute coronary syndrome (ACS) vs. non-ACS, and by site. Lesions planned to be treated must be declared and recorded at time of randomization. Planned staged procedures, if necessary, must be declared immediately post procedure. Clinical follow-up will be performed at 30 days, 6 months, and 1, 2, 3, 4, and 5 years post randomization. 200 patients at participating North American sites will be consented for planned angiographic follow-up at 13 months after enrollment, with 100 of these patients consented to undergo planned IVUS at baseline and at 13 months following randomization. The primary endpoint is Target Lesion Failure (TLF) at 12 months, defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization. Clinical Secondary Endpoints to be evaluated at 30 days, 6 months, and 1, 2, 3, 4 and 5, except as noted: * Device, Lesion, and Procedure Success at time of baseline procedure * TLF at 30 days, 6 months, and 2, 3, 4 and 5 years defined as the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR. * Major adverse cardiac events (MACE; the composite rate of cardiac death, any MI or ischemia-driven TLR) * Target vessel failure (TVF; the composite rate of death, target vessel related MI or ischemia-driven TVR) * All-cause mortality * Cardiac death * Myocardial Infarction * Target Vessel Related MI * Ischemia-driven TLR * Ischemia-driven TVR * Stent Thrombosis (ARC definite and probable) Angiographic Sub-Study Secondary Endpoint to be evaluated at 13 months: • Angiographic in-stent and in-segment late loss IVUS Sub-Study Secondary Endpoint to be evaluated at 13 months: * In-stent percent neointimal hyperplasia * Stent mal-apposition A key component of this trial will be a prospective assessment of health care resource utilization, costs and cost effectiveness. A separate cost effectiveness assessment plan describes the data collection and analysis. Sample Size Consideration: From recent US trials of best in class DES (Xience V, Promus Element and Resolute), the 1-year TLF rate in patients with non-complex lesions not undergoing routine angiographic follow-up is approximately 3.8%. Using the assumption of the more-comers' design, the 1-year event rate will be conservatively increased by 50% (assuming enrollment rate for complex patients/lesions is 50% with double the standard event rate) - thus 5.8%. Therefore, with a one-sided 95% upper bound of the confidence interval of 3.3% (a relative 57% margin) and 1:1 randomization, enrolling 1810 patients (905 per group) provides 90% power to demonstrate non-inferiority. Assuming 95% follow-up rate at 1 year, approximately 1906 patients will be enrolled (953 in each group).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient with indication for PCI including angina/silent ischemia/NSTEMI/recent STEMI
- •Non-target vessel PCI allowed prior to randomization depending on time interval and certain conditions
- •Patient/legal guardian willing \& able to provide informed written consent \& comply with follow-up visits \& testing schedule
- •Target lesion(s) must be located in native coronary artery/bypass graft conduit w/visually estimated diameter ≥2.5mm to ≤4.25mm.
- •Complex lesions allowed, including calcified, presence of thrombus, CTO, bifurcation (except as per exclusion criteria #30), ostial RCA, tortuous, bare metal stent restenotic, protected left main, and saphenous vein graft
Exclusion Criteria
- •STEMI within 24 hours of init. time of presentation to first treating hospital, or in whom enzyme levels (either CK-MB or Troponin) have not peaked
- •PCI within 24 hours preceding baseline procedure
- •Non-target lesion PCI in target vessel within 12 months of baseline procedure
- •History of stent thrombosis
- •Cardiogenic shock (persistent hypotension \[systolic blood pressure \<90mm/Hg for MT 30 min\] or requiring pressors/hemodynamic support, including IABP)
- •Subject is intubated
- •Known LVEF \<30%
- •Relative/absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject indicated for chronic oral anticoagulant treatment)
- •Calculated creatinine clearance \<30 mL/min per Cockcroft-Gault equation (\<40mL/min for subjects participating in angiographic follow-up sub-study)
- •Hemoglobin \<10g/dL
Outcomes
Primary Outcomes
Target Lesion Failure (TLF)
Time Frame: 12 months
The primary endpoint of TLF at 12 months was defined as the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR.
Secondary Outcomes
- TLF(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
- Target Vessel Related MI(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
- Ischemia Driven TLR(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
- Lesion Success(Determined at time of baseline procedure)
- All Cause Mortality(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
- Cardiac Death(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
- Angiographic Sub-Study: In-stent and In-segment Late Loss(13 months)
- IVUS Sub-Study: In-stent Percent Neointimal Hyperplasia(13 months)
- Device Success(Determined at time of baseline procedure)
- Target Vessel Failure(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
- Myocardial Infarction(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
- Ischemia Driven TVR(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
- IVUS Sub-Study: Stent Mal-apposition(13 months)
- Procedure Success(Determined at time of baseline procedure)
- Major Adverse Cardiac Events(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
- Stent Thrombosis(30 days, 6 months, and 1, 2, 3, 4 and 5 years)