News | Stents | November 07, 2016

Elastic Polymer Coated Medinol Stent Found Non-inferior to Medtronic Resolute

Results from the BIONICS Trial Reported at TCT 2016; data will be submitted to FDA 

Bionics trial, Medinol, BioNIR stent, elastic polymer

Imaging of stent struts after expansion, showing the elastic polymer used on Medinol’s BioNIR stent does not crack or flake off, possibly leading to better patient outcomes. 

Bionics trial, Medinol, BioNIR stent, elastic polymer
Bionics trial, Medinol, BioNIR stent, elastic polymer
Bionics trial, Medinol, BioNIR stent, elastic polymer
Bionics trial, Medinol, BioNIR stent, elastic polymer

November 7, 2016 – The large multinational randomized BIONICS study found that a novel elastic polymer coated ridaforolimus-eluting stent (Medinol’s BioNIR stent) was non-inferior to a zotarolimus-eluting stent (Medtronic’s Resolute) for one-year clinical outcomes in a broad, less selected ‘more comers’ population. Results of this trial will be submitted to the FDA for U.S. approval of this novel drug-eluting stent. 

Findings were reported at the 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. 

“One-year clinical outcomes from the BIONICS study clearly show that the ridaforolimus-eluting stent was non-inferior to the zotarolimus-eluting stent with identical target lesion failure rates,” said principal investigator, David E. Kandzari, M.D., director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute in Atlanta, Ga. “In addition, it had a low stent thrombosis rate with no events beyond 30 days.”

The ridaforolimus-eluting stent is a thin-strut (90 microns) cobalt chromium stent that elutes the rapamycin analogue ridaforolimus from a durable elastomeric polymeric coating. The multicenter randomized trial was conducted at 76 medical centers in the U.S., Canada, Europe, and Israel and enrolled a broad range of patients with coronary artery disease including patients with non-ST elevation MI (NSTEMI) as well as complex lesions. The primary endpoint was target lesion failure (TLF) at one year, the composite rate of cardiac death, target vessel myocardial infarction (TV-MI), and ischemia driven target lesion revascularization (ID-TLR). Secondary endpoints were one year major adverse cardiovascular events (MACE), target vessel failure (TVF) and individual component endpoints, definite/probable stent thrombosis and procedural success.

A total of 1,919 patients were randomized 1:1 to the BioNIR ridaforolimus-eluting stent (n= 958, 1,275 lesions) or Resolute zotarolimus-eluting stent (n=961, 1,277 lesions) stent. The baseline clinical characteristics were well balanced between the two arms, as were angiographic baseline characteristics with the exception of severe calcification (13.3% in the BioNIR group vs. 10.5% in the Resolute group, P=0.03).

The primary endpoint of TLF at one year was identical for both at 5.3% (P=0.98). In addition, the rates of cardiac death (0.5 vs. 0.2%, P=0.29), TV-MI (3.1 vs. 3.3%, P=0.81) and ID-TLR (3 vs. 2.4%, P=0.38) were similar. Definite/probable stent thrombosis was 0.4% (4/921) for the ridaforolimus-eluting stent and 0.6% (6/927) for the zotarolimus-eluting stent (P=0.75). Device success was 98.3% for the ridaforolimus-eluting compared to 99.5% for the zotarolimus-eluting stent (P=0.004).

The BIONICS trial was funded by Medinol and designed and conducted by the CRF Clinical Trials Center in collaboration with Novella Clinical which provided site management. Kandzari reported grant or research support from Abbott Vascular, Boston Scientific, Medtronic, Biotronik, St. Jude Medical/Thoratec, and Ablative Solutions, and consulting fees/honoraria from Boston Scientific, Medtronic, Micell Technologies, and St. Jude Medical.

For more information: www.crf.org 

Related Content

Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Overlay Init