FORTITUDE: 9-Month Results of BVS in CAD

The Amaranth PLLA-based sirolimus-eluting coronary bioresorbable stent showed low rates of major adverse cardiac events, according to the results of the FORTITUDE study presented Oct. 31 at TCT 2016.

In an international, multi-center investigation, Antonio Colombo, MD, FACC, et al., examined the nine-month clinical and imaging outcomes of the Amaranth bioresorbable stent in patients with coronary artery disease. The primary safety endpoint was target vessel failure at nine months, including death, target vessel myocardial infarction and ischemia driven target lesion revascularization. The primary efficacy endpoint was the rate of in-scaffold late lumen loss.

The results of the study showed a 98.4 percent clinical device success rate in patients, with angiographic binary restenosis occurring in only 1.6 percent of patients. Further, researchers reported high levels of strut coverage (96 percent) and scaffold stability (1.7 percent late discontinuities) in optical coherence tomography at nine-months.

Colombo, et al., note that “Amaranth’s proprietary ultra-high molecular weight PLLA combined with unique polymer processing technology has led to the further miniaturization of the bioresorbable stent.” They add that “due to the unique polymer features, these future generation scaffolds have the potential to match the biological performance of current metallic drug-eluting stents.”

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Transcatheter Cardiovascular Therapeutics, Absorbable Implants, Angiography, Coronary Artery Disease, Drug-Eluting Stents, Sirolimus, Miniaturization, Myocardial Infarction, Polymers, Stents, Tomography, Optical Coherence

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