The ABSORB everolimus-eluting bioresorbable vascular scaffold is non-inferior to the Xience cobalt-chromium everolimus-eluting stent, according to the results of the ABSORB III trial, presented Oct. 12 at TCT 2015 and simultaneously published in the New England Journal of Medicine. 

In a prospective, multicenter, single blind, randomized study, Dean J. Kereiakes, MD, FACC, et al. evaluated the efficacy and safety of the ABSORB bioresorbable vascular scaffold in patients with coronary artery disease (CAD), with the primary endpoint of target lesion failure at one year. The results of the trial showed the non-inferiority of the scaffold, although the target lesion failure components were not significantly different between the two devices at one year follow-up.

A sub-study of the ABSORB III trial, also presented at TCT 2015 and simultaneously published in the Journal of the American College of Cardiology, analyzed the pharmacokinetics from the everolimus-eluting bioresorbable vascular scaffold. David Gerard Rizik, MD, FACC, et al. found that the pharmacokinetics were predictable with dose-proportional behavior. “Local coronary arterial delivery [of the scaffold] results in limited systemic exposure suggesting low risk of systemic toxicity,” according to the authors.

The ABSORB China Trial, presented Oct. 12 at TCT 2015 and simultaneously published in the Journal of the American College of Cardiology, found similar results to the ABSORB III Trial in China, showing the non-inferiority of the everolimus-eluting bioresorbable vascular scaffold versus metallic drug-eluting stents (DES) in terms of angiographic in-segment late loss at one-year follow-up. According to Runlin Gao, MD, FACC, et al., both the scaffold and the stent had similar acute clinical device success, procedural success and one-year rates of target lesion failure.

“The concordance of findings across different ethnicities corroborates their generalizability, and the consistency in a STEMI cohort extends the disease-specific indications of the device to patients with higher-risk clinical presentation,” state Stephan Windecker, MD, Konstantinos C. Koskinas, MD, and Georgios Siontis, MD, in an accompanying editorial comment to the ABSORB China Trial.

The ABSORB everolimus-eluting bioresorbable vascular scaffold further demonstrated noninferiority to the XIENCE everolimus-eluting stent in CAD patients at two-year follow-up in the ABSORB II trial, presented Oct. 12 at TCT 2015. According to lead author Bernard R. Chevalier, MD, FACC, et al., this is the first randomized, single blind, active-controlled trial to compare the two stents, with a primary endpoint of three-year measure of vasomotion. The one-year follow-up results were presented last year at TCT 2014. 

Keywords: Transcatheter Cardiovascular Therapeutics, Coronary Artery Disease, Coronary Disease, Sirolimus, Stents, China, Coronary Angiography, Radial Artery

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