Previous studies have documented higher rates of adverse events with bioresorbable scaffolds (ABSORB) compared with metallic drug-eluting stents (DES). However, these studies included lesions smaller than recommended for these scaffolds and a suboptimal implantation technique.
The ABSORB IV study, presented by Dr. Stone at TCT 2018 and published simultaneously in The Lancet, randomized patients to polymeric everolimus-eluting scaffold Absorb with optimized implantation technique vs. cobalt-chromium everolimus-eluting stent Xience. Patients and clinical evaluators were masked to randomization. The primary endpoint was the classic composite of death, infarction, and clinically-justified revascularization with a non-inferiority analysis.
Overall, 1296 patients were randomized to Absorb and 1308, to Xience.
The primary endpoint occurred in 7.8% of patients who received Absorb and in 6.4% of patients who received Xience, thus achieving the limit for non-inferiority.
Read also: TCT 2018 | RADIOSOUND-HTN: Testing Different Renal Ablation Techniques and Devices.
Definite thrombosis occurred in 0.7% of Absorb patients vs. 0.3% of Xience patients (p = 0.15).
With optimized implantation technique in a barely selected population, Absorb showed that it is still not dead.
Original title: A Blinded Randomized Trial of a Polymeric Everolimus-Eluting Bioresorbable Scaffold in an Expanded Patient Population Using Optimized Technique.
Presenter: Gregg Stone.
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