ABSORB: Two Trials Compare BVS to Metal Stents in PCI Patients
Use of the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) in patients undergoing percutaneous coronary intervention (PCI) had a similar mid-term (12-month) clinical safety and efficacy profile as using the cobalt-chromium everolimus-eluting stent (CoCr-EES), with comparable 13-month angiographic outcomes, according to results from the ABSORB Japan Study presented Sept. 1 during ESC Congress 2015 in London and simultaneously published in European Heart Journal (EHJ). These results support the feasibility of using BVSs to potentially improve the long-term outcomes of patients undergoing PCI, investigators said.
ABSORB Japan, which included 400 patients from 38 Japanese sites, was a single-blind, active-controlled, randomized trial designed to support regulatory approval of the Absorb BVS in Japan. Patients with one or two de novo lesions in different epicardial vessels were randomized in a 2:1 ratio to Absorb BVS or CoCr-EESs. The primary endpoint was target lesion failure at 12 months or ischemia-driven target lesion revascularization (ID-TLR) at one year, powered for non-inferiority. The major secondary endpoint was angiographic in-segment late lumen loss at 13 months.
Results showed that target lesion failure through 12 months was comparable across both groups: 4.2 percent with Absorb BVS and 3.8 percent with CoCr-EES. Definite/probable stent/scaffold thrombosis at 12 months occurred in 1.5 percent of the patients with both devices and ID-TLR for restenosis was infrequent (1.1 percent/BVS vs. 1.5 percent/CoCr-EESs). Absorb BVS was also comparable for the major secondary angiographic endpoint of in-segment late lumen loss at 13 months.
In an accompanying EHJ editorial, Steen D. Kristensen, MD, Evald H. Christiansen, MD, and Michael Maeng, MD, of Aarhus University Hospital in Denmark, write: "These new devices share the feature of being able to deliver the drug and then be resorbed. This may change coronary intervention from treatment with a permanent metallic stent to a resorbable cure. However, more studies in more complex lesion subsets and also longer-term follow-up of the published studies are needed before we can conclude whether these new stents will be a significant game changer that will benefit the majority of patients with coronary artery disease."
Meanwhile, the results of the ABSORB STEMI TROFI II trial also presented Sept. 1 show the BVS performed similarly to metal stents in patients with ST-segment elevation myocardial infarction (STEMI). The study randomized 191 STEMI patients undergoing PCI to receive either a BVS or metallic stent. The primary endpoint was a six-month score assessing stent coverage and restenosis of the vessel using coronary optical coherence tomography imaging. Results showed similar scores of 1.74 in the BVS group and 2.80 in the metallic stent group, indicating almost complete arterial healing in both groups and meeting the criteria for non-inferiority, investigators said. Clinical events, defined as a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization, were 1.1 percent in the BVS group and 0 percent in the metallic stent group.
"This trial provides the basis for further exploration in clinical outcomes trials," noted Patrick W. Serruys, MD, PhD, FACC.
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