New Research Examines Outcomes of Absorb BVS, OMT and PCI Approaches

Research highlighting new insights on the Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) and comparing only medical treatment (OMT) to percutaneous coronary intervention (PCI) was presented in both the ABSORB III and DECISION CTO trials on March 18 during ACC.17 in Washington, DC.

In the ABSORB III study, led by Stephen Ellis, MD, FACC, Dean Kereiakes, MD, FACC, and Gregg Stone, MD, patients who received the Absorb BVS showed one- and two-year outcomes comparable to those who received the Xience. The study followed 2,008 patients treated at 193 centers primarily across the U.S., 1,322 of which received the Absorb BVS and 686 the Xience. Between the first two years, target lesion failure was comparable (3.7 percent vs. 2.6 percent); however, at the end year two, Absorb BVS recipients experienced an elevated risk of adverse outcomes (10.9 percent vs. 7.8 percent). Target vessel heart attack drove this difference and appears to be a result of clinicians placing the Absorb BVS in vessels that surpassed U.S. Food and Drug Administration (FDA) recommendations (2.5-3.75 mm in diameter).

"The value proposition of the Absorb BVS is that once the device is fully dissolved after three years there will be better long-term outcomes, but there are as of yet no long-term, large studies available to show that," the authors state.

The FDA on March 18 issued a safety alert informing health care providers that there is an increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with XIENCE.

A separate study, ABSORB IV, is currently enrolling patients, and a landmark analysis in collaboration with the FDA will combine the ABSORB III and ABSORB IV studies to evaluate the effectiveness of the Absorb BVS once fully dissolved.

In the DECISION CTO trial, led by Seung-Jung Park, MD, PHD, FACC, et al., patients who received OMT (aspirin, a beta-blocker, a calcium channel blocker and a statin) had similar outcomes to those who received PCI. The trial, which enrolled 798 patients across nine cardiac centers in Asia, assigned 387 patients to OMT and 411 to PCI. After year three, 19 percent of the OMT group and 21.4 percent of the PCI group reached the trial's endpoint (death, myocardial infarction, stroke or repeat revascularization).

The authors state that "in terms of patient outcomes, cost versus benefit, and other considerations, it is not beneficial to use PCI for all chronic total occlusion lesions. They add that "if patients suffer from a large ischemic burden, PCI is crucial [...], but for small occlusions, optimal medical treatment is sufficient."

The authors suggest a large, global, multi-center study to further validate the DECISION CTO trial results.


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