Findings showing the Absorb bioresorbable vascular scaffolds (BVS) were non-inferior to the Xience CoCr-EES for target lesion failure (TLF) at 30 days and one year, "emphasize the need for further advancements in device technology and improvements in technique to further improve the early safety profile of BVS if the benefits of late scaffold bioresorption are to be realized," said Gregg W. Stone, MD, FACC, presenting on the ABSORB IV trial Sept. 25 at TCT 2018.

The trial randomized approximately 2,600 patients with stable ischemic heart disease or acute coronary syndrome to either the Absorb BVS (N=1,300) or the Xience CoCr-EES (N=1,300) at 147 sites in the U.S., Canada, Germany, Australia and Singapore between August 2014 and March 2017. The primary endpoints were TLF at 30 days and TLF between three and seven to 10 years (pooled with ABSORB III). Secondary endpoints were TLF at one year and angina at one year.

When compared with ABSORB III, overall ABSORB IV results showed that nearly eliminating treatment of very small vessels substantially reduced the scaffold thrombosis rate in the Absorb BVS group, as well as the Xience CoCr-EES group. Additionally, angina recurred in a relatively high, but nearly identical rate, in both groups. Stone, et al., said they observed a "bimodal pattern suggesting contributions from incomplete revascularization, restenosis, and possibly non-CAD-related mechanisms."

Researchers also noted that 30-day and one-year rates of myocardial infarction, ischemia-driven TLF and device thrombosis tended to be higher in the Absorb BVS group compared with the Xience CoCr-EES group, despite improved patient and lesion section, as well as technique.

Looking ahead, Stone, et al., suggest that longer-term follow-up is needed to understand the true safety and efficacy profile of BVS during the first three years, as well as beyond its complete bioresorption.

Keywords: TCT18, Transcatheter Cardiovascular Therapeutics, Angiography, Percutaneous Coronary Intervention, Absorbable Implants, Polymers, Drug-Eluting Stents, Sirolimus

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