ABSORB Substudy: Bioresorbable Vascular Scaffold Safe for Diabetes

The 1-year target lesion failure was 8.3% for patients with diabetes which was significantly lower than the pre-specified goal of 12.7%.

The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS; Abbott Vascular) can be used safely and effectively in patients with diabetes, according to results from a pooled analysis presented at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting and simultaneously published in JACC: Cardiovascular Interventions.

The researchers, led by Dean J. Kereiakes, MD, medical director of the Christ Hospital Heart and Vascular Center in Cincinnati, found that the 1-year rate of target lesion failure (TLF) was 8.3% for diabetic patients who received at least one Absorb scaffold. That result was “significantly” lower than the pre-specified performance goal of 12.7%, and the rate of scaffold thrombosis was 2.3%.

“Of note, among those patients with diabetes who had baseline reference vessel diameter appropriate for trial enrollment, 2.25 mm or greater, the 1-year TLF rate was only 6.6%,” Dr Kereiakes said in an email interview with Cardiology Advisor. “This is truly remarkable and suggests that among patients with diabetes and target vessel size appropriate for Absorb BVS implantation—2.25 mm or greater—clinical outcomes are actually very good. Stent thrombosis at 1 year in this group with appropriate vessel size was only 1.3%.”

“The take-home message, I believe, is to stay away from very small vessels—[smaller] than 2.25 mm—and to always utilize optimal deployment technique.”

Patients with diabetes are at greater risk for adverse outcomes including myocardial infarction (MI), stent thrombosis,restenosis, and death following percutaneous coronary intervention (PCI) with current drug-eluting stents. This poor prognosis in patients with diabetes has been attributed to a greater level of vascular inflammation, the presence of a pro-thrombotic state and more complex clinical and angiographic features.

This study included 754 patients enrolled in the ABSORB II, ABSORB III, and ABSORB JAPAN randomized trials, and the single arm, open-label ABSORB EXTEND registry. All patients in the analysis cohort had the Absorb scaffold implanted in at least 1 target lesion. Target lesion lengths >24mm in the ABSORB EXTEND and ABSORB II were excluded for consistency across studies.

In the individual studies, 1-year TLF ranged from 4.4% to 10.9%. In the sensitivity analysis, meta-analysis models showed that 1-year TLF following implantation of the scaffold was significantly below the performance goal both fixed effect (P for noninferiority= .0008) and random effect (P for noninferiority= .006).

Among patients with diabetes, the rates of TLF, and the TLF components of target vessel MI and ischemia-driven target lesion revascularization were significantly increased among patients treated with insulin compared to those who were not.

On multivariate regression analysis, the researchers found that older age, smaller target vessel reference vessel diameter by quantitative coronary angiography, and insulin treatment were independent predictors of 1-year TLF.

Disclosures: Drs Kereiakes and Ellis have served as consultants to Abbott Vascular, and Dr Chevalier is a current consultant. Dr Kimura has served on the advisory board of Abbott Vascular and Dr Stone has served as a consultant to Reva Corp. Drs Zhao, Veldhof, Vu, and Zhang are full time employees of Abbott Vascular.

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Kereiakes DJ, Ellis SG, Kimura T, et al. Efficacy and safety of the Absorb everolimus-eluting bioresorbable scaffold for treatment of patients with diabetes mellitus: results of the Absorb diabetic substudy. JACC Cardiovasc Interv. 2016 Oct 31. doi: 10.1016/j.jcin.2016.10.019 [Epub ahead of print].