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BVS shows efficacy, safety in patients with diabetes
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An everolimus-eluting bioresorbable vascular scaffold appears to be safe and effective in patients with diabetes, particularly those with baseline reference vessel diameter of at least 2.25 mm, according to recent findings.
In the prespecified, powered, pooled subanalysis of the ABSORB II, ABSORB III and ABSORB Japan randomized trials, as well as the single-arm, open-label ABSORB EXTEND registry, Dean J. Kereiakes, MD, from The Christ Hospital Heart and Vascular Center and The Lindner Research Center, Cincinnati, and colleagues evaluated 754 patients with diabetes (27.3% treated with insulin) who had a BVS (Absorb, Abbott Vascular) implanted in at least one target lesion.
The study’s powered primary endpoint was incidence of target lesion failure at 1 year in the BVS cohort with diabetes. Patient-level data from the four studies were combined into a common database, and the powered primary endpoint of 1-year TLF rate of the pooled cohort was tested against a predetermined performance goal.
TLF favorable
The researchers found that the primary endpoint of 1-year TLF occurred in 8.3% of patients with diabetes treated with the BVS, with an upper-sided 95% confidence limit (CL) of 10.1%, which was below the prespecified performance goal of 12.7% (P for noninferiority = .0001).
The range of 1-year TLF by study was from 4.4% to 10.9% (chi-square test for poolability P = .08). In sensitivity analyses using fixed-effect (BVS 1-year TLF, 8.7%; upper 1-sided 95% CL, 10.6%; P for noninferiority = .0008) and random-effect (BVS 1-year TLF, 7.1%; upper 1-sided 95% CL, 10.5%; P for noninferiority = .006) models, the researchers confirmed that 1-year TLF after BVS implantation was well below the prespecified performance goal. There was a 2.3% rate of definite or probable stent thrombosis.
In multivariable Cox regression analysis, Kereiakes and colleagues identified the following as significant independent predictors of 1-year TLF in patients with diabetes when the proportional hazards assumption was met for all variables: older age, insulin treatment and smaller baseline reference vessel diameter. In an analysis stratified by baseline quantitative coronary reference vessel diameter, the researchers found less frequent adverse events among patients with diabetes with a reference vessel diameter of at least 2.25 mm.
Performance goals questioned
In a related editorial, Ron Waksman, MD, associate director of the division of cardiology at MedStar Heart Institute, Washington, D.C., questioned the value of performance goals in determining FDA labeling indications.
“The available [drug-eluting stent] technology is not specifically designed to address lesions in diabetic patients,” Waksman wrote. “Granting the current DES, including Absorb, an indication for diabetic patients based on [performance goals] is not supported by science and can be potentially misinterpreted, especially considering that the second-generation DES perform similarly to each other in randomized clinical trials.” – by Jennifer Byrne
Disclosure: Kereiakes reports receiving research funding from Abbott Vascular and Boston Scientific; and consulting for Abbott Vascular, Boston Scientific, Micell Technologies, Sino Medical Sciences Technology and Svelte Medical Systems. Please see the full study for a list of all other researchers’ relevant financial disclosures. Waksman reports financial ties with Abbott Vascular, AstraZeneca, Biosensors International, Biotronik, Boston Scientific, Edwards Lifesciences, Medtronic, Merck and St. Jude Medical.
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