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Device treatment effects of BVS, EES consistent in men, women with CAD
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Two-year clinical outcomes were consistent among women and men treated with a bioresorbable vascular scaffold or everolimus-eluting stent, despite varying CV risk profiles, according to results published in JACC: Cardiovascular Interventions.
According to the study, women are underrepresented in coronary stent trials and the relative safety and efficacy of the BVS (Absorb, Abbott Vascular) in the female population was previously unknown.
The pooled data analysis of four randomized trials comparing the BVS with the cobalt-chromium EES (Xience, Abbott Vascular) suggested treatment effects of the BVS and EES on 2-year target lesion failure and other CV outcomes were consistent in men and women.
“Although coronary heart disease remains the leading cause of mortality in females, women are underrepresented in trials of coronary stenting, including ABSORB III, so that analysis from any single trial lacks power to provide accurate estimates of device efficacy or safety in this subgroup,” Satya Shreenivas, MD, from the Christ Hospital and Heart and Vascular Center at the Lindner Research Center in Cincinnati, and colleagues wrote. “Furthermore, females enrolled into clinical trials are often distinguished by significant differences in baseline clinical and angiographic variables that their male counterparts, including older age, more frequent comorbid risk factors and smaller coronary arteries.”
To characterize the demographics of women vs. men receiving BVS vs. EES and evaluate the sex-specific relative safety and efficacy of BVS vs. EES, Shreenivas and colleagues used pooled data from the ABSORB II, ABSORB III, ABSORB Japan and ABSORB China trials and analyzed baseline clinical, angiography, procedural variables and 2-year outcomes by sex and device.
The analysis consisted of 3,384 randomly assigned patients and had a primary endpoint of TLF at 2 years.
Of the patients included in the pooled analysis, 932 (27.5%) were women, who tended to be older with higher rates of diabetes and hypertension compared with men.
Women had fewer rates of EES or three-vessel disease and were less likely to be smokers than men included in the analysis (P .001).
The analysis showed rates of TLF with BVS vs. EES in women were 8.9% vs. 6.2% (study-level adjusted HR = 1.47; 95% CI, 0.88-2.46) and 8.9% vs. 6.4% in males (HR = 1.4; 95% CI, 1.02-1.92; P for interaction = .85) at 2 years.
The researchers found no significant interactions between sex and device type for any of the components of TLF.
According to an accompanying editorial from Gennaro Giustino, MD, and George D. Dangas, MD, PhD, from the Zena and Michael A. Wiener Cardiovascular Institute, and Icahn School of Medicine at Mount Sinai, the study had many strengths, including prospective, multicenter randomized controlled trial data with masked event adjudication and angiographic core laboratory analysis.
“Although the present report constitutes a significant contribution to sex-specific analysis in the field of coronary stents, many questions remain unanswered,” they wrote. “Data sharing and pooling of [randomized controlled trials], like the present study, will be key to estimate the risk and benefits of different stent types across relevant subsets of patients, such as women and minorities.” – by Dave Quaile
Disclosures: The ABSORB trials were sponsored by Abbott Vascular. Shreenivas and Giustino report no relevant financial disclosures. Dangas reports he is an unpaid consultant to Boston Scientific and Medtronic, and his spouse has received speaking honoraria from Abbott and is a member of the advisory board for Abbott. Please see the study for all other authors’ financial disclosures.
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