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March 21, 2020
Study Shows Similar 1-Year Outcomes for Women and Men Treated With OrbusNeich's Combo DES
March 21, 2020—Online in Catheterization and Cardiovascular Interventions, Jaya Chandrasekhar, MBBS, et al published findings from an examination of sex differences in 1‐year outcomes with the Combo drug-eluting stent (OrbusNeich). The study included 861 (23.8%) women and 2,753 (76.2%) men. Women were older with a higher prevalence of several comorbidities including diabetes mellitus.
The investigators concluded that despite greater clinical risks at baseline, women treated with Combo stents had similarly low 1‐year target lesion failure (TLF) and other ischemic outcomes compared with men.
As summarized in Catheterization and Cardiovascular Interventions, the investigators used a pooled patient‐level data set from the MASCOT and REMEDEE multicenter registries evaluating the Combo device, which features luminal endothelial progenitor cell capture technology for rapid homogeneous endothelialization.
The primary endpoint was 1‐year TLF (a composite of cardiac death, target vessel‐myocardial infarction [TV‐MI], or clinically driven target lesion revascularization [CD‐TLR]). Secondary outcomes included stent thrombosis. Adjusted outcomes were assessed using Cox regression methods.
The risk of 1‐year TLF was similar in both sexes (3.8% vs 3.9%; hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.59–1.42; P = .7), without sex differences in the incidence of cardiac death (1.6% vs 1.5%; P = .78), TV‐MI (1.5% vs 1.1%; P = .32), or CD‐TLR (2% vs 2.2%; P = .67). Definite or probable stent thrombosis occurred in 0.4% women and 1.0% men (HR, 0.26; 95% CI, 0.06–1.11; P = .069), reported the investigators in Catheterization and Cardiovascular Interventions.
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