Sex differences in 1-year clinical outcomes after percutaneous coronary intervention with COMBO stents: From the
Jaya Chandrasekhar1,2, Laura S Kerkmeijer2, Deborah N Kalkman2
1Icahn School of Medicine at Mount Sinai Hospital, New York, USA.
Insights
Women treated with COMBO drug-eluting stents experienced similar 1-year target lesion failure (TLF) outcomes compared to men, despite having higher baseline clinical risks. This indicates comparable safety and efficacy in both sexes for this novel stent technology.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- The COMBO drug-eluting stent utilizes endothelial progenitor cell capture technology for enhanced endothelialization.
- Previous studies have not fully elucidated sex-based differences in outcomes following COMBO stent implantation.
Purpose of the Study:
- To investigate potential sex differences in 1-year clinical outcomes after implantation of the COMBO drug-eluting stent.
- To compare the incidence of target lesion failure (TLF) and stent thrombosis (ST) between women and men.
Main Methods:
- Pooled patient-level data from the MASCOT and REMEDEE multicenter registries were analyzed.
- 1-year outcomes, including TLF (cardiac death, target vessel-myocardial infarction, or clinically driven target lesion revascularization) and stent thrombosis, were assessed.
- Cox regression models were used for adjusted outcome analysis, stratifying by sex.
Main Results:
- The study included 861 women (23.8%) and 2,753 men (76.2%). Women presented with older age and higher comorbidity prevalence, including diabetes mellitus.
- 1-year TLF rates were similar between sexes (3.8% in women vs. 3.9% in men; HR 0.92; P=.70).
- Rates of cardiac death, target vessel-myocardial infarction, and clinically driven target lesion revascularization were also comparable. Definite or probable stent thrombosis was numerically lower in women (0.4% vs. 1.0%; HR 0.26; P=.069).
Conclusions:
- Despite higher baseline risk factors, women undergoing COMBO stenting demonstrated comparable 1-year target lesion failure and other ischemic outcomes to men.
- The COMBO drug-eluting stent appears to offer similar safety and efficacy profiles for both female and male patients in the short term.
Background:
The COMBO drug eluting stent is a novel device with luminal endothelial progenitor cell capture technology for rapid homogeneous endothelialization.
Methods And Results:
We examined for sex differences in 1-year outcomes after COMBO stenting from the COMBO collaboration, a pooled patient-level dataset from the MASCOT and REMEDEE multicenter registries. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR). Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods. The study included 861 (23.8%) women and 2,753 (76.2%) men. Women were older with higher prevalence of several comorbidities including diabetes mellitus. Risk of 1-year TLF was similar in both sexes (3.8% vs. 3.9%, HR 0.92, 95% CI 0.59-1.42, p = .70), 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 (2.0% vs. 2.2%, p = .67). Definite or probable ST occurred in 0.4% women and 1.0% men (HR 0.26, 95% CI 0.06-1.11, p = .069).
Conclusions:
Despite greater clinical risks at baseline, women treated with COMBO stents had similarly low 1-year TLF and other ischemic outcomes compared to men.
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