Comparison of One-Year Outcomes in Patients >75 Versus ≤75 Years With Coronary Artery Disease Treated With COMBO Stents (From The MASCOT Registry)

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Older patients who undergo coronary interventions are at greater risk of ischemic events and less likely to tolerate prolonged dual antiplatelet therapy (DAPT) due to bleeding risk. The COMBO biodegradable polymer sirolimus-eluting stent promotes rapid endothelialization through endothelial progenitor cell capture technology which may be advantageous in elderly patients. We compared 1-year clinical outcomes and DAPT cessation events in patients >75 versus ≤75 years from the MASCOT registry. MASCOT was a prospective, multicenter cohort study of all-comers undergoing attempted COMBO stenting. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a nontarget vessel or clinically driven target lesion revascularization. Bleeding was adjudicated using the Bleeding Academic Research Consortium criteria. Adjusted outcomes were analyzed using Cox regression methods. The study included 18% (n = 479) patients >75 years and 72% (n = 2,135) patients ≤75 years. One-year TLF occurred in 4.6% patients >75 years versus 3.1% patients ≤75years of age, p = 0.10; adj hazard ratio 1.36, 95% confidence intervals 0.77 to 2.38, p = 0.29. There were no significant differences in cardiac death (1.7% vs 1.3%, p = 0.55), MI (2.1% vs 1.2%, p = 0.14), target lesion revascularization (1.7% vs 1.4%, p = 0.60) and definite stent thrombosis (0.8% vs 0.4%, p = 0.19). Major Bleeding Academic Research Consortium 3,5 bleeding (3.1% vs 1.5%, p = 0.01) and DAPT cessation rates (32.4% vs 23.0%, p <0.001) were significantly higher in elderly patients. In conclusion, elderly patients >75 years treated with COMBO stents had similar TLF but significantly greater incidence of bleeding than younger patients and DAPT cessation in one-third of patients over 1 year.

Section snippets

Methods

The MASCOT registry (clinicaltrials.gov identifier NCT02183454) was a post marketing observational study conducted to evaluate the long-term safety and performance of the COMBO stent in routine clinical practice.1 Patients were enrolled in 60 sites across Europe, Middle East, Asia, and South America. The study design has been previously described and the study was managed by the Clinical Coordinating Center at the Icahn School of Medicine at Mount Sinai with full oversight of the study

Results

Of the study cohort, 18% (n = 479) patients were >75 years and 72% (n = 2,135) were ≤75years of age. Table 1 shows the baseline characteristics of the 2 groups. Elderly patients included more women and had lower body mass index with higher prevalence of several comorbidities including hypertension, chronic kidney disease, anemia and congestive heart failure but lower prevalence of current smokers. With respect to vascular disease older patients had greater prevalence of prior stroke, peripheral

Discussion

The main findings of this analysis comparing patients >75 years and those ≤75 years of age from the all-comers MASCOT registry treated with COMBO stents are as follows: 1. Elderly patients had a greater prevalence of several baseline comorbidities, and included more women, however, they presented less often with ST-segment elevation myocardial infarction; 2. there were no differences in the rates of radial access PCI, or implanted stent size in elderly compared with younger patients. The use of

Disclosures

The authors declare that they have no known competing financial interests or personal relations that could have appeared to influence the work reported in this study.

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  • Cited by (0)

    The MASCOT registry was sponsored by OrbusNeich Medical (Ft. Lauderdale, Florida).

    Dr. Mehran has received institutional research grant support from Eli Lilly/Daiichi-Sankyo Inc., AstraZeneca, The Medicines Company, Bristol-Myers Squibb, OrbusNeich, Beth Israel Deaconess, and Bayer; has served as a consultant for Boston Scientific, Cardiovascular Systems Inc., Medscape, and Shanghai BraccoSine Pharmaceutical; has received institutional advisory board funding from Bristol-Myers Squibb; has received institutional funding from Claret Medical; owns equity in Claret Medical and Elixir Medical; has served on the executive committee for Janssen Pharmaceuticals and Osprey Medical; has served on the data safety monitoring board for Watermark Research Partners; and has a spouse who has served as a consultant for Abiomed and the Medicines Company. Dr. Kala has served as a consultant for Boston Scientific; has received research support from Astra Zeneca, Novartis, Zoll; has served on advisory board for Astra Zeneca, Bayer, Medtronic and Boston Scientific. All other authors have reported that they have no relations relevant to the contents of this study to disclose.

    Clinicaltrials.gov identifier: NCT02183454.

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