Triple therapy in the elderly patients and women – results from the MUNICH triple cohort in patients with AF undergoing PCI

Abstract

Introduction: Approximately 20% of patients with atrial fibrillation (AF) are suffering from coronary artery disease (CAD), requiring percutaneous coronary intervention (PCI) and stenting over time. These patients are in need of a so-called “triple therapy” (TT) for prevention of stent thrombosis and stroke. Prospective and randomized trials examined risk for bleeding in TT and compared it to a dual regimen, but in majority excluded elderly patients. Moreover, in all to date presented triple therapy trials women represent a minority of included patients (mostly <30%). This raises the question, why female and elderly patients are underrepresented and these groups have a different outcome then younger and male patients, when treated with a guideline recommended TT. Methods: The objective of our retrospective cohort study was to determine the number of women and elderly patients with the indication for TT and to evaluate the differences in medical treatment. Furthermore, we evaluated safety, represented by bleeding (BARC ≥2 bleedings) and efficacy endpoints (composite clinical endpoint: all-cause-death, myocardial infarction, stent thrombosis, stroke and other systemic thromboembolism) in women vs. men, and elderly vs. younger patients. Moreover, we investigated the influence of NOAC (new oral anticoagulant) vs. VKA (vitamin K antagonist) treatment. Follow-ups were performed via phone-calls or in-hospital visits. Results: In total, we included 928 patients with AF, that underwent PCI and stenting. Mean follow-up was 464 days. 627 patients were <80 years old (mean age: 72±7 years), 301 were ≥80 years old (mean age: 84±4 years). Only 27.9% of all patients were female. The number of men and women receiving TT was comparable (83.0% vs. 82.2%, p=0.78), while in the younger group significantly more patients received TT (537 (85.6%) vs. 228 (74.7%) (p<0.001). The incidence of BARC ≥2 bleedings in patients with TT was not significantly different in younger vs. older patients and in men vs. women. Also, the incidence of the composite clinical endpoint did not differ significantly in both comparisons. Conclusion: In our real-life cohort female sex represents around a quarter of TT patients in line with large RCTs. But, unlike the large RCTs, 1/3 of our included patients were older then 80 years and seem to be underrepresented in randomized TT trials. TT seems to be safe in elderly as well as in female patients. As they both represent an important group, future trials should focus more on including a well balanced patient cohort to improve the applicability of the results.