Safety Outcomes in High Risk Patients Receiving Triple Therapy after Percutaneous Coronary Intervention

Objectives: Individuals with coronary heart disease undergoing percutaneous coronary intervention may have compelling indications for anticoagulation with warfarin and may also require additional antiplatelet therapy such as clopidogrel and aspirin.  The benefits of preventing thrombus formation must be carefully weighed against the risks of bleeding events in patients receiving triple therapy (TT).  There is no consensus on how to best manage these patients, other than a careful individualized approach.  This ongoing study evaluates safety outcomes in patients receiving TT with warfarin, clopidogrel, and aspirin concomitantly.

Methods: A retrospective analysis of computerized medical records from veterans undergoing heart catheterization on concomitant anticoagulation and antiplatelet therapies was performed. Indication for TT, CHADS₂ scores, HAS-BLED scores, warfarin and aspirin dose, hospital admissions, and thromboembolic events were recorded. Bleeding was defined using TIMI and GUSTO classification.

Results: Currently 26 patients have met inclusion criteria. Eighteen patients (69%) received drug-eluting stents, and 19 patients (73%) had atrial fibrillation. The average length of TT was 9.8 months ± 8.29.  Fourteen patients (53.8%) had bleeding episodes that met one or both bleeding criteria.  A total of 26 bleeds occurred in these 14 patients. Ten (40%) met TIMI major or minor and 2 (8%) met GUSTO severe or moderate criteria. Sixty-two percent of bleeds occurred within 90 days of initiating TT. INR range during bleeding episodes was 1.5 – 3.9. Seventy-two percent of patients receiving stents had bleeding episodes.  Twenty percent of bleeding episodes resulted in hospital visits. No thromboembolic events or deaths occurred.

Conclusion: In this small population undergoing heart catheterization, bleeding while on TT was high and required additional hospital visits.  Most bleeding events occurred early in therapy. Strategies to reduce bleeding events in patients requiring TT need further investigation.  Evaluation of additional patients is in progress.