Author + information
- Dieter Fischer,
- Grigorios Chatzantonis,
- Ali Yilmaz,
- Hannes Findeisen,
- Alexander Samol,
- Johannes Waltenberger and
- Matthias Paul
Patients at high risk of bleeding requiring percutaneous coronary intervention (PCI) are a challenging group who need careful evaluation of both their thrombotic and bleeding risks. Deciding on duration and intensity of antithrombotic management is difficult and has to be well balanced. In these patients, a polymer-free metallic stent coated with biolimus-A9 (Biofreedom®) followed by a one-month dual antiplatelet therapy has shown to be safer and more effective when compared to a bare metal stent during a two year follow-up (LEADERS-free trial). Yet, data on safety and efficacy outside a trial are scare. Therefore, we analyzed this regimen in a real-world scenario.
Between November 2015 and August 2016, Patients at high bleeding risk and indication for PCI were treated with Biofreedom® stents followed by a DAPT consisting of aspirin (100 mg/day) and clopidogrel (75 mg/day) for one month. Clinical follow-up was performed to evaluate the safety and efficacy of this therapeutic regimen. Therefore, patients were followed by standardized telephone interview.
Overall, 93 patients were enrolled in this study (mean age 73 ± 11 years; 28 female (30 %)). Mean HASBLED-score was 2.9 ± 0.86. High bleeding risk characteristics were: High HASBLED-score (≥ 3) in 66 pt., age ≥ 75 y (51 pt.), indication for oral anticoagulation (63 pt.), tumor (21 pt.), need for non-cardiac surgery (16 pt.), and history of severe bleeding (9 pt.). In sum 113 interventions were performed. Patients received a mean of 1.84 ± 1.13 stents. No stent thrombosis occurred during a mean follow-up of 6.1 ± 2.7 months. Nine patients died during follow-up, all deaths were not related to bleeding events or myocardial infarction. In six patients (6%), bleeding events occurred.
In patients at high risk of bleeding, implantation of the polymer-free metallic stent coated with biolimus-A9 (Biofreedom®) followed by a one-month dual antiplatelet therapy was safe and effective in a real-world scenario, no stent thrombosis occurred.