For patients with coronary heart disease at high risk of bleeding, how to perform safe and effective antiplatelet therapy after percutaneous coronary intervention (PCI) has been a hot topic of concern. Only the risk of thrombotic events and bleeding events can be accurately assessed to find the right balance between the risk of thrombosis and bleeding.
In the afternoon of May 17th, Professor Arthburg reported the results of the LEADERS FREE study. LEADERS FREE was a prospective, double-blind, randomized controlled trial of 2466 patients with high risk of bleeding who were randomized to two groups, BioFreedom Drug Coating Stent or bare metal stent group, followed by 1 month Of double antiplatelet therapy and long-term monoclonal antibody platelet therapy. During the 1-year follow-up, 7.2% of patients in the drug-eluting stent group had a bleeding event and 5.7% had a thrombotic event: 7.3% of the patients in the bare metal stent had a bleeding event and 8.6% had a thrombus event. The mortality rates for patients with bleeding and thrombotic events during follow-up were 25.4% and 24.4%, respectively (no statistically significant).
By COX regression analysis, the LEADERS FREE team established a risk prediction model for assessing major bleeding events and thrombotic events. The independent risk factors for thrombotic events were: serum creatinine> 150 nmol / L, multiple lesions, at least one bifurcation treatment, treatment with bare metal stent, age> 75 years, stent number and low hemoglobin.The risk factors for bleeding were: age> 75 years, number of stents, low hemoglobin, femoral artery puncture and oral anticoagulant. The area under the ROC curve of the thrombosis risk model and the bleeding risk model were 0.66 and 0.71, respectively.
The risk of thrombosis and bleeding was assessed in all patients. Patients with high risk of bleeding were often also at high risk of thrombosis, with only 8.1% (177 patients) with a risk of bleeding greater than twice the risk of thrombosis; thrombosis risk was greater than bleeding The risk of bleeding and the risk of thrombosis in most patients (78.8%) showed a consistent trend, that is, the higher the risk of bleeding and the higher risk of thrombosis.
For patients with significant differences in bleeding risk and risk of thrombosis, the clinician can choose the appropriate treatment regimen based on the patient's own characteristics. However, it is important to note that the BioFreedom Drug Coating Stent and the bare metal stent used in the LEADERS FREE study are significantly different from the most commonly used clinical drug scaffolds in the present day. Therefore, further studies have confirmed that the scoring model The effectiveness of the application in clinical practice.