BACKGROUND: Long-term oral anticoagulant treatment is obligatory in patients (class I) with mechanical heart valves and most patients with atrial fibrillation. When these patients undergo percutaneous coronary intervention with stenting, there is also an indication for treatment with aspirin and clopidogrel. However, triple therapy is known to increase the risk of bleeding complications. Unfortunately, there are no prospective data available to resolve this issue. Nevertheless, it all comes down to finding the ideal therapy in patients with indications of both chronic anticoagulation therapy andpercutaneous intervention to prevent thrombotic complications (eg, stent thrombosis) without increasing the risk of bleeding. OBJECTIVES: This prospective randomized multicenter study will assess the hypothesis that after percutaneous coronary intervention with stent implantation in patients on oral anticoagulant therapy, the combination of oral anticoagulation therapy and clopidogrel 75 mg/d reduces the risk of bleeding and is not inferior to triple therapy treatment with respect to the prevention of thrombotic complications. DESIGN: Multicenter, international, open-label randomized trial evaluating triple therapy (clopidogrel + oral anticoagulants + aspirin) in patients with an indication for oral anticoagulants who undergo coronary stenting versus the combination of oral anticoagulants and clopidogrel. The primary outcome is the combination of TIMI and GUSTO minor and major bleeding up to 30 days and 1 year. The secondary outcomes are major adverse cardiac events. The sample size is 496. CONCLUSIONS: No prospective randomized study has yet addressed the issue of optimal antiplatelet therapy in patients with chronic oral anticoagulant therapy undergoing coronary stenting. Therefore, the WOEST trial will help to define new guidelines for patients with indication for chronic anticoagulation who need coronary stenting.
RCT Entities:
BACKGROUND: Long-term oral anticoagulant treatment is obligatory in patients (class I) with mechanical heart valves and most patients with atrial fibrillation. When these patients undergo percutaneous coronary intervention with stenting, there is also an indication for treatment with aspirin and clopidogrel. However, triple therapy is known to increase the risk of bleeding complications. Unfortunately, there are no prospective data available to resolve this issue. Nevertheless, it all comes down to finding the ideal therapy in patients with indications of both chronic anticoagulation therapy and percutaneous intervention to prevent thrombotic complications (eg, stent thrombosis) without increasing the risk of bleeding. OBJECTIVES: This prospective randomized multicenter study will assess the hypothesis that after percutaneous coronary intervention with stent implantation in patients on oral anticoagulant therapy, the combination of oral anticoagulation therapy and clopidogrel 75 mg/d reduces the risk of bleeding and is not inferior to triple therapy treatment with respect to the prevention of thrombotic complications. DESIGN: Multicenter, international, open-label randomized trial evaluating triple therapy (clopidogrel + oral anticoagulants + aspirin) in patients with an indication for oral anticoagulants who undergo coronary stenting versus the combination of oral anticoagulants and clopidogrel. The primary outcome is the combination of TIMI and GUSTO minor and major bleeding up to 30 days and 1 year. The secondary outcomes are major adverse cardiac events. The sample size is 496. CONCLUSIONS: No prospective randomized study has yet addressed the issue of optimal antiplatelet therapy in patients with chronic oral anticoagulant therapy undergoing coronary stenting. Therefore, the WOEST trial will help to define new guidelines for patients with indication for chronic anticoagulation who need coronary stenting.