Design and rationale of the WOEST trial: What is the Optimal antiplatElet and anticoagulant therapy in patients with oral anticoagulation and coronary StenTing (WOEST).
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.


OBJECTIVE
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.


METHODS
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.
Dewilde
Willem
W
Sint Antonius Hospital, Nieuwegein, The Netherlands. willemdewilde@yahoo.com
Berg
Jurriën Ten
JT
D000284:Administration, Oral; D000925:Anticoagulants / Q000008:administration & dosage*; D001241:Aspirin / Q000008:administration & dosage; D002986:Clinical Trials as Topic; D000077144:Clopidogrel; D003324:Coronary Artery Disease / Q000628:therapy*; D004359:Drug Therapy, Combination; D006801:Humans; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D015607:Stents; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D016896:Treatment Outcome
D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin