Outcome of Patients on Oral Anticoagulation Undergoing CAS
Outcome of Patients on Oral Anticoagulation Undergoing CAS
Objectives To obtain further, and more focused, information on the efficacy and safety of the antithrombotic regimens, including triple therapy (TT) of warfarin, aspirin, and clopidogrel; dual therapy (DT) of warfarin and single antiplatelet agent (aspirin or clopidogrel); and dual-antiplatelet therapy (DAPT) of aspirin and clopidogrel, prescribed to patients on oral anticoagulation (OAC) undergoing percutaneous coronary intervention with stent (PCI-S).
Background The true efficacy and safety of TT, DT, and DAPT in OAC patients undergoing PCI-S is largely undefined.
Methods We analyzed the database of the prospective, multicenter WARfarin and coronary STENTing (WAR-STENT) registry (ClinicalTrials.gov identifier NCT00722319), only including the post-discharge period.
Results Of the 401 patients discharged alive from index hospitalization, 339 (85%), 20 (5%), and 42 (10%) were prescribed TT, DT, and DAPT, respectively. Throughout a mean follow-up of 368.3 ± 22.8 days, major adverse cardiovascular events (MACE) (including cardiovascular death, myocardial infarction, repeat revascularization, stent thrombosis, and thromboembolism), total bleeding, major bleeding, and combination of MACE plus total bleeding were comparable across the three treatment groups. The absolute rate of major bleeding with TT was 4%. The antithrombotic treatment actually ongoing at major bleeding was TT in 44%, DT in 50%, and DAPT in 6% of cases.
Conclusion In the real-world population of OAC patients undergoing PCI-S in the WAR-STENT registry, the three antithrombotic regimens of TT, DT, and DAPT showed comparable efficacy and safety. Due to several limitations, our data cannot be considered conclusive in confuting the current recommendations to prescribe TT. Further properly designed and sized studies are warranted.
In patients on oral anticoagulation (OAC) undergoing percutaneous coronary intervention with stent (PCI-S), triple therapy (TT) of warfarin, aspirin, and clopidogrel is currently recommended throughout the period most vulnerable to stent thrombosis and recurrent coronary events (ie, 1 to 3–6 months) to prevent a major adverse cardiovascular event (MACE), including cardiovascular death, myocardial infarction, repeat revascularization, stent thrombosis, and thromboembolism. The analyses of efficacy, however, have generally yielded mixed results regarding the superiority of TT over other antithrombotic regimens, including dual therapy (DT) of OAC plus single antiplatelet agent (either aspirin or clopidogrel) and dual-antiplatelet therapy (DAPT) of aspirin and clopidogrel, with regard to the MACE rate. In contrast, the incidence of major and total bleeding has been consistently reported to be significantly increased (2- to 3-fold) with TT.
Most of the data on which the current recommendations are based, however, are retrospective or derived from administrative databases, thereby not allowing evaluation of the bleeding events occurring after discharge separate from those in-hospital (which may be related more to periprocedural variables such as management of anticoagulation, vascular access site, use and dose of intraprocedural anticoagulants, and use of glycoprotein IIb/IIIa inhibitors than to the ongoing antithrombotic regimen), or to match a bleeding event to the antithrombotic regimen actually ongoing at the time of occurrence (which may not be the same as prescribed at discharge). Because of these factors, the true safety profile and absolute incidence of bleeding with the various antithrombotic regimens (especially TT) remain uncertain.
To obtain further, more focused information on the clinical outcomes of patients on OAC undergoing PCI-S, we analyzed the database of the prospective, multicenter WARfarin and coronary STENTing (WAR-STENT) registry, only including the postdischarge period.
Abstract and Introduction
Abstract
Objectives To obtain further, and more focused, information on the efficacy and safety of the antithrombotic regimens, including triple therapy (TT) of warfarin, aspirin, and clopidogrel; dual therapy (DT) of warfarin and single antiplatelet agent (aspirin or clopidogrel); and dual-antiplatelet therapy (DAPT) of aspirin and clopidogrel, prescribed to patients on oral anticoagulation (OAC) undergoing percutaneous coronary intervention with stent (PCI-S).
Background The true efficacy and safety of TT, DT, and DAPT in OAC patients undergoing PCI-S is largely undefined.
Methods We analyzed the database of the prospective, multicenter WARfarin and coronary STENTing (WAR-STENT) registry (ClinicalTrials.gov identifier NCT00722319), only including the post-discharge period.
Results Of the 401 patients discharged alive from index hospitalization, 339 (85%), 20 (5%), and 42 (10%) were prescribed TT, DT, and DAPT, respectively. Throughout a mean follow-up of 368.3 ± 22.8 days, major adverse cardiovascular events (MACE) (including cardiovascular death, myocardial infarction, repeat revascularization, stent thrombosis, and thromboembolism), total bleeding, major bleeding, and combination of MACE plus total bleeding were comparable across the three treatment groups. The absolute rate of major bleeding with TT was 4%. The antithrombotic treatment actually ongoing at major bleeding was TT in 44%, DT in 50%, and DAPT in 6% of cases.
Conclusion In the real-world population of OAC patients undergoing PCI-S in the WAR-STENT registry, the three antithrombotic regimens of TT, DT, and DAPT showed comparable efficacy and safety. Due to several limitations, our data cannot be considered conclusive in confuting the current recommendations to prescribe TT. Further properly designed and sized studies are warranted.
Introduction
In patients on oral anticoagulation (OAC) undergoing percutaneous coronary intervention with stent (PCI-S), triple therapy (TT) of warfarin, aspirin, and clopidogrel is currently recommended throughout the period most vulnerable to stent thrombosis and recurrent coronary events (ie, 1 to 3–6 months) to prevent a major adverse cardiovascular event (MACE), including cardiovascular death, myocardial infarction, repeat revascularization, stent thrombosis, and thromboembolism. The analyses of efficacy, however, have generally yielded mixed results regarding the superiority of TT over other antithrombotic regimens, including dual therapy (DT) of OAC plus single antiplatelet agent (either aspirin or clopidogrel) and dual-antiplatelet therapy (DAPT) of aspirin and clopidogrel, with regard to the MACE rate. In contrast, the incidence of major and total bleeding has been consistently reported to be significantly increased (2- to 3-fold) with TT.
Most of the data on which the current recommendations are based, however, are retrospective or derived from administrative databases, thereby not allowing evaluation of the bleeding events occurring after discharge separate from those in-hospital (which may be related more to periprocedural variables such as management of anticoagulation, vascular access site, use and dose of intraprocedural anticoagulants, and use of glycoprotein IIb/IIIa inhibitors than to the ongoing antithrombotic regimen), or to match a bleeding event to the antithrombotic regimen actually ongoing at the time of occurrence (which may not be the same as prescribed at discharge). Because of these factors, the true safety profile and absolute incidence of bleeding with the various antithrombotic regimens (especially TT) remain uncertain.
To obtain further, more focused information on the clinical outcomes of patients on OAC undergoing PCI-S, we analyzed the database of the prospective, multicenter WARfarin and coronary STENTing (WAR-STENT) registry, only including the postdischarge period.
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