Major bleeding in patients undergoing PCI and triple or dual antithrombotic therapy: a parallel-cohort study

• Published in: Journal of thrombosis and thrombolysis Vol. 35; no. 2; pp. 178 - 184
• Main Authors: Denas, G., Padayattil Jose, S., Gresele, P., Erba, N., Testa, S., De Micheli, V., Quintavalla, R., Poli, D., Bracco, A., Fierro, T., Iliceto, S., Pengo, V.
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01-02-2013; Springer Nature B.V
• Subjects: Adult; Aged; Cardiology; Cohort Studies; Drug Therapy, Combination; Female; Fibrinolytic Agents - administration & dosage; Fibrinolytic Agents - adverse effects; Follow-Up Studies; Hematology; Hemorrhage - chemically induced; Hemorrhage - diagnosis; Hemorrhage - epidemiology; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; Percutaneous Coronary Intervention - adverse effects; Retrospective Studies; Warfarin; MACE; Triple antithrombotic therapy; Major bleeding; Dual antiplatelet therapy
• ISSN: 0929-5305; 1573-742X
• DOI: 10.1007/s11239-012-0790-y

The combination of oral anticoagulants with dual antiplatelet therapy (DAT) in patients undergoing percutaneous coronary intervention with stent implantation (PCI-stenting) is subject to controversy due to the high risk of bleeding. In this multicenter retrospective parallel-group study, we compared the rate of adverse events in chronically anticoagulated patients who underwent PCI-stenting and were discharged on aspirin, clopidogrel and warfarin (triple antithrombotic therapy [TT] group) and were followed in Italian anticoagulation centers, with a parallel cohort of patients who underwent PCI-stenting and were discharged on DAT group. The primary endpoint was the incidence of major bleeding while the patients were in TT and DAT. A secondary endpoint was the occurrence of major ischemic adverse events (MACEs). The final cohort consisted of 229 TT patients and 231 DAT patients followed up for 6 and 7 months, respectively. There were 11 (4.8 %; 9.1 % patient/years) major bleeding events in the TT group (1 was fatal) as compared to 1 (0.4 %; 0.7 % patient/years) event in the DAT group (
p
 = 0.003). Of the 28 (6.1 %) MACE recorded during the follow-up, 12 (5.2 %) occurred in the TT group and 16 (6.9 %) in the DAT group. In conclusion, despite close monitoring of anticoagulated patients in dedicated centers, the major bleeding incidence remains high among unselected patients undergoing PCI-stenting and treated with TT. Any efforts to minimize these events should be pursued.