title: Major bleeding in patients undergoing PCI and triple or dual antithrombotic therapy: a parallel-cohort study.
abstract: 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.
authors: Cardiology Clinic, Thrombosis Center, University Hospital, Via Giustiniani 2, 35128, Padua, PD, Italy.
authors: G
authors: G
authors: Denas
authors: S
authors: S
authors: Padayattil Jose
authors: P
authors: P
authors: Gresele
authors: N
authors: N
authors: Erba
authors: S
authors: S
authors: Testa
authors: V
authors: V
authors: De Micheli
authors: R
authors: R
authors: Quintavalla
authors: D
authors: D
authors: Poli
authors: A
authors: A
authors: Bracco
authors: T
authors: T
authors: Fierro
authors: S
authors: S
authors: Iliceto
authors: V
authors: V
authors: Pengo
mesh_terms: D000328:Adult; D000368:Aged; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000139:chemically induced* / Q000175:diagnosis / Q000453:epidemiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D012189:Retrospective Studies
chemical_list: D005343:Fibrinolytic Agents