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Published on: March 15, 2022
Major bleeding in patients undergoing PCI and triple or dual antithrombotic therapy: a parallel-cohort study
G Denas1, S Padayattil Jose, P Gresele
1Cardiology Clinic, Thrombosis Center, University Hospital, Via Giustiniani 2, 35128, Padua, PD, Italy.
Insights
Triple antithrombotic therapy (TT) combining oral anticoagulants with dual antiplatelet therapy (DAT) after PCI-stenting leads to significantly higher major bleeding rates. Careful consideration of bleeding risks is crucial for patients undergoing these procedures.
Area of Science:
- Cardiology
- Interventional Cardiology
- Antithrombotic Therapy
Background:
- Combining oral anticoagulants with dual antiplatelet therapy (DAT) after percutaneous coronary intervention with stent implantation (PCI-stenting) presents a high bleeding risk.
- Managing antithrombotic therapy in patients requiring both anticoagulation and dual antiplatelet therapy is complex and controversial.
Purpose of the Study:
- To compare the incidence of major bleeding and major adverse cardiovascular events (MACE) between triple antithrombotic therapy (TT) and dual antiplatelet therapy (DAT) in patients after PCI-stenting.
Main Methods:
- A multicenter retrospective parallel-group study comparing 229 patients on TT (warfarin, aspirin, clopidogrel) with 231 patients on DAT after PCI-stenting.
- Primary endpoint: incidence of major bleeding. Secondary endpoint: occurrence of MACE.
- Follow-up duration was 6 months for the TT group and 7 months for the DAT group.
Main Results:
- Major bleeding occurred in 4.8% of the TT group (9.1% patient/years) versus 0.4% in the DAT group (0.7% patient/years), a statistically significant difference (p = 0.003).
- One fatal bleeding event was reported in the TT group.
- MACE occurred in 5.2% of the TT group and 6.9% of the DAT group, with no significant difference.
Conclusions:
- Triple antithrombotic therapy (TT) in patients after PCI-stenting is associated with a high incidence of major bleeding, even with close monitoring in specialized centers.
- Strategies to mitigate bleeding risk in patients requiring TT after PCI-stenting should be prioritized.
- DAT appears safer regarding bleeding risk, but MACE rates were similar in this 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.
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