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Antithrombotic therapy with or without clopidogrel after transcatheter aortic valve replacement. A meta-analysis of
Costanza Pellegrini1, Erion Xhepa1, Gjin Ndrepepa1
1Klinik Für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse, 36, Munich, Germany.
Insights
Adding clopidogrel to antithrombotic therapy after transcatheter aortic valve replacement (TAVR) significantly increases major bleeding risk without affecting mortality or ischemic outcomes. Further research is needed on long-term effects and valve function.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Transcatheter aortic valve replacement (TAVR) is a common procedure for aortic stenosis.
- Optimal antithrombotic therapy post-TAVR is crucial for patient outcomes.
- Current guidelines vary regarding the use of clopidogrel in addition to aspirin or oral anticoagulation (OAC).
Purpose of the Study:
- To investigate the clinical outcomes associated with antithrombotic therapy with or without clopidogrel after TAVR.
- To compare the risks of death, bleeding, myocardial infarction, and stroke between different antithrombotic strategies.
Main Methods:
- A study-level meta-analysis of randomized controlled trials was conducted.
- Searched electronic databases for eligible studies, with the protocol registered on PROSPERO.
- Included six trials with 3056 TAVR patients comparing clopidogrel-inclusive regimens versus those without clopidogrel.
Main Results:
- Antithrombotic therapy with clopidogrel showed comparable risks of all-cause death and major bleeding compared to regimens without clopidogrel in overall estimates.
- However, the combination of aspirin or OAC with clopidogrel significantly doubled the risk of major bleeding (P=0.015).
- No significant differences were observed in the risk of life-threatening bleeding, myocardial infarction, or stroke.
Conclusions:
- In TAVR patients, adding clopidogrel to aspirin or OAC significantly increases major bleeding risk without improving mortality or ischemic outcomes.
- The long-term clinical outcomes and bioprosthesis valve function of different antithrombotic regimens require further investigation.
Aims:
To investigate the clinical outcomes associated with an antithrombotic therapy with or without clopidogrel after transcatheter aortic valve replacement (TAVR).
Methods And Results:
This is a study-level meta-analysis including all randomized trials investigating antithrombotic regimens after TAVR. The protocol was registered with PROSPERO (CRD42020191036). We searched electronic scientific databases for eligible studies. The primary outcome was all-cause death. Main secondary outcome was major bleeding. Other outcomes were life-threatening (or disabling) bleeding, myocardial infarction (MI) and stroke. Six eligible trials randomly allocated 3056 TAVR patients to aspirin or oral anticoagulation (OAC) with clopidogrel (n = 1525) versus aspirin and/or OAC without clopidogrel (n = 1531). In the overall estimates, an antithrombotic therapy with clopidogrel versus without displayed a comparable risk of all-cause death [Risk Ratio-RR = 0.83, 95% Confidence intervals-CI (0.57-1.20); P = 0.25] and major bleeding [RR = 1.33, 95% CI (0.61-2.92); P = 0.39]. However, the combination of aspirin or OAC with clopidogrel doubled the risk of major bleeding as compared to aspirin or OAC without clopidogrel [RR = 2.08, 95% CI (1.27-3.42); P = 0.015, P for interaction = 0.021]. Treatment strategies did not differ with respect to the risk of life-threatening bleeding, MI and stroke.
Conclusions:
In patients receiving TAVR, a therapeutic strategy of aspirin or OAC with clopidogrel significantly increases the risk of major bleeding without impact on mortality and ischemic outcomes compared to aspirin or OAC without clopidogrel. The performance of different antithrombotic regimens in terms of long-term clinical outcomes and bioprosthesis valve function requires further investigation. Forest plots from pairwise and network meta-analyses associated with an antithrombotic therapy with or without clopidogrel Risk ratio for all outcomes of interest calculated with the pairwise meta-analysis (left side) and for main outcomes calculated with the network meta-analysis (right side) in patients allocated to an antithrombotic therapy with clopidogrel or without. The diamonds indicate the point estimate and the left and the right ends of the lines the [95% CI]. CI: Confidence intervals; OAC; oral anticoagulation.
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