Key result
Pre-procedural use of clopidogrel independently increased the risk of early bleeding after transcatheter aortic valve implantation (OR 4.43).
Why the study?
How do different antithrombotic therapies and patient characteristics impact early and late bleeding complications in patients undergoing TAVI?
Observational (n=83)
No
How do different antithrombotic therapies and patient characteristics impact early and late bleeding complications in patients undergoing TAVI?
Effect estimate: OR 4.43 (95% CI 1.02-19.24)
p-value: p=0.04
In TAVI patients, peri-procedural DAPT and triple therapy increase early bleeding risk compared to VKA with clopidogrel, challenging the routine recommendation of DAPT.
May warrant caution with pre-procedural clopidogrel in TAVI; hypothesis-generating and requires randomized confirmation before practice change.
INTRODUCTION: Dual antiplatelet therapy (DAPT) - aspirin and clopidogrel - is recommended after transcatheter aortic valve implantation (TAVI) without an evidence base. The main aim of the study was to estimate the impact of antithrombotic therapy on early and late bleeding. Moreover, we assessed the impact of patients' characteristics on early bleeding and the influence of bleeding on prognosis. MATERIAL AND METHODS: Between 2009 and 2011, 83 consecutive TAVI patients, age 81.1 ±7.2 years, were included. Bleeding complications were defined by the Valve Academic Research Consortium (VARC) scale. The median follow-up was 12 ±15.5 months (range: 1 to 23) and included 68 (81.9%) patients. RESULTS: Early bleeding occurred in 51 (61.4%) patients. Vitamin K antagonists (VKA) pre-TAVI (p = 0.001) and VKA + clopidogrel early post-TAVI (p = 0.04) were the safest therapies; in comparison to the safest one, peri-procedural DAPT (p = 0.002; p = 0.05) or triple anticoagulant therapy (TAT) (p = 0.003, p = 0.05) increased the risk for early bleeding. Predictors for early bleeding were: clopidogrel pre-TAVI (OR: 4.43, 95% CI: 1.02-19.24, p = 0.04), preceding percutaneous coronary intervention (PCI) (10.08, OR: 95% CI: 1.12-90.56, p = 0.04), anemia (OR: 4.00, 95% CI: 1.32-12.15, p = 0.01), age > 85 years (OR: 5.96, 95% CI: 1.47-24.13, p = 0.01), body mass index (BMI) (OR: 0.86, 95% CI: 0.74-0.99, p = 0.04). Late bleeding occurred in 35 patients (51.4%) on combined therapy, and none on VKA or clopidogrel monotherapy (p = 0.04). Bleeding complications did not worsen the survival. CONCLUSIONS: This study seems to suggest that advanced age, BMI, and a history of anemia increased the risk for early bleeding after TAVI. Clopidogrel pre-TAVI should be avoided; therefore, time of preceding PCI should take into account discontinuation of clopidogrel in the pre-TAVI period. Vitamin K antagonists with clopidogrel seems to be the safest therapy in the early post-TAVI period, similarly as VKA/clopidogrel monotherapy in long-term prophylaxis.
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Czerwińska et al. (2013) conducted an observational in Aortic stenosis (n=83). Clopidogrel pre-TAVI vs. No clopidogrel pre-TAVI was evaluated on Early bleeding complications (within 30 days) (OR 4.43, 95% CI 1.02-19.24, p=0.04). Pre-procedural use of clopidogrel independently increased the risk of early bleeding after transcatheter aortic valve implantation (OR 4.43).
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