Anticoagulation with or without Clopidogrel after TAVI

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Posted by Carla Rothaus

In the trial by Nijenhuis et al., what was the incidence of bleeding with oral anticoagulation alone as compared to oral anticoagulation plus clopidogrel? 

Nijenhuis et al. recently reported the results for cohort B of the POPular TAVI trial, which investigated antithrombotic treatment with oral anticoagulation alone as compared with oral anticoagulation plus clopidogrel for 3 months after transcatheter aortic-valve implantation (TAVI) in patients who had an established indication for long-term oral anticoagulation. Read the NEJM Original Article here.

Clinical Pearls

Q: What therapy is currently recommended after TAVI in patients with an indication for long-term oral anticoagulation?

A: Current guidelines recommend the use of a vitamin K antagonist with or without antiplatelet therapy for 3 to 6 months after TAVI in patients with a long-term indication for oral anticoagulation. 

Q: In the trial by Nijenhuis et al., what was the incidence of bleeding with oral anticoagulation alone as compared to oral anticoagulation plus clopidogrel?

A: Antithrombotic treatment with oral anticoagulation alone was associated with a lower incidence of serious bleeding events than oral anticoagulation plus clopidogrel with regard to the primary outcomes of all bleeding and of non–procedure-related bleeding at 12 months. At 12 months, bleeding of any type had occurred in 34 patients (21.7%) receiving oral anticoagulation alone and in 54 patients (34.6%) receiving oral anticoagulation plus clopidogrel (risk ratio, 0.63; 95% confidence interval [CI], 0.43 to 0.90; P=0.01), and non–procedure-related bleeding had occurred in 34 patients (21.7%) and in 53 patients (34.0%), respectively (risk ratio, 0.64; 95% CI, 0.44 to 0.92; P=0.02). The TAVI access site was the most common location of bleeding in both groups (15 of 34 patients [44%] receiving oral anticoagulation alone and 27 of 54 patients [50%] receiving oral anticoagulation plus clopidogrel) and was classified as non–procedure-related because it was not BARC type 4. Severe procedure-related bleeding, defined as BARC type 4, was observed in 1 patient receiving oral anticoagulation plus clopidogrel and in none receiving oral anticoagulation alone.


Morning Report Questions

Q: How did results for the two secondary outcomes compare in the two trial groups in the POPular TAVI trial?

A: A secondary composite 1 event (death from cardiovascular causes, non–procedure-related bleeding, stroke from any cause, or myocardial infarction) occurred in 49 patients (31.2%) receiving oral anticoagulation alone and in 71 patients (45.5%) receiving oral anticoagulation plus clopidogrel (difference, −14.3 percentage points; 95% CI for noninferiority, −25.0 to −3.6; risk ratio, 0.69; 95% CI for superiority, 0.51 to 0.92). A secondary composite 2 event (death from cardiovascular causes, ischemic stroke, or myocardial infarction) occurred in 21 patients (13.4%) receiving oral anticoagulation alone and in 27 patients (17.3%) receiving oral anticoagulation plus clopidogrel (difference, −3.9 percentage points; 95% CI for noninferiority, −11.9 to 4.0; risk ratio, 0.77; 95% CI for superiority, 0.46 to 1.31). 

Q: Describe some of the limitations of the trial by Nijenhuis et al.

A: The trial was an open-label trial and thereby potentially subject to reporting and ascertainment biases. Comparisons between trial groups for the secondary outcomes were not adjusted for multiple comparisons, and no clinical inferences can be made from these results. The results of this report do not apply to patients undergoing TAVI who do not have an indication for long-term oral anticoagulation. This population is currently under investigation in cohort A of the POPular TAVI trial. The most important limitation is the unconventional definition of procedural bleeding as BARC type 4, which represents severe bleeding and would exclude most bleeding at the puncture site.

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