Introduction and methods

Antithrombotic Therapy After Transcatheter Aortic Valve Implantation In Patients With A Long-term Indication For Oral Anticoagulation (POPular TAVI Trial – Cohort B)

Presented at ACC.20 by Jurrien ten Berg, MD, PhD (Nieuwegein, The Netherlands)

30% Of patients undergoing transcatheter aortic valve implantation (TAVI) have atrial fibrillation (AF). These patients are in need of oral anticoagulation (OAC) therapy. After TAVI, antiplatelet therapy in the form of clopidogrel can be added (in addition to OAC treatment). This may decrease the risk of thromboembolism, but it can also increase the risk of bleeding.

The POPular TAVI cohort B was a randomized, open label, multicenter study of OAC with or without clopidogrel after TAVI. Patients who were planned to undergo TAVI and who were already on an OAC for AF were randomized to either OAC alone (n=157) or to receive 3 months clopidogrel on top of OAC (n=156). Follow-up was 1 year.

The study had two co-primary outcomes which were powered for superiority. First, all bleeding (according to VARC-2 definitions) and second, non-procedural bleeding (according to BARC definitions). Two co-secondary outcomes were powered for non-inferiority. First, CV mortality, non-procedural bleeding, all-cause stroke, and MI, and second, CV mortality, ischemic stroke, and MI.

Main results

• OAC alone was superior to OAC plus clopidogrel for the co-primary outcomes all bleeding and non-procedural bleeding. Bleeding of any type occurred in 34.6% of patients on OAC plus clopidogrel and in 21.7% of patients on OAC alone (risk ratio (RR) 0.63, 95%CI 0.43-0.90, P=0.011). Non-procedural bleeding occurred in 34.0% of patients on OAC plus clopidogrel and in 21.7% of patients on OAC alone (RR 0.64, 95%CI 0.44-0.92, P=0.015).
• CV mortality, non-procedural bleeding, stroke or MI occurred in 45.5% of patients receiving OAC plus clopidogrel and in 31.2% receiving OAC alone (RR 0.69, 95%CI 0.51-0.92). CV mortality, ischemic stroke or MI occurred in 17.3% of patients receiving OAC plus clopidogrel and in 13.4% of those receiving OAC alone (RR 0.77, 95%CI 0.46-1.31). These co-secondary outcomes showed that OAC alone was non-inferior compared to OAC plus clopidogrel.

Conclusion

These results indicate that treatment with OAC alone as compared to OAC plus clopidogrel reduced the rate of bleeding events and did not increase the rate of thrombotic events in AF patients with an established indication for OAC undergoing TAVI.

Discussion

Discussant Joseph Cleveland, MD, notes that these results confirm what we have already seen in other patient populations, for instance in patients with ischemic heart disease. When clopidogrel is added to OAC, more bleeding events are observed. Cleveland further mentions that it was reassuring that there was not an increase in thrombotic events in the OAC alone group compared to the OAC plus clopidogrel group. These results are a good start in helping understand the management of these patients, according to Cleveland. He also mentioned that further data are desired and it is worth investigating why the difference in outcomes between treatment groups was observed very early.

- Our coverage of ACC.20 is based on the information provided during the congress -

The results were published simultaneously in NEJM.