Physicians' Academy for Cardiovascular Education

No indication for oral anticoagulation after TAVI: SAPT outperforms DAPT and DOAC-based regimens

Antithrombotic Therapy and Cardiovascular Outcomes After Transcatheter Aortic Valve Implantation in Patients Without Indications for Chronic Oral Anticoagulation: A systematic review and network meta-analysis of randomized controlled trials

Literature - Guedeney P, Roule V, Mesnier J, et al. - Eur Heart J Cardiovasc Pharmacother. 2023 Jan 14;pvad003. doi: 10.1093/ehjcvp/pvad003

Introduction and methods

Background

For patients undergoing transcatheter aortic valve implantation (TAVI) who have no baseline indication for chronic oral anticoagulation, current European guidelines now recommend lifelong single antiplatelet therapy (SAPT) [1,2]. However, these guidelines did not include the latest results from RCTs comparing direct oral anticoagulants (DOACs) with antiplatelet therapy [3,4].

Aim of the study

The study aim was to compare the safety and efficacy of several antithrombotic regimens following TAVI in patients with no indication for chronic oral anticoagulation.

Methods

The authors conducted a systematic review of the literature (according to the PRISMA guidelines) and network meta-analysis of RCTs that evaluated any antithrombotic regimen in patients undergoing TAVI for symptomatic severe aortic valve stenosis who did not have an indication for chronic oral anticoagulation (publication up to April 2022).

In total, 7 studies were included, which comprised 4006 patients, of whom 650 (16.2%) received SAPT, 1893 (47.3%) were taking dual antiplatelet therapy (DAPT), and 1463 (36.5%) were on DOACs (of whom 526 (13.1%) on apixaban, 111 (2.8%) on edoxaban, and 826 (20.6%) on low-dose rivaroxaban plus 3-month SAPT). The patient population was deemed to be old and frail and have an intermediate-to-high risk profile. Mean weighted follow-up time was 12.9 months.

Outcomes

The primary efficacy endpoint was all-cause death, and the primary safety endpoint was life-threatening, disabling, or major bleeding as defined in each study. Other endpoints of interest were CV and non-CV death, MI, stroke, systemic embolism, and grade 3 or 4 reduced leaflet motion (RLM) as reported in each study. Endpoints were collected at the longest available time of follow-up, according to the intention-to-treat principle.

Main results

Results

Efficacy outcomes

Safety outcomes

Secondary outcomes

Conclusion

This systematic review and network meta-analysis of 7 RCTs evaluating patients undergoing TAVI for symptomatic severe aortic valve stenosis who did not have an indication for chronic oral anticoagulation showed that the use of SAPT was associated with a 55% reduction of bleeding risk compared with DAPT or DOAC only treatment. There was no difference in the occurrence of all-cause death between SAPT and the other antithrombotic regimens.

According to the authors, this “superior benefit-risk ratio” of SAPT compared with DAPT and various DOAC regimens confirms the current European guideline recommendations on lifelong SAPT after TAVI for patients with no indication for chronic oral anticoagulation.

References

Show references

Find this article online at Eur Heart J Cardiovasc Pharmacother.

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