Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation

Jorn Brouwer*, Vincent J. Nijenhuis, Ronak Delewi, Renicus S. Hermanides, Wouter Holvoet, Christophe L. F. Dubois, Peter Frambach, Bernard De Bruyne, Gert K. van Houwelingen, Jan A. S. Van der Heyden, Petr Tousek, Frank van der Kley, Ian Buysschaert, Carl E. Schotborgh, Bert Ferdinande, Pim van der Harst, John Roosen, Joyce Peper, Frederick W. F. Thielen, Leo VeenstraDean R. P. P. Chan Pin Yin, Martin J. Swaans, Benno J. W. M. Rensing, Arnoud W. J. van 't Hof, Leo Timmers, Johannes C. Kelder, Pieter R. Stella, Jan Baan, Jurrien M. ten Berg

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

123 Citations (Web of Science)

Abstract

BACKGROUND

The effect of single as compared with dual antiplatelet treatment on bleeding and thromboembolic events after transcatheter aortic-valve implantation (TAVI) in patients who do not have an indication for long-term anticoagulation has not been well studied.

METHODS

In a randomized, controlled trial, we assigned a subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive aspirin alone or aspirin plus clopidogrel for 3 months. The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2) at 1 year, with both outcomes tested sequentially for noninferiority (noninferiority margin, 7.5 percentage points) and superiority.

RESULTS

A total of 331 patients were assigned to receive aspirin alone and 334 were assigned to receive aspirin plus clopidogrel. A bleeding event occurred in 50 patients (15.1%) receiving aspirin alone and in 89 (26.6%) receiving aspirin plus clopidogrel (risk ratio, 0.57; 95% confidence interval [CI], 0.42 to 0.77; P=0.001). Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P=0.005). A secondary composite 1 event occurred in 76 patients (23.0%) receiving aspirin alone and in 104 (31.1%) receiving aspirin plus clopidogrel (difference, -8.2 percentage points; 95% CI for noninferiority, -14.9 to -1.5; P

CONCLUSIONS

Among patients undergoing TAVI who did not have an indication for oral anticoagulation, the incidence of bleeding and the composite of bleeding or thromboembolic events at 1 year were significantly less frequent with aspirin than with aspirin plus clopidogrel administered for 3 months.

Original languageEnglish
Pages (from-to)1447-1457
Number of pages11
JournalNew England Journal of Medicine
Volume383
Issue number15
DOIs
Publication statusPublished - 8 Oct 2020

Keywords

  • DUAL ANTIPLATELET THERAPY
  • REPLACEMENT
  • RISK
  • DEFINITIONS
  • TAVI
  • METAANALYSIS
  • OUTCOMES
  • DISEASE
  • ESC

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