Author + information
- Akhil Parashar, MD,
- Shikhar Agarwal, MD, MPH,
- Navkaranbir S. Bajaj, MD,
- E. Murat Tuzcu, MD and
- Samir R. Kapadia, MD∗ ()
- ↵∗Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, 9500 Euclid Avenue, J2-3, Cleveland, Ohio 44195
We thank Messori et al. for their interest in our recent systematic review of outcomes after implantation of percutaneous left atrial appendage (LAA) occlusion devices (1). The authors have used a novel statistical analysis to raise the possibility that LAA occlusion devices might be superior to newer oral anticoagulants (NOACs) in preventing stroke or systemic embolism. This is potentially a thought-provoking observation in favor of the efficacy of the percutaneous closure of the LAA.
The pivotal noninferiority randomized, controlled trials like RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy), ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation), and ROCKET-AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibitor Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) have tested whether individual NOACs were noninferior to warfarin in preventing stroke or systemic embolism (2–4). The noninferiority margin in these trials was derived from an earlier meta-analysis of outcomes after administration of warfarin compared with placebo (5). The noninferiority margin was set at half the 95% confidence interval of the estimated effect of warfarin compared with placebo. Messori et al. have used this methodology in a unique quantitative-analytic framework to calculate the difference in outcomes between LAA occlusion devices and NOACs.
Although the superiority of LAA occlusion devices over NOACs is a possibility, the analysis described by Messori et al. is also somewhat provocative. We agree that this is a very interesting hypothesis and therefore would need to be verified in head-to-head randomized, controlled trials before widespread acceptability in clinical practice.
- American College of Cardiology Foundation