George C M Siontis1, Pavel Overtchouk1, Thomas J Cahill2, Thomas Modine3, Bernard Prendergast4, Fabien Praz1, Thomas Pilgrim1, Tatjana Petrinic5, Adriani Nikolakopoulou6, Georgia Salanti6, Lars Søndergaard7, Subodh Verma8, Peter Jüni9, Stephan Windecker1. 1. Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland. 2. Department of Cardiology, Oxford Heart Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK. 3. Institut Coeur-Poumon, Service de Chirurgie Cardiovasculaire, Hôpital Cardiologique, CHRU de Lille, 2 Av Oscar Lambret, Lille, France. 4. Department of Cardiology, St Thomas' Hospital, Westminster Bridge Rd, London, UK. 5. Cairns Library, Oxford University Hospitals NHS Foundation Trust, Oxford, UK. 6. Institute of Social and Preventive Medicine (ISPM), University of Bern, Mittelstrasse 43, Bern, Switzerland. 7. Department of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark. 8. Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, Toronto, ON, Canada. 9. Department of Medicine and Institute of Health Policy, Management and Evaluation, Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, University of Toronto, 30 Bond Street, Toronto, Ontario, Canada.
Abstract
AIMS: Owing to new evidence from randomized controlled trials (RCTs) in low-risk patients with severe aortic stenosis, we compared the collective safety and efficacy of transcatheter aortic valve implantation (TAVI) vs. surgical aortic valve replacement (SAVR) across the entire spectrum of surgical risk patients. METHODS AND RESULTS: The meta-analysis is registered with PROSPERO (CRD42016037273). We identified RCTs comparing TAVI with SAVR in patients with severe aortic stenosis reporting at different follow-up periods. We extracted trial, patient, intervention, and outcome characteristics following predefined criteria. The primary outcome was all-cause mortality up to 2 years for the main analysis. Seven trials that randomly assigned 8020 participants to TAVI (4014 patients) and SAVR (4006 patients) were included. The combined mean STS score in the TAVI arm was 9.4%, 5.1%, and 2.0% for high-, intermediate-, and low surgical risk trials, respectively. Transcatheter aortic valve implantation was associated with a significant reduction of all-cause mortality compared to SAVR {hazard ratio [HR] 0.88 [95% confidence interval (CI) 0.78-0.99], P = 0.030}; an effect that was consistent across the entire spectrum of surgical risk (P-for-interaction = 0.410) and irrespective of type of transcatheter heart valve (THV) system (P-for-interaction = 0.674). Transcatheter aortic valve implantation resulted in lower risk of strokes [HR 0.81 (95% CI 0.68-0.98), P = 0.028]. Surgical aortic valve replacement was associated with a lower risk of major vascular complications [HR 1.99 (95% CI 1.34-2.93), P = 0.001] and permanent pacemaker implantations [HR 2.27 (95% CI 1.47-3.64), P < 0.001] compared to TAVI. CONCLUSION: Compared with SAVR, TAVI is associated with reduction in all-cause mortality and stroke up to 2 years irrespective of baseline surgical risk and type of THV system. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: Owing to new evidence from randomized controlled trials (RCTs) in low-risk patients with severe aortic stenosis, we compared the collective safety and efficacy of transcatheter aortic valve implantation (TAVI) vs. surgical aortic valve replacement (SAVR) across the entire spectrum of surgical risk patients. METHODS AND RESULTS: The meta-analysis is registered with PROSPERO (CRD42016037273). We identified RCTs comparing TAVI with SAVR in patients with severe aortic stenosis reporting at different follow-up periods. We extracted trial, patient, intervention, and outcome characteristics following predefined criteria. The primary outcome was all-cause mortality up to 2 years for the main analysis. Seven trials that randomly assigned 8020 participants to TAVI (4014 patients) and SAVR (4006 patients) were included. The combined mean STS score in the TAVI arm was 9.4%, 5.1%, and 2.0% for high-, intermediate-, and low surgical risk trials, respectively. Transcatheter aortic valve implantation was associated with a significant reduction of all-cause mortality compared to SAVR {hazard ratio [HR] 0.88 [95% confidence interval (CI) 0.78-0.99], P = 0.030}; an effect that was consistent across the entire spectrum of surgical risk (P-for-interaction = 0.410) and irrespective of type of transcatheter heart valve (THV) system (P-for-interaction = 0.674). Transcatheter aortic valve implantation resulted in lower risk of strokes [HR 0.81 (95% CI 0.68-0.98), P = 0.028]. Surgical aortic valve replacement was associated with a lower risk of major vascular complications [HR 1.99 (95% CI 1.34-2.93), P = 0.001] and permanent pacemaker implantations [HR 2.27 (95% CI 1.47-3.64), P < 0.001] compared to TAVI. CONCLUSION: Compared with SAVR, TAVI is associated with reduction in all-cause mortality and stroke up to 2 years irrespective of baseline surgical risk and type of THV system. Published on behalf of the European Society of Cardiology. All rights reserved.
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