Felix Hofer1, Christian Hengstenberg1, Georg Goliasch1, Marek Grygier2, Julia Mascherbauer1, Jolanta M Siller-Matula3,4. 1. Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria. 2. 1st Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland. 3. Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria. Jolanta.siller-matula@meduniwien.ac.at. 4. Department of Experimental and Clinical Pharmacology, Centre for Preclinical Research and Technology (CEPT), Medical University of Warsaw, Warsaw, Poland. Jolanta.siller-matula@meduniwien.ac.at.
Abstract
BACKGROUND: Transcatheter aortic valve replacement (TAVR) has emerged as a treatment option for severe aortic stenosis in patients at intermediate or high surgical risk. However, until recently there was insufficient evidence regarding the outcomes of TAVR compared to surgical aortic valve replacement (SAVR) for patients at low risk. METHODS: We conducted a meta-analysis and systematic review of all randomized trials comparing the efficacy and safety of TAVR versus SAVR in patients at low surgical risk. Risk ratios (RR) and 95% confidence intervals (CIs) were calculated, using fixed- or random-effects model. RESULTS: Four trials were eligible for analysis and comprised a total of 2887 patients (1497 allocated to TAVR and 1390 allocated to SAVR group). TAVR was associated with a 39% relative risk reduction (RRR) of major adverse cardiac events (MACE) (absolute risk reduction ARR of 3.7%; RR 0.61; 95% CI 0.47-0.79); 39% RRR of overall mortality (ARR of 1.4%; RR 0.61; 95% CI 0.39-0.96) and 45% RRR of cardiovascular mortality (ARR of 1.3%; RR 0.55; 95% CI 0.33-0.90), 69% RRR of life threatening or disabling bleeding (ARR of 7.0%; RR 0.31; 95% CI 0.22-0.44), 73% RRR of new-onset atrial fibrillation (ARR of 29%; RR 0.27; 95% CI 0.20-0.35) and 73% RRR of acute kidney injury (ARR of 2.1%; RR 0.27; 95% CI 0.14-0.56) as compared with SAVR. In contrast, TAVR was associated with a 4.7-fold increased risk of new pacemaker (PM) implantation (RR 4.72; 95% CI 1.83-12.15), which was driven by use of self-expanding valves. CONCLUSION: TAVR in low-risk patients is superior to SAVR for the majority of outcomes.
BACKGROUND: Transcatheter aortic valve replacement (TAVR) has emerged as a treatment option for severe aortic stenosis in patients at intermediate or high surgical risk. However, until recently there was insufficient evidence regarding the outcomes of TAVR compared to surgical aortic valve replacement (SAVR) for patients at low risk. METHODS: We conducted a meta-analysis and systematic review of all randomized trials comparing the efficacy and safety of TAVR versus SAVR in patients at low surgical risk. Risk ratios (RR) and 95% confidence intervals (CIs) were calculated, using fixed- or random-effects model. RESULTS: Four trials were eligible for analysis and comprised a total of 2887 patients (1497 allocated to TAVR and 1390 allocated to SAVR group). TAVR was associated with a 39% relative risk reduction (RRR) of major adverse cardiac events (MACE) (absolute risk reduction ARR of 3.7%; RR 0.61; 95% CI 0.47-0.79); 39% RRR of overall mortality (ARR of 1.4%; RR 0.61; 95% CI 0.39-0.96) and 45% RRR of cardiovascular mortality (ARR of 1.3%; RR 0.55; 95% CI 0.33-0.90), 69% RRR of life threatening or disabling bleeding (ARR of 7.0%; RR 0.31; 95% CI 0.22-0.44), 73% RRR of new-onset atrial fibrillation (ARR of 29%; RR 0.27; 95% CI 0.20-0.35) and 73% RRR of acute kidney injury (ARR of 2.1%; RR 0.27; 95% CI 0.14-0.56) as compared with SAVR. In contrast, TAVR was associated with a 4.7-fold increased risk of new pacemaker (PM) implantation (RR 4.72; 95% CI 1.83-12.15), which was driven by use of self-expanding valves. CONCLUSION: TAVR in low-risk patients is superior to SAVR for the majority of outcomes.
Authors: Daniela Haase; Laura Bäz; Marcus Franz; P Christian Schulze; Tarek Bekfani; Sophie Neugebauer; Michael Kiehntopf; Sven Möbius-Winkler Journal: Clin Res Cardiol Date: 2020-10-14 Impact factor: 5.460
Authors: Gloria M Gager; Georg Gelbenegger; Bernd Jilma; Dirk von Lewinski; Harald Sourij; Ceren Eyileten; Krzysztof Filipiak; Marek Postula; Jolanta M Siller-Matula Journal: Front Cardiovasc Med Date: 2021-07-14