Comparison of a Complete Percutaneous Versus Surgical Approach to Aortic Valve Replacement and Revascularization in Patients at Intermediate Surgical Risk
Authors: Lars Søndergaard, Jeffrey J. Popma, Michael J. Reardon, Nicolas M. Van Mieghem, G. Michael Deeb, Susheel Kodali, Isaac George, Mathew R. Williams, Steven J. Yakubov, Arie P. Kappetein, Patrick W. Serruys, Eberhard Grube, Molly B. Schiltgen, Yanping Chang, Thomas Engstrøm, Paul Sorajja, Benjamin Sun, Himanshu Agarwal, Thomas Langdon, Peter den Heijer, Mohamed Bentala, Daniel O’Hair, Tanvir Bajwa, Timothy Byrne, Michael Caskey, Basil Paulus, Edward Garrett, Robert Stoler, Robert Hebeler, Kamal Khabbaz, David Scott Lim, Mark Bladergroen, Peter Fail, Edgar Feinberg, Michael Rinaldi, Eric Skipper, Atul Chawla, David Hockmuth, Raj Makkar, Wen Cheng, Janah Aji, Frank Bowen, Theodore Schreiber, Scott Henry, Christian Hengstenberg, Sabine Bleiziffer, J. Kevin Harrison, Chad Hughes, James Joye, Vincent Gaudiani, Vasilis Babaliaros, Vinod Thourani, Harold Dauerman, Joseph Schmoker, Kimberly Skelding, Alfred Casale, Jan Kovac, Tomasz Spyt, Puvi Seshiah, J. Michael Smith, Raymond McKay, Robert Hagberg, Ray Matthews, Vaughn Starnes, William O’Neill, Gaetano Paone, Jose Maria Hernandez García, Miguel Such, Cesar Morís de la Tassa, Juan Carlos Llosa Cortina, Stephan Windecker, Thierry Carrel, Brian Whisenant, John Doty, Jon Resar, John Conte, Vicken Aharonian, Thomas Pfeffer, Andreas Rück, Matthias Corbascio, Daniel Blackman, Pankaj Kaul, Chad Kliger, Derek Brinster, Patrick Teefy, Bob Kiaii, Ferdinand Leya, Mamdouh Bakhos, Gurpreet Sandhu, Alberto Pochettino, Nicolo Piazza, Benoit de Varennes, Ad van Boven, Piet Boonstra, Ron Waksman, Ammar Bafi, Anita Asgar, Raymond Cartier, Robert Kipperman, John Brown, Lang Lin, Joshua Rovin, Samin Sharma, David Adams, Stanley Katz, Alan Hartman, Hasanian Al-Jilaihawi, Juan Crestanello, Scott Lilly, Mohammad Ghani, Robert Mark Bodenhamer, Vivek Rajagopal, James Kauten, Mumbashir Mumtaz, Williams Bachinsky, Georg Nickenig, Armin Welz, Peter Olsen, Daniel Watson, Adnan Chhatriwalla, Keith Allen, Paul Teirstein, Jeffrey Tyner, Paul Mahoney, Joseph Newton, William Merhi, John Keiser, Alan Yeung, Craig Miller, Jurriën ten Berg, Robin Heijmen, George Petrossian, Newell Robinson, Stephen Brecker, Marjan Jahangiri, Thomas Davis, Sanjay Batra, James Hermiller, David Heimansohn, Sam Radhakrishnan, Stephen Fremes, Brijeshwar Maini, Brian Bethea, David Brown, William Ryan, Neal Kleiman, Christian Spies, Jeffrey Lau, Howard Herrmann, Joseph Bavaria, Eric Horlick, Chris Feindel, Franz-Josef Neumann, Friedhelm Beyersdorf, Ronald Binder, Francesco Maisano, Marco Costa, Alan Markowitz, Peter Tadros, George Zorn, Eduardo de Marchena, Tomas Salerno, Stanley Chetcuti, Marino Labinz, Marc Ruel, Joon Sup Lee, Thomas Gleason, Frederick Ling, Peter Knight, Mark Robbins, Stephen Ball, John Giacomini, Thomas Burdon, Robert Applegate, Neal Kon, Richard Schwartz, Scott Schubach, John Forrest, Abeel Mangi
Journal: Circulation (2019)

For patients with severe aortic stenosis and coronary artery disease, the completely percutaneous approach to aortic valve replacement and revascularization has not been compared with the standard surgical approach.The prospective SURTAVI trial (Safety and Efficiency Study of the Medtronic CoreValve System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement) enrolled intermediate-risk patients with severe aortic stenosis from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score (Synergy Between PCI with Taxus and Cardiac Surgery Trial) >22 was an exclusion criterion. Patients were stratified according to the need for revascularization and then randomly assigned to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in the TAVR group underwent percutaneous coronary intervention, whereas those in the SAVR group had coronary artery bypass grafting. The primary end point was the rate of all-cause mortality or disabling stroke at 2 years.Of 1660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization. They had a higher Society of Thoracic Surgeons risk score for mortality (4.8±1.7% versus 4.4±1.5%; P<0.01) and were more likely to be male (65.1% versus 54.2%; P<0.01) than the 1328 patients not assigned to revascularization. After randomization to treatment, there were 169 patients undergoing TAVR and percutaneous coronary intervention, 163 patients undergoing SAVR and coronary artery bypass grafting, 695 patients undergoing TAVR, and 633 patients undergoing SAVR. No significant difference in the rate of the primary end point was found between TAVR and percutaneous coronary intervention and SAVR and coronary artery bypass grafting (16.0%; 95% CI, 11.1-22.9 versus 14.0%; 95% CI, 9.2-21.1; P=0.62), or between TAVR and SAVR (11.9%; 95% CI, 9.5-14.7 versus 12.3%; 95% CI, 9.8-15.4; P=0.76).For patients at intermediate surgical risk with severe aortic stenosis and noncomplex coronary artery disease (SYNTAX score ≤22), a complete percutaneous approach of TAVR and percutaneous coronary intervention is a reasonable alternative to SAVR and coronary artery bypass grafting.URL: https://www.gov. Unique identifier: NCT01586910.