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

Background:
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.

Methods:
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.

Results:

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).

Conclusions:
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.

Clinical Trial Registration:

URL:
https://www.clinicaltrials.gov
. Unique identifier: NCT01586910.