5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial

• Published in: The Lancet (British edition) 2015-06, Vol.385 (9986), p.2477-2484
• Main Authors: Mack, Michael J, Prof, Leon, Martin B, Prof, Smith, Craig R, Prof, Miller, D Craig, Prof, Moses, Jeffrey W, Prof, Tuzcu, E Murat, Prof, Webb, John G, Prof, Douglas, Pamela S, Prof, Anderson, William N, PhD, Blackstone, Eugene H, MD, Kodali, Susheel K, MD, Makkar, Raj R, MD, Fontana, Gregory P, MD, Kapadia, Samir, Prof, Bavaria, Joseph, Prof, Hahn, Rebecca T, MD, Thourani, Vinod H, Prof, Babaliaros, Vasilis, MD, Pichard, Augusto, Prof, Herrmann, Howard C, Prof, Brown, David L, MD, Williams, Mathew, MD, Davidson, Michael J, MD, Svensson, Lars G, Prof, Akin, Jodi
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Aortic Valve - surgery; Aortic Valve Insufficiency - epidemiology; Aortic Valve Stenosis - epidemiology; Aortic Valve Stenosis - surgery; Canada; Cardiology; Catheters; Cause of Death; Clinical outcomes; Comorbidity; Coronary vessels; Female; Follow-Up Studies; Germany; Heart surgery; Heart Valve Prosthesis Implantation - methods; Heart Valve Prosthesis Implantation - mortality; Humans; Internal Medicine; Male; Medical personnel; Mortality; Mortality risk; Survival Analysis; Survival Rate; Transcatheter Aortic Valve Replacement - methods; Transcatheter Aortic Valve Replacement - mortality; Treatment Outcome; United States
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(15)60308-7

Summary Background The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that mortality at 1 year, 2 years, and 3 years is much the same with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for high-risk patients with aortic stenosis. We report here the 5-year outcomes. Methods We did this randomised controlled trial at 25 hospitals, in Canada (two), Germany (one), and the USA (23). We used a computer-generated randomisation sequence to randomly assign high-risk patients with severe aortic stenosis to either SAVR or TAVR with a balloon-expandable bovine pericardial tissue valve by either a transfemoral or transapical approach. Patients and their treating physicians were not masked to treatment allocation. The primary outcome of the trial was all-cause mortality in the intention-to-treat population at 1 year, we present here predefined outcomes at 5 years. The study is registered with ClinicalTrials.gov , number NCT00530894. Findings We screened 3105 patients, of whom 699 were enrolled (348 assigned to TAVR, 351 assigned to SAVR). Overall mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 11·7%. At 5 years, risk of death was 67·8% in the TAVR group compared with 62·4% in the SAVR group (hazard ratio 1·04, 95% CI 0·86–1·24; p=0·76). We recorded no structural valve deterioration requiring surgical valve replacement in either group. Moderate or severe aortic regurgitation occurred in 40 (14%) of 280 patients in the TAVR group and two (1%) of 228 in the SAVR group (p