Slater, James N.

Importance In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm 2 vs 1.8 [0.6] cm 2 ; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.

Introduction . The addition of percutaneous coronary intervention (PCI) to the treatment options for patients with atherothrombotic (AT) coronary heart disease (CHD) has resulted in considerable debate regarding its overall clinical benefit. Although rates of “hard” clinical endpoints have been used as measures of both clinical outcome and disease burden, a comprehensive, clinically relevant measure of disease burden in the general population of patients undergoing PCI is lacking. Hypothesis . A comprehensive measure of AT clinical burden in patients undergoing PCI can be used to detect the qualitative and quantitative impact of PCI over time. Methods . Four distinct cohorts (Waves) of ~ 2,000 patients each participating in the NHLBI Dynamic Registry beginning in 1997 (Wave 1) and terminating in 2005 (Wave 4) and surviving to hospital discharge comprise the study population (n= 7,750). A composite clincally relevant measure of AT disease burden over the year following PCI was defined as: any death, myocardial infarction (MI), hospitalization for recurrent angina (A) or congestive heart failure (HF), stroke, any repeat PCI or coronary bypass surgery. Cumulative event rates, expressed as the presence of any of the above-cited components by one year, were calculated using Kaplan-Meier statistics. Comparison of rates across Waves was accomplished using Cochran- Mantel-Haenszel method. Results. see Table Exclusion of patients requiring PCI for restenosis did not substantially change the overall AT burden. Conclusion. There was a statistically significant decrease in AT disease burden over the time studied. However, the burden of disease in patients undergoing PCI remains substantial for 25% of patients. This measure of AT burden may be of clinical value in assessing the contribution of PCI to patient outcomes and strongly supports more comprehensive treatment strategies for patients following PCI. Component and composite rates at one year