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【正文】 ter versus Surgical AorticValve Replacement in HighRisk Patients. N Engl J Med, 2023. 364(23): p. 218798. Key Exclusion Criteria ? Aortic annulus diameter (echo measurement) 18 mm or 25 mm ? Iliacfemoral anatomy precluding safe sheath insertion ? Severe LV dysfunction (LVEF 20%) ? Untreated CAD requiring revascularization Anatomic: ? Serum Cr mg/dL or dialysis dependent ? Acute MI within 1 month ? CVA or TIA within 6 months ? Hemodynamic instability Clinical: Study Devices Edwards SAPIEN THV 23 and 26 mm valves RetroFlex 22 and 24 F sheaths Ascendra 24 and 26 F sheaths Transfemoral Transapical Enrolling Study Sites Intermountain Medical Center Salt Lake City, UT Emory University Atlanta, GA Univ. of Miami Miami, FL Univ. of Virginia Charlottesville, VA St. Luke’s Hospital Kansas City, MO BarnesJewish Hospital St. Louis, MO Medical City Dallas Dallas, TX St. Paul39。s Hospital Vancouver, Canada Univ. of Washington Seattle, WA Mayo Clinic Rochester, MN Stanford University Palo Alto, CA Hospital Laval Quebec City, Canada Ochsner Foundation New Orleans, LA Scripps Clinic La Jolla, CA CedarsSinai Medical Center Los Angeles, CA Cleveland Clinic Cleveland, OH Columbia University Cornell University New York, NY Washington Hosp. Center Wash., DC Univ. of Penn Phila., PA Brigham Women’s Mass General Boston, MA Northwestern Univ. Chicago, IL Evanston HospitalLeipzig Heart Center Leipzig, Germany n = 699 patients 25 investigator sites 22 USA, 2 Canada, 1 Germany Key EndPoints ? Allcause mortality (primary endpoint) ? Cardiovascular mortality ? Rehospitalization ? Strokes ? Vascular and bleeding events ? NYHA functional class ? Echocardiographic measures of valve performance (including valve gradients/areas and postprocedural aortic regurgitation) Study Methodology ? All patients followed for at least three years ? Primary analysis performed by intentiontotreat (ITT), although astreated (AT) analyses performed when appropriate (. echo data = AT) ? Event rates as KaplanMeier estimates, with groups pared by logrank over the length of followup ? Composite analyses prespecified ? Effect of baseline variables on 3yr mortality studied with Cox proportional hazards regression (multivariable analysis with covariates pvalue ) ? Effect of procedural plications on 3yr mortality studied with timedependent covariate analysis Study Flow 3 Years Alive = 132 Dead = 96 LTFU = 3 Withdrawal = 3 Ongoing F/U = 10 3 Years Alive = 119 Dead = 101 LTFU = 3 Withdrawal = 17 Ongoing F/U = 8 AVR (248) Randomized = 699 patients TF = 492 (70%) TA = 207 (30%) Transfemoral n = 492 TAVR (244) 3 Yea
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