Tomii, Daijiro and Lanz, Jonas and Thiele, Holger and Heg, Dik and Kim, Won-Keun and Joner, Michael and Moellmann, Helge and Burgdorf, Christof and Linke, Axel and Redwood, Simon and Hilker, Michael and Conradi, Lenard and Kerber, Sebastian and Thilo, Christian and Toggweiler, Stefan and Walther, Thomas and Prendergast, Bernard and Windecker, Stephan and Pilgrim, Thomas (2025) Obstructive Coronary Artery Disease and Health Status in Transcatheter Aortic Valve Replacement. JAMA NETWORK OPEN, 8 (12): e2547111. ISSN 2574-3805,
Full text not available from this repository. (Request a copy)Abstract
This secondary post hoc analysis of a randomized clinical trial investigates the association of obstructive coronary artery disease with patient-reported disease-specific health status and clinical efficacy among patients with symptomatic severe aortic stenosis undergoing transcatheter aortic valve replacement. QuestionIs the presence of obstructive coronary artery disease (CAD) associated with clinical outcomes and health status among patients with symptomatic severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR)?FindingsIn a post hoc analysis of the SCOPE I randomized clinical trial including 732 patients, no statistically significant differences were observed between patients with vs without obstructive CAD in patient-reported health status, mortality, and clinical efficacy according to Valve Academic Research Consortium-3 (VARC-3) definitions of TAVR throughout 3 years of follow-up.MeaningThese findings suggest that concomitant CAD may not adversely affect survival, patient-reported health status, or VARC-3 clinical efficacy in patients with AS undergoing TAVR. ImportanceAortic stenosis (AS) and obstructive coronary artery disease (CAD) often coexist, yet the impact of obstructive CAD on clinical and patient-reported outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) remains a subject of ongoing debate.ObjectivesTo investigate the association of obstructive CAD with clinical outcomes and health status among patients with symptomatic severe AS undergoing TAVR.Design, Setting, and ParticipantsThis post hoc analysis of the investigator-initiated, multicenter SCOPE I (Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis for Transcatheter Aortic Valve Implantation by Transfemoral Approach) randomized clinical trial was conducted at 20 tertiary heart centers in Europe from February 8, 2017, to February 2, 2019, with follow-up through 3 years. Data were analyzed from February 17 through August 13, 2025.ExposurePresence vs absence of obstructive CAD, defined as greater than 50% stenosis in at least 1 major epicardial coronary vessel.Main Outcomes and MeasuresParameters of interest included vital and patient-reported disease-specific health status (Kansas City Cardiomyopathy Questionnaire [KCCQ] scores, ranging from 0 to 100, with higher numbers indicating better health status), and clinical efficacy according to Valve Academic Research Consortium (VARC)-3 definitions. Analyses were conducted using the as treated population.ResultsOf 732 patients with symptomatic severe AS undergoing TAVR (mean [SD] age, 82 [4] years; 416 [56.8%] female), obstructive CAD was identified in 373 (51.0%), 144 (38.6%) of whom underwent elective percutaneous coronary intervention (PCI) during the periprocedural period. At 3 years after TAVR, there were no statistically significant differences in patient-reported health status (eg, median [IQR] baseline overall KCCQ scores with CAD, 54.2 [40.3-69.8] vs without CAD, 55.2 [38.5-72.9] and at 3-year follow-up with CAD, 79.7 [64.4-90.6] vs without CAD, 82.3 [68.2-91.7]), mortality (all-cause death: 88 of 373 [24.7%] vs 76 of 359 [22.3%], adjusted hazard ratio, [HR], 0.97 [95% CI, 0.66-1.43]; cardiovascular death: 59 of 373 [17.6%] vs 51 of 359 [15.5%], adjusted HR, 0.87 [95% CI, 0.54-1.42]), and clinical efficacy of TAVR (163 of 313 [52.1%] vs 159 of 298 [53.4%]; adjusted risk ratio, 1.10 [95% CI, 0.92-1.32]) between patients with vs without obstructive CAD. Having (vs not having) obstructive CAD was associated with a numerically albeit not statistically significantly higher risk of myocardial infarction (18 of 372 [5.5%] vs 3 of 359 [1.1%]; adjusted HR, 3.83 [95% CI, 0.96-15.31]). Periprocedural PCI among patients with obstructive CAD did not improve clinical outcomes, patient-reported health status, nor the integrated end points of clinical outcomes and quality of life measures.Conclusions and RelevanceIn this post hoc analysis of SCOPE I, patients with obstructive CAD who underwent TAVR had no statistically significant differences in survival, patient-reported health status, or VARC-3 clinical efficacy compared with patients without CAD through 3 years of follow-up. Findings suggest that a tailored approach may be essential in the treatment of TAVR candidates with severe AS and CAD.Trial RegistrationClinicalTrials.gov Identifier: NCT03011346
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | END-POINT DEFINITIONS; REVASCULARIZATION; OUTCOMES; IMPLANTATION; STENOSIS; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Herz-, Thorax- und herznahe Gefäßchirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 25 Mar 2026 10:28 |
| Last Modified: | 25 Mar 2026 10:28 |
| URI: | https://pred.uni-regensburg.de/id/eprint/68016 |
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