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Final Research Report PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE FINAL RESEARCH REPORT Comparing Two Treatments for Aortic Valve Disease J. Matthew Brennan, MD, MPH1; Rachel S. Dokholyan, MPH1; Felicia Graham, MBA1; Laine Thomas, PhD1; David J. Cohen, MD, MSc2; David Shahian, MD3; Alice Wang, MD4; Michael J. Mack, MD5; David R. Holmes, MD6; Fred H. Edwards, MD7; Naftali Z. Frankel, MS*; Suzanne J. Baron, MD8; John Carroll, MD9; Vinod H. Thourani, MD10; E. Murat Tuzcu, MD11; Suzanne V. Arnold, MD2,12; Roberta Cohn*; Todd Maser*; Brenda Schawe*; Susan Strong*; Allen Stickfort*; Elizabeth Patrick-Lake*; Dadi Dai, PhD1; Fan (Frank) Li, PhD13; Roland A. Matsouaka, PhD1; Sean O’Brien, PhD1; Michael J. Pencina, PhD1; Eric D. Peterson, MD, MPH1 AFFILIATIONS: 1Duke University, Duke Clinical Research Institute, Durham, North Carolina 2University of Missouri–Kansas City, Kansas City 3Massachusetts General Hospital, Codman Center, Boston, Massachusetts 4Duke University School of Medicine, Duke Surgery, Durham, North Carolina 5Baylor Scott & White The Heart Hospital, Plano, Texas 6Mayo Clinic, Rochester, Minnesota 7University of Florida College of Medicine, Jacksonville 8Beth Israel Lahey Health, Burlington, Massachusetts 9University of Colorado School of Medicine, Aurora 10Piedmont Heart Institute, Atlanta, Georgia 11Cleveland Clinic, Heart, Vascular & Thoracic Institute, Cleveland, Ohio 12Saint Luke’s Cardiovascular Consultants, Kansas City, Missouri 13Yale University, Yale School of Medicine, New Haven, Connecticut *Patient and caregiver collaborators Institution Receiving Award: Duke University Original Project Title: Optimizing Health Outcomes in Patients with Symptomatic Aortic Valve Disease PCORI ID: CER-1306-04350 HSRProj ID: HSRP20143549 ClinicalTrials.gov ID: NCT02266251 _______________________________ To cite this document, please use: Brennan JM, Dokholyan RS, Graham F, et al. (2020). Comparing Two Treatments for Aortic Valve Disease. Patient-Centered Outcomes Research Institute (PCORI). https://doi.org/10.25302/08.2020.CER-1306-04350 TABLE OF CONTENTS ABSTRACT .............................................................................................................................. 4 BACKGROUND ........................................................................................................................ 6 Report Organization and Deviation From Initial Aims ............................................................... 6 PARTICIPATION OF PATIENTS AND OTHER STAKEHOLDERS ..................................................... 8 Table 1. Patient and Caregiver Collaborators ..................................................................... 8 Table 2. Stakeholders and Collaborators Involved in the Project ....................................... 9 METHODS .............................................................................................................................. 11 Aim 1—Comparative Analysis .................................................................................................. 11 Figure 1. Propensity Score Distribution Before Matchinga ............................................... 14 Figure 2. Unmeasured Confounders—Falsification Outcome (UTI)a ................................ 15 Figure 3. Standardized Differences on the Matched Populationa .................................... 18 Aim 2—Decision Aid Development .......................................................................................... 20 Aim 3—Educational Resource ................................................................................................. 31 RESULTS ................................................................................................................................ 35 Aim 1—Comparative Analysis .................................................................................................. 35 Aim 2—Decision Aid Development .......................................................................................... 35 Table 3. Model for 1-Year Mortalitya ................................................................................ 36 Figure 4. One-Year Mortality Model Calibrationa ............................................................. 37 Table 4. One-Year Stroke Model ....................................................................................... 38 Figure 5a. One-Year Stroke Model: Matched Populationa ............................................... 38 Figure 5b. One-Year Stroke Model: Unmatched Populationa ........................................... 39 Figure 6. Discharge-to-Home Subgroupsa ........................................................................ 40 Figure 7. Discharge-to-Home Patient Characteristicsa ..................................................... 41 Table 5. Discharge Location Model Parameter Estimatesa ............................................... 42 Figure 8a. DAOH: SAVR vs TAVRa ...................................................................................... 43 Figure 8b. DAOH: Associated Risk Prediction Modela ...................................................... 43 Table 6. QOL Model Coefficients ...................................................................................... 45 Figure 9. Validation of the Modela .................................................................................... 46 Aim 3—Educational Resource ................................................................................................. 49 Analysis of Website Use ........................................................................................................... 53 Figure 10a. Website Use Overview ................................................................................... 53 2 Figure 10b. Website Engaged Usea ................................................................................... 54 Figure 10c. Website Acquisition Usea ............................................................................... 54 DISCUSSION ........................................................................................................................... 55 Aim 1—Comparative Analysis .................................................................................................. 55 Aim 2—Decision Aid Development .......................................................................................... 55 Aim 3—Educational Resource ................................................................................................. 59 CONCLUSIONS ....................................................................................................................... 63 REFERENCES .......................................................................................................................... 64 RELATED PUBLICATION .......................................................................................................... 67 ACKNOWLEDGMENTS ............................................................................................................ 68 APPENDICES .......................................................................................................................... 69 Appendix 1. PCORI AV Replacement Study Recruitment Brochure ......................................... 69 Appendix 2. Covariate Definitions ........................................................................................... 69 Appendix 3. PCORI ADVICE Study Meeting Slides .................................................................... 69 Appendix 4. ADVICE Quick Reference For Patients ................................................................. 69 Appendix 5. ADVICE Website Informational Card for Providers .............................................. 69 Appendix 6. Supplementary Methods, Tables, and Figures .................................................... 69 3 ABSTRACT Background: Transcatheter aortic valve replacement (TAVR) is a relatively new treatment for aortic valve (AV) stenosis in inoperable patients and those at high and intermediate risk of mortality with surgical AV replacement (SAVR). While randomized trials support the use of TAVR, the generalizability of those results in clinical practice has been challenged. Beyond average treatment effects, no mechanism exists to estimate an individual’s expected 1-year outcomes following TAVR or SAVR in the United States, and no independent educational resource exists to help patients and their caregivers evaluate the options of SAVR or TAVR for the treatment of AV stenosis. Objectives: In this project, we sought to address these evidence gaps through 3 aims: (1) to determine the safety and effectiveness of TAVR vs SAVR in a nationally representative real- world cohort; (2) to develop a decision aid to help individualize the assessment of expected 1- year outcomes among intermediate-risk, high-risk, and inoperable patients; and (3) to create a peer-to-peer educational resource, including patient and caregiver testimonials and clear translations of state-of-the-art science for patients diagnosed with AV stenosis. Methods: To achieve the first and second aims, we linked data from the Transcatheter Valve Therapy Registry and Society of Thoracic Surgeons (STS) National Database to Medicare administrative claims for follow-up. In a propensity-matched cohort of 9464 intermediate- and high-risk (STS predicted risk of operative mortality [PROM] ≥3%) US patients who underwent commercial TAVR or SAVR, we compared death, stroke, and days alive and out of hospital (DAOH) at 1 year, as well as discharge to home,
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