Cerebrovascular Events After Transcatheter Edge-to-Edge Repair and Guideline-Directed Medical Therapy in the COAPT Trial

Flavien Vincent; Björn Redfors; Lak N Kotinkaduwa; Saibal Kar; D Scott Lim; Jacob M Mishell; Brian K Whisenant; JoAnn Lindenfeld; William T Abraham; Michael J Mack; Gregg W Stone

doi:10.1016/j.jcin.2023.03.023

Cerebrovascular Events After Transcatheter Edge-to-Edge Repair and Guideline-Directed Medical Therapy in the COAPT Trial

JACC Cardiovasc Interv. 2023 Jun 26;16(12):1448-1459. doi: 10.1016/j.jcin.2023.03.023.

Authors

Affiliations

¹ Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA; Department of Cardiology, Regional Hospital ISSSTE Puebla, Puebla, Mexico.
² Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden; Department of Molecular and Clinical Medicine, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.
³ Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.
⁴ Los Robles Regional Medical Center, Thousand Oaks, California, USA; Bakersfield Heart Hospital, Bakersfield, California, USA.
⁵ Division of Cardiology, University of Virginia, Charlottesville, Virginia, USA.
⁶ Kaiser Permanente San Francisco Hospital, San Francisco, California, USA.
⁷ Intermountain Medical Center, Murray, Utah, USA.
⁸ Advanced Heart Failure and Cardiac Transplantation Section, Vanderbilt Heart and Vascular Institute, Nashville, Tennessee, USA.
⁹ Department of Medicine, The Ohio State University, Columbus, Ohio, USA; Department of Physiology and Cell Biology, The Ohio State University, Columbus, Ohio, USA; Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio, USA; Davis Heart and Lung Research Institute, The Ohio State University, Columbus, Ohio, USA.
¹⁰ Baylor Scott & White Heart Hospital Plano, Plano, Texas, USA.
¹¹ Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: gregg.stone@mountsinai.org.

PMID: 37380226
DOI: 10.1016/j.jcin.2023.03.023

Abstract

Background: Little is known regarding the risk of cerebrovascular events (CVE) in patients with heart failure and severe secondary mitral regurgitation treated with transcatheter edge-to-edge repair (TEER).

Objectives: The study sought to examine the incidence, predictors, timing, and prognostic impact of CVE (stroke or transient ischemic attack) in the COAPT (Cardiovascular Outcomes Assessment of the Mitraclip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial.

Methods: A total of 614 patients with heart failure and severe secondary mitral regurgitation were randomized to TEER plus guideline-directed medical therapy (GDMT) vs GDMT alone.

Results: At 4-year follow-up, 50 CVEs occurred in 48 (7.8%) of the 614 total patients enrolled in the COAPT trial; Kaplan-Meier event rates were 12.3% in the TEER group and 10.2 in the GDMT alone group (P = 0.91). Within 30 days of randomization, CVE occurred in 2 (0.7%) patients randomized to TEER and 0% randomized to GDMT (P = 0.15). Baseline renal dysfunction and diabetes were independently associated with increased risk of CVE, while baseline anticoagulation was associated with a reduction of CVE. A significant interaction was present between treatment group and anticoagulation such that TEER compared with GDMT alone was associated with a reduced risk of CVE among patients with anticoagulation (adjusted HR: 0.24; 95% CI: 0.08-0.73) compared with an increased risk of CVE in patients without anticoagulation (adjusted HR: 2.27; 95% CI: 1.08-4.81; P_interaction = 0.001). CVE was an independent predictor of death within 30 days after the event (HR: 14.37; 95% CI: 7.61, 27.14; P < 0.0001).

Conclusions: In the COAPT trial, the 4-year rate of CVE was similar after TEER or GDMT alone. CVE was strongly associated with mortality. Whether anticoagulation is effective at reducing CVE risk after TEER warrants further study. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] and COAPT CAS [COAPT); NCT01626079).

Keywords: heart failure; mitral regurgitation; stroke; transcatheter edge-to-edge repair; transient ischemic event(s).

Publication types

Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Anticoagulants
Heart Failure* / epidemiology
Heart Failure* / therapy
Humans
Ischemic Attack, Transient*
Mitral Valve Insufficiency* / diagnostic imaging
Mitral Valve Insufficiency* / surgery
Treatment Outcome

Substances

Anticoagulants

Associated data

ClinicalTrials.gov/NCT01626079

Grants and funding

UH3 HL140144/HL/NHLBI NIH HHS/United States