Clinical ResearchGuideline-Directed Medical Therapy Tolerability in Patients With Heart Failure and Mitral Regurgitation: The COAPT Trial
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Data availability statement
The data that support the findings of this study may be made available to qualified researchers upon reasonable request to the COAPT Publications Office ([email protected]).
Study design
The COAPT trial design and results have been previously published.9,10 In brief, the COAPT trial was a multicenter, randomized, controlled, open-label trial of transcatheter edge-to-edge mitral valve repair (TEER) with the MitraClip device (Abbott Laboratories) in patients with HF and symptomatic moderate-to-severe or severe
Study population
Between December 2012 and June 2017, 1,576 subjects were screened at 78 centers in the United States and Canada; 911 (57.8%) of were ineligible. Among the 614 randomized patients, 472 (76.9%) had LVEFs ≤40% at enrollment. Individual GDMT medication class information was available in all 472. Of these, 464 (98.3%) had complete screening GDMT regimen data. Baseline characteristics are presented in Table 1, according to the number of GDMT medication classes used after HF specialist-guided GDMT
Discussion
To our knowledge, COAPT is the first HF trial to require HF medication optimization systematically by a multidisciplinary team of HF experts, providing the first understanding into intolerances limiting GDMT optimization in a HF trial. The major findings are as follows: 1) only 39% of patients with HFrEF tolerated any dose of all 3 required class I GDMT classes simultaneously, whereas 22% only tolerated only 1 or no GDMT class, and only 2.2% of patients with HFrEF tolerated target doses of all
Conclusions
In the COAPT trial, most enrolled patients with HFrEF had medical intolerances prohibiting use of at least 1 of the 3 core GDMT classes and of reaching target goal doses, despite systematic HF specialist-directed GDMT optimization. These findings emphasize that GDMT intolerances frequently underlie low GDMT prescription rates and suboptimal dose prescription in HFrEF and mitral regurgitation, likely contributing to poor prognoses in these high-risk patients. Whether improved hemodynamics and
Funding Support and Author Disclosures
Abbott Laboratories has provided funding for this paper. Dr Cox has received grants from AstraZeneca, and Cumberland Pharmaceuticals; and consulting fees from Roche. Dr Udelson has served on steering committees for Abiomed; and has received consulting fees from Imbria Pharmaceuticals. Dr Lim has received grants from Abbott, Edwards, Medtronic, and Gore; consulting fees from Abbott, Edwards, Keystone Heart, Pipeline, Siemens, Valgen, and Venus; has served on advisory boards for Ancora and Venus;
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Cited by (11)
Transcatheter Edge-to-Edge Repair in COAPT-Ineligible Patients With Functional Mitral Regurgitation
2024, Journal of the American College of CardiologyValvular heart disease: from mechanisms to management
2024, The LancetHeart Failure and Secondary Mitral Regurgitation: A Contemporary Review
2023, Journal of the Society for Cardiovascular Angiography and InterventionsMitral Interventions in Heart Failure
2023, JACC: Heart Failure
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