Benefits of MitraClip sustained to 5 years in COAPT trial

After 5 years, results of the COAPT study showed that transcatheter edge-to-edge repair (TEER) procedures using a transcatheter clip device to reduce mitral regurgitation (MR) was safe and led to a lower rate of hospitalisation for heart failure (HF) and lower all-cause mortality than medical therapy alone in patients with severe HF.

COAPT (NCT01626079) randomised 614 patients with HF with a very specific background: they had moderate-to-severe (3+) or severe (4+) secondary MR and remained symptomatic despite maximally-tolerated guideline-directed medical therapy (GDMT). The participants were randomised 1:1 to MR correction with the MitraClip^TM device (n=302) or to GDMT alone (n=312). “At 2 years, the MitraClip led to a substantial reduction in HF hospitalisations and improved survival and quality of life compared with maximally-tolerated GDMT alone,” said lead author Prof. Gregg Stone (Icahn School of Medicine at Mount Sinai, NY, USA) [1,2]. As per protocol, subjects randomised to GDMT were allowed to cross over to the MitraClip only after 2 years.

At 5 years of follow-up, the positive effect on the primary endpoint of all HF hospitalisations was sustained in the device group [1]. There had been 314 HF hospitalisations among 151 patients in the device group versus 447 among 208 patients in the control group, yielding an annualised hospitalisation rate of 33.1% and 57.2%, respectively (HR 0.53; 95% CI 0.41–0.68; P<0.001).

The secondary composite endpoint of death or HF hospitalisation was reached by 73.6% in the device group versus 91.5% in the control group (HR 0.53; 95% CI 0.44–0.64; P<0.001). This result was consistent in all prespecified subgroups. All-cause mortality was 57.3% in the device group and 67.2% in the control group (HR 0.72; 95% CI 0.58–0.89; P<0.001). Symptomatic status (NYHA class) in the device group was also improved throughout the 5-year follow-up, and MitraClip treatment provided durable repair of mitral regurgitation.

Prof. Stone said the difference in mortality originated from the first 2 years. “We believe the lack of divergence in the last 3 years is largely explained by the effect of cross over from the control to the device group.” Of 138 surviving patients in the control group, 62 (45.9%) elected to cross over to undergo TEER. The prognosis of this cross-over group was substantially improved, similar to that of patients originally assigned to device treatment. “However, nearly half of the control group had died before becoming eligible for cross over at 2 years,” noted Prof. Stone. “HF patients appropriate for TEER with the MitraClip should therefore be identified and considered for treatment as early as possible.”

1. Stone GW, et al. Transcatheter Edge-to-edge Repair Of Functional Mitral Regurgitation In Heart Failure: Final Five-year Results From The COAPT Trial. Session 405-12, ACC Scientific Session 2023, 4–6 March, New Orleans, USA.
2. Stone GW, et al. N Engl J Med 2018;379:2307–2318.

 

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Posted on 7 June 2023