1-Year Outcomes From the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation

doi:10.1016/j.jcin.2023.10.002

Valvular & structural heart disease

1-Year Outcomes From the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation

JACC Cardiovasc IntervPublished 26 Oct 2023Randomised controlled trial

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Authors' conclusion

The CLASP IID trial full cohort met primary and secondary noninferiority endpoints, and at 1 year, the PASCAL system demonstrated high survival, significant MR reduction, and sustained improvements in functional and quality-of-life outcomes.

Study context

Population: Prohibitive-surgical-risk patients with significant symptomatic 3+/4+ degenerative mitral regurgitation
Participants: Three hundred patients

Comparison: PASCAL system vs MitraClip system
PASCALn = 204
MitraClipn = 96reference
Primary endpoint: Primary safety: composite MAE at 30 days; primary effectiveness: MR ≤2+ at 6 months (full cohort)
Follow-up: 30 days (safety); 6 months (effectiveness)

Methodological detailsnon-inferiority, 2:1 randomisation

Non-inferiority
2:1 randomisation

Primary result

As reported in the abstract

Primary endpoints:

Non-inferiority
Full cohort

PASCAL

30-day MAE: 4.6%
6-month MR≤2+: 97.9%

MitraClip

30-day MAE: 5.4%
6-month MR≤2+: 95.7%

30-day MAE

PASCAL4.6%

MitraClip5.4%

6-month MR≤2+

PASCAL97.9%

MitraClip95.7%

Rate difference

30-day MAE; 95% upper confidence bound 4.6%: −0.8%
6-month MR≤2+; 95% lower confidence bound (LCB) −2.5%: 2.2%

Secondary outcomes

MR≤2+ (secondary effectiveness endpoint) · 1 year · 95% LCB −4.1% · non-inferiority met

rate difference 2.1%

PASCAL95.8%

MitraClip93.8%

MR≤1+ (secondary effectiveness endpoint) · 1 year · 95% LCB −5.3% · non-inferiority met

rate difference 5.8%

PASCAL77.1%

MitraClip71.3%

Survival, freedom from HF hospitalization, MAE · 1 year

Differences nonsignificant: P > 0.05 for all

Functional classification and quality of life · 1 year

Significant improvements sustained in both groups vs baseline: P < 0.05 for all vs baseline

Original publication

1-Year Outcomes From the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation. JACC Cardiovasc Interv. Published 26 October 2023. doi:10.1016/j.jcin.2023.10.002

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Summarised from the published abstract; every number is checked against it