Valvular & structural heart diseaseRandomised controlled trial
1-Year Outcomes From the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation
- Randomised controlled trial
- non-inferiority
- 2:1 randomisation
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)
Primary result
As reported in the abstract
- Non-inferiority
- Full cohort
PASCAL
4.6%
30-day MAE · 6-month MR≤2+ 97.9%
MitraClip
5.4%
30-day MAE · 6-month MR≤2+ 95.7%
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%
MR≤1+ (secondary effectiveness endpoint) · 1 year · 95% LCB −5.3% · non-inferiority met
rate difference 5.8%
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
Summarised from the published abstract; every number is checked against it