背景:对于患有功能性二尖瓣反流(FMR)和症状性心力衰竭(HF)的患者,经二尖瓣导管边缘对边缘修复(M-TEER)的随机试验产生了相互矛盾的结果.
目的:本研究旨在评估M-TEER对住院率的影响,并探讨M-TEER对在接受M-TEER之前有或没有近期HF住院史的患者的影响。
方法:RESHAPE-HF2(MitraClip装置在心力衰竭中的随机调查:在临床上有意义的功能性二尖瓣反流患者中的第2项试验)包括有症状的HF和中度至重度FMR患者(平均有效反流孔口面积0.25cm2;14%>0.40cm2,23%<0.20cm2),并显示alM-TEER降低了心力衰竭的住院质量和我们现在报告了在随机化前12个月内住院率和HF住院患者亚组(n=333)的预设分析结果。
结果:在24个月时,首次心血管死亡或HF住院的时间(HR:0.65;95%CI:0.49-0.85;P=0.002),复发性CV住院率(比率[RR]:0.75;95%CI:0.57-0.99;P=0.046),复发性CV住院和全因死亡率的复合率(RR:0.74;95%CI:0.57-0.95;P=0.017),复发性CV死亡和CV住院(RR:0.76;95%CI:0.58-0.99;P=0.040),M-TEER组均较低。M-TEER组与对照组患者因任何原因反复住院的RR为0.82(95%CI:0.63-1.07;P=0.15)。随机接受M-TEER的患者因死亡或HF住院而损失的天数较少(13.9%[95%CI:13.0%-14.8%]vs17.4%[95%CI:16.4%-18.4%]随访时间;P<0.0001,1,067vs1,776天;P<0.0001)。随机接受M-TEER的患者在随访30天和6、12和24个月时也有更好的NYHA功能分级(P<0.0001)。随机分组前HF住院史与M-TEER对复发性HF住院和CV死亡(P交互作用=0.03)和24个月内复发性HF住院(P交互作用=0.06)的复合率和更大的获益相关。
结论:这些结果表明,在有症状的HF和中度至重度FMR患者中,除了最佳的指导药物治疗外,还应考虑M-TEER的更广泛的应用。特别是那些有最近因HF住院史的人。
BACKGROUND: For patients with functional mitral regurgitation (FMR) and symptomatic heart failure (HF), randomized trials of mitral transcatheter edge-to-edge repair (M-TEER) have produced conflicting results.
OBJECTIVE: This study sought to assess the impact of M-TEER on hospitalization rates, and explore the effects of M-TEER on patients who did or did not have a history of recent HF hospitalizations before undergoing M-TEER.
METHODS: RESHAPE-HF2 (Randomized Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients with Clinically Significant Functional Mitral Regurgitation) included patients with symptomatic HF and moderate to severe FMR (mean effective regurgitant orifice area 0.25 cm2; 14% >0.40 cm2, 23% <0.20 cm2) and showed that M-TEER reduced recurrent HF hospitalizations with and without the addition of cardiovascular (CV) death and improved quality of life. We now report the results of prespecified analyses on hospitalization rates and for the subgroup of patients (n = 333) with a HF hospitalization in the 12 months before randomization.
RESULTS: At 24 months, the time to first event of CV death or HF hospitalization (HR: 0.65; 95% CI: 0.49-0.85; P = 0.002), the rate of recurrent CV hospitalizations (rate ratio [RR]: 0.75; 95% CI: 0.57-0.99; P = 0.046), the composite rate of recurrent CV hospitalizations and all-cause mortality (RR: 0.74; 95% CI: 0.57-0.95; P = 0.017), and of recurrent CV death and CV hospitalizations (RR: 0.76; 95% CI: 0.58-0.99; P = 0.040), were all lower in the M-TEER group. The RR of recurrent hospitalizations for any cause was 0.82 (95% CI: 0.63-1.07; P = 0.15) for patients in the M-TEER group vs control group patients. Patients randomized to M-TEER lost fewer days due to death or HF hospitalization (13.9% [95% CI: 13.0%-14.8%] vs 17.4% [95% CI: 16.4%-18.4%] of follow-up time; P < 0.0001, and 1,067 vs 1,776 total days lost; P < 0.0001). Patients randomized to M-TEER also had better NYHA functional class at 30 days and at 6, 12, and 24 months of follow-up (P < 0.0001). A history of HF hospitalizations before randomization was associated with worse outcomes and greater benefit with M-TEER on the rate of the composite of recurrent HF hospitalizations and CV death (Pinteraction = 0.03) and of recurrent HF hospitalizations within 24 months (Pinteraction = 0.06).
CONCLUSIONS: These results indicate that a broader application of M-TEER in addition to optimal guideline-directed medical therapy should be considered among patients with symptomatic HF and moderate to severe FMR, particularly in those with a history of a recent hospitalization for HF.