当前位置：
X-MOL 学术
›
JACC Heart Fail.
›
论文详情
Our official English website, www.x-mol.net, welcomes your
feedback! (Note: you will need to create a separate account there.)
The REDUCE FMR Trial: A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation.
JACC: Heart Failure ( IF 10.3 ) Pub Date : 2019-09-11 , DOI: 10.1016/j.jchf.2019.06.011 Klaus K Witte 1 , Janusz Lipiecki 2 , Tomasz Siminiak 3 , Ian T Meredith 4 , Christopher J Malkin 1 , Steven L Goldberg 5 , Matthew A Stark 6 , Ralph Stephan von Bardeleben 7 , Paul C Cremer 8 , Wael A Jaber 8 , David S Celermajer 9 , David M Kaye 10 , Horst Sievert 11
JACC: Heart Failure ( IF 10.3 ) Pub Date : 2019-09-11 , DOI: 10.1016/j.jchf.2019.06.011 Klaus K Witte 1 , Janusz Lipiecki 2 , Tomasz Siminiak 3 , Ian T Meredith 4 , Christopher J Malkin 1 , Steven L Goldberg 5 , Matthew A Stark 6 , Ralph Stephan von Bardeleben 7 , Paul C Cremer 8 , Wael A Jaber 8 , David S Celermajer 9 , David M Kaye 10 , Horst Sievert 11
Affiliation
|
OBJECTIVES
This study sought to evaluate the effects of the Carillon device on mitral regurgitation severity and left ventricular remodeling.
BACKGROUND
Functional mitral regurgitation (FMR) complicates heart failure with reduced ejection fraction and is associated with a poor prognosis.
METHODS
In this blinded, randomized, proof-of-concept, sham-controlled trial, 120 patients receiving optimal heart failure medical therapy were assigned to a coronary sinus-based mitral annular reduction approach for FMR or sham. The pre-specified primary endpoint was change in mitral regurgitant volume at 12 months, measured by quantitative echocardiography according to an intention-to-treat analysis.
RESULTS
Patients (69.8 ± 9.5 years of age) were randomized to either the treatment (n = 87) or the sham-controlled (n = 33) arm. There were no significant differences in baseline characteristics between the groups. In the treatment group, 73 of 87 (84%) had the device implanted. The primary endpoint was met, with a statistically significant reduction in mitral regurgitant volume in the treatment group compared to the control group (decrease of 7.1 ml/beat [95% confidence interval [CI]: -11.7 to -2.5] vs. an increase of 3.3 ml/beat [95% CI: -6.0 to 12.6], respectively; p = 0.049). Additionally, there was a significant reduction in left ventricular volumes in patients receiving the device versus those in the control group (left ventricular end-diastolic volume decrease of 10.4 ml [95% CI: -18.5 to -2.4] vs. an increase of 6.5 ml [95% CI: -5.1 to 18.2]; p = 0.03 and left ventricular end-systolic volume decrease of 6.2 ml [95% CI: -12.8 to 0.4] vs. an increase of 6.1 ml [95% CI: -1.42 to 13.6]; p = 0.04).
CONCLUSIONS
The Carillon device significantly reduced mitral regurgitant volume and left ventricular volumes in symptomatic patients with functional mitral regurgitation receiving optimal medical therapy. (Carillon Mitral Contour System for Reducing Functional Mitral Regurgitation [REDUCE FMR]; NCT02325830).
中文翻译：
REDUCE FMR试验：功能性二尖瓣关闭不全的经皮二尖瓣瓣环成形术的假手术对照研究。
目的本研究试图评估钟琴装置对二尖瓣关闭不全的严重程度和左心室重塑的影响。背景技术功能性二尖瓣关闭不全（FMR）使心力衰竭并发射血分数降低，并与不良预后相关。方法在这项盲目的，随机，概念验证的假手术对照试验中，将120例接受最佳心力衰竭药物治疗的患者分配至基于冠状窦的二尖瓣环减少术中进行FMR或假手术。预先指定的主要终点是根据意向性治疗分析通过定量超声心动图测量的12个月时二尖瓣反流量的变化。结果患者（69.8±9.5岁）被随机分配至治疗组（n = 87）或假对照组（n = 33）。两组之间的基线特征无显着差异。在治疗组中，有87例中有73例（84％）植入了该装置。达到了主要终点，与对照组相比，治疗组二尖瓣反流体积有统计学意义的减少（减少7.1 ml /次[95％置信区间[CI]：-11.7至-2.5]，而增加分别为3.3毫升/次[95％CI：-6.0至12.6]； p = 0.049）。此外，与对照组相比，接受该装置的患者的左心室容积显着减少（左心室舒张末期容积减少了10.4 ml [95％CI：-18.5至-2.4]，而增加了6.5。 ml [95％CI：-1.2.8至0.4]； p [95％CI：-5.1至18.2]； p = 0.03，左室收缩末期容积减少6.2 ml [95％CI：-12.8至0.4]。1毫升[95％CI：-1.42至13.6]；p = 0.04）。结论Carillon装置可显着减少有症状的功能性二尖瓣反流患者接受最佳药物治疗的二尖瓣反流和左心室容积。（用于减少功能性二尖瓣关闭不全的钟琴二尖瓣轮廓系统[REDUCE FMR]； NCT02325830）。
更新日期：2019-09-11
中文翻译：
REDUCE FMR试验：功能性二尖瓣关闭不全的经皮二尖瓣瓣环成形术的假手术对照研究。
目的本研究试图评估钟琴装置对二尖瓣关闭不全的严重程度和左心室重塑的影响。背景技术功能性二尖瓣关闭不全（FMR）使心力衰竭并发射血分数降低，并与不良预后相关。方法在这项盲目的，随机，概念验证的假手术对照试验中，将120例接受最佳心力衰竭药物治疗的患者分配至基于冠状窦的二尖瓣环减少术中进行FMR或假手术。预先指定的主要终点是根据意向性治疗分析通过定量超声心动图测量的12个月时二尖瓣反流量的变化。结果患者（69.8±9.5岁）被随机分配至治疗组（n = 87）或假对照组（n = 33）。两组之间的基线特征无显着差异。在治疗组中，有87例中有73例（84％）植入了该装置。达到了主要终点，与对照组相比，治疗组二尖瓣反流体积有统计学意义的减少（减少7.1 ml /次[95％置信区间[CI]：-11.7至-2.5]，而增加分别为3.3毫升/次[95％CI：-6.0至12.6]； p = 0.049）。此外，与对照组相比，接受该装置的患者的左心室容积显着减少（左心室舒张末期容积减少了10.4 ml [95％CI：-18.5至-2.4]，而增加了6.5。 ml [95％CI：-1.2.8至0.4]； p [95％CI：-5.1至18.2]； p = 0.03，左室收缩末期容积减少6.2 ml [95％CI：-12.8至0.4]。1毫升[95％CI：-1.42至13.6]；p = 0.04）。结论Carillon装置可显着减少有症状的功能性二尖瓣反流患者接受最佳药物治疗的二尖瓣反流和左心室容积。（用于减少功能性二尖瓣关闭不全的钟琴二尖瓣轮廓系统[REDUCE FMR]； NCT02325830）。
京公网安备 11010802027423号