Cardiology Department Hospital Clínico Universitario de Valladolid Spain.
CIBERCV (Centro de Investigación biomédica en red-Enfermedades Cardiovasculares) Instituto de Salud Carlos III Madrid Spain.
J Am Heart Assoc. 2024 Oct;13(19):e035460. doi: 10.1161/JAHA.124.035460. Epub 2024 Sep 18.
Patients with aortic stenosis may continue to have an increased risk of heart failure, arrhythmias, and death after successful transcatheter aortic valve implantation. Renin-angiotensin system inhibitors may be beneficial in this setting. We aimed to explore whether ramipril improves the outcomes of patients with aortic stenosis after transcatheter aortic valve implantation.
PROBE (Prospective Randomized Open, Blinded Endpoint) was a multicenter trial comparing ramipril with standard care (control) following successful transcatheter aortic valve implantation in patients with left ventricular ejection fraction >40%. The primary end point was the composite of cardiac mortality, heart failure readmission, and stroke at 1-year follow-up. Secondary end points included left ventricular remodeling and fibrosis. A total of 186 patients with median age 83 years (range 79-86), 58.1% women, and EuroSCORE-II 3.75% (range 3.08-4.97) were randomized to receive either ramipril (n=94) or standard treatment (n=92). There were no significant baseline, procedural, or in-hospital differences. The primary end point occurred in 10.6% in the ramipril group versus 12% in the control group (=0.776), with no differences in cardiac mortality (ramipril 1.1% versus control group 2.2%, =0.619) but lower rate of heart failure readmissions in the ramipril group (3.2% versus 10.9%, =0.040). Cardiac magnetic resonance analysis demonstrated better remodeling in the ramipril compared with the control group, with greater reduction in end-systolic and end-diastolic left ventricular volumes, but nonsignificant differences were found in the percentage of myocardial fibrosis.
Ramipril administration after transcatheter aortic valve implantation in patients with preserved left ventricular function did not meet the primary end point but was associated with a reduction in heart failure re-admissions at 1-year follow-up.
URL: https://www.clinicaltrials.gov; Unique Identifier: NCT03201185.
主动脉瓣狭窄患者经经导管主动脉瓣置换术（TAVR）成功治疗后，仍可能存在心力衰竭、心律失常和死亡风险增加的问题。肾素-血管紧张素系统抑制剂可能对此有益。我们旨在探讨雷米普利能否改善 TAVR 后主动脉瓣狭窄患者的预后。
PROBE（前瞻性随机开放盲终点）试验是一项多中心试验，比较了 TAVR 成功后左心室射血分数>40%的患者使用雷米普利与标准治疗（对照组）的效果。主要终点是 1 年随访时的心脏死亡率、心力衰竭再入院和中风的复合终点。次要终点包括左心室重构和纤维化。共纳入 186 例中位年龄 83 岁（79-86 岁）、58.1%为女性、欧洲心脏手术风险评估系统 II 评分 3.75%（3.08-4.97）的患者，随机分为雷米普利组（n=94）或标准治疗组（n=92）。两组在基线、手术和住院期间均无显著差异。雷米普利组主要终点发生率为 10.6%，对照组为 12%（=0.776），两组心脏死亡率无差异（雷米普利组 1.1%，对照组 2.2%，=0.619），但雷米普利组心力衰竭再入院率较低（3.2% vs 10.9%，=0.040）。心脏磁共振分析显示，雷米普利组的重构情况优于对照组，左心室收缩末期和舒张末期容积减少更明显，但心肌纤维化的百分比差异无统计学意义。
在保留左心室功能的 TAVR 患者中，雷米普利治疗并未达到主要终点，但与 1 年随访时心力衰竭再入院率降低相关。
