Rivard Lena, Samuel Michelle, Fortier Annik, Guertin Marie-Claude, Khairy Paul, Roy Denis, Talajic Mario, Tardif Jean-Claude
Research Centre, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.
Montreal Health Innovations Coordinating Center, Montreal Heart Institute, Montreal, Quebec, Canada.
CJC Open. 2021 May 5;3(9):1100-1107. doi: 10.1016/j.cjco.2021.04.014. eCollection 2021 Sep.
Hypertension is a risk factor for the development and exacerbation of atrial fibrillation (AF). Angiotensin-converting enzyme inhibitors are a standard-of-care treatment option for patients with hypertension; however, there is conflicting evidence about their effects on AF recurrence. Therefore, our objective was to assess the efficacy of perindopril, compared with placebo, to reduce AF recurrence in patients with hypertension and AF.
In a multicenter, double-blind, placebo-controlled trial, patients with hypertension and symptomatic AF were randomly assigned (1:1) to perindopril or placebo based on a stratification factor of antiarrhythmic drug use. Patients with terminated AF were followed up from 30 days after randomization to 7 to 13 months. The primary endpoint was AF recurrence. Secondary endpoints included AF hospitalization, cardioversion, and blood pressure control. Recurrent events, AF burden, and safety endpoints were also investigated.
A total of 315 patients were randomly assigned, and 301 patients were included in the modified intent-to-treat analysis (155 vs 146 patients in the perindopril and placebo groups, respectively). The mean follow-up was 336 ± 70 days, and 91.1% of patients were compliant to the treatment medication throughout the study. After adjustment for baseline antiarrhythmic drugs, there was no statistically significant difference in the hazards of AF recurrence (hazard ratio, 1.22; 95% confidence interval, 0.92-1.61), with similar blood pressure. The incidence of secondary endpoints and adverse events also did not differ between treatment arms.
Perindopril does not reduce recurrence or the number of AF episodes in patients with hypertension and AF.
高血压是心房颤动(AF)发生和加重的危险因素。血管紧张素转换酶抑制剂是高血压患者的标准治疗选择;然而,关于其对房颤复发的影响存在相互矛盾的证据。因此,我们的目的是评估培哚普利与安慰剂相比,在降低高血压合并房颤患者房颤复发方面的疗效。
在一项多中心、双盲、安慰剂对照试验中,根据抗心律失常药物使用的分层因素,将高血压合并症状性房颤患者随机(1:1)分配至培哚普利或安慰剂组。房颤终止的患者从随机分组后30天开始随访至7至13个月。主要终点是房颤复发。次要终点包括房颤住院、心脏复律和血压控制。还调查了复发事件、房颤负荷和安全性终点。
共315例患者被随机分配,301例患者纳入改良意向性分析(培哚普利组和安慰剂组分别为155例和146例患者)。平均随访时间为336±70天,91.1%的患者在整个研究过程中依从治疗药物。在调整基线抗心律失常药物后,房颤复发风险(风险比,1.22;95%置信区间,0.92 - 1.61)无统计学显著差异,血压相似。治疗组之间次要终点和不良事件的发生率也无差异。
培哚普利不能降低高血压合并房颤患者的复发率或房颤发作次数。