Five-year comparison of clinical and echocardiographic outcomes of pure aortic stenosis with pure aortic regurgitation or mixed aortic valve disease in the COMMENCE trial

Vinod H. Thourani MD , John D. Puskas MD , Bartley Griffith MD , Lars G. Svensson MD, PhD , Philippe Pibarot DVM, PhD , Michael A. Borger MD, PhD , David Heimansohn MD , Thomas Beaver MD, MPH , Eugene H. Blackstone MD , Anna Liza M. Antonio DrPH , Joseph E. Bavaria MD, MPH , COMMENCE Trial Investigators
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Abstract

Objective

To compare outcomes of aortic valve replacement (AVR) in patients with pure aortic stenosis (Pure AS) and those with pure aortic regurgitation (Pure AR) or mixed AS and AR (MAVD) in the COMMENCE trial.

Methods

Of 689 patients who underwent AVR in the COMMENCE trial, patients with moderate or severe AR with or without AS (Pure AR + MAVD; n = 135) or Pure AS (n = 323) were included. Inverse probability of treatment weighting Kaplan-Meier survival curves were used for time-to-event endpoints, and longitudinal changes in hemodynamics were evaluated using mixed-effects models. Echocardiographic outcomes were assessed by an echo core laboratory and clinical outcomes adjudicated by a clinical events committee. The mean duration of follow-up was 5.3 ± 2.2 years.

Results

At 5 years, adjusted safety endpoints were not statistically different between groups; no structural valve deterioration (SVD) event occurred in either group. After adjustment, the Pure AR + MAVD group had a greater change in body surface area–corrected left ventricular (LV) mass reduction (P = .03) compared to the Pure AS patients. Those patients with a baseline LV ejection fraction (LVEF) >55% continued to demonstrate preserved contractility compared to patients with an LVEF ≤55% at baseline (P < .0001). No significant difference in mean gradient (P = .07) or effective orifice area (P = .96) at 5 years was evident between the groups.

Conclusions

Patients with Pure AR + MAVD demonstrated similar clinical safety and freedom from SVD at 5 years compared to those with Pure AS. There was a significant difference in LV reverse remodeling in the Pure AR + MAVD group compared to the Pure AS group at 5 years. These favorable outcomes in patients with AR may reinforce the need for treatment before irreversible changes occur.
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纯主动脉瓣狭窄与纯主动脉瓣反流或混合性主动脉瓣疾病的5年临床和超声心动图结果比较
目的:比较单纯主动脉瓣狭窄(pure AS)与单纯主动脉瓣返流(pure AR)或混合型主动脉瓣返流(MAVD)患者主动脉瓣置换术(AVR)的疗效。方法:在开始试验中接受AVR的689例患者中,中度或重度AR伴或不伴AS的患者(纯AR + MAVD;n = 135)或Pure AS (n = 323)。使用治疗加权的逆概率Kaplan-Meier生存曲线作为时间到事件的终点,使用混合效应模型评估血流动力学的纵向变化。超声心动图结果由超声核心实验室评估,临床结果由临床事件委员会裁决。平均随访时间5.3±2.2年。结果:5年时,两组间调整后的安全终点无统计学差异;两组均未发生结构性瓣膜恶化(SVD)事件。调整后,与Pure AS患者相比,Pure AR + MAVD组体表面积校正左室(LV)质量缩小变化更大(P = .03)。与基线时左室射血分数(LVEF)≤55% (P = 0.07)或有效孔口面积(P = 0.96)的患者相比,基线时左室射血分数(LVEF)≤55%的患者在5年时继续表现出保留的收缩能力,这在两组之间是明显的。结论:与纯AS患者相比,纯AR + MAVD患者在5年的临床安全性和SVD自由度相似。5年时,纯AR + MAVD组与纯AS组相比,左室逆转重构有显著差异。AR患者的这些有利结果可能会加强在不可逆变化发生之前进行治疗的必要性。
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