Division of Cardiology, Asan Medical Center, Seoul, Republic of Korea
Division of Cardiology, Samsung Medical Center, Seoul, Republic of Korea.
Heart. 2021 Dec;107(24):1980-1986. doi: 10.1136/heartjnl-2021-319857. Epub 2021 Sep 15.
The decision to perform percutaneous mitral commissurotomy (PMC) on asymptomatic patients requires careful weighing of the potential benefits against the risks of PMC, and we conducted a multicentre, randomised trial to compare long-term outcomes of early PMC and conventional treatment in asymptomatic, severe mitral stenosis (MS).
We randomly assigned asymptomatic patients with severe MS (defined as mitral valve area between 1.0 and 1.5 cm) to early PMC (84 patients) or to conventional treatment (83 patients). The primary endpoint was a composite of major cardiovascular events, including PMC-related complications, cardiovascular mortality, cerebral infarction and systemic thromboembolic events. The secondary endpoints were death from any cause and mitral valve (MV) replacement during follow-up.
In the early PMC group, there were no PMC-related complications. During the median follow-up of 6.4 years, the composite primary endpoint occurred in seven patients in the early PMC group (8.3%) and in nine patients in the conventional treatment group (10.8%) (HR 0.77; 95% CI 0.29 to 2.07; p=0.61). Death from any cause occurred in four patients in the early PMC group (4.8%) and three patients in the conventional treatment group (3.6%) (HR 1.30; 95% CI 0.29 to 5.77). Ten patients (11.9%) in the early PMC group and 17 patients (20.5%) in the conventional treatment group underwent MV replacement (HR 0.59; 95% CI 0.27 to 1.29).
Compared with conventional treatment, early PMC did not significantly reduce the incidence of cardiovascular events among asymptomatic patients with severe MS during the median follow-up of 6 years.
NCT01406353.
对无症状患者行经皮二尖瓣交界切开术（PMC）的决策需要仔细权衡 PMC 的潜在益处与风险，我们进行了一项多中心、随机试验，以比较早期 PMC 和无症状、重度二尖瓣狭窄（MS）的常规治疗的长期结果。
我们将无症状的重度 MS 患者（定义为二尖瓣瓣口面积在 1.0 至 1.5cm 之间）随机分为早期 PMC 组（84 例）和常规治疗组（83 例）。主要终点是主要心血管事件的综合指标，包括 PMC 相关并发症、心血管死亡率、脑梗死和全身血栓栓塞事件。次要终点是随访期间任何原因导致的死亡和二尖瓣（MV）置换。
在早期 PMC 组中，没有 PMC 相关并发症。在中位随访 6.4 年期间，早期 PMC 组中有 7 例（8.3%）患者发生了复合主要终点事件，常规治疗组中有 9 例（10.8%）患者发生了复合主要终点事件（HR 0.77；95%CI 0.29 至 2.07；p=0.61）。早期 PMC 组有 4 例（4.8%）患者死于任何原因，常规治疗组有 3 例（3.6%）患者死于任何原因（HR 1.30；95%CI 0.29 至 5.77）。早期 PMC 组有 10 例（11.9%）患者和常规治疗组有 17 例（20.5%）患者接受了 MV 置换（HR 0.59；95%CI 0.27 至 1.29）。
与常规治疗相比，在中位随访 6 年期间，早期 PMC 并未显著降低无症状重度 MS 患者心血管事件的发生率。
NCT01406353。
