Objective 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). Methods We randomly assigned asymptomatic patients with severe MS (defined as mitral valve area between 1.0 and 1.5 cm2) 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. Results 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). Conclusions 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. Trial registration number [NCT01406353][1]. All data relevant to the study are included in the article or uploaded as supplementary information. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01406353&atom=%2Fheartjnl%2F107%2F24%2F1980.atom

中文翻译：

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无症状二尖瓣狭窄的早期经皮二尖瓣连合切开术或常规治疗：一项随机临床试验

目的 对无症状患者进行经皮二尖瓣连合切开术 (PMC) 的决定需要仔细权衡 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 和常规治疗在无症状患者中的长期结果，严重二尖瓣狭窄 (MS)。方法 我们将无症状的重度 MS 患者（定义为二尖瓣面积在 1.0 到 1.5 cm2 之间）随机分配到早期 PMC（84 名患者）或常规治疗（83 名患者）。主要终点是主要心血管事件的复合，包括 PMC 相关并发症、心血管死亡率、脑梗塞和全身血栓栓塞事件。次要终点是随访期间全因死亡和二尖瓣（MV）置换。结果 在早期 PMC 组中，没有与 PMC 相关的并发症。在 6.4 年的中位随访期间，早期 PMC 组 7 名患者 (8.3%) 和常规治疗组 9 名患者 (10.8%) 发生复合主要终点（HR 0.77；95% CI 0.29 至 2.07） ；p=0.61）。早期 PMC 组 4 名患者 (4.8%) 和常规治疗组 3 名患者 (3.6%) 发生全因死亡（HR 1.30；95% CI 0.29 至 5.77）。早期 PMC 组 10 名患者（11.9%）和常规治疗组 17 名患者（20.5%）接受了 MV 置换术（HR 0.59；95% CI 0.27 至 1.29）。结论 与常规治疗相比，早期 PMC 在中位随访 6 年期间并未显着降低无症状重度 MS 患者的心血管事件发生率。试验注册号 [NCT01406353][1]。与研究相关的所有数据都包含在文章中或作为补充信息上传。[1]：/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01406353&atom=%2Fheartjnl%2F107%2F24%2F1980.atom