RT Journal Article
SR Electronic
T1 Early percutaneous mitral commissurotomy or conventional management for asymptomatic mitral stenosis: a randomised clinical trial
JF Heart
JO Heart
FD BMJ Publishing Group Ltd and British Cardiovascular Society
SP 1980
OP 1986
DO 10.1136/heartjnl-2021-319857
VO 107
IS 24
A1 Duk-Hyun Kang
A1 Sung-Ji Park
A1 Seung-Ah Lee
A1 Sahmin Lee
A1 Dae-Hee Kim
A1 Duk-Woo Park
A1 Sung-Cheol Yun
A1 Geu-Ru Hong
A1 Jong-Min Song
A1 Myeong-Ki Hong
A1 Seung Woo Park
A1 Seung-Jung Park
YR 2021
UL http://heart.bmj.com/content/107/24/1980.abstract
AB 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.All data relevant to the study are included in the article or uploaded as supplementary information. The data collected for this study will not be be made available to others.