Safety of six-month dual antiplatelet therapy after second-generation drug-eluting stent implantation: OPTIMA-C Randomised Clinical Trial and OCT Substudy.

AIMS: There are few randomised studies concerning the optimal duration of dual antiplatelet therapy (DAPT) for patients who receive a second-generation drug-eluting stent (DES). This trial aimed to investigate the safety of six-month compared with 12-month DAPT maintenance after second-generation DES implantation. METHODS AND RESULTS: A prospective, randomised, multicentre trial was performed at 10 medical centres. The 1,368 patients included in the study received a biolimus-eluting stent (BES) or a zotarolimus-eluting stent (ZES). The primary outcome measured was the composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), or ischaemia-driven target lesion revascularisation at the 12-month follow-up. The secondary outcome was the percentage of uncovered struts at six months in 60 patients (30 ZES, 30 BES) using optical coherence tomography (OCT) assessment. Each patient was randomly assigned to six-month (n=684) or 12-month DAPT (n=684). Major adverse cardiac events at 12 months occurred in eight patients (1.2%) in the six-month DAPT group and in four patients (0.6%) in the 12-month DAPT group (risk difference 0.6%; 95% confidence interval [CI]: -0.4-1.6%; p=0.24). The upper 95% CI limit was lower than the pre-specified limit of 4% non-inferiority (p for non-inferiority <0.05). The percentage of uncovered struts was 3.16±4.30% at six months in 60 stents of 60 patients. CONCLUSIONS: After second-generation DES implantation, six-month DAPT was not inferior to 12-month DAPT in terms of MACE occurrence over the 12-month follow-up period. OCT examination revealed favourable stent strut coverage at six months after stent implantation.

Diverse left ventricular morphology and predictors of short-term outcome in patients with stress-induced cardiomyopathy.

BACKGROUND: There is paucity of data with regard to the clinical spectrum according to left ventricle (LV) morphological variation in stress-induced cardiomyopathy (SCMP) patients, and still there is controversy in terms of prognosis since some people believe that the published in-hospital mortality data of patients with SCMP are underestimated. Therefore, we sought to investigate the morphological features of LV and in-hospital outcome of patients with SCMP and explored predictors of short-term prognosis. METHODS: This was a multicenter, observational study of 208 SCMP patients. Morphological features of LV were determined by echocardiography and were divided into typical (apical) and atypical ballooning types, which were subcategorized into mid-LV ballooning and basal 'inverted' ballooning type. All-cause mortality of patients with SCMP during hospitalization was recorded. RESULTS: The apical ballooning type was most common (67.3%) in SCMP followed by the mid-LV ballooning type (28.3%), and the basal 'inverted' ballooning type (4.3%). There were no differences in stressor types and in-hospital mortality between patients with typical and atypical SCMP. Notably, all the in-hospital mortality of SCMP patients occurred in patients with physical stressors, where age, shock, and LV ejection fraction were the independent risk factors for predicting in-hospital mortality. CONCLUSIONS: SCMP patients showed diverse patterns of LV morphology, but there were no definite differences on clinical spectrum among SCMP patients presenting various LV morphological patterns. In terms of short-term prognosis, underlying physical conditions combined with old age, hemodynamic compromise, and low LV systolic function might be the most important factors in SCMP patients.