Background—: The optimal duration of dual antiplatelet therapy (DAPT) after implantation of drug-eluting coronary stents remains undetermined. We aimed to test whether 6-month DAPT would be noninferior to 12-month DAPT after implantation of drug-eluting stents. Methods and Results—: We randomly assigned 1443 patients undergoing implantation of drug-eluting stents to receive 6- or 12-month DAPT (in a 1:1 ratio). The primary end point was a target vessel failure, defined as the composite of cardiac death, myocardial infarction, or ischemia-driven target vessel revascularization at 12 months. Rates of target vessel failure at 12 months were 4.8% in the 6-month DAPT group and 4.3% in the 12-month DAPT group (the upper limit of 1-sided 95% confidence interval, 2.4%; P =0.001 for noninferiority with a predefined noninferiority margin of 4.0%). Although stent thrombosis tended to occur more frequently in the 6-month DAPT group than in the 12-month group (0.9% versus 0.1%; hazard ratio, 6.02; 95% confidence interval, 0.72–49.96; P =0.10), the risk of death or myocardial infarction did not differ in the 2 groups (2.4% versus 1.9%; hazard ratio, 1.21; 95% confidence interval, 0.60–2.47; P =0.58). In the prespecified subgroup analysis, target vessel failure occurred more frequently in the 6-month DAPT group than in the 12-month group (hazard ratio, 3.16; 95% confidence interval, 1.42–7.03; P =0.005) among diabetic patients. Conclusions—: Six-month DAPT did not increase the risk of target vessel failure at 12 months after implantation of drug-eluting stents compared with 12-month DAPT. However, the noninferiority margin was wide, and the study was underpowered for death or myocardial infarction. Our results need to be confirmed in larger trials. Clinical Trial Registration—: URL: http://www.clinicaltrials.gov . Unique identifier: NCT00698607.
We investigated whether the survival of patients with inhospital cardiac arrest could be extended by extracorporeal cardiopulmonary resuscitation supported with extracorporeal membrane oxygenation compared with those of conventional cardiopulmonary resuscitation. : A retrospective, single-center, observational study. A tertiary care university hospital. We retrospectively analyzed a total of 406 adult patients with witnessed inhospital cardiac arrest receiving cardiopulmonary resuscitation for >10 mins from January 2003 to June 2009 (85 in the extracorporeal cardiopulmonary resuscitation group and 321 in the conventional cardiopulmonary resuscitation group). None. The primary end point was a survival discharge with minimal neurologic impairment. Propensity score matching was used to balance the baseline characteristics and cardiopulmonary resuscitation variables that could potentially affect prognosis. In the matched population (n = 120), the survival discharge rate with minimal neurologic impairment in the extracorporeal cardiopulmonary resuscitation group was significantly higher than that in the conventional cardiopulmonary resuscitation group (odds ratio of mortality or significant neurologic deficit, 0.17; 95% confidence interval, 0.04-0.68; p = .012). In addition, there was a significant difference in the 6-month survival rates with minimal neurologic impairment (hazard ratio, 0.48; 95% confidence interval, 0.29-0.77; p = .003; p <.001 by stratified log-rank test). In the subgroup based on cardiac origin, extracorporeal cardiopulmonary resuscitation also showed benefits for survival discharge (odds ratio, 0.19; 95% confidence interval, 0.04-0.82; p = .026) and 6-month survival with minimal neurologic impairment (hazard ratio, 0.56; 95% confidence interval, 0.33-0.97; p = .038; p = .013 by stratified log-rank test). Extracorporeal cardiopulmonary resuscitation showed a survival benefit over conventional cardiopulmonary resuscitation in patients who received cardiopulmonary resuscitation for >10 mins after witnessed inhospital arrest, especially in cases with cardiac origins.
Background—: Ischemic postconditioning has been reported to reduce infarct size in patients with ST-segment–elevation myocardial infarction. However, cardioprotective effects of postconditioning have not been demonstrated in a large-scale trial. Methods and Results—: We performed a multicenter, prospective, randomized, open-label, blinded end-point trial. A total of 700 patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment–elevation myocardial infarction within 12 hours after symptom onset were randomly assigned to the postconditioning group or to the conventional primary PCI group in a 1:1 ratio. Postconditioning was performed immediately after restoration of coronary flow as follows: The angioplasty balloon was positioned at the culprit lesion and inflated 4 times for 1 minute with low-pressure (70%) measured at 30 minutes after PCI. Complete ST-segment resolution occurred in 40.5% of patients in the postconditioning group and 41.5% of patients in the conventional PCI group (absolute difference, −1.0%; 95% confidence interval, −8.4 to 6.4; P =0.79). The rate of myocardial blush grade of 0 or 1 and the rate of major adverse cardiac events (a composite of death, myocardial infarction, severe heart failure, or stent thrombosis) at 30 days did not differ significantly between the postconditioning group and the conventional PCI group (17.2% versus 22.4% [ P =0.20] and 4.3% versus 3.7% [ P =0.70], respectively). Conclusion—: Ischemic postconditioning did not improve myocardial reperfusion in patients with ST-segment–elevation myocardial infarction undergoing primary PCI with current standard practice. Clinical Trial Registration—: URL: http://clinicaltrials.gov . Unique identifier: NCT00942500.
1 October 2013 in International Journal of Cardiology