Safety and efficacy of bivalirudin versus unfractionated heparin during perioperative period of percutaneous coronary intervention / 中华心血管病杂志

Objective: To compare the safety and efficacy of bivalirudin versus unfractionated heparin during perioperative period of percutaneous coronary intervention(PCI) in real-world. Methods: A total of 13 097 serial patients who underwent PCI from January 2016 to November 2018 in the Northern Theater Command were enrolled in the present study. Patients were stratified as the bivalirudin group or the heparin group according to antithrombotic therapy during PCI. The primary efficiency endpoint was 30-day net adverse clinical event(NACE), defined as all-cause death, re-infarction, urgent target lesion revascularization (uTLR), stroke or any bleeding. The second efficiency endpoint was 30-day major cardiac and cerebral events (MACCE), defined as all-cause death, re-infarction, uTLR and stroke. Additional end points included the rates of stent thrombosis at 30 days. Propensity scores included clinical and demographic variables, with 1∶2 matching. Compared the incidence of events above between the two groups before and after matching. Results: Among the 13 097 included patients(age was (61±10) years old), 3 421 (26.1%) were female. And 2 734 patients were divided into the bivalirudin group, and 10 363 patients to the heparin group(5 468 after matching). Before propensity score matching, patients in bivalirudin group were older and received higher levels of CRUSADE score than heparin group. These patients were more likely to have hypertension and more with ST-segment elevation acute coronary syndromes（all P＜0.05）. After propensity score matching, the incidence of 30-day NACE(3.8%(103/2 734) vs.5.0%(271/5 468), P=0.015) and any bleeding (2.0%(54/2 734) vs. 2.8%(151/5 468), P=0.032) in the bivalirudin group were lower than that in the heparin group, but the incidence of MACCE (1.9%(51/2 734) vs. 2.3%(127/5 468), P=0.180) and stent thrombosis (0.1%(2/2 734) vs. 0.1%(3/5 468), P=1.000) were comparable between the two groups. Conclusion: The risk of bleeding and the incidence of NACE are significantly lower for patients using bivalirudin during perioperative period of PCI compared to heparin, without significant differences in ischemic events.

Six versus twelve months of dual antiplatelet therapy after implantation of biodegradable polymer sirolimus-eluting stent in elderly patients / 中国介入心脏病学杂志

Objective To explore the eff cacy and safety of 6-month and 12-month dual antiplatelet therapy(DAPT)after implantation of biodegradable polymer-drug eluting stents(BP-DES) in elderly patients. Methods This study was a subgroup analysis of the I-LOVE-IT 2 trial, which was a prospectively randomized study enrolling 2737 patients receiving either a BP-SES or a DP-SES in a 2:1 ratio. This studied further divided the patients who were randomized to the BP-SES group,whose age ≥ 65 year old, in a 1:1 ratio to receive a 6-month DAPT (n=319) or 12-month DAPT (n=308)randomly before the index PCI. The primary end point of this study was 12-month target lesion failure (FhF, including cardiac death,target vessel myocardial infarction and clinically indicated target lesion revascularization)and the secondary end points was 12-month net adverse clinical and cerebral events (including all-cause death, all myocardial infarction, stroke and all bleeding). Results Rates of TLF at 12 months were 7.1% in the 6-month DAPT group and 7.2% in the 12-month DAPT group (P=0.980). No diff erences were observed in the occurrence of events in the secondary endpoint at 12 months follow-up between the 6-month DAPT group and 12-months DAPT group(14.1% versus 13.0%, P=0.726). There were no signifi cant diff erences in stent thrombosis or bleeding complications between the 2 groups. Conclusions This study shorted that 6-month DAPT did not increase the risk of TLF at 12 months after implantation of DES in elderly patients compared with 12-month DAPT. Elderly patients are at high risk of bleeding and ischemic events and study show that 6-month DAPT would be adequate. These results need to be confi rmed with trials of scale in the future.

Impact of Baseline Bleeding Risk on Efficacy and Safety of Ticagrelor versus Clopidogrel in Chinese Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention / 中华医学杂志(英文版)

Background@#There was still conflict on the antithrombotic advantage of ticagrelor versus clopidogrel among East Asian population with acute coronary syndrome (ACS). We considered that the baseline bleeding risk might be an undetected key factor that significantly affected the efficacy of ticagrelor.@*Methods@#A total of 20,816 serial patients who underwent percutaneous coronary intervention (PCI) from October 2011 to August 2014 in the General Hospital of Shenyang Military Region were enrolled in the present study. Patients receiving ticagrelor or clopidogrel were further subdivided according to basic bleeding risk. The primary outcome was net adverse clinical events (NACEs) defined as major adverse cardiac or cerebral events (MACCE, including all-cause death, myocardial infarction, ischemia-driven target vessel revascularization, or stroke) and any bleeding during 1-year follow-up. Comparison between ticagrelor and clopidogrel was adjusted by propensity score matching (PSM).@*Results@#Among the 20,816 eligible PCI patients who were included in this study, there were 1578 and 779 patients in the clopidogrel and ticagrelor groups, respectively, after PSM, their clinical parameters were well matched. Patients receiving ticagrelor showed comparable NACE risk compared with those treated by clopidogrel (5.3% vs. 5.1%, P = 0.842). Furthermore, ticagrelor might reduce the MACCE risk in patients with low bleeding risk but increase MACCE in patients with moderate-to-high bleeding potential (ticagrelor vs. clopidogrel, low bleeding risk: 2.5% vs. 4.9%, P = 0.022; moderate-to-high bleeding risk: 4.8% vs. 3.0%, P = 0.225; interaction P = 0.021), with vast differences in all bleeding (low bleeding risk: 1.5% vs. 0.8%, P = 0.210; moderate-to-high bleeding risk: 4.8% vs. 3.0%, P = 0.002; interaction P = 0.296).@*Conclusion@#Among real-world Chinese patients with ACS treated by PCI, ticagrelor only showed superior efficacy in patients with low bleeding risk but lost its advantage in patients with moderate-to-high bleeding potential.