Hisao Ogawa

Low-dose aspirin for primary prevention of atherosclerotic events in patients with type 2 diabetes: A randomized controlled trial

CONTEXT Previous trials have investigated the effects of low-dose aspirin on primary prevention of cardiovascular events, but not in patients with type 2 diabetes. OBJECTIVE To examine the efficacy of low-dose aspirin for the primary prevention of atherosclerotic events in patients with type 2 diabetes. DESIGN, SETTING, AND PARTICIPANTS Multicenter, prospective, randomized, open-label, blinded, end-point trial conducted from December 2002 through April 2008 at 163 institutions throughout Japan, which enrolled 2539 patients with type 2 diabetes without a history of atherosclerotic disease and had a median follow-up of 4.37 years. INTERVENTIONS Patients were assigned to the low-dose aspirin group (81 or 100 mg per day) or the nonaspirin group. MAIN OUTCOME MEASURES Primary end points were atherosclerotic events, including fatal or nonfatal ischemic heart disease, fatal or nonfatal stroke, and peripheral arterial disease. Secondary end points included each primary end point and combinations of primary end points as well as death from any cause. RESULTS A total of 154 atherosclerotic events occurred: 68 in the aspirin group (13.6 per 1000 person-years) and 86 in the nonaspirin group (17.0 per 1000 person-years) (hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.58-1.10; log-rank test, P = .16). The combined end point of fatal coronary events and fatal cerebrovascular events occurred in 1 patient (stroke) in the aspirin group and 10 patients (5 fatal myocardial infarctions and 5 fatal strokes) in the nonaspirin group (HR, 0.10; 95% CI, 0.01-0.79; P = .0037). A total of 34 patients in the aspirin group and 38 patients in the nonaspirin group died from any cause (HR, 0.90; 95% CI, 0.57-1.14; log-rank test, P = .67). The composite of hemorrhagic stroke and significant gastrointestinal bleeding was not significantly different between the aspirin and nonaspirin groups. CONCLUSION In this study of patients with type 2 diabetes, low-dose aspirin as primary prevention did not reduce the risk of cardiovascular events. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00110448.

Re-evaluation of Bleeding Events in the Japanese PRASFIT-Elective andPRASFIT-ACS Clinical Trials using the Bleeding Academic ResearchConsortium Criteria

Background: In 2011, the Bleeding Academic Research Consortium (BARC) criteria were published to standardize the assessment of bleeding events following PCI. However, the status of bleeding events as assessed using the BARC criteria is not established in Japan. The aim of this post-hoc analysis of the PRASFIT-ACS and PRASFIT-Elective trials was to re-classify the bleeding events from the Thrombolysis in Myocardial Infarction (TIMI) criteria into the BARC criteria. Methods: Bleeding events had previously been assessed in both trials using the TIMI criteria. In the post-hoc analysis, the BARC criteria were applied retrospectively to each category of bleeding. Results: In PRASFIT-ACS, the incidences of severe bleeds (combined type 3 or 5 bleeds according to BARC criteria) were 43/685 [6.3%] with prasugrel and 37/678 [5.5%] with clopidogrel [HR 1.071; 95% CI 0.668–1.667]. Types 3 or 5 events occurred at a higher rate closer to the time of PCI, and then plateaued. In PRASFIT-Elective, Type 3 bleeding occurred in 10/370 (2.7%) patients in the prasugrel group and 12/372 (3.2%) in the clopidogrel group. There was a higher incidence of bleeding events in PRASFIT-ACS than in PRASFIT-Elective, particularly more severe bleeds (combination of type 3 or 5 events). Conclusions: The results obtained with the BARC criteria were similar to those reported using the original TIMI criteria. The incidences of type 3 or 5 events according to the BARC criteria were similar in the prasugrel and clopidogrel groups. Medical interventions might be needed during the acute period of PCI for ACS to reduce the risk of type 2 bleeding events in patients with low platelet aggregation.

FREQUENCY AND PROGNOSTIC IMPACT OF INTRAVASCULAR IMAGING-GUIDED URGENT PERCUTANEOUS CORONARY INTERVENTION IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION: RESULTS FROM J-MINUET

Previous studies have demonstrated that use of intravascular ultrasound (IVUS) during percutaneous coronary intervention (PCI) was associated with lower incidence of death, myocardial infarction, and target vessel revascularization. Recently, optical coherence tomography (OCT) has emerged as an alternative intravascular imaging device with better resolution. The aim of this study was to investigate frequency and prognostic impact of IVUS or OCT-guided PCI during urgent revascularization for acute myocardial infarction diagnosed by the universal definition. A total of 2788 patients who underwent urgent PCI were selected from a multicenter, Japanese registry of acute myocardial infarction diagnosed by universal definition (J-MINUET). Frequency, clinical characteristics and prognostic impact of the IVUS-, or OCT- guided PCI were investigated. Clinical endpoint was in-hospital death. Angiography-, IVUS-, and OCT-guided urgent PCI were performed in 689 (24.7%), 1947 (69.8%), and 152 (5.5%) patients. In-hospital death in each group was 10.4%, 5.1%, and 3.3%, respectively (P < 0.01). By univariate and multivariate logistic regression analysis, IVUS-guided PCI (vs. angiography-guided PCI, OR 0.49, 95% CI 0.30–0.81, P = 0.006) was a significant independent predictor of in-hospital death. Intravascular imaging guided-PCI was frequently adopted during urgent PCI for acute myocardial infarction diagnosed by universal definition and was associated with better in-hospital survival.