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Aims: We aimed to determine whether shortening the duration of P2Y12 inhibitor therapy can reduce the risk of bleeding without increasing the risk of major adverse cardiovascular events following coronary stenting in patients with atrial fibrillation (AF)., Methods and Results: The SAFE-A is a randomised controlled trial that compared one-month and six-month P2Y12 inhibitor therapy, in combination with aspirin and apixaban for patients with AF who require coronary stenting. The primary endpoint was the incidence of any bleeding events, defined as Thrombolysis In Myocardial Infarction major/minor bleeding, bleeding with various Bleeding Academic Research Consortium grades, or bleeding requiring blood transfusion within 12 months after stenting. The study aimed to enrol 600 patients but enrolment was slow. Enrolment was terminated prematurely after enrolling 210 patients (72.7±8.2 years; 81% male). The incidence of the primary endpoint did not differ between the one-month and six-month groups (11.8% vs 16.0%; hazard ratio [HR] 0.70, 95% confidence interval [CI]: 0.33-1.47; p=0.35)., Conclusions: The study evaluated the safety of withdrawing the P2Y12 inhibitor from triple antithrombotic prescription one month after coronary stenting. However, enrolment was prematurely terminated because it was slow. Therefore, statistical power was not sufficient to assess the differences in the primary endpoint.

Background: The association of Mehran risk score (MRS) with long-term prognosis in patients treated with percutaneous coronary intervention (PCI) has not been fully reported. We investigated the association between MRS and clinical outcomes in patients who underwent PCI., Methods: Study subjects comprised 2198 patients treated with PCI from the Ibaraki Cardiovascular Assessment Study multicenter registry, excluding patients receiving hemodialysis or who died within 7 days. We categorized them into 4 groups according to MRS (low-risk: ≤5; medium-risk: 6-10; high-risk: 11-16; and very high-risk: ≥16). Contrast-induced acute kidney injury (CI-AKI) was defined as an increase of 0.5mg/dL or 25% in pre-PCI serum creatinine within 1-week post procedure. We evaluated CI-AKI and major adverse cardiac and cerebrovascular events (MACCE), and defined as all-cause death, myocardial infarction, congestive heart failure, or cerebrovascular disorder (stroke or transient ischemic attack)., Results: A total of 192 (8.7%) patients developed CI-AKI. At multivariate analysis, odds ratio for CI-AKI was 4.09 (95% CI: 1.72-9.17, p=0.002) in the very high-risk group, 1.49 (95% CI: 0.89-2.42, p=0.120) in the high-risk group, and 1.08 (95% CI: 0.74-1.54, p=0.693) in the medium-risk group, as compared with the low-risk group. MACCE in the very high-risk group was more than 5-fold higher [hazard ratio (HR) 5.40, 95% CI: 2.96-9.28, p<0.001] compared with the low-risk group and was also increased in the high-risk (HR 3.72, CI: 2.59-5.32, p<0.001) and medium-risk groups (HR 1.97, CI: 1.45-2.69, p<0.001). Kaplan-Meier analysis showed that increasing risk for MACCE was seen across the groups as MRS increased (p<0.001)., Conclusion: MRS might provide potentially useful information for prediction of CI-AKI and clinical outcomes after PCI., (Copyright © 2015 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Background and Purpose: There are a few retrospective subgroup analyses or registries of large-vessel (≥ 3.5mm) stenting. We investigated clinical outcomes of patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and bare-metal stents (BMS) in large coronary vessels., Methods and Subjects: Of 1100 STEMI patients registered in the Ibaraki Cardiovascular Assessment Study (ICAS) multicenter registry from April 2007 to June 2012 who underwent PCI, we enrolled 454 patients (65.8 ± 12.7 years old, 81% male) with ≥ 3.5-mm stents. We excluded 53 patients with cardiogenic shock or left main trunk lesions. The remaining 401 patients were divided into Group-D, PCI with DES (n = 184), and Group-B, PCI with BMS (n = 217). Propensity score analysis matched 1:1 according to treatment with DES (n = 101) or with BMS (n = 101). We evaluated major adverse cardiac and cerebrovascular events (MACCE) and incidence of stent thrombosis (ST). MACCE was defined as all-cause death, myocardial infarction (MI), target-vessel revascularization (TVR), or cerebrovascular accident (CVA)., Essential Results: During a mean follow-up period of 526 days, all-cause death, MI, CVA, MACCE, and ST were not significantly different in Group-D versus Group-B (all-cause death: 4.35% vs. 4.61%, p = 0.90; MI: 0% vs. 0%; CVA: 2.72% vs. 3.23%, p = 0.76; MACCE: 15.2% vs. 20.3%, p = 0.19; and ST: 0.0% vs. 1.38%, p = 0.11). After adjusting for age, insulin use, multivessel disease, intra-aortic balloon pump use, culprit lesions, and estimated glomerular filtration rate <60 ml/min/1.73 m(2), MACCE was not significantly different between the groups (odds ratio: 0.69; 95% CI: 0.40-1.23; p = 0.21). However, TVR was significantly lower in Group-D than Group-B in Kaplan-Meier analysis (p = 0.048) after propensity score matching., Principal Conclusion: There was no advantage to using a DES in large vessels for preventing a hard endpoint, whereas DES use resulted in a significant reduction in TVR in the patients with STEMI in this registry., (Copyright © 2014 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Background: The association between contrast-induced acute kidney injury (CI-AKI) and chronic kidney disease (CKD) in patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI) has not been fully reported. We evaluated the association of CI-AKI on cardiovascular events in ACS patients with CKD., Methods: A total of 1059 ACS patients who underwent emergent PCI in our multicenter registry were enrolled (69±12 years, 804 men, 604 STEMI patients). CKD was defined as at least stage 3 CKD, and CI-AKI was defined as an increase of at least 0.5 mg/dL and/or an increase of at least 25% of pre-PCI to post-PCI serum creatinine levels within 1 week after the procedure. Primary endpoints included cardiovascular death, myocardial infarction, and cerebrovascular disorder (stroke or transient ischemic attack)., Results: In our study, 368 (34.7%) patients had CKD. During follow-up periods (435±330 days), CI-AKI and primary endpoints occurred in 164 (15.5%) patients and 106 (10.0%) patients, respectively. Multivariate Cox proportional hazards model revealed that age, female gender, peak creatinine kinase>4000, IABP use, CI-AKI (hazard ratio [HR], 2.17; 95% confidential interval [CI], 1.52 to 4.00; P<0.001), and CKD (HR, 1.66; 95% CI, 1.01 to 2.72; P=0.046) were independent predictors of primary endpoints. Kaplan-Meier analysis showed that occurrence of primary endpoints increased significantly with an increase in CKD stage, and CI-AKI yielded worse long-term prognosis at every stage of CKD (P<0.001)., Conclusions: CI-AKI was revealed to be a significant incremental predictor of cardiovascular events at each stage of CKD in ACS patients., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

We investigated clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (CAD) treated for initial culprit-only or by initial simultaneous treatment of nonculprit lesion with culprit lesion. Optimal management of multivessel disease in STEMI patients treated by primary percutaneous coronary intervention (PCI) is still unclear in the drug-eluting stent era. We compared clinical outcomes of 274 STEMI patients (69.3 ± 11.8 years, 77 % men) in the Ibaraki Cardiovascular Assessment Study registry who underwent initial culprit-only (OCL, n = 220) or initial multivessel PCI of nonculprit lesion with culprit lesion (NCL, n = 54) from April 2007 to August 2010. Major adverse cardiac and cerebrovascular events (MACCE) included all-cause death, myocardial infarction (MI), target-vessel revascularization (TVR), and cerebrovascular accident (CVA). Patients in the NCL group were older and had higher Killip class and lower estimated glomerular filtration rate than those in the OCL group. MI, TVR, CVA, and stent thrombosis were not significantly different between the two groups. Incidences of all-cause death and MACCE were lower in the OCL than in the NCL group (all-cause death: 10.9 % vs 31.5 %, P < 0.05; MACCE: 27.7 % vs 46.2 %, P < 0.05). After adjusting for patient characteristics, NCL remained at significantly higher risk compared with OCL for in-hospital and all-cause death (P = 0.001, respectively), and MACCE were not significantly different (odds ratio 1.95, 95 % confidence interval 0.94-4.08; P = 0.07) between groups. Initial multivessel PCI was associated with significantly increased risk of in-hospital death, all-cause death, and MACCE, which was somewhat attenuated in a multivariable model, but the numerically excessive risk with NCL still persisted.

Background: To evaluate the incidence and clinical predictors of contrast-induced acute kidney injury (CI-AKI) in patients with ST-segment elevation myocardial infarction (STEMI), unstable angina pectoris/non-STEMI (UAP/NSTEMI), and stable AP (SAP) undergoing percutaneous coronary intervention (PCI)., Methods and Results: We enrolled 1,954 patients (SAP, n=1,222; UAP/NSTEMI, n=277; STEMI, n=455) who underwent PCI. Patients were categorized according to contrast media volume/estimated glomerular filtration rate ratio (CV/eGFR low: <2.0, mid: 2.0-2.9, high: ≥3.0). CI-AKI was defined as an increase in serum creatinine of 0.5mg/dl or 25% within 1 week from contrast-medium injection. The incidence of CI-AKI was highest among the STEMI patients (SAP, 4.24%; UAP/NSTEMI, 10.7%; STEMI, 16.1%, P<0.01). Significant predictors of CI-AKI were emergency PCI (odds ratio [OR] 3.70; 95% confidence interval [CI] 2.55-5.37; P<0.001), ejection fraction <40% (OR 2.04; 95% CI 1.24-3.36; P=0.005), and hemoglobin <10g/dl (OR 0.02; 95% CI 1.17-4.55; P=0.02) after multivariate logistic regression analysis. In the SAP group, a CV/eGFR ratio ≥3.0 was a significant predictor of CI-AKI (P=0.048), but not in UAP/NSTEMI and STEMI patients., Conclusions: UAP/NSTEMI and STEMI patients undergoing emergency PCI were at high risk for CI-AKI regardless of CV/eGFR ratio. Minimizing the dose of contrast medium based on eGFR might be valuable in reducing the risk of CI-AKI in SAP patients.

Objectives: The aim of this study was to evaluate whether combination therapy of clopidogrel and proton pump inhibitors (PPIs) causes higher numbers of cardiovascular events than clopidogrel alone in Japanese patients., Background: PPIs are often prescribed in combination with clopidogrel following coronary stenting. PPIs are reported to diminish the effect of clopidogrel because both are metabolized by CYP2C19. However, no reports address the effects of PPIs on cardiovascular events following coronary stenting in the Japanese population., Methods: A total of 1,887 patients treated with clopidogrel following coronary stenting were enrolled in the Ibaraki Cardiac Assessment Study (ICAS) registry. All subjects were classified into two groups according to treatment without (n = 819) or with (n = 1,068) PPI. Propensity score analysis matched 1:1 according to treatment without PPI (n = 500) or with PPI (n = 500). Primary endpoint was the composite of all-cause death or myocardial infarction., Results: No significant difference was observed in the primary endpoint between the group without PPI and the group with PPI (4.6% vs. 4.6%, P = 0.77). In contrast, a significant difference was found between the group without PPI and with PPI in regard to the incidence of gastrointestinal bleeding at the end of the follow-up period and the specific PPI prescribed (2.4% vs. 0.8%, adjusted HR = 0.30, 95% Confidence interval 0.08-0.87, P = 0.026) after propensity score matching., Conclusions: No significant association between PPI use and primary endpoint was observed in the Japanese population, whereas PPI use resulted in a significant reduction in the rate of gastrointestinal bleeding., (Copyright © 2012 Wiley Periodicals, Inc.)