One-Month Dual Antiplatelet Therapy Followed by P2Y12 Inhibitor Monotherapy After Biodegradable Polymer Drug-Eluting Stent Implantation　- The REIWA Region-Wide Registry.

BACKGROUND: The safety and feasibility of using 1-month dual antiplatelet therapy (DAPT) followed by P2Y12inhibitor monotherapy for patients after percutaneous coronary intervention (PCI) with thin-strut biodegradable polymer drug-eluting stents (BP-DES) in daily clinical practice remain uncertain.Methods and Results: The REIWA region-wide registry is a prospective study conducted in 1 PCI center and 9 local hospitals in northern Japan. A total of 1,202 patients who successfully underwent final PCI using BP-DES (Synergy: n=400; Ultimaster: n=401; Orsiro: n=401), were enrolled in the registry, and received 1-month DAPT followed by P2Y12inhibitor (prasugrel 3.75 mg/day or clopidogrel 75 mg/day) monotherapy. The primary endpoint was a composite of cardiovascular and bleeding events at 12 months, including cardiovascular death, myocardial infarction (MI), definite stent thrombosis (ST), ischemic or hemorrhagic stroke, and Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding. Based on the results of a previous study, we set the performance goal at 5.0%. Over the 1-year follow-up, the primary endpoint occurred in 3.08% of patients, which was lower than the predefined performance goal (Pnon-inferiority<0.0001). Notably, definite ST occurred in only 1 patient (0.08%) within 1 year (at 258 days). No differences were observed in the primary endpoint between stent types. CONCLUSIONS: The REIWA region-wide registry suggests that 1-month DAPT followed by P2Y12inhibitor monotherapy is safe and feasible for Japanese patients with BP-DES.

Detailed Lipid Profiles and Lipid-related Residual Risk after 12-week 10 mg Rosuvastatin Treatment for Acute Myocardial Infarction.

Objective We aimed to reveal detailed on-treatment lipid profiles, lipid-related surrogate markers, and factors predicting failure to achieve the guideline-recommended lipid management goal following guideline-recommended statin treatment in Japanese patients with acute myocardial infarction (AMI). Methods and Results Sixty AMI patients who underwent coronary intervention and had received rosuvastatin 10 mg/day since the start of their hospitalization were assessed for on-treatment lipid-related profiles, including high-sensitivity C-reactive protein, small dense low-density lipoprotein cholesterol (sd LDL-C), and lipoprotein (a), at the 12-week follow-up. Patients who failed to achieve the guideline-recommended lipid management at 12 weeks were defined as the "unachieved group." Univariate and multivariate logistic regression analyses were performed to evaluate the predictors of inclusion in the unachieved group after high-dose statin treatment. Despite the use of high-dose rosuvastatin, 61.7% of the enrolled AMI patients were included in the unachieved group. In addition, the unachieved group had higher sd LDL-C and lipoprotein (a) levels than the achieved group. Logistic regression analyses demonstrated that low baseline high-density lipoprotein cholesterol (HDL-C) levels and the absence of diabetes were predictors of inclusion in the unachieved group. Conclusion More than half of the Japanese AMI patients treated with rosuvastatin 10 mg/day did not achieve the guideline-recommended goal of lipid management and still had lipid-related residual risk at 12 weeks. Particular attention should be paid to patients with low baseline HDL-C levels and those without diabetes with regard to their on-treatment lipid profiles.

An In-depth Single-center Retrospective Assessment of In-Hospital Outcomes in Acute Myocardial Infarction Patients with and without Diabetes.

Objective This study examined variations in in-hospital mortality causes and identified independent mortality predictors among patients with acute myocardial infarction (AMI) with and without diabetes mellitus (DM). Methods We examined factors influencing in-hospital mortality in a single-center retrospective observational study. Separate multivariate analyses were conducted for both groups to identify independent predictors of in-hospital mortality. Patients This study included consecutive patients admitted to Iwate Medical University Hospital between January 2012 and December 2017 with a diagnosis of AMI. Results Of 1,140 patients meeting the AMI criteria (average age: 68.2±12.8 years old, 75% men), 408 (35.8%) had diabetes. The DM group had a 1.87-times higher 30-day mortality rate, a lower prevalence of ST-elevated MI (56.6% vs. 65.3% in non-DM, p=0.004), and more frequent non-cardiac causes of death (32% vs. 14% in non-DM, p=0.046) than the non-DM group. Independent predictors of in-hospital mortality in both groups were cardiogenic shock (CS) [DM: hazard ratio (HR) 6.59, 95% confidence interval (CI) 2.90-14.95; non-DM: HR 4.42, 95% CI 1.99-9.77] and renal dysfunction (DM: HR 5.64, 95% CI 1.59-20.04; non-DM: HR 5.92, 95% CI 1.79-19.53). Among patients with DM, a history of stroke was an additional independent predictor of in-hospital mortality (HR 2.59, 95% CI 1.07-6.31). Conclusion Notable disparities were identified in the causes of death and predictive factors of mortality between these two groups of patients with AMI. To further improve AMI outcomes, individualized management and prioritizing non-cardiac comorbidities during hospitalization may be crucial, particularly in patients with DM.

Prevalence, clinical characteristics, and impact of active cancer in patients with acute myocardial infarction: data from an all-comer registry.

BACKGROUND: Although a history of cancer is a poor prognostic factor in patients with acute myocardial infarction (AMI), the clinical importance of coexisting active cancer remains unclear. METHODS: In this single-center retrospective study, we reviewed an AMI registry and assessed the prevalence and predictors of active cancer, 1-year incidence of cardiac death or major bleeding events (defined as a Bleeding Academy Research Consortium type 3 or 5), and the impact of coexisting active cancer on clinical outcomes. Active cancer was defined as either an already-diagnosed or undiagnosed occult cancer. RESULTS: Between January 2012 and December 2017, 1140 AMI patients (median age, 69 years; male, 76.0%) were enrolled. Active and historical cancers were diagnosed in 63 patients (5.5%) and 50 patients (4.4%), respectively. The most common location was the urinary tract (n=21). In the Kaplan-Meier analysis, the active cancer group had a higher incidence of 1-year cardiac death (17.5% vs. 5.3%, p < 0.001) and major bleeding events (19.0% vs. 5.6%, p < 0.001) than the non-cancer group. In the multivariate Cox proportional hazards regression models, active cancer was an independent predictor of both cardiac death and major bleeding at 1 year. Specifically, gastrointestinal tract and advanced-stage cancers had the poorest outcomes. Compared to the non-cancer group, the 1-year major bleeding rate was higher for all cancer types and stages. In contrast, early-stage cancers had a weaker impact on the 1-year cardiac mortality compared to advanced-stage cancers. Similarly, cardiac death during 1-year also occurred less frequently in occult cancers than in already-known cancers. CONCLUSIONS: In patients with AMI, coexisting active cancer was rare, but it significantly impacted cardiac death and major bleeding events.

Coronary Flow Disturbance Phenomenon After Percutaneous Coronary Intervention Is Associated with New-Onset Atrial Fibrillation in Patients with Acute Myocardial Infarction.

Atrial fibrillation (AF) is a common complication of acute myocardial infarction (AMI). Although previous studies have investigated mortality rates and the incidences of adverse events associated with new-onset AF (NOAF) in patients with AMI, the effects of emergency percutaneous coronary intervention (PCI) on the incidence of NOAF in patients with AMI remain unclear. The purpose of this study was to investigate the relationship of clinical characteristics, medical history, and the coronary flow disturbance phenomenon (TIMI < 3) following emergency PCI with NOAF in patients with AMI. Between 2012 and 2016, 731 patients with AMI underwent PCI at our facility. Among these, 52 had a history of chronic/paroxysmal AF before admission and were excluded. The remaining 679 patients (mean age 66.4 years, 532 males) were analyzed in this retrospective observational study.New-onset AF was observed in 45 patients (6.6%). In univariate analysis, the hazard ratios (HRs) for patient age (HR 1.04, 95%CI 1.02-1.07), Killip II-IV (HR 2.34, 95%CI 1.29-4.23), elevated D-dimer level (> 1.0 µg/mL; HR 3.32; 95%CI 1.77-6.23), and coronary flow disturbance phenomenon (HR 5.61; 95%CI 2.88-10.9) were significantly higher in the NOAF group. In multivariate analysis, an elevated D-dimer level (> 1.0 µg/mL; HR 2.44; 95%CI 1.17-5.11) and coronary flow disturbance phenomenon (HR 4.61; 95%CI 2.29-9.27) were found to be independent risk factors for NOAF. An elevated D-dimer level at admission and the presence of coronary flow disturbance phenomenon after PCI were risk factors for NOAF following emergency PCI in patients with AMI.

Clinical outcomes of patients treated using very short duration dual antiplatelet therapy after implantation of biodegradable-polymer drug-eluting stents: rationale and design of a prospective multicenter REIWA registry.

Several studies have demonstrated the safety and feasibility of short (3-6 months) and very short duration (< 2 months) dual antiplatelet therapy (DAPT) in patients with a durable-polymer drug-eluting stent (DP-DES). However, the clinical importance of using very short duration DAPT has yet to be established in patients with a biodegradable polymer drug-eluting stent (BP-DES). The aim of this REIWA registry (multicenter and prospective registry; investigation of clinical outcomes of patients treated with short duration dual antiplatelet therapy after implantation of biodresorbable-polymer drug-eluting stent: a multicenter, prospective registry from Iwate medical university affiliated hospitals) is to determine the safety and feasibility of using 1-month DAPT followed by P2Y12 inhibitor monotherapy in patients after BP-DES implantation. This study is an observational, prospective, multicenter registry encompassing the entire local medical region of Iwate Prefecture (northern area of mainland Japan). A total of 1200 patients who underwent successful PCI with a novel thin strut BP-DES (Synergy, Ultimaster or Orsiro) and are considered to be appropriate patients for very short DAPT, are registered and subsequently administered 1-month DAPT followed by P2Y12 inhibitor monotherapy (clopidogrel 75 mg/day or prasugrel 3.75 mg/day). The primary endpoint was a composite of cardiovascular and bleeding events, which included cardiovascular death, spontaneous myocardial infarction, definite stent thrombosis, ischemic or hemorrhagic stroke, or TIMI major or minor bleeding at 12 months. The REIWA registry (UMIN000037321) will demonstrate both the safety and feasibility of using 1-month DAPT in patients with BP-DES. Furthermore, results of this study will also be able to provide supportive evidence for P2Y12 inhibitor monotherapy after 1-month DAPT following BP-DES implantation.

Optimized interpretation of fractional flow reserve derived from computed tomography: Comparison of three interpretation methods.

BACKGROUND: An optimal system for interpreting fractional flow reserve (FFR) values derived from CT (FFRCT) is lacking. We sought to evaluate performance of three FFRCT measurements in detecting ischemia by comparing them with invasive FFR. METHODS: For 73 vessels in 50 patients who underwent coronary CT angiography (CCTA) and FFRCT analysis followed by invasive FFR, the greatest diameter stenosis on CCTA, FFRCT difference between distal and proximal to the stenosis (ΔFFRCT), FFRCT 2 cm distal to the stenosis (lesion-specific FFRCT), and the lowest FFRCT in distal vessel tip were calculated. Significant obstruction (≥50% diameter stenosis) and ischemia (lesion-specific FFRCT ≤0.80, the lowest FFRCT ≤0.80, or ΔFFRCT ≥0.12 based on the greatest Youden index) were compared with invasive FFR (≤0.80). RESULTS: Forty (55%) vessels demonstrated ischemia during invasive FFR. On multivariable generalized estimating equations, ΔFFRCT (odds ratio [OR] 10.2, p < 0.01) remained a predictor of ischemia over CCTA (OR 2.9), lesion-specific FFRCT (OR 3.1), and the lowest FFRCT (OR 0.9) (p > 0.05 for all). Area under the curve (AUC) of ΔFFRCT (0.86) was higher than CCTA (0.66), lesion-specific FFRCT (0.71), and the lowest FFRCT (0.65) (p < 0.01 for all). Addition of each FFRCT measure to CCTA showed improvement of AUC and significant net reclassification improvement (NRI): ΔFFRCT (AUC 0.84, NRI 1.24); lesion-specific FFRCT (AUC 0.77, NRI 0.83); and the lowest FFRCT (AUC 0.76, NRI 0.59) (p < 0.01 for all). CONCLUSIONS: Compared with diameter stenosis, ΔFFRCT, lesion-specific FFRCT, and the lowest FFRCT improved ischemia discrimination and reclassification, with ΔFFRCT being superior in identifying and discriminating ischemia.

Temporal Trends in the Incidence and Clinical Features of Acute Myocardial Infarction in a Japanese Rural Area From 2006 to 2014.

BACKGROUND: Recent temporal trends in the incidence and clinical features of acute myocardial infarction (MI) in the Japanese population are not well known.Methods and Results:This study used comprehensive registration for first-ever MI during the 9-year period from 2006 to 2014 in a rural area of northeastern Japan. The study period was divided into three 3-year terms (T1, 2006-2008; T2, 2009-2011; T3, 2012-2014). During the study period, a total of 814 patients with MI were registered. Although the age-adjusted incidence rate (100,000 person-years) in the middle-aged group (<70 years) was relatively stable, the rate for the elderly group (≥70 years) in T3 was significantly lower than that in T1 in both men (368 vs. 279; P<0.01) and women (204 vs. 108; P<0.01). In the general population of the study area, the rate of prescribed anticholesterol drugs was significantly increased during the study period, especially in the elderly population (P<0.01). From a clinical perspective, although the performance rate of primary percutaneous coronary intervention significantly increased with a shortened duration of hospital stay, the in-hospital mortality rate, especially in the elderly, did not significantly decrease during the study period. CONCLUSIONS: The present study is the first to demonstrate a decreased age-adjusted incidence of MI during the period from 2006 to 2014 in a Japanese rural population, especially in the elderly.

Long-Term Effects of the 2011 Japan Earthquake and Tsunami on Incidence of Fatal and Nonfatal Myocardial Infarction.

This study aimed to examine the long-term effects of the 2011 Japan earthquake and tsunami on the incidence of fatal and nonfatal myocardial infarction (MI). In the present study, the incidence of 2 types of cardiac events was comprehensively recorded. The study area was divided into 2 zones based on the severity of tsunami damage, which was determined by the percentage of the inundated area within the residential area (<10%, low-impact zone and ≥10%, high-impact zone). The standardized incidence ratio (SIR) and 95% CI for both types of cardiac events during the disaster year and the postdisaster years were determined in each zone. During the 4-year period after the disaster, the SIRs for nonfatal MI did not change to a statistically significant extent in either zones. For fatal MI, the SIR was stable during the study period in the low-impact zone. However, in the high-impact zone, the SIR was significantly elevated in the disaster year of 2011 (1.80 [95% CI 1.32 to 2.28]), and this increase was sustained for the following 3 years (2012, 2.06 [1.55 to 2.57]; 2013, 1.99 [1.49 to 2.48]; 2014, 2.12 [1.62 to 2.63]). The SIRs for fatal MI for the 4 postdisaster years in the municipal areas were significantly correlated with the percentage of the inundated area (r = 0.83; p <0.001) and the number of deaths due to the tsunami (r = 0.77; p <0.005) but not with the maximum seismic intensity (r = 0.43; p = 0.12). In conclusion, these results suggest that the devastating tsunami was associated with a continual increase in the incidence of fatal MI among disaster survivors.

Possible usefulness of gadolinium-enhanced brain MRI for evaluating risk of perioperative hemorrhage: a case of infective endocarditis.

A 59-year-old woman visited a local hospital for fever and was diagnosed as having infective endocarditis (IE) on the basis of blood cultures and transthoracic echocardiography. Based on clinical episodes of subarachnoid hemorrhage after admission, it was judged that she was not a good candidate for urgent open heart surgery, and it was decided to treat her with conservative medical therapy for the acute phase. We explored the optimum timing for surgery by employing gadolinium (Gd) contrast medium-enhanced magnetic resonance imaging (MRI) T2* weighted image (black dots) due to her high risk of perioperative cerebral hemorrhage. After the disappearance of the contrast media enhancement effect around the black dots, open heart surgery was performed successfully on the 103rd hospitalization day. The patient was discharged 22 days after the surgery with no clinical complications. This case suggests that disappearance of the contrast media enhancement effect around the black dots may be a useful marker for optimal timing of surgery to minimize the risk of perioperative cerebral hemorrhage in patients with IE. Learning Objective. The MRI T2* weighted images including those with Gd contrast medium enhancement effect may be useful for evaluating the risk of perioperative intracranial hemorrhage in IE.

Population-based incidence of sudden cardiac and unexpected death before and after the 2011 earthquake and tsunami in Iwate, northeast Japan.

BACKGROUND: The aim of this study was to evaluate the temporal impact of the 2011 Japan earthquake and tsunami on the incidence of sudden cardiac and unexpected death (SCUD). METHODS AND RESULTS: We surveyed the impact of the disaster on the incidence and clinical characteristics of SCUD in Iwate. To perform complete identification of SCUD for 8 weeks before and 40 weeks after the disaster, medical records and death certificates relevant to SCUD were surveyed in the study area. Compared with the previous year's rate, the incidence (per 10 000 person-year) of SCUD for the initial 4 weeks after the disaster (acute phase) was double (33.5 vs 18.9), and thereafter the rate returned to the previous level. Significant relationships were found between weekly numbers of SCUD and seismic activity (intensity, r=0.43; P<0.005: frequency, r=0.46; P<0.002). The standardized incidence ratio (SIR) of SCUD in the acute phase was significantly increased compared with that of previous years (1.71, 95% CI 1.33 to 2.16). Increased SIRs were predominantly found in female subjects (1.73, 95% CI 1.22 to 2.37), the elderly (1.73, 95% CI 1.29 to 2.27), and residents living in the tsunami-stricken area (1.83, 95% CI 1.33 to 2.46). In addition, SIRs for weekdays (1.71, 95% CI 1.28 to 2.24) and nights-mornings (2.09, 95% CI 1.48 to 2.86) were amplified. CONCLUSIONS: The present results suggest that the magnitude of a disaster, related stress, and population aging may cause a temporary increase in the incidence of SCUD with amplification of ordinary weekly and circadian variations.

Acute coronary syndrome caused by coronary vasospasms associated with Churg-Strauss syndrome: effects of betamethasone therapy.

A 42-year-old woman with a history of aspirin-induced asthma was admitted with severe chest pain. Emergency coronary angiography revealed coronary artery spasms. The administration of vasodilators did not suppress the anginal symptoms, and the differential white blood cell count continued to show eosinophilia. The patient's symptoms of aspirin-induced asthma, eosinophilia and other allergic states led to the diagnosis of Churg-Strauss syndrome (CSS). After starting betamethasone therapy, the eosinophilia and cardiac symptoms rapidly disappeared. Although coronary vasospasms related to CSS are rare, the present case suggests that a differential white blood cell count should be obtained in patients with refractory coronary vasospasms.

Comparison of the incidence of acute decompensated heart failure before and after the major tsunami in Northeast Japan.

On March 11, 2011, a huge tsunami attacked the northeastern coast of Japan after a magnitude 9 earthquake. No reports have investigated the impact of tsunamis on the incidence of cardiovascular disease, especially heart failure (HF). We investigated the number and clinical characteristics of hospitalized patients with acute decompensated HF (ADHF) in the east coast of Iwate hit by the tsunami (tsunami area) for a 12-week period around the disaster. For comparison with previous years, numbers of ADHF were surveyed in the corresponding area in 2009 and 2010. In addition, to elucidate the impact of the tsunami, a similar study was performed in a remote area where the tsunami had minimal effect (control area). After the disaster, the number of patients with ADHF in the tsunami area was significantly increased compared to the predisaster period (relative risk 1.97, 95% confidence interval 1.50 to 2.59). The peak was found 3 to 4 weeks after the disaster. In contrast, in the control area, no significant change in ADHF events was observed (relative risk 1.29, 95% confidence interval 0.94 to 1.78). There was a significant correlation between changes in the number of ADHF admissions and percent tsunami flood area (r = 0.73, p <0.001) or the number of shelter evacuees (r = 0.83, p <0.001). In conclusion, these findings suggest that large and sudden changes in daily life and the trauma associated with a devastating tsunami have a significant impact on the incidence of ADHF.