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Protocols for hemostasis after trans-radial approach (TRA) vary depending on the institute as there is no established evidence-based protocol. This study aimed to investigate the clinical implications of radial compression protocols. Consecutive patients who underwent outpatient invasive catheter angiography before and after April 2018 were treated with traditional and new protocols, respectively. Using the same hemostasis band, in the conventional protocol, fixed amount of air was removed soon after the procedure, 2 h later, and 3 h later, whereas the air was removed as much as possible every 30 min in the new protocol. A total of 1842 patients (71 ± 10 years old, 77% male) were included. Compared with the traditional protocol group (n = 1001), the new protocol group (n = 841) had a significantly lower rate of dual antiplatelet therapy (35% and 24% in the traditional and new groups, respectively, p p p p p

BACKGROUND The impact of chronic kidney disease (CKD) on long-term outcomes following acute myocardial infarction (AMI) in the era of modern primary PCI with optimal medical therapy is still in debate.Methods and Results:A total of 3,281 patients with AMI were enrolled in the J-MINUET registry, with primary PCI of 93.1% in STEMI. CKD stage on admission was classified into: no CKD (eGFR ≥60 mL/min/1.73 m2); moderate CKD (60>eGFR≥30 mL/min/1.73 m2); and severe CKD (eGFR

Background This analysis aimed to evaluate the clinical impact of high bleeding risk (HBR) on adverse events after percutaneous coronary intervention (PCI). Methods We retrospectively analyzed 1695 patients in the MODEL U-SES study, which was a multicenter, open-label, prospective observational study evaluating safety of 3-month dual antiplatelet therapy (DAPT) after Ultimaster stent (Terumo Corporation, Tokyo, Japan) implantation at 65 sites in Japan. Patients were divided into 2 groups (HBR/Non-HBR) according to modified Academic Research Consortium-HBR criteria. Ischemic/thrombotic event (cardiovascular death, myocardial infarction, ischemic stroke, and stent thrombosis) and bleeding event (Bleeding Academic Research Consortium 3 or 5) at 1 year were evaluated. Results Of 1695 patients, 840 patients were categorized as HBR and 855 patients were Non-HBR. One-year follow-up was completed in 95.3%. During 1-year follow-up, ischemic/thrombotic events were observed in 31 cases (1.8%) and bleeding events occurred in 21 cases (1.2%). Presence of HBR was significantly associated with higher incidence of ischemic/thrombotic events as compared to Non-HBR (adjusted hazard ratio, 0.16; 95% confidence interval, 0.05 to 0.50), whereas the incidence of bleeding events did not reach statistical significance between HBR and Non-HBR. In comparison of monotherapy after DAPT, P2Y12 inhibitor monotherapy after DAPT had comparable ischemic/thrombotic and bleeding events with aspirin monotherapy after DAPT in both HBR and Non-HBR. Conclusion In contemporary PCI practice, nearly half of patients had HBR and presence of HBR significantly increased risk of ischemic/thrombotic events. Both aspirin and P2Y12 inhibitor monotherapy following short DAPT had low and comparable ischemic/bleeding events.

Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS2°P) is a contemporary risk scoring system for secondary prevention based on nine clinical factors. However, this scoring system has not been validated in other populations. The aim of this study was to validate the TRS2°P in patients with acute myocardial infarction (AMI) treated with primary percutaneous coronary intervention (PCI) in a nationwide registry cohort. Among 3283 consecutive patients with AMI enrolled in the Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET), a total of 2611 patients who underwent primary PCI were included in this study. The performance of the TRS2°P to predict major adverse cardiovascular events (MACE) composed of all-cause death, non-fatal MI, and non-fatal stroke up to 3 years in the present cohort was evaluated. The TRS2°P had modest discriminative performance in this J-MINUET cohort with a c-statistic of 0.63, similar to that in the derived cohort (TRA2°P-TIMI50, c-statistic 0.67). A strong graded relationship between the TRS2°P and 3-year cardiovascular event rates was also observed in the J-MINUET cohort. Age ≥ 75 years, Killip ≥ 2, prior stroke, peripheral artery disease, anemia, and non-ST-elevation myocardial infarction were identified as independent factors for the incidence of MACE. The TRS2°P modestly predicted secondary cardiovascular events among patients with AMI treated by primary PCI in a nationwide cohort of Japan. Further studies are needed to develop a novel risk score better predicting secondary cardiovascular events.

Although gender difference in long-term outcomes after acute myocardial infarction have been shown previously, impact of age on gender difference is still controversial. This study focused on the association between age and gender difference in long-term outcome. We analyzed data from 3,283 consecutive patients who were included in a prospective, nationwide, multicenter registry (Japan Registry of Acute Myocardial Infarction Diagnosed by Universal Definition) from 2012 to 2014. The primary end point was the major adverse cardiovascular event (MACE), which was defined as a composite of death, myocardial infarction, stroke, heart failure, and revascularization for unstable angina during 3 years. Patients were divided into 4 strata according to age: those with age65 years (group 1: n = 1161), 65 to 74 years (group 2: n = 954), 75 to 84 years (group 3: n = 866) and 84years (group 4: n = 302). Although the crude incidence of 3-year MACE was significantly higher in women than men (36.4% vs. 28.5%, p0.001), there was not significant gender difference in each group (group 1, 19.6% vs 19.0%, p = 0.74; group 2, 33.1% vs 28.3%, p = 0.25; group 3, 38.9% vs 39.6%, p = 0.54; and group 4, 54.0% vs 56.8%, p = 0.24). In conclusion, although women had higher crude incidence of 3-year MACE than men, there was no gender difference in each group.

Background The prevalence of acute myocardial infarction (AMI) in elderly people is increasing worldwide. However, their characteristics and prognosis have been rarely investigated. This study aimed to investigate the characteristics and prognosis in elderly patients with cardiac troponin-positive AMI. Methods Consecutive patients with AMI from the J-MINUET study were divided into the following 3 groups: patients aged less than 65 years, those aged between 65 and 79 years, and those aged 80 years or over. Their characteristics and in-hospital outcomes were compared. Results Patients with AMI aged 80 years or over had the highest incidence of female gender, and the highest incidence of hypertension, chronic kidney disease, and cardiovascular disease, such as peripheral artery disease, atrial fibrillation, and stroke, whereas they had the lowest body mass index, and the lowest incidence of current smoker, diabetes mellitus, and dyslipidemia. Patients with AMI aged 80 years or over had significantly longer onset to door time and longer door to device time, and lower peak creatine kinase (CK). The incidence of ST-segment elevation myocardial infarction (STEMI) was the lowest in the AMI patients aged 80 years or over, but the patients had a higher incidence of in-hospital death and cardiac failure than the other two groups. In addition, the presentation with STEMI and non-ST-segment elevation myocardial infarction with CK elevation among patients aged 80 years or over showed the highest incidence of in-hospital death and cardiac failure. Conclusions J-MINUET showed different clinical characteristics between the aged and younger populations. The incidence of in-hospital death and cardiac failure in patients aged 80 years or over with AMI was poorer than their younger counterparts.

BACKGROUND This study evaluated the safety of 3-month dual antiplatelet therapy (DAPT) after implantation of a bioresorbable polymer sirolimus-eluting stent (BP-SES) and compared P2Y12inhibitor with aspirin monotherapy 3 months after DAPT.Methods and Results:Patients who underwent percutaneous coronary intervention using BP-SES were enrolled and followed for 1 year. Patients with a history of stent thrombosis were excluded. The primary endpoint was a composite of all-cause death, myocardial infarction, stroke (ischemic and hemorrhagic), definite or probable stent thrombosis, and severe bleeding at 12 months. The BP-SES arm of the CENTURY II trial was used as a conventional DAPT group for comparison. After DAPT, patients were maintained on either aspirin (n=846) or a P2Y12inhibitor (n=674 patients).In all, 1,695 patients were enrolled in the study across 65 centers. The primary endpoint occurred in 4.3% of patients at 1 year. After propensity score adjustment, the incidence of the primary endpoint was not inferior in those receiving DAPT for 3 months compared with conventional DAPT (5.5%; Pnon-inferiority

Beta-blockers are associated with several clinical benefits in patients with reduced left ventricular ejection fraction (REF) after acute myocardial infarction (AMI), such as lower rates of mortality, recurrence of myocardial infarction, and heart failure. However, the long-term prognosis of beta-blockers has rarely been investigated in patients with non-REF after AMI. This study aimed to investigate the clinical benefits of beta-blockers in these patients.A total of 3281 consecutive patients who were hospitalized within 48 h after AMI were registered in the J-MINUET study. Patients who underwent primary percutaneous coronary intervention (PCI) and had a left ventricular ejection fraction ≥40 % were enrolled, and patients who died during admission were excluded. Included patients were divided into two groups according to the prescription of beta-blockers at discharge. Their characteristics and clinical outcomes were compared.The number of AMI patients treated with beta-blockers was 1353 (70.4 %). Patients who received beta-blockers were younger and had a higher incidence of hypertension, dyslipidemia, and ST-segment elevation myocardial infarction than those who did not receive beta-blockers. The peak creatine kinase level after primary PCI was significantly higher in patients who received beta-blockers. These patients also had a lower incidence of a composite of all-cause death, myocardial infarction, and stroke compared to those that did not receive beta-blockers (7.3 % vs. 11.9 %, p = 0.001). Multivariate analysis showed that beta-blocker use was an independent factor for better clinical outcomes.The J-MINUET study revealed the clinical benefit of beta-blockers in AMI patients with non-REF after primary PCI.

Discordant results have been reported on outcomes of acute myocardial infarction (AMI) patients who present during off-hours.We investigated 3283 consecutive patients with AMI who were selected from the prospective, nationwide, multicenter registry (J-MINUET) database comprising 28 institutions in Japan between July 2012 and March 2014 to determine the current impact of off-hours presentation (defined as weekends, holidays, and weekdays from 8:01 PM to 7:59 AM) at hospitals on long-term clinical outcomes. The primary endpoint was a composite of all-cause death, non-fatal MI, non-fatal stroke, cardiac failure, and urgent revascularization for unstable angina for up to 3 years from the index event.During off-hours, 52% of patients presented. Primary percutaneous coronary intervention was performed in 85% of patients, and the door-to-balloon time was comparable between off-hours and regular hours (74, interquartile range [IQR] 52 to 113 versus 75, IQR 52 to 126 minutes, P = 0.34). Rate of overall primary endpoint overall did not overall significantly differ (25.3% versus 23.5%, log-rank P = 0.26), in patients with ST-elevation myocardial infarction (STEMI) (log-rank P = 0.93) and in patients with non-ST-elevation myocardial infarction (NSTEMI) (log-rank P = 0.14). Multivariate Cox regression analysis showed that off-hours presentation was not significantly associated with long-term clinical events in all cohorts.The impact of presentation during off-hours or regular hours on the long-term clinical outcomes of Japanese patients with AMI is comparable in contemporary practice.

A 60-year-old man with history of exertional angina pectoris was referred for treatment of an ostial left circumflex (LCX) coronary artery stenosis. The branch angle between left anterior descending artery (LAD) and LCX was shallow, therefore stent implantation seemed at risk of “carina shift” of plaque to the LAD ostium as well as higher in-stent restenosis. Therefore, directional coronary atherectomy (DCA, Atherocut™, L-size, NIPRO, Osaka, Japan) was performed at the ostium of the LCX lesion. After evaluating plaque accumulation using intravascular ultrasound (IVUS), DCA was circumferentially performed 16 times, from 2 atm to 3 atm, using an 8 fr guide system. Although angiogram and IVUS showed excellent results, adjunctive balloon dilatation with 3.5 mm paclitaxel-coated balloon was performed to prevent restenosis. At 8 months, the patient reported being angina-free, and subsequent follow-up angiogram showed no restenosis of LCX. Paclitaxel-coated balloon following DCA for LCX ostial stenosis seems to be safe and effective for both acute and chronic results, suggesting a potential stentless therapeutic option.

Options for shaping the delivery sheath of leadless pacemakers (LPs) based on the cardiac anatomy of patients are limited. We predicted the shape of the LP sheath during implantation using preoperative computed tomography (CT) and intraoperative fluoroscopy.Forty-eight patients with implanted LPs due to symptomatic bradyarrhythmia were divided into two groups, α-loop and non-α-loop, based on the shape of the LP delivery sheath head at implantation. Angles between the inferior vena cava (IVC) and the interventricular septum (IVST), and the IVC and right ventricular apex (RVA) were measured by CT. The relationship between the final sheath shape and position of the IVC and the right or left side of the line drawn vertically from the deflection point of the sheath in the LAO view on fluoroscopy was assessed.Angles between the IVC and IVST (44.4 ± 5.9° vs. 50.2 ± 6.8°) and IVC and RVA (52.5 ± 5.3° vs. 58.8 ± 7.8°) on CT were significantly (p 0.01) smaller in the α-loop group. To predict the α-loop shape, a combined IVC-IVST angle 50° and IVC-RVA angle 55° revealed higher sensitivity (81.8%). The delivery sheath positioned right of the vertical line was more frequent in the α-loop group (90.9% vs. 23.1%, p 0.01).When the preoperatively calculated angles of IVC to IVST and RVA on CT were narrow, the right side of the sheath in the IVC from the vertical line drawn from the deflection point in the LAO view indicated the need to shape the delivery sheath head into an α-loop during LP implantation.

Protocols for hemostasis after trans-radial approach (TRA) vary depending on the institute as there is no established evidence-based protocol. This study aimed to investigate the clinical implications of radial compression protocols. Consecutive patients who underwent outpatient invasive catheter angiography before and after April 2018 were treated with traditional and new protocols, respectively. Using the same hemostasis band, the amount and timing of deflation were fixed in the traditional protocol, whereas the air was removed as much as possible every 30 min in the new protocol. A total of 1,842 patients (71±10 years old, 77% male) were included. Compared with the traditional protocol group (n=1,001), the new protocol group (n=841) had a significantly lower rate of dual antiplatelet therapy (24% vs. 35%, p

Background We sought to investigate prognostic implication of microvascular dysfunction as assessed by the index of microcirculatory index (IMR) in patients without residual obstructive CAD with non-flow limiting fractional flow reserve (FFR) (>0.80) following percutaneous coronary intervention (PCI). Methods A total of 570 patients who had both post-PCI FFR and IMR values were included in the present analysis; of these, 65 patients had FFR ≤ 0.80 and 505 had FFR > 0.80. Of the 505 patients with FFR > 0.80, 137 had high IMR and 368 had low IMR. The primary outcome of the present analysis is a composite of all-cause death, spontaneous myocardial infarction, or target-vessel revascularization. Impaired microvascular function was defined as IMR ≥ 25 (high IMR). Results During a median follow-up duration of 4.0 years, those with FFR > 0.80 and low IMR demonstrated lower rate or primary outcome event than those with FFR ≤ 0.80 (hazard ratio 0.49 [95% confidence interval 0.27–0.92], p = 0.026) and those with FFR > 0.80 and high IMR (hazard ratio 1.60 [0.99–2.16], p = 0.056). The patients with FFR > 0.80 and IMR ≥ 25 had similar rate of primary outcome event compared with those with FFR ≤ 0.80 (p = 0.49). Conclusion Microvascular dysfunction following PCI is not rare and is associated with adverse events even in the setting of a non-flow limiting FFR; these results suggest that when performing coronary physiologic assessment following PCI, interrogating not only the epicardial vessel, but also the microvasculature is useful for the risk stratification in patients undergoing PCI.

Background A myocardial bridge (MB) is a congenital coronary anomaly, wherein the epicardial coronary artery tunnels through the myocardial band. Treatment is indicated when clinical symptoms occur, and β-blockers are the first choice of treatment. Symptomatic patients refractory to medical therapy are considered for other options, including stent placement, coronary artery bypass grafting, or surgical supra-arterial myotomy. Supra-arterial myotomy is effective; however, the symptoms might persist if myocardial resection is inadequately performed. Case summary We encountered a patient experiencing exertional chest pain. Coronary angiography revealed a MB at the mid-left anterior descending artery with systolic compression. The patient’s fractional flow reserves (FFRs) were 0.93 at rest and 0.72 with intravenous administration of 50 µg/kg/min dobutamine. The symptoms were refractory to drugs, and supra-arterial myotomy was performed with intraoperative coronary artery angiography, which revealed the milking effect of the residual myocardium; therefore, additional myocardial resection was performed. Postoperative coronary artery angiography showed no systolic compression, and the postoperative FFRs were 0.88 at rest and 0.92 with intravenous administration of dobutamine 50 µg/kg/min. Discussion Although surgical supra-arterial myotomy is safe and effective, inadequate myocardial resection might cause symptom recurrence. Intraoperative coronary artery angiography during the surgery can indicate whether additional resection is required. Objective assessment of ischaemia might be useful in cases with a MB, which can cause asymptomatic myocardial ischaemia and sudden cardiac death. FFRs before surgery can help in evaluating the need for surgery and for confirming the therapeutic effect and subsequent treatment.

Chronic total coronary occlusion (CTO) remains one of the most technically challenging clinical scenarios in which to perform interventions. Although the antegrade approach is a general approach for CTO recanalization, a retrograde attempt improves the success rate and its usage has been increasingly adopted in recent years. Congenital coronary anomaly represents another technically challenging factor especially when accompanied with CTO lesions. We report the case of a 43-year-old man with no relevant cardiac history who presented for evaluation of exertional chest discomfort with palpitation. Coronary angiography revealed the existence of CTOs at just ostial of anomalously originating right coronary artery (RCA) with no angiographic ostial dimple in Valsalva sinus. Because it was not possible to engage with the antegrade guiding catheter (GC) at the inlet of the RCA, we decided to perform revascularization using the retrograde approach. Percutaneous coronary intervention (PCI) of such an anomalous RCA, which is chronically occluded, is difficult and is rarely described. Retrograde approach has been used to overcome the impossible placement of antegrade GC to RCA ostium. After successful CTO-PCI, his chest discomfort promptly disappeared.

It is known that incidence and short-term mortality rate of acute myocardial infarction (AMI) tend to be higher in the cold season. The aim of our study was to investigate the association of onset-season with patient characteristics and long-term prognosis of AMI. This was a prospective, multicenter, Japanese investigation of 3,283 patients with AMI who were hospitalized within 48 h of symptom onset between July 2012 and March 2014. Patients were divided into 3 seasonal groups according to admission date: cold season group (December–March), hot season group (June–September), and moderate season group (April, May, October, and November). We identified 1356 patients (41.3%) admitted during the cold season, 901 (27.4%) during the hot season, and 1026 (31.3%) during the moderate season. We investigated the seasonal effect on patient characteristics and clinical outcomes. Baseline characteristics of each seasonal group were comparable, with the exception of age, Killip class, and conduction disturbances. The rates of higher Killip class and complete atrioventricular block were significantly higher in the cold season group. The 3-year cumulative survival free from major adverse cardiac events (MACE) rate was the lowest in the cold season (67.1%), showing a significant difference, followed by the moderate (70.0%) and hot seasons (72.9%) (p

Beta-blockers are standard therapy for acute myocardial infarction (AMI). However, despite current advances in the management of AMI, it remains unclear whether all AMI patients benefit from β-blockers. We investigated whether admission heart rate (HR) is a determinant of the effectiveness of β-blockers for AMI patients. Methods and Results: We enrolled 3,283 consecutive AMI patients who were admitted to 28 participating institutions in the Japanese Registry of Acute Myocardial Infarction Diagnosed by Universal Definition (J-MINUET) study. According to admission HR, we divided patients into 3 groups: bradycardia (HR60 beats/min, n=444), normocardia (HR 60 to ≤100 beats/min, n=2,013), and tachycardia (HR100 beats/min, n=342). The primary endpoint was major adverse cardiac events (MACE), including all-cause death, non-fatal MI, non-fatal stroke, heart failure (HF), and urgent revascularization for unstable angina, at 3-year follow-up. Beta-blocker at discharge was significantly associated with a lower risk of MACE in the tachycardia group (23.6% vs. 33.0%; P=0.033), but it did not affect rates of MACE in the normocardia group (17.8% vs. 18.4%; P=0.681). In the bradycardia group, β-blocker use at discharge was significantly associated with a higher risk of MACE (21.6% vs. 12.7%; P=0.026). Results were consistent for multivariable regression and stepwise multivariable regression.Admission HR might determine the efficacy of β-blockers for current AMI patients.

Background: There is wide variability of visit-to-visit (V2V) B-type natriuretic peptide (BNP) in patients with chronic heart failure (CHF), even when they are stable. The prognostic significance of V2V-BNP variability has not been investigated. We aimed to test whether V2V-BNP variability during the stable period of CHF has prognostic value regardless of BNP level. Methods: In 278 stable outpatients (75 ± 10 years, 65% male) with CHF, we studied V2V-BNP variability, which was defined as the coefficient of variance of BNP values measured during 1 year before enrollment. All-cause death and rehospitalization due to HF were considered the primary endpoint. Results: The median V2V-BNP variability was 25.7% (IQR: 19.2–34.4%). During the follow-up period (median 3.2 years), 100 patients reached the endpoint and those with high V2V-BNP variability (≥25.7%) had a significantly higher rate of events (p = 0.001). CHF severity in terms of BNP level and MAGGIC risk score was not significantly different between those with high and low V2V-BNP variability. Multivariable analysis showed that high V2V-BNP variability was independently associated with increased event rates even after adjustment for other known prognostic predictors, including BNP (hazard ratio 1.90, p = 0.003), or for MAGGIC risk score and BNP (hazard ratio 1.72, p = 0.010). The hazard for the outcome consistently increased as V2V-BNP variability increased, with a marked increase up to about 30%. Conclusions: Even in the stable phase of CHF, V2V-BNP variability was associated with worse long-term outcomes, independent of BNP level.

Long-term clinical outcomes among patients with cardiogenic shock (CS) and heart failure (HF) who survive the early phase of acute myocardial infarction (AMI) remain uncertain. We investigated 3283 consecutive patients with AMI, selected from a prospective, nation-wide multicenter registry (J-MINUET) database comprising 28 institutions in Japan between July 2012 and March 2014. The 3263 eligible patients were divided into the following three groups: CS-/HF- group (n = 2467, 75.6%); CS-/HF+ group (n = 479, 14.7%); and CS+ group (n = 317, 9.7%). The thirty-day mortality rate in CS+ patients was 32.8%, significantly higher than in CS- patients. Among CS+ patients, multivariate logistic regression analysis identified statin use before admission (Odds ratio (OR) 0.32, 95% confidence interval (CI) 0.14-0.66, P = 0.002), renal deficiency (OR 8.72, 95%CI 2.81-38.67, P0.0001) and final thrombolysis in myocardial infarction flow grade (OR 0.42, 95%CI 0.18-0.99, P = 0.046) were associated with 30-day mortality. Landmark Kaplan-Meier analysis showed that mortality rates after 30 days were comparable between CS+ and CS-/HF+ groups but were lower in the CS-/HF- group. Multivariate Cox hazard analysis also showed that hazard risk of mortality after 30 days was comparable between the CS+ and CS-/HF+ groups (Hazard ratio (HR) 1.03, 95%CI 0.63-1.68, P = 0.90), and significantly lower in the CS-/HF- group (HR 0.44, 95%CI 0.32-059, P0.0001). In conclusion, AMI patients with CS who survived 30 days experienced worse long-term outcomes compared with those without CS up to 3 years. Attention is required for patients who show HF on admission without CS to improve long-term AMI outcomes.

Background: Lethal arrhythmias including ventricular tachycardia and fibrillation (VT/VF) are common complications of acute myocardial infarction (AMI). Predictors of in-hospital VT/VF after AMI, however, have not been thoroughly investigated. In this study, we sought to elucidate the predictors of in-hospital VT/VF events after AMI in the Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET). Methods and Results: In-hospital VT/VF was defined as a hemodynamically unstable VT or VF in the first week of hospitalization, on which the patients were classified as the VT/VF group. Of the patients in the J-MINUET study, 3,175 were finally enrolled in this study. A total of 114 patients had VT/VF. On multivariate logistic analysis, maximum creatine kinase >3,000 IU/L (adjusted OR, 1.67; 95% CI: 1.085–2.572; P=0.02), Killip class III or IV (adjusted OR, 8.93; 95% CI: 5.668–14.082; P

This study evaluated the safety of 3-month dual antiplatelet therapy (DAPT) after implantation of a bioresorbable polymer sirolimus-eluting stent (BP-SES) and compared P2YAfter adjustment, 3-month DAPT was not inferior to longer DAPT after BP-SES implantation in terms of net adverse clinical events. There was no difference in bleeding and thrombotic events between P2Y

Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS2°P) is a contemporary risk scoring system for secondary prevention based on nine clinical factors. However, this scoring system has not been validated in other populations. The aim of this study was to validate the TRS2°P in patients with acute myocardial infarction (AMI) treated with primary percutaneous coronary intervention (PCI) in a nationwide registry cohort. Among 3283 consecutive patients with AMI enrolled in the Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET), a total of 2611 patients who underwent primary PCI were included in this study. The performance of the TRS2°P to predict major adverse cardiovascular events (MACE) composed of all-cause death, non-fatal MI, and non-fatal stroke up to 3 years in the present cohort was evaluated. The TRS2°P had modest discriminative performance in this J-MINUET cohort with a c-statistic of 0.63, similar to that in the derived cohort (TRA2°P-TIMI50, c-statistic 0.67). A strong graded relationship between the TRS2°P and 3-year cardiovascular event rates was also observed in the J-MINUET cohort. Age ≥ 75 years, Killip ≥ 2, prior stroke, peripheral artery disease, anemia, and non-ST-elevation myocardial infarction were identified as independent factors for the incidence of MACE. The TRS2°P modestly predicted secondary cardiovascular events among patients with AMI treated by primary PCI in a nationwide cohort of Japan. Further studies are needed to develop a novel risk score better predicting secondary cardiovascular events.

Although B-type natriuretic peptide (BNP) has gradually gained recognition as an indicator in risk stratification for patients with acute myocardial infarction (AMI), the prognostic impact on long-term clinical outcomes in patients with non-ST-segment elevation acute myocardial infarction (NSTEMI) without creatine kinase (CK) elevation remains unclear.This prospective multicenter study assessed 3,283 consecutive patients with AMI admitted to 28 institutions in Japan between 2012 and 2014. We analyzed 218 patients with NSTEMI without CK elevation (NSTEMI-CK) for whom BNP was available. In the NSTEMI-CK group, patients were assigned to high- and low-BNP groups according to BNP values (cut-off BNP, 100 pg/mL). The primary endpoint was defined as a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, cardiac failure, and urgent revascularization for unstable angina up to 3 years. Primary endpoints were observed in 60 (33.3%) events among patients with NSTEMI-CK. Kaplan-Meier analysis revealed a significantly higher event rate for primary endpoints among patients with high BNP (log-rank P0.001). After adjusting for covariates, a higher BNP level was significantly associated with long-term clinical outcomes in NSTEMI-CK (adjusted hazard ratio, 4.86; 95% confidence interval, 2.18-12.44; P0.001).The BNP concentration is associated with adverse long-term clinical outcomes among patients with NSTEMI-CK who are considered low risk. Careful clinical management may be warranted for secondary prevention in patients with NSTEMI-CK with high BNP levels.

Background: A Japanese prospective, nation-wide, multicenter registry (J-MINUET) showed that long-term outcomes were worse in non-ST elevation acute myocardial infarction (NSTEMI), diagnosed by increased cardiac troponin levels, compared to STEMI. This was observed in both non-STEMI with elevated creatine kinase (CK) (NSTEMI+CK) and non-STEMI without elevated CK (NSTEMI-CK). However, predictive factors for long-term outcomes in STEMI, NSTEMI+CK, and NSTEMI-CK have not been elucidated. Methods: Using the Cox proportional hazards model, we determined significant independent predictors of long-term outcomes from a total of 111 parameters evaluated in the J-MINUET study in each of our groups, including STEMI, NSTEMI+CK, and NSTEMI-CK. Then, we calculated the risk score using the regression coefficients for the determined independent predictors for the strict prediction of long-term outcomes. Results: Prognostic factors, as well as composite cardiovascular events and all-cause death, were different between STEMI, NSTEMI+CK, and NSTEMI-CK. Risk scores could effectively and powerfully predict both composite cardiovascular events and all-cause death in each group. Conclusions: The prediction of long-term outcomes using cored parameters of baseline demographics and clinical characteristics is feasible and could prove useful in establishing therapeutic strategies in patients with STEMI, NSTEMI+CK, and NSTEMI-CK.

While prognoses in relation to myocardial infarction (MI) type have been elucidated in past reports, the results were not consistent, perhaps due to occurrence of Type 2 MI with CVS and its mortality. The Japanese registry of acute Myocardial Infarction diagnosed by Universal Definition (J-MINUET) is a prospective multicenter registry in Japan. In contrast to thromboembolic event-related Type 1 myocardial infarction (MI), clinical features of Type 2 MI, including coronary vasospasm (CVS), are varied due to the heterogeneous nature of its development. To elucidate the MI type-related all-cause mortality, 2989 consecutive patients with AMI were stratified as Type 1 MI, Type 2 MI with CVS, and Type 2 MI with non-CVS. Most patients (n = 2834, 94.8%) were classified as Type 1 MI and 155 patients (5.2%) were classified as Type 2 MI. Of the Type 2 MI patients, 87 (56% of Type 2 MI) were diagnosed as MI with CVS. Although the 3-year mortality was comparable between Type 1 and Type 2 MI patients, significant differences were observed between Type 2 MI with CVS and with non-CVS (3.4% and 22.1%, p &lt, 0.001). Among Japanese patients with AMI, mortality rates between Type 1 MI and Type 2 MI are comparable, but further stratification of Type 2 MI (with or without CVS) may be useful in predicting the prognosis of patients with Type 2 MI.

Discordant results have been reported on outcomes of acute myocardial infarction (AMI) patients who present during off-hours.We investigated 3283 consecutive patients with AMI who were selected from the prospective, nationwide, multicenter registry (J-MINUET) database comprising 28 institutions in Japan between July 2012 and March 2014 to determine the current impact of off-hours presentation (defined as weekends, holidays, and weekdays from 8:01 PM to 7:59 AM) at hospitals on long-term clinical outcomes. The primary endpoint was a composite of all-cause death, non-fatal MI, non-fatal stroke, cardiac failure, and urgent revascularization for unstable angina for up to 3 years from the index event.During off-hours, 52% of patients presented. Primary percutaneous coronary intervention was performed in 85% of patients, and the door-to-balloon time was comparable between off-hours and regular hours (74, interquartile range [IQR] 52 to 113 versus 75, IQR 52 to 126 minutes, P = 0.34). Rate of overall primary endpoint overall did not overall significantly differ (25.3% versus 23.5%, log-rank P = 0.26), in patients with ST-elevation myocardial infarction (STEMI) (log-rank P = 0.93) and in patients with non-ST-elevation myocardial infarction (NSTEMI) (log-rank P = 0.14). Multivariate Cox regression analysis showed that off-hours presentation was not significantly associated with long-term clinical events in all cohorts.The impact of presentation during off-hours or regular hours on the long-term clinical outcomes of Japanese patients with AMI is comparable in contemporary practice.

Background: The association between guideline adherence and long-term outcomes in patients with acute myocardial infarction in real-world clinical practice remains unclear. Methods: We investigated 3283 consecutive patients with acute myocardial infarction who were selected from a prospective, nation-wide, multicentre registry (J-MINUET) database covering 28 institutions in Japan between July 2012 and March 2014. Among the 2757 eligible patients, we evaluated the use of seven guideline-recommended therapies, including urgent revascularisation, door-to-balloon time of 90 minutes or less, and five discharge medications (P2Y12 inhibitors on aspirin, beta-blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, statins, lipid-lowering drugs). The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, cardiac failure and urgent revascularisation for unstable angina up to 3 years. Results: The overall median composite guideline adherence was 85.7%. Patients were divided into the following three groups: complete (100%) adherence group (n=862); moderate adherence (75% to Conclusion: The use of guideline-based therapies for patients with acute myocardial infarction in contemporary clinical practice was associated with significant decreases in adverse long-term clinical outcomes. Trial registration: UMIN Unique trial Number: UMIN000010037

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

It has been shown that the patency of an infarct-related artery (IRA) before primary percutaneous coronary intervention determines post-procedural success, better preservation of left ventricular function, and lower in-hospital mortality. However, the factors associated with pre-procedural Thrombolysis In Myocardial Infarction (TIMI) flow have not been fully investigated.The Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET) is a prospective multicenter registry conducted at 28 Japanese medical institutions between July 2012 and March 2014. We enrolled 3,283 consecutive patients with acute myocardial infarction who were admitted to a participating institution within 48 hours of symptom onset. There were 2,262 patients (68.9%) with ST-elevation myocardial infarction (STEMI), among whom 2,182 patients underwent emergent or urgent coronary angiography.Pre-procedural TIMI flow grade 3 was related to post-procedural TIMI flow grade 3 (P < 0.001), lower enzymatic infarct size (P < 0.001), lower ventricular tachycardia and ventricular fibrillation (P = 0.049), and lower in-hospital mortality (P = 0.020). A history of antiplatelet drug use was associated with pre-procedural TIMI flow.Antiplatelet drug use on admission was associated with pre-procedural TIMI flow. The patency of the IRA in patients with STEMI was related to procedural success and decreased enzymatic infarct size, fatal arrhythmic events, and in-hospital mortality.

Patients with peripheral artery disease (PAD) are at high risk of cardiovascular events, including myocardial infarction (MI), stroke, and cardiovascular death. However, the impact of PAD on prognosis in Japanese patients with acute MI remains unclear.The Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET) is a prospective multicenter registry that registered 3283 patients with acute MI. Among them, 2970 patients with available data of PAD were divided into the following 4 groups: 2513 patients without prior MI or PAD (None group), 320 patients with only prior MI (Prior MI group), 100 patients with only PAD (PAD group), and 37 patients with both previous MI and PAD (Both group). The primary endpoint was a composite of all-cause death, non-fatal MI, non-fatal stroke, cardiac failure, and urgent revascularization for unstable angina.The 3-year cumulative incidence of the primary endpoint was 26.9% in None group, 41.4% in Prior MI group, 48.0% in PAD group, and 60.3% in Both group (p 0.001). In multivariate analysis, hazard ratio using None group as reference was 1.55 (95% confidence intervals 1.25-1.91; p 0.001) for MI group, 2.26 (1.61-3.07; p 0.001) for PAD group, and 2.52 (1.52-3.90; p 0.001) for Both group.Concomitant PAD was associated with poor prognosis in Japanese patients with acute MI.

The association between patients with acute myocardial infarction (AMI) who present during off-hours and clinical outcomes has not been fully elucidated.We investigated 3283 consecutive patients with AMI who were selected from a prospective, nationwide, multicenter registry (J-MINUET) database comprising 28 institutions in Japan between July 2012 and March 2014 to determine the current impact of off-hours presentation on in-hospital mortality among Japanese patients with AMI.Among the patients, 52% presented in off-hours. Baseline characteristics were comparable, although those who presented during off-hours were younger and had a higher incidence of ST-elevation myocardial infarction and advanced Killip Class. The time from symptom onset to presentation time was shorter in off-hour patients (120min, interquartile range 60 to 256 vs. 215min, interquartile range 90 to 610, p0.0001). In contrast, 85% of patients underwent primary percutaneous coronary intervention (PCI) and door to balloon time was comparable between the groups (74min, interquartile range 52 to 113 vs. 75min, interquartile range 52 to 126, p=0.34). The rates of in-hospital mortality were comparable (6.2% vs 6.8%, p=0.39). Multivariate logistic regression analysis revealed that off-hours presentation was not significantly associated with in-hospital mortality [odds ratio (OR) 0.94; 95% CI, 0.68-1.30, p=0.70].The clinical impact of presenting during off-hours or regular hours on AMI patients in Japan is comparable in contemporary practice.UMIN Unique trial Number: UMIN000010037.

The ratio of serum eicosapentaenoic acid (EPA) to arachidonic acid (AA) is significantly associated with long-term clinical outcomes in patients with acute myocardial infarction (AMI). However, it has not been conclusively demonstrated that higher serum EPA/AA ratio fares better clinical outcomes in the early phase of AMI. The Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET) is a prospective multicenter registry conducted in 28 Japanese medical institutions between July 2012 and March 2014. We enrolled 3,283 consecutive AMI patients who were admitted to participating institutions within 48 h of symptom onset. A serum EPA/AA ratio was available for 629 of these patients. The endpoints were in-hospital mortality and major adverse cardiac events (MACE), defined as a composite of all cause death, cardiac failure, ventricular tachycardia (VT) and/or ventricular fibrillation (VF) and bleeding during hospitalization. Although similar rates of in-hospital mortality, cardiac failure, bleeding, and MACE were found in the lower serum EPA/AA group and higher serum EPA/AA group, the incidence of VT/VF during hospitalization was significantly higher in the low ratio group (p = 0.008). Receiver operating characteristic curve analysis showed that an EPA/AA ratio

Background Limited data exist regarding the association between symptom presentation of acute myocardial infarction (AMI) and in-hospital outcomes. Methods We analyzed data of the Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET). This was a prospective and multicenter registry consisting of 3085 AMI patients with available data of symptoms, who were hospitalized within 48 h from onset during July 2012 to March 2014. We defined typical symptoms as any of chest pain or pressure due to myocardial ischemia. Results Of this study population, 642 patients (20.8%) had atypical symptoms (atypical group) and the remaining 2443 patients (79.2%) showed typical symptoms (typical group). Compared to the typical group, the atypical group was associated with higher age, more females, hypertension, diabetes, chronic kidney disease, history of cardiovascular disease, non-ST elevation MI, and Killip class ≥2. In the atypical group, urgent percutaneous coronary intervention was less frequently performed than in the typical group, and in STEMI patients door-to-balloon time was longer in the atypical than typical group. Atypical group had larger infarct size than typical group. Furthermore, in-hospital mortality was significantly higher in atypical than in typical group (19.5% vs. 3.3%, p

Background Thrombolysis in Myocardial Infarction (TIMI) Risk Score for Secondary Prevention and CREDO-Kyoto Thrombotic Risk Score are contemporary secondary prevention risk scoring systems. However, these scoring systems have not been validated in other populations. Purpose The aim of this study was to validate of the TIMI Risk Score for Secondary Prevention and CREDO-Kyoto Thrombotic Risk Score in patients in the early phase of acute myocardial infarction (AMI). Methods The Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET) is a prospective multicenter registry conducted in 28 Japanese medical institutions. We enrolled 3,283 consecutive patients with AMI who were admitted to participating institutions within 48 hours of symptom onset between July 2012 and May 2014. Among them, 3,070 patients were included in this study after excluding 213 patients who died in the hospital. Clinical follow-up data were obtained up to 3 years. The primary endpoint was a composite of all-cause death, non-fatal MI and non-fatal stroke. The patients were stratified by the TIMI Risk Score for Secondary Prevention and CREDO-Kyoto Thrombotic Risk Score. Results At the 3-year follow-up, the primary endpoint had occurred in 337 patients (11.0%). All-cause death, non-fatal MI and non-fatal stroke had occurred in 177 (5.8%), 80 (2.6%) and 80 (2.6%) patients, respectively. TIMI Risk Score for Secondary Prevention and CREDO-Kyoto Thrombotic Risk Score showed a graded association with the composite of all-cause death, non-fatal MI and non-fatal stroke at 3 years in the J-MINUET population (Figure). Validation of atherothrombotic risk Conclusions TIMI Risk Score for Secondary Prevention and CREDO-Kyoto Thrombotic Risk Score were shown to be applicable to the patients in the early phase of AMI.

Background Cardiac troponin (cTn) is the preferred biomarker for the diagnosis of acute myocardial infarction (AMI). Octogenarians who presented cTn positive AMI are not usually recruited in clinical trials. Therefore, their clinical characteristics and prognosis are rarely investigated. Objective To study the characteristics and prognosis in octogenarians who presented cTn positive AMI. Methods and results The Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET) is a prospective and multicenter registry. A total of 3,283 consecutive AMI patients who were diagnosed by cTn-based criteria were included. The patients were divided into non-octogenarians (n=2,593) and octogenarians (n=690). Compared with non- octogenarians, octogenarians showed significantly lower incidence of diabetes mellitus (37.6% and 31.9%, p=0.006) and dyslipidemia (53.6% and 45.6%, p Conclusions J-MINUET showed the poor prognosis of octogenarians who were diagnosed as AMI based on cTn. Acknowledgement/Funding None

Background: The prognostic impact of coronary microvascular dysfunction after percutaneous coronary intervention (PCI) remains unclear in patients with stable coronary artery disease. This study sought to investigate the prognostic value of microvascular function measured immediately after PCI in patients with stable coronary artery disease. Methods: We enrolled 572 patients with stable coronary artery disease who underwent PCI and elective measurement of the index of microcirculatory resistance (IMR) immediately after PCI from 8 centers in 4 countries. Impaired microvascular function was defined as IMR≥25 (high IMR). Major adverse cardiac events, including death, myocardial infarction (MI) and target vessel revascularization, were evaluated. Results: During a median follow-up duration of 4.0 years, the cumulative major adverse cardiac events rate was significantly higher in the high IMR group (n=66/148) compared with the low IMR group (n=128/424; hazard ratio [HR], 1.56; 95% CI, 1.16−2.105; P =0.001), primarily due to a higher rate of periprocedural MI (HR, 1.59; 95% CI, 1.11−2.28; P =0.004) but also due to higher rates of mortality (HR, 1.59; 95% CI, 0.76−3.35; P =0.22), spontaneous MI (HR, 2.10; 95% CI, 0.67−6.63; P =0.20) and target vessel revascularization (HR, 1.40; 95% CI, 0.77−2.54; P =0.27). Cumulative risk for death, spontaneous MI, and target vessel revascularization was higher in the high IMR group (HR, 1.55; 95% CI, 0.99−2.43; P =0.056), as was death and spontaneous MI alone (HR, 1.79; 95% CI, 0.96−3.36; P =0.065). On multivariable analysis, high IMR post-PCI was an independent predictor of major adverse cardiac events. Conclusions: IMR measured immediately after PCI predicts adverse events in patients with stable coronary artery disease.