Cardiovascular disease, including ischemic heart disease, is a leading cause of death worldwide. Improvement of the secondary prevention of ischemic heart disease is necessary. We established a ...unique referral system to connect hospitals and outpatient clinics to coordinate care between general practitioners and cardiologists. Here, we evaluated the impact and long-term benefits of our system for ischemic heart disease patients undergoing secondary prevention therapy after percutaneous coronary intervention. This single-center retrospective observational study included 3658 consecutive patients who underwent percutaneous coronary intervention at Shizuoka City Hospital between 2010 and 2019. After percutaneous coronary intervention, patients were considered conventional outpatients (conventional follow-up group) or subjected to our unique referral system (referral system group) at the attending cardiologist's discretion. To audit compliance of the treatment with the latest Japanese guidelines, we adopted a circulation-type referral system, whereby general practitioners needed to refer registered patients at least once a year, even if no cardiac events occurred. Clinical events in each patient were evaluated. Net adverse clinical events were defined as a combination of major adverse cardiac, cerebrovascular, and major bleeding events. There were 2241 and 1417 patients in the conventional follow-up and referral system groups, with mean follow-ups of 1255 and 1548 days and cumulative net adverse clinical event incidences of 27.6% and 21.5%, respectively. Kaplan-Meier analysis showed that the occurrence of net adverse clinical events was significantly lower in the referral system group than in the conventional follow-up group (log-rank: P<0.001). Univariate and multivariate analyses revealed that the unique referral system was a significant predictor of the net clinical benefits (hazard ratio: 0.56, 95% confidence interval: 0.37-0.83, P = 0.004). This result was consistent after propensity-score matching. In summary, our unique referral system contributed to long-term net clinical benefits for the secondary prevention of ischemic heart disease after percutaneous coronary intervention.
Background:Data evaluating the effects of acute coronary syndrome (ACS) relative to stable coronary artery disease (CAD) on bleeding risk after percutaneous coronary intervention (PCI) are ...scarce.Methods and Results:From the CREDO-Kyoto Registry Cohort-3, 13,258 patients undergoing first PCI (5,521 ACS; 7,737 stable CAD) were identified. Patients were further stratified according to ACS presentation and Academic Research Consortium High Bleeding Risk (HBR): ACS/HBR: n=2,502; ACS/no-HBR: n=3,019; stable CAD/HBR: n=3,905; and stable CAD/no-HBR: n=3,832. The primary bleeding endpoint was Bleeding Academic Research Consortium 3/5 bleeding, whereas the primary ischemic endpoint was myocardial infarction (MI)/ischemic stroke. Compared with stable CAD, ACS was associated with a significantly higher adjusted risk for bleeding (hazard ratio HR 1.85; 95% confidence interval CI 1.68–2.03; P<0.0001), with a markedly higher risk within 30 days (HR 4.24; 95% CI 3.56–5.06; P<0.0001). Compared with the stable CAD/no-HBR group, the ACS/HBR, no-ACS/HBR, and ACS/no-HBR groups were associated with significantly higher adjusted risks for bleeding, with HRs of 3.05 (95% CI 2.64–3.54; P<0.0001), 1.89 (95% CI 1.66–2.15; P<0.0001), and 1.69 (95% CI 1.45–1.98; P<0.0001), respectively. There was no excess adjusted risk of the ACS relative to stable CAD group for MI/ischemic stroke (HR 1.07; 95% CI 0.94–1.22; P=0.33).Conclusions:Bleeding risk after PCI depended on both ACS presentation and HBR, with a significant effect of ACS within 30 days.
There has been continuing discussion regarding the treatment strategy for acute type A intramural hematoma (IMH). Most patients are treated conservatively in Japan; hence, predicting fatal events and ...stratifying risks based on results normally obtained on hospital arrival are important. We aimed to examine the incidences and risk factors of death or need for surgery for acute type A IMH in patients receiving medical treatment and to identify high-risk patients using clinical findings on hospital arrival. From 2011 to 2016, 57 consecutive patients (mean age 72.5 years; male 36.8%) diagnosed with acute type A IMH who were receiving treatment at Shizuoka City Shizuoka Hospital were retrospectively included. Primary endpoint was a composite of cardiovascular death and operation within 1 year after onset. To evaluate sensitivity and specificity of the risk factors and risk score, we estimated the area under the receiver operating characteristic (ROC) curve. Mean follow-up duration was 621 days. Mean systolic blood pressure (SBP) was 129 mmHg. Computed tomography (CT) on arrival showed a mean ascending aorta diameter of 46 mm. Ulcer-like projection (ULP) in the ascending aorta and pericardial effusion (PE) were seen in 33% and 42% of cases, respectively. Twenty-eight patients (49.1%) reached the primary endpoint (cardiovascular death, 7 cases 12.3%; operation, 21 cases 36.8%). In univariate analysis of admission values, the primary endpoint group had significantly lower SBP (113.0 ± 28.5 vs 144.3 ± 33.5 mmHg), higher ascending aorta diameter (49.5 ± 8.1 vs 43.6 ± 5.9 mm), and higher frequency of ULP (53.8% vs 13.8%) and PE (58.6% vs 25.0%) than the event-free group. Multivariate analysis showed that ULP on admission CT was a significant predictor of the primary endpoint. The risk score was considered using these risk factors. On admission, the primary endpoint could be predicted with 89.7% sensitivity and 75% specificity (area under the ROC curve 0.823) if the patient had ULP and/or > 2 of the following factors: SBP < 120 mmHg, ascending aorta diameter > 45 mm, and PE. SBP and CT findings on arrival were significantly associated with cardiovascular death and the need for surgery in patients with acute type A IMH receiving initial medical therapy. The novel risk score was useful for predicting cardiovascular death and surgery.
Ventricular septal rupture (VSR) is a rare but fatal complication after acute myocardial infarction (AMI). However, the mortality in patients with recent VSR and appropriate timing of surgical repair ...have not been clarified. To examine the background characteristics and mortality of VSR patients as well as the usefulness and appropriate timing of surgery in this patient cohort. Among 3,947 consecutive patients with AMI at our hospital, 39 patients diagnosed with VSR from 2002 to 2020 were included in the analysis. All patients underwent transthoracic echocardiography to confirm VSR on admission. Coronary angiography (CAG) and measurement of pulmonary-systemic flow ratio were performed before emergent surgery. The use of mechanical support devices before or after procedures was considered for all patients who underwent CAG. Basically, we performed emergent or urgent operations to patients who were in a shock state or who needed mechanical support. The final decision of the timing of the operation was made by the cardiac team. Patients’ mean age was 76.3 years, and 33.3% of them were males. Most culprit lesions were located in the left anterior ascending artery (81.3%). The mean pulmonary-systemic flow ratio after VSR onset was 3.07 ± 1.98. On admission, 48.7% of patients were in a shock state. Surgical repair was possible in 28 patients at a median of 1 day after admission, with a mortality rate of 25%. Among all patients, the mortality rate was 43.6%. Survivors were significantly younger (71.3 ± 11.3 vs. 82.7 ± 6.2 years,
p
< 0.01), had higher mean arterial blood pressure (75.6 ± 14.4 vs. 62.8 ± 16.2 mmHg,
p
= 0.0496) and lower ejection fraction (44.3 ± 11.7% vs. 54.8 ± 7.9%,
p
= 0.04), and underwent surgical repair more frequently (95.5% vs. 41.2%,
p
< 0.01) than the non-survivors. In multivariate analysis, younger age (odds ratio OR 1.18 95% confidence interval CI 1.01–1.38,
p
= 0.04) and surgical repair (OR 0.04, 95% CI 0.00–0.73,
p
= 0.03) were significant predictors of survival. In surgical repair cases, time from admission to operation did not differ significantly between survivors and non-survivors. Surgical repair and younger age are predictors of survival in patients with recent VSR, but the timing of surgery was not.
Background. Secondary prevention of ischaemic heart disease (IHD) is an important aspect of healthcare. To improve the prognosis of and control risk factors for IHD patients, we created a unique ...referral system called the Shizuoka IHD patient registry. Methods. From 2009 to 2013, we enrolled 1240 patients; they participated in follow-up until 2018. The risk factor target values were as follows: low-density-lipoprotein cholesterol, <100 mg/dl; glycated haemoglobin of diabetes patients, <7%; systolic blood pressure, <130 mmHg; and diastolic blood pressure, <80 mmHg (mean follow-up interval, 2001 ± 794 days). The cumulative incidence rates were 10.8% for all-cause death (cardiac death, 1.5%), 15.7% for coronary events, and 2.6% for major bleeding. Patients were separated into the major bleeding group (n = 32), coronary event group (n = 195), and event-free group (n = 1013) without overlapping. Results. We observed significant differences in age, rate antithrombotic drug use, and mortality. A Kaplan–Meier analysis of all-cause death showed significant differences between the event-free and major bleeding groups (P=0.002) and between the coronary event and major bleeding groups (P=0.026); there was no significant difference between the event-free and coronary event groups. Conclusion. Major bleeding events were stronger predictors of long-term mortality than coronary events during the long-term follow-up of stable IHD.
Background: Patients with appropriately selected low-risk pulmonary embolism (PE) can be treated at home, although it has been controversial whether applies to patients with cancer, who are ...considered not to be at low risk.Methods and Results: The current predetermined companion report from the ONCO PE trial evaluated the 3-month clinical outcomes of patients with home treatment and those with in-hospital treatment. The ONCO PE trial was a multicenter, randomized clinical trial among 32 institutions in Japan investigating the optimal duration of rivaroxaban treatment in cancer-associated PE patients with a score of 1 using the simplified version of the Pulmonary Embolism Severity Index (sPESI). Among 178 study patients, there were 66 (37%) in the home treatment group and 112 (63%) in the in-hospital treatment group. The primary endpoint of a composite of PE-related death, recurrent venous thromboembolism (VTE) and major bleeding occurred in 3 patients (4.6% 0.0–9.6%) in the home treatment group and in 2 patients (1.8% 0.0–4.3%) in the in-hospital treatment group. In the home treatment group, there were no cases of PE-related death or recurrent VTE, but major bleeding occurred in 3 patients (4.6% 0.0–9.6%), and 2 patients (3.0% 0.0–7.2%) required hospitalization due to bleeding events.Conclusions: Active cancer patients with PE of sPESI score=1 could be potential candidates for home treatment.
Background:Although bioprosthetic valve (BPV) replacements are becoming more common within our aging society, there are limited prospective data on the appropriate antithrombotic therapy for East ...Asian patients with atrial fibrillation (AF) and BPV replacement. Antithrombotic therapy and thrombotic and hemorrhagic event rates in Japanese patients with AF and BPV replacement are investigated.Methods and Results:This multicenter, prospective, observational study enrolled patients with BPV replacement and AF. The primary efficacy outcome was stroke or systemic embolism, and the primary safety outcome was major bleeding. Of the 894 patients analyzed, 54.7%, 29.4%, and 9.6%, were treated with warfarin-based therapy, direct oral anticoagulant (DOAC)-based therapy, or antiplatelet therapy without anticoagulants, respectively; 6.3% did not receive any antithrombotic drugs. The mean observation period was 15.3±4.0 months. The event rates for stroke or systemic embolism and major bleeding were 1.95%/year and 1.86%/year, respectively. The multivariate adjusted hazard ratios for DOAC vs. warfarin were 1.02 (95% confidence intervals CI, 0.30–3.41 P=0.979) for systemic embolic events and 0.96 (95% CI, 0.29–3.16 P=0.945) for major bleeding.Conclusions:Approximately 30% of patients with AF and BPV replacement were treated with DOAC. The risks of major bleeding and stroke or systemic embolism were similar between warfarin- and DOAC-treated patients with AF who had BPV replacement. Treatment with DOACs could be an alternative to warfarin in this population.
Background: Current guidelines equally recommend direct oral anticoagulants (DOACs) and warfarin for atrial fibrillation (AF) patients with a bioprosthetic valve (BPV); however, there are limited ...data comparing DOACs and warfarin in AF patients with an aortic BPV.Methods and Results: This post-hoc subgroup analysis of a multicenter, prospective, observational registry (BPV-AF Registry) aimed to compare DOACs and warfarin in AF patients with an aortic BPV. The primary outcome was a composite of stroke, systemic embolism, major bleeding, heart failure requiring hospitalization, all-cause death, or BPV reoperation. The analysis included 479 patients (warfarin group, n=258; DOAC group, n=221). Surgical aortic valve replacement was performed in 74.4% and 36.7% of patients in the warfarin and DOAC groups, respectively. During a mean follow up of 15.5 months, the primary outcome occurred in 45 (17.4%) and 32 (14.5%) patients in the warfarin and DOAC groups, respectively. No significant difference was found in the primary outcome between the 2 groups (adjusted hazard ratio: 0.88, 95% confidence interval: 0.51–1.50). No significant multiplicative interaction was observed between the anticoagulant effects and type of aortic valve procedure (P=0.577).Conclusions: Among AF patients with an aortic BPV, no significant difference was observed in the composite outcome of adverse clinical events between patients treated with warfarin and those treated with DOACs, suggesting that DOACs can be used as alternatives to warfarin in these patients.
Background: Optimal intensity is unclear for P2Y12receptor blocker therapy after percutaneous coronary intervention (PCI) in real-world clinical practice.Methods and Results: From the CREDO-Kyoto ...Registry, the current study population consisted of 25,419 patients (Cohort-2: n=12,161 and Cohort-3: n=13,258) who underwent their first PCI. P2Y12receptor blocker therapies were reduced dose of ticlopidine (200 mg/day), and global dose of clopidogrel (75 mg/day) in 87.7% and 94.8% of patients in Cohort-2 and Cohort-3, respectively. Cumulative 3-year incidence of GUSTO moderate/severe bleeding was significantly higher in Cohort-3 than in Cohort-2 (12.1% and 9.0%, P<0.0001). After adjusting 17 demographic factors and 9 management factors potentially related to the bleeding events other than the type of P2Y12receptor blocker, the higher bleeding risk in Cohort-3 relative to Cohort-2 remained significant (hazard ratio (HR): 1.52 95% confidence interval (CI) 1.37–1.68, P<0.0001). Cohort-3 compared with Cohort-2 was not associated with lower adjusted risk for myocardial infarction/ischemic stroke (HR: 0.96, 95% CI: 0.87–1.06, P=0.44).Conclusions: In this historical comparative study, Cohort-3 compared with Cohort-2 was associated with excess bleeding risk, which might be at least partly explained by the difference in P2Y12receptor blockers.
Background Heart failure might be an important determinant in choosing coronary revascularization modalities. There was no previous study evaluating the effect of heart failure on long‐term clinical ...outcomes after percutaneous coronary intervention (PCI) relative to coronary artery bypass grafting (CABG). Methods and Results Among 14 867 consecutive patients undergoing first coronary revascularization with PCI or isolated CABG between January 2011 and December 2013 in the CREDO‐Kyoto PCI/CABG registry Cohort‐3, we identified the current study population of 3380 patients with three‐vessel or left main coronary artery disease, and compared clinical outcomes between PCI and CABG stratified by the subgroup based on the status of heart failure. There were 827 patients with heart failure (PCI: N=511, and CABG: N=316), and 2553 patients without heart failure (PCI: N=1619, and CABG: N=934). In patients with heart failure, the PCI group compared with the CABG group more often had advanced age, severe frailty, acute and severe heart failure, and elevated inflammatory markers. During a median 5.9 years of follow‐up, there was a significant interaction between heart failure and the mortality risk of PCI relative to CABG (interaction P =0.009), with excess mortality risk of PCI relative to CABG in patients with heart failure (HR, 1.75; 95% CI, 1.28–2.42; P <0.001) and no excess mortality risk in patients without heart failure (HR, 1.04; 95% CI, 0.80–1.34; P =0.77). Conclusions There was a significant interaction between heart failure and the mortality risk of PCI relative to CABG with excess risk in patients with heart failure and neutral risk in patients without heart failure.
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