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The impact of very low baseline levels of low-density lipoprotein cholesterol (LDL-C) on patients with coronary artery disease remains unclear. We enrolled 39,439 patients of the pooled population from the CREDO-Kyoto registries Cohorts 1, 2, and 3. The study population consisted of 33,133 patients who had undergone their first coronary revascularization. We assessed the risk for mortality and cardiovascular events according to quintiles of the baseline LDL-C levels. Patients in the very low LDL-C quintile (<85 mg/dL) had more comorbidities than those in the other quintiles. Lower LDL-C levels were strongly associated with anemia, thrombocytopenia, and end-stage renal disease. The cumulative 4-year incidence of all-cause death increased as LDL-C levels decreased (very low: 19.4 %, low: 14.5 %, intermediate: 11.1 %, high: 10.0 %, and very high: 9.2 %; p < 0.001), which was driven by both the early and late events. After adjusting for baseline characteristics, the adjusted risks of the very low and low LDL-C quintiles relative to the intermediate LDL-C quintile remained significant for all-cause death (very low: HR 1.29, 95 % CI 1.16–1.44, p < 0.001; low: HR 1.15, 95 % CI 1.03–1.29, p = 0.01). The excess adjusted risks of the lowest LDL-C quintile relative to the intermediate LDL-C quintile were significant for clinical outcomes such as cardiovascular death (HR 1.17, 95 % CI 1.01–1.35), non-cardiovascular death (HR 1.35, 95 % CI 1.15–1.60), sudden death (HR 1.44, 95 % CI 1.01–2.06), and heart failure admission (HR 1.11 95 % CI 1.01–1.22), while there was no excess risk for the lowest LDL-C quintile relative to the intermediate LDL-C quintile for myocardial infarction and stroke. Lower baseline LDL-C levels were associated with more comorbidities and a significantly higher risk of death, regardless of cardiovascular or non-cardiovascular causes, in patients who underwent coronary revascularization. [Display omitted] • The patients underwent revascularization with low baseline LDL-C levels have more comorbidities and poor clinical outcomes. • These include poor cardiovascular and non-cardiovascular outcomes, sudden death, and heart failure admission. • Patients with coronary artery disease and low LDL-C levels need to be managed with special care. • Special attention should be given not only to cardiovascular problems but also to non-cardiovascular problems. [ABSTRACT FROM AUTHOR]

Although computed tomography-derived fractional flow reserve (FFR CT) has been reimbursed in a few countries, its impacts on daily practice of coronary artery diseases are not fully elucidated. We evaluated the clinical impacts of FFR CT under the real Japanese insurance reimbursement. In the multicenter prospective registry: DYNAMIC-FFR CT study, a total of 410 patients who underwent FFR CT analysis under reimbursement were prospectively enrolled at 6 Japanese sites from October 2019 to November 2021. Coronary CT angiography and FFR CT findings, treatment plans, and 90-day outcomes were recorded. The primary endpoint was the redirection rate from the tests that might be expected without FFR CT [invasive coronary angiography (ICA)-selected group, myocardial perfusion single photon emission CT (MPS)-selected group, optimal medical therapy (OMT)-selected group, and others-selected group] to those that were actually performed based on FFR CT. ICA could be avoided in 39.5 % in the ICA-selected group (N = 233). In particular, in 94.3 % of patients with an FFR CT value of >0.80, additional examinations, such as ICA, were avoided. In addition, in the MPS-selected group (N = 133), 92.6 % had no additional tests with FFR CT > 0.80, while only 2 cases with FFR CT ≤ 0.80 underwent additional MPS examination. On the contrary, 33.3 % of the OMT-selected group (N = 33) had FFR CT ≤ 0.80. Approximately, 35 % medical cost reduction was also finally expected. Introduction of FFR CT could not only reduce unnecessary ICA and be a test that replaces the conventional non-invasive functional assessment modality but also result in medical cost reduction even when used under real Japanese insurance reimbursement. Clinical impact of FFR CT introduction under insurance reimbursement. The introduction of FFR CT could reduce unnecessary ICA even under actual insurance reimbursement, and also could be used as an alternative to conventional functional tests such as MPS. Moreover, approximately 35 % medical cost reduction was also finally expected. FFR CT , computed tomography-derived fractional flow reserve; CAD, coronary artery disease; CTA, computed tomography angiography; ICA, invasive coronary angiography; MPS, myocardial perfusion single photon emission computed tomography. [Display omitted] • Unnecessary invasive coronary angiography could be avoided by introducing FFR CT. • FFR CT may become an alternative test for conventional noninvasive functional tests. • FFR CT also could result in approximately 35 % medical cost reduction in Japan. [ABSTRACT FROM AUTHOR]

A 38-year-old man without a history of coronavirus disease 2019 (COVID-19) vaccination presented with dyspnea and fever. Polymerase chain reaction nasopharyngeal swab for severe acute respiratory syndrome coronavirus 2 was positive. Electrocardiogram showed diffuse ST-segment elevation, and chest radiography showed mild pulmonary congestion. The left ventricular (LV) function was markedly impaired. Vital signs were unstable, and serum lactate level was elevated. The patient was diagnosed with cardiogenic shock due to COVID-19 fulminant myocarditis and received veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and Impella CP (Abiomed, Inc., Danvers, MA, USA). Remdesivir and intravenous immunoglobulin were also administered. Corticosteroids were not administered because of the absence of pneumonia. On admission, endomyocardial biopsy showed a small direct inflammatory infiltrate of the myocardium. During mechanical support, the cardiac function improved, the patient was weaned off VA-ECMO on day 6, and Impella CP on day 7. Cardiac magnetic resonance imaging implied recent myocardial damage. The patient was discharged on day 30, and the LV function fully recovered. Since the treatment and prognosis of COVID-19 fulminant myocarditis remain unclear, we report the course of COVID-19 fulminant myocarditis with favorable outcomes. Mechanical circulatory support might be an important factor in determining the prognosis of COVID-19 fulminant myocarditis. Coronavirus disease 2019 fulminant myocarditis sometimes requires mechanical circulatory support. The prognosis and treatment have not yet been adequately established. The prognosis is favorable if adequate hemodynamic support is provided. [ABSTRACT FROM AUTHOR]

Data on long-term outcomes of transcatheter aortic valve replacement (TAVR) in Japanese patients beyond 5 years are limited. Between June 2010 and December 2014, 55 consecutive inoperable or high surgical risk patients underwent TAVR with SAPIEN XT valves (Edwards Lifesciences, Irvine, CA, USA) for severe aortic stenosis at our institution. Among them, 2 patients were excluded from the analysis because one was converted to open surgery during the TAVR procedure and the other could not undergo TAVR due to device delivery failure. We retrospectively analyzed long-term clinical outcomes of these 53 patients (mean age: 84.1 years; mean STS score: 8.4) who had at least a 7-year follow-up after TAVR. The rates of freedom from all-cause and cardiovascular deaths at 7 years were 35.8 % and 79.3 %, respectively. The moderate or severe structural valve deterioration (SVD) rate at 5 and 7 years was 7.2 % and 11.4 %, respectively. The rate of bioprosthetic valve failure (BVF) at 7 years was 6.2 %. The 7-year mortality rate of inoperable or high surgical risk patients treated with SAPIEN XT was high, while the cardiovascular mortality rate was acceptable. Although the poor survival rate limited the long-term assessment of SAPIEN XT valve durability, the incidence of SVD and BVF was not rare. [Display omitted] • Data on long-term outcomes of transcatheter aortic valve replacement (TAVR) in Japanese patients beyond 5 years are limited. • The rate of freedom from all-cause death at 7 years was 35.8%. • The rates of structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) at 7 years were 11.4% and 6.2%, respectively. • Although the mortality was high, the incidence of SVD and BVF was not rare. [ABSTRACT FROM AUTHOR]

Vitamin K antagonist (VKA) remains an essential option for venous thromboembolism (VTE), although direct oral anticoagulants have become available. However, there is a paucity of data on the optimal intensity and quality of control for VKA in Japanese. The COMMAND VTE Registry is a multicenter registry enrolling consecutive 3027 patients with acute symptomatic VTE among 29 centers in Japan. The current study population consisted of 1938 patients who received VKA with prothrombin time-international normalized ratio (PT-INR) measurement >5 times. The primary outcome measure was a composite of symptomatic VTE recurrence or major bleeding at 1 year. The presumed optimal quality of VKA therapy was defined as the combination of PT-INR range and time in therapeutic range (TTR) with the numerically lowest event rate. The group with TTR ≥70 % based on PT-INR range ≥1.5 and <2.0 showed the lowest cumulative incidence rate. The cumulative 1-year incidence and the adjusted risk for the primary outcome measure were significantly lower in the optimal quality group than in the non-optimal quality group (5.2 % vs. 11.7 %, p = 0.001, and HR 0.49, 95%CI 0.28–0.81). Similarly, the cumulative 1-year incidences of a recurrent VTE, major bleeding, and all-cause death were significantly lower in the optimal quality group (recurrent VTE: 2.5 % vs. 6.0 %, p = 0.02; major bleeding: 2.8 % vs. 7.0 %, p = 0.008; and all-cause death: 2.8 % vs. 12.6 %, p < 0.0001). The lower risk of the optimal quality group relative to non-optimal quality group for the clinical outcomes was consistent regardless of the etiology of VTE (active cancer, transient risk factor, and unprovoked). The current VTE registry showed the optimal intensity of VKA therapy was target PT-INR range ≥1.5 and <2.0, which could support the current Japanese guideline recommendation, and the good quality of control for VKA therapy of TTR ≥70 % was independently associated with better outcomes. [Display omitted] • Vitamin K antagonist (VKA) is an essential option for venous thromboembolism (VTE). • Optimal VKA therapy for Japanese VTE patients has not been established. • Optimal VKA therapy was time in therapeutic range ≥70% based on target prothrombin time-international normalized ratio range ≥1.5 and <2.0. • Optimal VKA therapy related to better outcomes irrespective of the etiologies of VTE. [ABSTRACT FROM AUTHOR]

The Academic Research Consortium for High Bleeding Risk (ARC-HBR) defined high bleeding risk (HBR) in patients undergoing percutaneous coronary intervention. We have reported a simplified HBR (S-HBR), excluding six items with prevalences under 1% from ARC-HBR. The Japanese Circulation Society developed an HBR specific to Japanese (J-HBR), adding three items to ARC-HBR in consideration of ethnicity. Data comparing each HBR are scarce. Patients treated with second-generation drug-eluting stents between January 2010 and December 2013 were enrolled, in whom all items of ARC-HBR, and the incidences of major bleeding and ischemic events were examined. Also, the diagnostic values of ARC-HBR, S-HBR, and J-HBR at 1 and 7 years post procedure were compared by using receiver-operating characteristic curves. The study sample consisted of 3430 patients. Mean follow-up period was 2299 ± 904 days. The incidence of major bleeding at 1 and 7 years in each definition was as follows: ARC-HBC, 3.3% and 10.6%; S-HBR, 3.3% and 10.7%; and J-HBR, 2.9% and 10.0%. The diagnostic value of J-HBR for major bleeding at 1 year was lower than that of ARC-HBR (C statistics 0.64 vs. 0.68, p < 0.001). Other diagnostic values of S-HBR and J-HBR were comparable to those of ARC-HBR. S-HBR was as useful as ARC-HBR in predicting both short- and long-term HBR, and J-HBR is useful for predicting long-term HBR. [Display omitted] • Simplified high bleeding risk (S-HBR) consists of 11 factors which had prevalence greater than 1%. • S-HBR had similar diagnostic value of bleeding and ischemic events with Academic Research Consortium for High Bleeding Risk (ARC-HBR). • Japan HBR was able to predict larger number of at-risk patients than ARC-HBR. [ABSTRACT FROM AUTHOR]

The distal radial approach (DRA) has been proposed as an alternative approach for coronary angiography (CAG) and percutaneous coronary intervention (PCI). However, its outcomes in hemodialysis (HD) patients have not been well studied in detail. We aimed to determine the feasibility and safety of coronary intervention with the DRA for HD patients. We performed CAG or PCI with the DRA in 2500 consecutive patients between October 2018 and February 2020. The patients included 98 HD patients (HD group) and 2402 non-HD patients (non-HD group). The primary endpoints were the rates of procedural success and puncture site-related complications. The secondary endpoints were puncture site-related complications one year after the procedure. As a subanalysis, we also compared the outcomes on the basis of CAG and PCI. The procedural success rates were similar in the HD and non-HD groups (80.6% vs. 82.6%, p = 0.61 for the entire cohort; 78.3% vs. 80.9%, p = 0.58 for CAG; and 86.2% vs. 88.0%, p = 0.78 for PCI). The bleeding complications rates were low and there was no difference between groups (6.1% vs. 4.1%, p = 0.33 for the entire cohort; 0% vs. 2.2%, p = 0.21 for CAG; and 20.7% vs. 10.3%, p = 0.079 for PCI). Radial artery occlusion occurred in only one patient in the HD group after the procedure. Although modified hemostasis methods could be necessary for HD patients undergoing PCI, coronary intervention with the DRA is feasible and safe for both HD and non-HD patients. [Display omitted] • This is the first study demonstrating the safety and efficacy of distal radial approach for HD patients. • The procedural success rates were similar in the hemodialysis (HD) and non-HD groups. • The rate of radial artery occlusion was low in HD patients. [ABSTRACT FROM AUTHOR]

Previous trials suggested the superiority of ultrathin- over thin-strut drug-eluting stents (DES) concerning target lesion failure (TLF) at 1 year after index percutaneous coronary intervention. The aim of this randomized comparison study of ultrathin-strut and thin-strut DES (CASTLE [Randomized Comparison All-Comer Study of Ultrathin Strut and Thin Strut Drug-Eluting Stent]; jRCTs032180084) was to examine the impact of differences in strut thickness of DES on clinical outcomes when implanted with angiography and intravascular ultrasound or optical coherence tomographic guidance. CASTLE was a multicenter, prospective, noninferiority study conducted at 65 institutions in Japan. Percutaneous coronary intervention patients were assigned (1:1) to an ultrathin, biodegradable-polymer sirolimus-eluting stent (BP-SES) or a thin, durable-polymer everolimus-eluting stent (DP-EES). The primary endpoint was TLF, defined as a composite of cardiac death, target vessel–related myocardial infarction, and clinically driven target lesion revascularization at 1-year follow-up. Between May 2019 and March 2020, 1,440 patients were randomly assigned to BP-SES (n = 722) or DP-EES (n = 718). TLF occurred in 6.0% and 5.7% of patients, respectively. Noninferiority (P = 0.040) was met because the upper limit (2.67%) of the 1-sided 95% CI between the groups was lower than the prespecified noninferiority margin (3.3%). No significant interactions were observed in the relative rates of TLF between prespecified subgroups. The BP-SES was noninferior to the DP-EES regarding 1-year TLF. This demonstrates that strut thickness differences among DES have little impact on clinical outcomes when implanted with intravascular imaging guidance. [Display omitted] [ABSTRACT FROM AUTHOR]

Mechanical circulatory support (MCS) is essential to maintain the hemodynamics in selected patients with cardiogenic shock (CS). However, little is known about predictors and clinical impact of device-related complications on clinical outcomes in patients with MCS. We retrospectively reviewed consecutive 477 patients who received veno-arterial extracorporeal membrane oxygenation (VA-ECMO), Impella (Abiomed, Danvers, MA, USA), and intra-aortic balloon pump (IABP) from January 2012 to May 2020. After excluding patients with only VA-ECMO and patients with MCS for procedural support, 403 patients were included in this study. Predictors and clinical outcomes of device-related complications were analyzed. Furthermore, complication rates were compared between Impella and IABP groups in patients with and without VA-ECMO. Hemolysis, major bleeding defined by Bleeding Academic Research Consortium type 3 or 5 bleeding, thromboembolic events, and ischemic stroke were observed in 42 (10.4%), 150 (37.2%), 52 (12.9%), and 30 patients (7.4%), respectively. Patients with major bleeding had a higher in-hospital mortality than those without major bleeding (31.2% vs. 56.0%, p<0.001), whereas hemolysis (47.6% vs. 52.4%, p=0.32), thromboembolic events (38.5% vs. 40.7%, p=0.76), and ischemic stroke (48.5% vs. 39.7%, p=0.33) did not increase the in-hospital mortality. In multivariate analysis, both Impella and VA-ECMO were independent predictors of major bleeding and thromboembolic events. However, in-hospital mortality was similar between the Impella and IABP groups irrespective of the VA-ECMO insertion. Among several important complications in CS patients with MCS, major bleeding events most strongly affected the mortality. Implanted MCS type was associated with the device-related complications. [Display omitted] [ABSTRACT FROM AUTHOR]

Pulmonary artery intimal sarcoma (PAIS) is a rare tumor with an incidence of 0.001%–0.03% that usually grows along artery walls and absorbs fluorodeoxyglucose. It is difficult to distinguish PAIS from pulmonary thromboembolism due to the similarities of their symptoms. Therefore, contrast-enhanced computed tomography and positron emission tomography-computed tomography (PET-CT) should be used to establish a correct diagnosis. Here we report a case of an extremely rare type of PAIS, pedunculated PAIS, which could not be visualized on PET-CT. Histological features of a tumor with a low accumulation of fluorodeoxyglucose revealed low-cellularity and necrotizing background. Multimodal imaging was useful to diagnose PET-CT negative PAIS accurately. < Learning objective: Pedunculated pulmonary artery intimal sarcoma (PAIS) is a rare form of neoplasm. You need to know that PAIS which has low cellularity with marked interstitial myxoid tissue cannot be detected on positron emission tomography-computed tomography.> [ABSTRACT FROM AUTHOR]

The primary objective of the current analysis was to assess the association between the clinical presentation at index procedure and mortality in patients with second-generation drug-eluting stent thrombosis (G2-ST). Patients with acute coronary syndrome (ACS) have a higher risk for stent thrombosis (ST) as compared with those with chronic coronary syndrome (CCS). However, clinical outcomes of patients with G2-ST after treatment for ACS and CCS remain poorly understood. From the REAL-ST (Retrospective Multicenter Registry of ST After First- and Second-Generation Drug-Eluting Stent Implantation) registry, this study evaluated 313 patients with G2-ST. According to baseline clinical presentation, patients were divided into the 2 groups: the ACS and CCS groups (n = 147 and n = 166, respectively). The primary endpoint was the cumulative 3-year incidence of all-cause death after the index ST events. Timing of ST, target lesion revascularization, and recurrent ST were also assessed. Early ST was more frequently observed in the ACS group (71.4% vs. 44.6%), while very late ST was less likely to occur in the ACS group than in the CCS group (11.6% vs. 30.7%). Cumulative 3-year incidence of all-cause death after the index ST events was comparable between the ACS and CCS groups (28.6% vs. 28.3%; hazard ratio: 1.14; 95% confidence interval: 0.75 to 1.73; p = 0.55). Compared with the CCS group, the ACS group showed higher incidences of target lesion revascularization and recurrent ST (23.8% vs. 17.2%; p = 0.06; and 9.9% vs. 1.4%; p = 0.001, respectively). Patients with G2-ST were associated with higher mortality irrespective of baseline clinical presentation. [Display omitted] [ABSTRACT FROM AUTHOR]

• We investigated the clinical implication of post-stent fractional flow reserve (FFR). • Inadequate FFR group was significantly associated with high major adverse cardiovascular events (MACE). • Inadequate FFR group affected high incidence of non-target lesion revascularization in MACE. • Post-stent FFR may be a surrogate marker for atherosclerosis in whole of the coronary artery. Adequate improvement in fractional flow reserve (FFR) is not necessarily achieved in some cases of drug-eluting stent (DES) implantation, even when imaging confirms successful placement. We hypothesized that post-stent FFR may be associated with advanced diffuse atherosclerotic condition. We explored the relationships between FFR values after DES implantation (post-stent FFR). A total of 218 patients were included in this prospective, multicenter study and were divided into two groups: adequate FFR group (post-stent FFR >0.80, n =176) and inadequate FFR group (post-stent FFR ≤0.80, n =42). The primary endpoint was a major adverse cardiovascular event (MACE) including cardiac death, non-fatal myocardial infarction (MI), unplanned coronary revascularization, and hospitalization for heart failure. The secondary endpoints were event rate of all-cause death, non-fatal MI, unplanned coronary revascularization, non-fatal stroke, and hospitalization for heart failure. During follow-up of 31.4±8.7 months, 34 patients (16%) had cardiovascular events. Inadequate FFR group was significantly associated with higher risk of MACE (hazard ratio: 3.86; 95% confidence interval: 1.17–12.76, p =0.026; log-rank p =0.027). In particular, the incidence of unplanned coronary revascularization on non-target lesions was significantly higher in the inadequate FFR group (log-rank p =0.031). Post-stent FFR ≤0.80 was associated with a high incidence of non-target lesion revascularization and could be a surrogate marker for advanced atherosclerotic condition in the vessels of the entire coronary artery. [ABSTRACT FROM AUTHOR]

• This study elucidated the real-world features of acute decompensated heart failure with reduced left ventricular ejection fraction. • The prevalence of implantable cardioverter defibrillator (ICD) use was low (8.2%). • Patients with ICD were younger, sicker, and more often received heart failure medications. • ICD use was associated with significant risk reduction for arrhythmic events. It remains unclear the clinical characteristics and prognosis of implantable cardioverter defibrillator (ICD) on prevention for sudden cardiac death (SCD) in Japanese patients with acute decompensated heart failure (ADHF) and reduced left ventricular ejection fraction (LVEF). We investigated the prevalence, clinical characteristics, and clinical outcomes in a contemporary large-scale Japanese ADHF registry. Among the consecutive 3785 patients hospitalized for ADHF and discharged alive in the Kyoto Congestive Heart Failure registry, we identified 1409 patients with reduced LVEF (ICD: N = 115, non-ICD: N = 1294). Patients in the ICD group were younger (69.3 ± 12.9/74.2 ± 13.6 years; p < 0.001), more likely to be men (84%/65%), and more often had a history of heart failure hospitalization (70%/36%; p = 0.001), cardiomyopathy as the underlying heart disease (51%/27%; p < 0.001), and previous serious ventricular arrhythmia (57%/3.8%; p < 0.001), and had lower LVEF (25.4±7.4%/29.5±6.9%; p < 0.001), and estimated glomerular filtration rate (43.0±19.7/47.8±23.4 mL/min/1.73m2; p = 0.04) than those in the non-ICD group. The cumulative 1-year incidence of the primary arrhythmic composite endpoint of SCD, arrhythmic death, or resuscitated cardiac arrest trended to be lower in the ICD group than in the non-ICD group (0.0% versus 3.4%, p = 0.053), and the lower adjusted risk of the ICD group relative to the non-ICD group was significant for the primary arrhythmic endpoint (HR 0.10, 95% CI, 0.01-0.53; p = 0.003). However, there were no differences in the cumulative incidences of all-cause death between the ICD and non-ICD groups (17.3% versus 17.5%, p = 0.68), and the adjusted risk of the ICD group relative to the non-ICD group remained insignificant for all-cause death (HR, 0.85; 95%CI, 0.52-1.36, p = 0.51). This study elucidated the real-world features of ADHF patients between those with ICD and those without. ICD use in patients with ADHF and reduced LVEF as compared with non-ICD use was associated with significant risk reduction for arrhythmic events, but not for mortality. [ABSTRACT FROM AUTHOR]

Abstract Objectives The aim of this study was to compare 7-year outcomes between the first-generation sirolimus-eluting stent (SES) and the new-generation everolimus-eluting stent (EES) in a randomized clinical trial. Background There is a scarcity of very long-term (beyond 5 years) data from clinical trials investigating whether new-generation drug-eluting stents have clear clinical advantages over first-generation drug-eluting stents. Methods RESET (Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial) is the largest randomized trial comparing EES with SES (NCT01035450). Among a total of 3,197 patients in the original RESET population from 100 centers, the present extended 7-year follow-up study was conducted in 2,667 patients from 75 centers after excluding those patients enrolled from centers that denied participation. Complete 7-year follow-up was achieved in 91.5% of patients. Results The cumulative 7-year incidence of the primary efficacy endpoint of target lesion revascularization was not significantly different between EES and SES (10.2% vs. 11.7%; hazard ratio: 0.87; 95% confidence interval: 0.68 to 1.10; p = 0.24). The risk for the primary safety endpoint of death or myocardial infarction trended lower with EES than with SES (20.6% vs. 23.6%; hazard ratio: 0.85; 95% confidence interval: 0.72 to 1.005; p = 0.06). The cumulative 7-year incidence of definite stent thrombosis was very low and similar between EES and SES (0.9% vs. 1.0%; p = 0.82). The lower risk of EES relative to SES was significant for the composite secondary endpoint of target lesion failure (13.3% vs. 18.1%; hazard ratio: 0.72; 95% confidence interval: 0.59 to 0.88; p = 0.001). Conclusions During 7 years of follow-up, the risk for target lesion revascularization was not significantly different between the new-generation EES and the first-generation SES. Central Illustration [ABSTRACT FROM AUTHOR]

Highlights • The cost of tests was increased by 185,660 JPY per patient by the addition of fractional flow reserve (FFR). • The cost of treatment with percutaneous coronary intervention was reduced by 473,012 JPY per patient. • In scenario analysis, the cost reduction by FFR measurement was 109,758 JPY. • The one-way sensitivity analysis confirmed the robustness of this analysis. Abstract Background Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) could improve outcome compared with angiography-guided PCI. However, the economic impact of FFR-guided PCI remains largely unknown in the medical system in Japan. We evaluated the impact of treatment strategy modification by FFR measurement on the direct medical cost using a model analysis with a decision tree model in Japan. Methods For the clinical parameters set in the model, the findings from CVIT-DEFER registry were adopted. Cost parameters were considered on the assumption that coronary angiography, FFR measurement, and the treatment are performed at Diagnosis Procedure combination (DPC) hospitals, and the costs were calculated based on the medical fee reimbursement systems in Japan. Results The probability of deferral of PCI in patients who were allocated to PCI based on coronary angiography was set as 90.1% based on the CVIT-DEFER registry. In the model analysis, the cost of tests was increased by 185,660 JPY per patient by the addition of FFR measurement, but the cost of treatment with PCI was reduced by 561,425 JPY per patient, and the entire cost of treatment was reduced by 322,675 JPY, resulting in the expected reduction in the total expected medical cost by 137,015 JPY per patient. Conclusion Under contemporary Japanese practice, FFR-guided PCI has potential to reduce the medical cost by effective reassessment of coronary stenosis and reducing inappropriate application of PCI. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to evaluate the prognostic impact of left ventricular ejection fraction (LVEF) in patients with severe aortic stenosis (AS). Background The prognostic impact of LVEF in severe AS remains controversial. Methods Among 3,815 consecutive patients with severe AS enrolled in the CURRENT AS (Contemporary Outcomes After Surgery and Medical Treatment in Patients With Severe Aortic Stenosis) registry, the present study population consisted of 3,794 patients after excluding 21 patients without LVEF data. Patients were divided into 4 groups according to LVEF at index echocardiography (<50%, 50% to 59%, 60% to 69%, and ≥70%; conservative strategy: n = 388, n = 390, n = 1,025, and n = 800; initial aortic valve replacement strategy: n = 206, n = 170, n = 375, and n = 440). Echocardiographic data were site reported, and there was no echocardiography core laboratory. Results In the conservative group, the cumulative 5-year incidence of the primary outcome measure (a composite of aortic valve–related death or heart failure hospitalization) was significantly higher in patients with LVEFs <50% and 50% to 59% than in those with LVEFs 60% to 69% and ≥70% (72.3%, 58.4%, 38.7%, and 35.0%, respectively, p < 0.001), whereas in the initial aortic valve replacement group, the negative effect of low LVEF was markedly attenuated (20.2%, 20.3%, 17.7%, and 12.4%, respectively, p = 0.03). After adjusting for confounders, LVEF <50% (hazard ratio: 1.82; 95% confidence interval: 1.44 to 2.28; p < 0.001) and 50% to 59% (hazard ratio: 1.77; 95% confidence interval: 1.42 to 2.20; p < 0.001) but not 60% to 69% (hazard ratio: 1.14; 95% confidence interval: 0.94 to 1.39; p = 0.17) were independently associated with poorer outcomes compared with LVEF ≥70% (reference) in the conservative group. In the initial aortic valve replacement group, the adjusted risk for the primary outcome measure was not significantly different across the 4 LVEF groups. Conclusions This study demonstrates that survival in patients with severe AS is impaired when LVEF is <60%, and these findings have implications for decision making with regard to the timing of surgical intervention. [ABSTRACT FROM AUTHOR]

Background This study aimed to compare very late vascular response after stent implantation between everolimus-eluting stent (EES) with a thin, non-adhesive, durable, biocompatible fluorinated polymer and biolimus-eluting stent (BES) with a biodegradable polymer by optical coherence tomography (OCT). Methods and results In the NOBORI-BES Versus XIENCE V/PROMUS-EES Trial (NEXT), a formal OCT substudy investigated 48 patients (27 EES-treated lesions in 23 patients and 28 BES-treated lesions in 25 patients) with 2-year (18–30 months) follow-up imaging at 18 centers. The percentage of uncovered strut by neointima was significantly lower in EES compared with BES (2.1 ± 4.7% vs. 7.9 ± 10.8%, p = 0.013). The percentage of malapposed strut was not different between EES and BES (0.1 ± 0.3% vs. 0.5 ± 1.3%, p = 0.138). The frequency of stent with evagination, which is identified as outward bulges in the luminal contour between struts, was significantly lower in EES compared with BES (22% vs. 86%, p < 0.001). The frequency of neoatherosclerosis was not different between EES and BES (11% vs. 11%, p = 1.000). Conclusions At 2 years after stent implantation, uncovered stent strut by neointima and evagination were less frequently observed in EES compared with BES. This OCT study suggests that the very late vascular response is different between EES and BES. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to assess the volume–outcome relationship for PCI within the nationwide registration system in Japan. Background The effect of site and operator case load for percutaneous coronary intervention (PCI) on outcomes has not been investigated thoroughly in non-Western regions. Methods In the present study, PCI procedural data recorded between January 2014 and December 2015 in the Japanese PCI registry, a nationwide registration system, were analyzed. Institutions and operators were categorized into deciles based on the number of PCIs performed per year. Odds ratios (ORs) for in-hospital mortality and the composite endpoint (in-hospital death and periprocedural complications) were estimated for each decile (with the lowest volume group as a reference group). Results A total of 323,322 PCIs (at 625 hospitals [median PCI cases/year: 216; quartiles: 121 to 332] by 4,211 operators [median PCI cases/year: 28; quartiles: 10 to 56]) were analyzed, of which 2,959 patients (0.9%) and 7,205 patients (2.2%) experienced in-hospital mortality and the composite endpoint after PCI, respectively. The adjusted risk for in-hospital mortality and the composite endpoint was significantly higher in hospitals included in the lowest decile (<150 PCIs/year); the risk remained consistently low across the remaining deciles. Contrastingly, no significant volume–outcome relationship was observed between operator volume and outcomes. A similar trend was observed when the analysis was confined to emergency/urgent PCI cases. Conclusions In contemporary Japanese PCI practice, lower institutional volume was related inversely to in-hospital outcomes, but the association of annual operator volume with outcomes was less clear. [ABSTRACT FROM AUTHOR]

Background Stent fracture (SF) after drug-eluting stent (DES) implantation was reported to be associated with target lesion revascularization (TLR). We have noted abnormal late acquired stent axial deformation in lesions after DES implantation, especially in SF lesions, and defined it as stent recoil (SR). We evaluated the incidence, predictive factors, and clinical impact of SR in SF lesions. Methods Between 2003 and 2012, 5456 patients (11,712 lesions) underwent DES implantations and follow-up angiography within one year after the index procedure. SR was defined as an axial recoil deformation less than 80% of the stent diameter and SF was defined as the separation of stent segments or stent struts. SF and SR were confirmed by follow-up angiography. The primary endpoint was defined as clinically driven TLR. Results SF was observed in 494 lesions (4.2%) and SR in 138 of SF lesions (27.9%). According to multinomial logistic regression analyses, severe calcification and ostial lesion in the right coronary artery were stronger predictive factors of SF with SR lesions. The cumulative incidences of any and clinically driven TLR at 5 years were both significantly higher in the SF with SR group than in the SF without SR group (51.7% versus 35.0%, P < 0.001; 22.2% versus 12.8%, P = 0.019; respectively). Conclusions SR in SF lesions after DES implantation could be related to the lesion characteristics. SF with SR was highly associated with subsequent TLR compared with SF without SR. [ABSTRACT FROM AUTHOR]

Unlabelled: Little is known about the long-term outcomes after first-generation sirolimus-eluting stent (SES) implantation. We aimed to investigate the clinical outcomes up to 10 years after SES implantation.Methods: The study population comprised 342 patients (504 lesions) who underwent SES implantation between January 2002 and December 2004. The median duration of follow-up was 3816 days (interquartile range [Q1-Q3], 3,705-3,883 days).Results: The cumulative event rate of definite stent thrombosis was 3.9%. The cumulative rate of target lesion revascularization (TLR) at 1, 5, and 10 years was 8.7%, 18.8%, and 31.1%, respectively, and the annual rate of TLR was 3.1%. Clinically driven TLR occurred at relatively constant rate during 10 years (2.0% per year). In a multivariate analysis, higher body mass index, hemodialysis, in-stent restenosis (ISR) target lesion, and total stent length >30 mm were independent risk factors of TLR within 5 years. An independent risk factor of TLR beyond 5 years was ISR target lesion.Conclusions: Late TLR after SES implantation is a long-term hazard, lasting up to 10 years. The ISR target lesion is a risk factor of TLR during 10 years. [ABSTRACT FROM AUTHOR]

Background There are currently inadequate data on whether “late restenosis” occurs after paclitaxel-coated balloon (PCB) angioplasty for in-stent restenosis (ISR) lesions. Objectives To evaluate the long-term safety and efficacy of PCB angioplasty, we investigated serial clinical and angiographic outcomes after PCB angioplasty for ISR lesions. Methods Between September 2008 and December 2012, PCB angioplasty was performed in 468 patients with 550 ISR lesions (bare-metal stent restenosis [BMS-ISR]: 114 lesions, drug-eluting stent restenosis [DES-ISR]: 436 lesions). Two serial angiographic follow-ups were routinely planned for the patients (at 6 and 18 months after the procedure). Results Early follow-up (6 months) angiography was performed for 488 lesions (89%), and recurrent restenosis occurred in 13 lesions (13.0%) in the BMS-ISR group and in 82 lesions (21.1%) in the DES-ISR group. Target lesion revascularization was performed for 7 lesions (7.0%) in the BMS-ISR group and 54 lesions (13.9%) in the DES-ISR group. Late follow-up (18 months) angiography was performed for 377 (88%) of the remaining 427 lesions (excluding target lesion revascularization lesions), and late restenosis was found in 2 lesions (2.5%) in the BMS-ISR group and 50 lesions (16.8%) in the DES-ISR group. Delayed late lumen loss was significantly larger in the DES-ISR group. Previous stent size ≤2.5 mm, percentage diameter stenosis after the procedure, and in-stent occlusion lesion were independent predictors of early restenosis. DES-ISR, percentage diameter stenosis at early follow-up, and hemodialysis were independent predictors of late restenosis. Conclusions Late restenosis occurs after PCB angioplasty for DES-ISR lesions. [ABSTRACT FROM AUTHOR]

Objectives: This study assessed 5-year outcomes after implantation of sirolimus-eluting stents (SES) for unprotected left main coronary artery (ULMCA) disease in comparison with that for non-left main disease. Background: More information on long-term outcomes after ULMCA stenting is needed. Methods: The j-Cypher is a multicenter prospective registry of consecutive patients undergoing SES implantation in Japan. Results: Among 12,812 patients enrolled in the j-Cypher registry, the unadjusted mortality rate at 5 years was significantly higher in patients with ULMCA stenting than in patients without ULMCA stenting (22.8% vs. 14.1%; p < 0.0001); however, the risk for death with ULMCA stenting was no longer significant after adjusting for confounders (hazard ratio: 1.18, 95% confidence interval: 0.95 to 1.46; p = 0.14). In the lesion-level comparison, the nonbifurcation ULMCA lesions treated exclusively with SES had a significantly lower rate of target lesion revascularization (TLR) than those in non-ULMCA nonbifurcation lesions (2.4% vs. 12.7%; p = 0.04). Among bifurcation lesions, those treated with a provisional 2-stent approach had similar rates of TLR (12.1% vs. 11.4%; p = 0.79) between the ULMCA and non-ULMCA groups. Lesions treated with an elective 2-stent approach had higher TLR rates in the ULMCA group as compared with the non-ULMCA group (33.5% vs. 19.7%; p = 0.002). Conclusions: The safety of ULMCA stenting relative to non-LMCA stenting was maintained through 5 years follow-up. In terms of efficacy, SES implantation in nonbifurcation ULMCA lesions was associated with an extremely low cumulative incidence of TLR, whereas the elective 2-stent approach for ULMCA bifurcation lesions was associated with a markedly higher cumulative incidence of TLR as compared with that for non-ULMCA bifurcation lesions. [Copyright &y& Elsevier]

Objectives: The aim of this study was to investigate the efficacy of a paclitaxel-eluting balloon (PEB) for the treatment of sirolimus-eluting stent (SES) restenosis. Background: Because drug-eluting stents (DES) are being used in increasingly complicated settings, DES restenosis is no longer an uncommon phenomenon, and its optimal treatment is unknown. Methods: This study was a prospective single-blind randomized trial conducted in 50 patients with SES restenosis. Patients were randomly assigned to a PEB group (n = 25) or a conventional balloon angioplasty (BA) group (n = 25). The primary end point was late lumen loss at 6-month follow-up. Secondary end points included the rate of binary restenosis (in-segment analysis) and major adverse cardiac events (MACE) at 6-month follow-up. Results: At 6-month angiographic follow-up (follow-up rate: 94%), in-segment late lumen loss was lower in the PEB group than in the BA group (0.18 ± 0.45 mm vs. 0.72 ± 0.55 mm; p = 0.001). The incidence of recurrent restenosis (8.7% vs. 62.5%; p = 0.0001) and target lesion revascularization (4.3% vs. 41.7%; p = 0.003) was also lower in the PEB group than in the BA group. The cumulative MACE-free survival was significantly better in the PEB group than in the BA group (96% vs. 60%; p = 0.005). Conclusions: In patients with SES restenosis, PEB provided much better clinical, angiographic outcomes than conventional BA. [Copyright &y& Elsevier]

There is still a scarcity of data on causes of long-term mortality in patients with venous thromboembolism (VTE). The COMMAND VTE Registry is a physician-initiated, retrospective, multicenter cohort study in which consecutive 3027 patients with acute symptomatic VTE among 29 centers in Japan were included between January 2010 and August 2014. We investigated detailed causes and risk factors for long-term mortality. During a median observation period of 1218 days, a total of 764 patients died, and the prevalence of active cancer was higher in patients who died than in patients alive (61 % versus 10 %, P < 0.001). The cumulative incidences of cardiac death, pulmonary embolism (PE)-related death, bleeding death, cancer death, and non-cardiovascular non-cancer death were 2.2 %, 2.9 %, 2.0 %, 16.1 %, and 6.7 % at 5 years, respectively. The incidence of cancer death increased gradually, which was the most common cause of long-term death. Among patients without active cancer, the incidence of PE-related death increased rapidly and became a plateau beyond the acute phase, whereas the incidence of non-cardiovascular non-cancer death kept increasing, which became most common in the long term. The separate multivariable analysis among patient with and without active cancer identified independent risk factors of all-cause death including a few patient characteristics among patients with active cancer and several patient characteristics among patients without active cancer. Cancer was the most common cause of long-term mortality, while non-cardiovascular non-cancer death became most common among patients without active cancer. [Display omitted] [ABSTRACT FROM AUTHOR]

There is a paucity of data on real-world management strategies and clinical outcomes of cancer-associated venous thromboembolism (VTE) in the direct oral anticoagulants (DOACs) era. To investigate the status of cancer-associated VTE in the DOAC era. This multicenter, retrospective cohort study among 31 centers in Japan between 2015 and 2020 enrolled 5197 consecutive patients with acute symptomatic VTE, who were divided into 1507 patients (29 %) with active cancer and 3690 patients (71 %) without. The cumulative 3-year rate of anticoagulation discontinuation was significantly higher in patients with active cancer than in those without (62.7 % vs. 59.1 %, P < 0.001). The cumulative 5-year incidence of recurrent VTE was higher in patients with active cancer than in those without (10.1 % vs. 9.1 %, P = 0.01), however, after adjusting for the confounders and competing risk of mortality, the excess risk of the active cancer group relative to the no active cancer group was no longer significant (HR: 0.95, 95 % CI: 0.73-1.24). The cumulative 5-year incidence of major bleeding was much higher in the active cancer group (20.4 % vs. 11.6 %, P < 0.001). Even after adjusting for the confounders and competing risk of mortality, the risk of the active cancer group relative to the no active cancer group remained significant (HR: 1.36, 95 % CI: 1.11–1.66). The current large real-world registry revealed that the risk of major bleeding was still higher in patients with active cancer than in those without, leading to the frequent anticoagulation discontinuation, which has been still a huge challenge to overcome in the DOAC era. VTE, venous thromboembolism; DOAC, direct oral anticoagulant; GI, gastrointestinal. [Display omitted] • We investigated the current status of cancer-associated VTE in the real world, using a large observational database in the DOAC era. • The risk of major bleeding was still higher in active cancer patients than those without, leading to the frequent anticoagulation discontinuation. • The gastrointestinal bleeding was the major bleeding site in active cancer patients reflecting the higher risk of anticoagulation-related bleeding. • The risk of recurrent VTE in the early phase seemed to be higher in patients with active cancer. [ABSTRACT FROM AUTHOR]