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The distal radial approach (DRA) has been proposed as an alternative approach for coronary angiography (CAG) and percutaneous coronary intervention (PCI); however, the predictors of DRA failure and puncture site complications are unclear. Among 7153 consecutive patients undergoing CAG or PCI between November 2018 and January 2021, 3610 patients undergoing CAG or PCI with DRA were analyzed. The primary endpoint of this study was the procedural success, and the secondary endpoint of this study was puncture site complications during procedure. Puncture site complications during procedure were defined as a composite of major bleeding, minor bleeding, arteriovenous fistula, pseudoaneurysm, and neuropathy. The DRA success rate and the puncture site complication rate were 90.4% and 7.7%, respectively. The predictors of DRA failure were low body weight and dual antiplatelet therapy; those of DRA success were PCI and ultrasonography-guided DRA; those of puncture site complications during procedure were low body weight, peripheral arterial disease, dual antiplatelet therapy, anticoagulant therapy, and PCI; and that of no puncture site complications were previous PCI and ultrasonography-guided DRA. The negative predictors of DRA success with no puncture site complication during procedure were low body weight and dual antiplatelet therapy. The positive predictor of DRA success with no puncture site complication during procedure was ultrasonography-guided DRA. We identified the predictors of DRA failure and puncture site complications during procedure in patients undergoing CAG and PCI with DRA. Ultrasonography-guided DRA was associated with a high DRA success rate and a low puncture site complication rate in patients undergoing CAG or PCI with DRA.

Background The association between renal morphological findings and changes in renal function in patients undergoing transcatheter aortic valve implantation (TAVI) is unexplored. Aims We aimed to investigate the association between renal morphological findings and changes in renal function in patients undergoing TAVI. Methods Among 283 consecutive patients undergoing TAVI between 2018 and 2021, the study sample included 224 patients. Renal morphological measurements were performed by preoperative multi-detector computed tomography. Estimated glomerular filtration rate (eGFR) improvement and deterioration were defined as positive or negative changes in an eGFR of ≥10% one month after TAVI. The renal cortex thickness index was defined as the ratio of total renal cortex thickness to body surface area. Results The incidences of eGFR improvement and deterioration were 33.9% and 24.1%, respectively. The renal cortex thickness index had a significant correlation with changes in eGFR (r=0.34, pl0.01). The index of the area under the curve of renal cortex thickness for eGFR improvement and deterioration were 0.73 and 0.68, respectively. The cut-off values were 5.82 mm/m2 for eGFR improvement (odds ratio [OR]: 0.10; 95% confidence interval: 0.05-0.20; pl0.01) and 4.89 mm/m2 for eGFR deterioration (OR: 9.07; 95% confidence interval: 4.55-18.6; pl0.01). Conclusions The renal cortex thickness index was associated with changes in renal function in patients who underwent TAVI. Its measurements might be useful for predicting the renal function change in patients undergoing TAVI.

Anticoagulation therapy is prescribed for the prevention of recurrence in patients with venous thromboembolism, which could be temporarily interrupted during invasive procedures. The COMMAND VTE Registry is a multicenter registry enrolling 3027 consecutive patients with acute symptomatic VTE in Japan between January 2010 and August 2014. We identified patients who underwent invasive procedures during the entire follow-up period and evaluated periprocedural managements and clinical outcomes at 30 days after invasive procedures. During a median follow-up period of 1213 (IQR: 847–1764) days, 518 patients underwent invasive procedures with the cumulative incidences of 5.8% at 3 months, 11.1% at 1 year, and 24.0% at 5 years. Among 382 patients in high bleeding-risk category of invasive procedures, anticoagulation therapy had been discontinued already in 62 patients (16%) and interrupted temporarily in 288 patients (75%) during the invasive procedures with bridging anticoagulation therapy with heparin in 214 patients (56%). Among 80 patients in low bleeding-risk category, anticoagulation therapy had been already discontinued in 15 patients (19%) and interrupted temporarily in 31 patients (39%) during invasive procedure with bridging anticoagulation therapy with heparin in 17 patients (21%). At 30 days after the invasive procedures, 14 patients (2.7%) experienced recurrent VTE, while 28 patients (5.4%) had major bleeding. This study elucidated the real-world features of peri-procedural management and prognosis in patients with VTE who underwent invasive procedures during follow-up in the large multicenter VTE registry. The 30-day incidence rates of recurrent VTE and major bleeding events were 2.7% and 5.4%.

Prolonged anticoagulation therapy is recommended for patients with intermediate-risk for recurrence of venous thromboembolism (VTE). The current study aimed to identify risk factors of VTE recurrence and major bleeding in intermediate-risk patients. The COMMAND VTE Registry is a multicenter registry enrolled consecutive 3027 patients with acute symptomatic VTE among 29 centers in Japan. The current study population consisted of 1703 patients with intermediate-risk for recurrence. The primary outcome measure was recurrent VTE during the entire follow-up period, and the secondary outcome measures were recurrent VTE and major bleeding during anticoagulation therapy. In the multivariable Cox regression model for recurrent VTE incorporating the status of anticoagulation therapy as a time-updated covariate, off-anticoagulation therapy was strongly associated with an increased risk for recurrent VTE (HR 9.42, 95% CI 5.97–14.86). During anticoagulation therapy, the independent risk factor for recurrent VTE was thrombophilia (HR 3.58, 95% CI 1.56–7.50), while the independent risk factors for major bleeding were age ≥ 75 years (HR 2.04, 95% CI 1.36–3.07), men (HR 1.52, 95% CI 1.02–2.27), history of major bleeding (HR 3.48, 95% CI 1.82–6.14) and thrombocytopenia (HR 3.73, 95% CI 2.04–6.37). Among VTE patients with intermediate-risk for recurrence, discontinuation of anticoagulation therapy was a very strong independent risk factor of recurrence during the entire follow-up period. The independent risk factors of recurrent VTE and those of major bleeding during anticoagulation therapy were different: thrombophilia for recurrent VTE, and advanced age, men, history of major bleeding, and thrombocytopenia for major bleeding. Unique identifier: UMIN000021132. COMMAND VTE Registry: http://www.umin.ac.jp/ctr/index.htm .

The Academic Research Consortium for High Bleeding Risk (ARC-HBR) defined a consensus clinical criterion for patients at HBR undergoing percutaneous coronary intervention (PCI). This study aimed to validate and compare the ARC-HBR criteria and the contemporary risk score for long-term bleeding outcomes using a cohort of patients undergoing PCI.Methods and Results: This study analyzed 3,410 patients who underwent PCI between 2010 and 2013. The endpoint was defined as incidence of The Bleeding Academic Research Consortium 3 or 5 bleeding events. In addition to ARC-HBR, this study validated the predictability of the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score, Patterns of non-adherence to Anti-platelet Regimens In Stented patients (PARIS) bleeding score, and Coronary Revascularization Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) bleeding scores for bleeding events. There was a trend toward an increase in bleeding events, as the risk score increased for all bleeding risk scores used in this study. The ARC-HBR criteria had higher diagnostic sensitivity for bleeding events than other bleeding risk scores.Patients with a higher number of risk factors in each of the four bleeding risk scores had a higher risk of long-term bleeding events. In comparison to other contemporary risk scores, the ARC-HBR criteria were more sensitive in the identification of patients with bleeding events in the long-term.

Gastrointestinal bleeding (GIB) and intracranial bleeding (ICB) are frequently observed as major bleeding events after percutaneous coronary intervention (PCI); however, there are few reports on these predictors and their association with the Academic Research Consortium for High Bleeding Risk (ARC-HBR).Methods and Results: The study included 3,453 patients who underwent PCI with second-generation drug-eluting stents between 2010 and 2013. Mean follow up was 2,663±596 days. The cumulative incidences of GIB and ICB were significantly higher in the HBR group than in the non-HBR group (6.3% vs. 1.9%, P0.001, 5.5% vs. 2.3%, P0.001). Older age, oral anticoagulant (OAC), and severe chronic kidney disease were independent predictors of GIB (hazard ratios [HR], 1.64; 95% confidence intervals [CI], 1.11-2.41; P=0.012; HR, 1.94; 95% CI, 1.23-3.05; P=0.004; HR, 1.80; 95% CI, 1.02-3.19, P=0.043 respectively), and low body weight, OAC, and left main coronary artery stenting were independent predictors of ICB by multivariate logistic regression analysis (HR, 1.83; 95% CI, 1.20-2.80; P=0.005; HR, 2.04; 95% CI, 1.31-3.19; P=0.002; HR, 1.79; 95% CI, 1.18-2.70; P=0.006 respectively).ARC-HBR was consistently associated with GIB and ICB within a 7-year period. GIB and ICB had three predictors each. Of these, only OAC administration was common, and the other two were different.

Anticoagulation therapy is prescribed for the prevention of recurrence in patients with venous thromboembolism, which could be temporarily interrupted during invasive procedures. The COMMAND VTE Registry is a multicenter registry enrolling 3027 consecutive patients with acute symptomatic VTE in Japan between January 2010 and August 2014. We identified patients who underwent invasive procedures during the entire follow-up period and evaluated periprocedural managements and clinical outcomes at 30 days after invasive procedures. During a median follow-up period of 1213 (IQR: 847-1764) days, 518 patients underwent invasive procedures with the cumulative incidences of 5.8% at 3 months, 11.1% at 1 year, and 24.0% at 5 years. Among 382 patients in high bleeding-risk category of invasive procedures, anticoagulation therapy had been discontinued already in 62 patients (16%) and interrupted temporarily in 288 patients (75%) during the invasive procedures with bridging anticoagulation therapy with heparin in 214 patients (56%). Among 80 patients in low bleeding-risk category, anticoagulation therapy had been already discontinued in 15 patients (19%) and interrupted temporarily in 31 patients (39%) during invasive procedure with bridging anticoagulation therapy with heparin in 17 patients (21%). At 30 days after the invasive procedures, 14 patients (2.7%) experienced recurrent VTE, while 28 patients (5.4%) had major bleeding. This study elucidated the real-world features of peri-procedural management and prognosis in patients with VTE who underwent invasive procedures during follow-up in the large multicenter VTE registry. The 30-day incidence rates of recurrent VTE and major bleeding events were 2.7% and 5.4%.

Prolonged anticoagulation therapy is recommended for patients with intermediate-risk for recurrence of venous thromboembolism (VTE). The current study aimed to identify risk factors of VTE recurrence and major bleeding in intermediate-risk patients. The COMMAND VTE Registry is a multicenter registry enrolled consecutive 3027 patients with acute symptomatic VTE among 29 centers in Japan. The current study population consisted of 1703 patients with intermediate-risk for recurrence. The primary outcome measure was recurrent VTE during the entire follow-up period, and the secondary outcome measures were recurrent VTE and major bleeding during anticoagulation therapy. In the multivariable Cox regression model for recurrent VTE incorporating the status of anticoagulation therapy as a time-updated covariate, off-anticoagulation therapy was strongly associated with an increased risk for recurrent VTE (HR 9.42, 95% CI 5.97-14.86). During anticoagulation therapy, the independent risk factor for recurrent VTE was thrombophilia (HR 3.58, 95% CI 1.56-7.50), while the independent risk factors for major bleeding were age ≥ 75 years (HR 2.04, 95% CI 1.36-3.07), men (HR 1.52, 95% CI 1.02-2.27), history of major bleeding (HR 3.48, 95% CI 1.82-6.14) and thrombocytopenia (HR 3.73, 95% CI 2.04-6.37). Among VTE patients with intermediate-risk for recurrence, discontinuation of anticoagulation therapy was a very strong independent risk factor of recurrence during the entire follow-up period. The independent risk factors of recurrent VTE and those of major bleeding during anticoagulation therapy were different: thrombophilia for recurrent VTE, and advanced age, men, history of major bleeding, and thrombocytopenia for major bleeding. CLINICAL TRIAL REGISTRATION: Unique identifier: UMIN000021132. COMMAND VTE Registry: http://www.umin.ac.jp/ctr/index.htm .

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%, p0.001), 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.

The clinical outcomes of patients undergoing percutaneous coronary intervention (PCI) for left main coronary artery (LMCA) malperfusion caused by acute type A aortic dissection (AAAD) remains largely unexplored. The aim of this study was to determine the clinical outcomes of patients undergoing PCI for LMCA malperfusion caused by AAAD. We examined nine consecutive patients undergoing PCI for LMCA malperfusion caused by AAAD between 1995 and 2020. The mean age was 55.4 ± 7.7 years. Eight patients presented cardiogenic shock, and five patients cardiopulmonary arrest. Two patients were diagnosed with AAAD before coronary angiography using computed tomography and transthoracic echocardiography, respectively, and in the other seven patients after coronary angiography using other modalities. Four patients underwent PCI on intra-aortic balloon pumping support, and four patients on venoarterial extracorporeal membrane oxygenation (VA-ECMO) support, including one patient on both. PCI was successful in eight patients, with final thrombolysis in myocardial infarction grade 2 or 3. The four patients on VA-ECMO did not undergo aortic dissection repair due to poor recovery of cardiac function and died during the hospital stay, and the other five patients had successful PCI, underwent aortic dissection repair, and remained alive at 5 year follow-up. In conclusion, LMCA malperfusion caused by AAAD seemed to have clinical presentations and electrocardiogram changes similar to acute coronary syndrome. PCI and subsequent surgical aortic repair saved the lives of all AAAD patients with LMCA malperfusion who had not required VA-ECMO.

Background Guide catheter-induced iatrogenic coronary artery dissection is a rare but feared complication. When it occurs, bailout stenting is widely performed; however, its prognosis and the impact of stent type remains unclear.Methods and Results:The study population consisted of 77,257 consecutive patients (coronary angiography, 55,864; percutaneous coronary intervention, 21,393) between 2000 and 2015. We investigated the incidence, clinical outcomes, and angiographic results after bailout stenting and compared by stent type: bare-metal stent (BMS) and drug-eluting stent (DES). Iatrogenic coronary artery dissection occurred in 105 patients (incidence rate, 0.14%). All cases of iatrogenic coronary artery dissection that were recognized as requiring bailout procedure could be managed by stent implantation, and no patients died during bailout procedure. The 5-year cumulative incidences of cardiac death, target lesion revascularization, and major adverse cardiac events were 11.3%, 10.3%, and 21.0%, respectively. The binary restenosis rate was 10.4%, and it was not significantly different between BMS and DES implantation. In lesions with preprocedural stenosis, however, it was significantly lower in the DES group than in the BMS group. On the other hand, coronary artery dissection recurred in 8 patients, which was observed only after DES implantation. Conclusions The immediate and long-term outcomes of bailout stenting for iatrogenic coronary artery dissection were acceptable. Although DES may be favorable for stenotic lesions, coronary artery dissection can recur after DES implantation.

Little is known about the impact of a high-dose statin on cardiovascular outcomes after ST-elevation acute myocardial infarction (STEMI) in real-world Japanese patients. Between July 2011 and June 2017, 1110 consecutive STEMI patients underwent primary percutaneous coronary intervention at our hospital and were discharged. A high-dose statin was administered in 117 patients (10.5%) and non-high-dose statin was administered in 947 patients (85.3%). The low-density lipoprotein cholesterol level was significantly higher in the high-dose statin group at admission (129.8 ± 44.9 vs. 110.4 ± 32.7, p

A relationship between serum polyunsaturated fatty acids (PUFAs) and cardiovascular disease has been reported; however, the existence of a relationship between serum PUFAs and extent of vessel disease (VD) in patients with ST elevation myocardial infarction (STEMI) remains unclear.Between July 2011 and June 2015, 866 consecutive STEMI patients underwent emergent percutaneous coronary intervention, 507 of whom were enrolled and classified into three groups according to the initial angiograms: 1VD, 294 patients; 2VD, 110 patients; and 3VD/left main trunk disease (LMTD), 103 patients. Serum levels of PUFAs, including eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and arachidonic acid, and other laboratory data during hospitalization were evaluated.The serum EPA level in the 3VD/LMTD group was significantly lower than that in the 1VD group (55.5 ± 22.1 versus 66.2 ± 28.7, P = 0.002) and was slightly lower than that in the 2VD group (55.5 ± 22.1 versus 65.2 ± 28.9, P = 0.0167). Multivariate adjustment analysis revealed that age ≥ 70 years (odds ratio, 1.72; 95% confidence interval, 1.03-2.89; P = 0.038) and a low serum EPA level (odds ratio, 0.98; 95% confidence interval, 0.99-1.00; P = 0.023) were independent risk factors for 3VD/LMTD, while a low serum DHA level was not.A low serum EPA level may be more strongly related than a low serum DHA level to the extent of VD in STEMI patients. Age ≥ 70 years and a low serum EPA level may be independent risk factors for 3VD/LMTD.

Background Data on bleeding events in Japanese patients with acute coronary syndrome (ACS) are insufficient. In addition, the efficacy and safety of a maintenance dose of prasugrel 2.5 mg/day in high bleeding risk patients are unknown.Methods and Results:We prospectively enrolled 1,167 consecutive patients with suspected ACS and undergoing percutaneous coronary intervention. The maintenance dose of prasugrel 2.5 mg/day was prescribed for patients with a low body weight (≤50 kg), elderly (≥75 years), or renal insufficiency (eGFR ≤30 mL/min/1.73 m2). In-hospital events were assessed in 992 ACS patients treated with drug-eluting stents. Excluding 29 in-hospital deaths, out-of-hospital events were assessed in 963 ACS patients. The primary safety outcome measure was major bleeding (Bleeding Academic Research Consortium types 3 and 5). The incidence of in-hospital major bleeding was 3.4%. Multivariate analysis showed that being elderly, low body weight, renal insufficiency, stroke history, femoral approach, and mechanical support usage were independent predictors of in-hospital major bleeding. The cumulative 1-year incidence of out-of-hospital major bleeding was not significantly different between the prasugrel 2.5 mg/day (n=284) and 3.75 mg/day (n=487) groups (1.6% vs. 0.7%, log-rank P=0.24). That of out-of-hospital definite or probable stent thrombosis was 0% in both groups. Conclusions The maintenance dose of adjusted prasugrel 2.5 mg/day seems to be one option in ACS patients at high bleeding risk.

In-stent restenosis after drug-eluting stent implantation (DES-ISR) in the left main coronary artery remains challenging to manage. Our aim was to assess the effectiveness of paclitaxel-coated balloon angioplasty for DES-ISR in the left main coronary artery. We identified 91 DES-ISR lesions in the

We sought to determine the predictors of recurrent in-stent restenosis (ISR) after paclitaxel-coated balloon (PCB) angioplasty for ISR in patients with renal failure receiving hemodialysis. A total of 235 ISR lesions in patients with renal failure receiving hemodialysis treated with PCB between

Stent fracture (SF) and peri-stent contrast staining (PSS) after sirolimus-eluting stent implantation are reported to be associated with target lesion revascularization (TLR). We aimed to assess the impact of SF and PSS on TLR at 10 years after the procedure. Between 2002 and 2005, 972 patients (