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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.

Drug-coated balloon (DCB) angioplasty for side branches with main branch stenting is effective for bifurcation lesions and reduces late lumen loss (LLL) in side branches. However, the predictors and clinical implications of LLL after DCB angioplasty are largely unexplored.Among 181 patients undergoing DCB angioplasty for side branches with drug-eluting stent implantation for main branches between 2016 and 2018, we enrolled 138 patients (138 lesions) undergoing follow-up coronary angiography within 1 year. The 1-year cumulative rates of target lesion revascularization (TLR) and major adverse cardiac events (MACE: defined as a composite of all-cause death, myocardial infarction, and TLR) were compared between patients with late lumen gain (LLG) (LLG group) and those with LLL (LLL group).The binary restenosis rate of the side branch was 8.0% (11 lesions), mean LLL was -0.14 ± 0.43 mm, and LLG was observed in 99 lesions (71.7%). The DCB size/reference vessel diameter ratio showed mild discrimination (area under the curve, 0.60; 95% confidence interval, 1.2-65.0; p = 0.03) for predicting the side branch progression. The 1-year cumulative rates of MACE and TLR were not significantly different but numerically lower in the LLG group than in the LLL group (2.0% vs. 7.8%, p = 0.11 and 2.0% vs. 7.7%, p = 0.11, respectively). Lumen regression after DCB angioplasty for side branches are associated with improved clinical outcomes.The DCB size relative to the reference vessel diameter is a predictor of late lumen enlargement in side branches.

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.

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.

Cholesterol crystal embolism (CCE) is a rare but serious complication of percutaneous coronary intervention (PCI). However, its incidence, risk factors, and prognosis in the contemporary era are not well known. We included 23,184 patients who underwent PCI in our institution between January 2000 and December 2019 in this study. The diagnosis of CCE was made histologically or by the combination of cutaneous signs and specific blood test results. In patients with CCE, we evaluated the incidence, risk factors, and prognosis. A total of 88 patients (0.38%) were diagnosed with CCE. The incidence of CCE seemed to decline through the investigated 20 years. Positive predictors of CCE were age ≥70 years (68% vs 59%, p = 0.012), aortic aneurysm (23% vs 7.2% p0.001), and a femoral approach (71% vs 45%, p0.001), whereas a negative predictor of CCE was the use of an inner sheath (63% vs 77%, p0.001). The rate of 1-year mortality and the requirement for chronic hemodialysis within 1 year after PCI in patients with CCE were 10% and 11%, respectively. The use of an inner sheath and a nonfemoral approach was associated with a lower incidence of CCE. In conclusion, because the prognosis of patients with CCE is still poor, preprocedural identification of high-risk patients and selection of low-risk procedures could be important for preventing CCE.

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.

BACKGROUND Data on the clinical outcomes of percutaneous coronary intervention (PCI) for unprotected left main coronary artery (LMCA) in patients with acute coronary syndrome (ACS) are limited. Therefore, this study aimed to assess the clinical outcome of patients with ACS who underwent PCI for LMCA culprit lesion.Methods and Results:Of 1,809 patients enrolled in the Assessing Optimal Percutaneous Coronary Intervention for the LMCA (AOI-LMCA) registry (a retrospective 6-center registry of consecutive patients undergoing LMCA stenting in Japan), the current study population consisited of 1,500 patients with unprotected LMCA stenting for LMCA ACS (ACS with shock: 115 patients, ACS without shock: 281 patients) and stable CAD (1,104 patients). The cumulative 180-day incidence of death was markedly higher in the ACS with shock group than in the other groups (49.5%, 8.6%, and 3.3%, respectively; P

The validity of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) definitions of early (1 year), late (1-4 years), and very late (4 years) bleeding events is unknown.Methods and Results:This study was performed on patients (n=3,453) implanted with second-generation drug-eluting stents (DES) between 2010 and 2013. Data on all criteria of the ARC-HBR definition were collected retrospectively. The primary endpoint was Bleeding Academic Research Consortium Type 3 or 5 bleeding events; the ischemic endpoint was a composite of cardiac death, myocardial infarction, and ischemic stroke. The mean follow-up period was 7.5 years. Compared with non-high bleeding risk (HBR) patients, HBR patients (n=1,840; 53.3%) had an increased risk of the primary endpoint (early events, 3.6% vs. 0.5% [P0.0001]; late events, 5.3% vs. 2.5% [P0.0001]; very late events, 5.5% vs. 2.1% [P0.0001]) and of ischemic events during follow-up. The discrimination ability of the ARC-HBR definition for late and very late bleeding events was comparable to that of early bleeding events (C statistics 0.679, 0.621, and 0.620, respectively) with high negative predictive value (96.6%, 95.1%, and 93.1%, respectively). Multivariate analysis revealed the different effects of individual criteria on bleeding events in each follow-up period.The ARC-HBR definition consistently identified patients at risk of long-term bleeding and ischemic events after second-generation DES implantation.

The concept of hybrid coronary revascularization (HCR) combines the advantages of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) to improve the treatment of patients with complex multivessel disease. This study aimed to investigate a 1-year clinical follow-up of a prospective multicenter registry of HCR combined with non-saphenous vein graft surgical bypass and PCI using everolimus-eluting metallic stents (the PRIDE-METAL study). From June 2016 to June 2018, a total of 54 patients with multivessel coronary disease from six Japanese institutes were enrolled in this study. The primary endpoint of the study was the occurrence of major adverse cardiovascular event (MACE; all-cause death, myocardial infarction, stroke, and repeat revascularization) at 1 year. Three patients declined before complete HCR, and two patients were lost by the 1-year follow-up. All-cause mortality at 30 days and at 1 year was 0% and 4.1%, respectively. The rates of myocardial infarction, repeat revascularization, stroke, and MACE were 0% at 30 days, and 0%, 2.0%, 2.0%, and 8.2% at 1-year follow-up, respectively. No occlusion of arterial bypass graft at the 30-day follow-up was observed, and was observed in 1.7% at the 1-year follow-up. HCR was safe and feasible and associated with a low risk of MACE at the 1-year follow-up. Further validation in multicenter and randomized studies is needed.

Background The current guidelines have recommended to shorten the dual antiplatelet therapy duration in patients at high bleeding risk (HBR) to minimize the bleeding complications. The impact of ischemic risk factors (IRF) on long-term ischemic events in patients with and without HBR after percutaneous coronary intervention remains unclear. Methods The study population comprised 1219 patients who were treated with everolimus-eluting stents between 2010 and 2011. The mean follow-up period was 2996 ± 433 days. HBR was defined as set by the Academic Research Consortium. IRF was defined as high-risk features of stent-driven recurrent ischemic events endorsed in the 2017 European Society of Cardiology Guidelines. Major bleeding was defined as the occurrence of Bleeding Academic Research Consortium type 3 or 5 bleeding. Primary ischemic events included myocardial infarction, definite stent thrombosis, and cardiac death. Results The 1219 patients were divided into two groups: 614 patients at HBR (HBR group) and 605 patients at no HBR (non-HBR group). The rate of IRF patients was significantly higher in the HBR group than in the non-HBR group (81.4% versus 47.6%, P 0.001). The cumulative rate of ischemic events in the HBR group was significantly higher in IRF patients than in non-IRF patients (21.0% versus 7.0%, log rank P 0.001), whereas that in the non-HBR group was not significantly different between IRF and non-IRF patients (10.1% versus 6.3%, log rank P = 0.09). Conclusions More than 80% of HBR patients treated with everolimus-eluting stents were at IRF. A combination of HBR and IRF may increase the risk of long-term ischemic events.

Background Delayed coronary obstruction after transcatheter aortic valve implantation has been reported to occur more commonly after self-expandable aortic valve implantation than balloon-expandable valve. Case summary An 86-year-old woman treated by transcatheter self-expandable aortic valve implantation had acute coronary syndrome 3 months after the procedure. Emergent coronary angiography showed decreased blood flow in the left coronary artery. Balloon angioplasty between the valve frame and the left coronary cusp was performed, and her ischaemia resolved. Contrast-enhanced computed tomography showed a commissural post of the supra-annular valve overlying the left coronary cusp, and serial computed tomography showed the valve frame expanding over time. She received coronary bypass grafting using saphenous vein grafts for the left anterior descending and left circumflex arteries. Four months after surgery for the left anterior descending artery, the patient had recurrent chest pain, and computed tomography showed a graft occlusion in the left anterior descending artery. Shortly afterwards, she died of sudden cardiac arrest. Discussion In this report, we describe delayed Valsalva obstruction after transcatheter self-expandable aortic valve implantation, which can be detectable by serial computed tomography. The sealing of a coronary cusp by a commissural post of the valve may be one of the causes of delayed coronary ischaemia after transcatheter self-expandable aortic valve implantation.

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.

BACKGROUND: Calcified nodules (CN) have been reported as being associated with stent failure including in-stent restenosis (ISR). However, there is no systematic study of this condition. AIMS: We aimed to clarify the prevalence, predictors, and midterm results of ISR lesions with CN. METHODS: We examined the clinical characteristics of 651 ISR lesions in patients who underwent percutaneous coronary intervention (PCI) with optical coherence tomography (OCT) between October 2008 and July 2016, and their 6- to 8-month follow-up angiography results. CN was defined as a high backscattering mass with small nodular calcium depositions which protruded into the vessel lumen. RESULTS: Thirty-two ISR lesions (4.9%) had CN. Multivariable analysis showed that calcified lesion (odds ratio [OR] 12.441, p

Background There are no data comparing transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) outcomes in real clinical practice in Japan. Methods and results We combined 2 independent registries, the K-TAVI Registry (a 6-center prospective registry of consecutive patients who underwent TAVI) and the CURRENT AS Registry (a large, 27-center registry of 3,815 consecutive patients with severe aortic stenosis [AS]). In the K-TAVI Registry, 338 patients underwent TAVI with SAPIEN XT balloon-expandable valves from October 2013 to January 2016, whereas in the CURRENT AS Registry 237 patients with severe AS underwent SAVR from January 2003 to December 2011. Propensity score matching was conducted, with final cohort comprising 306 patients. The cumulative 2-year incidence of all-cause death and heart failure (HF) hospitalization did not differ significantly between the TAVI and SAVR groups (13.7% vs. 12.4% [P=0.81] and 7.9% vs 3.9% [P=0.13], respectively). After adjusting for residual confounders, there were no significant differences between the TAVI and SAVR groups in the risk for all-cause death (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.35-1.58; P=0.43) or HF hospitalization (HR 1.27; 95% CI 0.40-4.59; P=0.69). Conclusions These findings from 2 independent Japanese registries suggest that the 2-year risk of all-cause mortality and HF does not differ significantly between TAVI and SAVR groups in real-world practice in Japan.

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.

ObjectivePostprocedural ischaemic and bleeding risks after transcatheter aortic valve replacement (TAVR) remain a major concern. Nevertheless, no reliable risk models incorporating both possibilities are currently available. We aimed to assess the accuracy of percutaneous coronary intervention (PCI)-derived models and the performance of a recalibrated model that included variables more applicable to TAVR.MethodsThis study included 26 869 patients who had been enrolled in a national registry. Ischaemic events were defined as myocardial infarction, stroke, transient ischaemic attack or peripheral embolism at 1 year. Bleeding events were defined as any bleeding based on the Valve Academic Research Consortium-2 consensus document at 1 year. Patterns of Non-adherence to Anti-Platelet Regimen in Stented Patients (PARIS) and Coronary Revascularisation Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) integer scoring systems were tested. The models were recalibrated by applying new variables using the Fine and Gray method.ResultsThe 1-year cumulative incidences for ischaemic and bleeding events were 2.7% and 3.1%. Patients with high PARIS and CREDO-Kyoto risk scores had higher incidences of both ischaemic (3.3% vs 2.4% vs 2.4%, pConclusionsThe PCI-derived models demonstrated modest accuracy but was inadequate for risk stratification of TAVR patients at 1-year follow-up.Trial registration number3395.

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.

BACKGROUND The clinical significance of concomitant mitral regurgitation (MR) has not been well addressed in patients with severe aortic stenosis (AS).Methods and Results:We analyzed 3,815 patients from a retrospective multicenter registry of severe AS in Japan (CURRENT AS registry). We compared the clinical outcomes between patients with moderate/severe MR and with none/mild MR according to the initial treatment strategy (initial aortic valve replacement [AVR] or conservative strategy). The primary outcome measure was a composite of aortic valve-related death or heart failure hospitalization. At baseline, moderate/severe MR was present in 227/1,197 (19%) patients with initial AVR strategy and in 536/2,618 (20%) patients with a conservative strategy. The crude cumulative 5-year incidence of the primary outcome measure was significantly higher in patients with moderate/severe MR than in those with none/mild MR, regardless of the initial treatment strategy (25.2% vs. 14.4%, P

Studies on the outcomes of de novo three-vessel coronary artery disease (3VD) are limited. This study evaluated the outcomes after coronary revascularization in patients with 3VD treated by percutaneous coronary intervention (PCI) using second-generation drug-eluting stents (2ndDES) in comparison with coronary artery bypass grafting (CABG). We analyzed 853 patients undergoing either PCI or CABG for 3VD between 2010 and 2014. Of them, this study included 298 undergoing PCI with 2ndDES alone (PCI group) and 171 undergoing CABG (CABG group). The primary outcome measure was a composite of all-cause death, non-fatal myocardial infarction (MI), or stroke. The secondary outcome measures were cardiac death, MI, stroke, and target vessel revascularization (TVR). Propensity matching was used to adjust a cohort of patients with similar baseline characteristics. Between the PCI and CABG groups, no significant differences were found in the 3-year cumulative incidence of the primary outcome measure (14.9% vs. 12.9%, p = 0.60). After propensity score matching, no significant differences were found in the incidences of primary outcome measure (13.0% vs. 12.8%, p = 0.95), cardiac death, MI, and stroke (3.5% vs. 2.7%, p = 0.72; 1.2% vs. 0.0%, p = 0.31; and 4.9% vs. 3.1%, p = 0.35), whereas that of TVR was significantly higher in the PCI group (24.5 vs. 7.1%, p

Aims The aim of the study was to assess the long-term outcomes of coronary chronic total occlusion (CTO) lesions after retrograde percutaneous coronary intervention (PCI) in comparison with those after antegrade PCI alone. Methods and results A total of 842 consecutive patients (928 CTO lesions) undergoing PCI and subsequent follow-up were classified into two groups: retrograde PCI for at least one CTO (n=302, retrograde group) and antegrade PCI alone (n=540, antegrade group). The total procedural success rate was 89.7%. The retrograde group had significantly higher incidences of periprocedural myocardial infarction and coronary perforation (7.3% vs. 3.7%, p=0.01; 7.9% vs. 4.4%, p=0.04, respectively). Median follow-up duration was 7.7 (interquartile range 5.6-8.7) years. Seven-year relative risk comparing the retrograde and antegrade groups was neutral in all-cause death (adjusted HR [aHR] 1.06, 95% CI: 0.75-1.49; p=0.745), cardiac death (aHR 0.85, 95% CI: 0.47-1.55; p=0.598), coronary artery bypass grafting (aHR 1.62, 95% CI: 0.74-3.54; p=0.229), and non-target vessel revascularisation (aHR 0.96, 95% CI: 0.78-1.17; p=0.663). Conclusions Retrograde CTO PCI did not lead to worse long-term outcomes despite increased risk in periprocedural myocardial infarction and coronary perforation.

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.

ObjectiveTherapeutic strategies for atrial septal defect (ASD) with severe pulmonary arterial hypertension (PAH) are controversial. This study aimed to evaluate the efficacy of PAH-specific medications and subsequent transcatheter closure (ie, treat-and-repair strategy) on clinical outcomes.MethodsWe enrolled 42 patients who were referred to 13 institutions for consideration of ASD closure with concomitant PAH and underwent the treat-and-repair strategy. The endpoint was cardiovascular death or hospitalisation due to heart failure or exacerbated PAH.ResultsAt baseline prior to PAH-specific medications, pulmonary to systemic blood flow ratio (Qp:Qs), pulmonary vascular resistance (PVR), and mean pulmonary artery pressure (PAP) were 1.9±0.8, 6.9±3.2 Wood units and 45±15 mm Hg. Qp:Qs was increased to 2.4±1.2, and PVR and mean PAP were decreased to 4.0±1.5 Wood units and 35±9 mm Hg at the time of transcatheter ASD closure after PAH-specific medications. Transcatheter ASD closure was performed without any complications. During a median follow-up period of 33 months (1–126 months) after transcatheter ASD closure, one older patient died and one patient was hospitalised due to heart failure, but the other patients survived with an improvement in WHO functional class. PAP was further decreased after transcatheter ASD closure.ConclusionsThe treat-and-repair strategy results in low complication and mortality rates with a reduction in PAP in selected patients with ASD complicated with PAH who have a favourable response of medical therapy.

Background Impact of ischemic risk (IR) on long term outcomes in patients at high bleeding risk (HBR) after everolimus-eluting stent (EES) implantation remains unclear. Purpose We aimed to evaluate long term bleeding and ischemic events in patient with HBR or IR after EES implantation. Methods The study population comprised 1219 patients treated with EES without in-hospital events between 2010 and 2011. The follow-up period was 2996±433 days. HBR was defined as Academic research consortium. IR defined as high-risk features of stent-driven recurrent ischemic events in Europe society of cardiology guidelines in 2019: prior stent thrombosis on adequate antiplatelet therapy, diffuse multivessel disease especially in diabetic patients, creatinine clearance 60 mm, and treatment of a chronic total occlusion. Major bleeding (MB) was defined as defined as the occurrence of a Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding event. Primary ischemic events included myocardial infarction, definite stent thrombosis, and cardiac death. The Kaplan-Meier method was used for time-to-event analyses. Results Of the 1219 patients, 317 (26.0%) patients had no risk, 114 (9.4%) patients had only HBR, 288 (23.6%) patients had only IR, and 500 (41.0%) patients had both risks. The 81.4% of HBR patients had IR. The figure of Kaplan-Meier showed MB and CE for 7–8 years. Both risk groups had higher bleeding risk and Ischemic events (log rank p=0.0039, 0.0001). Conclusion HBR patients with EES had a high incidence of IR. Patients who had both HBR and IR are especially at risk for both ischemic events and bleeding compared to those who had no or only one risk. Funding Acknowledgement Type of funding source: None

Background Coronary artery embolism (CE) is one of the important causes of acute coronary syndrome (ACS). The feature of CE is that angiographic evidence of coronary artery embolism and thrombosis without atherosclerotic components. However, the prevalence of CE remains unknown because of the diffifulty to diagnose in the acute settings. A recent retrospective analysis suggested that up to 3% of ACS cases may result from CE. Purpose The aim of this study was to elucidate the prevalence, clinical features and long-term outcomes including all-cause and cardiac death. Methods We analysed the consecutive 2695 patients with first AMI performed coronary intervention between January 2004 and July 2017. CE was diagnosed by clinical histories and angiographic findings. We retrospectively evaluated the clinical and lesion characteristics and outcomes including all-cause and cardiac death. Results The prevalence of CE was 2.0% (n=55; CE group and n=2640; non-CE group), including 8 (15%) patients with multivessel CE. The CE group had higher average age (70.8±14.9 vs. 68.4±12.6, p Conclusion Compared with non-CE group, the prevalence of distal infarction site was significantly higher in the CE group, and the incidence of cardiac death is not significantly different. Funding Acknowledgement Type of funding source: None

Background It is yet to be known whether mechanisms underlying restenosis in newer-generation durable-polymer (DP) and biodegradable-polymer (BP) drug-eluting stents (DES) are different. Purpose This study aims to assess the incidences and predictors of early restenosis and late catch-up phenomenon after newer-generation durable-polymer (DP) and biodegradable-polymer (BP) DES. Methods Between 2010 and 2017, 13858 lesions in 6350 patients were treated with DES (4393 BP-DES, 9465 DP-DES). The early-term (within 1 year) and late-term (from 1 to 2 years) follow-up angiographies were scheduled. Late catch-up phenomenon was defined as in-stent restenosis (ISR) in lesions that evaded ISR within 1 year after stent implantation. ISR was defined as angiographic restenosis of more than 50%. Results The mean patient age was 71 years, and 76.7% were male. Early-term angiographies were performed in 10955 lesions (79.0%). Of those without early-term ISR, late-term angiographies were performed in 7771 lesions (56.1%). The incidences of mid-term restenosis and late catch-up phenomenon were 6.6% and 3.9%, respectively. In the multivariate regression analyses, history of diabetes, hemodialysis and previous PCI were independent predictors of both early restenosis and late catch-up phenomenon. Also, some lesion characteristics such as chronic total occlusion, right coronary artery ostial lesion, small vessel (defined as reference diameter 30mm) and treatment of ISR lesion were independent predictors of both early restenosis and late catch-up phenomenon. Bifurcation lesion and heavily calcified lesion treated with rotablator were independent risk of early restenosis. Bypass graft lesion was an independent predictor of late catch-up phenomenon. Early restenosis was observed less frequently in DP-DES than in BP-DES (6.3% versus 7.4%, P=0.012). On the contrary, late catch-up phenomenon was observed more frequently in DP-DES than in BP-DES (4.3% versus 2.9%, P=0.026). Conclusions Some lesion characteristics were independent predictors of early restenosis and late catch-up phenomenon after newer-generation DES implantation. The deployment of BP-DES resulted in more early restenosis and less late catch-up phenomenon compared to that of DP-DES. Early Restenosis and Late Catch-Up Funding Acknowledgement Type of funding source: None

Background Recently, the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria has been suggested as the standard definition of HBR. Purpose We aimed to investigate the risk stratification based on ARC-HBR Criteria for long-term bleeding event after everolimus-eluting stent implantation Methods The study population comprised 1193 patients treated with EES without in-hospital event between 2010 and 2011. Individual ARC-HBR criteria was retrospectively assessed. Major bleeding were defined as the occurrence of a Bleeding Academic Research Consortium type 3 or 5 bleeding event. The mean follow-up period was 2996±433 days. Results There were 656 patients (55.0%) in HBR-groups. Cumulative incidence of major bleeding was significantly higher in HBR-group (8.1% vs 3.4% at 4 year, and 16.2% vs 5.7% at 8 year, P Conclusion ARC-HBR criteria successfully stratified the long-term bleeding risk after drug-eluting stent implantation in real-world practice. Funding Acknowledgement Type of funding source: None

Background Clinical significance of concomitant mitral regurgitation (MR) in patients with severe aortic stenosis (AS) has not been well-studied. Purpose The purpose of this study is to investigate the prognostic impact of concomitant MR in patients with severe AS. Method We used the data of 3815 patients from the CURRENT AS registry, a retrospective multicenter registry of severe AS in Japan. We compared the clinical outcomes between patients with moderate/severe MR and with none/mild MR according to the initial treatment strategies (initial aortic valve replacement [AVR] or conservative strategy). The primary outcome measure was a composite of aortic valve-related death and heart failure hospitalisation. Results Among the study population, moderate/severe MR were observed in 227/1197 (19%) patients with initial AVR strategy and in 536/2618 (20%) patients with conservative strategy. Among survivors with the initial AVR strategy, moderate/severe MR improved in 61/62 (98%) patients with concomitant mitral procedures. The crude cumulative 5-year incidence of the primary outcome measure was significantly higher in patients with moderate/severe MR than in those with none/mild MR regardless of the treatment strategies (25.2% vs. 14.4%, P Conclusion Moderate/severe MR was independently associated with poorer outcome in patients with severe AS who were managed conservatively, but not in those with initial AVR strategy. Funding Acknowledgement Type of funding source: None

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.

BACKGROUND The Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria have been suggested as the standard definition of HBR. However, the prevalence of individual criteria and their prognostic value for long-term bleeding events after percutaneous coronary intervention are scarcely studied.Methods and Results:The study population comprised 1,193 patients treated with everolimus-eluting stents between 2010 and 2011. Data on all 17 major and minor criteria of the ARC-HBR definition were retrospectively collected, and applied to this study population. Major bleeding was defined as the occurrence of a BARC type 3 or 5 bleeding event. A simplified definition was developed by excluding the low-frequency criterion, and the prognostic value was assessed by a receiver-operating characteristic curve. Mean follow-up was 2,996±433 days and there were 656 HBR patients (55.0%). The cumulative incidence of major bleeding was significantly higher in the HBR group than in the non-HBR group (16.2% vs. 5.7% at 8 years, P

We aimed to compare the intravascular imaging findings, and clinical outcomes between three-dimensional optical coherence tomography (OCT)- and intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) for the left main coronary artery (LMCA). We enrolled 331 patients underwent OCT- or IVUS-guide single crossover stenting across the side branch (SB) and subsequent kissing balloon inflation (KBT) for LMCA bifurcation. Primary endpoint was defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization. Of 331 patients, 58 patients (17.5%) underwent OCT-guide PCI. OCT-guide PCI associated with higher frequency of proximal optimization technique (POT) (98.3% vs 85.3%, P = 0.013) and smaller balloon size of POT (4.29 ± 0.44 mm vs 4.43 ± 0.42, P = 0.02) than IVUS-guide PCI. Although maximal stent area at LMCA and minimal stent area at main vessel were significantly smaller in OCT-guide PCI in intravascular imaging (P = 0.01, and P = 0.002, respectively), the restenosis rate at follow-up angiography was comparable in both groups (15.2% vs. 9.4%, P = 0.387). Cumulative rate of primary endpoint was not significantly different between 2 groups both before and after propensity score adjustment (7.0% vs. 7.4%, P = 0.98 and 2.6% vs. 7.3%, P = 0.18). In conclusion, the clinical outcomes at 1 year were comparable, suggesting OCT- and IVUS-guided PCI for LMCA were similarly feasible. The balloon size of POT in OCT-guide PCI might be influenced by the limited visibility in the proximal LMCA.

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 26-year-old man presented with mild chest discomfort on exertion. He had had the Rastelli operation for tetralogy of Fallot and pulmonary atresia at 3 years of age. Coronary computed tomography (CT) angiography showed ostial right coronary artery (RCA) and left anterior descending coronary artery

BACKGROUND Little is known of the relationship between optical coherence tomography (OCT) findings and recurrent restenosis after paclitaxel-coated balloon (PCB) angioplasty for drug-eluting stent in-stent restenosis (DES-ISR). To identify the predictors of recurrent restenosis after PCB angioplasty, we investigated quantitative and qualitative OCT findings during PCB angioplasty for DES-ISR. Methods and Results: In all, 222 DES-ISR lesions treated by PCB angioplasty with OCT assessment and followed-up angiographically at 6 months were divided into restenotic and non-restenotic lesions on the basis of the presence or absence of restenosis at follow-up. There was a significantly higher proportion of the heterogeneous tissue pattern in restenotic than non-restenotic lesions (26.5% vs. 11.0%, respectively; P=0.02). The OCT-derived post-procedural minimal lumen and stent areas were significantly smaller in restenotic lesions, but the intima area was similar in both groups. Post-procedural stent underexpansion, defined as a stent diameter : size of the previous stent ratio

Objectives The clinical implications of subintimal stenting (SS) of the recanalized chronic total occlusion (CTO) segment have not been characterized. We evaluated the in-hospital and the long-term clinical and angiographic outcomes of drug-eluting stents (DESs) deployed in true vs. false lumen of successfully recanalized CTO. Methods and results Two independent reviewers analyzed the intravascular ultrasound (IVUS) images of 173 successfully recanalized CTO lesions (157 patients), between August 2011 and October 2012. After successful guidewire (GW) crossing, lesions were classified according to IVUS evaluation into two groups: (1) true lumen (TL) stenting group and (2) SS group; and compared with regards to in-hospital and long-term clinical outcomes. In 154 lesions, DESs were deployed in the TL; and in 19 (11%) lesions, DESs were deployed in the subintimal space (95% confidence interval: 6.3-15.6%). False GW tracking in the SS group resulted in increased rates of IVUS-detected dissection flaps (84% vs. 42.6%, P ≤ 0.001), intramural hematoma (32 vs. 11%, P = 0.01), and minor perforations 6/19 (31.6% vs. 8.4%, P = 0.002). At 1-year follow-up, both groups had similar cumulative rates of binary restenosis and target lesion revascularization (P = 0.73 and P = 0.97, respectively). Six patients (4.6%, 6/129 patients) in the TL group and none in the subintimal group died at 1 year. Conclusions Acknowledging some limitations, our observations may suggest that, subintimal stent deployment in a recanalized CTO segments, using second generation DES and IVUS guidance, might have a comparable success rate and long-term angiographic and clinical outcomes as TL stenting.

It is still uncertain whether the final kissing balloon technique (FKBT) is mandatory after crossover stenting for the left main coronary artery (LMCA). Assessing Optimal Percutaneous Coronary Intervention for LMCA (AOI-LMCA) registry, a 6-center retrospective registry, enrolled 1809 consecutive patients for LMCA stenting in Japan. In the present analysis, 5-year clinical outcomes were compared between non-FKBT (n = 160) and FKBT (n = 578) groups in patients treated with crossover stenting with drug-eluting stents from the LMCA to the left anterior descending artery. Propensity score-matched analysis was also performed in 160 patient pairs. In the entire study population as well as in the propensity-matched population, the cumulative 5-year incidence of the primary outcome measure (target lesion revascularization: TLR) was not significantly different between the FKBT and non-FKBT groups (10.7 versus 14.3%, P = 0.49, and 11.8 versus 14.3%, P = 0.53, respectively). In the sensitivity analysis by the multivariable Cox proportional hazard model, the effect of FKBT relative to non-FKBT for TLR remained insignificant (adjusted HR 0.89, 95% CI 0.47–1.69, P = 0.72). Regarding the TLR location, there were no significant differences in the cumulative incidences of TLR for LMCA-only, for the main branch, and for the side branch between the 2 groups (2.2 versus 1.3%, P = 0.93, 11.8 versus 9.1%, P = 0.71, and 8.2 versus 7.6%, P = 0.82, respectively). FKBT after a 1-stent strategy for LMCA crossover stenting did not affect TLR and other clinical outcomes during 5-year follow-up.Clinical Trial Registration: Assessing Optimal Percutaneous Coronary Intervention for Left Main Coronary Artery Stenting Registry (AOI LMCA Stenting Registry). http://www.umin.ac.jp/ctr/index/htm/. Unique Identifier: UMIN000014706.