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The treatment of coronary artery disease has substantially changed over the past two decades. However, it is unknown whether and how much these changes have contributed to the improvement of long-term outcomes after coronary revascularization. We assessed trends in the demographics, practice patterns and long-term outcomes in 24,951 patients who underwent their first percutaneous coronary intervention (PCI) (n = 20,106), or isolated coronary artery bypass grafting (CABG) (n = 4,845) using the data in a series of the CREDO-Kyoto PCI/CABG Registries (Cohort-1 [2000 to 2002]: n = 7,435, Cohort-2 [2005 to 2007]: n = 8,435, and Cohort-3 [2011 to 2013]: n = 9,081). From Cohort-1 to Cohort-3, the patients got progressively older across subsequent cohorts (67.0 ± 10.0, 68.4 ± 9.9, and 69.8 ± 10.2 years, ptrend

There is a scarcity of data on incidence, risk factors, especially clinical severity, and long-term prognostic impact of periprocedural stroke after coronary revascularization in contemporary real-world practice. Among 14,867 consecutive patients undergoing first coronary revascularization between January 2011 and December 2013 (percutaneous coronary intervention [PCI]: N = 13258, and coronary artery bypass grafting [CABG]: N = 1609) in the Coronary Revascularization Demonstrating Outcome Study in Kyoto PCI/CABG registry Cohort-3, we evaluated the details on periprocedural stroke. Periprocedural stroke was defined as stroke within 30 days after the index procedure. Incidence of periprocedural stroke was 0.96% after PCI and 2.13% after CABG (log-rank p0.001). Proportions of major stroke defined by modified Rankin Scale ≥2 at hospital discharge were 68% after PCI, and 77% after CABG. Independent risk factors of periprocedural stroke were acute coronary syndrome (ACS), carotid artery disease, advanced age, heart failure, and end-stage renal disease after PCI, whereas they were ACS, carotid artery disease, atrial fibrillation, chronic obstructive pulmonary disease, malignancy, and frailty after CABG. There was excess long-term mortality risk of patients with periprocedural stroke relative to those without after both PCI and CABG (hazard ratio 1.71 [1.25 to 2.33], and hazard ratio 4.55 [2.79 to 7.43]). In conclusion, incidence of periprocedural stroke was not negligible not only after CABG, but also after PCI in contemporary real-world practice. Majority of patients with periprocedural stroke had at least mild disability at hospital discharge. ACS and carotid artery disease were independent strong risk factors of periprocedural stroke after both PCI and CABG. Periprocedural stroke was associated with significant long-term mortality risk after both PCI and CABG.

Due to the COVID-19 pandemic, the 84thAnnual Meeting of the Japanese Circulation Society (JCS) was held in a web-based format for the first time in its history as "The Week for JCS 2020" from Monday, July 27 to Sunday, August 2, 2020. All sessions, including general abstracts, were streamed live or on-demand. The main theme of the meeting was "Change Practice!" and the aim was to organize the latest findings in the field of cardiovascular medicine and discuss how to change practice. The total number of registered attendees was over 16,800, far exceeding our expectations, and many of the sessions were viewed by far more people than at conventional face-to-face scientific meetings. At this conference, the power of online information dissemination was fully demonstrated, and the evolution of online academic meetings will be a direction that cannot be reversed in the future. The meeting was completed with great success, and we express our heartfelt gratitude to all affiliates for their enormous amount of work, cooperation, and support.

The effect of body weight (BW) on bleeding and ischemic events has not been adequately evaluated in real-world percutaneous coronary intervention (PCI) practice.Methods and Results:12,690 consecutive patients undergoing first PCI in the CREDO-Kyoto registry cohort-2 were divided into 3 groups according to tertiles of BW stratified by sex (male; Tertile 1 [60.0 kg], 2 [60.0-68.0 kg], and 3 [68.0 kg], and female; Tertile 1 [47.9 kg], 2 [47.9-55.8 kg], and 3 [55.8 kg]). Cumulative 5-year incidences of the primary bleeding (GUSTO moderate/severe) and ischemic (myocardial infarction/ischemic stroke) endpoints increased incrementally with decrease in BW in both strata (male Tertiles 1, 2, and 3: 13.7%, 10.3%, and 8.0%, P0.001, and 13.9%, 11.3%, and 10.2%, P0.001; female Tertiles 1, 2, and 3: 17.9%, 12.9%, and 10.1%, P0.001, and 17.9%, 12.9%, and 10.1%, P0.001). Compared with Tertile 3, the adjusted risks of Tertile 1 for the primary bleeding and ischemic endpoints remained significant in the female stratum (hazard ratio (HR): 1.45, 95% confidence interval (CI): 1.14-1.87, P=0.003, and HR:1.49, 95% CI:1.13-1.95, P=0.004), but not in the male stratum (HR:1.10, 95% CI:0.92-1.32, P=0.31, and HR:1.06, 95% CI:0.90-1.27, P=0.47).Cumulative incidences of bleeding and ischemic events increased incrementally as BW decreased in both men and women. The adjusted risks of underweight relative to overweight for bleeding and ischemic events were significant only in women.

BACKGROUND The transradial approach is reportedly associated with reduced bleeding complications and mortality after percutaneous coronary intervention (PCI). It is unknown whether the clinical benefits of transradial vs. transfemoral PCI differ between high bleeding risk (HBR) and non-HBR patients.Methods and Results:After excluding patients with acute myocardial infarction, dialysis, and a transbrachial approach from the 13,087 patients undergoing first PCI in the CREDO-Kyoto Registry Cohort-2, 6,828 patients were eligible for this study. Patients were divided into 2 groups according to bleeding risk based on Academic Research Consortium HBR criteria, and then divided into a further 2 groups according to access site, radial or femoral: HBR-radial, n=1,054 (38.3%); HBR-femoral, n=1,699 (61.7%); non-HBR-radial, n=1,682 (41.3%); and non-HBR-femoral, n=2,393 (58.7%). In the HBR group, the 30-day incidence and adjusted risk for major bleeding (1.9% vs. 4.7% [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.

There is a paucity of studies exploring whether the ischemia-bleeding trade-off could be different according to the stages of renal dysfunction in patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI). Among 19,598 patients in a pooled database from 3 Japanese PCI studies (CREDO-Kyoto Cohort-2, RESET, and NEXT), 1,547 patients had concomitant AF. Patients were divided into 4 groups according to their renal function (Creatinine clearance [CCr]60 ml/min: n = 703, 60≥ CCr30 ml/min: n = 627, CCr ≤30 ml/min: n = 126, Dialysis: n = 91). The cumulative 3-year incidences of both the primary ischemic (ischemic stroke/myocardial infarction) and bleeding (GUSTO moderate/severe) outcome increased incrementally with worsening renal function (11.4%, 12.6%, 16.8%, and 31.7%, p0.001, and 7.5%, 14.9%, 26.3%, and 29.5%, p0.001, respectively). Compared with CCr60 ml/min group, the excess adjusted risk for the primary ischemic outcome was significant only in dialysis group (hazards ratio [HR] 2.15, 95% confidence interval [CI] 1.22 to 3.69, p = 0.009), but not in 60≥ CCr30 ml/min and CCr ≤30 ml/min groups (HR 0.89, 95% CI 0.62 to 1.29, p = 0.54, and HR 0.94, 95% CI 0.49 to 1.69, p = 0.83, respectively), whereas the excess adjusted risk for the primary bleeding outcome was significant in all 3 groups of renal dysfunction (HR 1.66, 95% CI 1.13 to 2.45, p = 0.01, HR 2.70, 95% CI 1.58 to 4.61, p0.001, and HR 3.26, 95% CI 1.85 to 5.75, p0.001, respectively). In conclusion, in AF patients receiving PCI, the worsening renal function was strongly associated with the increasingly higher risk for bleeding events, whereas the excess risk for ischemic events was significant only in patients on dialysis.

BACKGROUND Optimal intensity is unclear for P2Y12receptor blocker therapy after percutaneous coronary intervention (PCI) in real-world clinical practice.Methods and Results:From the CREDO-Kyoto Registry, the current study population consisted of 25,419 patients (Cohort-2: n=12,161 and Cohort-3: n=13,258) who underwent their first PCI. P2Y12receptor blocker therapies were reduced dose of ticlopidine (200 mg/day), and global dose of clopidogrel (75 mg/day) in 87.7% and 94.8% of patients in Cohort-2 and Cohort-3, respectively. Cumulative 3-year incidence of GUSTO moderate/severe bleeding was significantly higher in Cohort-3 than in Cohort-2 (12.1% and 9.0%, P

There is a scarcity of data on ischemic and bleeding events in patients who experienced major bleeding after percutaneous coronary intervention (PCI). Moreover, there also is a shortage of data on comparative outcomes between patients with and without interruption of an antithrombotic drug after major bleeding. We evaluated the incidence and prognostic impacts of ischemic (myocardial infarction or ischemic stroke) and bleeding (Bleeding Academic Research Consortium type 3 or 5) events after major bleeding in 12,691 consecutive patients who underwent first PCI in the Coronary Revascularization Demonstrating Outcome Study in Kyoto PCI registry cohort-3. In the entire cohort, incidence of the first ischemic event and bleeding event was 2.3 per 100 person-years and 3.8 per 100 person-years, respectively. Major bleeding (Bleeding Academic Research Consortium type 3) occurred in 2,142 patients during a median follow-up of 5.7 years. In patients with major bleeding, cumulative 30-day, 1-year, and 5-year incidence of an ischemic event was 2.6%, 4.8%, and 13.2% (3.2 per 100 person-years), respectively, whereas that of a bleeding event was 6.3%, 16.1%, and 29.2% (8.5 per 100 person-years), respectively. Ischemic and bleeding events were independently associated with mortality (hazard ratio 2.36, 95% confidence interval 1.87 to 2.96, p

[Background] There are limited data on the long-term stent-related adverse events as related to the duration of dual antiplatelet therapy (DAPT) in second-generation (G2) drug-eluting stents (DES) compared with first-generation (G1) DES. [Objectives] This study sought to compare the long-term stent-related outcomes of G2-DES with those of G1-DES. [Methods] The study group consisted of 15, 009 patients who underwent their first coronary revascularization with DES from the CREDO-Kyoto PCI/CABG (Coronary Revascularization Demonstrating Outcome Study in Kyoto Percutaneous Coronary Intervention/Coronary Artery Bypass Grafting) Registry Cohort-2 (first-generation drug-eluting stent [G1-DES] period; n = 5, 382) and Cohort-3 (second-generation drug eluting stent [G2-DES] period; n = 9, 627). The primary outcome measures were definite stent thrombosis (ST) and target vessel revascularization (TVR). [Results] The cumulative 5-year incidences of definite ST and TVR were significantly lower in the G2-DES group than in the G1-DES group (0.7% vs 1.4%; P < 0.001; and 16.2% vs 22.1%; P < 0.001, respectively). The lower adjusted risk of G2-DES relative to G1-DES for definite ST and TVR remained significant (HR: 0.53; 95% CI: 0.37-0.76; P < 0.001; and HR: 0.74; 95% CI: 0.68-0.81; P < 0.001, respectively). In the landmark analysis that was based on the DAPT status at 1 year, the lower adjusted risk of on-DAPT status relative to off-DAPT was significant for definite ST beyond 1 year in the G1-DES stratum (HR: 0.42; 95% CI: 0.24-0.76; P = 0.004) but not in the G2-DES stratum (HR: 0.66; 95% CI: 0.26-1.68; P = 0.38) (Pinteraction = 0.14). [Conclusions] G2-DES compared with G1-DES were associated with a significantly lower risk for stent-related adverse events, including definite ST and TVR. DAPT beyond 1 year was associated with a significantly lower risk for very late ST of G1-DES but not for that of G2-DES.

Coronary bifurcations exhibit localized turbulent flow and enhanced propensity for platelet deposition, plaque rupture, and atherothrombosis. Percutaneous coronary intervention (PCI) of bifurcation lesions is associated with an increased risk of thrombotic events. Such risk is modulated by anatomical complexity, intraprocedural factors and pharmacological therapy. There is no consensus on the appropriate PCI strategy or the optimal regimen and duration of antithrombotic treatment in order to decrease the risk of ischemic and bleeding complications in the setting of coronary bifurcation. A uniform therapeutic approach meets a clinical need. The present initiative, promoted by the European Bifurcation Club (EBC), involves opinion leaders from Europe, America, and Asia with the aim to analyze the currently available evidence. Although mainly derived from sub-studies of large trials or small studies, or from authors' opinions, an algorithm for the optimal management of patients undergoing bifurcation PCI, developed on the basis of clinical presentation, bleeding risk, and intraprocedural strategy is here proposed.

Background: Safety and efficacy of clopidogrel monotherapy after very short dual antiplatelet therapy (DAPT) is uncertain in patients undergoing complex percutaneous coronary intervention (PCI). Methods: We conducted a post hoc subgroup analysis based on the complexity of PCI in the STOPDAPT-2 trial (Short and Optimal Duration of Dual Antiplatelet Therapy-2), which randomly compared 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT after cobalt-chromium everolimus-eluting stent implantation. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents, >60 mm total stent lengths, and target of chronic total occlusion. The primary end point was the composite of cardiovascular (cardiovascular death/myocardial infarction/definite stent thrombosis/stroke) and bleeding (TIMI [Thrombolysis in Myocardial Infarction] major/minor) end points. The major secondary end points were the cardiovascular and bleeding end points. Results: Among the 3009 study patients, there were 509 patients (16.9%) with complex PCI (1-month DAPT: N=245, and 12-month DAPT: N=264) and 2500 patients (83.1%) without complex PCI (1-month DAPT: N=1255, and 12-month DAPT: N=1245). There were no significant interactions between the complexity of PCI and the effects of 1-month DAPT versus 12-month DAPT on the primary end point (complex PCI: 1.67% versus 5.32%, hazard ratio, 0.30 [95% CI, 0.10–0.92], P =0.04, and noncomplex PCI: 2.50% versus 3.35%, hazard ratio, 0.75 [95% CI, 0.47–1.20], P =0.23; P interaction =0.14), and on the major secondary cardiovascular end point (complex PCI: 1.67% versus 3.04%, hazard ratio, 0.54 [95% CI, 0.16–1.79], P =0.31, and noncomplex PCI: 2.02% versus 2.39%, hazard ratio, 0.86 [95% CI, 0.50–1.47], P =0.58; P interaction =0.49). The cumulative 1-year incidence of the major secondary bleeding end point was significantly lower in the 1-month DAPT group than in the 12-month DAPT group regardless of the complexity of PCI (complex PCI: 0% versus 2.29%, log-rank P =0.02, and noncomplex PCI: 0.48% versus 1.38%, log-rank P =0.02). Conclusions: The effects of clopidogrel monotherapy after 1-month DAPT relative to 12-month DAPT for the primary and major secondary end points were comparable in complex PCI and noncomplex PCI without significant interactions. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02619760.

BACKGROUND Data evaluating the effects of acute coronary syndrome (ACS) relative to stable coronary artery disease (CAD) on bleeding risk after percutaneous coronary intervention (PCI) are scarce.Methods and Results:From the CREDO-Kyoto Registry Cohort-3, 13,258 patients undergoing first PCI (5,521 ACS; 7,737 stable CAD) were identified. Patients were further stratified according to ACS presentation and Academic Research Consortium High Bleeding Risk (HBR): ACS/HBR: n=2,502; ACS/no-HBR: n=3,019; stable CAD/HBR: n=3,905; and stable CAD/no-HBR: n=3,832. The primary bleeding endpoint was Bleeding Academic Research Consortium 3/5 bleeding, whereas the primary ischemic endpoint was myocardial infarction (MI)/ischemic stroke. Compared with stable CAD, ACS was associated with a significantly higher adjusted risk for bleeding (hazard ratio [HR] 1.85; 95% confidence interval [CI] 1.68-2.03; P

Background: We sought to evaluate the impact of patient selection for the STOPDAPT-2 trial (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2) on clinical outcomes in a registry from a single center that participated in the STOPDAPT-2 trial. Methods: Among 2190 consecutive patients who underwent percutaneous coronary intervention using stent in Kokura Memorial Hospital during the enrollment period of the STOPDAPT-2 trial, 521 patients had exclusion criteria such as in-hospital major complications, anticoagulant use, or prior intracranial bleeding (ineligible group). Among 1669 patients who met the eligibility criteria (eligible group), 582 were enrolled (enrolled group) and 1087 were not enrolled (nonenrolled group) in the STOPDAPT-2 trial. The primary outcome measure was defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, stroke, or Thrombolysis in Myocardial Infarction major and minor bleeding. Results: Compared with the enrolled group, patients in the nonenrolled group more often had high bleeding risk according to the Academic Research Consortium for High Bleeding Risk definition (52.6% versus 41.2%; P P P =0.03; 4.1% versus 0.9%, P P =0.03, respectively) and in the ineligible group than in the eligible group (21.2% versus 6.3%, P P P Conclusions: Patients who were ineligible, eligible but not enrolled, and enrolled in the STOPDAPT-2 trial had different risk profiles and clinical outcomes, suggesting important implications in applying the trial results in daily clinical practice.

Objective To assess the risks and benefits of P2Y 12 inhibitor monotherapy compared with dual antiplatelet therapy (DAPT) and whether these associations are modified by patients’ characteristics. Design Individual patient level meta-analysis of randomised controlled trials. Data sources Searches were conducted in Ovid Medline, Embase, and three websites ( www.tctmd.com , www.escardio.org , www.acc.org/cardiosourceplus ) from inception to 16 July 2020. The primary authors provided individual participant data. Eligibility criteria Randomised controlled trials comparing effects of oral P2Y 12 monotherapy and DAPT on centrally adjudicated endpoints after coronary revascularisation in patients without an indication for oral anticoagulation. Main outcome measures The primary outcome was a composite of all cause death, myocardial infarction, and stroke, tested for non-inferiority against a margin of 1.15 for the hazard ratio. The key safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding. Results The meta-analysis included data from six trials, including 24 096 patients. The primary outcome occurred in 283 (2.95%) patients with P2Y 12 inhibitor monotherapy and 315 (3.27%) with DAPT in the per protocol population (hazard ratio 0.93, 95% confidence interval 0.79 to 1.09; P=0.005 for non-inferiority; P=0.38 for superiority; τ 2 =0.00) and in 303 (2.94%) with P2Y 12 inhibitor monotherapy and 338 (3.36%) with DAPT in the intention to treat population (0.90, 0.77 to 1.05; P=0.18 for superiority; τ 2 =0.00). The treatment effect was consistent across all subgroups, except for sex (P for interaction=0.02), suggesting that P2Y 12 inhibitor monotherapy lowers the risk of the primary ischaemic endpoint in women (hazard ratio 0.64, 0.46 to 0.89) but not in men (1.00, 0.83 to 1.19). The risk of bleeding was lower with P2Y 12 inhibitor monotherapy than with DAPT (97 (0.89%) v 197 (1.83%); hazard ratio 0.49, 0.39 to 0.63; P2 =0.03), which was consistent across subgroups, except for type of P2Y 12 inhibitor (P for interaction=0.02), suggesting greater benefit when a newer P2Y 12 inhibitor rather than clopidogrel was part of the DAPT regimen. Conclusions P2Y 12 inhibitor monotherapy was associated with a similar risk of death, myocardial infarction, or stroke, with evidence that this association may be modified by sex, and a lower bleeding risk compared with DAPT. Registration PROSPERO CRD42020176853.

BACKGROUND The prevalence of and expected bleeding event rate in patients with the Japanese version of high bleeding risk (J-HBR) criteria are currently unknown in real-world percutaneous coronary intervention (PCI) practice.Methods and Results:We applied the J-HBR criteria in the multicenter CREDO-Kyoto registry cohort-3 that enrolled 13,258 consecutive patients who underwent first PCI. The J-HBR criteria included Japanese-specific major criteria such as heart failure, low body weight, peripheral artery disease and frailty in addition to the Academic Research Consortium (ARC)-HBR criteria. There were 8,496 patients with J-HBR, and 4,762 patients without J-HBR. The J-HBR criteria identified a greater proportion of patients with HBR than did ARC-HBR (64% and 48%, respectively). Cumulative incidence of the Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding was significantly higher in the J-HBR group than in the no-HBR group (14.0% vs. 4.1% at 1 year; 23.1% vs. 8.4% at 5 years, P

Background Two-dimensional speckle tracking echocardiography (2D-STE) has been reported to be useful for the diagnosis of myocardial ischemia by detecting delayed relaxation (diastolic stunning) after an episode of angina. 2D-longitudinal strain is not specific besides ischemia such as diastolic dysfunction, and diabetes have been associated with abnormal longitudinal fibers. The aim is to evaluate the diagnostic accuracy of Left ventricular (LV) diastolic transverse strain imaging by STE to detect the presence of acute coronary syndrome (ACS) in diabetic patients with acute chest pain. Methods 385 consecutive patients with acute chest pain and without wall motion abnormality, who were admitted to an emergency department (ED) at 1 of 12 clinical sites in Japan, were enrolled and underwent 2D-STE at ED. Left ventricular (LV) transverse strain values at aortic valve closure (A) and one-third of diastole duration (B) were measured. The strain imaging diastolic index (SI-DI) was value was determined as: (A − B)/A × 100% to assess the LV diastolic strain imaging and was used to identify the regional LV delayed relaxation. All patients underwent coronary CT or coronary angiography to establish the diagnosis of ACS. Clinicians were blinded to the 2D-STE results. Results Out of 385 patients, 2D-STE analysis was possible in 365 patients (94%). 76 patients were diabetic (DM+), and 289 patients were non-diabetic (DM-). With assessment of coronary CT or coronary angiography, ACS was diagnosed in 125 patients (34%). 2D-STE was obtained at a mean of 5.3 hours after chest pain episode. Transverse SI-DI of ischemic segments were significantly lower than those of non-ischemic segments (p value Conclusion LV diastolic transverse strain imaging by 2D-STE at ED increase the sensitivity, specificity and accuracy to predict the presence of ACS in diabetic patients with chest pain, as well as non-diabetic patients. (UMIN000013859). Figure 1. Transverse Strain (SI-DI): AUC (95% CI) Funding Acknowledgement Type of funding source: None

OBJECTIVES To evaluate utility of the complex percutaneous coronary intervention (PCI) criteria in real-world practice. BACKGROUND Applicability of procedural complexity criteria for risk stratification has not been adequately evaluated in real-world practice. METHODS Among 13,087 patients undergoing first PCI in the CREDO-Kyoto registry cohort-2, the study population consisted of 7,871 patients after excluding patients with acute myocardial infarction and those without stent implantation. Complex PCI was defined as PCI, which fulfills at least one of the followings: three vessels treated, > = 3 stents implanted, > = 3 lesions treated, bifurcation with two stents, >60 mm total stent lengths, and target of chronic total occlusion. RESULTS The cumulative incidences of and adjusted risks for the primary ischemic (myocardial infarction/ischemic stroke), and bleeding (GUSTO moderate/severe) endpoints were significantly higher in patients with complex PCI (N = 2,777 [35%]) than in those with noncomplex PCI (N = 5,094 [65%]) (15.4% vs. 10.9%, log-rank p

Background There is a scarcity of data on short-duration dual antiplatelet therapy (DAPT) followed by P2Y12 inhibitor monotherapy as compared with aspirin monotherapy after percutaneous coronary intervention (PCI).Methods and Results:STOPDAPT-1 is a prospective trial enrolling patients who agreed to 3-month DAPT followed by aspirin monotherapy after everolimus-eluting stent (EES) implantation. STOPDAPT-2 is a randomized trial comparing 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT after EES implantation. We compared the clinical outcomes of patients assigned to the 1-month DAPT group in STOPDAPT-2 and the 3-month DAPT group enrolled in STOPDAPT-1. The current study population consisted of 1,480 patients in STOPDAPT-2 and 1,339 patients in STOPDAPT-1. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis and TIMI major/minor bleeding. Cumulative 1-year incidence of the primary endpoint was not significantly different between STOPDAPT-2 and STOPDAPT-1 (2.3% vs. 2.3%, P=0.98). After adjusting for confounders, there was no excess risk of STOPDAPT-2 relative to STOPDAPT-1 for the primary endpoint. Between 3 and 12 months, the cumulative incidence of primary endpoint was not significantly different between STOPDAPT-2 and STOPDAPT-1 (1.7% vs. 1.6%, P=0.77). Conclusions The effect of 1-month DAPT followed by clopidogrel monotherapy on clinical outcomes was similar to that of 3-month DAPT followed by aspirin monotherapy in patients receiving PCI.

There has been no previous prospective study evaluating 3-month dual antiplatelet therapy (DAPT) after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation in patients with acute coronary syndrome (ACS). The STOPDAPT trial is a prospective multi-center single-arm study evaluating 3-month DAPT duration in all-comer population after CoCr-EES implantation. Among 1525 study patients enrolled from 58 Japanese centers, the present study compared the 1-year clinical outcomes between ACS patients (N = 487) and stable coronary artery disease (CAD) patients (N = 1038). In the ACS group, 228 patients (47%) had unstable angina and 259 patients (53%) had myocardial infarction. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis (ST) and TIMI major/minor bleeding. Thienopyridine was discontinued within 4-month in 455 patients (94.0%) in the ACS group and 977 patients (94.3%) in the stable CAD group. Cumulative 1-year incidence of and the adjusted risk for the primary endpoint were not significantly different between the ACS and stable CAD groups (2.3% vs. 3.0%, P = 0.42, and HR 0.94, 95%CI 0.44–1.87, P = 0.87). In the 3-month landmark analysis, cumulative incidence of the primary endpoint was also not significantly different between the ACS and stable CAD groups (1.3% vs. 2.4%, P = 0.16). There was no definite/probable ST through 1-year in both groups. In the propensity matched analysis, the cumulative 1-year incidence of the primary endpoint were similar between the ACS and stable CAD groups (2.3% versus 2.1%, P = 0.82). In conclusion, stopping DAPT at 3 months after CoCr-EES implantation in patients with ACS including 47% of unstable angina was as safe as that in patients with stable CAD.

Background The contemporary medications for secondary prevention like statins and antithrombotic agents are targeting to delay the progression of atherothrombosis. However, there is limited data on the relation between death and progressive coronary atherothrombosis. This study sought to evaluate what proportion of death after coronary revascularization is related to documented progressive coronary atherothrombosis. Methods We reviewed the detailed causes of death among 15,231 patients receiving their first coronary revascularization enrolled in the CREDO-Kyoto PCI/CABG registry cohort-2, dividing into two groups; 13,839 patients with clinical success and without major complication (uncomplicated) and the other 1392 patients (complicated). Documented progressive coronary atherothrombosis as the cause of death was defined as preceding coronary revascularization within 30 days before death or irreversible brain damage and/or proof of coronary thrombus by autopsy. Results During the median follow-up of 5.4 years, 2837 patients died with cumulative 5-year incidence of 17.5%. The proportions of cardiac/non-cardiovascular death among all-cause death in uncomplicated patients and complicated patients were 36.6%/51.5% and 74.2%/17.4%, respectively. The numbers of patients died with documented progressive coronary atherothrombosis were 41 (1.9% of all-cause death) and 304 (47.3%). The number was only 51 (2.1%) among all post-discharge patients. Dominant causes of cardiac death in post-discharge patients included heart failure (10.0%) and sudden cardiac death (9.1%), both without apparent relation with progressive coronary atherothrombosis. Conclusions Only about one-third of deaths were cardiac in origin during 5-year follow-up in post-discharge patients after coronary revascularization. Cardiac death after discharge was very infrequently related to documented progressive coronary atherothrombosis.

It is still controversial whether baseline thrombocytopenia is independently associated with adverse events after percutaneous coronary intervention. We evaluated the influence of baseline thrombocytopenia against ischemic, bleeding and mortality among the 19,353 patients whose baseline platelet counts were available in the pooled database from the 3 studies in Japan. Baseline thrombocytopenia was classified as follows: mild, ≥100 and

It is unknown whether there is a threshold of creatine kinase (CK) or CK-MB affecting the subsequent mortality for post-discharge myocardial infarction (PDMI) after percutaneous coronary intervention. Current study sought to evaluate the impact of PDMI. The study population included 30,051 patients with successful coronary stenting and discharged alive in the pooled patient-level database of 4 Japanese studies (j-Cypher registry, CREDO-Kyoto PCI/CABG registry cohort-2, RESET, and NEXT). During 4.4 ± 1.4 year follow-up, 915 patients experienced PDMI (cumulative 5-year incidence of 3.6%). Among 466 patients with available peak CK ratio (peak CK/upper limit of normal), peak CK ratio (

Background: The dual antiplatelet therapy (DAPT) score was developed to estimate ischemic and bleeding risks from the DAPT study. However, few studies validated its utility externally. We sought to validate the utility of the DAPT score in the Japanese population. Methods: In a pooled cohort of 3 studies conducted in Japan (the CREDO-Kyoto [Coronary Revascularization Demonstrating Outcome Study in Kyoto] Registry Cohort-2, RESET [Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial], and NEXT [NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial]), we compared risks for ischemic and bleeding events from 13 to 36 months after percutaneous coronary intervention among patients with a DAPT score ≥2 (high DS) and a DAPT score Results: Among 12 223 patients receiving drug-eluting stents who were free from ischemic or bleeding events at 13 months after percutaneous coronary intervention, 3944 patients had high DS and 8279 had low DS. The cumulative incidence of primary ischemic end point (myocardial infarction/stent thrombosis) was significantly higher in high DS than in low DS (1.5% versus 0.9%, P =0.002), whereas the cumulative incidence of primary bleeding end point (GUSTO moderate/severe) tended to be lower in high DS than in low DS (2.1% versus 2.7%, P =0.07). The cumulative incidences of cardiac death, myocardial infarction, and stent thrombosis were also significantly higher in high DS than in low DS (2.0% versus 1.4%, P =0.03; 1.5% versus 0.8%, P =0.002; 0.7% versus 0.3%, P P P =0.03, respectively). Conclusions: In the current population, the DAPT score successfully stratified ischemic and bleeding risks, although the ischemic event rate was remarkably low even in high DS. Further studies would be warranted to evaluate the utility of prolonged DAPT guided by the DAPT score.

The ultra-short dual antiplatelet therapy (DAPT) followed by P2Y12 inhibitor monotherapy might be promising after percutaneous coronary intervention (PCI). However, CYP2C19 loss-of-function (LOF) alleles have been reported to diminish the effect of clopidogrel, and clopidogrel monotherapy has a concern about the increased ischemic risk for patients with such alleles. STOPDAPT-2 is the multicenter prospective open-label, but adjudicator-blinded randomized control study comparing 1-month DAPT followed by clopidogrel monotherapy with the standard 12-month DAPT after PCI with cobalt–chromium everolimus-eluting stents. Among the participants of STOPDAPT-2, selected patients participated in a substudy of the CYP2C19 gene test. Patients with two CYP2C19*2 or *3 alleles were defined as the poor metabolizer (PM), one allele as the intermediate metabolizer (IM), and no allele as the extensive metabolizer (EM). The primary endpoint was the composite of cardiovascular and bleeding events, as defined in STOPDAPT-2. Among 750 (24.9%) patients with known CYP2C19 genotypes, 129 (17.2%) were PM, 367 (49.0%) were IM, and 254 (33.9%) were EM. The hazard ratios of 1-month DAPT relative to 12-month DAPT for the primary endpoint in PM, IM, and EM strata were 0.66 (95% CI 0.11–3.94), 1.94 (95% CI 0.60–6.31), and 0.21 (95% CI 0.02–1.78), respectively (P interaction = 0.17), and those for cardiovascular composite endpoint were 1.00 (95% CI 0.14–7.10), 6.10 (95% CI 0.75–49.55), and 0.26 (95% CI 0.03–2.34), respectively (P interaction = 0.12). In conclusion, for the selected patients in STOPDAPT-2 trial, CYP2C19 LOF alleles had no significant, consistent interaction with the effect of 1-month DAPT relative to 12-month DAPT for clinical outcomes, although the study was overtly underpowered. STOPDAPT-2 ClinicalTrials.gov number, NCT02619760.

The incidence of heart failure (HF) hospitalization and its impact on long-term outcomes have not been well evaluated in contemporary patients with ST-segment elevation myocardial infarction (STEMI) after primary percutaneous coronary intervention (PCI). The Coronary Revascularization Demonstrating Outcome Study in Kyoto Acute Myocardial Infarction (AMI) Registry is a multicenter registry enrolling 5,429 consecutive patients with AMI undergoing PCI from 2005 to 2007. The present study population consisted of 3,682 patients with STEMI who underwent primary PCI within 24 hours of symptom onset and discharged alive. The incidence of HF hospitalization was 4.4%/year during the first year after the index STEMI, which attenuated to approximately 1.0%/year beyond 1 year to 5 years with the median follow-up period of 1,956 days. The independent risk factors for HF hospitalization within 1 year included older age, previous myocardial infarction, HF at STEMI, left ventricular dysfunction, anterior AMI, and onset-to-balloon time3 hours, use of β blocker, and nonuse of statin at discharge. By the landmark analysis at 1 year, the cumulative incidences of all-cause death and HF hospitalization beyond 1 year and up to 5 years were significantly higher in patients with HF hospitalization within 1 year of STEMI than in patients without (36.3% vs 10.1%, p0.001, and 40.4% vs 4.3%, p0.001, respectively). Even after adjusting for confounders, HF hospitalization within 1 year remained independently associated with a higher risk for death and HF hospitalization beyond 1 year (hazard ratio 1.64, 95% CI 1.02 to 2.52, p = 0.04 and HR 5.72, 95% CI 3.46 to 9.22, p0.001, respectively). In conclusion, HF hospitalization within 1 year was independently associated with a higher risk for all-cause death and HF hospitalization beyond 1 year.

Background Association of baseline hemoglobin levels with long‐term adverse events after percutaneous coronary interventions has not been yet thoroughly defined. We aimed to assess the clinical impact of baseline hemoglobin on long‐term ischemic and bleeding risk after percutaneous coronary intervention. Methods and Results Using the pooled individual patient‐level data from the 3 percutaneous coronary intervention studies, we categorized 19 288 patients into 4 groups: high‐normal hemoglobin (≥14.0 g/dL; n=7555), low‐normal hemoglobin (13.0–13.9 g/dL in men and 12.0–13.9 g/dL in women; n=5303), mild anemia (11.0–12.9 g/dL in men and 11.0–11.9 g/dL in women; n=4117), and moderate/severe anemia (GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries Trial) moderate/severe bleeding, with adjusted hazard ratios of 1.22 (95% CI, 1.04–1.44), 1.73 (95% CI, 1.47–2.04), and 2.31 (95% CI, 1.92–2.78), respectively. Moderate/severe anemia also correlated with significant excess risk relative to high‐normal hemoglobin for the ischemic composite end point of myocardial infarction/ischemic stroke (adjusted hazard ratio, 1.33; 95% CI, 1.11–1.60), whereas low‐normal hemoglobin and mild anemia did not. However, the excess risk of low‐normal hemoglobin, mild anemia, and moderate/severe anemia relative to high‐normal hemoglobin remained significant for ischemic stroke and for mortality. Conclusions Decreasing baseline hemoglobin correlated with incrementally higher long‐term risk for major bleeding, ischemic stroke, and mortality after percutaneous coronary intervention. Even within normal range, lower baseline hemoglobin level correlated with higher ischemic and bleeding risk.

Background: Recently, the Academic Research Consortium for High Bleeding Risk (ARC-HBR) has been proposed to standardize the definition of HBR, which was arbitrarily defined as a Bleeding Academic Research Consortium 3 or 5 bleeding ≥4% at 1-year. However, the prevalence and the expected bleeding event rate of HBR patients defined by ARC-HBR criteria are currently unknown in the real-world percutaneous coronary intervention practice. Methods: We applied the ARC-HBR criteria in the CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) registry cohort-2, a multicenter registry that enrolled 13 058 consecutive patients who underwent their first percutaneous coronary intervention. The primary bleeding end point was defined as the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries moderate/severe bleeding. There were 5570 patients (43%) in the HBR group and 7488 patients in the no-HBR group. Results: Cumulative incidence of the primary bleeding end point was much higher in the HBR group than in the no-HBR group (10.4% versus 3.4% at 1-year, and 18.9% versus 6.6% at 5-year, P P Conclusions: ARC-HBR criteria successfully identified those patients with very HBR after percutaneous coronary intervention, who represented 43% of patients in this all-comers registry.

Background Prior stroke is regarded as risk factor for bleeding after percutaneous coronary intervention ( PCI ). However, there is a paucity of data on detailed bleeding risk of patients with prior hemorrhagic and ischemic strokes after PCI . Methods and Results In a pooled cohort of 19 475 patients from 3 Japanese PCI studies, we assessed the influence of prior hemorrhagic (n=285) or ischemic stroke (n=1773) relative to no‐prior stroke (n=17 417) on ischemic and bleeding outcomes after PCI . Cumulative 3‐year incidences of the co‐primary bleeding end points of intracranial hemorrhage, non‐intracranial global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries (GUSTO) moderate/severe bleeding, and the primary ischemic end point of ischemic stroke/myocardial infarction were higher in the prior hemorrhagic and ischemic stroke groups than in the no‐prior stroke group (6.8%, 2.5%, and 1.3%, P P =0.001, and 12.7%, 13.4%, and 7.5%, P CI 2.64–7.01, P HR 1.52, 95% CI 1.06–2.12, P =0.02), but not for non‐intracranial bleeding ( HR 1.18, 95% CI 0.76–1.73, P =0.44, and HR 0.94, 95% CI 0.78–1.13, P =0.53). The excess risks of both prior hemorrhagic and ischemic strokes relative to no‐prior stroke remained significant for ischemic events mainly driven by the higher risk for ischemic stroke ( HR 1.46, 95% CI 1.02–2.01, P =0.04, and HR 1.49, 95% CI 1.29–1.72, P Conclusions Patients with prior hemorrhagic or ischemic stroke as compared with those with no‐prior stroke had higher risk for intracranial hemorrhage and ischemic events, but not for non‐intracranial bleeding after PCI .

Background: Transcatheter aortic valve implantation (TAVI) is criticized by some as an expensive treatment in super-elder patients with limited life expectancy. However, there is a knowledge gap regarding the magnitude of clinical benefit provided by TAVI in comparison with conservative management in patients with severe aortic stenosis (AS) in real clinical practice, which would be important in the decision making for TAVI. Methods: We combined two independent registries, namely CURRENT AS and K-TAVI registries. CURRENT AS was a multicenter registry enrolling 3815 consecutive patients with severe AS irrespective to treatment modalities between January 2003 and December 2011. K-TAVI was a multicenter, prospective registry including 449 consecutive patients with severe AS, who underwent TAVI with SAPIEN XT balloon-expandable valves between October 2013 and June 2016. In these 2 registries, 449 patients received TAVI and 894 patients were managed with conservative strategy. We conducted propensity score matching and finally obtained a cohort of 556 patients (278 patients for each group) for the analysis. The primary outcome measures were all-cause death and heart failure (HF) hospitalization at 2-year. Results: The cumulative 2-year incidences of all-cause death and HF hospitalization were significantly lower in the TAVI group than in the conservative group (16.8% versus 36.6%, P, 竹治, 泰明, 谷口, 智彦, 森本, 剛, 齋藤, 成達, 安藤, 献児, 白井, 伸一, 新井, 善雄, 坂口, 元一, 福, 康志, 川瀬, 裕一, 小宮, 達彦, 江原, 夏彦, 北井, 豪, 小山, 忠明, 渡邉, 真, 渡部, 宏俊, 塩見, 紘樹, 南野-牟田, 恵里, 松田, 真太郎, 夜久, 英憲, 芳川, 裕亮, 山﨑, 和裕, 川東, 正英, 坂本, 和久, 田村, 俊寛, 三宅, 誠, 阪口, 仁寿, 村田, 耕一郎, 中井, 真尚, 泉, 知里, 稲田, 司, 竹内, 泰代, 山根, 啓一郎, 田村, 崇, 豊福, 守, 石井, 充, 猪子, 森明, 池田, 智之, 石井, 克尚, 堀田, 幸造, 陣内, 俊和, 東谷, 暢也, 犬塚, 康孝, 湊谷, 謙司, 木村, 剛

Background: The optimal cutoff value of fractional flow reserve (FFR) derived from coronary computed tomography angiography (FFR CT ) remains unclear. Methods: The current study population consisted of 93 patients with 139 vessels, who had suspected coronary artery disease by computed tomography angiography and underwent invasive FFR. We evaluated diagnostic performance of FFR CT according to different FFR CT cutoff values and FFR CT ranges with invasive FFR ≤0.80 as the reference standard. Results: In per-vessel analysis, median invasive FFR was 0.85 (interquartile range, 0.75–0.90), and 57 out of 139 vessels (41%) showed hemodynamically significant stenosis (≤0.80). Median FFR CT was 0.77 (interquartile range, 0.66–0.84; mean difference [invasive FFR-FFR CT ], 0.06±0.11). Per-vessel accuracy, sensitivity, specificity, positive predictive value, and negative predictive value were 73%, 95%, 59%, 61%, and 94% for the cutoff value of FFR CT ≤0.80, 81%, 86%, 78%, 73%, and 89% for FFR CT ≤0.75, and 83%, 74%, 89%, 82%, and 83% for FFR CT ≤0.70, respectively. Per-vessel accuracy across the different ranges of FFR CT ≤0.60, 0.61 to 0.70, 0.71 to 0.80, 0.81 to 0.90, and >0.90 with the cutoff value of FFR CT ≤0.80 were 95%, 74%, 32%, 93%, and 100%, respectively. Setting a gray zone of FFR CT 0.71 to 0.80 provided high positive predictive value (82%; n=42/51) in the range of FFR CT ≤0.70 and high negative predictive value (94%; n=48/51) in FFR CT >0.80. Conclusions: This study suggested that referral to invasive coronary angiography should be considered individually in the range of FFR CT 0.71 to 0.80, whereas dichotomous decision could be made in FFR CT ≤0.70 and >0.80. Future prospective studies evaluating clinical outcomes are needed to establish optimal FFR CT -based diagnostic algorithm.

Background Data are scarce on the role of aortic valve area (AVA) to identify those patients with asymptomatic severe aortic stenosis (AS) who are at high risk of adverse events. We sought to explore the prognostic impact of AVA in asymptomatic patients with severe AS in a large observational database. Methods and Results Among 3815 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 included 1309 conservatively managed asymptomatic patients with left ventricular ejection fraction ≥50%. The study patients were subdivided into 3 groups based on AVA (group 1: AVA >0.80 cm2, N=645; group 2: 0.8 cm2 ≥AVA >0.6 cm2, N=465; and group 3: AVA ≤0.6 cm2, N=199). The prevalence of very severe AS patients (peak aortic jet velocity ≥5 m/s or mean aortic pressure gradient ≥60 mm Hg) was 2.0%, 5.8%, and 26.1% in groups 1, 2, and 3, respectively. The cumulative 5‐year incidence of AVR was not different across the 3 groups (39.7%, 43.7%, and 39.9%; P=0.43). The cumulative 5‐year incidence of the primary outcome measure (a composite of aortic valve–related death or heart failure hospitalization) was incrementally higher with decreasing AVA (24.1%, 29.1%, and 48.1%; P, See Editorial by Tribouilloy et al

Non-invasive fractional flow reserve measured by coronary computed tomography angiography (FFRCT) has demonstrated a high diagnostic accuracy for detecting coronary artery disease (CAD) in selected patients in prior clinical trials. However, feasibility of FFRCT in unselected population have not been fully evaluated. Among 60 consecutive patients who had suspected significant CAD by coronary computed tomography angiography (CCTA) and were planned to undergo invasive coronary angiography, 48 patients were enrolled in this study comparing FFRCT with invasive fractional flow reserve (FFR) without any exclusion criteria for the quality of CCTA image. FFRCT was measured in a blinded fashion by an independent core laboratory. FFRCT value was evaluable in 43 out of 48 (89.6 %) patients with high prevalence of severe calcification in CCTA images [calcium score (CS) >400: 40 %, and CS > 1000: 19 %). Per-vessel FFRCT value showed good correlation with invasive FFR value (Spearman’s rank correlation = 0.69, P 1000), per-vessel FFRCT value showed a diagnostic performance similar to that in patients with CS ≤ 1000 (Spearman’s rank correlation = 0.81, P

One-month duration of dual antiplatelet therapy (DAPT) has widely been adopted after bare-metal stent (BMS) implantation in the real clinical practice. However, it has not been adequately addressed yet whether DAPT for only 1-month could provide sufficient protection from ischemic events beyond 1-month after BMS implantation. We assessed the effects of short DAPT relative to prolonged DAPT on clinical outcomes with the landmark analysis at 2 month after BMS implantation. Among 13,058 consecutive patients enrolled in the CREDO-Kyoto registry cohort-2, this study population consisted of 4905 patients treated with BMS only in whom the information on the status of antiplatelet therapy was available at 2 month after stent implantation [single-antiplatelet therapy (SAPT) group: N = 2575 (acute myocardial infarction (AMI): N = 1257, and non-AMI: N = 1318), and DAPT group: N = 2330 (AMI: N = 1304, and non-AMI: N = 1026)]. Cumulative 3-year incidence of the primary outcome measure (a composite of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis, and GUSTO moderate/severe bleeding) was not significantly different between the SAPT and DAPT groups (9.8 versus 10.6 %, P = 0.34). After adjusting confounders, the risk of SAPT relative to DAPT for the primary outcome measure remained insignificant in the entire cohort (HR 0.97, 95 % CI 0.79–1.19, P = 0.77), and in both AMI and non-AMI strata without any significant interaction between clinical presentation (AMI versus non-AMI) and the effect of SAPT relative to DAPT (P interaction = 0.56). In conclusion, short DAPT

Background— Female sex was reported to be associated with lower risk for midterm restenosis and repeat revascularization after bare-metal stent implantation. However, the influence of sex on very long-term outcomes after bare-metal stent implantation has not been yet reported. Methods and Results— Among the 9877 patients in the multicenter Coronary Revascularization Demonstrating Outcome study in Kyoto (CREDO-Kyoto) registry cohort-1, bare-metal stent implantation was performed in 5313 patients (men, n=3742 and women, n=1571). Follow-up was completed in 4515 patients (85.0%) at 10 years (duration, 10.3±3.1 [0.0–14.1] years). The cumulative incidence of target-lesion revascularization (TLR) was 27% at 1 year and 34% at 10 years (0.8%/y beyond 1 year). Non–target-lesion revascularization (non-TLR) was the dominant coronary revascularization beyond 1 year (13% at 1 year and 31% at 10 years [2.0%/y beyond 1 year]). Cumulative incidence of stent thrombosis was low (1.2% at 1 year and 1.9% at 10 years). Women were older and had greater prevalence of cardiovascular risk factors than men. The cumulative 10-year incidences of and adjusted risk for TLR were significantly higher in men than in women (36% versus 30%, P P Conclusions— TLR and stent thrombosis continued to occur without attenuation up to 10 years after bare-metal stent implantation. Men in comparison with women were associated with higher adjusted 10-year risks for all-cause death, myocardial infarction, stroke, coronary artery bypass grafting, TLR, and non-TLR.

OBJECTIVE To assess long-term outcomes after percutaneous coronary intervention (PCI) with drug-eluting stent only compared with coronary artery bypass grafting (CABG) in patients with triple-vessel disease. BACKGROUND Selection between PCI and CABG is still a clinically relevant issue in the management of patients with multi-vessel coronary artery disease. METHODS Among 15,939 patients enrolled in the CREDO-Kyoto PCI/CABG registry/cohort-2, the current study population consisted of 2,193 patients who underwent elective multi-vessel coronary revascularization including left anterior descending coronary artery (LAD) either by PCI with sirolimus-eluting stent (SES) only (N = 945) or CABG (N = 1,248). RESULTS The cumulative 5-year incidence of and the adjusted risk for the primary outcome measure (a composite of all-cause death, myocardial infarction [MI], or stroke) were not significantly different between PCI and CABG groups (22.6% vs. 23.0%, p = .40, and HR: 1.13, 95%CI: 0.91-1.40, p = .26). The risk of PCI relative to CABG for all-cause death and stroke was also insignificant (HR: 1.19, 95%CI: 0.92-1.53, p = .19; HR: 0.89, 95%CI: 0.62-1.27, p = .51). The adjusted 5-year risk for MI, hospitalization for heart failure (HF), any coronary revascularization and major bleeding was significantly different between the groups (HR: 1.59, 95%CI: 1.10-2.30, p = .01; HR: 1.49, 95%CI: 1.05-2.11, p = .02; HR: 3.70, 95%CI: 2.91-4.70, p

The influence of thrombocytopenia on the long-term clinical outcomes has not been thoroughly evaluated in patients with venous thromboembolism (VTE). This study sought to elucidate association of baseline thrombocytopenia with bleeding, recurrent VTE, and mortality risk. We evaluated the influence of baseline thrombocytopenia among 3,012 patients whose baseline platelet counts were available in the COMMAND VTE Registry in Japan with a median follow-up period of 1,219 days. Baseline thrombocytopenia was classified as follows: mild: 100,000 to 150,000/μl; moderate: 50,000 to 99,999/μl; and severe

Aims To evaluate the influence of a history of cancer on clinical outcomes in coronary artery disease (CAD) patients who underwent percutaneous coronary intervention (PCI). Methods and results In the Coronary REvascularization Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) PCI/coronary artery bypass grafting (CABG) Registry Cohort-2, there were 12 180 CAD patients who received PCI with stents. There were 1109 patients with a history of cancer (cancer group) and 11 071 patients without cancer (non-cancer group). The cumulative 5-year incidences of cardiac death and heart failure (HF) hospitalization were significantly higher in the cancer group than in the non-cancer group (12.4% vs. 7.5%, P

BACKGROUND Patients with concomitant atrial fibrillation (AF) and coronary stenting are at high risk for both cardiovascular and bleeding events. We aimed to evaluate the influence of sex on long-term clinical outcomes in this patient subset.Methods and Results:We identified 1,450 patients with AF and coronary stenting in a patient-level pooled database from 3 Japanese studies, and compared 3-year clinical outcomes between men and women (n=1,075, and n=375, respectively). The cumulative 3-year incidence of all-cause death was significantly higher in women than in men (26.5% vs. 17.2%, log-rank P

Balloon aortic valvuloplasty (BAV) has played a limited role in the management of patients with severe aortic stenosis. However, BAV is being performed more frequently these days with the emergence of transcatheter aortic valve implantation (TAVI). We previously described a technique named "looped Inoue balloon technique" to simplify the antegrade transvenous BAV by making a loop in the left atrium using two stylets. We present a case in which the looped Inoue balloon technique was successfully applied. The patient was an 83-year-old woman with progressive dyspnea due to severe aortic stenosis. The aortic valve area was 0.39 cm(2) with a mean transvalvular gradient of 46 mmHg. The patient was deemed high risk for surgical aortic valve replacement or TAVI in view of the multiple comorbidities and frailty. Antegrade BAV using the looped Inoue balloon technique was performed. The procedure was successful without any complications. The post procedural aortic valve area increased to 1.15 cm(2) with a mean pressure gradient of 23 mmHg. This is the first report of clinical use of the looped Inoue balloon technique for antegrade BAV.

In Japan, transcatheter aortic valve implantation (TAVI) with Edwards-SAPIEN XT valve (Edwards Lifesciences Inc., Irvine, CA, USA) started in October 2013. All institutions should undergo a training period to perform TAVI independently. Balloon aortic valvuloplasty (BAV) as a bridge to TAVI during the training period should be performed with caution to avoid severe aortic regurgitation (AR) because bailout TAVI is not possible. We present a case in which BAV was successfully performed as a bridge to TAVI during the training period. The patient was an 85-year-old man with medically uncontrollable congestive heart failure due to severe aortic valve stenosis. The aortic valve area was 0.60cm2 with a left ventricular ejection fraction of 20%. TAVI was considered a safe but high-risk strategy owing to the unstable hemodynamic condition. We chose BAV as a bridge therapy to TAVI. The aortic annulus diameter was 25.3mm on computed tomography scans. We chose a 20-mm balloon catheter to avoid BAV-induced AR. Transfemoral TAVI was performed successfully 16 days after BAV using a 26-mm SAPIEN XT valve. The postoperative course was uneventful. The case demonstrated BAV as a bridge therapy to TAVI can be safely and effectively performed during the training period.

An 86-year-old woman with severe aortic stenosis was referred for transcatheter aortic valve replacement (TAVR). The transfemoral TAVR procedure was conducted under general anesthesia. Aortography during pre-dilatation with a 20-mm balloon demonstrated reduced blood flow through the left main