Low-Dose Prasugrel vs. Standard-Dose Clopidogrel for Patients Undergoing Percutaneous Coronary Intervention.

BACKGROUND: Low-dose prasugrel (3.75 mg) is used as maintenance therapy for percutaneous coronary intervention; however, data on long-term outcomes are scarce.Methods and Results: We analyzed 5,392 participants in the KiCS-PCI registry who were administered low-dose prasugrel or clopidogrel at discharge between 2008 and 2018 and for whom 2-year follow-up data were available. We adjusted for confounders using matching weight analyses and multiple imputations. Similarly, we used inverse probability- and propensity score-weighted analyses. We also performed instrumental variable analyses. The primary outcomes were acute coronary syndrome (ACS) and bleeding requiring readmission. Secondary outcomes were all-cause death and a composite outcome of ACS, bleeding, heart failure, stroke, coronary bypass requiring admission, and all-cause death. In this cohort, 12.2% of patients were discharged with low-dose prasugrel. Compared with clopidogrel, low-dose prasugrel was associated with a reduced risk of ACS (hazard ratio [HR] 0.58; 95% confidence interval [CI] 0.39-0.85), bleeding (HR 0.62; 95% CI 0.40-0.97), and the composite outcome (HR 0.71; 95% CI 0.59-0.86). Inverse probability-weighted analysis yielded similar results; however, matching weight analysis without multiple imputations and propensity score-matched analyses showed similar outcomes in both groups. Instrumental variable analyses showed reduced risks of ACS and composite outcome for those on low-dose prasugrel. All-cause mortality did not differ in all analyses. CONCLUSIONS: Low-dose prasugrel demonstrates comparable outcomes to clopidogrel in terms of ACS and bleeding.

In-hospital Bleeding Outcomes of Oral Anticoagulant and Dual Antiplatelet Therapy During Percutaneous Coronary Intervention: An Analysis From the Japanese Nationwide Registry.

ABSTRACT: The type of periprocedural antithrombotic regimen that is the safest and most effective in percutaneous coronary intervention (PCI) patients on oral anticoagulant (OAC) therapy has not been fully investigated. We aimed to retrospectively investigate the in-hospital bleeding outcomes of patients receiving OAC and antiplatelet therapies during PCI using Japanese nationwide multicenter registry data. A total of 26,938 patients who underwent PCI with OAC and antiplatelet therapies between 2016 and 2017 were included. We investigated in-hospital bleeding requiring blood transfusion, mortality, and stent thrombosis according to the antithrombotic regimens used at the time of PCI: OAC + single antiplatelet therapy (double therapy) and OAC + dual antiplatelet therapy (triple therapy). The antiplatelet agents included aspirin, clopidogrel, and prasugrel. The OAC agents included warfarin and direct OACs. Adjusting the dose of OAC or intermitting OAC before PCI was at each operator's discretion. In the study population [mean age (SD), 73.5 (9.5) years; women, 21.5%], the double therapy and triple therapy groups comprised 5546 (20.6%) and 21,392 (79.4%) patients, respectively. Bleeding requiring transfusion was not significantly different between the groups [adjusted odds ratio (aOR), 0.700; 95% confidence interval (CI), 0.420-1.160; P = 0.165] (triple therapy as a reference). Mortality was not significantly different (aOR, 1.370; 95% CI, 0.790-2.360; P = 0.258). Stent thrombosis was significantly different between the groups (aOR, 3.310; 95% CI, 1.040-10.500; P = 0.042) (triple therapy as a reference). In conclusion, for patients on OAC therapy who underwent PCI, periprocedural triple therapy may be safe with respect to in-hospital bleeding risks. However, further investigations are warranted to establish the safety and efficacy of periprocedural triple therapy.

Real-world use of intravascular ultrasound in Japan: a report from contemporary multicenter PCI registry.

Clinical trial data suggest that intravascular ultrasound (IVUS) may improve clinical outcomes after PCI. The aim of this study was to investigate the safety of IVUS in its broader use for percutaneous coronary intervention (PCI). A total of 11,570 consecutive patients undergoing PCI between 2008 and 2014 in Japan were analyzed. Associations between IVUS use, PCI-related complications were assessed with logistic regression and propensity score matching analyses. Subgroup analysis was performed in elective PCI patients. IVUS was used in 84.8% of patients (N = 9814; IVUS group); its use was almost universal in elective PCIs (90.8 vs. 81.7% in urgent/emergent PCIs, P < 0.001). The non-IVUS group were older (68.7 ± 11.4 vs. 67.9 ± 10.8 years, P = 0.004), with more comorbid conditions. The non-IVUS group had smaller stent lumens (2.97 ± 0.42 mm vs. 3.09 ± 0.45 mm, P < 0.001) and a higher proportion of plain old balloon angioplasty. After matching, a lower rate of flow-impairing coronary dissections was observed in the IVUS group, although this was limited only to elective PCIs, not among urgent/emergent PCIs (non-IVUS vs. IVUS; 2.7% vs. 1.0%, P = 0.018, 0.7% vs. 1.2%, P = 0.32, respectively). With a multivariate logistic regression analysis, IVUS use remained an independent predictor to reduce risk of flow impairing severe coronary dissection among elective PCIs (odds ratio 0.38, 95% confidence interval 0.22-0.66: P = 0.001). In this Japanese PCI registry, IVUS was used extensively during the study period, particularly in elective cases. Using IVUS was associated with a lower event rate of flow-impairing coronary dissections that was limited to elective PCIs, not among urgent/emergent PCIs, without increasing PCI-related complications.

Barriers Associated With Door-to-Balloon Delay in Contemporary Japanese Practice.

BACKGROUND: Door-to-balloon (DTB) time ≤90 min is an important quality indicator in the management of ST-elevation myocardial infarction (STEMI), but a considerable number of patients still do not meet this goal, particularly in countries outside the USA and Europe.Methods and Results:We analyzed 2,428 STEMI patients who underwent primary PCI ≤12 h of symptom onset who were registered in an ongoing prospective multicenter database (JCD-KiCS registry), between 2008 and 2013. We analyzed both the time trend in DTB time within this cohort in the registry, and independent predictors of delayed DTB time >90 min. Median DTB time was 90 min (IQR, 68-115 min) during the study period and there were no significant changes with year. Predictors for delay in DTB time included peripheral artery disease, prior revascularization, off-hour arrival, age >75 years, heart failure at arrival, and use of IABP or VA-ECMO. Notably, high-volume PCI-capable institutions (PCI ≥200/year) were more adept at achieving shorter DTB time compared with low-volume institutions (PCI <200/year). CONCLUSIONS: Half of the present STEMI patients did not achieve DTB time ≤90 min. Targeting the elderly and patients with multiple comorbidities, and PCI performed in off-hours may aid in its improvement.

Acute coronary syndromes occurring while driving: frequency and patient characteristics.

BACKGROUND: Acute coronary syndrome (ACS) may occur during any human activity, including driving. The objectives of this study were to report the frequency of ACS occurring while driving, clarify patient characteristics, and analyze the behavioral patterns of drivers who sustained ACS. METHODS: A single-center, retrospective observational study was conducted using prospectively acquired data. Among 1605 ACS patients admitted between January 2011 and December 2016, 65 (60 men/5 women) patients who sustained ACS while driving were identified. Clinical variables were compared between these 65 patients and 1540 patients who sustained ACS while performing other activities. Furthermore, multivariable regression analysis was performed to identify variables associated with ACS. RESULTS: The frequency of ACS occurring while driving was 4.0% (65/1605). Compared with patients who sustained ACS while performing other activities, those who sustained ACS while driving were significantly younger (66.2 ± 13.0 vs. 57.5 ± 12.2 years, p < 0.001) and more likely to smoke (34.2 vs. 60.0%, p < 0.001). Multivariable regression analysis showed that age (OR 0.961; 95% CI 0.940-0.982) and current smoking (OR 1.978; 95% CI 1.145-3.417) were associated with ACS. While 55 drivers (85%) who remained conscious after ACS could seek medical attention without causing accidents, the other 10 (15%) who sustained cardiac arrest caused accidents. CONCLUSIONS: The association between current smoking and ACS occurring while driving suggests that smoking cessation is advised for smokers who drive from the standpoint of driving safety. We expect that prospective studies be conducted to verify our findings and identify individuals at risk for ACS while driving.

Appropriateness of coronary interventions in Japan by the US and Japanese standards.

BACKGROUND: Appropriateness use criteria (AUC) are widely used to assess quality of care. American professional organizations and Japanese experts have both developed original AUC for percutaneous coronary intervention (PCI). However, rating discrepancies have not been investigated. METHODS: Patients registered in the Japanese multicenter PCI registry were analyzed. We assessed the appropriateness of PCI based on both the US and Japanese criteria and compared the ratings. A logistic regression analysis was performed to identify clinical predictors of inappropriate ratings under both standards. RESULTS: From a total of 4,950 nonacute, consecutive PCIs, 1,982 and 2,077 procedures could be successfully rated using the US and Japanese criteria, respectively. The major difference between the 2 criteria was the rating of "asymptomatic, low- or intermediate-risk patients, no lesion in the proximal left anterior descending coronary artery (PLAD)"; this scenario was deemed appropriate in the Japanese but not in the US criteria. As a consequence, the rate of inappropriate PCI using the Japanese criteria (5.2%) was substantially lower when compared with the rating using the US criteria (15%). Common clinical variables associated with "inappropriate" PCI were male, multivessel diseases, and lesions in the non-PLAD. Suboptimal antianginal medication was also a significant predictor of inappropriate PCI under the US but not under the Japanese criteria. CONCLUSIONS: Significant and clinically relevant rating discrepancies were observed between the US and Japanese criteria-based assessments, owing largely to the ratings of asymptomatic, non-PLAD-related, low- or intermediate-risk cases.

Enhancing Coronary Intervention Outcomes Using Intravascular Ultrasound: Analysis of Long-Term Benefits in a Japanese Multicenter Registry.

Background: Although the use of intravascular ultrasound (IVUS) during percutaneous coronary intervention (PCI) has been shown to improve clinical outcomes, its utilization remains inconsistent. We aimed to assess the association between IVUS-guided PCI and long-term outcomes in Japan, where a high proportion of patients undergo IVUS. Methods: We analyzed 8721 consecutive patients in a multicenter PCI registry. The primary outcome was a composite of death, acute coronary syndrome, and heart failure requiring admission and coronary artery bypass grafting at 2 years after discharge. The secondary outcome was each component of the primary outcome. We used inverse probability-weighted analysis for adjustment. Subgroup analysis was conducted on patients with complex coronary anatomy (eg, those with bifurcation, chronic total occlusion, type C lesion, left main and those who underwent rotational atherectomy). Results: Overall, 83.8% of patients underwent IVUS-guided PCI (mean age, 68.3 ± 11.3 years). After adjustments, the IVUS group had significantly lower rates of death and coronary bypass compared to no IVUS group (hazard ratio [HR], 0.73; 95% CI, 0.55-0.96; and HR, 0.62; 95% CI, 0.39-0.98) at 2-year follow-up, although the primary outcome showed only marginal differences (HR, 0.85; 95% CI, 0.71-1.01). In the subgroup analysis of complex coronary anatomy, the use of IVUS was significantly associated with a reduced risk of the primary outcome (HR, 0.72; 95% CI, 0.55-0.93) as well as death, coronary bypass, and heart failure. Conclusions: IVUS was frequently utilized in our registry and demonstrated potential benefit in reducing mortality and need for coronary bypass surgery, particularly in patients with complex coronary anatomy.

Incidence of periprocedural myocardial infarction and cardiac biomarker testing after percutaneous coronary intervention in Japan: results from a multicenter registry.

Periprocedural myocardial infarction (pMI) is an important complication associated with percutaneous coronary intervention (PCI). However, data on the frequency of biomarker testing and the incidence of pMI remain unclear. Using the multicenter Japan Cardiovascular Database, we identified 2182 patients who underwent PCI without preprocedural cardiac biomarker elevation (silent ischemia, stable angina, or unstable angina without biomarker elevation) from September 2008 to August 2011. Of these, 550 patients (25.2 %) underwent cardiac biomarker testing within 6-24 h after PCI. The incidence of pMI was 2.7 % among all identified patients and 7.5 % among those who underwent cardiac marker testing. Of note, cardiac biomarker testing was performed more frequently than no testing in patients with a higher risk profile such as unstable angina (32.7 vs 24.7 %, P < 0.001), higher symptom scaling (28.2 vs 22.5 %, P = 0.008), urgent or emergent procedures (19.3 vs 15.0 %, P = 0.022 or 4.2 vs 1.0 %, P < 0.001, respectively), and type C lesion (31.3 vs 25.2 %, P = 0.006). Presentation with silent ischemia (odds ratio = 1.51, 95 % confidence interval (CI) 1.16-1.97) and nonemergent PCIs (odds ratio = 3.45, 95 % CI 1.79-6.67) were associated with no postprocedural cardiac biomarker testing. The real-world multicenter PCI registry in Japan revealed an incidence of 2.7 % for pMI; however, cardiac biomarkers were assessed in only 25.2 % of patients after PCI. The results suggest an underuse of postprocedural biomarker testing and room for procedural quality improvement, particularly in cases of silent ischemia and nonemergent cases.

Gender Differences in Long-Term Outcomes of Young Patients Who Underwent Percutaneous Coronary Intervention: Long-Term Outcome Analysis from a Multicenter Registry in Japan.

Young patients who underwent percutaneous coronary intervention (PCI) have shown worse long-term outcomes but remain inadequately investigated. We analyzed 1,186 consecutive young patients (aged ≤55 years) from the Keio Cardiovascular PCI registry who were successfully discharged after PCI (2008 to 2019) and compared them to 5,048 older patients (aged 55 to 75 years). The primary outcome was a composite of all-cause death, acute coronary syndrome, heart failure, bleeding, stroke requiring admission, and coronary artery bypass grafting within 2 years after discharge. In the young patients, the mean age was 48.4 ± 5.4 years, acute coronary syndrome cases accounted for 69.6%, and 92 (7.8%) were female. Body mass index; hemoglobin levels; and proportions of smoking, hyperlipidemia, and ST-elevation myocardial infarction were lower and dialysis or active cancer proportions were higher in young female patients than male patients. A higher number of young female than male patients reached the primary end point and all-cause death (15.2% vs 7.1%, p = 0.01; 4.3% vs 1.0%, p = 0.023), mainly because of noncardiac death (4.3% versus 0.5%, p = 0.001). After covariate adjustment, the primary end point rates were higher among young women than men (hazard ratio 2.00, 95% confidence interval 1.03 to 3.89, p = 0.042). Gender did not predict the primary end point among older patients (vs men; hazard ratio 0.84, 95% confidence interval 0.67 to 1.06, p = 0.14). In conclusion, young women showed worse outcomes during the 2-year post-PCI follow-up, but this gender difference was absent in patients aged 55 to 75 years.

Long-term outcomes of periprocedural coronary dissection and perforation for patients undergoing percutaneous coronary intervention in a Japanese multicenter registry.

Long-term outcomes of iatrogenic coronary dissection and perforation in patients undergoing percutaneous coronary intervention (PCI) remains under-investigated. We analyzed 8,721 consecutive patients discharged after PCI between 2008 and 2019 from Keio Cardiovascular (KiCS) PCI multicenter prospective registry in the Tokyo metropolitan area. Significant coronary dissection was defined as persistent contrast medium extravasation or spiral or persistent filling defects with complete distal and impaired flow. The primary outcome was a composite of all-cause death, acute coronary syndrome, heart failure, bleeding, stroke requiring admission, and coronary artery bypass grafting two years after discharge. We used a multivariable Cox hazard regression model to assess the effects of these complications. Among the patients, 68 (0.78%) had significant coronary dissections, and 61 (0.70%) had coronary perforations at the index PCI. Patients with significant coronary dissection had higher rates of the primary endpoint and heart failure than those without (25.0% versus 14.3%, P = 0.02; 10.3% versus 4.2%, P = 0.03); there were no significant differences in the primary outcomes between the patients with and without coronary perforation (i.e., primary outcome: 8.2% versus 14.5%, P = 0.23) at the two-year follow-up. After adjustments, patients with coronary dissection had a significantly higher rate of the primary endpoint than those without (HR 1.70, 95% CI 1.02-2.84; P = 0.04), but there was no significant difference in the primary endpoint between the patients with and without coronary perforation (HR 0.51, 95% CI 0.21-1.23; P = 0.13). For patients undergoing PCI, significant coronary dissection was associated with poor long-term outcomes, including heart failure readmission.

Standard modifiable cardiovascular risk factors in patients with acute coronary syndrome: A report from multicenter percutaneous coronary intervention registry.

BACKGROUND: High mortality in patients with acute coronary syndrome (ACS) without standard modifiable cardiovascular risk factors [SMuRFs (e.g. diabetes, hypertension, smoking, and dyslipidemia)] has been reported. However, details regarding their acute presentation and reasons for the excess risk remain unclear. METHOD: Patient-level data were extracted from a multicenter procedure-based registry (KiCS-PCI). We analyzed consecutive patients with ACS who underwent de novo percutaneous coronary intervention (PCI) between 2009 and 2020. The primary outcome of interest was the in-hospital mortality. RESULTS: Among the 10,523 patients with ACS, 7775 met the inclusion criteria. Patients without SMuRFs who underwent PCI [n = 529 (6.8 %)] were older [median 71 (IQR: 63-79) vs. 68 (59-76) years, p < 0.001] and more often presented with cardiogenic shock or cardiopulmonary arrest (14.6 % vs. 8.6 %, p < 0.001; 12.7 % vs. 5.3 %, p < 0.001, respectively). In patients with ST-elevation myocardial infarction (STEMI), median door-to-balloon time was significantly longer in SMuRF-less patients (90 min vs 82 min). In-hospital death was significantly higher in SMuRF-less patients [10.2 % vs. 4.1 %, p < 0.001, adjusted odds ratio, 1.81 (95%CI, 1.26-2.59); p = 0.001], whereas the rate of procedural complications showed no significant difference. When stratified by the ACS presentation pattern, the findings were consistent, although the association between SMuRF-less and the increased risk of in-hospital mortality was not statistically significant in patients with non-ST-elevation- (NSTE)-ACS. CONCLUSIONS: SMuRF-less ACS patients frequently presented with cardiopulmonary arrest and/or cardiogenic shock, leading to high in-hospital mortality. When stratified by the ACS presentation pattern, the association of SMuRF-less and the increased risk of mortality was more prominent in STEMI patients and it was not statistically significant in NSTE-ACS patients. Almost half of these patients had amendable left main trunk or left anterior descending artery disease and treating clinicians should be aware of this paradox to avoid the delay in treatment.

Time Trend in Incidence of Sudden Cardiac Death After Percutaneous Coronary Intervention from 2009 to 2017 (from the Japanese Multicenter Registry).

The advances in the integrated management of patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) have reduced subsequent cardiovascular events. Nonetheless, sudden cardiac death (SCD) remains a major concern. Therefore, we aimed to investigate the time trend in SCD incidence after PCI and to identify the clinical factors contributing to SCD. From a prospective, multicenter cohort registry in Japan, 8,723 consecutive patients with coronary artery disease undergoing PCI between 2009 and 2017 were included. We evaluated the SCD incidence 2 years after PCI; all death events were adjudicated, and SCD was defined as unexpected death without a noncardiovascular cause in a previously stable patient within 24 hours from the onset. The Fine and Gray method was used to identify the factors associated with SCD. Overall, the mean age of the patients was 68.3 ± 11.3 years, and 1,173 patients (13.4%) had heart failure (HF). During the study period, the use of second-generation drug-eluting stents increased. The 2-year cumulative incidence of all-cause mortality and SCD was 4.29% and 0.45%, respectively. All-cause mortality remained stable during the study period (p for trend = 0.98), whereas the crude incidence of SCD tended to decrease over the study period (p for trend = 0.052). HF was the strongest predictor associated with the risk of SCD (crude incidence [vs non-HF] 2.13% vs 0.19%; p <0.001). In conclusion, the incidence of SCD after PCI decreased over the last decade, albeit the high incidence of SCD among patients with HF remains concerning.

Genetic Backgrounds Associated With Stent Thrombosis: A Pilot Study From a Percutaneous Coronary Intervention Registry.

Background: Stent thrombosis (ST) is a rare, yet devastating, complication following percutaneous coronary intervention (PCI), with poorly understood pathophysiologic characteristics and genetic backgrounds. Objectives: The authors performed a genome-wide association study to identify the common genetic loci associated with early stent thrombosis (EST) and late/very late ST (LST/VLST) in a contemporary Japanese multicenter PCI registry. Methods: Among 8,642 PCI patients included in the registry, 42 who experienced stent thrombosis [EST (n = 15) and LST/VLST (n = 27)] were included (mean age, 67.6 ± 10.8 years; and 88.1% men). We conducted a genome-wide association study using the BioBank Japan patient population as the control (control #1: acute coronary syndrome [n = 29,542] and control #2: effort angina [n = 8,900]) to identify significant single nucleotide polymorphisms (SNPs) and evaluate the performance of polygenic risk scores (PRSs) for predicting these conditions. Results: We compared patients with EST with controls #1 and #2 and identified SNPs (rs565401593 and rs561634568) in NSD1, and patients with LST/VLST with controls #1 and #2 and identified SNPs (rs532623294 and rs199546342) in GRIN2A. PRS for LST/VLST showed high predictive performance (area under the curve 0.83 [95% CI: 0.76-0.89] and 0.83 [95% CI: 0.77-0.89]), whereas PRS for EST showed modest predictive performance (area under the curve 0.71 [95% CI: 0.58-0.85] and 0.72 [95% CI: 0.58-0.85]). Conclusions: We identified different genetic predispositions between EST and LST/VLST and demonstrated that the incorporation of PRS may aid in risk prediction of this highly fatal event.

Contrast volume and in-hospital outcomes of dialysis patients undergoing percutaneous coronary intervention.

Toxicity resulting from retained contrast media may cause adverse cardiovascular outcomes (e.g., heart failure and cardiogenic shock) for dialysis patients. However, the association between the administered contrast volume and outcomes of dialysis patients after percutaneous coronary intervention (PCI) has not been sufficiently investigated. We evaluated 953 consecutive dialysis patients (age, 67.9 ± 9.9 years; 30.1% with acute coronary syndrome) who underwent PCI between September 2008 and March 2019. Patients were divided into two groups: those with a contrast volume ≥ 200 ml and those with a contrast volume < 200 ml. The cutoff was 200 ml because 100 ml increment of contrast volume is known to raise the risk of acute kidney injury, and 200 ml is more than the average volume used at most PCI centers. The primary endpoint was a composite of in-hospital death, post-PCI cardiogenic shock and post-PCI heart failure. A multivariable logistic regression model and smooth spline curve were constructed to assess the association between contrast volume and the primary endpoint. The median contrast volume was 157 ml (interquartile range, 115-210 ml). The overall primary endpoint incidence was 6.8% (N = 65). A contrast volume ≥ 200 ml was associated with a higher risk of the primary endpoint (odds ratio 2.91; 95% confidence interval 1.42-6.05; P = 0.004). The smooth spline curve demonstrated a linear relationship between the contrast volume and primary endpoint. In conclusions, the contrast volume was associated with adverse in-hospital outcomes of dialysis patients undergoing PCI. Attention should be focused on the contrast volume used for dialysis patients undergoing PCI.

Machine learning prediction model of acute kidney injury after percutaneous coronary intervention.

Acute kidney injury (AKI) after percutaneous coronary intervention (PCI) is associated with a significant risk of morbidity and mortality. The traditional risk model provided by the National Cardiovascular Data Registry (NCDR) is useful for predicting the preprocedural risk of AKI, although the scoring system requires a number of clinical contents. We sought to examine whether machine learning (ML) techniques could predict AKI with fewer NCDR-AKI risk model variables within a comparable PCI database in Japan. We evaluated 19,222 consecutive patients undergoing PCI between 2008 and 2019 in a Japanese multicenter registry. AKI was defined as an absolute or a relative increase in serum creatinine of 0.3 mg/dL or 50%. The data were split into training (N = 16,644; 2008-2017) and testing datasets (N = 2578; 2017-2019). The area under the curve (AUC) was calculated using the light gradient boosting model (GBM) with selected variables by Lasso and SHapley Additive exPlanations (SHAP) methods among 12 traditional variables, excluding the use of an intra-aortic balloon pump, since its use was considered operator-dependent. The incidence of AKI was 9.4% in the cohort. Lasso and SHAP methods demonstrated that seven variables (age, eGFR, preprocedural hemoglobin, ST-elevation myocardial infarction, non-ST-elevation myocardial infarction/unstable angina, heart failure symptoms, and cardiogenic shock) were pertinent. AUC calculated by the light GBM with seven variables had a performance similar to that of the conventional logistic regression prediction model that included 12 variables (light GBM, AUC [training/testing datasets]: 0.779/0.772; logistic regression, AUC [training/testing datasets]: 0.797/0.755). The AKI risk model after PCI using ML enabled adequate risk quantification with fewer variables. ML techniques may aid in enhancing the international use of validated risk models.

Evidence-to-Practice Gap for Preventing Procedure-Related Acute Kidney Injury in Patients Undergoing Percutaneous Coronary Intervention.

Background Acute kidney injury (AKI) is a common complication of percutaneous coronary intervention. This risk can be minimized with reduction of contrast volume via preprocedural risk assessment. We aimed to identify quality gaps for implementing the available risk scores introduced to facilitate more judicious use of contrast volume. Methods and Results We grouped 14 702 patients who underwent percutaneous coronary intervention according to the calculated NCDR (National Cardiovascular Data Registry) AKI risk score quartiles (Q1 [lowest]-Q4 [highest]). We compared the used contrast volume by the baseline renal function and NCDR AKI risk score quartiles. Factors associated with increased contrast volume usage were determined using multivariable linear regression analysis. The overall incidence of AKI was 8.9%. The used contrast volume decreased in relation to the stages of chronic kidney disease (168 mL [SD, 73.8 mL], 161 mL [SD, 75.0 mL], 140 mL [SD, 70.0 mL], and 120 mL [SD, 73.7 mL] for no, mild, moderate, and severe chronic kidney disease, respectively; P<0.001), albeit no significant correlation was observed with the calculated NCDR AKI risk quartiles. Of the variables included in the NCDR AKI risk score, anemia (7.31 mL [1.76-12.9 mL], P=0.01), heart failure on admission (10.2 mL [6.05-14.3 mL], P<0.001), acute coronary syndrome presentation (10.3 mL [7.87-12.7 mL], P<0.001), and use of an intra-aortic balloon pump (17.7 mL [3.9-31.5 mL], P=0.012) were associated with increased contrast volume. Conclusions The contrast volume was largely determined according to the baseline renal function, not the patients' overall AKI risk. These findings highlight the importance of comprehensive risk assessment to minimize the contrast volume used in susceptible patients.

In-hospital outcome in patients presenting with acute coronary syndrome with left main coronary artery disease: A report from Japanese prospective multicenter percutaneous coronary intervention registry.

BACKGROUND: Patients presenting with acute coronary syndrome (ACS) from left main (LM) disease are at a high risk for mortality despite recent advancement in devices and techniques during percutaneous coronary interventions (PCI). We aimed to evaluate patient characteristics, clinical presentations, and key clinical characteristics associated with adverse in-hospital outcomes among ACS patients undergoing LM-PCI. METHODS: We retrospectively identified 280 LM-ACS patients (3.7 %) from 7608 ACS patients in the prospective multicenter Japan Cardiovascular Database-Keio Inter-Hospital Cardiovascular Studies registry from March 2009 to May 2016 and divided them into those with/without PCI/coronary artery bypass grafting. We compared baseline demographics, coronary lesion characteristics, PCI details, and short-term outcomes, including in-hospital mortality and periprocedural complications, between the two groups. RESULTS: Among LM-ACS patients, 38.6 % presented with ST elevation myocardial infarction, 29.6 % with cardiogenic shock (CS), and 15.4 % with cardiac arrest. The observed in-hospital mortality rate was 18.9 % with presence of CS [odds ratio (OR): 10.16, 95 % confidence interval (CI): 4.51-22.91, p<0.001] and absence of prior revascularization (de novo patients; OR: 4.31, 95 % CI: 1.43-12.94, p=0.009) was independently associated with higher incidence of in-hospital mortality. Notably, the observed mortality rate was substantially higher among de novo patients than the predicted mortality rate with a contemporary risk model (observed: 25.1 %; predicted: 11.6 %). CONCLUSIONS: Prior revascularization act as a protective factor among LM-ACS patients in the contemporary era of PCI. Further studies to detect those at higher risk for LM coronary lesion progression are needed to fully implement these findings into clinical practice.

Transradial Percutaneous Coronary Intervention in Patients With Advanced Chronic Kidney Disease.

BACKGROUND: Multiple randomized clinical trials have demonstrated that transradial intervention (TRI) improves clinical outcomes after percutaneous coronary intervention (PCI) compared with transfemoral intervention (TFI). However, chronic kidney disease (CKD) patients have more procedure-related complications; TRI is frequently avoided for future creation of arteriovenous fistulas essential for hemodialysis. Therefore, limited information on TRI among CKD patients exists. We aimed to assess the impact of TRI on CKD patients. METHODS: Consecutive PCI patients with advanced CKD registered in a multicenter Japanese registry between 2008 and 2017 (N = 20,420) were analyzed. Advanced CKD was defined as estimated glomerular filtration rate <30 mL/min/1.73 m2. Outcomes of interest were periprocedural bleeding (transfusion or decreasing hemoglobin by >3.0 g/dL within 72 h after PCI), acute kidney injury (AKI: absolute increase of 0.3 mg/dL or a relative increase of 50% in serum creatinine from baseline), and hemodialysis initiation after PCI. To account for baseline differences between patients with TRI and TFI, 1:1 propensity matching was performed. RESULTS: Overall, 498 patients (3.7%) had advanced CKD, and 199 (40.0%) underwent TRI. After propensity matching, 324 patients were included (age, 74.9 ±â€¯9.9 years; male, 63.6%; ACS, 46.0%). TRI was associated with reduced periprocedural AKI risks (12.4% versus 26.5%; p < 0.01) and hemodialysis initiation (3.1% versus 12.4%; p = 0.01) compared with TFI. TRI showed a trend toward lower rates of bleeding complications than those of TFI, but the difference was not statistically significant (1.9% versus 6.2%; p = 0.15). CONCLUSIONS: TRI might be beneficial over TFI in PCI patients with advanced CKD.

Exploring Triaging and Short-Term Outcomes of Early Invasive Strategy in Non-ST Segment Elevation Acute Coronary Syndrome: A Report from Japanese Multicenter Registry.

This observational study aimed to examine the extent of early invasive strategy (EIS) utilization in patients with non-ST elevation acute coronary syndrome (NSTE-ACS) according to the National Cardiovascular Data Registry (NCDR) CathPCI risk score, and its association with clinical outcomes. Using a prospective multicenter Japanese registry, 2968 patients with NSTE-ACS undergoing percutaneous coronary intervention within 72 hours of hospital arrival were analyzed. Multivariable logistic regression analyses were performed to determine predictors of EIS utilization. Additionally, adverse outcomes were compared between patients treated with and without EIS. Overall, 82.1% of the cohort (n = 2436) were treated with EIS, and the median NCDR CathPCI risk score was 22 (interquartile range: 14-32) with an expected 0.3-0.6% in-hospital mortality. Advanced age, peripheral artery disease, chronic kidney disease or patients without elevation of cardiac biomarkers were less likely to be treated with EIS. EIS utilization was not associated with a risk of in-hospital mortality; yet, it was associated with an increased risk of acute kidney injury (AKI) (adjusted odds ratio: 1.42; 95% confidence interval: 1.02-2.01) regardless of patients' in-hospital mortality risk. Broader use of EIS utilization comes at the cost of increased AKI development risk; thus, the pre-procedural risk-benefit profile of EIS should be reassessed appropriately in patients with lower mortality risk.

Applicability and Eligibility of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) for Patients who Underwent Revascularization with Percutaneous Coronary Intervention.

In the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial, an early invasive strategy did not decrease mortality compared to a conservative strategy for stable ischemic heart disease (SIHD) patients with moderate-to-severe ischemia, and the role of revascularization would be revised. However, the applicability and potential influence of this trial in daily practice remains unclear. Our objective was to assess the eligibility and representativeness of the ISCHEMIA trial on the patients with percutaneous coronary intervention (PCI). From a multicenter registry, we extracted a consecutive 13,223 SIHD patients with PCI (baseline cohort). We applied ISCHEMIA eligibility criteria and compared the baseline characteristics between the eligible patients and the actual study participants (randomized controlled trial (RCT) patients). In 3463 patients with follow-up information (follow-up cohort), the 2 year composite of major adverse cardiac events was evaluated between the eligible patients and RCT patients, as well as eligible and non-eligible patients in the registry. In the baseline cohort, 77.3% of SIHD patients with moderate-to-severe ischemia were eligible for the ISCHEMIA. They were comparable with RCT patients for baseline characteristics and outcomes unlike the non-eligible patients. In conclusion, the trial results seem applicable for the majority of PCI patients with moderate-to-severe ischemia except for the non-eligible patients.