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Background Female subjects have poorer outcomes in left main coronary artery (LMCA) disease compared with male subjects. However, limited information is available on the long-term prognost...

Objectives The aim of this study was to compare the incidence and prognostic significance of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) according to racial groups. Background PPM after TAVR may be of more concern in Asian populations considering their relatively small annular and valve sizes compared with Western populations. Methods TP-TAVR (Transpacific TAVR Registry) was an international multicenter cohort study of patients with severe aortic stenosis who underwent TAVR in the United States and South Korea from January 2015 to November 2019. PPM was defined as moderate (0.65-0.85 cm2/m2) or severe ( Results Among 1,101 eligible patients (533 Asian and 569 non-Asian), the incidence of PPM was significantly lower in the Asian population (33.6%; moderate, 26.5%; severe, 7.1%) than in the non-Asian population (54.5%; moderate, 29.8%; severe, 24.7%). The 1-year rate of the primary outcome was similar between the PPM and non-PPM groups (27.5% vs 28.1%; P = 0.69); this pattern was consistent between Asian (25.4% vs 25.2%; P = 0.31) and non-Asian (28.7% vs 32.1%; P = 0.97) patients. After multivariable adjustment, the risk for the primary outcome did not significantly differ between the PPM and non-PPM groups in the overall population (HR: 0.95; 95% CI: 0.74-1.21), in Asian patients (HR: 1.07; 95% CI: 0.74-1.55), and in non-Asian patients (HR: 0.86; 95% CI: 0.63-1.19). Conclusions In this study of patients with severe aortic stenosis who underwent TAVR, the incidence of PPM was significantly lower in Asian patients than in non-Asian patients. The 1-year risk for the primary composite outcome was similar between the PPM and non-PPM groups regardless of racial group. (Transpacific TAVR Registry [TP-TAVR]; NCT03826264 )

Background: Limited data are available on the long-term outcomes of drug-eluting stents (DES) vs bare-metal stents (BMS) in patients with left main coronary artery (LMCA) disease. Methods: In this observational cohort of the Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty vs Surgical Revascularization (MAIN-COMPARE) registry, we evaluated patients with unprotected LMCA stenosis who received DES or BMS between January 2000 and June 2006. The primary outcome was a composite of all-cause death or myocardial infarction (MI) at 10 years. Adjusted outcomes were compared using propensity scores and inverse probability of treatment weighting. Results: A total of 1102 patients underwent DES (n = 784) or BMS (n = 318) during the study period. At 10 years, the adjusted rate of the primary outcome was significantly lower in DES group than in the BMS group (27.9% vs 37.0%; hazard ratio [HR], 0.71; 95% confidence interval [CI], 0.53-0.94; P = 0.02). The adjusted 10-year mortality rate was significantly lower in DES group than in the BMS group (20.6% vs 29.6%; HR, 0.65; 95% CI, 0.46-0.91; P = 0.01), whereas the 10-year rate of MI was similar between the 2 groups (9.9% vs 11.0%; HR, 0.93; 95% CI, 0.54-1.59; P = 0.78). DES use was associated with a significant reduction in the rate of target-lesion revascularization (10.2% vs 21.8%; HR, 0.41; 95% CI, 0.27-0.61; P < 0.001). Conclusions: In this 10-year follow-up study in patients with LMCA disease, DES use was associated with a significant reduction in the rate of the composite of death or MI, mortality, and target-lesion revascularization, when compared with BMS. Résumé: Contexte: On dispose de peu de données sur les résultats à long terme de la mise en place d'endoprothèses médicamentées par rapport aux endoprothèses non médicamentées chez les patients atteints d'une maladie de l'artère coronaire principale gauche. Méthodologie: Dans cette cohorte d'observation du registre MAIN-COMPARE (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty vs Surgical Revascularization), nous avons évalué les patients présentant une sténose de l'artère coronaire principale gauche non protégée et ayant reçu une endoprothèse médicamentée ou une endoprothèse non médicamentée entre janvier 2000 et juin 2006. Le paramètre d’évaluation principal était composé de la mortalité toutes causes confondues et de l'infarctus du myocarde (IM) à 10 ans. Les résultats ajustés ont été comparés en utilisant des scores de propension et la pondération inverse sur la probabilité d’être traité. Résultats: Au total, 1 102 patients ont reçu des endoprothèses médicamentées (n = 784) ou des endoprothèses non médicamentées (n = 318) pendant la période d’étude. À 10 ans, le taux ajusté de survenue du paramètre d’évaluation principal était nettement plus faible dans le groupe endoprothèses médicamentées que dans le groupe endoprothèses non médicamentées (27,9 % vs 37,0 %; rapport des risques instantanés [RRI] : 0,71; intervalle de confiance [IC] à 95 % : 0,53-0,94; p = 0,02). Le taux de mortalité ajusté à 10 ans était considérablement plus faible dans le groupe endoprothèses médicamentées que dans le groupe endoprothèses non médicamentées (20,6 % vs 29,6 %; RRI : 0,65; IC à 95 % : 0,46-0,91; p = 0,01), tandis que le taux d'IM à 10 ans était similaire dans les deux groupes (9,9 % vs 11,0 %; RRI : 0,93; IC à 95 % : 0,54-1,59; p = 0,78). L'utilisation d'endoprothèses médicamentées était associée à une diminution importante du taux de revascularisation de la lésion cible (10,2 % vs 21,8 %; RRI : 0,41; IC à 95 % : 0,27-0,61; p < 0,001). Conclusions: Dans cette étude de suivi de 10 ans menée auprès de patients atteints d'une maladie de l'artère coronaire principale gauche, l'utilisation d'endoprothèses médicamentées a été associée à une diminution importante du taux des décès ou des IM regroupés, de la mortalité et du taux de revascularisation de la lésion cible, par rapport à l'utilisation d'endoprothèses non médicamentées.

Background: Diabetes mellitus (DM) is a well-known risk factor for adverse cardiovascular events in patients receiving percutaneous coronary intervention (PCI). Limited data are available on the relative performance of different types of contemporary drug-eluting stents (DES) for diabetic patients. Objectives: The authors investigated the effectiveness and safety profiles of several contemporary DES in patients with DM in a “real-world” clinical setting. Methods: Among 24,516 patients enrolled in a multicenter, prospective registry, 7,823 patients with DM were treated with 4 contemporary DES: 2,877 with a cobalt chromium everolimus-eluting stent (EES), 789 with a biodegradable polymer biolimus-eluting stent, 2,286 with a platinum chromium-EES, and 1,871 with a Resolute zotarolimus-eluting stent. The primary outcome was target vessel failure (TVF) (a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization). Results: The median follow-up duration was 2.9 years. Observed 3-year rates of TVF were not significantly different according to different DES types. On multigroup propensity-score analysis, the adjusted HRs for TVF were similar in between-group comparisons: biodegradable polymer biolimus-eluting stent (HR: 0.94; 95% CI: 0.76-1.16; P = 0.57), platinum chromium-EES (HR: 0.94; 95% CI: 0.81-1.09; P = 0.41), and Resolute zotarolimus-eluting stent (HR: 1.01; 95% CI: 0.86-1.18; P = 0.93) compared with the cobalt chromium-EES (reference). This trend was maintained in patients with non–insulin- and insulin-treated DM. Conclusions: In this multicenter clinical-practice PCI registry, no significant between-group differences were found for a 3-year risk of TVF in patients with DM undergoing PCI with various types of contemporary DES. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133)

Objectives This study evaluated the association between elevated levels of lipoprotein(a) [Lp(a)] and risk of recurrent ischemic events in patients who underwent percutaneous coronary intervention (PCI). Background Elevated levels of Lp(a) have been identified as an independent, possibly causal, risk factor for atherosclerotic cardiovascular disease in a general population study. Methods A prospective single-center registry was used to identify 12,064 patients with baseline Lp(a) measurements who underwent PCI between 2003 and 2013. The primary outcomes were a composite of cardiovascular death, spontaneous myocardial infarction, and ischemic stroke. Results From the registry, 3,747 (31.1%) patients had high Lp(a) (>30 mg/dL) and 8,317 (68.9%) patients had low Lp(a) (≤30 mg/dL). During a median follow-up of 7.4 years, primary outcomes occurred in 1,490 patients, and the incidence rates of primary outcomes were 2.0 per 100 person-years in the high-Lp(a) group and 1.6 per 100 person-years in the low-Lp(a) group (adjusted hazard ratio [aHR]: 1.17; 95% confidence interval [CI]: 1.05-1.30; P = 0.004). Increased risk of recurrent ischemic cardiovascular events in the high-Lp(a) group was consistent in various subgroups including patients receiving statin treatment at discharge (aHR: 1.18; 95% CI: 1.03-1.34; P = 0.011). In addition, the risk of repeated revascularization was significantly higher in the high-Lp(a) group (aHR: 1.13; 95% CI: 1.02-1.25; P = 0.022). Conclusions Elevated levels of Lp(a) were significantly associated with the recurrent ischemic events in patients who underwent PCI. This study provides a rationale for outcome trials to test Lp(a)-lowering therapy for secondary prevention in patients undergoing PCI.

Gender differences have been recognized in several aspects of coronary artery disease (CAD). However, evidence for gender differences in long-term outcomes after left main coronary artery (LMCA) revascularization is limited. We sought to evaluate the impact of gender on outcomes after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for unprotected LMCA disease. We evaluated 4,320 patients with LMCA disease who underwent CABG (n = 1,456) or PCI (n = 2,864) from the Interventional Research Incorporation Society-Left MAIN Revascularization registry. The primary outcome was a composite of death, myocardial infarction (MI), or stroke. Among 4,320 patients, 968 (22.4%) were females and 3,352 (77.6%) were males. Compared to males, females were older, had a higher prevalence of hypertension and insulin-requiring diabetes, more frequently presented with acute coronary syndrome, but had less extensive CAD and less frequent left main bifurcation involvement. The adjusted risk for the primary outcome was not different after PCI or CABG in females and males (hazard ratio [HR] 1.09; 95% confidence interval [CI]: 0.73-1.63 and HR 0.97; 95% CI: 0.80-1.19, respectively); there was no significant interaction between gender and the revascularization strategy (P for interaction = 0.775). In multivariable analysis, gender did not appear to be an independent predictor for the primary outcome. In revascularization for LMCA disease, females and males had a comparable primary composite outcome of death, MI, or stroke with either CABG or PCI without a significant interaction of gender with the revascularization strategy.

Background Paravalvular regurgitation (PVR) has been known to be the primary determinant of poor left ventricular (LV) mass regression after transcatheter aortic valve replacement (TAVR). However, the incidence of significant PVR has been reduced considerably as TAVR technology evolved rapidly. This study aimed to investigate the time course and impact of LV mass index (LVMi) regression on long-term clinical outcomes in severe aortic stenosis (AS) patients without significant PVR after TAVR. Methods Of 412 patients who underwent TAVR, 146 who had LV hypertrophy (LVMi ≥115 g/m2 for men and ≥ 95 g/m2 for women) at baseline and were alive at one year after TAVR were enrolled. The primary outcome was cardiovascular deaths and the impact of LVMi regression on clinical outcomes were examined. The patients with significant PVR were excluded. Results During a median follow-up of 40 months (interquartile range, 26–58 months), 9 (6.2%) cardiovascular deaths, 21 (14.4%) all-cause deaths, and 9 (6.2%) hospitalizations occurred. In the multivariable analysis, the percentage change of LVMi was an independent predictor of cardiovascular deaths (adjusted hazard ratio [HR], 1.03; 95% confidential interval [CI], 1.01–1.05; P = 0.010), and composite outcome of cardiovascular deaths and rehospitalization for heart failure (adjusted HR, 1.02; 95% CI, 1.00–1.04; P = 0.022). Baseline LVMi, eccentric hypertrophy, and TAVR-induced left bundle branch block were independently associated with LVMi regression. Conclusions In patients with severe AS who received successful TAVR without significant PVR, the degree of LVMi regression is an independent predictor of postoperative outcomes after TAVR.

BACKGROUND Sodium-glucose co-transporter 2 inhibitors reduce the risk of cardiovascular events in type 2 diabetic patients with coronary artery disease (CAD); however, the underlying mechanisms remain unclear. OBJECTIVES We compared the effects of empagliflozin vs. sitagliptin therapy on myocardial perfusion reserve (MPR) using dynamic single-photon emission computed tomography (SPECT) imaging. METHODS In total, 100 patients with type 2 diabetes, CAD and an MPR

Background and aims Although plaque characterization by intravascular ultrasound (IVUS) is important for risk stratification, frame-by-frame analysis of a whole vascular segment is time-consuming. The aim was to develop IVUS-based algorithms for classifying attenuation and calcified plaques. Methods IVUS image sets of 598 coronary arteries from 598 patients were randomized into training and test sets with 5:1 ratio. Each IVUS frame at a 0.4-mm interval was circumferentially labeled as one of three classes: attenuated plaque, calcified plaque, or plaque without attenuation or calcification. The model was trained on multi-class classification with 5-fold cross validation. By converting from Cartesian to polar coordinate images, the class corresponding to each array from 0 to 360° was plotted. Results At the angle-level, Dice similarity coefficients for identifying calcification vs. attenuation vs. none by using ensemble model were 0.79, 0.74 and 0.99, respectively. Also, the maximal accuracy was 98% to classify those groups in the test set. At the frame-level, the model identified the presence of attenuation with 80% sensitivity, 96% specificity, and 93% overall accuracy, and the presence of calcium with 86% sensitivity, 97% specificity, and 96% overall accuracy. In the per-vessel analysis, the attenuation and calcification burden index closely correlated with human measurements (r = 0.89 and r = 0.95, respectively), as did the maximal attenuation and calcification burden index over 4 mm (r = 0.82 and r = 0.91, respectively). The inference times were 0.05 s per frame and 7.8 s per vessel. Conclusions Our deep learning algorithms for plaque characterization may assist clinicians in recognizing high-risk coronary lesions.

Objectives The aim of this study was to develop pre-procedural intravascular ultrasound (IVUS)–based models for predicting the occurrence of stent underexpansion. Background Although post-stenting IVUS has been used to optimize percutaneous coronary intervention, there are no pre-procedural guidelines to estimate the degree of stent expansion and provide preemptive management before stent deployment. Methods A total of 618 coronary lesions in 618 patients undergoing percutaneous coronary intervention were randomized into training and test sets in a 5:1 ratio. Following the coregistration of pre- and post-stenting IVUS images, the pre-procedural images and clinical information (stent diameter, length, and inflation pressure; balloon diameter; and maximal balloon pressure) were used to develop a regression model using a convolutional neural network to predict post-stenting stent area. To separate the frames with from those without the occurrence of underexpansion (stent area Results Overall, the frequency of stent underexpansion was 15% (5,209 of 34,736 frames). At the frame level, stent areas predicted by the pre-procedural IVUS-based regression model significantly correlated with those measured on post-stenting IVUS (r = 0.802). To predict stent underexpansion, maximal accuracy of 94% (area under the curve = 0.94) was achieved when the convolutional neural network– and mask image–derived features were used for the classification model. At the lesion level, there were significant correlations between predicted and measured minimal stent area (r = 0.832) and between predicted and measured total stent volume (r = 0.958). Conclusions Deep-learning algorithms accurately predicted incomplete stent expansion. A data-driven approach may assist clinicians in making treatment decisions to avoid stent underexpansion as a preventable cause of stent failure.

We evaluated the benefit of left ventricular (LV) unloading using a percutaneous transseptal left atrial (LA) drain catheter via femoral vein incorporated into the ECMO venous circuit. This single-center retrospective observational study analyzed clinical outcomes of the LA venting group (N = 62) who underwent percutaneous transseptal LA drain placement comparing with the conventionally treated control group (N = 62) with an arterial pulse pressure below 10 mm Hg for at least 24 hours from December 2012 to August 2018. The ECMO weaning rate (61.3% vs. 38.7%, P = .012) and cardiac transplantation rate (29.0% vs. 11.3%, P = .014) were higher in the LA venting group than in the control group. Inhospital mortality was not significantly different (56.5% vs. 69.4%, P = .191). Pulmonary congestion mostly improved after LA decompression (61.3%, P = .003). A serum lactate level at 24 hours after LA venting of more than 2.2 mmol/L was associated with poor outcomes. LA venting via transseptal cannula reduced pulmonary venous congestion and achieved higher rates of successful ECMO weaning and cardiac transplantation. Placement of a transseptal venous drain cannula should be considered in patients with uncontrolled pulmonary edema secondary to severe LV loading undergoing VA-ECMO.

Platelets are crucial in the pathophysiology of coronary artery disease and are a major target of antithrombotic agents in patients receiving percutaneous coronary intervention (PCI). We sought to evaluate the incidence and prognostic impact of thrombocytopenia on clinical outcomes in patients undergoing PCI with drug-eluting stents (DES). We evaluated consecutive patients who received PCI with DES in the IRIS-DES registry between April 2008 and December 2017. Patients were divided into 2 groups based on the presence of thrombocytopenia (platelet count150 × 10

Background The clinical value of intracoronary imaging for percutaneous coronary intervention (PCI) guidance is well acknowledged. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are the most commonly used intravascular imaging to guide and optimize PCI in day-to-day practice. However, the comparative effectiveness of IVUS-guided versus OCT-guided PCI with respect to clinical end points remains unknown. Methods and design The OCTIVUS study is a prospective, multicenter, open-label, parallel-arm, randomized trial comparing the effectiveness of 2 imaging-guided strategies in patients with stable angina or acute coronary syndromes undergoing PCI in Korea. A total of 2,000 patients are randomly assigned in a 1:1 ratio to either an OCT-guided PCI strategy or an IVUS-guided PCI strategy. The trial uses a pragmatic comparative effectiveness design with inclusion criteria designed to capture a broad range of real-world patients with diverse clinical and anatomical features. PCI optimization criteria are predefined using a common algorithm for online OCT or IVUS. The primary end point, which was tested for both noninferiority (margin, 3.1 percentage points for the risk difference) and superiority, is target-vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) at 1 year. Results Up to the end of July 2020, approximately 1,200 "real-world" PCI patients have been randomly enrolled over 2 years. Enrollment is expected to be completed around the midterm of 2021, and primary results will be available by late 2022 or early 2023. Conclusion This large-scale, multicenter, pragmatic-design clinical trial will provide valuable clinical evidence on the relative efficacy and safety of OCT-guided versus IVUS-guided PCI strategies in a broad population of patients undergoing PCI in the daily clinical practice.

Introduction Distal left main (LM) bifurcation disease is one of the most challenging lesion subsets for percutaneous coronary intervention (PCI) and optimal stenting strategy for such complex lesions is still debated. This study aimed to compare clinical outcomes following single versus dual stenting for true distal LM bifurcation lesions. Methods Patients with true distal LM bifurcation lesions (type 1,1,1 or 0,1,1: both left anterior descending and circumflex artery >2.5 mm diameter) receiving PCI with drug-eluting stents (DES) from two large clinical registries were evaluated. The primary outcome was target-lesion failure (TLF), defined as a composite of cardiac death, target-vessel myocardial infarction (MI), or target-lesion revascularization (TLR). Outcomes were compared with the use of propensity scores and inverse probability-weighting adjustment to reduce treatment selection bias. Results Among 1,002 patients undergoing true distal LM PCI, 440 (43.9%) and 562 (56.1%) were treated with single and dual stents, respectively. The TLF rates at 3 year was 20.3% in the single-stent group and 24.1% in the dual-stenting group (log-rank p = 0.18). The adjusted risk for TLF did not differ significantly between two groups (hazard ratio [HR] with dual-stent vs. single-stent: 1.27, 95% confidence interval [CI]: 0.95-1.71). The adjusted risks for death, MI, repeat revascularization, or stent thrombosis were also similar between the single- and dual-stenting groups. Conclusions In patients undergoing PCI for true distal LM disease, single- and dual-stent strategies showed a similar adjusted risk of TLF at 3 years. Our findings should be confirmed or refuted through large, randomized clinical trials.

Left main coronary artery (LMCA) disease is associated with high mortality and morbidity due to a large area of jeopardized myocardium. However, the optimal revascularization strategy for patients with LMCA disease and left ventricular dysfunction is still unclear.This study sought to examine long-term comparative outcomes after percutaneous coronary intervention (PCI) or a coronary artery bypass grafting (CABG) according to the severity of left ventricular dysfunction.The authors evaluated a total of 3,488 patients with LMCA disease who underwent CABG (n = 1,355) or PCI (n = 2,133) from the IRIS-MAIN (Interventional Research Incorporation Society-Left MAIN Revascularization) registry. Left ventricular function was categorized according to left ventricular ejection fraction (LVEF) as normal function (LVEF ≥55%), mild dysfunction (LVEF ≥45% to 55%), moderate dysfunction (LVEF ≥35% to 45%), or severe dysfunction (LVEF 35%). The primary outcome was a composite of death, myocardial infarction, or stroke.Among the overall patient population, 2,641 (75.7%) patients had normal LVEF and 403 (11.6%), 260 (7.5%), and 184 (5.3%) had mild, moderate, and severe left ventricular dysfunction at baseline, respectively. Compared with CABG, PCI was associated with a higher adjusted risk of primary outcomes in patients with moderate (hazard ratio [HR]: 2.23; 95% confidence interval [CI]: 1.17 to 4.28) or severe (HR: 2.45; 95% CI: 1.27 to 4.73) dysfunction. In contrast, PCI and CABG had similar risks of the primary outcomes in patients with normal (HR: 0.80; 95% CI: 0.59 to 1.07) or mild (HR: 1.17; 95% CI: 0.63 to 2.17) dysfunction (p for interaction = 0.004).In the revascularization of LMCA disease, PCI was associated with an inferior primary composite outcome of death, MI, or stroke compared with CABG in patients with moderate or severe left ventricular dysfunction. However, the risk for the primary outcome was comparable between PCI and CABG in those with normal or mild left ventricular dysfunction. (Observational Study for Left Main Disease Treatment; NCT01341327).

Background Intracoronary physiology is increasingly used in nonculprit stenoses of patients with acute coronary syndromes (ACS). However, evidence regarding the safety of fractional flow reserve-based deferral in patients with ACS, compared with patients with stable angina pectoris (SAP), is scarce. Objectives The aim of this study was to evaluate the safety of revascularization deferral on the basis of fractional flow reserve interrogation of nonculprit lesions in patients with ACS. Methods A pooled analysis was performed of individual patient data included in 5 large international published studies on physiology-guided revascularization. The primary endpoint was major adverse cardiac events (MACE) (a composite of death, nonfatal myocardial infarction, or unplanned revascularization) at 1-year follow-up. Clinical outcomes of patients with ACS and SAP were compared in both the deferred and the revascularized groups. Results A total of 8,579 patients were included in the analysis, 6,461 with SAP and 2,118 with ACS and nonculprit stenoses. Using fractional flow reserve, revascularization was deferred in 5,129 patients (59.8%) and performed in 3,450 patients (40.2%). In the deferred ACS group, a higher MACE rate was observed compared with the deferred SAP group (4.46% vs. 2.83%; adjusted hazard ratio [HR]: 1.72; 95% confidence interval [CI]: 1.17 to 2.53; p Conclusions Patients with ACS in whom revascularization of nonculprit lesions was deferred on the basis of fractional flow reserve have more MACE at 1 year compared with patients with SAP with deferred revascularization. Unplanned revascularization mainly contributed to this excess of MACE.

Aims The aim of this study was to compare percutaneous coronary intervention (PCI) outcomes in relation to stent optimisation profiles between in-stent chronic total occlusions (CTOs) and de novo CTOs. Methods and results We evaluated 1,516 consecutive patients who underwent PCI for 147 in-stent CTOs (9.3%) and 1,439 de novo CTOs between 2007 and 2018. The primary endpoint was target vessel failure (TVF) consisting of a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularisation. The final post-stenting intravascular ultrasound (IVUS) images were analysed. Target lesion complexity reflected by the Japanese CTO score was similar, albeit calcification was more prevalent in de novo CTOs, whereas occlusion length >20 mm was more frequent in in-stent CTOs. The technical success (88.4% vs 87.5%, p=0.84) and in-hospital adverse event (1.4% vs 3.6%, p=0.26) rates were similar between CTO types. Among those who received drug-eluting stents, the five-year TVF (11.0% vs 10.7%, p=0.99) and target vessel revascularisation (4.2% vs 3.7%, p=0.81) rates were similar between groups. Total stent length, minimum stent area (5.4±1.8 vs 5.5±1.8 mm2, p=0.77), and maximal plaque burden of the reference segments were largely comparable between groups. Conclusions In-stent CTO PCI with drug-eluting stents optimised by IVUS guidance offers as acceptable long-term clinical results as those achieved in de novo CTOs.

AIMS The aim of this study was to develop a deep learning model for classifying frames with versus without optical coherence tomography (OCT)-derived thin-cap fibroatheroma (TCFA). METHODS AND RESULTS A total of 602 coronary lesions from 602 angina patients were randomised into training and test sets in a 4:1 ratio. A DenseNet model was developed to classify OCT frames with or without OCT-derived TCFA. Gradient-weighted class activation mapping was used to visualise the area of attention. In the training sample (35,678 frames of 480 lesions), the model with fivefold cross-validation had an overall accuracy of 91.6±1.7%, sensitivity of 88.7±3.4%, and specificity of 91.8±2.0% (averaged AUC=0.96±0.01) in predicting the presence of TCFA. In the test samples (9,722 frames of 122 lesions), the overall accuracy at the frame level was 92.8% within the lesion (AUC=0.96) and 91.3% in the entire OCT pullback. The correlation between the %TCFA burden per vessel predicted by the model compared with that identified by experts was significant (r=0.87, p

Background Although the need to detect restenosis has diminished in the contemporary practice of percutaneous coronary intervention (PCI) with drug-eluting stents (DES), the surveillance of ischemia owing to restenosis or disease progression deserves attention in high-risk PCI settings. It is unknown whether follow-up strategy of routine noninvasive functional testing potentially reduces the risk of major cardiovascular events in high-risk PCI patients. Methods The POST-PCI study is an investigator-initiated, multicenter, prospective randomized trial comparing the effectiveness of two follow-up strategies in patients with high-risk anatomic or clinical characteristics who underwent PCI. Study participants were randomly assigned to either (1) the routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing. In the routine stress testing group, depending on the testing results, all clinical decisions regarding subsequent diagnostic or therapeutic procedures were at the treating physician's discretion. The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI. Results More than 1700 high-risk PCI patients have been randomized over 2.0 years at 11 major cardiac centers in Korea. Conclusion This pragmatic POST-PCI trial will provide valuable clinical evidence on the effectiveness of follow-up strategy of routine noninvasive stress testing in high-risk PCI patients.

Objectives This study compared the 3-year outcomes of intracoronary imaging–guided pre-dilation, stent sizing, and post-dilation (iPSP) for patients with complex coronary artery lesions. Background The long-term effects of the optimal drug-eluting stent implantation technique in complex coronary artery disease have not been evaluated. Methods From the IRIS-DES (Interventional Cardiology Research In-cooperation Society-Drug-Eluting Stents) registry, the study evaluated 9,525 patients who underwent percutaneous coronary intervention for left main, bifurcation, long or diffuse (>30 mm), or angiographically severely calcified lesions. The primary outcome was a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization. The inverse probability of treatment weighting method was used to adjust for confounding factors. Results At the index procedure, intravascular ultrasound assessment PSP were performed in 8,522 (89.5%) patients, 5,141 (54.0%) patients, and 5,531 (58.1%) patients, respectively; overall, 3,374 (35.4%) patients underwent stent implantation using all 3 parts of the iPSP strategy and were defined as the iPSP group. At 3 years, the adjusted rate of the primary outcome was significantly lower in iPSP group (5.6% vs 7.9%; adjusted hazard ratio: 0.71; 95% confidence interval: 0.63 to 0.81; p Conclusions Among patients undergoing drug-eluting stent implantation in complex coronary artery stenosis, iPSP was associated with a lower risk of cardiac events at 3 years. Therefore, physicians should apply iPSP more actively for the treatment of complex coronary artery stenoses, even in the current era. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133)

AIMS Outcomes according to the status of renal insufficiency have not been fully evaluated in left main coronary artery disease (LMCAD). In the present study therefore, we sought to evaluate clinical outcomes in patients with significant LMCAD stratified by the degree of renal insufficiency and the relative clinical outcomes after PCI and CABG stratified by the differential levels of renal function using data from the large multinational "all-comers" Interventional Research Incorporation Society-Left MAIN Revascularization (IRIS-MAIN) registry. METHODS AND RESULTS Among 4,894 patients with LMCAD, renal insufficiency was graded according to the estimated glomerular filtration rate (eGFR). The primary outcome was major adverse cardiac and cerebrovascular events (MACCE), defined as death, myocardial infarction, stroke, or any revascularisation. The patients were stratified into three groups according to eGFR: 3,824 (78%) in group 1 (eGFR ≥60 ml·min-1·1.73 m2), 838 (17%) in group 2 (eGFR ≥30 and

Objectives The aim of this study was to investigate the long-term impact of SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS) on differential outcomes after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for left main coronary artery (LMCA) disease. Background The very long term prognostic effect of SS on mortality and major cardiovascular events after LMCA revascularization is still undetermined. Methods In the MAIN-COMPARE (Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease) registry, patients with baseline SS measurements were analyzed. The 10-year rates of all-cause mortality, the composite of death, Q-wave myocardial infarction, or stroke, and target vessel revascularization after PCI or CABG were compared according to baseline SS. Results Among 1,580 patients with baseline SS, 547 patients (34.6%) had low SS (≤22), 350 (22.2%) had intermediate SS (23 to 32), and 683 (43.2%) had high SS (≥33). In patients with low to intermediate SS, the adjusted 10-year risks for death and serious composite outcome were similar between the PCI group and the CABG group. However, in patients with high SS, PCI with stenting, compared with CABG, was associated with a higher risk for death (hazard ratio: 1.39; 95% confidence interval: 1.00 to 1.92; p = 0.048) and serious composite outcome (hazard ratio: 1.27; 95% confidence interval: 0.94 to 1.74; p = 0.123). In each revascularization group, conventional tertiles of SS had a differential prognostic impact on 10-year clinical outcomes in the PCI arm but not in the CABG arm. Conclusions In this 10-year extended follow-up of patients undergoing LMCA revascularization, CABG showed a clear prognostic benefit over PCI in patients with high anatomic complexity measured by SS at baseline. The discriminative capacity of SS on long-term outcomes was relevant in the PCI group but not in the CABG group. (Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease [MAIN-COMPARE]; NCT02791412)

Objective: The goal of this study was to determine the impact of late-acquired stent malapposition (LASM) on long-term clinical outcomes in patients treated with coronary stent implantation. Approach and Results: We investigated major adverse cardiac event during 10 years after 6-month intravascular ultrasound examination using our previous studies database. A total of 732 patients treated with bare-metal stent (54 LASM versus 678 non-LASM) and 529 patients treated with first-generation drug-eluting stent (82 LASM versus 447 non-LASM), who did not have clinical event or censoring at the time of follow-up intravascular ultrasound, were included for the present analysis. major adverse cardiac event was defined as the composite of cardiac death, target vessel–related myocardial infarction, target lesion revascularization and stent thrombosis. Multivariable adjustment and inverse probability weight were performed to consider baseline differences. After multivariable adjustment, LASM was related to a greater risk of major adverse cardiac event (hazard ratio, 1.666 [95% CI, 1.041–2.665]; P =0.0333) and very-late stent thrombosis (hazard ratio, 3.529 [95% CI, 1.153–10.798]; P =0.0271) than non-LASM in patients treated with first-generation drug-eluting stent, but not in those treated with bare-metal stent. Results were consistent after inverse probability weight. Among patients with LASM of first-generation drug-eluting stent, no late stent thrombosis occurred in patients who continued to receive dual antiplatelet therapy. Conclusions: The relationship between LASM and major adverse cardiac event might depend on the type of implanted stents during the long-term follow-up, highlighting the clinical significance of polymers and drugs in drug-eluting stent system.

Background: Compared with angiographic guidance, intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes. However, its very long-term clinical effect is still unclear in patients undergoing PCI for unprotected left main coronary artery disease. Methods: To compare 10-year outcomes of IVUS-guided versus angiography-guided PCI for left main coronary artery disease, we evaluated 975 patients who underwent unprotected left main coronary artery PCI between January 2000 and June 2006 from the MAIN-COMPARE (The Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization) registry. The 10-year rates of clinical outcomes (death; the composite of death, Q-wave myocardial infarction [MI], or stroke; and target-vessel revascularization) were compared between IVUS guidance and angiography guidance. Adjusted analyses were performed with the use of inverse-probability-treatment-weighting and propensity score matching. Results: Among the 975 patients, 756 (77.5%) had IVUS guidance. The observed 10-year incidence rate of death (16.4% versus 31.0%, P P P =0.41). After adjusting for potential confounders with inverse-probability-treatment-weighting, IVUS was associated with lower incidence of mortality (hazard ratio, 0.75 [95% CI, 0.55–1.03]; P =0.07) and composite of death, Q-wave MI, or stroke (hazard ratio, 0.79 [95% CI, 0.59–1.06]; P =0.11). In 208 propensity score–matched pairs, IVUS was also associated with lower incidence of death (hazard ratio, 0.73 [95% CI, 0.53–1.02]; P =0.07) and composite outcome of death, Q-wave MI, or stroke (hazard ratio, 0.71 [95% CI, 0.52–0.97]; P =0.03). The benefit of IVUS-guided PCI was consistent in the various subsets of clinical and anatomic characteristics. Conclusions: In patients undergoing PCI for unprotected left main coronary artery disease, IVUS-guided PCI compared with angiography-guided PCI was associated with lower long-term (10-year) risks of morality and composite of death, Q-wave MI, or stroke. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02791412.

Invasive coronary angiography is a primary imaging modality that visualizes the lumen area of coronary arteries for the diagnosis of coronary artery diseases and guidance for interventional devices. In the current practice of quantitative coronary analysis (QCA), semi-automatic segmentation tools require labor-intensive and time-consuming manual correction; this limits their application in the catheterization room. For a more automated QCA, it is necessary to minimize operator intervention through robust segmentation methods with improved predictability. In this study, we introduced two selective ensemble methods that integrated the weighted ensemble approach with per-image quality estimation. In our selective ensemble methods, the segmentation outcomes from five base models with different loss functions were ranked by mask morphology or estimated dice similarity coefficient (DSC). The final output was determined by imposing different weights according to the ranking. The ranking criteria based on mask morphology were determined empirically to avoid frequent types of segmentation errors, whereas the estimation of DSCs was performed by comparing the pseudo-ground truth generated from a meta-learner. In the assessment with 7,426 frames from 2,924 patients, the selective ensemble methods improved segmentation performance with DSCs of up to 93.11% and provided a better delineation of lumen boundaries near the coronary lesion with local DSCs of up to 94.04%, outperforming all individual models and hard voting ensembles. The probability of mask disconnection at the most narrowed region could be minimized to

To compare 10-year outcomes after implantation of sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES) for left main coronary artery (LMCA) stenosis. Very long-term outcome data of patients with LMCA disease treated with drug-eluting stents (DES) have not been well described. In 10-year extended follow-up of the MAINCOMPARE registry, we evaluated 778 patients with unprotected LMCA stenosis who were treated with SES (n = 607) or PES (n = 171) between January 2000 and June 2006. The primary composite outcome (a composite of death, myocardial infarction [MI] or target-vessel revascularization [TVR]) was compared with an inverse-probability-of-treatment-weighting (IPTW) adjustment. Clinical events have linearly accumulated over 10 years. At 10 years, there were no significant differences between SES and PES in the observed rates of the primary composite outcome (42.0% vs. 47.4%; hazard ratio [HR] 0.85; 95% confidence interval [CI] 0.66-1.10), and definite stent thrombosis (ST) (1.9% vs. 1.8%; HR 1.02, 95% CI 0.28-3.64). In the IPTW-adjusted analyses, there were no significant differences between SES and PES in the risks for the primary composite outcome (HR 0.89, 95% CI 0.65-1.14) or definite ST (adjusted HR 1.05, 95% CI 0.29-3.90). In patients who underwent DES implantation, high overall adverse clinical event rates (with a linearly increasing event rate over time) were observed during extended follow-up. At 10 years, there were no measurable differences in outcomes between patients treated with SES vs. PES for LMCA disease. The incidence of stent thrombosis was quite low and comparable between the groups.

Background The long‐term prognostic effect of the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS) after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for left main coronary artery disease is controversial. Methods and Results In the PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus‐Eluting Stent in Patients With Left Main Coronary Artery Disease) trial, 600 patients with left main coronary artery disease were randomized to undergo PCI with drug‐eluting stents (n=300) or CABG (n=300). We compared 10‐year outcomes after PCI and CABG according to SS categories and evaluated the predictive value of SS in each revascularization arm. The primary outcome was a major adverse cardiac or cerebrovascular event (composite of death, myocardial infarction, stroke, or ischemia‐driven target‐vessel revascularization) at 10 years. Among 566 patients with valid SS measurement at baseline, 240 (42.4%) had low SS, 200 (35.3%) had intermediate SS, and 126 (22.3%) had high SS. The 10‐year rates of major adverse cardiac or cerebrovascular events were not significantly different between PCI and CABG in low (21.6% versus 22.2%, P =0.97), intermediate (31.8% versus 22.2%; P =0.13), and high SS (46.2% versus 35.7%; P =0.31) ( P ‐for‐interaction=0.46). There were no significant interactions between SS categories and revascularization modalities for death ( P =0.92); composite of death, myocardial infarction, or stroke ( P =0.87); and target‐vessel revascularization ( P =0.06). Higher SS categories were associated with higher risks for major adverse cardiac or cerebrovascular events in the PCI arm but not in the CABG arm. Conclusions Ten‐year clinical outcomes between PCI and CABG were not significantly different according to the SS. The SS was predictive of major adverse cardiac or cerebrovascular events after PCI but not after CABG. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03871127.

Background Several trials reported differential outcomes after percutaneous coronary intervention with drug‐eluting stents (DES) and coronary‐artery bypass grafting (CABG) for multivessel coronary disease according to the presence of diabetes mellitus (DM). However, it is not well recognized how DM status affects very‐long‐term (10‐year) outcomes after DES and CABG for left main coronary artery disease. Methods and Results In the PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty using Sirolimus‐Eluting Stent in Patients with Left Main Coronary Artery Disease) trial, patients with LMCA were randomly assigned to undergo PCI with sirolimus‐eluting stents (n=300) or CABG (n=300). The primary outcome was the incidence of major adverse cardiac or cerebrovascular events (MACCE; a composite of death from any cause, myocardial infarction, stroke, or ischemia‐driven target‐vessel revascularization). Outcomes were examined in patients with (n=192) and without (n=408) medically treated diabetes. The follow‐up was extended to at least 10 years for all patients (median, 11.3 years). The 10‐year rates of MACCE were not significantly different between DES and CABG in patients with DM (36.3% versus 26.7%, respectively; hazard ratio [HR], 1.35; 95% CI, 0.83–2.19; P =0.23) and without DM (25.3% versus 22.9%, respectively; HR, 1.15; 95% CI, 0.79–1.67; P =0.48) ( P ‐for‐interaction=0.48). There were no significant between‐group differences in composite of death, MI, or stroke, and all‐cause mortality, regardless of DM status. TVR rates were consistently higher after DES than CABG. Conclusions In this 10‐year extended follow‐up of PRECOMBAT, we found no significant difference between DES and CABG with respect to the incidences of MACCE, serious composite outcome, and all‐cause mortality in patients with and without DM with LMCA disease. However, owing to the limited number of patients and no adjustment for multiple testing, overall findings should be considered hypothesis‐generating, highlighting the need for further research. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03871127 and NCT00422968.

More evidence is required with respect to the comparative effectiveness of percutaneous coronary intervention (PCI) with second-generation drug-eluting stents (DESs) versus coronary artery bypass grafting (CABG) in contemporary clinical practice. This prospective observational registry–based study compared the outcomes of 6,647 patients with multivessel disease who underwent PCI with second-generation DES (n = 3,858) or CABG (n = 2,789) between January 2006 and June 2018 and for whom follow-up data were available for at least 2 to 13 years (median 4.8). The primary outcome was a composite of death, spontaneous myocardial infarction, or stroke. Baseline differences were adjusted using propensity scores and inverse probability weighting. In the overall cohort, there were no significant between-group differences in the adjusted risks for the primary composite outcome (hazard ratio [HR] for PCI vs CABG 1.03, 95% confidence interval [CI] 0.86 to 1.25, p = 0.73) and all-cause mortality (HR 0.95, 95% CI 0.76 to 1.20, p = 0.68). This relative treatment effect on the primary outcome was similar in patients with diabetes (HR 1.15, 95% CI 0.91 to 1.46, p = 0.25) and without diabetes (HR 0.95, 95% CI 0.73 to 1.22, p = 0.67) (p for interaction = 0.24). The adjusted risk of the primary outcome was significantly greater after PCI than after CABG in patients with left main involvement (HR 1.39, 95% CI 1.01 to 1.90, p = 0.044), but not in those without left main involvement (HR 0.94, 95% CI 0.76 to 1.16, p = 0.56) (p = 0.03 for interaction). In this prospective real-world long-term registry, we observed that the risk for the primary composite of death, spontaneous myocardial infarction, or stroke was similar between PCI with contemporary DES and CABG.

Aims This study aimed to assess the impact of valvular/subvalvular calcium burden on procedural and long-term outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS). Methods and results In this prospective observational cohort study, we included patients with AS undergoing TAVR between March 2010 and December 2019. Calcium burden at baseline was quantified using multidetector computed tomography and the patients were classified into tertile groups according to the amount of calcium. Procedural outcomes [paravalvular leakage (PVL) or permanent pacemaker insertion (PPI)] and 12-month clinical outcomes (composite of death, stroke, or rehospitalization, and all-cause mortality) were assessed. A total of 676 patients (age, 79.8 ± 5.4 years) were analysed. The 30-day rates of moderate or severe PVL (P-for-trend = 0.03) and PPI (P-for-trend = 0.002) proportionally increased with the tertile levels of calcium volume. The 12-month rate of primary composite outcomes was 34.2% in low-tertile, 23.9% in middle-tertile, and 25.8% in high-tertile groups (log-rank P = 0.02). After multivariable adjustment, the risk for primary composite outcomes at 12 months was not significantly different between the tertile groups of calcium volume [reference = low-tertile; middle-tertile, hazard ratio (HR) 0.81; 95% confidence interval (CI) 0.54–1.22; P = 0.31; high-tertile, HR 0.93; 95% CI 0.56–1.57; P = 0.80]. A similar pattern was observed for all-cause mortality. Conclusion The rates of PVL and PPI proportionally increased according to the levels of valvular/subvalvular calcium volume, while the adjusted risks for composite outcomes and mortality at 12 months were not significantly different.

Age and sex contribute to determining coronary revascularization strategies for patients with left main coronary artery (LMCA) disease. We examined age- and sex-related differences in comparative outcomes after percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) for LMCA disease. A total of 4,001 patients with LMCA disease (men, n = 3,100, women, n = 901) who underwent PCI (n = 2,615) or CABG (n = 1,386) from the Interventional Research Incorporation Society-Left MAIN Revascularization registry were analyzed. Patients were stratified into subgroups according to the tertiles of age (60 years, 60 to 69 years, and ≥70 years) and sex. The primary outcome was the composite of death from any cause, myocardial infarction, or stroke. During the median 6.3 years of follow-up, the adjusted risks for primary outcome after PCI relative to CABG were similar in patients aged60 years (hazard ratio [HR]: 0.64, 95% confidence interval [CI]: 0.35 to 1.16), 60 to 69 years (HR: 1.21; 95% CI: 0.82 to 1.80), and ≥70 years (HR: 0.90; 95% CI: 0.66 to 1.22) with no significant age-related interactions (P

AIMS We aimed to evaluate the contribution of the retrograde approach to real-world practice over time and its long-term outcomes in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS AND RESULTS We evaluated 1,635 CTO procedures conducted at our high-volume centre between 2003 and 2015. The retrograde approach has been actively adopted in practice since January 2007. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularisation/reocclusion. The technical success rate of CTO-PCI has increased from 79.5% to 87.1% since 2007, although the complexity of the CTOs has also significantly increased in that time (J-CTO scores: from 1.8±1.2 to 2.0±1.1, p=0.03). The incidence of in-hospital MACCE using the retrograde approach was 4.5%, which was comparable to the antegrade-only approach rate of 4.1% (p=0.58). The retrograde approach showed a higher four-year TVF rate after successful stenting compared with the antegrade-only approach (17.1% vs 9.4%, p=0.01), but this difference was mainly driven by a higher target vessel revascularisation/reocclusion rate. Multivariable analysis revealed that renal dysfunction (hazard ratio [HR] 3.33, 95% confidence interval [CI]: 1.42-7.83), acute coronary syndrome (HR 1.99, 95% CI: 1.26-3.14), the J-CTO score (per 1, HR 1.23, 95% CI: 1.00-1.51), and the smallest stent diameter (per 1 mm, HR 0.39, 95% CI: 0.21-0.74) (all p

Background: Recent data suggest that serum biomarkers may predict worse outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). We examined the association and predic...

Data on the comparative effectiveness of contemporary drug-eluting stents (DES) in the unrestricted, real-world setting are limited. We investigated the long-term effectiveness and safety of contemporary different drug-eluting stents by means of multiple treatment propensity score weighting.From seven stent-specific, prospective DES registries conducted between July 2007 and July 2015, we evaluated 17 196 patients who received several contemporary DES and first-generation DES: 3053 treated with cobalt-chromium everolimus-eluting stents (CoCr-EES), 2985 with platinum-chromium EES (PtCr-EES), 2922 with Resolute zotarolimus-eluting stents (Re-ZES), 789 with Biomatrix biolimus-eluting stents (Bi-BES), 1907 with Nobori biolimus-eluting stents (No-BES), 1970 with Xience Prime cobalt-chromium everolimus-eluting stents (Pr-CoCr-EES), and 3570 with sirolimus-eluting stents (SES). The primary outcome was target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization) at 3 years of follow-up and major cardiovascular adverse events (a composite of all-cause death, any myocardial infarction, or any revascularization) was also evaluated.The observed 3-year rates of target-vessel failure were not significantly different among different second-generation DES and SES (CoCr-EES 9.8%, PtCr-EES 9.5%, Re-ZES 9.3%, Bi-BES 9.8%, No-BES 7.7%, Pr-CoCr-EES 10.4%, SES 10.2%; overall P=0.07). In multiple treatment propensity score analysis, adjusted hazard ratios for target-vessel failure were similar in between-group comparisons of several contemporary DES. In addition, no significant differences were observed with respect of the adjusted risk of major adverse cardiac events.In this comparative effectiveness research using stent-specific, clinical practice registries involving unrestricted use of several contemporary DES, there were no significant between-group differences in the 3-year rates of target-vessel failure.

Background Stent parameters (length and diameter) are well-known risk factors for adverse outcomes after percutaneous coronary intervention (PCI) with stenting. This study aimed to investigate the differential cutoff criteria and clinical impact of the length and diameter of various drug-eluting stents (DES) for predicting major cardiovascular events. Methods Using patient-level data from seven stent-specific, prospective DES registries, we evaluated 17,068 patients who underwent PCI with either various contemporary DES or first-generation DES between July 2007 and July 2015: 3053 treated with cobalt-chromium everolimus-eluting stents (CoCr-EES), 2976 with platinum-chromium EES (PtCr-EES), 2888 with Resolute zotarolimus-eluting stents (Re-ZES), 782 with Biomatrix biolimus-eluting stents (Bi-BES), 1868 with Nobori BES (No-BES), 1934 with Xience Prime cobalt-chromium EES (Pr-CoCr-EES), and 3567 with first-generation sirolimus-eluting stents (SES). Two clinical outcomes were assessed: target-vessel failure (TVF; a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization [TVR]) and TVR. Results Stent length and stent diameter were important factors for predicting TVF or TVR in the entire cohort and in each DES cohort. For TVF risk prediction, the Youden index-based cutoff of stent length was highest with Bi-BES (45.0 mm) and lowest with No-BES (29.0 mm), and the cutoff of stent diameter was smallest with Pr-CoCr-EES (2.78 mm) and largest with No-BES (3.20 mm). For TVR risk prediction, the cutoff of stent length was the highest with PtCr-EES (48.0 mm) and the lowest with No-BES (29.0 mm), and the cutoff of stent diameter was smallest with CoCr-EES (2.72 mm) and largest with first-generation SES (3.30 mm). The 3-year TVF and TVR rates were substantially different according to the presence or absence of long lesions and small vessels determined using these cutoff points. Conclusions For contemporary PCI practice involving diverse types of DES, we identified differential cutoff points of stent length and diameter for predicting adverse clinical outcomes. The clinical impact of these stent parameters on outcomes and its magnitude varied according to different DES. Clinical Trial Registration—URL: http://www.clinicaltrials.gov . Unique identifier: NCT01186133 .

AimsTo evaluate the acute and long-term prognosis of acute aortic syndrome (AAS) according to the disease entity [intramural haematoma (IMH) vs. aortic dissection (AD)] and the anatomical location (type A vs. B).Methods and resultsA total of 1012 patients [672 with AD and 340 with IMH (33.6%)] were enrolled between 1993 and 2015. Compared with AD patients, IMH patients were older and had higher frequency of female sex and distal aorta involvement. The overall crude in-hospital mortality of AAS was 8.6%; type A AD [15.0%; adjusted hazard ratio (aHR) 30.4; 95% confidence interval (CI) 8.62–107.3; P < 0.001], type A IMH (8.0%; aHR 4.85; 95% CI 1.29–18.2; P = 0.019), type B AD (5.0%; aHR 3.51; 95% CI 1.00–12.4; P = 0.051), and type B IMH [1.5%; aHR 1.00 (reference)]. During a median follow-up duration of 8.5 years (interquartile range: 4.0–13.5 years), AD (aHR 2.78; 95% CI 1.87–4.14; P < 0.001) and type A (aHR 2.28; 95% CI 1.45–3.58; P < 0.001) was associated with a higher risk of aortic death. After 90 days, a risk of aortic death was no longer associated with anatomical location (aHR 0.74; 95% CI 0.40–1.36; P = 0.33), but remained associated with disease entity (aHR 1.83; 95% CI 1.10–3.04; P = 0.02).ConclusionThe clinical features, response to treatment strategy, and outcomes of IMH patients were distinct from those of AD patients. Both early and late survival was better for IMH than for AD. In addition to the anatomical location of AAS, the disease entity is an independent factor associated with both acute and long-term mortality in patients with AAS. Further investigation is necessary to confirm the prognostic implication of disease entity in different patient populations.

Background: Procedural results for percutaneous coronary intervention (PCI) in coronary vessels with chronic total occlusion (CTO) have improved in recent years, and PCI strategies have moved toward more complete revascularization with more liberal use of CTO-PCI. However, evidence evaluating CTO-PCI is limited to observational studies and small clinical trials. Methods: In this open-label, multicenter, randomized, noninferiority trial, PCI-eligible patients were assigned to receive either 1 of 2 strategies: PCI or no PCI for the qualifying de novo CTO lesion with the option for PCI of obstructive non-CTO lesions at the discretion of the operator. The primary end point was a composite of death, myocardial infarction, stroke, or any revascularization. Health-related quality of life was assessed at baseline and at 1, 6, 12, 24, and 36 months. Because of slow recruitment, the trial was stopped before completion of the 1284 planned enrollments. Results: Between March 2010 and September 2016, 834 patients were randomly assigned to the CTO-PCI (n=417) or no CTO-PCI (n=398) strategy. Among the patients assigned to the no CTO-PCI strategy, 78 (19.6%) crossed over to receive staged CTO-PCI within 3 days of randomization. The overall CTO-PCI success rate was 90.6%. Serious nonfatal complications associated with CTO-PCI occurred in 3 patients (1 stroke, 1 cardiac tamponade, and 1 patient with recurrent episodes of ventricular tachyarrhythmia induced by intracoronary thrombus). Approximately half of the patients in each group underwent PCI for an average of 1.3 non-CTO lesions, resulting in a comparable residual SYNTAX score (Synergy Between PCI With TAXUS and Cardiac Surgery; 3.7±5.4 versus 4.0±5.9, P =0.42) confined to non-CTO vessels. During a median follow-up of 4.0 years (interquartile range, 2.4 to 5.1 years), there was no significant difference between the CTO-PCI and the no CTO-PCI strategies in the incidence of the primary end point (22.3% versus 22.4%, hazard ratio, 1.03; 95% CI, 0.77 to 1.37; P =0.86). Both CTO-PCI and no CTO-PCI strategy were associated with significant improvements but without between-group differences in disease-specific health status that was sustained through 36 months. Conclusions: CTO-PCI was feasible with high success rates. There was no difference in the incidence of major adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the study was limited by low power for clinical end points and high crossover rates between groups. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01078051.

Objectives This study examined the incremental value of subtended myocardial mass (Vsub) as assessed by coronary computed tomography angiography (CTA) for identifying lesion-specific ischemia verified by invasive fractional flow reserve (FFR) in quantitative coronary CTA. Background FFR is determined not only by coronary stenosis severity, but also by Vsub. One-step evaluation of combined Vsub and coronary lesion morphology may improve the accuracy of coronary CTA for identifying ischemia-producing lesions. Methods A total of 246 intermediate coronary artery lesions (30% to 80% diameter stenosis) in 220 patients (mean age 61.7 years, 168 men) interrogated by FFR were retrospectively studied. Coronary CTA data were used to assess the Vsub by coronary artery stenosis, minimal lumen area (MLA), percentage of aggregated plaque volume (%APV), positive remodeling, and low-attenuation plaque. The ability of Vsub/MLA2 to discriminate lesions with FFR ≤0.80 was examined. Diagnostic performance, odds ratios, and category-less net reclassification improvements of coronary CTA parameters for FFR-verified (≤0.80) ischemia were evaluated. On-site computed tomography (CT) derived–FFR (CT-FFR) and quantitative coronary angiography (QCA) data were also compared. Results Of 246 lesions, 84 (34.1%) showed an FFR ≤0.80. Vsub was independently associated with an FFR ≤0.80 (odds ratio: 1.04/1 cm3; p = 0.032) and showed incremental value over MLA. Vsub/MLA2 >4.16 was the best single parameter for discriminating an FFR ≤0.80 with 83.3% sensitivity and 67.9% specificity. The area under the curve (AUC) of Vsub/MLA2 >4.16 (0.80 [95% confidence interval: 0.75 to 0.85]) was better than that of MLA (change in [Δ]AUC: 0.069; p Conclusions Vsub is an independent determinant of an FFR ≤0.80. The mathematical index of Vsub/MLA2 >4.16 assessed by coronary CTA shows better diagnostic performance for the detection of ischemia-producing lesions than CT-derived MLA alone or %APV and QCA parameters and was comparable to that of on-site CT-FFR.

Aortic valve (AV) replacement (AVR) is the only effective treatment for severe aortic stenosis (AS). However, survival benefits by performing AVR in asymptomatic AS patients with preserved left ventricular (LV) function remains controversial. This study included 468 patients (aged 64.2 ± 13.0 years, 232 women) with preserved LV function (≥50%) and severe AS (AV area ≤1.0 cm2, peak trans-AV velocity [Vmax] ≥4.0 m/s, or mean AV pressure gradient ≥40 mm Hg) between 2000 and 2015. AVR was performed in 221 (47.2%) patients early (within 3 months; n = 130, 27.8%) or during follow-up (n = 91, 19.4%), whereas the remainder (n = 247) received medical treatment. Time-dependent Cox regression analyses were performed to determine the impact of AVR on long-term survival outcomes. During a median follow-up of 60.9 months (quartile 1 to 3, 29.9 to 107.0 months), 72 (15.4%) patients developed AS-related symptoms and 146 (31.2%) died. On time-dependent Cox models, AVR was associated with a significant risk reduction in all-cause death (hazard ratio [HR], 0.62; 95% confidence interval [CI], 0.40 to 0.97; p = 0.036) and cardiac death (HR, 0.59; 95% CI, 0.35 to 0.995; p = 0.048) after adjusting for significant contributors to mortality. Survival benefits by performing AVR were manifested in most risk subgroups. In conclusion, AVR in asymptomatic severe AS patients with preserved LV function resulted in significant survival benefits, suggesting that early recruitment for AVR may be warranted before ventricular dysfunction or symptom development.

Background: Veno-arterial (VA) extracorporeal membrane oxygenation (ECMO) is used in various cardiogenic shocks. In severe myocardial dysfunction, left heart (LH) distension may occur and aggravate pulmonary edema. Despite the recent case reports on various venting catheter insertion methods for LH decompression, the necessity and efficacy of LH venting procedure are still controversial. Therefore, we focused on evaluating efficacy of LH venting catheter insertion for LH decompression. Methods: In total, 373 patients received VA ECMO at our institution from May 2012 to January 2016. Of these, 25 patients underwent LH venting catheter insertion. Indication for the procedure included pulmonary congestion observed on chest radiogram, with arterial pulse pressure ≤10 mmHg. The control group comprised of 45 patients with peripheral VA ECMO having arterial pulse pressure ≤ for ≥24 hours during the same study period who did not undergo LH venting procedure. Finally, 70 patients were compared and analyzed. Results: Mean age of the patients was 52.6±17.1 years. The ECMO running time in each group was 7.2±7.1 days in the vent (−) group and 9.2±8.5 days in the vent (+) group. Successful weaning rate was higher in the LH vent (+) group (P=0.08). Moreover, LH venting catheter insertion was identified as a predictor of weaning success with marginal significance (OR =2.47; 95% CI: 0.90–6.72; P=0.07). Conclusions: LH decompression by venting catheter insertion in patients on VA ECMO may be more effective and helpful for successful ECMO weaning than conventional medical management without survival benefit.

BACKGROUND Little is known about how the relative treatment effect of percutaneous coronary intervention (PCI) and coronary-artery bypass grafting (CABG) on clinical outcomes in ostial or shaft left main coronary artery (LMCA) disease has evolved over time. METHODS This study included 2,112 patients with ostial or shaft LMCA disease from IRIS-MAIN registry who underwent PCI (n = 1,329) or CABG (n = 783). Patients were stratified by time period based on stent type availability: wave 1 (1995-2002, bare-metal stent [BMS] era); wave 2 (2003-2006, first-generation drug-eluting stent [DES] era); and wave 3 (2007-2014, second-generation DES era). RESULTS Compared to CABG, PCI has been used more frequently from wave 1 to wave 3. PCI showed substantial improvements over time with respect to death (P for trend = 0.012); the composite of death, myocardial infarction (MI), or stroke (P for trend = 0.047); repeat revascularization (P for trend

Obesity and overweight have been associated with better clinical outcomes in different populations with a diverse spectrum of cardiovascular disease (obesity paradox). However, conflicting data exist about the relation between body mass index (BMI) and outcomes after transcatheter aortic valve implantation (TAVI). The aim of this study is to evaluate the association of body mass index with clinical outcomes in patients with severe aortic stenosis (AS) who underwent TAVI. The study cohort included 379 consecutive patients with symptomatic severe AS who underwent TAVI between March 2010 and February 2017 in 3 centers in East Asia. Patients were grouped into tertiles of baseline BMI (first tertile: ≤22.3 kg/m2, second tertile: 22.4 to 24.8 kg/m2, and third tertile: ≥24.9 kg/m2). The primary outcome was a composite of death from any causes or stroke at 1 year. The median (interquartile range) BMI was 23.5 (21.8 to 26.1) kg/m2. During the median follow-up of 18.4 months, there were 69 deaths and 23 strokes. At 1 year, the primary outcome occurred in 21.9% in the first tertile, 18.7% in the second tertile, and 7.8% in the third tertile, respectively (p = 0.009). After adjustment for confounding variables, an inverse relation was observed between BMI and primary outcome: with the third BMI tertile as the reference category, the adjusted hazard ratios were 2.51 (95% confidence interval, 1.20 to 5.26) for the second BMI tertile and 2.61 (95% confidence interval, 1.20 to 5.66) for the first BMI tertile. In conclusion, in patients with severe AS who underwent TAVI, an inverse association between BMI and the risk of death or stroke was observed.

Outcomes for stent-based coronary intervention of lesions with long diseased segments remain relatively unfavorable. This study sought to compare the efficacy of Resolute zotarolimus-eluting stents (R-ZES) and Xience everolimus-eluting stents (EES) for very long coronary lesions.This randomized, multicenter, prospective trial compared the use of R-ZES with EES for very long (≥50 mm) native coronary lesions. The primary end point was in-segment late luminal loss at 12-month angiographic follow-up. A total of 400 patients were needed to assess the primary end point. However, owing to very slow enrollment of patients, this trial was early terminated (302 patients were enrolled), and thus, this report provides descriptive information on primary and secondary end points. The R-ZES and EES groups had similar baseline characteristics. Lesion length was 49.6±10.2 and 50.6±13.3 mm in the R-ZES and EES groups, respectively (P=0.47). The number of stents used at the target lesion was 2.1±0.3 and 2.2±0.5, respectively. Twelve-month angiographic follow-up was performed in 50% of eligible patients. In-segment late luminal loss did not significantly differ between the R-ZES and EES groups (0.17±0.57 vs. 0.09±0.43 mm, P=0.32). In-segment binary restenosis rates were 8.1 and 5.3% in the R-ZES and EES groups, respectively (P=0.49). There were no significant between-group differences in the rate of adverse events (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes).For patients with very long native coronary artery disease, R-ZES and EES implantation showed comparable angiographic and clinical outcomes through 1 year of follow-up.

Clinical advantages of sutureless rapid-deployment (RD) aortic valve replacement (AVR) for severe aortic valve stenosis (AS) have not been elucidated compared with surgical (SAVR) or transcatheter (TAVR) aortic valve replacement.This study sought to investigate comparative effectiveness and safety of RD-AVR compared with SAVR and TAVR in a prospective cohort of patients with severe AS.The primary outcome was a composite of death, stroke, or rehospitalization at 12 months. Propensity score matching was used to assemble a cohort of patients with similar baseline characteristics.Among 1,020 eligible patients, 107 (10.5%) underwent RD-AVR, 437 (42.8%) underwent SAVR, and 476 (46.7%) underwent TAVR. In the matched cohorts of RD-AVR and SAVR (n = 107), the incidence of primary composite outcome at 12 months was similar between the 2 groups (8.0% vs 10.8%, respectively; hazard ratio [HR]: 0.74; 95% confidence interval [CI]: 0.30-1.84;In this propensity-matched cohort of patients who underwent AVR for severe AS, we did not detect significant differences in the rates of the primary composite of death, stroke, or rehospitalization at 12 months when comparing RD-AVR with SAVR and TAVR. Because the study was underpowered, the results should be considered as hypothesis generating highlighting the need for further research. (ASAN Medical Center Aortic Valve Replacement Registry [ASAN-AVR]; NCT03298178).

Immediate improvement in left ventricular ejection fraction (LVEF) following transcatheter aortic valve implantation (TAVI) is common; however, data on the pattern and prognostic value of this improvement are limited. To evaluate the incidence, predictors, and clinical impact of immediate improvement in LVEF, we studied 694 consecutive patient who had underwent successful TAVI for severe aortic stenosis (AS) between March 2010 and December 2019. We defined immediate improvement of LVEF as an absolute increase of ≥5% in LVEF at post-procedure echocardiogram. The primary outcome was major adverse cardiac or cerebrovascular event (MACCE), defined as a composite of death from cardiovascular cause, myocardial infarction, stroke, or rehospitalization from cardiovascular cause. Among them, 160 patients showed immediate improvement in LVEF. The independent predictors of immediate LVEF improvement were absence of hypertension and baseline significant aortic regurgitation, and greater baseline LV mass index. Immediate improvement in LVEF was significantly associated with a lower risk of MACCE (adjusted hazard ratio, 0.48; 95% confidence interval, 0.28–0.81; p = 0.01). In conclusion, approximately one-fourth of patients with severe AS who underwent TAVI showed immediate improvement in LVEF during index hospitalization. Immediate LVEF recovery was associated with a lower risk of MACCE during follow-up.

There is limited data regarding the association between sarcopenia and clinical outcomes in patients who underwent transcatheter aortic valve implantation (TAVI). From the prospective ASAN-TAVI registry, we evaluated a total of 522 patients with severe aortic stenosis who underwent TAVI between March 2010 and November 2018. Routine pre-TAVI computed tomography scan was used to calculate the skeletal muscle index (SMI), which was defined as skeletal muscle area at the L3 level divided by height squared; subject patients were classified into the gender-specific tertile groups of SMI. The patients' mean age was 79 years and 49% were men. Mean SMI values were 41.3 ± 6.7 cm2/m2 in men and 34.1 ± 6.5 cm2/m2 in women. The Kaplan-Meier estimates of all-cause mortality at 12 months were higher in the low-tertile group than in the mid- and high-tertile groups (15.5%, 7.1%, and 6.2%, respectively; p = 0.036). In multivariate analysis, low-tertile of SMI was an independent predictor of mortality (vs high-tertile of SMI, hazard ratio 2.69; 95% confidence interval, 1.18 to 6.12; p = 0.019). The all-cause mortality was substantially higher in the groups with high-surgical risk plus low SMI tertile. The risk assessment with addition of SMI on conventional STS-PROM score was significantly improved by statistical measures of model reclassification and discrimination. In patients who underwent TAVI, sarcopenia measured by SMI was significantly associated with an increased risk of 1-year mortality. The prognostic impact of SMI-measured sarcopenia was more prominent in patients with high surgical risks.