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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 Various ECG criteria for left ventricular hypertrophy (LVH) have been proposed, but their association with clinical outcomes in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement is unknown. We investigated the prevalence of ECG LVH according to different criteria and its prognostic impact on clinical outcomes after transcatheter aortic valve replacement. Methods and Results In this prospective observational cohort, we evaluated 700 patients who underwent transcatheter aortic valve replacement between March 2010 and December 2019. Baseline preprocedural LVH was defined by 3 ECG criteria—Sokolow‐Lyon, Romhilt‐Estes, and Cornell voltage criteria. The primary outcome was major adverse cardiac or cerebrovascular event (MACCE; composite of death, myocardial infarction, stroke, or rehospitalization from cardiovascular cause); the key secondary outcome was all‐cause and cardiovascular mortality. Among 596 eligible patients, the prevalence of LVH was determined as 56.3% by Sokolow‐Lyon, 31.1% by Romhilt‐Estes, and 48.1% by Cornell criteria. Regardless of the criteria, patients with ECG LVH had more severe aortic stenosis hemodynamics and higher left ventricular mass index. After multivariate adjustment, the presence of LVH by the Cornell criteria was significantly associated with lower risks of MACCE (adjusted hazard ratio [HR], 0.68; 95% CI, 0.51–0.91; P=0.009), all‐cause mortality (adjusted HR, 0.55; 95% CI, 0.34–0.90 [P=0.017]), and cardiovascular mortality (adjusted HR, 0.40; 95% CI, 0.20–0.79 [P=0.008]). However, this association was absent with the Sokolow‐Lyon and Romhilt‐Estes criteria. Conclusions ECG LVH by Cornell criteria only was significantly associated with lower risks of MACCE and all‐cause or cardiovascular mortality. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03298178.

BACKGROUND: A high permanent pacemaker implantation (PPI) risk remains a concern of self-expandable transcatheter aortic valve implantation, despite the continued improvements in implantation methodology. We aimed to assess the impact of real-time direct visualization of the membranous septum using transjugular intracardiac echocardiography (ICE) during transcatheter aortic valve implantation on reducing the rates of conduction disturbances including the need for PPI. METHODS: Consecutive patients treated with Evolut R and Evolut PRO/PRO+ from February 2017 to September 2022 were included in this study. We compared outcomes between the conventional implantation method using the 3-cusps view (3 cusps without ICE group), the recent method using cusp-overlap view (cusp overlap without ICE group), and our novel method using ICE (cusp overlap with ICE group). RESULTS: Of the 446 patients eligible for analysis, 211 (47.3%) were categorized as the 3 cusps without ICE group, 129 (28.9%) were in the cusp overlap without ICE group, and 106 (23.8%) comprised the cusp overlap with ICE group. Compared with the 3 cusps without ICE group, the cusp overlap without ICE group had a smaller implantation depth (2.2 [interquartile range, 1.0-3.5] mm versus 4.3 [interquartile range, 3.3-5.4] mm; P<0.001) and lower 30-day PPI rates (7.0% versus 14.2%; P=0.035). Compared with the cusp overlap without ICE group, the cusp overlap with ICE group had lower 30-day PPI rates (0.9%; P=0.014), albeit with comparable implantation depths (1.9 [interquartile range, 0.9-2.9] mm; P=0.150). Multivariable analysis showed that our novel method using ICE with the cusp-overlap view was independently associated with a 30-day PPI rate reduction. There were no group differences in 30-day all-cause mortality (1.4% versus 1.6% versus 0%; P=0.608). CONCLUSIONS: Our novel implantation method using transjugular ICE, which enable real-time direct visualization of the membranous septum, achieved a predictably high position of prostheses, resulting in a substantial reduction of conduction disturbances requiring PPI after transcatheter aortic valve implantation. [ABSTRACT FROM AUTHOR]

Introduction Optimal antithrombotic strategy following transcatheter aortic valve replacement (TAVR) is still unknown. We hypothesised that the direct factor Xa inhibitor edoxaban can potentially prevent subclinical leaflet thrombosis and cerebral embolisation compared with conventional dual antiplatelet therapy (DAPT) in patients undergoing TAVR.Methods and analysis The ADAPT-TAVR trial is an international, multicentre, randomised, open-label, superiority trial comparing edoxaban-based strategy and DAPT strategy in patients without an indication for oral anticoagulation who underwent successful TAVR. A total of 220 patients are randomised (1:1 ratio), 1–7 days after successful TAVR, to receive either edoxaban (60 mg daily or 30 mg daily if patients had dose-reduction criteria) or DAPT using aspirin (100 mg daily) plus clopidogrel (75 mg daily) for 6 months. The primary endpoint was an incidence of leaflet thrombosis on four-dimensional, volume-rendered cardiac CT imaging at 6 months post-TAVR. The key secondary endpoints were the number of new lesions and new lesion volume on brain diffusion-weighted MRI and the changes in neurological and neurocognitive function assessment between immediate post-TAVR and 6 months of study drug administration. Detailed clinical information on thromboembolic and bleeding events were also assessed.Ethics and dissemination Ethic approval has been obtained from the Ethics Committee/Institutional Review Board of Asan Medical Center (approval number: 2017–1317) and this trial is also approved by National Institute of Food and Drug Safety Evaluation of Republic of Korea (approval number: 31511). Results of this study will be disseminated in scientific publication in reputed journals.Trial registration number NCT03284827.

Background Data are still limited regarding whether there are differential long‐term outcomes after percutaneous coronary intervention versus coronary artery bypass grafting (CABG) for left main coronary artery disease with or without diabetes mellitus (DM). Methods and Results Using the 10‐year data from the MAIN‐COMPARE (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization) registry, we sought to examine the effect of DM on comparative outcomes after percutaneous coronary intervention or CABG in patients with unprotected left main coronary artery disease. The outcomes of interest were all‐cause mortality; a composite of death, Q‐wave myocardial infarction, or stroke; and target‐vessel revascularization. The primary adjusted analyses were performed with the use of propensity scores and inverse‐probability weighting. Of 2240 patients with left main coronary artery revascularization, 722 (32%) had DM. In the overall population, the adjusted 10‐year risks of death and composite outcome were similar between percutaneous coronary intervention and CABG, irrespective of DM status (Pinteraction: 0.41, mortality; 0.40, composite outcome). However, in the cohort of bare‐metal stents and concurrent CABG, we observed differential outcomes after stenting and CABG by DM status (Pinteraction: 0.09, mortality; 0.04, composite outcome), favoring CABG in patients with DM. In the cohort of drug‐eluting stents and concurrent CABG, the better effect of CABG over stenting was narrowed in patients with DM without a significant interaction (Pinteraction: 0.63, mortality; 0.47, composite outcome). Conclusions In this cohort of patients with longest follow‐up who underwent left main coronary artery revascularization, the clinical impact of DM favoring CABG over percutaneous coronary intervention has diminished over time from the bare‐metal stent to the drug‐eluting stent era. Registration URL: http://www.clini​caltr​ials.gov. Unique identifier: NCT02791412.

Objective: Little information exists about inter-racial differences in patients with aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). We investigated whether differences in baseline characteristics between Asian and non-Asian population may contribute to disparities in clinical outcomes after TAVI.Methods: We performed a registry-based, multinational cohort study of patients with severe AS who underwent TAVI at two centres in the USA and one centre in South Korea. The primary outcome was a composite of death, stroke or rehospitalisation at 1 year.Results: Of 1412 patients, 581 patients were Asian and 831 were non-Asian (87.5% white, 1.7% black, 6.1% Hispanic or 4.7% others). There were substantial differences in baseline characteristics between two racial groups. The primary composite outcome was significantly lower in the Asian group than in the non-Asian group (26.0% vs 35.0%; HR 0.73; 95% CI 0.59 to 0.89; p=0.003). However, after adjustment of baseline covariates, the risk of primary composite outcome was not significantly different (HR 0.79; 95% CI 0.60 to 1.03; p=0.08). The all-cause mortality at 1 year was significantly lower in the Asian group than the non-Asian group (7.4% vs 12.5%; HR 0.60; 95% CI 0.41 to 0.88; p=0.009). After multivariable adjustment, the risk of all-cause mortality was also similar (HR 1.17; 95% CI 0.73 to 1.88; p=0.52).Conclusions: There were significant differences in baseline and procedural factors among Asian and non-Asian patients who underwent TAVI. Observed inter-racial differences in clinical outcomes were largely explained by baseline differences in clinical, anatomical and procedural factors.Trial Registration Number: NCT03826264 (https://wwwclinicaltrialsgov). [ABSTRACT FROM AUTHOR]

Introduction: Recently right atrial septal (RAS) pacing is often selected, but the benefit brought by RAS pacing has not been clear. The aim of this study was to evaluate the differences between RAS pacing and right appendage (RAA) pacing. Methods: 223 consecutive new patients with a right atrial (RA) electrode during the period from January 2004 to December 2012 were studied retrospectively. They were observed regularly at our pacemaker (PM) clinic, and we measured paced P - sensed QRS interval (pPQi) and left atrial dimension (LAD) during the observation period, furthermore the onset of atrial fibrillation (AF) was assessed. Results: Mean age was 74.5 years and 104 were men. Mean follow-up period was 4.5 years. 177 patients received RAA pacing and 46 received RAS pacing. There was no difference of LAD and pPQi between patients with RAA pacing and with RAS pacing with more than 50% of percentage as the atrial pacing (%AP). About the comparison between intrinsic PQ interval and pPQi, only RAA pacing made long significantly from intrinsic PQ interval to pPQi (p=0.020, 172.3±46.3 vs. 189.7±38.0). The %AP more than 50% brought less probability of the onset AF. On the other hand, none of pacing sites of RA, pacing mode, and the percentage of ventricular pacing influenced on the probability of the onset of AF. Although in patients with 50% as %AP RAA pacing made patients with AF increased (from 17 to 22), RAS pacing made them decreased (from 14 to 12). Conclusions: This study did not show the superiority of RAS pacing to RAA pacing, it seems that %AP is more important for the onset of AF. The possibility was seen that RAS pacing reduces the onset of AF. [ABSTRACT FROM AUTHOR]

Although lipid-lowering therapy with statin and ezetimibe has been reported to provide greater reduction in low-density lipoprotein cholesterol levels than statin monotherapy, the effect of supplemental therapy on plaque stabilization is yet to be fully elucidated. Cap thickness of fibroatheroma evaluated by optical coherence tomography (OCT) is a major determinant of vulnerable plaque. The primary objective of this study is to evaluate the effect of ezetimibe in addition to fluvastatin on the progression of coronary atherosclerotic plaque evaluated by OCT. Sixty-three patients with angina pectoris with intermediate, nonculprit, lipid-rich plaque lesions evaluated by OCT were enrolled. The patients were divided into 2 groups: ezetimibe (10 mg/day) D fluvastatin (30 mg/day), and fluvastatin (30 mg/day) alone, and serial OCT examinations were performed at baseline and 9-month follow-up. A total of 57 patients (ezetimibe D fluvastatin, n [ 31; fluvastatin alone, n [ 26) underwent serial OCT examinations. The change in low-density lipoprotein cholesterol level was significantly larger in the ezetimibe D fluvastatin group compared with fluvastatin- alone group (-34.0±32.0 vsL8.3±17.4 mg/dl, p <0.001). Fibrous cap thickness was significantly increased and the angle of the lipid plaque was significantly decreased in both groups. The change in the fibrous cap thickness was significantly greater in the ezetimibe D fluvastatin group (0.08±0.08 mm vs 0.04±0.06 mm, p <0.001). In conclusion, lipidlowering therapy by ezetimibe D fluvastatin could increase the fibrous cap thickness of lipid-rich plaque compared with fluvastatin monotherapy. [ABSTRACT FROM AUTHOR]

Introduction: Recently right atrial septal (RAS) pacing is often selected, but the benefit brought by RAS pacing has not been clear. The aim of this study was to evaluate the differences between RAS pacing and right appendage (RAA) pacing., Methods: 223 consecutive new patients with a right atrial (RA) electrode during the period from January 2004 to December 2012 were studied retrospectively. They were observed regularly at our pacemaker (PM) clinic, and we measured paced P - sensed QRS interval (pPQi) and left atrial dimension (LAD) during the observation period, furthermore the onset of atrial fibrillation (AF) was assessed., Results: Mean age was 74.5 years and 104 were men. Mean follow-up period was 4.5 years. 177 patients received RAA pacing and 46 received RAS pacing. There was no difference of LAD and pPQi between patients with RAA pacing and with RAS pacing with more than 50% of percentage as the atrial pacing (%AP). About the comparison between intrinsic PQ interval and pPQi, only RAA pacing made long significantly from intrinsic PQ interval to pPQi (p=0.020, 172.3±46.3 vs. 189.7±38.0). The %AP more than 50% brought less probability of the onset AF. On the other hand, none of pacing sites of RA, pacing mode, and the percentage of ventricular pacing influenced on the probability of the onset of AF. Although in patients with 50% as %AP RAA pacing made patients with AF increased (from 17 to 22), RAS pacing made them decreased (from 14 to 12)., Conclusions: This study did not show the superiority of RAS pacing to RAA pacing, it seems that %AP is more important for the onset of AF. The possibility was seen that RAS pacing reduces the onset of AF.