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Background: It is unknown whether the direct oral anticoagulant edoxaban can reduce leaflet thrombosis and the accompanying cerebral thromboembolic risk after transcatheter aortic valve replacement. In addition, the causal relationship of subclinical leaflet thrombosis with cerebral thromboembolism and neurological or neurocognitive dysfunction remains unclear. Methods: We conducted a multicenter, open-label randomized trial comparing edoxaban with dual antiplatelet therapy (aspirin plus clopidogrel) in patients who had undergone successful transcatheter aortic valve replacement and did not have an indication for anticoagulation. The primary end point was an incidence of leaflet thrombosis on 4-dimensional computed tomography at 6 months. Key secondary end points were the number and volume of new cerebral lesions on brain magnetic resonance imaging and the serial changes of neurological and neurocognitive function between 6 months and immediately after transcatheter aortic valve replacement. Results: A total of 229 patients were included in the final intention-to-treat population. There was a trend toward a lower incidence of leaflet thrombosis in the edoxaban group compared with the dual antiplatelet therapy group (9.8% versus 18.4%; absolute difference, −8.5% [95% CI, −17.8% to 0.8%]; P =0.076). The percentage of patients with new cerebral lesions on brain magnetic resonance imaging (edoxaban versus dual antiplatelet therapy, 25.0% versus 20.2%; difference, 4.8%; 95% CI, −6.4% to 16.0%) and median total new lesion number and volume were not different between the 2 groups. In addition, the percentages of patients with worsening of neurological and neurocognitive function were not different between the groups. The incidence of any or major bleeding events was not different between the 2 groups. We found no significant association between the presence or extent of leaflet thrombosis with new cerebral lesions and a change of neurological or neurocognitive function. Conclusions: In patients without an indication for long-term anticoagulation after successful transcatheter aortic valve replacement, the incidence of leaflet thrombosis was numerically lower with edoxaban than with dual antiplatelet therapy, but this was not statistically significant. The effects on new cerebral thromboembolism and neurological or neurocognitive function were also not different between the 2 groups. Because the study was underpowered, the results should be considered hypothesis generating, highlighting the need for further research. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03284827.

BackgroundA high permanent pacemaker implantation (PPI) risk remain a concern of self-expandable transcatheter aortic valve implantation (TAVI), despite 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 TAVI on reducing the rates of conduction disturbances including the need for PPI.MethodsConsecutive 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).ResultsOf 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 [IQR 1.0–3.5] mm vs 4.3 [IQR: 3.3–5.4],PP= 0.035). Compared with the “cusp-overlap without ICE” group, the “cusp-overlap with ICE” group had lower 30-day PPI rates (1.0%,P= 0.014), albeit with comparable implantation depths (1.9 [IQR 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% vs 1.6% vs 0%;P= 0.254).ConclusionsOur novel implantation method using transjugular ICE, which enabled a 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 TAVI.

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

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)

ObjectiveLittle 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.MethodsWe 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.ResultsOf 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).ConclusionsThere 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 numberNCT03826264(https://wwwclinicaltrialsgov).

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.

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...

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.

Background Although current guidelines recommend dual antiplatelet therapy (DAPT) for 3 to 6 months following transcatheter aortic valve replacement (TAVR), there are no studies directly comparing outcomes of different durations of DAPT following TAVR. Methods and Results PubMed, EMBASE, and Cochrane Database were searched through November 2020 to identify clinical studies that investigated single antiplatelet therapy versus DAPT use following TAVR. Studies using oral anticoagulants and antiplatelet therapy concomitantly were excluded. The DAPT group was subdivided by the duration of DAPT. We extracted the risk ratios (RRs) of major or life‐threatening bleeding, stroke, and all‐cause mortality. Four randomized controlled trials, 2 propensity‐score matched studies, and 1 observational study were identified, yielding a total of 2498 patients who underwent TAVR assigned to the single antiplatelet therapy group (n=1249), 3‐month DAPT group (n=485), or 6‐month DAPT group (n=764). Pooled analyses demonstrated that when compared with the single antiplatelet therapy group, the rates of major or life‐threatening bleeding were significantly higher in the 3‐ and 6‐month DAPT groups (RR [95% CI]=2.13 [1.33–3.40], P=0.016; RR [95% CI]=2.54 [1.49–4.33], P=0.007, respectively) with no difference between the 3‐month DAPT versus 6‐month DAPT groups. The rates of stroke and all‐cause mortality were similar among the 3 groups. Conclusions In this network meta‐analysis of antiplatelet therapy following TAVR, single antiplatelet therapy with aspirin had lower bleeding without increasing stroke or death when compared with either 3‐ or 6‐month DAPT.

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.

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 ( P interaction : 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 ( P interaction : 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 ( P interaction : 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: NCT 02791412.

Objectives The aim of this study was to investigate the impact of lesion site (ostial or shaft vs. distal bifurcation) on long-term outcomes after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for left main coronary artery (LMCA) disease. Background Long-term comparative data after PCI and CABG for LMCA disease according to lesion site are limited. Methods Patients from the MAIN-COMPARE (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization) registry were analyzed, comparing adverse outcomes (all-cause mortality [a composite outcome of death, Q-wave myocardial infarction, or stroke] and target vessel revascularization) between PCI and CABG according to LMCA lesion location during a median follow-up period of 12.0 years. Results In overall population, the adjusted risks for death and serious composite outcome were higher after PCI than after CABG for distal bifurcation disease, which was mainly separated beyond 5 years. These outcomes were not different for ostial or shaft disease. When comparing drug-eluting stents (DES) and CABG, the adjusted risks for death and serious composite outcome progressively diverged beyond 5 years after DES compared with CABG for distal bifurcation disease (death: hazard ratio: 1.78; 95% confidence interval: 1.22 to 2.59; composite outcome: hazard ratio: 1.94; 95% confidence interval: 1.35 to 2.79). This difference was driven mainly by PCI with a 2-stent technique for distal bifurcation. In contrast, the adjusted risks for these outcomes were similar between DES and CABG for ostial or shaft disease. Conclusions Among patients with distal LMCA bifurcation disease, CABG showed lower mortality and serious composite outcome rates compared with DES beyond 5 years. However, there were no between-group differences in these outcomes among patients with ostial or shaft LMCA disease.

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

Post-transcatheter aortic valve implantation (TAVI) computed tomography (CT) findings have not been fully elucidated, except hypoattenuating leaflet thickening (HALT). The objective of this study was to describe cardiac CT findings after TAVI, and investigate factors associated with HALT. This retrospective study included patients who underwent TAVI and post-TAVI cardiac CT scans. On CT, abnormal findings such as hypoattenuating subvalvular thickening (HAST), thrombus within the sinus of Valsalva, HALT, and leaflet motion limitation were thoroughly reviewed. Clinical and CT findings were compared between patients with HALT and those without HALT. Logistic regression analysis was performed to determine factors associated with HALT. A total of 138 patients (64 male, mean 78.5 ± 5.2 years of age) with post-TAVI CT scans were included. The median duration from TAVI to CT was 17.5 days (interquartile range, 3 to 390.8 days). HAST and thrombus within the sinus of Valsalva were detected in 32 (23%) and 5 (4%) patients, respectively. HALT and leaflet motion limitations were found in 25 (18%) and 20 (14%) of patients, respectively. Pannus was diagnosed in 2 patients. TAVI device implant duration (odds ratio [OR], 1.5; p = 0.01), hypertension (OR, 0.2; p = 0.03), and HAST (OR, 4.9; p = 0.003) were associated with HALT. Implant durations were longer in patients with HAST, HALT, or leaflet motion limitation (p 0.05, for all). In conclusion, HAST, HALT, thrombus within the sinus of Valsalva, and leaflet motion limitation are not uncommon after TAVI. Implant duration, hypertension, and HAST are associated with HALT.

Nutritional status, a key marker of patient frailty, is an important prognostic factor after transcatheter aortic valve replacement (TAVR). Few investigations have evaluated the clinical usefulness of nutritional assessment tools for predicting the risk of mortality following TAVR. A total of 412 patients with symptomatic severe AS who underwent TAVR between March 2010 and August 2017 were stratified into subgroups by their Geriatric Nutritional Risk Index [GNRI, low ≤ 98 vs. high > 98 (better nutritional status)] and Controlling Nutritional Status (CONUT) score [low ≤ 3 vs. high ≥ 4; (poorer nutritional status)]. The primary study outcome was all-cause mortality at 1 year. Patients with low GNRI score showed a significantly higher 1-year mortality rate as compared to those with high GNRI score (13.0% vs. 3.2%, respectively; P = 0.001). Similarly, patients with high CONUT score had a significantly higher rate of 1-year mortality than those with low CONUT score (15.7% vs. 6.2%, respectively; P = 0.005). However, in multivariable Cox proportional-hazards models, low GNRI was the only independent predictor of mortality (adjusted hazard ratio, 3.77; 95% confidence interval 1.54–9.20; P = 0.004). Overall, integration of GNRI into conventional risk models of STS score or logistic EuroSCORE resulted in improved predictive value for mortality measured by the net reclassification improvement and the integrated discrimination improvement. In patients undergoing TAVR, low GNRI (but not high CONUT score) was independently associated with a higher risk of 1-year mortality. Further research is required to determine whether nutritional screening and management can improve clinical outcomes in patients undergoing TAVR.

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

The clinical outcomes of drug-eluting stent (DES) implantation after rotational atherectomy (RA) for complex left main coronary artery (LMCA) bifurcation lesions remain unclear. Among 1,809 patients retrospectively enrolled in the Assessing Optimal percutaneous coronary Intervention for LMCA Registry, we identified 1,199 patients with LMCA bifurcation lesions treated by crossover stenting with DES for the main vessel. The study population was divided according to the use of RA. The patients in the RA group were further subdivided into the 2 subgroups on the basis of the stenting approach. The rates of periprocedural myocardial infarction and in-hospital death in the RA group were comparable to those in the non-RA group. The cumulative 5-year incidences of all-cause death and target lesion revascularization (TLR) were significantly higher in the RA group than those in the non-RA group. However, after adjusting confounders, the excess risks of the RA group relative to the non-RA group for all-cause death and TLR were no longer significant (hazard ratio 0.95, 95% confidence intervals 0.59 to 1.52, p = 0.83, and hazard ratio 1.46, 95% confidence intervals 0.82 to 2.60, p = 0.20, respectively). In the RA group, the cumulative 5-year incidences of all-cause death and TLR were markedly higher in the 2-stent subgroup than in the 1-stent subgroup (58.1% vs 26.0%, p = 0.001, and 43.0% vs 16.3%, p = 0.001, respectively). In conclusion, DES implantation after RA was a safe and feasible strategy in treating those patients with complex LMCA bifurcation lesions. In this strategy, the 2-stent approach was associated with markedly worse 5-year clinical outcomes than the 1-stent approach.

Data on the clinical outcomes of percutaneous coronary intervention (PCI) for unprotected left main coronary artery (LMCA) in patients with acute coronary syndrome (ACS) are limited. Therefore, this study aimed to assess the clinical outcome of patients with ACS who underwent PCI for LMCA culprit lesion.Methods and Results:Of 1,809 patients enrolled in the Assessing Optimal Percutaneous Coronary Intervention for the LMCA (AOI-LMCA) registry (a retrospective 6-center registry of consecutive patients undergoing LMCA stenting in Japan), the current study population consisited of 1,500 patients with unprotected LMCA stenting for LMCA ACS (ACS with shock: 115 patients, ACS without shock: 281 patients) and stable CAD (1,104 patients). The cumulative 180-day incidence of death was markedly higher in the ACS with shock group than in the other groups (49.5%, 8.6%, and 3.3%, respectively; P0.0001), but mortality beyond 180-day was not significantly different among the 3 groups (30.2%, 20.4%, and 19.5%, respectively; P=0.65). In the ACS with shock group, the initial TIMI flow grade did not affect 5-year mortality (57.1% and 62.2%, P=0.99), but in the ACS without shock group, 5-year mortality was significantly higher in patients with initial TIMI flow grade ≤1 than in patients with TIMI flow grade ≥2 (44.4% and 23.7%, respectively; P=0.008).In patients with LMCA ACS, survival correlates with baseline hemodynamic and coronary flow status.

IntroductionOptimal 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 analysisThe 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 disseminationEthic 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 numberNCT03284827.

There is limited information on the incidence, management, and prognostic impact of new-onset atrial fibrillation (NOAF) following transcatheter aortic valve implantation (TAVI) for severe aortic valve stenosis. In the prospective ASAN-TAVI registry, we evaluated a total of 347 consecutive patients who underwent TAVI from March 2010 to August 2017. The primary end point was a composite of stroke or systemic embolism at 12 months. The study subjects were categorized into 3 groups; pre-existing AF (50 patients), NOAF (31 patients), and non-AF (266 patients) group. NOAF developed in 10.4% of patients without pre-existing AF after TAVI and most cases were paroxysmal type (93.6%). Pharmacologic and electrical cardioversion were tried in 13 (41.9%) and 6 (19.4%) patients and success rates were 61.5% and 33.3%, respectively. NOAF-associated case rate for primary end point was 22.6%. Transfemoral access and cardiac tamponade were independent predictors of NOAF. Patients with NOAF, as compared with those with pre-existing AF and those without AF, had an increased 1-year rate of primary end point (24.0% vs 9.9% vs 7.2%, respectively; p0.001). By multivariable analysis, NOAF was an independent predictor of 1-year rate of primary end point (adjusted hazard ratio: 3.31; 95% CI: 1.34 to 8.20; p = 0.010). In conclusion, patients with severe aortic valve stenosis who underwent TAVI, NOAF occurred in 10% and 1 of 4 NOAF patients experienced stroke or systemic embolization. The presence of NOAF was associated with a substantially higher risk of stroke or systemic embolization.

The aim of this study was to evaluate the prognostic impact of left ventricular ejection fraction (LVEF) in patients with severe aortic stenosis (AS).The prognostic impact of LVEF in severe AS remains controversial.Among 3,815 consecutive patients with severe AS enrolled in the CURRENT AS (Contemporary Outcomes After Surgery and Medical Treatment in Patients With Severe Aortic Stenosis) registry, the present study population consisted of 3,794 patients after excluding 21 patients without LVEF data. Patients were divided into 4 groups according to LVEF at index echocardiography (50%, 50% to 59%, 60% to 69%, and ≥70%; conservative strategy: n = 388, n = 390, n = 1,025, and n = 800; initial aortic valve replacement strategy: n = 206, n = 170, n = 375, and n = 440). Echocardiographic data were site reported, and there was no echocardiography core laboratory.In the conservative group, the cumulative 5-year incidence of the primary outcome measure (a composite of aortic valve-related death or heart failure hospitalization) was significantly higher in patients with LVEFs 50% and 50% to 59% than in those with LVEFs 60% to 69% and ≥70% (72.3%, 58.4%, 38.7%, and 35.0%, respectively, p 0.001), whereas in the initial aortic valve replacement group, the negative effect of low LVEF was markedly attenuated (20.2%, 20.3%, 17.7%, and 12.4%, respectively, p = 0.03). After adjusting for confounders, LVEF 50% (hazard ratio: 1.82; 95% confidence interval: 1.44 to 2.28; p 0.001) and 50% to 59% (hazard ratio: 1.77; 95% confidence interval: 1.42 to 2.20; p 0.001) but not 60% to 69% (hazard ratio: 1.14; 95% confidence interval: 0.94 to 1.39; p = 0.17) were independently associated with poorer outcomes compared with LVEF ≥70% (reference) in the conservative group. In the initial aortic valve replacement group, the adjusted risk for the primary outcome measure was not significantly different across the 4 LVEF groups.This study demonstrates that survival in patients with severe AS is impaired when LVEF is 60%, and these findings have implications for decision making with regard to the timing of surgical intervention.

We hypothesized that patients who had previous target-lesion revascularization (TLR) for DES restenosis in non-left main coronary artery (LMCA) lesions might have a higher risk for restenosis after subsequent DES implantation for a de novo unprotected LMCA lesion. Among 1809 patients enrolled in the Assessing Optimal Percutaneous Coronary Intervention for LMCA (AOI-LMCA) registry, which is a retrospective 6-centre registry of consecutive patients undergoing LMCA stenting in Japan, 251 patients with previous DES implantation for non-LMCA lesions were subdivided into the 2 groups with (N = 56) or without (N = 195) previous TLR in non-LMCA lesions. The risk for TLR for LMCA was neutral between the prior TLR for DES restenosis group and the no prior TLR for DES restenosis group [hazard ratio (HR) 0.99, 95% confidence interval (CI) 0.44–2.02, P = 0.98]. The risks for both TLR caused by restenosis of the LMCA main branch, and second TLR for restenosis after first TLR for LMCA were also neutral between the 2 groups (HR 0.42, 95% CI 0.10–1.25, P = 0.13, and HR 0.59, 95% CI 0.03–3.63, P = 0.60, respectively). In conclusion, prior TLR for DES restenosis in non-LMCA lesions was not associated with worse long-term clinical outcomes after DES implantation for de novo unprotected LMCA lesions. Clinical Trial Registration: Assessing Optimal Percutaneous Coronary Intervention for Left Main Coronary Artery Stenting Registry (AOI LMCA Stenting Registry). http://www.umin.ac.jp/ctr/index/htm/ . Unique Identifier: UMIN000014706.

Background There are limited data regarding the risk stratification based on peak aortic jet velocity (Vmax) in patients with severe aortic stenosis ( AS ). Methods and Results Among 3815 consecutive patients with severe AS enrolled in the CURRENT AS (Contemporary Outcomes After Surgery and Medical Treatment in Patients With Severe Aortic Stenosis) registry, the study population consisted of 1075 conservatively managed patients with Vmax ≥4.0 m/s and left ventricular ejection fraction ≥50%. The study patients were subdivided into 3 groups based on Vmax (group 1, 4.0 ≤ Vmax AS ‐related events (aortic valve–related death or heart failure hospitalization) was incrementally higher with increasing Vmax (entire population; 38.0%, 49.4%, and 62.8%, P P =0.008; and asymptomatic patients; 29.4%, 38.9%, and 47.7%, P =0.005). After adjusting for confounders, the excess risk of group 2 and group 3 relative to group 1 for AS ‐related events remained significant (hazard ratio, 1.39; 95% CI , 1.07–1.81; P =0.02, and hazard ratio, 1.53; 95% CI , 1.17–2.00; P =0.002, respectively). The effect size of group 3 relative to group 1 for AS ‐related events in asymptomatic patients (N=479) was similar to that in symptomatic patients (N=596; hazard ratio, 1.59; 95% CI , 1.01–2.52; P =0.047, and hazard ratio, 1.67; 95% CI , 1.16–2.40, P =0.008, respectively), and there was no significant overall interaction between the symptomatic status and the effect of the Vmax categories on AS ‐related events (interaction, P =0.88). Conclusions In conservatively managed severe AS patients with preserved left ventricular ejection fraction, increasing Vmax was associated with incrementally higher risk for AS ‐related events. However, the cumulative 5‐year incidence of the AS ‐related events remained very high even in asymptomatic patients with less greater Vmax.

Despite the wide use of intravascular ultrasound (IVUS) for stent optimization, few studies have evaluated its use for chronic total occlusion percutaneous coronary intervention. A total of 1,077 patients who received percutaneous coronary intervention with drug-eluting stent were included. This

Patients undergoing myocardial revascularization for significant left main coronary artery disease (LMCA) are at high risk of ischemic events and death during follow-up. This study sought to determine the independent correlates for very long-term outcomes after LMCA revascularization, which would be

Chronic kidney disease (CKD) is a common complication in patients with diabetes. CKD was associated with adverse cardiovascular events in patients with diabetes who underwent percutaneous coronary intervention (PCI) before the drug-eluting stent (DES) era. However, the clinical impact of renal