756 results on '"Serruys, P.W.J.C. (Patrick)"'
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2. Association of Pulse Pressure With Clinical Outcomes in Patients Under Different Antiplatelet Strategies After Percutaneous Coronary Intervention: Analysis of GLOBAL LEADERS
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de Faria, A.P. (Ana Paula), Modolo, R. (Rodrigo), Chichareon, P. (Ply), Chang, C.-C. (Chun-Chin), Kogame, N. (Norihiro), Tomaniak, M. (Mariusz), Takahashi, K. (Kuniaki), Rademaker-Havinga, T.A.M. (Tessa), Wykrzykowska, J.J. (Joanna), Winter, R.J. (Robbert) de, Ferreira, R.C. (Rui C.), Sousa, A. (Amanda), Lemos, F.B.C. (Francine), Garg, S.A. (Scot), Hamm, C. (Christian), Juni, P. (Peter), Vranckx, P. (Pascal), Valgimigli, M. (Marco), Windecker, S.W. (Stephan), Onuma, Y. (Yoshinobu), Steg, P.G. (Philippe Gabriel), Serruys, P.W.J.C. (Patrick), de Faria, A.P. (Ana Paula), Modolo, R. (Rodrigo), Chichareon, P. (Ply), Chang, C.-C. (Chun-Chin), Kogame, N. (Norihiro), Tomaniak, M. (Mariusz), Takahashi, K. (Kuniaki), Rademaker-Havinga, T.A.M. (Tessa), Wykrzykowska, J.J. (Joanna), Winter, R.J. (Robbert) de, Ferreira, R.C. (Rui C.), Sousa, A. (Amanda), Lemos, F.B.C. (Francine), Garg, S.A. (Scot), Hamm, C. (Christian), Juni, P. (Peter), Vranckx, P. (Pascal), Valgimigli, M. (Marco), Windecker, S.W. (Stephan), Onuma, Y. (Yoshinobu), Steg, P.G. (Philippe Gabriel), and Serruys, P.W.J.C. (Patrick)
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Background: We evaluated the association of pulse pressure (PP) and different antiplatelet regimes with clinical and safety outcomes in an all-comers percutaneous coronary intervention (PCI) population. Methods: In this analysis of GLOBAL LEADERS (n = 15,936) we compared the experimental therapy of 23 months of ticagrelor after 1 month of dual-antiplatelet therapy (DAPT) versus standard DAPT for 12 months followed by aspirin monotherapy in subjects who underwent PCI and were divided into 2 groups according to the median PP (60 mm Hg). The primary end point (all-cause death or new Q-wave myocardial infarction) and the composite end points: patient-oriented composite end points (POCE), Bleeding Academic Research Consortium (BARC) 3 or 5, and net adverse clinical events (NACE) were evaluated. Results: At 2 years, subjects in the high-PP group (n = 7971) had similar rates of the primary end point (4.3% vs 3.9%; P = 0.058), POCE (14.9% vs 12.7%; P = 0.051), and BARC 3 or 5 (2.5% vs 1.7%; P = 0.355) and higher rates of NACE (16.4% vs 13.7%; P = 0.037) compared with the low-PP group (n = 7965). Among patients with PP < 60 mm Hg, the primary end point (3.4% vs 4.4%, adjusted hazard ratio [aHR] 0.77, 95% confidence interval [CI] 0.61-0.96), POCE (11.8% vs 13.5%, aHR 0.86, 95% CI 0.76-0.98), NACE (12.8% vs 14.7%, aHR 0.85, 95% CI 0.76-0.96), and BARC 3 or 5 (1.4% vs 2.1%, aHR 0.69, 95% CI 0.49-0.97) were lower with ticagrelor monotherapy compared with DAPT. The only significant interaction was for BARC 3 or 5 (P = 0.008). Conclusions: After contemporary PCI, subjects with high PP levels experienced high rates of NACE at 2 years. In those with low PP, ticagrelor monotherapy led to a lower risk of bleeding events compared with standard DAPT.
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- 2020
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3. Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial
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Tomaniak, M. (Mariusz), Chichareon, P. (Ply), Takahashi, K. (Kuniaki), Kogame, N. (Norihiro), Modolo, R. (Rodrigo), Chang, C.C. (Chun Chin), Spitzer, E. (Ernest), Neumann, F.J., Plante, S. (Sylvain), Hernandez-Antolin, R. (Rosana), Jambrik, Z. (Zoltan), Gelev, V. (Valeri), Brunel, P. (Philippe), Konteva, M. (Mariana), Beygui, F. (Farzin), Morelle, J.-F. (Jean-Francois), Filipiak, K.J. (Krzysztof J.), Geuns, R.J.M. (Robert Jan) van, Soliman, O.I.I. (Osama Ibrahim Ibrahim), Tijssen, J.G.P. (Jan), Rademaker-Havinga, T.A.M. (Tessa), Storey, D. (David), Hamm, C. (Christian), Steg, P.G. (Philippe Gabriel), Windecker, S.W. (Stephan), Onuma, Y. (Yoshinobu), Valgimigli, M. (Marco), Serruys, P.W.J.C. (Patrick), Tomaniak, M. (Mariusz), Chichareon, P. (Ply), Takahashi, K. (Kuniaki), Kogame, N. (Norihiro), Modolo, R. (Rodrigo), Chang, C.C. (Chun Chin), Spitzer, E. (Ernest), Neumann, F.J., Plante, S. (Sylvain), Hernandez-Antolin, R. (Rosana), Jambrik, Z. (Zoltan), Gelev, V. (Valeri), Brunel, P. (Philippe), Konteva, M. (Mariana), Beygui, F. (Farzin), Morelle, J.-F. (Jean-Francois), Filipiak, K.J. (Krzysztof J.), Geuns, R.J.M. (Robert Jan) van, Soliman, O.I.I. (Osama Ibrahim Ibrahim), Tijssen, J.G.P. (Jan), Rademaker-Havinga, T.A.M. (Tessa), Storey, D. (David), Hamm, C. (Christian), Steg, P.G. (Philippe Gabriel), Windecker, S.W. (Stephan), Onuma, Y. (Yoshinobu), Valgimigli, M. (Marco), and Serruys, P.W.J.C. (Patrick)
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AIMS: To evaluate long-term safety and efficacy of ticagrelor monotherapy in patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary disease (COPD) at baseline and the occurrence of dyspnoea reported as adverse event (AE) that may lead to treatment non-adherence. METHODS AND RESULTS: This is a non-prespecified, post hoc analysis of the randomized GLOBAL LEADERS trial (n = 15 991), comparing the experimental strategy of 23-month ticagrelor monotherapy following 1-mon
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- 2020
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4. Endothelial shear stress and vascular remodeling in bioresorbable scaffold and metallic stent
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Tenekecioglu, E, Katagiri, Y. (Yuki), Takahashi, K. (Kuniaki), Tomaniak, M., Dudek, D. (Dariusz), Cequier, A. (Angel), Carrié, D., Iñiguez, A., van der Schaaf, R, Dominici, M, Boven, A.J. (Ad) van, Helqvist, S. (Steffen), Sabaté, M., Baumbach, A. (Andreas), Piek, J.J. (Jan), Wykrzykowska, J.J. (Joanna), Kitslaar, P, Dijkstra, J. (Jouke), Reiber, JHC, Chevalier, B. (Bernard), Ural, D., Pekkan, K., Bourantas, CV, Gijsen, F.J.H. (Frank), Onuma, Y. (Yoshinobu), Torii, K. (Kan), Serruys, P.W.J.C. (Patrick), Tenekecioglu, E, Katagiri, Y. (Yuki), Takahashi, K. (Kuniaki), Tomaniak, M., Dudek, D. (Dariusz), Cequier, A. (Angel), Carrié, D., Iñiguez, A., van der Schaaf, R, Dominici, M, Boven, A.J. (Ad) van, Helqvist, S. (Steffen), Sabaté, M., Baumbach, A. (Andreas), Piek, J.J. (Jan), Wykrzykowska, J.J. (Joanna), Kitslaar, P, Dijkstra, J. (Jouke), Reiber, JHC, Chevalier, B. (Bernard), Ural, D., Pekkan, K., Bourantas, CV, Gijsen, F.J.H. (Frank), Onuma, Y. (Yoshinobu), Torii, K. (Kan), and Serruys, P.W.J.C. (Patrick)
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Background and aims: The impact of endothelial shear stress (ESS) on vessel remodeling in vessels implanted with bioresorbable scaffold (BRS) as compared to metallic drug-eluting stent (DES) remains elusive. The aim of this study was to determine whether the relationship between ESS and remodeling patterns differs in BRS from those seen in metallic DES at 3-year follow-up. Methods: In the ABSORB II randomized trial, lesions were investigated by serial coronary angiography and intravascular ultrasound (IVUS). Three-dimensional reconstructions of coronary arteries post-procedure and at 3 years were performed. ESS was quantified using non-Newtonian steady flow simulation. IVUS cross-sections in device segment were matched using identical landmarks. Results: Paired ESS calculations post-procedure and at 3 years were feasible in 57 lesions in 56 patients. Postprocedure, median ESS at frame level was higher in BRS than in DES, with marginal statistical significance (0.97 ± 0.48 vs. 0.75 ± 0.39 Pa, p = 0.063). In the BRS arm, vessel area and lumen area showed larger increases in the highest tercile of median ESS post-procedure as compared to the lowest tercile. In contrast, in DES, no significant relationship between median ESS post-procedure and remodeling was observed. In multivariate analysis, smaller vessel area, larger lumen area, higher plaque burden post-procedure, and higher median ESS post-procedure were independently associated with expansive remodeling in matched frames. Only in BRS, younger age was an additional significant predictor of expansive remodeling. Conclusions: In a subset of lesions with large plaque burden, shear stress could be associated with expansive remodeling and late lumen enlargement in BRS, while ESS had no impact on vessel dimension in metallic DES.
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- 2020
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5. The usefulness of cardiac CT integrated with FFRCT for planning myocardial revascularization in complex coronary artery disease: A lesson from SYNTAX studies
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Andreini, D. (Daniele), Mushtaq, S. (Saima), Conte, E. (Edoardo), Mei, M. (Mariachiara), Nicoli, F. (Flavia), Melotti, E. (Eleonora), Pompilio, G. (Giulio), Pepi, M. (Mauro), Bartorelli, A. (Antonio), Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), Andreini, D. (Daniele), Mushtaq, S. (Saima), Conte, E. (Edoardo), Mei, M. (Mariachiara), Nicoli, F. (Flavia), Melotti, E. (Eleonora), Pompilio, G. (Giulio), Pepi, M. (Mauro), Bartorelli, A. (Antonio), Onuma, Y. (Yoshinobu), and Serruys, P.W.J.C. (Patrick)
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After two decades of clinical use, during which coronary CT angiography (CCTA) was considered an appropriate method for the non-invasive assessment of patients with suspected stable coronary artery disease (CAD) and low-to-intermediate pretest likelihood of CAD, a growing body of literature is showing that CCTA may have also a clinical role in patients with high pretest likelihood of CAD, known CAD and complex and diffuse CAD. Particularly, the SYNTAX studies demonstrated the usefulness of CCTA in the field of non-invasive assessment of these patients and planning of interventional and surgical coronary procedures, thanks to its ability to combine, in a single method, precise stenosis quantification, accurate plaque characterization, functional assessment and selection of the revascularization modality for any individual patient and of the vessels that need to be revascularized. Of note, the SYNTAX III Revolution trial showed, in patients with three-vessel CAD, that treatment decision-making between PCI and CABG based on CCTA only has an almost perfect agreement with the treatment decision derived from invasive coronary angiography (ICA). Moreover, the SYNTAX Score II demonstrated a high degree of correlation between the two diagnostic strategies, suggesting the potential feasibility of a treatment decision-making based solely on non-invasive imaging and clinical information. New research prospects have opened up for the future to demonstrate the true feasibility and safety of this innovative approach in the clinical arena.
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- 2020
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6. Ticagrelor monotherapy in patients with concomitant diabetes mellitus and chronic kidney disease: a post hoc analysis of the GLOBAL LEADERS trial
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Gao, C. (Cheng), Tomaniak, M., Takahashi, K. (Kuniaki), Kawashima, H., Wang, R.T., Hara, H. (Hidetaka), Ono, M, Montalescot, G., Garg, S.A. (Scot), Haude, M. (Michael), Slagboom, T. (Ton), Vranckx, P. (Pascal), Valgimigli, M. (Marco), Windecker, S.W. (Stephan), van Geuns, R.J., Hamm, C.W. (Christian), Steg, P.G. (Philippe Gabriel), Onuma, Y. (Yoshinobu), Angiolillo, D.J. (Dominick), Serruys, P.W.J.C. (Patrick), Gao, C. (Cheng), Tomaniak, M., Takahashi, K. (Kuniaki), Kawashima, H., Wang, R.T., Hara, H. (Hidetaka), Ono, M, Montalescot, G., Garg, S.A. (Scot), Haude, M. (Michael), Slagboom, T. (Ton), Vranckx, P. (Pascal), Valgimigli, M. (Marco), Windecker, S.W. (Stephan), van Geuns, R.J., Hamm, C.W. (Christian), Steg, P.G. (Philippe Gabriel), Onuma, Y. (Yoshinobu), Angiolillo, D.J. (Dominick), and Serruys, P.W.J.C. (Patrick)
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- 2020
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7. Influence of Bleeding Risk on Outcomes of Radial and Femoral Access for Percutaneous Coronary Intervention: An Analysis From the GLOBAL LEADERS Trial
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Gao, C. (Chao), Buszman, P.P. (Piotr), Buszman, P.E. (Pawel), Chichareon, P. (Ply), Modolo, R. (Rodrigo), Garg, S.A. (Scot), Takahashi, K. (Kuniaki), Kawashima, H. (Hideyuki), Wang, R. (Rutao), Chang, C.C. (Chun Chin), Kogame, N. (Norihiro), Tomaniak, M. (Mariusz), Ono, M. (Masafumi), Hara, H. (Hironori), Slagboom, T. (Ton), Aminian, A. (Adel), Naber, C.K. (Christoph), Carrié, D. (Didier), Hamm, C. (Christian), Steg, P.G. (Philippe Gabriel), Onuma, Y. (Yoshinobu), Geuns, R.J.M. (Robert Jan) van, Serruys, P.W.J.C. (Patrick), Zurakowski, A. (Aleksander), Gao, C. (Chao), Buszman, P.P. (Piotr), Buszman, P.E. (Pawel), Chichareon, P. (Ply), Modolo, R. (Rodrigo), Garg, S.A. (Scot), Takahashi, K. (Kuniaki), Kawashima, H. (Hideyuki), Wang, R. (Rutao), Chang, C.C. (Chun Chin), Kogame, N. (Norihiro), Tomaniak, M. (Mariusz), Ono, M. (Masafumi), Hara, H. (Hironori), Slagboom, T. (Ton), Aminian, A. (Adel), Naber, C.K. (Christoph), Carrié, D. (Didier), Hamm, C. (Christian), Steg, P.G. (Philippe Gabriel), Onuma, Y. (Yoshinobu), Geuns, R.J.M. (Robert Jan) van, Serruys, P.W.J.C. (Patrick), and Zurakowski, A. (Aleksander)
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Background: Radial artery access has been shown to reduce mortality and bleeding events, especially in patients with acute coronary syndromes. Despite this, interventional cardiologists experienced in femoral artery access still prefer that route for percutaneous coronary intervention. Little is known regarding the merits of each vascular access in patients stratified by their risk of bleeding. Methods: Patients from the Global Leaders trial were dichotomized into low or high risk of bleeding by the median of the PRECISE-DAPT score. Clinical outcomes were compared at 30 days. Results: In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.42-1.15). Radial access was associated with a significantly lower rate of the secondary safety end point, Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding (HR 0.55, 95% CI 0.36-0.84). Compared by bleeding risk strata, in the high bleeding score population, the primary (HR 0.47, 95% CI 0.26-0.85; P = 0.012; Pinteraction = 0.019) and secondary safety (HR 0.57, 95% CI 0.35-0.95; P = 0.030; Pinteraction = 0.631) end points favoured radial access. In the low bleeding score population, however, the differences in the primary and secondary safety end points between radial and femoral artery access were no longer statistically significant. Conclusions: Our findings suggest that the outcomes of mortality or new Q-wave MI and BARC 3 or 5 bleeding favour radial access in patients with a high, but not those with a low, risk of bleeding. Because this, Contexte : Il a et e d emontr e que l ’accès par l’artère radiale reduit la mortalite et les h emorragies, en particulier chez les patients presentant un syndrome coronarien aigu. Malgr e cela, les cardiologues interventionnels qui ont acquis de l’experience en matière d ’accès par l’artère femorale pr efèrent encore utiliser cette voie lorsqu ’ils doivent pratiquer une intervention coronarienne percutanee. On connaît mal l’interêt de chacune de ces techniques d ’accès vasculaire au regard du risque d’hemorragie. Methodologie : Les patients de l’essai GLOBAL LEADERS ont et e repartis en deux groupes, selon qu ’ils presentaient un risque d’hemorragie faible ou elev e d ’après le score PRECISE-DAPT median, puis les resultats cliniques ont et e compar es à 30 jours. Resultats : Dans l’ensemble de la population, aucune difference sta- tistiquement significative n’a et e observ ee entre l ’accès radial et l’accès femoral quant au critère d ’evaluation principal, compos e de la mortalite toutes causes confondues et d ’un nouvel infarctus du myocarde (IM) avec onde Q (rapport des risques instantanes [RRI] de 0,70; intervalle de confiance [IC] à 95 % : 0,42-1,15). L’accès radial a et e associe à un taux signi ficativement plus faible de survenue du critère secondaire d’evaluation de l ’innocuite, c ’est-à-dire une hemorragie de type 3 ou 5 selon la classification du BARC (Bleeding Academic Research Consortium) (RRI de 0,55; IC à 95 % : 0,36-0,84). Lorsqu’on compare les sujets en fonction du risque d’hemorragie, les critères d’evaluation de l ’innocuite principal (RRI de 0,47; IC à 95 % : 0,26- 0,85; p ¼ 0,012; pinteraction ¼ 0,019) et secondaire (RRI de 0,57; IC à 95 % : 0,35-0,95; p ¼ 0,030; pinteraction ¼ 0,631) sont favorables à l’accès radial au sein de la population presentant un risque d ’hemor- ragie elev e. Dans la population pr esentant un risque d ’hemorragie faible, les differences entre l ’accès radial et l’accès femoral quant aux critères d’evaluation de l ’inn
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- 2020
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8. The impact of plaque type on strut embedment/protrusion and shear stress distribution in bioresorbable scaffold
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Torii, K. (Kan), Tenekecioglu, E. (Erhan), Katagiri, Y. (Yuki), Chichareon, P. (Ply), Sotomi, Y. (Yohei), Dijkstra, J. (Jouke), Asano, T. (Taku), Modolo, R. (Rodrigo), Takahashi, K. (Kuniaki), Jonker, H. (Hans), Geuns, R.J.M. (Robert Jan) van, Onuma, Y. (Yoshinobu), Pekkan, K. (Kerem), Bourantas, C.V. (Christos), Serruys, P.W.J.C. (Patrick), Torii, K. (Kan), Tenekecioglu, E. (Erhan), Katagiri, Y. (Yuki), Chichareon, P. (Ply), Sotomi, Y. (Yohei), Dijkstra, J. (Jouke), Asano, T. (Taku), Modolo, R. (Rodrigo), Takahashi, K. (Kuniaki), Jonker, H. (Hans), Geuns, R.J.M. (Robert Jan) van, Onuma, Y. (Yoshinobu), Pekkan, K. (Kerem), Bourantas, C.V. (Christos), and Serruys, P.W.J.C. (Patrick)
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AIMS: Scaffold design and plaque characteristics influence implantation outcomes and local flow dynamics in treated coronary segments. Our aim is to assess the impact of strut embedment/protrusion of bioresorbable scaffold on local shear stress distribution in different atherosclerotic plaque types. METHODS AND RESULTS: Fifteen Absorb everolimus-eluting Bioresorbable Vascular Scaffolds were implanted in human epicardial coronary arteries. Optical coherence tomography (OCT) was performed post-scaffold implantation and strut embedment/protrusion were analysed using a dedicated software. OCT data were fused with angiography to reconstruct 3D coronary anatomy. Blood flow simulation was performed and wall shear stress (WSS) was estimated in each scaffolded surface and the relationship between strut embedment/protrusion and WSS was evaluated. There were 9083 struts analysed. Ninety-seven percent of the struts (n = 8840) were well-apposed and 243 (3%) were malapposed. At cross-section level (n = 1289), strut embedment was significantly increased in fibroatheromatous plaques (76 ± 48 µm) and decreased in fibrocalcific plaques (35 ± 52 µm). Compatible with strut embedment, WSS was significantly higher in lipid-rich fibroatheromatous plaques (1.50 ± 0.81 Pa), whereas significantly decreased in fibrocalcified plaques (1.05 ± 0.91 Pa). After categorization of WSS as low (<1.0 Pa) and normal/high WSS (≥1.0 Pa), the percent of low WSS in the plaque subgroups were 30.1%, 31.1%, 25.4%, and 36.2% for non-diseased vessel wall, fibrous plaque, fibroatheromatous plaque, and fibrocalcific plaque, respectively (P-overall < 0.001). CONCLUSION: The composition of the underlying plaque influences strut embedment which seems to have effect on WSS. The struts deeply embedded in lipid-rich fibroatheromas plaques resulted in higher WSS compared with the other plaque types.
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- 2020
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9. Impact of non-respect of SYNTAX score II recommendation for surgery in patients with left main coronary artery disease treated by percutaneous coronary intervention: an EXCEL substudy
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Modolo, R. (Rodrigo), Chichareon, P. (Ply), Klaveren, D. (David) van, Dressler, O. (Ovidiu), Zhang, Y. (Yiran), Sabik, J.F. (Joseph), Onuma, Y. (Yoshinobu), Kappetein, A.P. (Arie Pieter), Stone, G.W. (Gregg), Serruys, P.W.J.C. (Patrick), Modolo, R. (Rodrigo), Chichareon, P. (Ply), Klaveren, D. (David) van, Dressler, O. (Ovidiu), Zhang, Y. (Yiran), Sabik, J.F. (Joseph), Onuma, Y. (Yoshinobu), Kappetein, A.P. (Arie Pieter), Stone, G.W. (Gregg), and Serruys, P.W.J.C. (Patrick)
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OBJECTIVES: The SYNTAX score II (SSII) was developed from the SYNTAX trial to predict the 4-year all-cause mortality after left main or multivessel disease revascularization and to facilitate the decision-making process. The SSII provides the following treatment recommendations: (i) coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) (equipoise risk), (ii) CABG preferred (excessive risk for PCI) or (iii) PCI preferred (excessive risk for CABG). We sought to externally validate SSII and to investigate the impact of not abiding by the SSII recommendations in the randomized EXCEL trial of PCI versus CABG for left main disease. METHODS: The calibration plot of predicted versus observed 4-year mortality was constructed from individual values of SSII in EXCEL. To assess overestimation versus underestimation of predicted mortality risk, an optimal fit regression line with slope and intercept was determined. Prospective treatment recommendations based on SSII were compared with actual treatments and all-cause mortality at 4 years. RESULTS: SSII variables were available from EXCEL trial in 1807/1905 (95%) patients. For the entire cohort, discrimination was possibly helpful (C statistic = 0.670). SSII-predicted all-cause mortality at 4 years overestimated the observed mortality, particularly in the highest-risk percentiles, as confirmed by the fit regression line [intercept 2.37 (1.51-3.24), P = 0.003; slope 0.67 (0.61-0.74), P < 0.001]. When the SSII-recommended treatment was CABG, randomized EXCEL patients treated with PCI had a trend towards higher mortality compared with those treated with CABG (14.1% vs 5.3%, P = 0.07) in the as-treat population. In the intention-to-treat population, patients randomized to PCI had higher mortality compared with those randomized to CABG (15.1% vs 4.1%, P = 0.02), when SSII recommended CABG. CONCLUSIONS: In the EXCEL trial of patients with left main disease, the SSII-predicted 4-year mortality overestimated t
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- 2020
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10. Vulnerable plaques and patients: state-of-the-art
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Tomaniak, M. (Mariusz), Katagiri, Y. (Yuki), Modolo, R. (Rodrigo), de Silva, R. (Ranil), Khamis, R.Y. (Ramzi Y.), Bourantas, C.V. (Christos), Torii, K. (Kan), Wentzel, J.J. (Jolanda), Gijsen, F.J.H. (Frank), Soest, G. (Gijs) van, Stone, P.H. (Peter), West, N.E.J. (Nick E J), Maehara, A. (Akiko), Lerman, A. (Amir), Steen, A.F.W. (Ton) van der, Lüscher, T.F., Virmani, R. (Renu), Koenig, W. (Wolfgang), Stone, G.W. (Gregg), Muller, J.E. (James), Wijns, W. (William), Serruys, P.W.J.C. (Patrick), Onuma, Y. (Yoshinobu), Tomaniak, M. (Mariusz), Katagiri, Y. (Yuki), Modolo, R. (Rodrigo), de Silva, R. (Ranil), Khamis, R.Y. (Ramzi Y.), Bourantas, C.V. (Christos), Torii, K. (Kan), Wentzel, J.J. (Jolanda), Gijsen, F.J.H. (Frank), Soest, G. (Gijs) van, Stone, P.H. (Peter), West, N.E.J. (Nick E J), Maehara, A. (Akiko), Lerman, A. (Amir), Steen, A.F.W. (Ton) van der, Lüscher, T.F., Virmani, R. (Renu), Koenig, W. (Wolfgang), Stone, G.W. (Gregg), Muller, J.E. (James), Wijns, W. (William), Serruys, P.W.J.C. (Patrick), and Onuma, Y. (Yoshinobu)
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Despite advanced understanding of the biology of atherosclerosis, coronary heart disease remains the leading cause of death worldwide. Progress has been challenging as half of the individuals who suffer sudden cardiac death do not experience premonitory symptoms. Furthermore, it is well-recognized that also a plaque that does not cause a haemodynamically significant stenosis can trigger a sudden cardiac event, yet the majority of ruptured or eroded plaques remain clinically silent. In the past 30 years since the term 'vulnerable plaque' was introduced, there have been major advances in the understanding of plaque pathogenesis and pathophysiology, shifting from pursuing features of 'vulnerability' of a specific lesion to the more comprehensive goal of identifying patient 'cardiovascular vulnerability'. It has been also recognized that aside a thin-capped, lipid-rich plaque associated with plaque rupture, acute coronary syndromes (ACS) are also caused by plaque erosion underlying between 25% and 60% of ACS nowadays, by calcified nodule or by functional coronary alterations. While there have been advances in preventive strategies and in pharmacotherapy, with improved agents to reduce cholesterol, thrombosis, and inflammation, events continue to occur in patients receiving optimal medical treatment. Although at present the positive predictive value of imaging precursors of the culprit plaques remains too low for clinical relevance, improving coronary plaque imaging may be instrumental in guiding pharmacotherapy intensity and could facilitate optimal allocation of novel, more aggressive, and costly treatment strategies. Recent technical and diagnostic advances justify continuation of interdisciplinary research efforts to improve cardiovascular prognosis by both systemic and 'local' diagnostics and therapies. The present state-of-the-art document aims to present and critically appraise the latest evidence, developments, and future perspectives in detection, prevention, an
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- 2020
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11. Uncertainties and challenges in surgical and transcatheter tricuspid valve therapy: a state-of-the-art expert review
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Chang, C.C., Veen, K.M., Hahn, R.T. (Rebecca), Bogers, A.J.J.C. (Ad), Latib, A. (Azeem), Oei, F.B.S. (Frans), Abdelghani, M, Modolo, R. (Rodrigo), Ho, S.Y.W. (Simon), Abdel-Wahab, M. (Mohamed), Fattouch, K., Bosmans, J. (Johan), Caliskan, K.C. (Kadir), Taramasso, M., Serruys, P.W.J.C. (Patrick), Bax, JJJ, Mieghem, N.M. (Nicolas) van, Takkenberg, J.J.M., Lurz, P., Modine, T, Soliman, O.I.I. (Osama Ibrahim Ibrahim), Chang, C.C., Veen, K.M., Hahn, R.T. (Rebecca), Bogers, A.J.J.C. (Ad), Latib, A. (Azeem), Oei, F.B.S. (Frans), Abdelghani, M, Modolo, R. (Rodrigo), Ho, S.Y.W. (Simon), Abdel-Wahab, M. (Mohamed), Fattouch, K., Bosmans, J. (Johan), Caliskan, K.C. (Kadir), Taramasso, M., Serruys, P.W.J.C. (Patrick), Bax, JJJ, Mieghem, N.M. (Nicolas) van, Takkenberg, J.J.M., Lurz, P., Modine, T, and Soliman, O.I.I. (Osama Ibrahim Ibrahim)
- Abstract
Tricuspid regurgitation (TR) is a frequent and complex problem, commonly combined with left-sided heart disease, such as mitral regurgitation. Significant TR is associated with increased mortality if left untreated or recurrent after therapy. Tricuspid regurgitation was historically often disregarded and remained undertreated. Surgery is currently the only Class I Guideline recommended therapy for TR, in the form of annuloplasty, leaflet repair, or valve replacement. As growing experience of transcatheter therapy in structural heart disease, many dedicated transcatheter tricuspid repair or replacement devices, which mimic well-established surgical techniques, are currently under development. Nevertheless, many aspects of TR are little understood, including the disease process, surgical or interventional risk stratification, and predictors of successful therapy. The optimal treatment timing and the choice of proper surgical or interventional technique for significant TR remain to be elucidated. In this context, we aim to highlight the current evidence, underline major controversial issues in this field and present a future roadmap for TR therapy.
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- 2020
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12. Predictive value of the QFR in detecting vulnerable plaques in non-flow limiting lesions: a combined analysis of the PROSPECT and IBIS-4 study
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Safi, H. (Hannah), Bourantas, C.V. (Christos), Ramasamy, A. (Anantharaman), Zanchin, T. (Thomas), Bär, S. (Sarah), Tufaro, V. (Vincenzo), Jin, C. (Chongying), Torii, K. (Kan), Karagiannis, A. (Alexios), Reiber, J.H.C. (Johan), Mathur, A. (Anthony), Onuma, Y. (Yoshinubo), Windecker, S.W. (Stephan), Lansky, A.J. (Alexandra), Maehara, A. (Akiko), Serruys, P.W.J.C. (Patrick), Stone, P.H. (Peter), Baumbach, A. (Andreas), Stone, G.W. (Gregg), Räber, L. (Lorenz), Safi, H. (Hannah), Bourantas, C.V. (Christos), Ramasamy, A. (Anantharaman), Zanchin, T. (Thomas), Bär, S. (Sarah), Tufaro, V. (Vincenzo), Jin, C. (Chongying), Torii, K. (Kan), Karagiannis, A. (Alexios), Reiber, J.H.C. (Johan), Mathur, A. (Anthony), Onuma, Y. (Yoshinubo), Windecker, S.W. (Stephan), Lansky, A.J. (Alexandra), Maehara, A. (Akiko), Serruys, P.W.J.C. (Patrick), Stone, P.H. (Peter), Baumbach, A. (Andreas), Stone, G.W. (Gregg), and Räber, L. (Lorenz)
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Studies have shown that the quantitative flow ratio (QFR), recently introduced to assess lesion severity from coronary angiography, provides useful prognostic information; however the additive value of this technique over intravascular imaging in detecting lesions that are likely to cause events is yet unclear. We analysed data acquired in the PROSPECT
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- 2020
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13. The influence of implantation techniques on lesion oriented-outcomes in Absorb BVS and Xience EES lesions treated in routine clinical practice at complete three year follow-up: AIDA trial QCA substudy
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Tijssen, R.Y.G. (Ruben Y. G.), Kerkmeijer, L.S.M. (Laura S. M.), Takahashi, K. (Kuniaki), Kogame, N. (Norihiro), Katagiri, Y. (Yuki), Kraak, P.H. van der, Chichareon, P. (Ply), Modolo, R. (Rodrigo), Asano, T. (Taku), Nassif, M. (Martina), Kalkman, D.N. (Deborah N.), Sotomi, Y. (Yohei), Collet, C. (Carlos), Hofma, S.H. (Sjoerd), Schaaf, R.J. van der, Arkenbout, E.K. (Elisabeth Karin), Weevers, A.P.J.D. (Auke P. J. D.), Piek, J.J. (Jan J.), Tijssen, J.G.P. (Jan), Henriques, J.P. (Jose P.), Winter, R.J. (Robbert) de, Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), Wykrzykowska, J.J. (Joanna), Tijssen, R.Y.G. (Ruben Y. G.), Kerkmeijer, L.S.M. (Laura S. M.), Takahashi, K. (Kuniaki), Kogame, N. (Norihiro), Katagiri, Y. (Yuki), Kraak, P.H. van der, Chichareon, P. (Ply), Modolo, R. (Rodrigo), Asano, T. (Taku), Nassif, M. (Martina), Kalkman, D.N. (Deborah N.), Sotomi, Y. (Yohei), Collet, C. (Carlos), Hofma, S.H. (Sjoerd), Schaaf, R.J. van der, Arkenbout, E.K. (Elisabeth Karin), Weevers, A.P.J.D. (Auke P. J. D.), Piek, J.J. (Jan J.), Tijssen, J.G.P. (Jan), Henriques, J.P. (Jose P.), Winter, R.J. (Robbert) de, Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), and Wykrzykowska, J.J. (Joanna)
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It has been hypothesized that dedicated optimized Absorb BVS implantation techniques might mitigate the risk of adverse events such as target vessel f
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- 2020
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14. Usefulness of the updated logistic clinical SYNTAX score after percutaneous coronary intervention in patients with prior coronary artery bypass graft surgery: Insights from the GLOBAL LEADERS trial
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Hara, H. (Hironori), Kogame, N. (Norihiro), Takahashi, K. (Kuniaki), Modolo, R. (Rodrigo), Chichareon, P. (Ply), Tomaniak, M. (Mariusz), Ono, M. (Masafumi), Kawashima, H. (Hideyuki), Gao, C. (Chao), Wang, R. (Rutao), Valkov, V.D. (Veselin D.), vom Dahl, J. (Jürgen), Steinwender, C. (Clemens), Geisler, T. (Tobias), Lemos Neto, P.A. (Pedro Alves), Macaya Miguel, C. (Carlos), Garg, S.A. (Scot), Jüni, P. (Peter), Hamm, C. (Christian), Steg, P.G. (Philippe Gabriel), Valgimigli, M. (Marco), Vranckx, P. (Pascal), Windecker, S.W. (Stephan), Farooq, V. (Vasim), Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), Hara, H. (Hironori), Kogame, N. (Norihiro), Takahashi, K. (Kuniaki), Modolo, R. (Rodrigo), Chichareon, P. (Ply), Tomaniak, M. (Mariusz), Ono, M. (Masafumi), Kawashima, H. (Hideyuki), Gao, C. (Chao), Wang, R. (Rutao), Valkov, V.D. (Veselin D.), vom Dahl, J. (Jürgen), Steinwender, C. (Clemens), Geisler, T. (Tobias), Lemos Neto, P.A. (Pedro Alves), Macaya Miguel, C. (Carlos), Garg, S.A. (Scot), Jüni, P. (Peter), Hamm, C. (Christian), Steg, P.G. (Philippe Gabriel), Valgimigli, M. (Marco), Vranckx, P. (Pascal), Windecker, S.W. (Stephan), Farooq, V. (Vasim), Onuma, Y. (Yoshinobu), and Serruys, P.W.J.C. (Patrick)
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Objectives: We aimed to investigate the prognostic utility of the anatomical CABG SYNTAX and logistic clinical SYNTAX scores for mortality after percutaneous coronary intervention (PCI) in patients with prior coronary artery bypass grafts (CABG). Background: The anatomical SYNTAX score evaluated the anatomical complexity of coronary artery disease and helped predict the prognosis of patients undergoing PCI. The anatomical CABG SYNTAX score was derived from the anatomical SYNTAX score in patients with prior CABG, whilst the logistic clinical SYNTAX score was developed by incorporating clinical factors into the anatomical SYNTAX score. Methods: We calculated the anatomical CABG SYNTAX score and logistic clinical SYNTAX score in 205 patients in the GLOBAL LEADERS trial. The predictive abilities of these scores for 2-year all-cause mortality were evaluated. Results: Using the median scores as categorical thresholds between low and high score groups, the logistic clinical SYNTAX score was able to discriminate the risk of 2-year mortality, unlike the anatomical CABG SYNTAX score. The logistic clinical SYNTAX was significantly better at predicting 2-year mortality, compared to the anatomical CABG SYNTAX score, as evidenced by AUC values in receiver-operating characteristic curve analysis (0.806 vs. 0.582, p <.001) and integrated discrimination improvement (0.121, p <.001). Conclusions: The logistic clinical SYNTAX score was superior to the anatomical CABG SYNTAX score in predicting 2-year mortality.
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- 2020
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15. Impact of renal function on clinical outcomes after PCI in ACS and stable CAD patients treated with ticagrelor: a prespecified analysis of the GLOBAL LEADERS randomized clinical trial
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Tomaniak, M. (Mariusz), Chichareon, P. (Ply), Klimczak-Tomaniak, D. (Dominika), Takahashi, K. (Kuniaki), Kogame, N. (Norihiro), Modolo, R. (Rodrigo), Wang, R. (Rutao), Ono, M. (Masafumi), Hara, H. (Hironori), Gao, C. (Chao), Kawashima, H. (Hideyuki), Rademaker-Havinga, T.A.M. (Tessa), Garg, S. (Scot), Curzen, N. (Nick), Haude, M. (Michael), Kochman, W. (Waclav), Gori, T. (Tommaso), Montalescot, G. (Gilles), Angiolillo, D.J. (Dominick J.), Capodanno, D. (Davide), Storey, D. (David), Hamm, C. (Christian), Vranckx, P. (Pascal), Valgimigli, M. (Marco), Windecker, S.W. (Stephan), Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), Anderson, R. (Richard), Tomaniak, M. (Mariusz), Chichareon, P. (Ply), Klimczak-Tomaniak, D. (Dominika), Takahashi, K. (Kuniaki), Kogame, N. (Norihiro), Modolo, R. (Rodrigo), Wang, R. (Rutao), Ono, M. (Masafumi), Hara, H. (Hironori), Gao, C. (Chao), Kawashima, H. (Hideyuki), Rademaker-Havinga, T.A.M. (Tessa), Garg, S. (Scot), Curzen, N. (Nick), Haude, M. (Michael), Kochman, W. (Waclav), Gori, T. (Tommaso), Montalescot, G. (Gilles), Angiolillo, D.J. (Dominick J.), Capodanno, D. (Davide), Storey, D. (David), Hamm, C. (Christian), Vranckx, P. (Pascal), Valgimigli, M. (Marco), Windecker, S.W. (Stephan), Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), and Anderson, R. (Richard)
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Background: Impaired renal function (IRF) is associated with increased risks of both ischemic and bleeding events. Ticagrelor has been shown to provide greater absolute reduction in ischemic risk following acute coronary syndrome (ACS) in those with versus without IRF. Methods: A pre-specified sub-analysis of the randomized GLOBAL LEADERS trial (n = 15,991) comparing the experimental strategy of 23-month ticagrelor monotherapy (after 1-month ticagrelor and aspirin dual anti-platelet therapy [DAPT]) with 12-month DAPT followed by 12-month aspirin after percutaneous coronary intervention (PCI) in ACS and stable coronary artery disease (CAD) patients stratified according to IRF (glomerular filtration rate < 60 ml/min/1.73 m2). Results: At 2 years, patients with IRF (n = 2171) had a higher rate of the primary endpoint (all-cause mortality or centrally adjudicated, new Q-wave myocardial infarction [MI](hazard ratio [HR] 1.64, 95% confidence interval [CI] 1.35–1.98, padj = 0.001), all-cause death, site-reported MI, all revascularization and BARC 3 or 5 type bleeding, compared with patients without IRF. Among patients with IRF, there were similar rates of the primary endpoint (HR 0.82, 95% CI 0.61–1.11, p = 0.192, pint = 0.680) and BARC 3 or 5 type bleeding (HR 1.10, 95% CI 0.71–1.71, p = 0.656, pint = 0.506) in the experimental versus the reference group. No significant interactions were seen between IRF and treatment effect for any of the secondary outcome variables. Among ACS patients with IRF, there were no between-group differences in the rates of the primary endpoint or BARC 3 or 5 type bleeding; however, the rates of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, MI, or revascularization (pint = 0.028) and net adverse clinical events (POCE and BARC 3 or 5 type bleeding) (pint = 0.045), were lower in the experimental versus the reference group. No treatment effects were found in stable CAD patients categorized according to presence of
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- 2020
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16. Advances in IVUS/OCT and Future Clinical Perspective of Novel Hybrid Catheter System in Coronary Imaging
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Ono, M, Kawashima, H., Hara, H. (Hidetaka), Gao, C. (Cheng), Wang, R.T., Kogame, N. (Norihiro), Takahashi, K. (Kuniaki), Chichareon, P. (Ply), Modolo, R. (Rodrigo), Tomaniak, M., Wykrzykowska, J.J. (Joanna), Piek, J.J. (Jan), Mori, I., Courtney, B.K., Wijns, W, Sharif, F., Bourantas, C., Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), Ono, M, Kawashima, H., Hara, H. (Hidetaka), Gao, C. (Cheng), Wang, R.T., Kogame, N. (Norihiro), Takahashi, K. (Kuniaki), Chichareon, P. (Ply), Modolo, R. (Rodrigo), Tomaniak, M., Wykrzykowska, J.J. (Joanna), Piek, J.J. (Jan), Mori, I., Courtney, B.K., Wijns, W, Sharif, F., Bourantas, C., Onuma, Y. (Yoshinobu), and Serruys, P.W.J.C. (Patrick)
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Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) have been developed and improved as both diagnostic and guidance tools for interventional procedures over the past three decades. IVUS has a resolution of 100µm with a high tissue penetration and capability of assessing the entire structure of a coronary artery including the external elastic membrane, whereas OCT has a higher resolution of 10–20µm to assess endoluminal structures with a limited tissue penetration compared to IVUS. Recently, two companies, CONAVI and TERUMO, integrated IVUS and OCT into a single catheter system. With their inherent strength and limitations, the combined IVUS and OCT probes are complementary and work synergistically to enable a comprehensive depiction of coronary artery. In this review, we summarize the performance of the two intracoronary imaging modaliti
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- 2020
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17. The Evolution of Data Fusion Methodologies Developed to Reconstruct Coronary Artery Geometry From Intravascular Imaging and Coronary Angiography Data: A Comprehensive Review
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Kilic, Y., Safi, H., Bajaj, R., Serruys, P.W.J.C. (Patrick), Kitslaar, P, Ramasamy, A. (Adaikalavan), Tufaro, V., Onuma, Y. (Yoshinobu), Mathur, A. (Anthony), Torii, K. (Kan), Baumbach, A. (Andreas), Bourantas, CV, Kilic, Y., Safi, H., Bajaj, R., Serruys, P.W.J.C. (Patrick), Kitslaar, P, Ramasamy, A. (Adaikalavan), Tufaro, V., Onuma, Y. (Yoshinobu), Mathur, A. (Anthony), Torii, K. (Kan), Baumbach, A. (Andreas), and Bourantas, CV
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Understanding the mechanisms that regulate atherosclerotic plaque formation and evolution is a crucial step for developing treatment strategies that will prevent plaque progression and reduce cardiovascular events. Advances in signal processing and the miniaturization of medical devices have enabled the design of multimodality intravascular imaging catheters that allow complete and detailed assessment of plaque morphology and biology. However, a significant limitation of these novel imaging catheters is that they provide two-dimensional (2D) visualization of the lumen and vessel wall and thus they cannot portray vessel geometry and 3D lesion architecture. To address this limitation computer-based methodologies and user-friendly software have been developed. These are able to off-line process and fuse intravascular imaging data with X-ray or computed tomography coronary angiography (CTCA) to reconstruct coronary artery anatomy. The aim of this review article is to summarize the evolution in the field of coronary artery modeling; we thus present the first methodologies that were developed to model vessel geometry, highlight the modifications introduced in revised methods to overcome the limitations of the first approaches and discuss the challenges that need to be addressed, so these techniques can have broad application in clinical practice and research.
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- 2020
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18. Defining device success for percutaneous coronary intervention trials
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Chang, C.C. (Chun Chin), Kogame, N. (Norihiro), Onuma, Y. (Yoshinobu), Byrne, R.A. (Robert), Capodanno, D. (Davide), Windecker, S.W. (Stephan), Morel, M.-A. (Marie-Angèle), Cutlip, D.E. (Donald), Krucoff, M. (Mitchell), Stone, G.W. (Gregg), Lansky, A.J. (Alexandra), Mehran, R. (Roxana), Spitzer, E. (Ernest), Fraser, A.G. (Andrew), Baumbach, A. (Andreas), Serruys, P.W.J.C. (Patrick), Chang, C.C. (Chun Chin), Kogame, N. (Norihiro), Onuma, Y. (Yoshinobu), Byrne, R.A. (Robert), Capodanno, D. (Davide), Windecker, S.W. (Stephan), Morel, M.-A. (Marie-Angèle), Cutlip, D.E. (Donald), Krucoff, M. (Mitchell), Stone, G.W. (Gregg), Lansky, A.J. (Alexandra), Mehran, R. (Roxana), Spitzer, E. (Ernest), Fraser, A.G. (Andrew), Baumbach, A. (Andreas), and Serruys, P.W.J.C. (Patrick)
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Percutaneous coronary intervention with implantation of drug-eluting stents has become the most commonly performed revascularisation procedure in patients with symptomatic coronary artery disease. Continuous iterations of coronary devices incorporating changes in platform materials, geometry, strut thickness, drug release mechanisms and antiproliferative drugs have progressively reduced the rate of device-related adverse clinical events. Objective performance criteria have been proposed for clinical and angiographic outcomes of drug-eluting stents. The rate of device success has been recognised as an intraprocedural endpoint to evaluate the mechanical ability to complete a procedure with the specific device assigned by protocol in randomised comparative trials. The European Commission and the U.S. Food and Drug Administration both provide guidance documents, including the mechanistic evaluation of coronary stents, which recommend operational definitions of device success. While the majority of clinical trials investigating drugeluting stents have adopted this endpoint definition, inconsistencies in application limit the reliability of comparisons across different trials reporting device success rates. In addition, it is not uncommon that device success rates are not reported by investigators. A consistent definition of device success is essential to allow scientific comparisons of this technical performance endpoint between devices across different trials. Therefore, we performed a systematic evaluation of definitions and reporting of device success in clinical trials. We propose an extended definition as well as considerations for approaching the determination of the device success rates in future percutaneous coronary intervention trials.
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- 2020
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19. Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent: Multimodality Imaging Through 3 Years
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Onuma, Y. (Yoshinobu), Honda, Y. (Yasuhiro), Asano, T. (Taku), Shiomi, H. (Hiroki), Kozuma, K. (Ken), Ozaki, Y. (Yukio), Namiki, A. (Atsuo), Yasuda, S. (Satoshi), Ueno, T. (Takafumi), Ando, K. (Kenji), Furuya, J. (Jungo), Hanaoka, K.I. (Keiichi Igarashi), Tanabe, K. (Kengo), Okada, K. (Kozo), Kitahara, H. (Hideki), Ono, M. (Masafumi), Kusano, H. (Hajime), Rapoza, R. (Richard), Simonton, C. (Charles), Popma, J.J. (Jeffrey J.), Stone, G.W. (Gregg), Fitzgerald, P.J. (Peter J.), Serruys, P.W.J.C. (Patrick), Kimura, T. (Takeshi), Onuma, Y. (Yoshinobu), Honda, Y. (Yasuhiro), Asano, T. (Taku), Shiomi, H. (Hiroki), Kozuma, K. (Ken), Ozaki, Y. (Yukio), Namiki, A. (Atsuo), Yasuda, S. (Satoshi), Ueno, T. (Takafumi), Ando, K. (Kenji), Furuya, J. (Jungo), Hanaoka, K.I. (Keiichi Igarashi), Tanabe, K. (Kengo), Okada, K. (Kozo), Kitahara, H. (Hideki), Ono, M. (Masafumi), Kusano, H. (Hajime), Rapoza, R. (Richard), Simonton, C. (Charles), Popma, J.J. (Jeffrey J.), Stone, G.W. (Gregg), Fitzgerald, P.J. (Peter J.), Serruys, P.W.J.C. (Patrick), and Kimura, T. (Takeshi)
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Objectives: The aim of this study was to investigate the vascular responses and fates of the scaffold after bioresorbable vascular scaffold (BVS) implantation using multimodality imaging. Background: Serial comprehens
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- 2020
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20. The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial
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Ono, M. (Masafumi), Chichareon, P. (Ply), Tomaniak, M. (Mariusz), Kawashima, H. (Hideyuki), Takahashi, K. (Kuniaki), Kogame, N. (Norihiro), Modolo, R. (Rodrigo), Hara, H. (Hironori), Gao, C. (Chao), Wang, R. (Rutao), Walsh, S. (Simon), Suryapranata, H. (Harry), da Silva, P.C. (Pedro Canas), Cotton, J.M., Koning, R. (René), Akin, I. (Ibrahim), Rensing, B.J.W.M. (Benno), Garg, S.A. (Scot), Wykrzykowska, J.J. (Joanna), Piek, J.J. (Jan), Jüni, P. (Peter), Hamm, C. (Christian), Steg, P.G. (Philippe Gabriel), Valgimigli, M. (Marco), Windecker, S.W. (Stephan), Storey, D. (David), Onuma, Y. (Yoshinobu), Vranckx, P. (Pascal), Serruys, P.W.J.C. (Patrick), Ono, M. (Masafumi), Chichareon, P. (Ply), Tomaniak, M. (Mariusz), Kawashima, H. (Hideyuki), Takahashi, K. (Kuniaki), Kogame, N. (Norihiro), Modolo, R. (Rodrigo), Hara, H. (Hironori), Gao, C. (Chao), Wang, R. (Rutao), Walsh, S. (Simon), Suryapranata, H. (Harry), da Silva, P.C. (Pedro Canas), Cotton, J.M., Koning, R. (René), Akin, I. (Ibrahim), Rensing, B.J.W.M. (Benno), Garg, S.A. (Scot), Wykrzykowska, J.J. (Joanna), Piek, J.J. (Jan), Jüni, P. (Peter), Hamm, C. (Christian), Steg, P.G. (Philippe Gabriel), Valgimigli, M. (Marco), Windecker, S.W. (Stephan), Storey, D. (David), Onuma, Y. (Yoshinobu), Vranckx, P. (Pascal), and Serruys, P.W.J.C. (Patrick)
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Background: The efficacy of antiplatelet therapies following percutaneous coronary intervention (PCI) may be affected by body mass index (BMI). Methods and results: This is a prespecified subgroup analysis of the GLOBAL LEADERS trial, a prospective, multicenter, open-label, randomized controlled trial in an all-comer population undergoing PCI, comparing the experimental strategy (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with a reference regimen (12-month aspirin monotherapy following 12-month DAPT). A total of 15,968 patients were stratified by baseline BMI with prespecified threshold of 27 kg/m2. Of those, 6973 (43.7%) patients with a BMI < 27 kg/m2 had a higher risk of all-cause mortality at 2 years than those with BMI ≥ 27 kg/m2 (adjusted HR 1.24, 95% CI 1.02–1.49). At 2 years, the rates of the primary endpoint (all-cause mortality or new Q-wave myocardial infarction) were similar between treatment strategies in either BMI group (pinteraction = 0.51). In acute coronary syndrome, however, the experimental strategy was associated with significant reduction of the primary endpoint compared to the reference strategy in patients with BMI < 27 kg/m2 (HR 0.69, 95% CI 0.51–0.94), but not in the ones with BMI ≥ 27 kg/m2 (pinteraction = 0.047). In chronic coronary syndrome, there was no between-group difference in the efficacy and safety of the two antiplatelet strategies. This is a prespecified subgroup analysis of the GLOBAL LEADERS trial, a prospective, multicenter, open-label, randomized controlled trial in an all-comer population undergoing PCI, comparing the experimental strategy (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with a reference regimen (12-month aspirin monotherapy following 12-month DAPT). A total of 15,968 patients were stratified by baseline BMI with prespecified threshold of 27 kg/m2. Of those, 6973 (43.7%) patients with a BMI < 27 kg/m2 had a higher risk of all-cause
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- 2020
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21. Impact of left ventricular ejection fraction on clinical outcomes after left main coronary artery revascularization
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Thuijs, D.J.F.M. (Daan), Milojevic, M. (Milan), Stone, G.W. (Gregg), Puskas, J.D. (John), Serruys, P.W.J.C. (Patrick), Sabik, J.F. (Joseph), Dressler, O. (Ovidiu), Crowley, A. (Aaron), Head, S.J. (Stuart), Kappetein, A.P. (Arie Pieter), Thuijs, D.J.F.M. (Daan), Milojevic, M. (Milan), Stone, G.W. (Gregg), Puskas, J.D. (John), Serruys, P.W.J.C. (Patrick), Sabik, J.F. (Joseph), Dressler, O. (Ovidiu), Crowley, A. (Aaron), Head, S.J. (Stuart), and Kappetein, A.P. (Arie Pieter)
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Aim: To evaluate the impact of left ventricular ejection fraction (LVEF) on 3-year outcomes in patients with left main coronary artery disease (LMCAD) undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in the EXCEL trial. Methods and results: The EXCEL trial randomized patients with LMCAD to PCI with everolimus-eluting stents (n = 948) or CABG (n = 957). Among 1804 patients with known baseline LVEF, 74 (4.1%) had LVEF <40% [heart failure with reduced ejection fraction (HFrEF)], 152 (8.4%) LVEF 40–49% [heart failure with mid-range ejection fraction (HFmrEF)] and 1578 (87.5%) LVEF ≥50% (heart failure with preserved ejection fraction). Patients with HFrEF vs. HFmrEF vs. preserved LVEF experienced a longer postoperative hospital stay (9.0 vs. 7.0 vs. 6.0 days, P = 0.02) with greater peri-procedural complications after CABG, while hospital stay after PCI was unaffected by LVEF (1.5 vs. 2.0 vs. 1.0 days, P = 0.20). The composite primary endpoint of death, stroke, or myocardial infarction at 3 years was 29.3% (PCI) vs. 27.6% (CABG) in patients with HFrEF, 16.2% vs. 15.0% in patients with HFmrEF, and 14.5% vs. 14.6% in those with preserved LVEF, respectively (Pinteraction = 0.90). Smoothing spline analysis demonstrated that the 3-year risk of all-cause death increased when LVEF decreased, both in patients undergoing CABG and PCI. Conclusion: In the EXCEL trial, the composite rate of death, stroke or myocardial infarction at 3 years was significantly higher in patients with HFrEF compared with HFmrEF or preserved LVEF, driven by an increased rate of all-cause death. No significant differences after PCI vs. CABG were observed among patients with HFrEF, HFmrEF and preserved LVEF. Longer-term follow-up could provide important insights on differences in clinical outcomes that might emerge over time. Clinical Trial Registration: ClinicalTrials.gov ID NCT01205776.
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- 2020
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22. Clinical relevance of ticagrelor monotherapy following 1-month dual antiplatelet therapy after bifurcation percutaneous coronary intervention: Insight from GLOBAL LEADERS trial
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Kogame, N. (Norihiro), Chichareon, P. (Ply), De Wilder, K. (Kenneth), Takahashi, K. (Kuniaki), Modolo, R. (Rodrigo), Chang, C.C. (Chun Chin), Tomaniak, M. (Mariusz), Komiyama, H. (Hidenori), Chieffo, A. (Alaide), Colombo, A. (Antonio), Garg, S.A. (Scot), Louvard, Y. (Yves), Jüni, P. (Peter), G. Steg, P. (Philippe), Hamm, C. (Christian), Vranckx, P. (Pascal), Valgimigli, M. (Marco), Windecker, S.W. (Stephan), Stoll, H.P., Onuma, Y. (Yoshinobu), Janssens, L. (Luc), Serruys, P.W.J.C. (Patrick), Kogame, N. (Norihiro), Chichareon, P. (Ply), De Wilder, K. (Kenneth), Takahashi, K. (Kuniaki), Modolo, R. (Rodrigo), Chang, C.C. (Chun Chin), Tomaniak, M. (Mariusz), Komiyama, H. (Hidenori), Chieffo, A. (Alaide), Colombo, A. (Antonio), Garg, S.A. (Scot), Louvard, Y. (Yves), Jüni, P. (Peter), G. Steg, P. (Philippe), Hamm, C. (Christian), Vranckx, P. (Pascal), Valgimigli, M. (Marco), Windecker, S.W. (Stephan), Stoll, H.P., Onuma, Y. (Yoshinobu), Janssens, L. (Luc), and Serruys, P.W.J.C. (Patrick)
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Background: The aim of this study was to investigate the impact of ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) for bifurcati
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- 2019
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23. Two years clinical outcomes with the state-of-the-art PCI for the treatment of bifurcation lesions: A sub-analysis of the SYNTAX II study
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Modolo, R. (Rodrigo), Kogame, N. (Norihiro), Komiyama, H. (Hidenori), Chichareon, P. (Ply), Vries, T. (Ton) de, Tomaniak, M. (Mariusz), Chang, C.C. (Chun Chin), Takahashi, K. (Kuniaki), Walsh, S. (Simon), Lesiak, M. (MacIej), Moreno, R. (Raúl), Farrooq, V. (Vasim), Escaned, J. (Javier), Banning, A. (Adrian), Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), Modolo, R. (Rodrigo), Kogame, N. (Norihiro), Komiyama, H. (Hidenori), Chichareon, P. (Ply), Vries, T. (Ton) de, Tomaniak, M. (Mariusz), Chang, C.C. (Chun Chin), Takahashi, K. (Kuniaki), Walsh, S. (Simon), Lesiak, M. (MacIej), Moreno, R. (Raúl), Farrooq, V. (Vasim), Escaned, J. (Javier), Banning, A. (Adrian), Onuma, Y. (Yoshinobu), and Serruys, P.W.J.C. (Patrick)
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Background: Bifurcation PCI is associated with a lower rate of procedural success, especially in multivessel disease patients. We aimed to determine the impact of bifurcation treatment on 2-years clinical outcomes when a state-of-the-art PCI strategy (heart team decision-making using the SYNTAX score II, physiology guided coronary stenosis assessment, thin strut bioresorbable polymer drug-eluting stent, and intravascular ultrasound guidance) is followed. Methods: Three-ves
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- 2019
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24. Neointimal characteristics comparison between biodegradable-polymer and durable-polymer drug-eluting stents: 3-month follow-up optical coherence tomography light property analysis from the RESTORE registry
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Kobayashi, T. (Tomoaki), Sotomi, Y. (Yohei), Suzuki, S. (Satoshi), Hamanaka, Y. (Yuma), Nakatani, T. (Tomoya), Dijkstra, J. (Jouke), Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), Sakata, Y. (Yasushi), Hirayama, A. (Atsushi), Higuchi, Y. (Yoshiharu), Kobayashi, T. (Tomoaki), Sotomi, Y. (Yohei), Suzuki, S. (Satoshi), Hamanaka, Y. (Yuma), Nakatani, T. (Tomoya), Dijkstra, J. (Jouke), Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), Sakata, Y. (Yasushi), Hirayama, A. (Atsushi), and Higuchi, Y. (Yoshiharu)
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We aimed to quantitatively assess a possible difference of the neointimal quality between biodegradable polymer- (BP-) and durable polymer drug-eluting stents (DP-DESs). We conducted a single-center all-comer prospective cohort study: the RESTORE registry (UMIN000033009). All patients who received successful OCT examination at planned 3-month follow-up after DES implantation were analyzed. Study population was divided into 2 groups, BP-DES versus DP-DES groups. We evaluated standard OCT variables, coverage percent, and the quantitative light property values including light intensity, attenuation, and backscatter. We performed OCT analyses of 121 lesions in 98 patients (BP-DES 55 lesions in 51 patients vs. DP-DES 66 lesions in DP-DES 53 patients). Lesion and procedural characteristics were overall well-balanced between both groups. At 3-month follow-up, neointimal thickness (BP-DES 49.3 [38.2, 57.7] µm versus DP-DES 54.7 [45.1, 70.7] µm, p = 0.059) and coverage percent (BP-DES 94.5 [89.8, 97.0]% vs. DP-DES 95.8 [91.1, 98.1]%, p = 0.083) did not significantly differ. Light intensity of superficial neointima in the BP-DES was lower than that in the DP-DES, whereas that of deep neointima did not differ between both groups.
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- 2019
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25. Stroke After Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention: Incidence, Pathogenesis, and Outcomes
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Gaudino, M., Angiolillo, D.J. (Dominick), Di Franco, A., Capodanno, D. (Davide), Bakaeen, F., Farkouh, M.E., Fremes, S.E., Holmes, D., Girardi, L.N., Nakamura, S, Head, S.J. (Stuart), Park, S.-J. (Seung-Jung), Mack, M, Serruys, P.W.J.C. (Patrick), Ruel, M. (Marc), Stone, G.W. (Gregg), Tam, D.Y., Vallely, M., Taggart, D.P. (David), Gaudino, M., Angiolillo, D.J. (Dominick), Di Franco, A., Capodanno, D. (Davide), Bakaeen, F., Farkouh, M.E., Fremes, S.E., Holmes, D., Girardi, L.N., Nakamura, S, Head, S.J. (Stuart), Park, S.-J. (Seung-Jung), Mack, M, Serruys, P.W.J.C. (Patrick), Ruel, M. (Marc), Stone, G.W. (Gregg), Tam, D.Y., Vallely, M., and Taggart, D.P. (David)
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- 2019
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26. Expert recommendations on the assessment of wall shear stress in human coronary arteries: existing methodologies, technical considerations, and clinical applications
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Gijsen, F.J.H. (Frank), Katagiri, Y. (Yuki), Barlis, P. (Peter), Bourantas, C.V. (Christos), Collet, C. (Carlos), Coskun, U. (Umit), Daemen, J. (Joost), Dijkstra, J. (Jouke), Edelman, E.R. (Elazer R.), Evans, P.C. (Paul), Heiden, K. (Kim) van der, Hose, R. (Rod), Koo, B.-K. (Bon-Kwon), Krams, R. (Rob), Marsden, J. (Jeremy), Migliavacca, F. (Francesco), Onuma, Y. (Yoshinobu), Ooi, A. (Andrew), Poon, E. (Eric), Samady, H. (Habib), Stone, P.H. (Peter), Takahashi, K. (Kuniaki), Tang, D. (Dalin), Thondapu, V. (Vikas), Tenekecioglu, E. (Erhan), Timmins, L.H. (Lucas), Torii, R. (Ryo), Wentzel, J.J. (Jolanda), Serruys, P.W.J.C. (Patrick), Gijsen, F.J.H. (Frank), Katagiri, Y. (Yuki), Barlis, P. (Peter), Bourantas, C.V. (Christos), Collet, C. (Carlos), Coskun, U. (Umit), Daemen, J. (Joost), Dijkstra, J. (Jouke), Edelman, E.R. (Elazer R.), Evans, P.C. (Paul), Heiden, K. (Kim) van der, Hose, R. (Rod), Koo, B.-K. (Bon-Kwon), Krams, R. (Rob), Marsden, J. (Jeremy), Migliavacca, F. (Francesco), Onuma, Y. (Yoshinobu), Ooi, A. (Andrew), Poon, E. (Eric), Samady, H. (Habib), Stone, P.H. (Peter), Takahashi, K. (Kuniaki), Tang, D. (Dalin), Thondapu, V. (Vikas), Tenekecioglu, E. (Erhan), Timmins, L.H. (Lucas), Torii, R. (Ryo), Wentzel, J.J. (Jolanda), and Serruys, P.W.J.C. (Patrick)
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- 2019
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27. The relationship of pre-procedural Dmax based sizing to lesion level outcomes in Absorb BVS and Xience EES treated patients in the AIDA trial
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Tijssen, R.Y.G., Kerkmeijer, L.S.M., Katagiri, Y., Kraak, R. P., Takahashi, K, Kogame, N., Chichareon, P., Modolo, R. (Rodrigo), Asano, T. (Taku), Nassif, M., Kalkman, D.N., Sotomi, Y, Collet, C. (Carlos), Hofma, SH, van der Schaaf, RJ, Arkenbout, E.K. (Elisabeth Karin), Weevers, A., Beijk, M.A.M., Piek, J.J. (Jan), Tijssen, J.G.P. (Jan), Henriques, J.P., Winter, R.J. de, Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), Wykrzykowska, JJ, Tijssen, R.Y.G., Kerkmeijer, L.S.M., Katagiri, Y., Kraak, R. P., Takahashi, K, Kogame, N., Chichareon, P., Modolo, R. (Rodrigo), Asano, T. (Taku), Nassif, M., Kalkman, D.N., Sotomi, Y, Collet, C. (Carlos), Hofma, SH, van der Schaaf, RJ, Arkenbout, E.K. (Elisabeth Karin), Weevers, A., Beijk, M.A.M., Piek, J.J. (Jan), Tijssen, J.G.P. (Jan), Henriques, J.P., Winter, R.J. de, Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), and Wykrzykowska, JJ
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- 2019
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28. Rationale and design of a prospective substudy of clinical endpoint adjudication processes within an investigator-reported randomised controlled trial in patients with coronary artery disease: the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY)
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Leonardi, S., Franzone, A., Piccolo, R., McFadden, E. (Eugene), Vranckx, P. (Pascal), Serruys, P.W.J.C. (Patrick), Benit, E. (Edouard), Liebetrau, C., Janssens, L. (Loes), Ferrario, M, Zurakowski, A., van Geuns, R.J., Dominici, M, Huber, K., Slagboom, T. (Ton), Buszman, P. (Pawel), Bolognese, L, Tumscitz, C. (Carlo), Bryniarski, K., Aminian, A., Vrolix, M.C. (Mathias), Petrov, I. (Ivo), Garg, S.A. (Scot), Naber, C, Prokopczuk, J., Hamm, C.W. (Christian), Steg, G. (G.), Heg, D. (Dik), Juni, P. (Peter), Windecker, S.W. (Stephan), Valgimigli, M. (Marco), Leonardi, S., Franzone, A., Piccolo, R., McFadden, E. (Eugene), Vranckx, P. (Pascal), Serruys, P.W.J.C. (Patrick), Benit, E. (Edouard), Liebetrau, C., Janssens, L. (Loes), Ferrario, M, Zurakowski, A., van Geuns, R.J., Dominici, M, Huber, K., Slagboom, T. (Ton), Buszman, P. (Pawel), Bolognese, L, Tumscitz, C. (Carlo), Bryniarski, K., Aminian, A., Vrolix, M.C. (Mathias), Petrov, I. (Ivo), Garg, S.A. (Scot), Naber, C, Prokopczuk, J., Hamm, C.W. (Christian), Steg, G. (G.), Heg, D. (Dik), Juni, P. (Peter), Windecker, S.W. (Stephan), and Valgimigli, M. (Marco)
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pragmatic and superiority randomised controlled trial designed to challenge the current treatment paradigm of dual antiplatelet therapy (DAPT) for 12 months followed by aspirin monotherapy among patients undergoing percutaneous coronary intervention. By design, all study endpoints are investigator reported (IR) and not subject to formal adjudication by an independent Clinical Event Committee (CEC), which may introduce detection, reporting or ascertainment bias. Methods and analysis We designed the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY) to prospectively implement, in a large sample of patients enrolled within the GLOBAL LEADERS trial (7585 of 15 991, 47.5%), an independent adjudication process of reported and unreported potential endpoints, using standardised CEC procedures, in order to assess whether 23-month ticagrelor monotherapy (90mg twice daily) after 1-month DAPT is non-inferior to a standard regimen of DAPT for 12 months followed by aspirin monotherapy for the primary efficacy endpoint of death, nonfatal myocardial infarction, non-fatal stroke or urgent target vessel revascularisation and superior for the primary safety endpoint of type 3 or 5 bleeding according to the Bleeding Academic Research Consortium criteria. This study will comprehensively assess the comparative safety and efficacy of the two tested antithrombotic strategies on CEC-adjudicated ischaemic and bleeding endpoints and will provide insights into the role of a standardised CEC adjudication process on the interpretation of study findings by quantifying the level of concordance between IR-reported and CEC-adjudicated events. Ethics and dissemination GLASSY has been approved by local ethics committee of all study sites and/or by the central ethics committee for the country depending on country-specific regulations. In all cases, they deemed that it was not necess
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- 2019
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29. Stroke After Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention: Incidence, Pathogenesis, and Outcomes
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Gaudino, M. (Mario), Angiolillo, D.J. (Dominick), Di Franco, A. (Antonino), Capodanno, D. (Davide), Bakaeen, F. (Faisal), Farkouh, M.E. (Michael E.), Fremes, S. (Stephen), Holmes, D.R. (David), Girardi, L.N. (Leonard N.), Nakamura, S. (Sunao), Head, S.J. (Stuart), Park, S.-J. (Seung-Jung), Mack, M.J. (Michael), Serruys, P.W.J.C. (Patrick), Ruel, M. (Marc), Stone, G.W. (Gregg), Tam, D.Y. (Derrick Y.), Vallely, M. (Michael), Taggart, D.P. (David), Gaudino, M. (Mario), Angiolillo, D.J. (Dominick), Di Franco, A. (Antonino), Capodanno, D. (Davide), Bakaeen, F. (Faisal), Farkouh, M.E. (Michael E.), Fremes, S. (Stephen), Holmes, D.R. (David), Girardi, L.N. (Leonard N.), Nakamura, S. (Sunao), Head, S.J. (Stuart), Park, S.-J. (Seung-Jung), Mack, M.J. (Michael), Serruys, P.W.J.C. (Patrick), Ruel, M. (Marc), Stone, G.W. (Gregg), Tam, D.Y. (Derrick Y.), Vallely, M. (Michael), and Taggart, D.P. (David)
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- 2019
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30. Associations of 26 Circulating Inflammatory and Renal Biomarkers with Near-Infrared Spectroscopy and Long-term Cardiovascular Outcome in Patients Undergoing Coronary Angiography
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Anroedh, S.S. (Sharda), Akkerhuis, K.M. (Martijn), Oemrawsingh, R.M. (Rohit), Garcia-Garcia, H.M. (Hector), Brankovic, M. (Milos), Regar, E.S. (Eveline), Geuns, R.J.M. (Robert Jan) van, Serruys, P.W.J.C. (Patrick), Daemen, J. (Joost), Mieghem, N.M. (Nicolas) van, Boersma, H. (Eric), Kardys, I. (Isabella), Anroedh, S.S. (Sharda), Akkerhuis, K.M. (Martijn), Oemrawsingh, R.M. (Rohit), Garcia-Garcia, H.M. (Hector), Brankovic, M. (Milos), Regar, E.S. (Eveline), Geuns, R.J.M. (Robert Jan) van, Serruys, P.W.J.C. (Patrick), Daemen, J. (Joost), Mieghem, N.M. (Nicolas) van, Boersma, H. (Eric), and Kardys, I. (Isabella)
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Purpose of Review: The purpose of this study was to investigate the association of 26 inflammatory biomarkers (acute phase proteins, cytokines, chemokines) and renal markers with coronary lipid core burden index (LCBI) assessed by near-infrared spectroscopy (NIRS) imaging, as well as the association of these biomarkers with long-term cardiovascular outcome. Recent Findings: NIRS-derived LCBI has recently been shown to be an independent predictor of major adverse cardiac events (MACE). However, studies on the association between circulating biomarkers and NIRS-derived characteristics have not yet been performed. Summary: Between 2008 and 2011, 581 patients underwent diagnostic coronary angiography or percutaneous coronary intervention for stable angina pectoris or acute coronary syndrome (ACS). NIRS of a non-culprit vessel was performed in a subset of 203 patient
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- 2018
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31. Acute molecular effects of pressure-controlled intermittent coronary sinus occlusion in patients with advanced heart failure
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Mohl, W. (Werner), Spitzer, E. (Ernest), Mader, R.M. (Robert M.), Wagh, V. (Vilas), Nguemo, F. (Filomain), Milasinovic, D. (Dejan), Jusić, A. (Alem), Khazen, C., Szodorai, E. (Edit), Birkenberg, B. (Beatrice), Lubec, G. (Gert), Hescheler, J. (Juergen), Serruys, P.W.J.C. (Patrick), Mohl, W. (Werner), Spitzer, E. (Ernest), Mader, R.M. (Robert M.), Wagh, V. (Vilas), Nguemo, F. (Filomain), Milasinovic, D. (Dejan), Jusić, A. (Alem), Khazen, C., Szodorai, E. (Edit), Birkenberg, B. (Beatrice), Lubec, G. (Gert), Hescheler, J. (Juergen), and Serruys, P.W.J.C. (Patrick)
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Aims: Cardiac repair has steered clinical attention and remains an unmet need, because available regenerative therapies lack robust mechanistic evidence. Pressure-controlled intermittent coronary sinus occlusion (PICSO), known to induce angiogenetic and vasoactive molecules as well as to reduce regional ischemia, may activate endogenous regenerative processes in failing myocardium. We aimed to investigate the effects of PICSO in patients with advanced heart failure undergoing cardiac resynchronization therapy. Methods and results: Eight out of 32 patients were treated with PICSO, and the remainder served as controls. After electrode testing including left ventricular leads, PICSO was performed for 20 min. To test immediate molecular responses, in both patient groups, coronary venous blood samples were taken at baseline and after 20 min, the time required for the intervention. Sera were tested for microRNAs and growth factors. To test the ability of up-regulated soluble factors on cell proliferation and expression of transcription factors [e.g. Krüppel-like factor 4 (KLF-4)], sera were co-cultured with human cardiomyocytes and fibroblasts. As compared with controls, significant differential expression (differences between pre-values and post-values in relation to both patient cohorts) of microRNA patterns associated with cardiac development was observed with PICSO. Importantly, miR-143 (P < 0.048) and miR-145 (P < 0,047) increased, both targeting a network of transcription factors (including KLF-4) that promote differentiation and repress proliferation of vascular smooth muscle cells. Additionally, an increase of miR-19b (P < 0.019) known to alleviate endothelial cell apoptosis was found, whereas disadvantageous miR-320b (P < 0.023) suspect to impair expression of c-myc, normally provoking cell cycle re-entry in post-mitotic myocytes and miR-25 (P < 0.023), decreased, a target of anti-miR application to improve contractility in the failing heart. Co-cultured post-PIC
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- 2018
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32. Cost-effectiveness of everolimus-eluting versus bare-metal stents in ST-segment elevation myocardial infarction: An analysis from the EXAMINATION randomized controlled trial
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Schur, N. (Nadine), Brugaletta, S. (Salvatore), Cequier, A. (Angel), Iiguez, A. (Andres), Serra, A., Jiménez-Quevedo, P., Mainar, V. (Vicente), Campo, G. (Gianluca), Tespili, M. (Maurizio), Heijer, P.D. (Peter Den), Bethencourt, A. (Armando), Vazquez, N. (Nicolás), Valgimigli, M. (Marco), Serruys, P.W.J.C. (Patrick), Ademi, Z. (Zanfina), Schwenkglenks, M. (Matthias), Sabaté, M. (Manel), Schur, N. (Nadine), Brugaletta, S. (Salvatore), Cequier, A. (Angel), Iiguez, A. (Andres), Serra, A., Jiménez-Quevedo, P., Mainar, V. (Vicente), Campo, G. (Gianluca), Tespili, M. (Maurizio), Heijer, P.D. (Peter Den), Bethencourt, A. (Armando), Vazquez, N. (Nicolás), Valgimigli, M. (Marco), Serruys, P.W.J.C. (Patrick), Ademi, Z. (Zanfina), Schwenkglenks, M. (Matthias), and Sabaté, M. (Manel)
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Background Use of everolimus-eluting stents (EES) has proven to be clinically effective and safe in patients with ST-segment elevation myocardial infarction but it remains unclear whether it is cost-effective compared to bare-metal stents (BMS) in the long-term. We sought to assess the cost-effectiveness of EES versus BMS based on the 5-year results of the EXAMINATION trial, from a Spanish health service perspective. Methods Decision analysis of the use of EES versus BMS was based on the patient-level clinical outcome data of the EXAMINATION trial. The analysis adopted a lifelong time horizon, assuming that long-term survival was independent of the initial treatment strategy after the end of follow-up. Life-expectancy, health-state utility scores and unit costs were extracted from published literature and publicly available sources. Non-parametric bootstrapping was combined with probabilistic sensitivity analysis to co-assess the impact of patient-level variation and parameter uncertainty. The main outcomes were total costs and quality-adjusted life-years. The incremental cost-effectiveness ratio was expressed as cost per quality-adjusted life-years gained. Costs and effects were discounted at 3%. Results The model predicted an average survival time in patients receiving EES and BMS of 10.52 and 10.38 undiscounted years, respectively. Over the life-long time horizon, the EES strategy was €430 more costly than BMS (€8,305 vs. €7,874), but went along with incremental gains of 0.10 quality-adjusted life-years. This resulted in an average incremental cost-effectiveness ratio over all simulations of €3,948 per quality-adjusted life-years gained and was below a willingness-to-pay threshold of €25,000 per quality-adjusted life-years gained in 86.9% of simulation runs. Conclusions Despite higher total costs relative to BMS, EES appeared to be a cost-effective therapy for ST-segment elevation myocardial infarction patients due to their incremental effectiveness. Predicted in
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- 2018
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33. Post-implantation shear stress assessment: an emerging tool for differentiation of bioresorbable scaffolds
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Tenekecioglu, E. (Erhan), Torii, K. (Kan), Katagiri, Y. (Yuki), Chichareon, P. (Ply), Asano, T. (Taku), Miyazaki, Y. (Yosuke), Takahashi, K. (Kuniaki), Modolo, R. (Rodrigo), Al-Lamee, R. (Rasha), Al-Lamee, K. (Kadem), Colet, C. (Carlos), Reiber, J.H.C. (Johan), Pekkan, K. (Kerem), Geuns, R.J.M. (Robert Jan) van, Bourantas, C.V. (Christos), Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), Tenekecioglu, E. (Erhan), Torii, K. (Kan), Katagiri, Y. (Yuki), Chichareon, P. (Ply), Asano, T. (Taku), Miyazaki, Y. (Yosuke), Takahashi, K. (Kuniaki), Modolo, R. (Rodrigo), Al-Lamee, R. (Rasha), Al-Lamee, K. (Kadem), Colet, C. (Carlos), Reiber, J.H.C. (Johan), Pekkan, K. (Kerem), Geuns, R.J.M. (Robert Jan) van, Bourantas, C.V. (Christos), Onuma, Y. (Yoshinobu), and Serruys, P.W.J.C. (Patrick)
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Optical coherence tomography based computational flow dynamic (CFD) modeling provides detailed information about the local flow behavior in stented/scaffolded vessel segments. Our aim is to investigate the in-vivo effect of strut thickness and strut protrusion on endothelial wall shear stress (ESS) distribution in ArterioSorb Absorbable Drug-Eluting Scaffold (ArterioSorb) and Absorb everolimus-eluting Bioresorbable Vascular Scaffold (Absorb) devices that struts with similar morphology (quadratic structure) but different thickness. In three animals, six coronary arteries were treated with ArterioSorb. At different six animals, six coronary arteries were treated with Absorb. Following three-dimensional(3D) reconstruction of the coronary arteries, Newtonian steady flow simulation was performed and the ESS were estimated. Mixed effects models were used to compare ESS distribution in the two devices. There were 4591 struts in the analyzed 477 cross-sections in Absorb (strut thickness = 157 µm) and 3105 struts in 429 cross-sections in ArterioSorb (strut thickness = 95 µm) for the protrusion analysis. In cross-section level analysis, there was significant difference between the scaffolds in the protrusion distances. The protrusion was higher in Absorb (97% of the strut thickness) than in ArterioSorb (88% of the strut thickness). ESS was significantly higher in ArterioSorb (1.52 ± 0.34 Pa) than in Absorb (0.73 ± 2.19 Pa) (p = 0.001). Low- and very-low ESS data were seen more often in Absorb than in ArterioSorb. ArterioSorb is associated with a more favorable ESS distribution compared to the Absorb. These differences should be attributed to different strut thickness/strut protrusion that has significant effect on shear stress distribution.
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- 2018
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34. B-Type Natriuretic Peptide Assessment in Patients Undergoing Revascularization for Left Main Coronary Artery Disease
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Redfors, B. (Björn), Chen, S. (Shmuel), Crowley, A. (Aaron), Ben-Yehuda, O. (Ori), Gersh, B.J. (Bernard), Lembo, N.J. (Nicholas J.), Brown, W.M. (W Morris), Banning, A. (Adrian), Taggart, D.P. (David), Serruys, P.W.J.C. (Patrick), Kappetein, A.P. (Arie Pieter), Sabik, J.F. (Joseph), Stone, G.W. (Gregg), Redfors, B. (Björn), Chen, S. (Shmuel), Crowley, A. (Aaron), Ben-Yehuda, O. (Ori), Gersh, B.J. (Bernard), Lembo, N.J. (Nicholas J.), Brown, W.M. (W Morris), Banning, A. (Adrian), Taggart, D.P. (David), Serruys, P.W.J.C. (Patrick), Kappetein, A.P. (Arie Pieter), Sabik, J.F. (Joseph), and Stone, G.W. (Gregg)
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BACKGROUND: Elevated B-type natriuretic peptide (BNP) is reflective of impaired cardiac function and is associated with worse prognosis among patients with coronary artery disease (CAD). We sought to assess the association between baseline BNP, adverse outcomes, and the relative efficacy of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) in patients with left main CAD. METHODS: The EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) randomized patients with left main CAD and low or intermediate SYNTAX scores (Synergy Between PCI With TAXUS and Cardiac Surgery) to PCI with everolimus-eluting stents versus CABG. The primary end point was the composite of all-cause death, myocardial infarction, or stroke. We used multivariable Cox proportional hazards regression to assess the associations between normal versus elevated BNP (≥100 pg/mL), randomized treatment, and the 3-year risk of adverse events. RESULTS: BNP at baseline was elevated in 410 of 1037 (39.5%) patients enrolled in EXCEL. Patients with elevated BNP levels were older and more frequently had additional cardiovascular risk factors and lower left ventricular ejection fraction than those with normal BNP, but had similar SYNTAX scores. Patients with elevated BNP had significantly higher 3-year rates of the primary end point (18.6% versus 11.7%; adjusted hazard ratio [HR], 1.62; 95% confidence interval [CI], 1.16-2.28; P=0.005) and higher mortality (11.5% versus 3.9%; adjusted HR, 2.49; 95% CI, 1.48-4.19; P=0.0006), both from cardiovascular and noncardiovascular causes. In contrast, there were no significant differences in the risks of myocardial infarction, stroke, ischemia-driven revascularization, stent thrombosis, graft occlusion, or major bleeding. A significant interaction ( Pinteraction=0.03) was present between elevated versus normal BNP and treatment with PCI versus CABG for the adjusted risk of th
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- 2018
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35. Plasma concentrations of molecular lipid species predict long-term clinical outcome in coronary artery disease patients
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Anroedh, S.S. (Sharda), Hilvo, M. (Mika), Akkerhuis, K.M. (Martijn), Kauhanen, D. (Dimple), Koistinen, K. (Kaisa), Oemrawsingh, R.M. (Rohit), Serruys, P.W.J.C. (Patrick), Geuns, R.J.M. (Robert Jan) van, Boersma, H. (Eric), Laaksonen, R. (Reijo), Kardys, I. (Isabella), Anroedh, S.S. (Sharda), Hilvo, M. (Mika), Akkerhuis, K.M. (Martijn), Kauhanen, D. (Dimple), Koistinen, K. (Kaisa), Oemrawsingh, R.M. (Rohit), Serruys, P.W.J.C. (Patrick), Geuns, R.J.M. (Robert Jan) van, Boersma, H. (Eric), Laaksonen, R. (Reijo), and Kardys, I. (Isabella)
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We investigated the associations of ten previously identified high risk molecular lipid species and three ceramide ratios with the occurrence of major adverse cardiac events (MACEs) during a median follow-up of 4.7 years in patients with coronary artery disease (CAD). Between 2008 and 2011, 581 patients underwent diagnostic coronary angiography or percutaneous coronary intervention for stable angina pectoris (SAP) or acute coronary syndrome (ACS). Blood was drawn prior to the index procedure and lipid species were determined. The primary endpoint was the occurrence of a MACE, comprising all-cause mortality, nonfatal ACS, or unplanned coronary revascularization. The secondary endpoint comprised all-cause mortality or nonfatal ACS. During a median follow-up of 4.7 [IQR: 4.2-5.6] years, 155 patients (27%) had MACEs. In multivariable analyses, Cer(d18:1/16:0) concentration was associated with MACEs (hazard ratio 2.32; 95% CI [1.09-4.96] per natural logarithm (ln) (pmol/ml) P = 0.0
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- 2018
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36. IgM anti-malondialdehyde low density lipoprotein antibody levels indicate coronary heart disease and necrotic core characteristics in the Nordic Diltiazem (NORDIL) study and the Integrated Imaging and Biomarker Study 3 (IBIS-3)
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van den Berg, V.J. (Victor J.), Haskard, D.O. (Dorian O.), Fedorowski, A. (Artur), Hartley, A. (Adam), Kardys, I. (Isabella), Caga-Anan, M. (Mikhail), Akkerhuis, K.M. (K. Martijn), Oemrawsingh, R.M. (Rohit), Geuns, R.J.M. (Robert Jan) van, Jaegere, P.P.T. (Peter) de, Mieghem, N.M. (Nicolas) van, Regar, E.S. (Eveline), Ligthart, J.M.R. (Jürgen), Umans, V.A.W.M. (Victor), Serruys, P.W.J.C. (Patrick), Melander, O. (Olle), Boersma, H. (Eric), Khamis, R.Y. (Ramzi Y.), van den Berg, V.J. (Victor J.), Haskard, D.O. (Dorian O.), Fedorowski, A. (Artur), Hartley, A. (Adam), Kardys, I. (Isabella), Caga-Anan, M. (Mikhail), Akkerhuis, K.M. (K. Martijn), Oemrawsingh, R.M. (Rohit), Geuns, R.J.M. (Robert Jan) van, Jaegere, P.P.T. (Peter) de, Mieghem, N.M. (Nicolas) van, Regar, E.S. (Eveline), Ligthart, J.M.R. (Jürgen), Umans, V.A.W.M. (Victor), Serruys, P.W.J.C. (Patrick), Melander, O. (Olle), Boersma, H. (Eric), and Khamis, R.Y. (Ramzi Y.)
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Background: Certain immunoglobulins (Ig) are proposed to have protective functions in atherosclerosis. Objectives: We tested whether serum levels of IgG and IgM autoantibodies against malondialdehyde low density lipoprotein (MDA-LDL) are associated with clinical coronary heart disease (CHD) and unfavorable plaque characteristics. Methods: NORDIL was a prospective study investigating adverse cardiovascular outcomes in hypertensive patients. IBIS-3 analyzed lesions in a non-culprit coronary artery with <50% stenosis using radiofrequency intravascular ultrasound (RF-IVUS) and near-infrared spectroscopy (NIRS). Imaging was repeated after a median of 386 days on rosuvastatin. Associations of antibodies with incident CHD and imaging parameters were assessed in the two sub-studies respectively. Findings: From 10,881 NORDIL patients, 87 had serum sampled at baseline and developed CHD over 4.5 years, matched to 227 controls. Higher titers of IgM anti-MDA-LDL had a protective effect on adverse outcomes, with odds ratio 0.29 (0.11, 0.76; p = 0.012; p = 0.016 for trend). Therefore, the effect was explored at the lesional level in IBIS-3. 143 patients had blood samples and RF-IVUS measurements available, and NIRS was performed in 90 of these. At baseline, IgM anti-MDA-LDL levels had a strong independent inverse relationship with lesional necrotic core volume (p = 0.027) and percentage of plaque occupied by necrotic core (p = 0.011), as well as lipid core burden index (p = 0.024) in the worst 4 mm segment. Interpretation: Our study supports the hypothesis that lower circulating levels of IgM anti-MDA-LDL are associated with clinical CHD development, and for the first time relates these findings to atherosclerotic plaque characteristics that are linked to vulnerability.
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- 2018
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37. Inter-technique consistency and prognostic value of intra-procedural angiographic and echocardiographic assessment of aortic regurgitation after transcatheter aortic valve implantation
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Tateishi, H. (Hiroki), Miyazaki, Y. (Yosuke), Okamura, T. (Takayuki), Abdelghani, M. (Mohammad), Modolo, R. (Rodrigo), Wada, Y. (Yasuaki), Okuda, S. (Shinichi), Omuro, A. (Ayumi), Ariyoshi, T. (Toru), Fujii, A. (Ayano), Oda, T. (Tetsuro), Fujimura, T. (Tatsuhiro), Nanno, T. (Takuma), Mikamo, A. (Akihito), Soliman, O.I.I. (Osama Ibrahim Ibrahim), Onuma, Y. (Yoshinobu), Hamano, K. (Kimikazu), Yano, M. (Masafumi), Serruys, P.W.J.C. (Patrick), Tateishi, H. (Hiroki), Miyazaki, Y. (Yosuke), Okamura, T. (Takayuki), Abdelghani, M. (Mohammad), Modolo, R. (Rodrigo), Wada, Y. (Yasuaki), Okuda, S. (Shinichi), Omuro, A. (Ayumi), Ariyoshi, T. (Toru), Fujii, A. (Ayano), Oda, T. (Tetsuro), Fujimura, T. (Tatsuhiro), Nanno, T. (Takuma), Mikamo, A. (Akihito), Soliman, O.I.I. (Osama Ibrahim Ibrahim), Onuma, Y. (Yoshinobu), Hamano, K. (Kimikazu), Yano, M. (Masafumi), and Serruys, P.W.J.C. (Patrick)
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Background: We investigated the relationship between intraprocedural angiographic and echocardiographic AR severity after TAVI, and the clinical robustness of angiographic assessment. Methods and Results: In 74 consecutive patients, the echocardiographic circumferential extent (CE) of the paravalvular regurgitant jet was retrospectively measured and graded based on the VARC-2 cut-points; and angiographic post-TAVI AR was retrospectively quantified using contrast videodensitometry (VD) software that calculates the ratio of the contrast time-density integral in the LV outflow tract to that in the ascending aorta (LVOT-AR). Seventy-four echocardiograms immediately after TAVI were analyzable, while 51 aortograms were analyzable for VD. These 51 echocardiograms and VD were evaluated. Median LVOT-AR across the echocardiographic AR grades was as follows: none-trace, 0.07 (IQR, 0.05–0.11); mild, 0.12 (IQR, 0.09–0.15); and moderate, 0.17 (IQR, 0.15–0.22; P<0.05 for none-trace vs. mild, and mild vs. moderate). LVOT-AR strongly correlated with %CE (r=0.72, P<0.0001). At 1 year, the rate of the composite end-point of all-cause death or HF re-hospitalization was significantly higher in >mild AR patients compared with no-mild AR on intra-procedural echocardiography (41.5% vs. 12.4%, P=0.03) as well as in patients with LVOT-AR >0.17 compared with LVOT-AR ≤0.17 (59.5% vs. 16.6%, P=0.03). Conclusions: VD (LVOT-AR) has good intra-procedural inter-technique consistency and clinical robustness. Greater than mild post-TAVI AR, but not mild post-TAVI AR, is associated with late mortality.
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- 2018
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38. SYNTAX II and SYNTAX III trials: What is the take home message for surgeons?
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Modolo, R. (Rodrigo), Collet, C. (Carlos), Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), Modolo, R. (Rodrigo), Collet, C. (Carlos), Onuma, Y. (Yoshinobu), and Serruys, P.W.J.C. (Patrick)
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Percutaneous coronary intervention (PCI) has evolved greatly in the last 40 years since its introduction by Andreas Grüntzig in 1977. Since then, we've observed an evolution in balloons, the development of stents, changes in stent structure, development of drug eluting stents, improvements in strut design, thickness and even their polymeric coating. Most recently we saw the rise and "fall" of bioabsorbable scaffolds for PCI. Trials with the most diverse devices for PCI and diagnostic techniques have been conducted. Two of the most recent trials were reported in the last year and deserve special attention-SYNTAX II and SYNTAX III. These trials are completely different in design but present valuable information for doctors managing coronary artery disease (CAD). Both trials take into account contemporary technology for assessing and treating CAD. The first uses so-called "state-of-the-art" PCI and compares the outcomes of that approach with the outcomes of the PCI arm of the pivotal SYNTAX trial. SYNTAX III Revolution on the other hand does not focus on clinical endpoints: it is a blinded trial that does not randomize patients but randomizes doctors ("the heart team") to make a decision on the best treatment for complex CAD. This decision was based either on multi-slice CT with physiological assessment using FFRCT or on conventional angiography. In this review we bring the most important aspects of those trials and the key messages for surgeons together; also, what the surgeon may expect in the future after the publication of these interesting concepts.
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- 2018
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39. SYNTAX score II predicts long-term mortality in patients with one- or two-vessel disease
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Vroegindewey, M.M. (Maxime), Schuurman, A.S. (Anne-Sophie), Oemrawsingh, R.M. (Rohit), Geuns, R.J.M. (Robert Jan) van, Kardys, I. (Isabella), Ligthart, J.M.R. (Jürgen), Daemen, J. (Joost), Boersma, H. (Eric), Serruys, P.W.J.C. (Patrick), Akkerhuis, K.M. (K Martijn), Vroegindewey, M.M. (Maxime), Schuurman, A.S. (Anne-Sophie), Oemrawsingh, R.M. (Rohit), Geuns, R.J.M. (Robert Jan) van, Kardys, I. (Isabella), Ligthart, J.M.R. (Jürgen), Daemen, J. (Joost), Boersma, H. (Eric), Serruys, P.W.J.C. (Patrick), and Akkerhuis, K.M. (K Martijn)
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Objective SYNTAX score II (SSII) is a long-term mortality prediction model to guide the decision making of the heart-team between coronary artery bypass grafting or percutaneous coronary intervention (PCI) in patients with left main or three-vessel coronary artery disease. This study aims to investigate the long-term predictive value of SSII for all-cause mortality in patients with one- or two-vessel disease undergoing PCI. Methods A total of 628 patients (76% men, mean age: 61±10 years) undergoing PCI due to stable angina pectoris (43%) or acute coronary syndrome (57%), included between January 2008 and June 2013, were eligible for the current study. SSII was calculated using the original SYNTAX score website (www.syntaxscore.com). Cox regression analysis was used to assess the association between continuous SSII and long-term all-cause mortality. The area under the receiver-operating characteristic curve was used to assess the performance of SSII. Results SSII ranged from 6.6 to 58.2 (median: 20.4, interquartile range: 16.1–26.8). In multivariable analysis, SSII proved to be an independent significant predictor for 4.5-year mortality (hazard ratio per point increase: 1.10; 95% confidence interval: 1.07–1.13; p<0.001). In terms of discrimination, SSII had a concordance index of 0.77. Conclusion In addition to its established value in patients with left main and three-vessel disease, SSII may also predict long-term mortality in PCI-treated patients with one- or two-vessel disease.
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- 2018
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40. Mid-term outcomes of the absorb bvs versus second-generation des: A systematic review and meta-analysis
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Felix, C.M. (Cordula), van den Berg, V.J. (Victor J.), Hoeks, S.E. (Sanne), Fam, J.M. (Jiang Ming), Lenzen, M.J. (Mattie), Boersma, H. (Eric), Smits, P. (Peter), Serruys, P.W.J.C. (Patrick), Onuma, Y. (Yoshinobu), van Geuns, R.J.M. (Robert Jan M.), Felix, C.M. (Cordula), van den Berg, V.J. (Victor J.), Hoeks, S.E. (Sanne), Fam, J.M. (Jiang Ming), Lenzen, M.J. (Mattie), Boersma, H. (Eric), Smits, P. (Peter), Serruys, P.W.J.C. (Patrick), Onuma, Y. (Yoshinobu), and van Geuns, R.J.M. (Robert Jan M.)
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Background Bioresorbable Vascular Scaffolds (BVS) were introduced to overcome some of the limitations of drug-eluting stent (DES) for PCI. Data regarding the clinical outcomes of the BVS versus DES beyond 2 years are emerging. Objective To study mid-term outcomes. Methods We searched online databases (PubMed/Medline, Embase, CENTRAL), several websites, meeting presentations and scientific session abstracts until August 8th, 2017 for studies comparing Absorb BVS with second-generation DES. The primary outcome was target lesion failure (TLF). Secondary outcomes were all-cause mortality, myocardial infarction, target lesion revascularization (TLR) and definite/probable device thrombosis. Odds ratios (ORs) with 95% confidence intervals (CIs) were derived using a random effects model. Results Ten studies, seven randomized controlled trials and three propensity-matched observational studies, with a total of 7320 patients (BVS n = 4007; DES n = 3313) and a median follow-up duration of 30.5 months, were included. Risk of TLF was increased for BVS-treated patients (OR 1.34 [95% CI: 1.12–1.60], p = 0.001, I2 = 0%). This was also the case for all myocardial infarction (1.58 [95% CI: 1.27–1.96], p<0.001, I2 = 0%), TLR (1.48 [95% CI: 1.19–1.85], p<0.001, I2 = 0%) and definite/probable device thrombosis (of 2.82 (95% CI: 1.86–3.89], p<0.001 and I2 = 40.3%). This did not result in a difference in all-cause mortality (0.78 [95% CI: 0.58–1.04], p = 0.09, I2 = 0%). OR for very late (>1 year) device thrombosis was 6.10 [95% CI: 1.40–26.65], p = 0.02). Conclusion At mid-term follow-up, BVS was associated with an increased risk of TLF, MI, TLR and definite/probable device thrombosis, but this did not result in an increased risk of all-cause mortality.
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- 2018
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41. Compliance With Guideline-Directed Medical Therapy in Contemporary Coronary Revascularization Trials
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Pinho-Gomes, A.-C. (Ana-Catarina), Azevedo, L. (Luis), Ahn, J.-M. (Jung-Min), Park, S.-J. (Seung-Jung), Hamza, T.H. (Taye), Farkouh, M.E. (Michael E.), Serruys, P.W.J.C. (Patrick), Milojevic, M. (Milan), Kappetein, A.P. (Arie Pieter), Stone, G.W. (Gregg), Lamy, A. (André), Fuster, V. (Valentin), Taggart, D.P. (David), Pinho-Gomes, A.-C. (Ana-Catarina), Azevedo, L. (Luis), Ahn, J.-M. (Jung-Min), Park, S.-J. (Seung-Jung), Hamza, T.H. (Taye), Farkouh, M.E. (Michael E.), Serruys, P.W.J.C. (Patrick), Milojevic, M. (Milan), Kappetein, A.P. (Arie Pieter), Stone, G.W. (Gregg), Lamy, A. (André), Fuster, V. (Valentin), and Taggart, D.P. (David)
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Background: Despite the well-established benefits of secondary cardiovascular prevention, the importance of concurrent medical therapy in clinical trials of coronary revascularization is often overlooked. Objectives: The goal of this study was to assess compliance with guideline-directed medical therapy (GDMT) in clinical trials and its potential impact on the comparison between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). Methods: The Cochrane Central Register of Controlled Trials and MEDLINE were searched from 2005 to August 2017. Clinical trial registries and reference lists of relevant studies were also searched. Randomized controlled trials comparing PCI with drug-eluting stents versus CABG and reporting medical therapy after revascularization were included. The study outcome was compliance with GDMT, defined as the following: 1) any antiplatelet agent plus beta-blocker plus statin (GDMT1); and 2) any antiplatelet agent plus beta-blocker plus statin plus angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (GDMT2). Data collection and analysis were performed according to the methodological recommendations of The Cochrane Collaboration. Results: From a total of 439 references, 5 trials were included based on our inclusion and exclusion criteria. Overall, compliance with GDMT1 was low and decreased over time from 67% at 1 year to 53% at 5 years. Compliance with GDMT2 was even lower and decreased from 40% at 1 year to 38% at 5 years. Compliance with both GDMT1 and GDMT2 was higher in PCI than in CABG at all time points. Meta-regression suggested an association between lower use of GDMT1 and adverse clinical outcomes in PCI versus CABG at 5 years. Conclusions: Compliance with GDMT in contemporary clinical trials remains suboptimal and is significantly lower after CABG than after PCI, which may influence the comparison of clinical trial endpoints between those study groups.
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- 2018
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42. New-Onset Atrial Fibrillation After PCI or CABG for Left Main Disease: The EXCEL Trial
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Kosmidou, I. (Ioanna), Chen, S. (Shmuel), Kappetein, A.P. (Arie Pieter), Serruys, P.W.J.C. (Patrick), Gersh, B.J. (Bernard), Puskas, J.D. (John), Kandzari, D.E. (David), Taggart, D.P. (David), Morice, M-C. (Marie-Claude), Buszman, P.E. (Pawel), Bochenek, A. (Andrzej), Schampaert, E. (Erick), Pagé, P. (Pierre), Sabik, J.F. (Joseph), McAndrew, T.C. (Thomas), Redfors, B. (Björn), Ben-Yehuda, O. (Ori), Stone, G.W. (Gregg), Kosmidou, I. (Ioanna), Chen, S. (Shmuel), Kappetein, A.P. (Arie Pieter), Serruys, P.W.J.C. (Patrick), Gersh, B.J. (Bernard), Puskas, J.D. (John), Kandzari, D.E. (David), Taggart, D.P. (David), Morice, M-C. (Marie-Claude), Buszman, P.E. (Pawel), Bochenek, A. (Andrzej), Schampaert, E. (Erick), Pagé, P. (Pierre), Sabik, J.F. (Joseph), McAndrew, T.C. (Thomas), Redfors, B. (Björn), Ben-Yehuda, O. (Ori), and Stone, G.W. (Gregg)
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Background: There is limited information on the incidence and prognostic impact of new-onset atrial fibrillation (NOAF) following percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD). Objectives: This study sought to determine the incidence of NOAF following PCI and CABG for LMCAD and its effect on 3-year cardiovascular outcomes. Methods: In the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, 1,905 patients with LMCAD and low or intermediate SYNTAX scores were randomized to PCI with everolimus-eluting stents versus CABG. Outcomes were analyzed according to the development of NOAF during the initial hospitalization following revascularization. Results: Among 1,812 patients without atrial fibrillation on presentation, NOAF developed at a mean of 2.7 ± 2.5 days after revascularization in 162 patients (8.9%), including 161 of 893 (18.0%) CABG-treated patients and 1 of 919 (0.1%) PCI-treated patients (p < 0.0001). Older age, greater body mass index, and reduced left ventricular ejection fraction were independent predictors of NOAF in patients undergoing CABG. Patients with versus without NOAF had a significantly longer duration of hospitalization, were more likely to be discharged on anticoagulant therapy, and had an increased 30-day rate of Thrombolysis In Myocardial Infarction major or minor bleeding (14.2% vs. 5.5%; p < 0.0001). By multivariable analysis, NOAF after CABG was an independent predictor of 3-year stroke (6.6% vs. 2.4%; adjusted hazard ratio [HR]: 4.19; 95% confidence interval [CI]: 1.74 to 10.11; p = 0.001), death (11.4% vs. 4.3%; adjusted HR: 3.02; 95% CI: 1.60 to 5.70; p = 0.0006), and the primary composite endpoint of death, MI, or stroke (22.6% vs. 12.8%; adjusted HR: 2.13; 95% CI: 1.39 to 3.25; p = 0.0004). Conclusions: In patients with LMCAD undergoing revascularization in the EXCEL trial, NOAF was c
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- 2018
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43. Endothelial shear stress 5 years after implantation of a coronary bioresorbable scaffold
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Thondapu, V. (Vikas), Tenekecioglu, E. (Erhan), Poon, E.K.W. (Eric), Collet, C. (Carlos), Torii, K. (Kan), Bourantas, C.V. (Christos), Chin, C. (Cheng), Sotomi, Y. (Yohei), Jonker, H. (Hans), Dijkstra, J. (Jouke), Revalor, E. (Eve), Gijsen, F.J.H. (Frank), Onuma, Y. (Yoshinobu), Ooi, A. (Andrew), Barlis, P. (Peter), Serruys, P.W.J.C. (Patrick), Thondapu, V. (Vikas), Tenekecioglu, E. (Erhan), Poon, E.K.W. (Eric), Collet, C. (Carlos), Torii, K. (Kan), Bourantas, C.V. (Christos), Chin, C. (Cheng), Sotomi, Y. (Yohei), Jonker, H. (Hans), Dijkstra, J. (Jouke), Revalor, E. (Eve), Gijsen, F.J.H. (Frank), Onuma, Y. (Yoshinobu), Ooi, A. (Andrew), Barlis, P. (Peter), and Serruys, P.W.J.C. (Patrick)
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Aims As a sine qua non for arterial wall physiology, local hemodynamic forces such as endothelial shear stress (ESS) may influence long-term vessel changes as bioabsorbable scaffolds dissolve. The aim of this study was to perform serial computational fluid dynamic (CFD) simulations to examine immediate and long-term haemodynamic and vascular changes following bioresorbable scaffold placement. Methods and results Coronary arterial models with long-term serial assessment (baseline and 5 years) were reconstructed through fusion of intravascular optical coherence tomography and angiography. Pulsatile non-Newtonian CFD simulations were performed to cal
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- 2018
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44. CVIT expert consensus document on primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) in 2018
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Ozaki, Y. (Yukio), Katagiri, Y. (Yuki), Onuma, Y. (Yoshinobu), Amano, T. (Tetsuya), Muramatsu, T. (Takashi), Kozuma, K. (Ken), Otsuji, S. (Satoru), Ueno, T. (Takafumi), Shiode, N. (Nobuo), Kawai, K. (Kazuya), Tanaka, N. (Nobuhiro), Ueda, K. (Kinzo), Akasaka, T. (Takashi), Hanaoka, K.I. (Keiichi Igarashi), Uemura, M. (Mayu), Oda, H. (Hirotaka), Katahira, Y. (Yoshiaki), Kadota, K. (Kazushige), Kyo, E. (Eisho), Sato, K. (Katsuhiko), Sato, T. (Tadaya), Shite, J. (Junya), Nakao, K. (Koichi), Nishino, M. (Masami), Hikichi, Y. (Yutaka), Honye, J. (Junko), Matsubara, T. (Tetsuo), Mizuno, S. (Sumio), Muramatsu, T. (Toshiya), Inohara, T. (Taku), Kohsaka, S. (Shun), Michishita, I. (Ichiro), Yokoi, H. (Hiroyoshi), Serruys, P.W.J.C. (Patrick), Ikari, Y. (Yuji), Nakamura, M. (Masato), Ozaki, Y. (Yukio), Katagiri, Y. (Yuki), Onuma, Y. (Yoshinobu), Amano, T. (Tetsuya), Muramatsu, T. (Takashi), Kozuma, K. (Ken), Otsuji, S. (Satoru), Ueno, T. (Takafumi), Shiode, N. (Nobuo), Kawai, K. (Kazuya), Tanaka, N. (Nobuhiro), Ueda, K. (Kinzo), Akasaka, T. (Takashi), Hanaoka, K.I. (Keiichi Igarashi), Uemura, M. (Mayu), Oda, H. (Hirotaka), Katahira, Y. (Yoshiaki), Kadota, K. (Kazushige), Kyo, E. (Eisho), Sato, K. (Katsuhiko), Sato, T. (Tadaya), Shite, J. (Junya), Nakao, K. (Koichi), Nishino, M. (Masami), Hikichi, Y. (Yutaka), Honye, J. (Junko), Matsubara, T. (Tetsuo), Mizuno, S. (Sumio), Muramatsu, T. (Toshiya), Inohara, T. (Taku), Kohsaka, S. (Shun), Michishita, I. (Ichiro), Yokoi, H. (Hiroyoshi), Serruys, P.W.J.C. (Patrick), Ikari, Y. (Yuji), and Nakamura, M. (Masato)
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While primary percutaneous coronary intervention (PCI) has significantly contributed to improve the mortality in patients with ST segment elevation myocardial infarction even in cardiogenic shock, primary PCI is a standard of care in most of Japanese institutions. Whereas there are high numbers of available facilities providing primary PCI in Japan, there are no clear guidelines focusing on procedural aspect of the standardized care. Whilst updated guidelines for the management of acute myocardial infarction were recently published by European Society of Cardiology, the following major changes are indicated; (1) radial access and drug-eluting stent over bare metal stent were recommended as Class I indication, and (2) complete revascularization before hospital discharge (either immediate or staged) is now considered as Class IIa recommendation. Although the primary PCI is consistently recommended in recent and previous guidelines, the device lag from Europe, the frequent usage of coronary imaging modalities in Japan, and the difference in available medical therapy or mechanical support may prevent direct application of European guidelines to Japanese population. The Task Force on Primary Percutaneous Coronary Intervention of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) has now proposed the expert consensus document for the management of acute myocardial infarction focusing on procedural aspect of primary PCI.
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- 2018
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45. Accuracy of coronary computed tomography angiography for bioresorbable scaffold luminal investigation: a comparison with optical coherence tomography
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Collet, C. (Carlos), Sotomi, Y. (Yohei), Cavalcante, R. (Rafael), Asano, T. (Taku), Miyazaki, Y. (Yosuke), Tenekecioglu, E. (Erhan), Kistlaar, P. (Pieter), Zeng, Y. (Yaping), Suwanasson, P. (Pannipa), Winter, R.J. (Robbert) de, Nieman, K. (Koen), Serruys, P.W.J.C. (Patrick), Onuma, Y. (Yoshinobu), Collet, C. (Carlos), Sotomi, Y. (Yohei), Cavalcante, R. (Rafael), Asano, T. (Taku), Miyazaki, Y. (Yosuke), Tenekecioglu, E. (Erhan), Kistlaar, P. (Pieter), Zeng, Y. (Yaping), Suwanasson, P. (Pannipa), Winter, R.J. (Robbert) de, Nieman, K. (Koen), Serruys, P.W.J.C. (Patrick), and Onuma, Y. (Yoshinobu)
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To establish the accuracy of coronary computed tomography angiography (CTA) for in-scaffold quantitative evaluation with opti
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- 2017
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46. Reply: Percutaneous Revascularization of Left Main Disease: Could the Angiographic Follow-Up Improve the Survival?
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Cavalcante, R. (Rafael), Sotomi, Y. (Yohei), Lee, M.S. (Michael), Ahn, J.-M. (Jung-Min), Onuma, Y. (Yoshinobu), Park, S.-J. (Seung-Jung), Serruys, P.W.J.C. (Patrick), Cavalcante, R. (Rafael), Sotomi, Y. (Yohei), Lee, M.S. (Michael), Ahn, J.-M. (Jung-Min), Onuma, Y. (Yoshinobu), Park, S.-J. (Seung-Jung), and Serruys, P.W.J.C. (Patrick)
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- 2017
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47. Late thrombotic events after bioresorbable scaffold implantation: A systematic review andmeta-analysis of randomized clinical trials
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Collet, C. (Carlos), Asano, T. (Taku), Miyazaki, Y. (Yosuke), Tenekecioglu, E. (Erhan), Katagiri, Y. (Yuki), Sotomi, Y. (Yohei), Cavalcante, R. (Rafael), Winter, R.J. (Robbert) de, Kimura, T. (Takeshi), Gao, R. (Runlin), Puricel, S. (Serban), Cook, S., Capodanno, D. (Davide), Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), Collet, C. (Carlos), Asano, T. (Taku), Miyazaki, Y. (Yosuke), Tenekecioglu, E. (Erhan), Katagiri, Y. (Yuki), Sotomi, Y. (Yohei), Cavalcante, R. (Rafael), Winter, R.J. (Robbert) de, Kimura, T. (Takeshi), Gao, R. (Runlin), Puricel, S. (Serban), Cook, S., Capodanno, D. (Davide), Onuma, Y. (Yoshinobu), and Serruys, P.W.J.C. (Patrick)
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Aims To compare the long-term safety and efficacy of bioresorbable vascular scaffold (BVS) with everolimus-eluting stent (EES) after percutaneous coronary interventions. Methods and results A systematic review and meta-analysis of randomized clinical trials comparing clinical outcomes of patients treated with BVS and EES with at least 24 months follow-up was performed. Adjusted random-effect model by the Knapp- Hartung method was used to compute odds ratios (OR) and 95% confidence intervals (CI). The primary safety outcome of interest was the risk of definite/probable device thrombosis (DT). The primary efficacy outcome of interest was the risk of target lesion failure (TLF). Five randomized clinical trials (n= 1730) were included. Patients treated with Absorb BVS had a higher risk of definite/probable DT compared with patients treated with EES (OR 2.93, 95%CI 1.37-6.26, P= 0.01). Very late DT (VLDT) occurred in 13 patients [12/996 (1.4%, 95%CI: 0.08-2.5) Absorb BVS vs. 1/701 (0.5%, 95%CI: 0.2-1.6) EES; OR 3.04; 95%CI 1.2-7.68, P = 0.03], 92% of the VLDT in the BVS group occurred in the absence of dual antiplatelet therapy (DAPT). Patients treated with Absorb BVS had a trend towards higher risk of TLF (OR 1.48, 95%CI 0.90-2.42, P= 0.09), driven by a higher risk of target vessel myocardial infarction and ischaemia-driven target lesion revascularization. No difference was found in the risk of cardiac death. Conclusion Compared with EES, the use of Absorb BVS was associated with a higher rate of DT and a trend towards higher risk of TLF. VLDT occurred in 1.4% of the patients, the majority of these events occurred in the absence of DAPT.
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- 2017
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48. Impact of TCFA on Unanticipated Ischemic Events in Medically Treated Diabetes Mellitus: Insights From the PROSPECT Study
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Kedhi, E. (Elvin), Kennedy, M.W. (Mark W.), Maehara, A. (Akiko), Lansky, A.J. (Alexandra), McAndrew, T.C. (Thomas), Marso, S.P. (Steven), Bruyne, B. (Bernard) de, Serruys, P.W.J.C. (Patrick), Stone, G.W. (Gregg), Kedhi, E. (Elvin), Kennedy, M.W. (Mark W.), Maehara, A. (Akiko), Lansky, A.J. (Alexandra), McAndrew, T.C. (Thomas), Marso, S.P. (Steven), Bruyne, B. (Bernard) de, Serruys, P.W.J.C. (Patrick), and Stone, G.W. (Gregg)
- Abstract
Objectives This study sought to investigate the relationship between thin-cap fibroatheromas (TCFAs) on major adverse cardiac events (MACEs) arising from medically treated nonculprit lesions (NCLs) in patients with acute coronary syndromes (ACS) with and without diabetes mellitus (DM). Background MACEs occur frequently in patients with DM and ACS. The impact of plaque composition on subsequent MACEs in DM patients with ACS is unknown. Methods In the PROSPECT (Providing Regional Observations Study Predictors of Events in the Coronary Tree) study, using 3-vessel radiofrequency intravascular ultrasound, we analyzed the incidence of NCL-MACE in 2 propensity-matched groups according to the presence of DM and TCFA. Results Among 697 patients, 119 (17.7%) had DM. The 3-year total MACE rate (29.4% vs. 18.8%; p = 0.01) was significantly higher in patients with versus without DM, driven by a higher rate of NCL-MACE in DM (18.7% vs. 10.4%; p = 0.02). Propensity score matching generated 2 balanced groups with and without DM of 82 patients each. Among DM patients, the presence of ≥1 TCFA was associated with higher NCL-MACE at 3 years (27.8% vs. 8.9% in patients without a TCFA, hazard ratio: 3.56; 95% confidence interval: 0.98 to 12.96; p = 0.04). DM patients without a TCFA had a similar 3-year rate of NCL-MACE as patients without DM (8.9% vs. 8.9%; hazard ratio: 1.09; 95% confidence interval: 0.27 to 4.41; p = 0.90). Conclusions ACS patients with DM and ≥1 TCFA have a high rate of NCL-MACE at 3 years. In contrast, the prognosis of ACS patients with DM but no TCFAs is favorable and similar to patients without DM.
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- 2017
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49. Corrigendum to 'Assessment of the hemodynamic characteristics of Absorb BVS in a porcine coronary artery model' [Int. J. Cardiol. 227 (2017) 467-473]
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Tenekecioglu, E. (Erhan), Torii, K. (Kan), Bourantas, C.V. (Christos), Abdelghani, M. (Mohammad), Cavalcante, R. (Rafael), Sotomi, Y. (Yohei), Crake, T. (Tom), Su, S. (Solomon), Santoso, T. (Teguh), Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), Tenekecioglu, E. (Erhan), Torii, K. (Kan), Bourantas, C.V. (Christos), Abdelghani, M. (Mohammad), Cavalcante, R. (Rafael), Sotomi, Y. (Yohei), Crake, T. (Tom), Su, S. (Solomon), Santoso, T. (Teguh), Onuma, Y. (Yoshinobu), and Serruys, P.W.J.C. (Patrick)
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We realized that during the proof of our published article entitled “Assessment of the hemodynamic characteristics of Absorb BVS in a porcine coronary artery model” we made a mistake probably because of copy-paste process of the table sketch for Table 5b and Table 5c. We sincerely apologize for that mistake and kindly request from the journal to amend it. The authors would like to apologize for any inconvenience caused.
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- 2017
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50. Outcomes of Coronary Artery Bypass Graft Surgery Versus Drug-Eluting Stents in Older Adults
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Chang, M. (Mineok), Lee, M.S. (Michael), Ahn, J.-M. (Jung-Min), Cavalcante, R. (Rafael), Sotomi, Y. (Yohei), Onuma, Y. (Yoshinobu), Park, D.-W. (Duk-Woo), Kang, S.-J. (Soo-Jin), Lee, S.-W. (Seung-Whan), Kim, Y.-H. (Young-Hak), Park, S.-J. (Seung-Jung), Serruys, P.W.J.C. (Patrick), Chang, M. (Mineok), Lee, M.S. (Michael), Ahn, J.-M. (Jung-Min), Cavalcante, R. (Rafael), Sotomi, Y. (Yohei), Onuma, Y. (Yoshinobu), Park, D.-W. (Duk-Woo), Kang, S.-J. (Soo-Jin), Lee, S.-W. (Seung-Whan), Kim, Y.-H. (Young-Hak), Park, S.-J. (Seung-Jung), and Serruys, P.W.J.C. (Patrick)
- Abstract
_Objectives:_ Little data are available to compare coronary artery bypass graft surgery (CABG) vs percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in older adults. We evaluate the long-term outcomes of CABG vs PCI with DES in older adults with left main or multivessel coronary artery disease (CAD). _Design:_ Individual patient-level meta-analysis. _Settings:_ Databases from the BEST, PRECOMBAT, and SYNTAX trials were combined. _Participants:_ A total 1,079 adults aged 70 to 89 years were pooled. _Measurements:_ The primary outcome was a composite of death from any causes, myocardial infarction, stroke, or repeat revascularization. _Results:_ During a total of 6.3 (median, 4.9) years of follow-up, the primary composite outcome of all-cause mortality, myocardial infarction, stroke, or repeat revascularization occurred in 26% (141/550) and 34% (179/529) of patients in the CABG and PCI groups, respectively (hazard ratio (HR), 0.75; 95% confidence interval (CI), 0.60-0.94; P = .012). CABG was associated with fewer myocardial infarction (4% vs 8% for PCI; HR, 0.48; 95% CI, 0.29-0.80; P = .037); and repeat revascularizations (8% vs 17% for PCI; HR, 044; 95% CI, 0.31-0.64; P < .001), but had little association with all-cause mortality or stroke. _Conclusion:_ Older adults age 70 to 89 years with left main or multivessel CAD who
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- 2017
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