72 results on '"Garg, Scot"'
Search Results
2. Quantitative coronary computed tomography assessment for differentiating between total occlusions and severe stenoses.
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Masuda, Shinichiro, Revaiah, Pruthvi C., Kageyama, Shigetaka, Tsai, Tsung-Ying, Miyashita, Kotaro, Tobe, Akihiro, Puskas, John D., Teichgräber, Ulf, Schneider, Ulrich, Doenst, Torsten, Tanaka, Kaoru, De Mey, Johan, La Meir, Mark, Mushtaq, Saima, Bartorelli, Antonio L., Pompilio, Giulio, Garg, Scot, Andreini, Daniele, Onuma, Yoshinobu, and Serruys, Patrick W.
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- 2024
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3. Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial
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Gao, Chao, He, Xingqiang, Ouyang, Fan, Zhang, Zhihui, Shen, Guidong, Wu, Mingxing, Yang, Ping, Ma, Likun, Yang, Feng, Ji, Zheng, Wang, Hua, Wu, Yanqing, Fang, Zhenfei, Jiang, Hong, Wen, Shangyu, Liu, Yi, Li, Fei, Zhou, Jingyu, Zhu, Bin, Liu, Yunpeng, Zhang, Ruining, Zhang, Tingting, Wang, Ping, Liu, Jianzheng, Jiang, Zhiwei, Xia, Jielai, van Geuns, Robert-Jan, Capodanno, Davide, Garg, Scot, Onuma, Yoshinobu, Wang, Duolao, Serruys, Patrick W, and Tao, Ling
- Abstract
The long-term impact of drug-coated balloon (DCB) angioplasty for the treatment of patients with de novo coronary artery lesions remains uncertain. We aimed to assess the non-inferiority of DCB angioplasty with rescue stenting to intended drug-eluting stent (DES) deployment for patients with de novo, non-complex coronary artery lesions.
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- 2024
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4. Systematic screening by a heart team and a machine learning approach contribute to unraveling novel risk factors in revascularization candidates with complex coronary artery disease.
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Shigetaka Kageyama, Kai Ninomiya, Jonik, Szymon, Shinichiro Masuda, Revaiah, Pruthvi C., Tsung‑Ying Tsai, Garg, Scot, Onuma, Yoshinobu, Serruys, Patrick W., and Mazurek, Tomasz
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- 2024
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5. The Impact of Microvascular Resistance Reserve on the Outcome of Patients With STEMI.
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Tsai, Tsung-Ying, Aldujeli, Ali, Haq, Ayman, Knokneris, Aurimas, Briedis, Kasparas, Hughes, Diarmaid, Unikas, Ramunas, Renkens, Mick, Revaiah, Pruthvi C., Tobe, Akihiro, Miyashita, Kotaro, Sharif, Faisal, Garg, Scot, Onuma, Yoshinobu, and Serruys, Patrick W.
- Abstract
Microvascular resistance reserve (MRR) can characterize coronary microvascular dysfunction (CMD); however, its prognostic impact in ST-segment elevation myocardial infarction (STEMI) patients remains undefined. This study sought to investigate the prevalence of CMD in STEMI patients and to elucidate the prognostic performance of MRR. This prospective cohort study enrolled 210 STEMI patients with multivessel disease who underwent successful revascularization and returned at 3 months for coronary physiology assessments with bolus thermodilution. The prevalence of CMD (MRR <3) and the association between MRR and major adverse cardiovascular and cerebrovascular events (MACCEs) at 12 months were investigated. The median age of patients was 65 years, and 59.5% were men. At the 3-month follow-up, 56 patients (27%) had CMD (MRR <3.0). The number of MACCEs at 12 months was higher in patients with vs without CMD (48.2% vs 11.0%; P < 0.001). MRR was independently associated with 12-month MACCEs (HR: 0.45 per unit increase; 95% CI: 0.31-0.67; P < 0.001) and with stroke, heart failure, and poorer recovery in left ventricular systolic function. The areas under the receiver-operating characteristic curves for predicting MACCEs at 12 months with fractional flow reserve, coronary flow reserve (CFR), the index of microvascular resistance (IMR), and MRR were 0.609, 0.762, 0.781, and 0.743, respectively. The prognostic performance of CFR, IMR, and MRR were all comparable. The novel parameter MRR is a prognostic marker of MACCEs in STEMI patients with a comparable performance to CFR and IMR. (Impact of TMAO Serum Levels on Hyperemic IMR in STEMI Patients [TAMIR]; NCT05406297) [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2024
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6. LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial
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Baumbach, Andreas, van Royen, Niels, Amat-Santos, Ignacio J, Hudec, Martin, Bunc, Matjaz, Ijsselmuiden, Alexander, Laanmets, Peep, Unic, Daniel, Merkely, Bela, Hermanides, Renicus S, Ninios, Vlasis, Protasiewicz, Marcin, Rensing, Benno J W M, Martin, Pedro L, Feres, Fausto, De Sousa Almeida, Manuel, van Belle, Eric, Linke, Axel, Ielasi, Alfonso, Montorfano, Matteo, Webster, Mark, Toutouzas, Konstantinos, Teiger, Emmanuel, Bedogni, Francesco, Voskuil, Michiel, Pan, Manuel, Angerås, Oskar, Kim, Won-Keun, Rothe, Jürgen, Kristić, Ivica, Peral, Vicente, Garg, Scot, Elzomor, Hesham, Tobe, Akihiro, Morice, Marie-Claude, Onuma, Yoshinobu, Soliman, Osama, Serruys, Patrick W, Siqueira, Dimytri, Pinto, Ibraim, Cervone, Alberto, Assef, Jorge, Vilela, Andrea, Paladino, Antonio, Ramos, Auristela, Rezende, Mariana, Ghorayeb, Samira, Braga Silva, Tacianne Rolemberg, Gjorgjievska, Savica, Hadzibegovic, Irzal, Jurin, Ivana, Sipic, Tomislav, Pavlovic, Nikola, Rudez, Igor, Manola, Sime, GALLET DE SAINT-AURIN, Romain, BOUKANTAR, Madjid, NICOLAS, Eroan, ENNEZAT, Pierre Valdimir, URIEN, Jean Marie, Vincent, Flavien, Delhaye, Cedric, Denimal, Tom, Cosenza, Alessandro, Pamart, Thibault, Porouchani, Sina, Pontana, Francois, Montaigne, David, Balmette, Vincent, Bechiri, Mohamed, Chen, Elisabeth, Janah, Dany, Renker, Matthias, Westermann, Dirk, Valina, Christian, Ferenc, Miroslaw, Löffelhardt, Nikolaus, Rahimi, Faridun, Breitbart, Philipp, Franke, Kilian, Czerny, Martin, Diab, Nawras, Sick, Peter, Adeishvili, Medea, Mangner, Norman, Haussig, Stephan, Sveric, Krunuslav, Crusius, Lisa, Roehlig, Marie, Koliastasis, Leonidas, Drakopoulou, Maria, Katsaros, Odysseas, Ktenopoulos, Nikolaos, Ioanniadis, Andreas, Evangelou, Sotirios, Ninios, Ilias, Molnar, Levente, Papp, Roland, Arnold-Béla, Ferencz, Demeterné Kiss, Orsolya, Nagy, Andrea, Czimbalmos, Csilla, Pellegrinni, Dario, Montonati, Carolina, Pellicano, Mariano, Guagliumi, Giulio, Tespili, Maurizio, Barbara, Bellini, Filippo, Russo, Marco, Ancona, Ciro, Vella, Luca, Ferri, Eustachio, Agricola, Giacomo, Ingallina, Cannone, Gaspare, Brambilla, Nedy, Testa, Luca, Avondo, Stefano, Valvo, Roberto, Clarke, Robin, Fish, Mandy, Kosowski, Michal, Krawczyk, Magdalena, Kubler, Piotr, Kotwica, Tomasz, Teles, Rui, Gonçalves, Pedro, Raposo, Luis, Brito, Joã, Leal, Silvio, Freitas, Pedro, Ribeiras, Regina, Poliacikova, Petra, Mihailovic, Peter Marko, Terseglav, Simon, Steblovnik, Klemen, Cercek, Miha, Vitez, Luka, Sustersic, Miha, Kovac, Ana, Kogoj, Polonca, Dimitrovska, Ljupka, Arana, J.Raul Delgado, Martinez, Sandra Santos, Dieguez, Alfredo Redondo, Barrero, Alejandro, Gonzalez-Bartol, Esther, Aristizabal, Cristhian, Frutos, Ana Serrador, Luna, Juan Pablo Sanchez, Gomez, Mario Garcia, Gabella, Tania Rodriguez, Nelson, Verónica Quevedo, Medina, Jose Novoa, Ojeda, Soledad, de Lezo, Javier Suarez, Romero, Miguel, Gonzalez-Manzanares, Rafael, Alvarado, Marco, Mesa, Dolores, Perea, Jorge, Petursson, Petur, Alchay, Monér, Andréen, Sofie, Gameren, Menno Van, Heijer, Peter den, Meuwissen, Martijn, CHENG, JIN M., Vos, Jeroen, Schölzel, B.E., Simsek, C, Hubbers, S, Van den Branden, Ben J.L., Stens, NA, Versteeg, GAA, Rooijakkers, MJP, Gehlmann, HR, Verkroost, MWA, Geuzebroek, GSC, Van Wely, MH, Van Geuns, RJ, van Nunen, LX, van Garsse, LAFM, Timmers, L, ten Berg, Jurrien, Kraaijeveld, A.O., Dickinson, M.G., Dessing, T.C., and Mokhles, M.M.
- Abstract
Transcatheter aortic valve implantation is an established, guideline-endorsed treatment for severe aortic stenosis. Precise sizing of the balloon-expandable Myval transcatheter heart valve (THV) series with the aortic annulus is facilitated by increasing its diameter in 1·5 mm increments, compared with the usual 3 mm increments in valve size. The LANDMARK trial aimed to show non-inferiority of the Myval THV series compared with the contemporary THVs Sapien Series (Edwards Lifesciences, Irvine, CA, USA) or Evolut Series (Medtronic, Minneapolis, MN, USA).
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- 2024
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7. Coronary computed tomography angiography-based SYNTAX score for comprehensive assessment of advanced coronary artery disease.
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Kageyama, Shigetaka, Serruys, Patrick W., Kotoku, Nozomi, Garg, Scot, Ninomiya, Kai, Masuda, Shinichiro, Morel, Marie-angele, Taylor, Charles A., Rogers, Campbell, Thomsen, Brian, Pontone, Gianluca, Pompilio, Giulio, Puskas, John D., Doenst, Torsten, La Meir, Mark, Teichgräber, Ulf, Gupta, Himanshu, De Mey, Johan, Andreini, Daniele, and Onuma, Yoshinobu
- Abstract
Since the initial attempt to adapt the anatomical SYNTAX score (aSS) to coronary computed tomography angiography (CCTA), CCTA imaging technology has evolved, and is currently used as a "decision-maker" for revascularization strategy in complex coronary artery disease (CAD) and has rendered necessary some updating of the aSS to the CCTA modality. The aim is to provide updated definitions of the aSS derived from CCTA in patients with complex CAD undergoing CABG. The modifications of CCTA-aSS are the following; (i) updated definition and detection criteria of total occlusion (TO) in CCTA based on length assessment, (ii) inclusion of scoring points for serial bifurcations located in one single coronary segment. (iii) inclusion of weighing score points for lesions located distal to a TO, not visualized on conventional coronary angiography, but visible in CCTA, (iv) removal of thrombus and bridging collateral items from the weighing score, considering the limited diagnostic capability of CCTA in detecting these specific lesion characteristics. the updated CCTA-aSS was tested in a first-in-man study using the sole guidance of CCTA for the planning and performance of bypass surgery in complex CAD (n = 114). An interobserver analysis showed excellent reproducibility (ICC = 0.96, 95 % confidence interval 0.94–0.97). The updated CCTA-aSS was implemented in a cohort of patients with complex CAD undergoing CABG with the sole guidance of CCTA and FFR CT and the Inter-reproducibility of the analysis of the updated score was found excellent. The prognostic value of the modified CCTA-aSS will be examined in future studies. An extensive lesion that involves serially one trifurcation, one bifurcation, and one total occlusion. Figure caption: In this case, stenosis and lesion extend from #5 to #7. Diffuse LAD disease (%DS ≥ 50 more than 75 % in #6–7) involves 3 side branches and total occlusion (TO). Angiography (low panel left) presents a complex lesion involving left main trifurcation, LAD/diagonal bifurcation, and TO (continuation of the vessel is shown in the right lower MPR). Abbreviation: TO, total occlusion; LAD, left anterior descending; MPR, multiplanar reconstruction. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2024
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8. A Prospective Randomized Trial Comparing Sirolimus-Coated Balloon With Paclitaxel-Coated Balloon in De Novo Small Vessels.
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Ninomiya, Kai, Serruys, Patrick W., Colombo, Antonio, Reimers, Bernhard, Basavarajaiah, Sandeep, Sharif, Faisal, Testa, Luca, Di Mario, Carlo, Nerla, Roberto, Ding, Daixin, Huang, Jiayue, Kotoku, Nozomi, Kageyama, Shigetaka, Kageyama, Momoko, Sevestre, Emelyne, Fezzi, Simone, Dijkstra, Jouke, O'Leary, Neil, Morel, Marie Angele, and Garg, Scot
- Abstract
There are no data comparing sirolimus-coated balloons (SCBs [MagicTouch, Concept Medical]) to paclitaxel-coated balloons (PCBs [SeQuent Please Neo, B. Braun]) for the treatment of de novo small vessel disease (SVD). This study sought to compare quantitative coronary angiographic outcomes at 6 months after treatment of de novo SVD with a PCB or SCB. This prospective, multicenter, noninferiority trial randomized 121 patients (129 SVD lesions) to treatment with an SCB or PCB, with balloon sizing determined using optical coherence tomography. The primary endpoint was noninferiority for the 6-month angiographic net lumen gain. Angiographic follow-up was completed in 109 (90.1%) patients in the per-protocol analysis. The mean ± SD angiographic net gains were 0.25 ± 0.40 mm with SCBs vs 0.48 ± 0.37 mm with PCBs, resulting in SCBs failing to meet the 0.30 mm criterion for noninferiority (P noninferiority = 0.173), with an absolute difference of −0.23 mm (95% CI: −0.37 to −0.09) secondary to a smaller late loss (0.00 ± 0.32 mm vs 0.32 ± 0.47 mm; P < 0.001) and more frequent late lumen enlargement (53.7% vs 30.0%; OR: 2.60; 95% CI: 1.22-5.67; P = 0.014) with PCBs. Binary restenosis rates were 32.8% and 12.5% following treatment with SCBs and PCBs, respectively (OR: 3.41; 95% CI: 1.36-9.44; P = 0.012). The mean angiography-derived fractional flow ratio at follow-up was 0.86 ± 0.15 following treatment with SCBs and 0.91 ± 0.09 following PCBs (P = 0.026); a fractional flow ratio ≤0.80 occurred in 13 and 5 vessels after treatment with SCBs and PCBs, respectively. The SCB MagicTouch failed to demonstrate noninferiority for angiographic net lumen gain at 6 months compared to the PCB SeQuent Please Neo. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2023
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9. The ability of computed tomography angiography to predict 5-year mortality in the SYNTAX III REVOLUTION trial.
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Masuda, Shinichiro, Serruys, Patrick W., Mushtaq, Saima, Tanaka, Kaoru, Mandry, Damien, Buechel, Ronny R., Digne, Franck, Schneider, Ulrich, Pompilio, Giulio, La Meir, Mark, Doenst, Torsten, Teichgraber, Ulf, Morel, Marie-Angele, Kotoku, Nozomi, Ninomiya, Kai, Kageyama, Shigetaka, O'Leary, Neil, Collet, Carlos, Garg, Scot, and de Mey, Johan
- Abstract
The feasibility of using coronary computed tomography angiography (CCTA) for long-term prediction of vital prognosis post-revascularization remains unknown. To compare the prognostic value of the SYNTAX score II 2020 (SS-2020) derived from invasive coronary angiography (ICA) or CCTA in patients with three-vessel disease and/or left main coronary artery disease undergoing percutaneous or surgical revascularization. In the SYNTAX III REVOLUTION trial, the probability of death at five years was retrospectively assessed by calculating the SS-2020 using ICA and CCTA. High- and low-risk patients for mortality were categorized according to the median percentages of predicted mortality based on both modalities. The discriminative abilities of the SS-2020 were assessed using Harrell's C statistic. The vital status at five years of the 215 patients revascularized percutaneously (64 patients, 29.8%) or surgically (151 patients, 70.2%) was established through national registries. In patients undergoing revascularization, the SS-2020 was possibly helpful in discriminating vital prognosis at 5 years, with similar results seen with ICA and CCTA (C-index with ICA = 0.75, intercept = −0.19, slope = 0.92 and C-index with CCTA = 0.75, intercept = −0.22, slope = 0.99). In high- and low-risk patients, Kaplan-Meier estimates showed significant, and almost identical relative differences in observed mortality, irrespective of imaging modality (ICA: 93.8% vs 78.7%, log-lank P < 0.001; CCTA: 93.7% vs 78.5%, log-lank P < 0.001). The predictive ability of the SS-2020 for five-year all-cause mortality derived from ICA and CCTA was comparable, and could helpfully discriminate vital prognosis in high- and low-risk patients. [ABSTRACT FROM AUTHOR]
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- 2023
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10. Anonymous Comparison of Various Angiography-Derived Fractional Flow Reserve Software With Pressure-Derived Physiological Assessment.
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Ninomiya, Kai, Serruys, Patrick W., Kotoku, Nozomi, Zhou, Jinying, Kageyama, Shigetaka, Masuda, Shinichiro, Revaiah, Pruthvi C., Wang, Bo, He, Xingqiang, Tsai, Tsung-Ying, Kageyama, Momoko, Sevestre, Emelyne, Sharif, Faisal, Garg, Scot, Akasaka, Takashi, Escaned, Javier, Patel, Manesh R., and Onuma, Yoshinobu
- Abstract
Software to compute angiography-derived fractional flow reserve (angio-FFR) have been validated against pressure wire–derived fractional flow reserve (PW-FFR) with an area under the receiver-operating characteristic curve (AUC) of 0.93 to 0.97. The aim of this study was to investigate diagnostic accuracies of 5 angio-FFR software/methods by an independent core lab in a prospective cohort of 390 vessels with carefully documented sites of PW-FFR and pressure wire–derived instantaneous wave-free ratio. One "matcher investigator" colocalized on angiography the sites of pressure wire measurement with angio-FFR measurements and provided the same 2 optimal angiographic views and frame selection to independent analysts who were blinded to invasive physiological results and results from other software. The results were anonymized and randomly presented. The AUC of each angio-FFR was compared with 2-dimensional quantitative coronary angiography (QCA) percent diameter stenosis (%DS) using a 2-tailed paired comparison of AUC. All 5 software/methods yielded a high proportion of analyzable vessels (A: 100%, B: 100%, C: 92.1%, D: 99.5%, and E: 92.1%). The AUCs for predicting fractional flow reserve ≤0.8 for software A, B, C, D, E, and 2-dimensional QCA %DS were 0.75, 0.74, 0.74, 0.73, 0.73, and 0.65, respectively. The AUC for each angio-FFR was significantly greater than that for 2-dimensional QCA %DS. This head-to-head comparison by an independent core lab demonstrated that the diagnostic accuracy of various angio-FFR software for predicting PW-FFR ≤0.80 was useful, with a higher discrimination compared with 2-dimensional QCA %DS; however, it did not reach the diagnostic accuracy previously reported in validation studies of various vendors. Therefore, the intrinsic clinical value of "angiography-derived fractional flow reserve" requires confirmation in large clinical trials. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2023
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11. Impact of residual angina on long-term clinical outcomes after percutaneous coronary intervention or coronary artery bypass graft for complex coronary artery disease
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Ono, Masafumi, Serruys, Patrick W, Kawashima, Hideyuki, Lunardi, Mattia, Wang, Rutao, Hara, Hironori, Gao, Chao, Garg, Scot, O'Leary, Neil, Wykrzykowska, Joanna J, Piek, Jan J, Holmes, David R, Morice, Marie-Claude, Kappetein, Arie Pieter, Noack, Thilo, Davierwala, Piroze M, Spertus, John A, Cohen, David J, and Onuma, Yoshinobu
- Abstract
Graphical AbstractResidual angina, which was common (26.1%) at 1 year after coronary revascularization, was associated with repeat revascularization events up to 5 years, but not with all-cause death up to 10 years.
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- 2023
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12. Intravascular Ultrasound and Optical Coherent Tomography Combined Catheter.
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Kageyama, Shigetaka, Kotoku, Nozomi, Ninomiya, Kai, Masuda, Shinichiro, Huang, Jiayue, Okamura, Takayuki, Garg, Scot, Mori, Isao, Courtney, Brian, Sharif, Faisal, Bourantas, Christos V., Serruys, Patrick W., and Onuma, Yoshinobu
- Abstract
Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are established intravascular imaging tools for evaluating plaque characteristics and volume, together with guiding percutaneous coronary interventions. The high tissue penetration of IVUS facilitates assessment of the entire vessel wall, whereas the higher resolution of OCT allows detailed assessment of endoluminal structures. A combined IVUS-OCT probe works synergistically, facilitating a greater understanding of de novo coronary artery disease and a better correlation with pathological specimens. In this review, we discuss the rationale and potential roles of the combined IVUS–OCT catheter system. [ABSTRACT FROM AUTHOR]
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- 2023
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13. Neocommissural/Coronary Alignment With a Novel Balloon Expandable Transcatheter Aortic Valve: First-in-Human Experience.
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Revaiah, Pruthvi C., Jose, John, Gunasekaran, Sengottuvelu, Mandalay, Asishkumar, Garg, Scot, Bhatt, Sanjeev, Seth, Ashok, Soliman, Osama, Onuma, Yoshinobu, and Serruys, Patrick W.
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- 2023
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14. In the Beginning There Was Angina Pectoris, at the End There Was Still Angina Pectoris.
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Serruys, Patrick W., Kageyama, Shigetaka, Garg, Scot, and Onuma, Yoshinobu
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[Display omitted] [ABSTRACT FROM AUTHOR]
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- 2022
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15. Intravascular Ultrasound and Optical Coherent Tomography Combined Catheter
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Kageyama, Shigetaka, Kotoku, Nozomi, Ninomiya, Kai, Masuda, Shinichiro, Huang, Jiayue, Okamura, Takayuki, Garg, Scot, Mori, Isao, Courtney, Brian, Sharif, Faisal, Bourantas, Christos V., Serruys, Patrick W., and Onuma, Yoshinobu
- Abstract
Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are established intravascular imaging tools for evaluating plaque characteristics and volume, together with guiding percutaneous coronary interventions. The high tissue penetration of IVUS facilitates assessment of the entire vessel wall, whereas the higher resolution of OCT allows detailed assessment of endoluminal structures. A combined IVUS-OCT probe works synergistically, facilitating a greater understanding of de novo coronary artery disease and a better correlation with pathological specimens. In this review, we discuss the rationale and potential roles of the combined IVUS–OCT catheter system.
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- 2023
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16. Predicted and Observed Mortality at 10 Years in Patients With Bifurcation Lesions in the SYNTAX Trial.
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Ninomiya, Kai, Serruys, Patrick W., Garg, Scot, Gao, Chao, Masuda, Shinichiro, Lunardi, Mattia, Lassen, Jens F., Banning, Adrian P., Colombo, Antonio, Burzotta, Francesco, Morice, Marie-Claude, Mack, Michael J., Holmes, David R., Davierwala, Piroze M., Thuijs, Daniel J.F.M., van Klaveren, David, and Onuma, Yoshinobu
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Percutaneous coronary intervention (PCI) of bifurcation lesions is associated with higher rates of adverse events, and currently it is unclear whether PCI or coronary artery bypass grafting (CABG) is the safer treatment for these patients at very long-term follow-up. The aim of this study was to investigate the impact of bifurcation lesions on individual predicted and observed all-cause 10-year mortality in the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trial. In the SYNTAXES (SYNTAX Extended Survival) study, 10-year observed and individual predicted mortality derived from the SYNTAX score 2020 (SS-2020) was compared between patients with ≥1 bifurcation (n = 1,300) and those with no bifurcations (n = 487). Among patients treated with PCI, patients with >1 bifurcation lesion compared with those without bifurcation lesions had a significantly higher risk for all-cause death (19.8% vs 30.1%; HR: 1.55; 95% CI: 1.12-2.14; P = 0.007), whereas following CABG, mortality was similar in patients with and those without bifurcation lesions (23.3% vs 23.0%; HR: 0.81; 95% CI: 0.59-1.12; P = 0.207; P interaction = 0.006). In PCI patients, a 2-stent vs a 1-stent technique was associated with higher mortality (33.3% vs 25.9%; HR: 1.51; 95% CI: 1.06-2.14; P = 0.021). According to the SS-2020, among those with ≥1 bifurcation, there was equipoise for all-cause mortality between PCI and CABG in 2 quartiles of the population, whereas CABG was superior to PCI in the 2 remaining quartiles. Bifurcation lesions require special attention from the heart team, considering the higher 10-year all-cause mortality associated with PCI. Careful evaluation of bifurcation lesion complexity and calculation of individualized 10-year prognosis using the SS-2020 may therefore be helpful in decision making. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES], NCT03417050 ; Taxus Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX], NCT00114972) [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2022
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17. Effect of Patient-Reported Preprocedural Physical and Mental Health on 10-Year Mortality After Percutaneous or Surgical Coronary Revascularization
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Ono, Masafumi, Serruys, Patrick W., Garg, Scot, Kawashima, Hideyuki, Gao, Chao, Hara, Hironori, Lunardi, Mattia, Wang, Rutao, O’Leary, Neil, Wykrzykowska, Joanna J., Piek, Jan J., Mack, Michael J., Holmes, David R., Morice, Marie-Claude, Kappetein, Arie Pieter, Thuijs, Daniel J.F.M., Noack, Thilo, Mohr, Friedrich W., Davierwala, Piroze M., Spertus, John A., Cohen, David J., and Onuma, Yoshinobu
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- 2022
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18. Routine Pressure Wire Assessment Versus Conventional Angiography in the Management of Patients With Coronary Artery Disease: The RIPCORD 2 Trial
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Stables, Rodney H., Mullen, Liam J., Elguindy, Mostafa, Nicholas, Zoe, Aboul-Enien, Yousra H., Kemp, Ian, O’Kane, Peter, Hobson, Alex, Johnson, Thomas W., Khan, Sohail Q., Wheatcroft, Stephen B., Garg, Scot, Zaman, Azfar G., Mamas, Mamas A., Nolan, James, Jadhav, Sachin, Berry, Colin, Watkins, Stuart, Hildick-Smith, David, Gunn, Julian, Conway, Dwayne, Hoye, Angels, Fazal, Iftikhar A., Hanratty, Colm G., De Bruyne, Bernard, and Curzen, Nick
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- 2022
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19. Angiography-derived physiology guidance vs usual care in an All-comers PCI population treated with the healing-targeted supreme stent and Ticagrelor monotherapy: PIONEER IV trial design.
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Hara, Hironori, Serruys, Patrick W., O'Leary, Neil, Gao, Chao, Murray, Alicia, Breslin, Elaine, Garg, Scot, Bureau, Christophe, Reiber, Johan HC, Barbato, Emanuele, Aminian, Adel, Janssens, Luc, Rosseel, Liesbeth, Benit, Edouard, Campo, Gianluca, Guiducci, Vincenzo, Casella, Gianni, Santarelli, Andrea, Franzè, Alfonso, and Diaz, Victor Alfonso Jimenez
- Abstract
Background: Current ESC guidelines recommend the use of intra-coronary pressure guidewires for functional assessment of intermediate-grade coronary stenoses. Angiography-derived quantitative flow ratio (QFR) is a novel method of assessing these stenoses, and guiding percutaneous coronary intervention (PCI).Methods/design: The PIONEER IV trial is a prospective, all-comers, multi-center trial, which will randomize 2,540 patients in a 1:1 ratio to PCI guided by angiography-derived physiology or usual care, with unrestricted use in both arms of the Healing-Targeted Supreme sirolimus-eluting stent (HT Supreme). The stent's fast, biologically healthy, and robust endothelial coverage allows for short dual-antiplatelet therapy (DAPT); hence the antiplatelet regimen of choice is 1-month DAPT, followed by ticagrelor monotherapy. In the angiography-derived physiology guided arm, lesions will be functionally assessed using on-line QFR, with stenting indicated in lesions with a QFR ≤0.80. Post-stenting, QFR will be repeated in the stented vessel(s), with post-dilatation or additional stenting recommended if the QFR<0.91 distal to the stent, or if the delta QFR (across the stent) is >0.05. Usual care PCI is performed according to standard clinical practice. The primary endpoint is a non-inferiority comparison of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization with a non-inferiority risk-difference margin of 3.2%, at 1-year post-procedure. Clinical follow-up will be up to 3 years.Summary: The PIONEER IV trial aims to demonstrate non-inferiority of QFR-guided PCI to usual care PCI with respect to POCE at 1-year in patients treated with HT Supreme stents and ticagrelor monotherapy.Clinical Trial Registration: ClinicalTrials.gov UNIQUE IDENTIFIER: NCT04923191 CLASSIFICATIONS: Interventional Cardiology. [ABSTRACT FROM AUTHOR]- Published
- 2022
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20. 10-Year All-Cause Mortality Following Percutaneous or Surgical Revascularization in Patients With Heavy Calcification.
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Kawashima, Hideyuki, Serruys, Patrick W., Hara, Hironori, Ono, Masafumi, Gao, Chao, Wang, Rutao, Garg, Scot, Sharif, Faisal, de Winter, Robbert J., Mack, Michael J., Holmes, David R., Morice, Marie-Claude, Kappetein, Arie Pieter, Thuijs, Daniel J.F.M., Milojevic, Milan, Noack, Thilo, Mohr, Friedrich-Wilhelm, Davierwala, Piroze M., and Onuma, Yoshinobu
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The aim of this study was to assess 10-year all-cause mortality in patients with heavily calcified lesions (HCLs) undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Limited data are available on very long term outcomes in patients with HCLs according to the mode of revascularization. This substudy of the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study assessed 10-year all-cause mortality according to the presence of HCLs within lesions with >50% diameter stenosis and identified during the calculation of the anatomical SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score among 1,800 patients with the 3-vessel disease and/or left main disease randomized to PCI or CABG in the SYNTAX trial. Patients with HCLs were further stratified according to disease type (3-vessel disease or left main disease) and assigned treatment (PCI or CABG). The 532 patients with ≥1 HCL had a higher crude mortality rate at 10 years than those without (36.4% vs 22.3%; HR: 1.79; 95% CI: 1.49-2.16; P < 0.001). After adjustment, an HCL remained an independent predictor of 10-year mortality (HR: 1.36; 95% CI: 1.09-1.69; P = 0.006). There was a significant interaction in mortality between treatment effect (PCI and CABG) and the presence or absence of HCLs (P interaction = 0.005). In patients without HCLs, mortality was significantly higher after PCI than after CABG (26.0% vs 18.8%; HR: 1.44; 95% CI: 0.97-1.41; P = 0.003), whereas in those with HCLs, there was no significant difference (34.0% vs 39.0%; HR: 0.85; 95% CI: 0.64-1.13; P = 0.264). At 10 years, the presence of an HCL was an independent predictor of mortality, with a similar prognosis following PCI or CABG. Whether HCLs require special consideration when deciding the mode of revascularization beyond their current contribution to the anatomical SYNTAX score deserves further evaluation. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES], NCT03417050 ; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX], NCT00114972) [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2022
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21. Sex-Related Outcomes of Successful Drug-Coated Balloon Treatment in De Novo Coronary Artery Disease.
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Liu Kun, Eun-Seok Shin, Eun Jung Jun, Bhak, Youngjune, Garg, Scot, Tae-Hyun Kim, Chang-Bae Sohn, Byung Joo Choi, Lin Hui, Song Lin Yuan, Wang Zhi, Jiang Hao, Shi Zhentao, and Tang Qiang
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Purpose: Although drug-coated balloon (DCB) treatment is known to be effective for de novo lesions, the influence of sex on angiographic and clinical outcomes remains unknown. This study aimed to investigate the angiographic and clinical impact of DCB treatment in patients with de novo coronary lesions according to sex. Materials and Methods: A total of 227 patients successfully treated with DCB were retrospectively enrolled and divided into two groups according to sex. The primary endpoint was late lumen loss (LLL) at 6-month angiography, and the secondary endpoint was target vessel failure (TVF), which included cardiac death, target vessel myocardial infarction, target lesion revascularization, and target vessel thrombosis. Results: The study enrolled 60 women (26.4%) and 167 men (73.6%). Compared to men, women had a smaller vessel size, larger DCB to reference vessel ratio, and more dissections after DCB treatment (55.0% vs. 37.1%, p=0.016). Women also had a significantly higher LLL compared to men (0.12±0.26 mm vs. 0.02±0.22 mm, p=0.012) at the 6-month follow-up angiography. During a median follow-up of 3.4 years (range 12.7-28.9 months), TVF was similar (women 6.7% vs. men 7.8%, p=0.944). In multivariable analysis, women were independently associated with a higher LLL. Conclusion: LLL was higher in women, but there was no difference in TVF between women and men. Based on multivariable analysis, the women sex was an independent predictor of higher LLL (Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion; NCT04619277). [ABSTRACT FROM AUTHOR]
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- 2021
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22. A prospective multicenter validation study for a novel angiography-derived physiological assessment software: Rationale and design of the radiographic imaging validation and evaluation for Angio-iFR (ReVEAL iFR) study.
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Ono, Masafumi, Serruys, Patrick W., Patel, Manesh R., Escaned, Javier, Akasaka, Takashi, Lavieren, Martijn A. van, Haase, Christian, Grass, Michael, Kogame, Norihiro, Hara, Hironori, Kawashima, Hideyuki, Wykrzykowska, Joanna J., Piek, Jan J., Garg, Scot, O'Leary, Neil, Inderbitzen, Becky, and Onuma, Yoshinobu
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Angiography-derived physiological assessment of coronary lesions has emerged as an alternative to wire-based assessment aiming at less-invasiveness and shorter procedural time as well as cost effectiveness in physiology-guided decision making. However, current available image-derived physiology software have limitations including the requirement of multiple projections and are time consuming. METHODS/DESIGN: The ReVEAL iFR (Radiographic imaging Validation and EvALuation for Angio-iFR) trial is a multicenter, multicontinental, validation study which aims to validate the diagnostic accuracy of the Angio-iFR medical software device (Philips, San Diego, US) in patients undergoing angiography for Chronic Coronary Syndrome (CCS). The Angio-iFR will enable operators to predict both the iFR and FFR value within a few seconds from a single projection of cine angiography by using a lumped parameter fluid dynamics model. Approximately 440 patients with at least one de-novo 40% to 90% stenosis by visual angiographic assessment will be enrolled in the study. The primary endpoint is the sensitivity and specificity of the iFR and FFR for a given lesion compared to the corresponding invasive measures. The enrollment started in August 2019, and was completed in March 2021. SUMMARY: The Angio-iFR system has the potential of simplifying physiological evaluation of coronary stenosis compared with available systems, providing estimates of both FFR and iFR. The ReVEAL iFR study will investigate the predictive performance of the novel Angio-iFR software in CCS patients. Ultimately, based on its unique characteristics, the Angio-iFR system may contribute to improve adoption of functional coronary assessment and the workflow in the catheter laboratory. [ABSTRACT FROM AUTHOR]
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- 2021
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23. Have We Overdefined Periprocedural Myocardial Infarction to the Point of Extinction?
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Serruys, Patrick W., Hara, Hironori, Garg, Scot, and Onuma, Yoshinobu
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[Display omitted] [ABSTRACT FROM AUTHOR]
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- 2021
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24. PRECISE-DAPT score for bleeding risk prediction in patients on dual or single antiplatelet regimens: insights from the GLOBAL LEADERS and GLASSY
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Gragnano, Felice, Heg, Dik, Franzone, Anna, McFadden, Eugène P, Leonardi, Sergio, Piccolo, Raffaele, Vranckx, Pascal, Branca, Mattia, Serruys, Patrick W, Benit, Edouard, Liebetrau, Christoph, Janssens, Luc, Ferrario, Maurizio, Zurakowski, Aleksander, Diletti, Roberto, Dominici, Marcello, Huber, Kurt, Slagboom, Ton, Buszman, Paweł, Bolognese, Leonardo, Tumscitz, Carlo, Bryniarski, Krzysztof, Aminian, Adel, Vrolix, Mathias, Petrov, Ivo, Garg, Scot, Naber, Christoph, Prokopczuk, Janusz, Hamm, Christian, Steg, Philippe Gabriel, Jüni, Peter, Windecker, Stephan, and Valgimigli, Marco
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- 2022
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25. Mortality after multivessel revascularisation involving the proximal left anterior descending artery
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Ono, Masafumi, Hara, Hironori, Gao, Chao, Kawashima, Hideyuki, Wang, Rutao, O’Leary, Neil, Wykrzykowska, Joanna J, Piek, Jan J, Mack, Michael J, Holmes, David, Morice, Marie-Claude, Head, Stuart, Kappetein, Arie Pieter, Noack, Thilo, Davierwala, Piroze M, Mohr, Friedrich W, Garg, Scot, Onuma, Yoshinobu, and Serruys, Patrick W
- Abstract
ObjectiveWe sought to investigate whether long-term clinical outcomes differ following percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with three-vessel disease (3VD) and lesions in the proximal left anterior descending artery (P-LAD).MethodsThis post-hoc analysis of the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) Extended Survival study included patients with 3VD who were classified according to the presence or absence of lesions located in the P-LAD. Ten-year all-cause death and 5-year major adverse cardiac or cerebrovascular events (MACCE) were assessed.ResultsAmong 1088 patients with 3VD, 559 (51.4%) had involvement of P-LAD and their 10-year mortality was numerically higher following PCI versus CABG (28.9% vs 21.9%; HR: 1.39, 95% CI 0.99 to 1.95). Although patients without P-LAD lesions had significantly higher 10-year mortality following PCI compared with CABG, there was no evidence of a treatment-by-subgroup interaction (28.8% vs 20.2%; HR: 1.47, 95% CI 1.03 to 2.09, pinteraction=0.837). The incidence of MACCE at 5 years was significantly higher with PCI than CABG, irrespective of involvement of P-LAD (with P-LAD: HR: 1.86, 95% CI 1.36 to 2.55; without P-LAD: HR: 1.54, 95% CI 1.11 to 2.12; pinteraction=0.408). Individualised assessment using the SYNTAX Score II 2020 established that a quarter of patients with P-LAD lesions had significantly higher mortality with PCI than CABG, whereas in the remaining three-quarters CABG had similar mortality.ConclusionsAmong patients with 3VD, the presence or absence of a P-LAD lesion was not associated with any treatment effect on long-term outcomes following PCI or CABG.Trial registration numberSYNTAXES: NCT03417050; SYNTAX: NCT00114972.
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- 2022
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26. Aspirin-free antiplatelet regimens after PCI: insights from the GLOBAL LEADERS trial and beyond
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Wang, Rutao, Wu, Sijing, Gamal, Amr, Gao, Chao, Hara, Hironori, Kawashima, Hideyuki, Ono, Masafumi, van Geuns, Robert-Jan, Vranckx, Pascal, Windecker, Stephan, Onuma, Yoshinobu, Serruys, Patrick W, and Garg, Scot
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Historically, aspirin has been the primary treatment for the prevention of ischaemic events in patients with coronary artery disease. For patients undergoing percutaneous coronary intervention (PCI) standard treatment has been 12 months of dual antiplatelet therapy (DAPT) with aspirin and clopidogrel, followed by aspirin monotherapy; however, DAPT is undeniably associated with an increased risk of bleeding. For over a decade novel P2Y12inhibitors, which have increased specificity, potency, and efficacy have been available, prompting studies which have tested whether these newer agents can be used in aspirin-free antiplatelet regimens to augment clinical benefits in patients post-PCI. Among these studies, the GLOBAL LEADERS trial is the largest by cohort size, and so far has provided a wealth of evidence in a variety of clinical settings and patient groups. This article summarizes the state-of-the-art evidence obtained from the GLOBAL LEADERS and other trials of aspirin-free strategies.
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- 2021
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27. Impact of Dissection after Drug-Coated Balloon Treatment of De Novo Coronary Lesions: Angiographic and Clinical Outcomes.
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Lin Hui, Eun-Seok Shin, Eun Jung Jun, Youngjune Bhak, Garg, Scot, Tae-Hyun Kim, Chang-Bae Sohn, Byung Joo Choi, Liu Kun, Song Lin Yuan, Wang Zhi, Jiang Hao, Shi Zhentao, and Tang Qiang
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Purpose: Dissection after plain balloon angioplasty is required to achieve adequate luminal area; however, it is associated with a high risk of vascular events. This study aimed to examine the relationship between non-flow limiting coronary dissections and subsequent lumen loss and long-term clinical outcomes following successful drug-coated balloon (DCB) treatment of de novo coronary lesions. Materials and Methods: A total of 227 patients with good distal flow (Thrombolysis in Myocardial Infarction flow grade 3) following DCB treatment were retrospectively enrolled and stratified according to the presence or absence of a non-flow limiting dissection. The primary endpoint was late lumen loss (LLL) at 6-month angiography, and the secondary endpoint was target vessel failure (TVF, a composite of cardiac death, target vessel myocardial infarction, target vessel revascularization, and target vessel thrombosis). Results: The cohort consisted of 95 patients with and 132 patients without a dissection. There were no between-group differences in LLL (90.8%) returning for angiography at 6 months (0.05±0.19 mm in non-dissection and 0.05±0.30 mm in dissection group, p= 0.886) or in TVF (6.8% in non-dissection and 8.4% in dissection group, p=0.799) at a median follow-up of 3.4 years. In a multivariate analysis, the presence of dissection and its severity were not associated with LLL or TVF. Almost dissections (93.9%) were completely healed, and there was no newly developed dissection at 6-month angiography. Conclusion: The presence of a dissection following successful DCB treatment of a de novo coronary lesion may not be associated with an increased risk of LLL or TVF (Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion; NCT04619277). [ABSTRACT FROM AUTHOR]
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- 2020
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28. Effect of Sex Difference of Coronary Microvascular Dysfunction on Long-Term Outcomes in Deferred Lesions.
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Chung, Ju-Hyun, Lee, Kyung Eun, Lee, Joo Myung, Her, Ae-Young, Kim, Chee Hae, Choi, Ki Hong, Song, Young Bin, Hahn, Joo-Yong, Kim, Hyung Yoon, Choi, Jin-Ho, Garg, Scot, Doh, Joon-Hyung, Nam, Chang-Wook, Koo, Bon-Kwon, and Shin, Eun-Seok
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This study investigated the sex difference of long-term cardiovascular outcomes on coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) in patients with deferred coronary artery lesions. Coronary microvascular dysfunction is associated with poorer long-term outcomes. It can be assessed by CFR and the IMR. The study prospectively enrolled 434 patients (133 women and 301 men) and analyzed CFR, IMR, fractional flow reserve, and quantitative coronary angiography. Clinical outcomes were assessed by major adverse cardiovascular event(s) (MACE) of cardiac death, myocardial infarction, and revascularization during 5 years of follow-up. The study protocol was approved by the Institutional Review Board or Ethics Committee at each participating center, and all patients provided written informed consent. The study protocol was in accordance with the Declaration of Helsinki. Women had milder epicardial disease compared with men (fractional flow reserve: 0.91 [interquartile range (IQR): 0.87 to 0.96] vs. 0.90 [IQR: 0.86 to 0.95]; p = 0.037). IMR was similar between the sexes, but CFR was lower in women (2.69 [IQR: 2.08 to 3.90] vs. 3.20 [IQR: 2.20 to 4.31]; p = 0.006) due to a shorter resting mean transit time, whereas hyperemic mean transit times were similar. At 5-year follow-up, MACE was significantly lower in women compared with men (1.1% vs. 5.5%; p = 0.017). Sex, diabetes mellitus, and CFR were independent predictors for MACE for all patients. The risk of MACE was significantly higher in men with low versus high CFR (hazard ratio: 4.58; 95% confidence interval: 1.85 to 11.30; p = 0.011) which was not seen in women. There was no sex difference in microvascular function by IMR. CFR was lower in women due to a higher resting coronary flow; however, long-term clinical outcomes in deferred lesions were better in women compared with men. (Clinical, Physiological and Prognostic Implication of Microvascular Status; NCT02186093). [ABSTRACT FROM AUTHOR]
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- 2020
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29. 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, Chao, Buszman, Piotr, Buszman, Paweł, Chichareon, Ply, Modolo, Rodrigo, Garg, Scot, Takahashi, Kuniaki, Kawashima, Hideyuki, Wang, Rutao, Chang, Chun Chin, Kogame, Norihiro, Tomaniak, Mariusz, Ono, Masafumi, Hara, Hironori, Slagboom, Ton, Aminian, Adel, Naber, Christoph Kurt, Carrie, Didier, Hamm, Christian, Steg, Philippe Gabriel, Onuma, Yoshinobu, Geuns, Robert-Jan van, Serruys, Patrick W., and Zurakowski, Aleksander
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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.
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- 2021
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30. Pitfalls of Simplifying the Original SYNTAX Score: A Temptation That Should Be Resisted.
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Kageyama, Shigetaka, Onuma, Yoshinobu, Garg, Scot, and Serruys, Patrick W.
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- 2023
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31. CRT-100.03 Pre- and Post-Percutaneous Coronary Intervention Quantitative Flow Ratio: An Analysis and Tentative Prediction of 2-Year Vessel-Oriented Composite Events in the MULTIVESSEL TALENT Trial.
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Serruys, Patrick W., Kageyama, Shigetaka, O'Leary, Neil, Revaiah, Purthvi Chenniganahosahalli, Ninomiya, Kai, Masuda, Shinichiro, Kotoku, Nozomi, Garg, Scot, Reiber, Johan HC., Tu, Shengxian, Zaman, Azfar, Sabaté, Manel, Möllmann, Helge, Sharif, Faisal, Lemoine, Julien, Wlodarczak, Adrian, and Onuma, Yoshinobu
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- 2023
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32. Comparative Assessment of Predictive Performance of PRECISE-DAPT, CRUSADE, and ACUITY Scores in Risk Stratifying 30-Day Bleeding Events
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Kawashima, Hideyuki, Gao, Chao, Takahashi, Kuniaki, Tomaniak, Mariusz, Ono, Masafumi, Hara, Hironori, Wang, Rutao, Chichareon, Ply, Suryapranata, Harry, Walsh, Simon, Cotton, James, Koning, Rene, Rensing, Benno, Wykrzykowska, Joanna, de Winter, Robbert J., Garg, Scot, Anderson, Richard, Hamm, Christian, Steg, Philippe Gabriel, Onuma, Yoshinobu, and Serruys, Patrick W.
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- 2020
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33. 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, Ana Paula, Modolo, Rodrigo, Chichareon, Ply, Chang, Chun-Chin, Kogame, Norihiro, Tomaniak, Mariusz, Takahashi, Kuniaki, Rademaker-Havinga, Tessa, Wykrzykowska, Joanna, de Winter, Rob J., Ferreira, Rui C., Sousa, Amanda, Lemos, Pedro A., Garg, Scot, Hamm, Christian, Juni, Peter, Vranckx, Pascal, Valgimigli, Marco, Windecker, Stephan, Onuma, Yoshinobu, Steg, Philippe Gabriel, and Serruys, Patrick W.
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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.
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- 2020
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34. Association of Sex With Outcomes in Patients Undergoing Percutaneous Coronary Intervention: A Subgroup Analysis of the GLOBAL LEADERS Randomized Clinical Trial
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Chichareon, Ply, Modolo, Rodrigo, Kerkmeijer, Laura, Tomaniak, Mariusz, Kogame, Norihiro, Takahashi, Kuniaki, Chang, Chun-Chin, Komiyama, Hidenori, Moccetti, Tiziano, Talwar, Suneel, Colombo, Antonio, Maillard, Luc, Barlis, Peter, Wykrzykowska, Joanna, Piek, Jan J., Garg, Scot, Hamm, Christian, Steg, Philippe Gabriel, Jüni, Peter, Valgimigli, Marco, Windecker, Stephan, Onuma, Yoshinobu, Mehran, Roxana, and Serruys, Patrick W.
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IMPORTANCE: Women experience worse ischemic and bleeding outcomes after percutaneous coronary intervention (PCI). OBJECTIVES: To assess the association of sex with patient outcomes at 2 years after contemporary PCI and with the efficacy and safety of 2 antiplatelet strategies. DESIGN, SETTING, AND PARTICIPANTS: This study is a prespecified subgroup analysis of the investigator-initiated, prospective, randomized GLOBAL LEADERS study evaluating 2 strategies of antiplatelet therapy after PCI in an unselected population including 130 secondary/tertiary care hospitals in different countries. The main study enrolled 15 991 unselected patients undergoing PCI between July 2013 and November 2015. Patients had an outpatient clinic visit at 30 days and 3, 6, 12, 18, and 24 months after the index procedure. Data were analyzed between January 1, 2019, and March 31, 2019. INTERVENTIONS: Eligible patients were randomized to either the experimental or reference antiplatelet strategy. Experimental strategy consisted of 1 month of dual antiplatelet therapy (DAPT) followed by 23 months of ticagrelor monotherapy, while the reference strategy comprised of 12 months of DAPT followed by 12 months of aspirin monotherapy. MAIN OUTCOMES AND MEASURES: The primary efficacy end point was the composite of all-cause mortality and new Q-wave myocardial infarction at 2 years. The secondary safety end point was Bleeding Academic Research Consortium type 3 or 5 bleeding. RESULTS: Of the 15 968 patients included in this study, 3714 (23.3%) were women. The risk of the primary end point at 2 years was similar between women and men (adjusted hazard ratio [HR], 1.00; 95% CI, 0.83-1.20). Compared with men, women had higher risk of Bleeding Academic Research Consortium type 3 or 5 bleeding (adjusted HR, 1.32; 95% CI, 1.04-1.67) and hemorrhagic stroke at 2 years (adjusted HR, 4.76; 95% CI, 1.92-11.81). At 2 years, there was no between-sex difference in the efficacy and safety of the 2 antiplatelet strategies. At 1 year, compared with DAPT, ticagrelor monotherapy was associated with a lower risk of bleeding in men (HR, 0.72; 95% CI, 0.53-0.98) but not in women (HR, 1.23; 95% CI, 0.80-1.89; P for interaction = .045). CONCLUSIONS AND RELEVANCE: Compared with men, women experienced a higher risk of bleeding and hemorrhagic stroke after PCI. The effect of 2 antiplatelet strategies on death and Q-wave myocardial infarction following PCI did not differ between the sexes at 2 years. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01813435
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- 2020
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35. Quantitative Aortography analysis of JenaValve´s Trilogy TAVI system in Patients with Aortic Regurgitation or Stenosis
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Tsai, Tsung-Ying, Elzomor, Hesham, Wienemann, Hendrik, Revaiah, Pruthvi Chenniganahosahalli, von Bardeleben, Ralph Stephan, Tamm, Alexander, Garg, Scot, Soliman, Osama, Onuma, Yoshinobu, Figulla, Hans R., Adam, Matti, Rudolph, Tanja, and Serruys, Patrick W.
- Abstract
JenaValve’s Trilogy transcatheter heart valve (THV) (JenaValve Inc., Irvine, CA) is the only CE-marked THV system for the treatment of aortic regurgitation (AR) or aortic stenosis (AS). However, its efficacy has not been quantitatively investigated pre- and post-implantation using video-densitometric analysis.
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- 2024
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36. Short-Term Outcomes of ACURATE neo2
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Tobe, Akihiro, Garg, Scot, Möllmann, Helge, Rück, Andreas, Kim, Won-Keun, Buono, Andrea, Scotti, Andrea, Latib, Azeem, Toggweiler, Stefan, Mangieri, Antonio, Laine, Mika, Meduri, Christopher U., Rheude, Tobias, Wong, Ivan, Pruthvi, Chenniganahosahalli Revaiah, Tsai, Tsung-Ying, Onuma, Yoshinobu, and Serruys, Patrick W.
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Inferior outcomes with ACURATE neo, a self-expanding transcatheter heart valve (THV) for the treatment of severe aortic stenosis, were mainly driven by higher rates of moderate/severe paravalvular leak (PVL). To overcome this limitation, the next-generation ACURATE neo2 features a 60% larger external sealing skirt. Data on long-term performance are limited; however, clinical evidence suggests improved short-term performance which is comparable to contemporary THVs. This report reviews data on short-term clinical and echocardiographic outcomes of ACURATE neo2. A PubMed search yielded 13 studies, including 5 single arm and 8 nonrandomized comparative studies with other THVs which reported in-hospital or 30-day clinical and echocardiographic outcomes. In-hospital or 30-day all-cause mortality was ≤3.3%, which is comparable to other contemporary THVs. The rates of postprocedural ≧moderate PVL ranged 0.6%-4.7%. In multicenter propensity-matched analyses, neo2 significantly reduced the rate of ≧moderate PVL compared to neo (3.5% vs. 11.3%, p < 0.01), whereas rates were comparable to Evolut Pro/Pro+ (Neo2: 2.0% vs. Pro/Pro+: 3.1%, p = 0.28) and SAPIEN 3 Ultra (Neo2: 0.6% vs. Ultra: 1.1%, p = 0.72). The rate of permanent pacemaker implantation with neo2 was consistently low (3.3%-8.6%) except in one study, and in propensity-matched analyses were significantly lower than Evolut Pro/Pro+ (6.7% vs. 16.7%, p < 0.01), and comparable to SAPIEN 3 Ultra (8.1% vs. 10.3%, p = 0.29). In conclusion, ACURATE neo2 showed better short-term performance by considerably reducing PVL compared to its predecessor, with short-term clinical and echocardiographic outcomes comparable to contemporary THVs.
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- 2024
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37. CRT-100.08 Can a Machine Learning-Based Approach Improve Risk Prediction and Individualise Decision Making Between Percutaneous and Surgical Revascularisation in Patients With Complex Coronary Artery Disease?
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Ninomiya, Kai, Kageyama, Shigetaka, Shiomi, Hiroki, Kotoku, Nozomi, Masuda, Shinichiro, Revaiah, Pruthvi, Garg, Scot, O'leary, Neil, Kimura, Takeshi, Onuma, Yoshinobu, and Serruys, Patrick
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- 2023
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38. CRT-100.02 On-Pump and Off-Pump Coronary Artery Bypass Grafting on 10-Year Mortality Versus Percutaneous Coronary Intervention.
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Serruys, Patrick W., Kageyama, Shigetaka, Ninomiya, Kai, O'Leary, Neil, Masuda, Shinichiro, Kotoku, Nozomi, Colombo, Antonio, van Geuns, Robert-Jan, Milojevic, Milan, Mack, Michael J., Soo, Alan, Garg, Scot, and Onuma, Yoshinobu
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- 2023
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39. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vsaspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial
- Author
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Vranckx, Pascal, Valgimigli, Marco, Jüni, Peter, Hamm, Christian, Steg, Philippe Gabriel, Heg, Dik, van Es, Gerrit Anne, McFadden, Eugene P, Onuma, Yoshinobu, van Meijeren, Cokky, Chichareon, Ply, Benit, Edouard, Möllmann, Helge, Janssens, Luc, Ferrario, Maurizio, Moschovitis, Aris, Zurakowski, Aleksander, Dominici, Marcello, Van Geuns, Robert Jan, Huber, Kurt, Slagboom, Ton, Serruys, Patrick W, Windecker, Stephan, Abdellaoui, Mohamed, Adlam, David, Akin, Ibrahim, Albarran Gonzalez-Trevilla, Agustin, Almeida, Manuel, Alves Lemos Neto, Pedro, Aminian, Adel, Anderson, Richard, Andreae, Rick, Angioi, Michael, Asano, Taku, Barbato, Emanuele, Barlis, Peter, Barraud, Pascal, Benit, Edouard, Bertrand, Olivier, Beygui, Farzin, Bolognese, Leonardo, Botelho, Roberto, Bouwman, Coby, Bressers, Marco, Brunel, Philippe, Buszman, Pawel, Buysschaert, Ian, Canas da Silva, Pedro, Carrie, Didier, Cequier, Angel, Chichareon, Ply, Chin Chang, Chun, Chowdhary, Saqib, Collet, Carlos, Colombo, Antonio, Cotton, James, Cruz Ferreira, Rui, Curello, Salvatore, Curzen, Nick, de Bot, Judith, de Vreede, Tone, Delle Karth, Georg, Dijksma, Lynn, Dominici, Marcello, Édes, István, Eeckhout, Eric, Eitel, Ingo, Faluközy, József, Fath-Ordoubadi, Farzin, Ferrario, Maurizio, Fontos, Geza, Francisco Diaz, Jose, Freitas Quintella, Edgard, Frey, Bernhard, Friedrich, Guy, Galasko, Gavin, Galuszka, Grzegorz, Gama Ribeiro, Vasco, Garg, Scot, Gargiulo, Giuseppe, Geisler, Tobias, Gelev, Valeri, Ghandilyan, Art, Goicolea, Javier, Gori, Tommaso, Gragnano, Felice, Guimarães, Ana, Hamm, Christian, Haude, Michael, Heg, Dik, Heijke, Pieter, Hernández Antolin, Rosa Ana, Hildick-Smith, David, Hillen, Dorien, Hoekman, Ina, Hofma, Sjoerd, Holmvang, Lene, Hoole, Stephen, Horváth, Iván, Huber, Kurt, Hugense, Annemarie, Ibrahim, Karim, Iñiguez, Andres, Isaaz, Karl, Jambrik, Zoltán, Janssens, Luc, Jasionowicz, Pawel, Jonk, Judith, Jung, Werner, Jüni, Peter, Katagiri, Yuki, Kogame, Norihiro, Koh, Tian Hai, Koning, René, Konteva, Mariana, Kőszegi, Zsolt, Krackhardt, Florian, Kreuger, Yvonne, Kukreja, Neville, Ladan, Boudijn, Lantelme, Pierre, Leandro, Sergio, Leibundgut, Gregor, Liebetrau, Christoph, Lindeboom, Wietze, Macaya Miguel, Carlos, Mach, François, Magro, Michael, Maillard, Luc, Manavifar, Negar, Mauri, Laura, McFadden, Eugene, Merkely, Bela, Miyazaki, Yosuke, Młodziankowski, Adam, Moccetti, Tiziano, Modolo, Rodrigo, Möllman, Helge, Morelle, Jean-François, Moschovitis, Aris, Munndt Ottesen, Michael, Muurling, Martin, Naber, Christoph Kurt, Neumann, Franz-Josef, Oldroyd, Keith, Ong, Paul, Onuma, Yoshinobu, Palsrok, Sanne, Petrov, Ivo, Plante, Sylvain, Prokopczuk, Janusz, Rademaker-Havinga, Tessa, Raffel, Christopher, Rensing, Benno, Roffi, Marco, Royaards, Kees-Jan, Sabate, Manel, Schächinger, Volker, Seidler, Tim, Serra Peñaranda, Antonio, Serruys, Patrick, Sikarulidze, Lali, Slagboom, Ton, Soliman, Osama I, Sousa, Amanda, Spitzer, Ernest, Stables, Rod, Steg, Gabriel, Steinwender, Clemens, Subkovas, Eduardas, Suryapranata, Harry, Takahashi, Kuniaki, Talwar, Suneel, Teiger, Emmanuel, ter Weele, Addy, Teurlings, Eva, Thury, Attila, Tijssen, Jan, Tonev, Gincho, Trendafilova-Lazarova, Diana, Tumscitz, Carlo, Umans, Victor, Ungi, Imre, Valkov, Veselin, van der Harst, Pim, van Geuns, Robert Jan, van Meijeren, Cokky, Vassilev, Dobrin, Velchev, Vasil, Velthuizen, Esther, Verheugt, Freek, Vlcek, Natalia, vom Dahl, Jürgen, Vrolix, Mathias, Walsh, Simon, Werner, Nikos, Windecker, Stephan, Witsenburg, Maarten, Zaman, Azfar, Żmudka, Krzysztof, Zrenner, Bernhard, Zurakowski, Aleksander, and Zweiker, Robert
- Abstract
We hypothesised that ticagrelor, in combination with aspirin for 1 month, followed by ticagrelor alone, improves outcomes after percutaneous coronary intervention compared with standard antiplatelet regimens.
- Published
- 2018
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40. Impact of paclitaxel-coated balloon versus newer-generation drug-eluting stent on periprocedural myocardial infarction in stable angina patients
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Her, Ae-Young, Kim, Yong Hoon, Garg, Scot, and Shin, Eun-Seok
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- 2018
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41. Comparison of Paclitaxel-Coated Balloon Treatment and Plain Old Balloon Angioplasty for De Novo Coronary Lesions.
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Ae-Young Her, Soe Hee Ann, Singh, Gillian Balbir, Yong Hoon Kim, Sang-Yong Yoo, Garg, Scot, Bon-Kwon Koo, and Eun-Seok Shin
- Abstract
Purpose: This study compared the angiographic outcomes of paclitaxel-coated balloon (PCB) versus plain old balloon angioplasty (POBA) treatment for de novo coronary artery lesions. At present, there is no available data comparing the efficacy of PCB versus POBA for the treatment of de novo coronary lesions. Materials and Methods: This multicenter retrospective observational study enrolled patients with de novo coronary lesions with a reference vessel diameter between 2.5 mm and 3.0 mm and lesion length =24 mm who were successfully treated with PCB or POBA. Angiographic measurements and quantitative coronary analysis were performed before and after the procedure, and at 9 months follow-up. Results: A total of 72 patients (49 receiving PCB and 23 receiving POBA) were enrolled in this study. Late luminal loss was -0.12±0.30 mm in the PCB group and 0.25±0.50 mm in the POBA group (p<0.001). There was a higher percentage of binary restenosis (diameter stenosis =50%) in POBA, compared to PCB (30.4%, n=7 vs. 4.1%, n=2, p<0.001). Target vessel revascularization was higher in the POBA group (13.0%, n=3 vs. 0%, p=0.033). Conclusion: PCB treatment of de novo coronary lesions showed better 9-month angiographic outcomes than POBA treatment alone. [ABSTRACT FROM AUTHOR]
- Published
- 2016
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42. Letter by Kawashima et al Regarding Article, "Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention in Patients With Chronic Total Occlusion and Multivessel Disease".
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Kawashima, Hideyuki, Garg, Scot, and Serruys, Patrick W.
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- 2022
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43. Progress in Treatment by Percutaneous Coronary Intervention: The Stent of the Future.
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Muramatsu, Takashi, Onuma, Yoshinobu, Zhang, Yao-Jun, Bourantas, Christos V., Kharlamov, Alexander, Diletti, Roberto, Farooq, Vasim, Gogas, Bill D., Garg, Scot, García-García, Hector M., Ozaki, Yukio, and Serruys, Patrick W.
- Abstract
Copyright of Revista Española de Cardiología (18855857) is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2013
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44. A Patient-Level Pooled Analysis Assessing the Impact of the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) Score on 1-Year Clinical Outcomes in 6,508 Patients Enrolled in Contemporary Coronary Stent Trials.
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Garg, Scot, Sarno, Giovanna, Girasis, Chrysafios, Vranckx, Pascal, de Vries, Ton, Swart, Michael, Bressers, Marco, Garcia-Garcia, Hector M., van Es, Gerrit-Anne, Räber, Lorenz, Campo, Gianluca, Valgimigli, Marco, Dawkins, Keith D., Windecker, Stephan, and Serruys, Patrick W.
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SURGICAL stents ,ANGIOPLASTY ,CLINICAL trials ,CARDIAC surgery ,CORONARY disease ,CORONARY artery bypass ,MYOCARDIAL revascularization ,THROMBOSIS ,MYOCARDIAL infarction - Abstract
Objectives: This study sought to assess the impact of the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SXscore) on clinical outcomes in patients undergoing percutaneous coronary intervention. Background: The SXscore has been demonstrated to have an ability to predict clinical outcomes in patients undergoing percutaneous revascularization. Current studies are limited by the relatively small number of patients in each SXscore group. Methods: Patient-level data from 7 contemporary coronary stent trials were pooled by an independent academic research organization (Cardialysis, Rotterdam, the Netherlands). Analysis was performed on a cohort of 6,508 patients treated with drug-eluting stents and who had calculated SXscores. Clinical outcomes in terms of death, myocardial infarction (MI), repeat revascularization, and major adverse cardiac events (MACE, a composite of death, MI, and repeat revascularization) were subsequently stratified according to SXscore quartiles: SXscore
Q1 ≤8 (n = 1,702); 8 < SXscoreQ2 <15 (n = 1,528); 15 ≤ SXscoreQ3 <23 (n = 1,620); and SXscoreQ4 ≥23 (n = 1,658). Results: One-year outcomes were available in 6,496 patients (99.8%). At 1-year follow-up, all clinical outcomes including mortality, MI, repeat revascularization, MACE, and definite and any stent thrombosis were all significantly higher in patients in the highest SXscore quartile. Similar trends were observed in a subgroup of 2,093 patients (32.2%) who presented with an ST- or non–ST-segment elevation MI. The rate of MACE among patients with an SXscore >32 and ≤32 was 24.9% and 14.0%, respectively (p < 0.001). The SXscore was identified as an independent predictor of all clinical outcomes including mortality, MACE, and stent thrombosis (p < 0.001 for all). Conclusions: This study confirms the consistent ability of the SXscore to identify patients who are at highest risk of adverse events. [Copyright &y& Elsevier]- Published
- 2011
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45. The Prognostic Utility of the SYNTAX Score on 1-Year Outcomes After Revascularization With Zotarolimus- and Everolimus-Eluting Stents: A Substudy of the RESOLUTE All Comers Trial.
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Garg, Scot, Serruys, Patrick W., Silber, Sigmund, Wykrzykowska, Joanna, van Geuns, Robert Jan, Richardt, Gert, Buszman, Pawel E., Kelbæk, Henning, van Boven, Adrianus Johannes, Hofma, Sjoerd H., Linke, Axel, Klauss, Volker, Wijns, William, Macaya, Carlos, Garot, Philippe, DiMario, Carlo, Manoharan, Ganesh, Kornowski, Ran, Ischinger, Thomas, and Bartorelli, Antonio
- Subjects
CORONARY disease ,ANGIOGRAPHY ,ADVERSE health care events ,MYOCARDIAL infarction ,REVASCULARIZATION (Surgery) ,ELECTROCARDIOGRAPHY ,PROGNOSIS - Abstract
Objectives: This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents. Background: The SXscore can identify patients treated with PCI who are at highest risk of adverse events. Methods: The SXscore was calculated prospectively in 2,033 of the 2,292 patients enrolled in the RESOLUTE All Comers study (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention). Clinical outcomes in terms of a patient-oriented composite endpoint (POCE) of all-cause death, myocardial infarction (MI), and repeat revascularization; the individual components of POCE; target lesion failure (TLF) (a composite of cardiac death, target-vessel MI, and clinically driven target lesion revascularization); and stent thrombosis were subsequently stratified according to SXscore tertiles: SXscore
LOW ≤9 (n = 698), 9MID ≤17 (n = 676); SXscore HIGH >17 (n = 659). Results: At 12-month follow-up, rates of POCE, MI, repeat revascularization, TLF, and the composite of death/MI were all significantly higher in patients in the highest SXscore tercile. Rates of stent thrombosis were all highest in the SXscoreHIGH tertile (p > 0.05). After multivariate adjustment, the SXscore was identified as an independent predictor of POCE, MI, repeat revascularization, and TLF (p < 0.05 for all). At 12-month follow-up, the SXscore, ACEF score, and Clinical SXscore had C-statistics of 0.57, 0.78, and 0.67, respectively, for mortality and of 0.62, 0.56, 0.63, respectively, for POCE. No significant between-stent differences were observed for TLF or POCE in any of the SXscore tertiles. Conclusions: The SYNTAX score is able to stratify risk amongst an all-comers population treated with PCI with second-generation drug-eluting stents (DES); however, improvements can be made with the inclusion of clinical variables. (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention; NCT00617084) [Copyright &y& Elsevier]- Published
- 2011
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46. Value of the SYNTAX score in patients treated by primary percutaneous coronary intervention for acute ST-elevation myocardial infarction: The MI SYNTAXscore study.
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Magro, Michael, Nauta, Sjoerd, Simsek, Cihan, Onuma, Yoshinobu, Garg, Scot, van der Heide, Elco, van der Giessen, Willem J., Boersma, Eric, van Domburg, Ron T., van Geuns, Robert Jan, and Serruys, Patrick W.
- Abstract
Aims: The aims of this study were to evaluate the SYNTAX score (SXscore) calculated at 2 stages during a primary percutaneous intervention (PPCI), that is, SXscore I (diagnostic) and SXscore II (postwiring), and assess its additional value to standard clinical risk scores in acute myocardial infarction. Methods and Results: SXscores I and II were applied to 736 consecutive acute ST-elevation myocardial infarction patients referred for PPCI between November 2006 and February 2008. SXscore changed significantly before (I: 16, interquartile range 9.5-23) and after wiring (II: 11, interquartile range 6-19), P < .001. Kaplan-Meier methods were used to compare the primary end point major adverse coronary events (MACE; composite of repeat MI, target vessel revascularization [TVR], and mortality) and secondary end point mortality at 1.5 years in tertiles of SXscore I and SXscore II. Major adverse coronary event was highest in the higher SXscore I tertile (11% vs 15% vs 23%, log-rank <0.01), driven primarily by increased rate of mortality (9% vs 11% vs 17%, log-rank 0.02). Major adverse coronary event was also highest in SXscore II tertile, by a combination of increased mortality and also TVR (TVR rate 2% vs 3% vs 9%, log-rank <0.01). Predictive Cox regression models for mortality and MACE were significantly and similarly improved by the addition of either SXscore I or SXscore II (hazard ratio 1.63, 95% CI 1.18-2.26, P < .01 for MACE) with respective c indices of 0.61 and 0.63 for MACE and 0.60 and 0.61 for mortality. Conclusions: SXscore during PPCI is a useful tool that provides additional risk stratification to known risk factors of long-term mortality and MACE in patients with ST-elevation myocardial infarction. [ABSTRACT FROM AUTHOR]
- Published
- 2011
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47. 5-Year Follow-Up of Coronary Revascularization in Diabetic Patients With Multivessel Coronary Artery Disease: Insights From ARTS (Arterial Revascularization Therapy Study)-II and ARTS-I Trials.
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Onuma, Yoshinobu, Wykrzykowska, Joanna J., Garg, Scot, Vranckx, Pascal, and Serruys, Patrick W.
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MYOCARDIAL revascularization ,SURGICAL stents ,DIABETES ,CORONARY artery bypass ,RAPAMYCIN ,CREATININE ,MYOCARDIAL infarction ,CLINICAL trials - Abstract
Objectives: We compared the 5-year outcomes of diabetic patients with multivessel disease treated with sirolimus-eluting stents (SES), bare-metal stents (BMS), and coronary artery bypass graft surgery (CABG) enrolled in the ARTS (Arterial Revascularization Therapy Study) I and II studies. Background: Diabetes is an established risk factor for major adverse cardiac events after revascularization. Recent trials suggest that revascularization with drug-eluting stents has equivalent safety to CABG up to 2 years. Methods: The ARTS I and II studies included 367 diabetic patients (SES: 159, CABG: 96, and BMS: 112) compared with respect to 5-year clinical outcomes. Results: The rate of major adverse cardiovascular and cerebrovascular events was significantly higher in patients treated with BMS (BMS 53.6% vs. CABG 23.4% vs. SES 40.5%; log-rank, p < 0.01 for SES vs. BMS and SES vs. CABG). There was no significant difference in mortality among all 3 groups. There was, however, a statistically significant difference in the myocardial infarction rate between BMS and CABG arms (BMS 11.0%, CABG 5.2%, SES 4.8%, p = 0.04 for SES vs. BMS and p = 0.76 for SES vs. CABG). The rate of repeat revascularization was significantly lower in patients treated with CABG compared with SES (SES 33.2% vs. CABG 10.7%, p < 0.001). Revascularization rate of patients treated with SES at 5 years approached that of patients treated with BMS although remained significantly lower. This “catch-up” phenomenon was not apparent in the nondiabetic population. Conclusions: At 5-year follow-up, CABG has comparable safety and superior efficacy compared with BMS and SES in the treatment of diabetic patients with multivessel disease. [ABSTRACT FROM AUTHOR]
- Published
- 2011
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48. Value of Age, Creatinine, and Ejection Fraction (ACEF Score) in Assessing Risk in Patients Undergoing Percutaneous Coronary Interventions in the 'All-Comers' LEADERS Trial.
- Author
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Wykrzykowska, Joanna J., Garg, Scot, Onulna, Yoshinobu, De Vries, Ton, Goedhart, Dick, Morel, Marie-Angele, Es, Gerrit-Anne van, Buszman, Pawel, Linke, Axel, Ischinger, Thomas, Klauss, Volker, Corti, Roberto, Eberli, Franz, Wijns, William, Morice, Marie-Claude, di Mario, Carlo, van Geuns, Robert Jan, Juni, Peter, Windecker, Stephan, and Serruys, Patrick W.
- Subjects
CREATININE ,DISEASE risk factors ,HEART diseases ,REVASCULARIZATION (Surgery) ,MYOCARDIAL infarction ,THERAPEUTIC complications - Abstract
The article discusses a study on a simplified risk model proposed and tested in patients undergoing coronary artery bypass graft surgery incorporating age, creatinine and ejection fraction (ACEF score). It assesses the value of the ACEF score in predicting major adverse cardiac events (MACEs) and compares its predictive value with the SYNTAX score. It suggests that the SYNTAX score was better in predicting overall MACEs and the risk of repeat revascularization while ACEF score was a better model to predict risk of cardiac death and myocardial infarction.
- Published
- 2011
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49. Prediction of 1-Year Clinical Outcomes Using the SYNTAX Score in Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: A Substudy of the STRATEGY (Single High-Dose Bolus Tirofiban and ...
- Author
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Garg, Scot, Sarno, Giovanna, Serruys, Patrick W., Rodriguez, Alfredo E., Bolognese, Leonardo, Anselmi, Maurizio, De Cesare, Nicoletta, Colangelo, Salvatore, Moreno, Raul, Gambetti, Stefania, Monti, Monia, Bristot, Laura, Bressers, Marco, Garcia-Garcia, Hector M., Parrinello, Giovanni, Campo, Gianluca, and Valgimigli, Marco
- Subjects
HEALTH outcome assessment ,CLINICAL trials ,MYOCARDIAL infarction ,ANGIOPLASTY ,PERFORMANCE evaluation ,SURGICAL stents ,THROMBOSIS ,MYOCARDIAL revascularization ,PATIENTS - Abstract
Objectives: This study sought to evaluate the impact of SYNTAX score (SXscore), and compare its performance in isolation and combination with the PAMI (The Primary Angioplasty in Myocardial Infarction Study) score, for the prediction of 1-year clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. Background: Patients with STEMI were excluded from the original SYNTAX score (SXscore) algorithm. Therefore, the utility of using the SXscore in this patient group remains undefined. Methods: SXscore was calculated retrospectively in 807 patients with STEMI enrolled in the randomized STRATEGY (Single High-Dose Bolus Tirofiban and Sirolimus-Eluting Stent Versus Abciximab and Bare-Metal Stent in Acute Myocardial Infarction) and MULTISTRATEGY (Multicenter Evaluation of Single High-Dose Bolus Tirofiban Versus Abciximab With Sirolimus-Eluting Stent or Bare-Metal Stent in Acute Myocardial Infarction Study) clinical trials. Clinical outcomes of all-cause death, reinfarction, and clinically driven target vessel revascularization were subsequently stratified according to SXscore tertiles: SX
LOW ≤9 (n = 311), 9 < SXMID ≤16 (n = 234), SXHIGH >16 (n = 262). Results: At 1-year follow-up, all clinical outcomes including mortality, mortality/reinfarction, major adverse cardiac events (MACE) (a composite of all-cause death, reinfarction and target vessel revascularization), and definite, definite/probable, and any stent thrombosis were all significantly higher in patients in the highest SXscore tertile. SXscore was identified as an independent predictor of mortality, MACE, and stent thrombosis out to 1-year follow-up. The combination SYNTAX-PAMI score led to a net reclassification improvement of 15.7% and 4.6% for mortality and MACE, respectively. The C-statistics for the SXscore, PAMI score, and the combined SYNTAX-PAMI score were 0.65, 0.81, and 0.73 for 1-year mortality, and 0.68, 0.64, and 0.69 for 1-year MACE, respectively. Conclusions: SXscore does have a role in the risk stratification of patients with STEMI having primary percutaneous coronary intervention; however, this ability can be improved through a combination with clinical variables. (Multicentre 2×2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI; NCT00229515) [Copyright &y& Elsevier]- Published
- 2011
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50. A Comparison of the Conformability of Everolimus-Eluting Bioresorbable Vascular Scaffolds to Metal Platform Coronary Stents.
- Author
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Gomez-Lara, Josep, Garcia-Garcia, Hector M., Onuma, Yoshinobu, Garg, Scot, Regar, Evelyn, De Bruyne, Bernard, Windecker, Stefan, McClean, Dougal, Thuesen, Leif, Dudek, Dariusz, Koolen, Jacques, Whitbourn, Robert, Smits, Pieter C., Chevalier, Bernard, Dorange, Cécile, Veldhof, Susan, Morel, Marie-Angèle, de Vries, Ton, Ormiston, John A., and Serruys, Patrick W.
- Subjects
TISSUE scaffolds ,SURGICAL stents ,CORONARY arteries ,REGRESSION analysis ,ANGIOGRAPHY ,ARTIFICIAL implants - Abstract
Objectives: The aim of this study was to assess the differences in terms of curvature and angulation of the treated vessel after the deployment of either a metallic stent or a polymeric scaffold device. Background: Conformability of metallic platform stents (MPS) is the major determinant of geometric changes in coronary arteries caused by the stent deployment. It is not known how bioresorbable polymeric devices perform in this setting. Methods: This retrospective study compares 102 patients who received an MPS (Multi-link Vision or Xience V, Abbott Vascular, Santa Clara, California) in the SPIRIT FIRST and II trials with 89 patients treated with the Revision 1.1 everolimus-eluting bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California) from cohort B of the ABSORB (A bioabsorbable everolimus-eluting coronary stent system) trial. All patients were treated with a single 3 × 18 mm device. Curvature and angulation were measured with dedicated software by angiography. Results: Both the MPS and BVS groups had significant changes in relative region curvature (MPS vs. BVS: 28.7% vs. 7.5%) and angulation (MPS vs. BVS: 25.4% vs. 13.4%) after deployment. The unadjusted comparisons between the 2 groups showed for BVS a nonsignificant trend for less change in region curvature after deployment (MPS vs. BVS: 0.085 cm
−1 vs. 0.056 cm−1 , p = 0.06) and a significantly lower modification of angulation (MPS vs. BVS 6.4° vs. 4.3°, p = 0.03). By multivariate regression analysis, the independent predictors of changes in curvature and angulation were the pre-treatment region curvature, the pre-treatment region angulation, and the used device. Conclusions: Bioresorbable vascular scaffolds have better conformability than conventional MPS. The clinical significance of the observed differences will require further investigation. [ABSTRACT FROM AUTHOR]- Published
- 2010
- Full Text
- View/download PDF
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