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52. Del Nido vs. Cold Blood Cardioplegia for High-Risk Isolated Coronary Artery Bypass Grafting in Patients with Reduced Ventricular Function.

Author

Sanetra, Krzysztof, Gerber, Witold, Mazur, Marta, Kubaszewska, Marta, Pietrzyk, Ewa, Buszman, Piotr Paweł, Kaźmierczak, Paweł, and Bochenek, Andrzej

Abstract

Introduction: The evidence for using del Nido cardioplegia protocol in high-risk patients with reduced ejection fraction undergoing isolated coronary surgery is insufficient. Methods: The institutional database was searched for isolated coronary bypass procedures. Patients with ejection fraction < 40% were selected. Propensity matching (age, sex, infarction, number of grafts) was used to pair del Nido (Group 1) and cold blood (Group 2) cardioplegia patients. Investigation of biomarker release, changes in ejection fraction, mortality, stroke, perioperative myocardial infarction, composite endpoint (major adverse cardiac and cerebrovascular events), and other perioperative parameters was performed. Results: Matching allowed the selection of 45 patient pairs. No differences were noted at baseline. After cross-clamp release, spontaneous sinus rhythm return was observed more frequently in Group 1 (80% vs. 48.9%; P=0.003). Troponin values were similar in both groups 12 and 36 hours after surgery, as well as creatine kinase at 12 hours. A trend favored Group 1 in creatine kinase release at 36 hours (median 4.9; interquartile range 3.8-9.6 ng/mL vs. 7.3; 4.5-17.5 ng/mL; P=0.085). Perioperative mortality, rates of myocardial infarction, stroke, or major adverse cardiac and cerebrovascular events were similar. No difference in postoperative ejection fraction was noted (median 35.0%; interquartile range 32.0-38.0% vs. 35.0%; 32.0-40.0%; P=0.381). There was a trend for lower atrial fibrillation rate in Group 1 (6.7% vs. 17.8%; P=0.051). Conclusion: The findings indicate that del Nido cardioplegia provides satisfactory protection in patients with reduced ejection fraction undergoing coronary bypass surgery. Further prospective trials are required. [ABSTRACT FROM AUTHOR]

Published
2024
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53. Influence of Bleeding Risk on Outcomes of Radial and Femoral Access for Percutaneous Coronary Intervention: An Analysis From the GLOBAL LEADERS Trial

Author

Gao, C, Buszman, P, Buszman, PA, Chichareon, P, Modolo, R, Garg, S, Takahashi, K, Kawashima, H, Wang, R, Chang, CC, Kogame, N, Tomaniak, Mariusz, Ono, M, Hara, H, Slagboom, T, Aminian, A, Naber, CK, Carrie, D, Hamm, C, Steg, PG, Onuma, Yoshinobu, van Geuns, RJ, Serruys, PWJC, Zurakowski, A, Gao, C, Buszman, P, Buszman, PA, Chichareon, P, Modolo, R, Garg, S, Takahashi, K, Kawashima, H, Wang, R, Chang, CC, Kogame, N, Tomaniak, Mariusz, Ono, M, Hara, H, Slagboom, T, Aminian, A, Naber, CK, Carrie, D, Hamm, C, Steg, PG, Onuma, Yoshinobu, van Geuns, RJ, Serruys, PWJC, and Zurakowski, A

Abstract

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 was not a primary analysis, it should be considered hypothesis generating.

Published
2021

58. Use of multidetector computed tomography for the assessment of acute chest pain: a consensus statement of the North American Society of Cardiac Imaging and the European Society of Cardiac Radiology

Author

Stillman, Arthur E., Oudkerk, Matthijs, Ackerman, Margaret, Becker, Christoph R., Buszman, Pawel E., de Feyter, Pim J., Hoffmann, Udo, Keadey, Matthew T., Marano, Riccardo, Lipton, Martin J., Raff, Gilbert L., Reddy, Gautham P., Rees, Michael R., Rubin, Geoffrey D., Schoepf, U. Joseph, Tarulli, Giuseppe, van Beek, Edwin J. R., Wexler, Lewis, and White, Charles S.

Published
2007
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64. An examination of the factor structure of the Goldfarb Fear of Fat Scale in clinical and non-clinical samples of Polish women.

Author

Przybyła-Basista, Hanna, Buszman, Krystyna, and Flakus, Maria

Abstract

Although associations between fear of fat and eating disorders (ED) have been frequently studied, it appears that the construct of fear of fat requires in-depth understanding to determine whether it is similar in individuals diagnosed with bulimia nervosa, anorexia nervosa, and individuals from the general population. The purpose of our study was to confirm the factor structure of the Goldfarb Fear of Fat Scale (GFFS) in clinical and non-clinical settings. This issue has not yet been investigated in the literature. Data were collected from 126 female patients diagnosed with ED and a total of 581 women from the general population. Our findings are highly consistent with the original single-factor structure of GFFS but only in the clinical sample. In the non-clinical sample, a good fit to the data has been achieved with a two-factor model composed of Fear of gaining weight and Fear of losing control over eating/weight. The Polish version of GFFS demonstrated good psychometric properties. It can be used as a fast screening tool to identify individuals with eating disorders and those at risk of developing such disorders. We recommend the two-factor model for non-clinical samples and the one-dimensional model for clinical samples for both research and practice. • The GFFS is a brief 10-item measure of fear of fat with high internal consistency • The single-factor structure of the original GFFS was confirmed in the clinical sample • In the non-clinical sample the GFFS revealed a two-factor structure • Two factor structure: Fear of gaining weight and Fear of losing control over eating/weight • The GFFS shows excellent test-retest reliability [ABSTRACT FROM AUTHOR]

Published
2022
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66. Social Media and Task Performance: Does Being Online distract task completion?

Author

Piotrowski, Michał, Ślebarska, Katarzyna, and Buszman, Krystyna

Subjects
TASK performance, SOCIAL media, SOCIAL networks, CLOCKS & watches, COLLEGE students
Abstract

At present, social media are connected with education. Both influence daily life and studying since they impact formal and informal relations. This study explores the role of social media in task performance. Based on Mackworth's clock test, we experimented with university students (N=54), which assessed their capacity to concentrate on the task when exposed to notifications from social networking. We explored whether the appearance of social media notifications regarding different stimulus properties (i.e., sound and vision) lowered cognitive resource capacity to concentrate on the main task. The findings revealed that the mere presence of notifications affected task performance. However, the focal relationship was more complex. [ABSTRACT FROM AUTHOR]

Published
2022
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67. Benefit and Risks of Aspirin in Addition to Ticagrelor in Acute Coronary Syndromes: A Post Hoc Analysis of the Randomized GLOBAL LEADERS Trial

Author

Tomaniak, M, Chichareon, P, Onuma, Y, Deliargyris, EN, Takahashi, K, Kogame, N, Modolo, R, Chang, CC, Rademaker-Havinga, T, Storey, RF, Dangas, GD, Bhatt, DL, Angiolillo, DJ, Hamm, C, Valgimigli, M, Windecker, S, Steg, PG, Vranckx, P, Serruys, PW, Bertrand, OF, Plante, S, Van Geuns, RJ, Hofma, SH, Royaards, KJ, Slagboom, T, Suryapranata, H, Umans, VAWM, Rensing, B, van der Harst, P, Magro, M, Barbato, E, Aminian, A, Benit, E, Janssens, L, Vrolix, M, Buysschaert, I, Carrie, D, Barraud, P, Teiger, E, Koning, R, Farzin, B, Morelle, JF, Isaaz, K, Maillard, L, Abdellaoui, M, Brunel, P, Angioi, M, Lantelme, P, Sabate, M, Gonzalez-Trevilla, AA, Cequier, A, Iiguez, A, Penaranda, AS, Miguel, CM, Diaz, JF, Antolin, RAH, Goicolea, J, Ribeiro, VG, da Silva, PC, Ferreira, RC, Almeida, M, Ungi, I, Merkely, B, Fontos, G, Horvath, I, Koszegi, Z, Jambrik, Z, Edes, I, Jozsef, F, Colombo, A, Bolognese, L, Ferrario, M, Tumscitz, C, Dominici, M, Curello, S, Roffi, M, Eeckhout, E, Moccetti, T, Moschovitis, A, Leibundgut, G, Huber, K, Frey, B, Delle Karth, G, Friedrich, G, Steinwender, C, Zweiker, R, Stables, R, Anderson, R, Chowdhary, S, Garg, S, Hildick-Smith, D, Fath-Ordoubadi, F, Oldroyd, KG, Galasko, G, Kukreja, N, Zaman, A, Subkovas, E, Curzen, N, Hoole, S, Talwar, S, Walsh, S, Adlam, D, Cotton, J, Holmvang, L, Ottesen, MM, Buszman, P, Zurakowski, A, Galuszka, G, Prokopczuk, J, Zmudka, K, Jasionowicz, P, Mlodziankowski, A, Liebetrau, C, Naber, CK, Neumann, FJ, Schchinger, V, Seidler, T, Ibrahim, K, Zrenner, B, Gori, T, Werner, N, Akin, I, Geisler, T, vom Dahl, J, Haude, M, Eitel, I, Krackhardt, F, Jung, W, Neto, PAL, Sousa, A, Quintella, EF, Leandro, S, Botelho, R, Raffel, C, Barlis, P, Hai, KT, Ong, P, Petrov, I, Konteva, M, Velchev, V, Gelev, V, Tonev, G, Valkov, V, Vassilev, D, and Trendafilova-Lazarova, D

Abstract

Key PointsQuestionWhat are the benefits and risks of continuing aspirin in addition to P2Y12 receptor inhibition with ticagrelor among patients with acute coronary syndrome between 1 month and 12 months after percutaneous coronary intervention? FindingsIn this nonprespecified, post hoc analysis of the GLOBAL LEADERS randomized clinical trial, beyond 1 month after percutaneous coronary intervention in acute coronary syndrome, aspirin was associated with increased bleeding risk and appeared not to add to the benefit of ticagrelor on ischemic events. MeaningThe findings of this hypothesis-generating analysis pave the way for further trials evaluating aspirin-free antiplatelet strategies after percutaneous coronary intervention. ImportanceThe role of aspirin as part of antiplatelet regimens in acute coronary syndromes (ACS) needs to be clarified in the context of newer potent P2Y12 antagonists. ObjectiveTo evaluate the benefit and risks of aspirin in addition to ticagrelor among patients with ACS beyond 1 month after percutaneous coronary intervention (PCI). Design, Setting, and ParticipantsThis is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI. The trial included 130 secondary/tertiary care hospitals in different countries, with 15991 unselected patients with stable coronary artery disease or ACS undergoing PCI. Patients had outpatient visits at 1, 3, 6, 12, 18, and 24 months after index procedure. InterventionsThe experimental group received aspirin plus ticagrelor for 1 month followed by 23-month ticagrelor monotherapy; the reference group received aspirin plus either clopidogrel (stable coronary artery disease) or ticagrelor (ACS) for 12 months, followed by 12-month aspirin monotherapy. In this analysis, we examined the clinical outcomes occurring between 31 days and 365 days after randomization, specifically in patients with ACS who, within this time frame, were assigned to receive either ticagrelor alone or ticagrelor and aspirin. Main Outcomes and MeasuresThe primary outcome was the composite of all-cause death or new Q-wave myocardial infarction. ResultsOf 15968 participants, there were 7487 patients with ACS enrolled; 3750 patients were assigned to the experimental group and 3737 patients to the reference group. Between 31 and 365 days after randomization, the primary outcome occurred in 55 patients (1.5%) in the experimental group and in 75 patients (2.0%) in the reference group (hazard ratio [HR], 0.73; 95% CI, 0.51-1.03; P=.07); investigator-reported Bleeding Academic Research Consortium-defined bleeding type 3 or 5 occurred in 28 patients (0.8%) in the experimental group and in 54 patients (1.5%) in the reference arm (HR, 0.52; 95% CI, 0.33-0.81; P=.004). Conclusions and RelevanceBetween 1 month and 12 months after PCI in ACS, aspirin was associated with increased bleeding risk and appeared not to add to the benefit of ticagrelor on ischemic events. These findings should be interpreted as exploratory and hypothesis generating; however, they pave the way for further trials evaluating aspirin-free antiplatelet strategies after PCI. Trial RegistrationClinicalTrials.gov identifier: NCT01813435. This secondary analysis of the GLOBAL LEADERS randomized clinical trial evaluates the benefit and risks of aspirin in addition to ticagrelor among patients with acute coronary syndrome beyond 1 month after percutaneous coronary intervention.

Published
2019

68. 2-Year Clinical Outcomes of an Abluminal Groove-Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent

Author

Xu, B., Saito, Y., Baumbach, A., Kelbaek, H., Royen, N. van, Zheng, M., Morel, M.A., Knaapen, P., Slagboom, T., Johnson, T.W., Vlachojannis, G., Arkenbout, K.E., Holmvang, L., Janssens, L., Ochala, A., Brugaletta, S., Naber, C.K., Anderson, R., Rittger, H., Berti, S., Barbato, E., Toth, G.G., Maillard, L., Valina, C., Buszman, P., Thiele, H., Schachinger, V., Lansky, A., Wijns, W., Xu, B., Saito, Y., Baumbach, A., Kelbaek, H., Royen, N. van, Zheng, M., Morel, M.A., Knaapen, P., Slagboom, T., Johnson, T.W., Vlachojannis, G., Arkenbout, K.E., Holmvang, L., Janssens, L., Ochala, A., Brugaletta, S., Naber, C.K., Anderson, R., Rittger, H., Berti, S., Barbato, E., Toth, G.G., Maillard, L., Valina, C., Buszman, P., Thiele, H., Schachinger, V., Lansky, A., and Wijns, W.

Abstract

Item does not contain fulltext, OBJECTIVES: The aim of this study was to assess the 2-year clinical outcomes of the Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel abluminal groove-filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE (Abbott Vascular, Santa Clara, California), a durable-polymer everolimus-eluting coronary stent. BACKGROUND: The long-term outcomes of the Firehawk stent have not been evaluated beyond 1 year in a randomized all-comers clinical trial. METHODS: The TARGET All Comers study is a prospective, multicenter, all-comers, randomized, noninferiority trial conducted in Europe. A total of 1,653 patients were randomly assigned to undergo implantation of either the Firehawk or the XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. RESULTS: At 2-year follow-up, the incidence of target lesion failure was 8.7% in the Firehawk group versus 8.6% in the XIENCE group (p = 0.92). The event rates of individual components of the primary endpoint were comparable for the 2 groups. Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent. Beyond 1 year, very late definite or probable stent thrombosis occurred in 3 patients (0.4%) in the Firehawk group and in 7 patients (0.9%) in the XIENCE group (p = 0.34). CONCLUSIONS: The 2-year follow-up of the TARGET All Comers study confirms comparable safety and efficacy profiles of the Firehawk and XIENCE stents.

Published
2019

69. 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)

Author

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)

Abstract

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

Published
2019
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70. 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)

Author

Leonardi, S, Franzone, A, Piccolo, R, McFadden, E, Vranckx, P, Serruys, PWJC, Benit, E, Liebetrau, C, Janssens, L, Ferrario, M, Zurakowski, A, van Geuns, Robert Jan, Dominici, M, Huber, K, Slagboom, T, Buszman, P, Bolognese, L, Tumscitz, C, Bryniarski, K, Aminian, A, Vrolix, M, Petrov, I, Garg, S, Naber, C, Prokopczuk, J, Hamm, C, Steg, G, Heg, D, Juni, P, Windecker, S, Valgimigli, M, Leonardi, S, Franzone, A, Piccolo, R, McFadden, E, Vranckx, P, Serruys, PWJC, Benit, E, Liebetrau, C, Janssens, L, Ferrario, M, Zurakowski, A, van Geuns, Robert Jan, Dominici, M, Huber, K, Slagboom, T, Buszman, P, Bolognese, L, Tumscitz, C, Bryniarski, K, Aminian, A, Vrolix, M, Petrov, I, Garg, S, Naber, C, Prokopczuk, J, Hamm, C, Steg, G, Heg, D, Juni, P, Windecker, S, and Valgimigli, M

Published
2019

71. Influence of Bleeding Risk on Outcomes of Radial and Femoral Access for Percutaneous Coronary Intervention: An Analysis From the GLOBAL LEADERS Trial

Author

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

Abstract

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.

Published
2021
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72. P3599Novel, preclinical model of aortic banding for evaluation of implantation feasibility and long term durability of transcatheter aortic valves

Author

Buszman, P E, primary, Buszman, P P, additional, Milewski, K, additional, Fernandez, C, additional, Michalak, M, additional, Kachel, M, additional, Domaradzki, W, additional, Czerwinska, K, additional, Swiatkiewicz, M, additional, Cisowski, M, additional, Gerber, W, additional, and Bochenek, A, additional

Published
2018
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73. P2531Impact of age on clinical outcomes after PCI in patients with ACS and stable CAD treated with 23-month ticagrelor monotherapy following 1-month DAPT in the randomized GLOBAL LEADERS study

Author

Tomaniak, M, primary, Chichareon, P, additional, Modolo, R, additional, Buszman, P, additional, Sabate, M, additional, Geisler, T, additional, Hamm, C, additional, Steg, P G, additional, Onuma, Y, additional, Vranckx, P, additional, Valgimigli, M, additional, Windecker, S, additional, Anderson, R, additional, Dominici, M, additional, and Serruys, P W, additional

Published
2019
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75. Everolimus-eluting stents or bypass surgery for left main coronary artery disease

Author

Stone, Gw, Sabik, Jf, Serruys, Pw, Simonton, Ca, Généreux, P, Puskas, J, Kandzari, De, Morice, Mc, Lembo, N, Brown WM 3rd, Taggart, Dp, Banning, A, Merkely, B, Horkay, F, Boonstra, Pw, van Boven AJ, Ungi, I, Bogáts, G, Mansour, S, Noiseux, N, Sabaté, M, Pomar, J, Hickey, M, Gershlick, A, Buszman, P, Bochenek, A, Schampaert, E, Pagé, P, Dressler, O, Kosmidou, I, Mehran, R, Pocock, Sj, Kappetein, Ap, van Es GA, Leon, Mb, Gersh, B, Chaturvedi, S, Kint, Pp, Valgimigli, M, Colombo, A, Costa, M, Di Mario, C, Ellis, S, Fajadet, J, Fearon, W, Kereiakes, D, Makkar, R, Mintz, Gs, Moses, Jw, Teirstein, P, Ruel, M, Sergeant, P, Mack, M, Fontana, G, Mohr, Fw, Nataf, P, Smith, C, Boden, B, Fox, K, Maron, D, Steg, G, Blackstone, E, Juni, P, Parise, H, Wallentin, L, Bertrand, M, Krucoff, M, Turina, M, Ståhle, E, Tijssen, J, Brill, D, Atkins, C, Applegate, B, Argenziano, M, Faly, Rc, Dauerman, H, Davidson, C, Griffith, B, Reisman, M, Rizik, D, Sakwa, M, Shemin, R, Romano, M, Hamm, C, Gummert, J, Tamburino, C, Alfieri, O, Savina, C, de Bruyne, B, Machado, Fp, Uva, S, Moccetti, T, Siclari, F, Hildick Smith, D, Szekely, L, Erglis, A, Stradins, P, Abizaid, A, Bento Sousa LC, Belardi, J, Navia, D, Park, Sj, Lee, Jw, Meredith, I, Smith, J, Yehuda, Ob, Schneijdenberg, R, Ronden, J, Jonk, J, Jonkman, A, van Remortel, E, de Zwart, I, Elshout, L, de Vries, T, Andreae, R, Tol van, J, Teurlings, E, Balachandran, S, Breazna, A, Jenkins, P, Mcandrew, T, Marx, So, Connolly, Mw, Hong, Mk, Weinberger, J, Wong, Sc, Dizon, J, Biviano, A, Morrow, J, Wang, D, Corral, M, Alfonso, M, Sanchez, R, Wright, D, Djurkovic, C, Lustre, M, Jankovic, I, Sanidas, E, Lasalle, L, Maehara, A, Matsumura, M, Sun, E, Iacono, S, Greenberg, T, Jacobson, J, Pullano, A, Gacki, M, Liu, S, Cohen, Dj, Magnuson, E, Baron, Sj, Wang, K, Traylor, K, Worthley, S, Stuklis, R, Barbato, E, Stockman, B, Dubois, C, Meuris, B, Vrolix, M, Dion, R, Bento de Souza LC, Costantini, C, Woitowicz, V, Hueb, W, Stolf, N, Beydoun, H, Baskett, R, Curtis, M, Kieser, T, Doucet, S, Pellerin, M, Hamburger, J, Cook, R, Kutryk, M, Peterson, M, Madan, M, Fremes, S, Mehta, S, Cybulsky, I, Prabhakar, M, Peniston, C, Welsh, R, Macarthur, R, Berland, J, Bessou, Jp, Carrié, D, Glock, Y, Darremont, O, Deville, C, Grimaud, Jp, Soula, P, Lefèvre, T, Maupas, E, Durrleman, N, Silvestri, M, Houel, R, Pratt, A, Francis, J, Van Belle, E, Vicentelli, A, Luchner, A, Hilker, M, Endemann, Dh, Felix, S, Wollert, Hg, Walther, T, Erbel, R, Jacob, H, Kahlert, P, Kupatt, C, Näbauer, M, Schmitz, C, Scholtz, W, Börgermann, J, Schuler, G, Borger, M, Davierwala, P, Fontos, G, Székely, L, Bedogni, F, Panisi, P, Berti, S, Glauber, M, Marzocchi, A, Di Bartolomeo, R, Merlo, M, Guagliumi, G, Fenili, F, Napodano, M, Gerosa, G, Ribichini, F, Faggian, Giuseppe, Saccà, S, Giacomin, A, Mignosa, C, Tumscitz, C, Savini, C, Van Mieghem, N, von Birgelen, C, Grandjean, J, Kubica, J, Anisimowicz, L, Zmudka, K, Sadowski, J, Hernández García, J, Such, M, Macaya, C, Rodríguez Hernández JE, Maroto, L, Serra, A, Padro, J, Tenas, Ms, De Souza, A, Egred, M, Clark, S, Trivedi, U, Jain, A, Uppal, R, Redwood, S, Young, C, Stables, Rh, Pullan, M, Uren, N, Pessotto, R, Abu Fadel, M, Peyton, M, Allaqaband, S, O’Hair, D, Bachinsky, W, Mumtaz, M, Blankenship, J, Casale, A, Brott, B, Davies, J, Brown, D, Cannon, L, Talbott, J, Chang, G, Macheers, S, Choi, J, Henry, C, Cutlip, D, Khabbaz, K, Das, G, Liao, K, Diver, D, Thayer, J, Dobies, D, Fliegner, K, Fischbein, M, Feldman, T, Pearson, P, Foster, M, Briggs, R, Giugliano, G, Engelman, D, Gordon, P, Ehsan, A, Grantham, J, Allen, K, Grodin, J, Jessen, M, Gruberg, L, Taylor JR Jr, Gupta, S, Hermiller J., Jr, Heimansohn, D, Iwaoka, R, Chan, B, Kander, Nh, Duff, S, Brown, W, Karmpaliotis, D, Kini, A, Filsoufi, F, Kong, D, Lin, S, Kutcher, M, Kincaid, E, Leya, F, Bakhos, M, Liberman, H, Halkos, M, Lips, D, Eales, F, Mahoney, P, Rich, J, Barreiro, C, Cheng, W, Metzger, C, Greenfield, T, Moses, J, Palacios, I, Macgillivray, T, Perin, E, Del Prete, J, Pompili, V, Kilic, A, Ragosta, M, Kron, I, Rashid, J, Mueller, D, Riley, R, Reimers, C, Patel, N, Resar, J, Shah, A, Schneider, J, Landvater, L, Reardon, M, Shavelle, D, Baker, C, Singh, J, Maniar, H, Wei, L, Strain, J, Zapolanski, A, Taheri, H, Ad, N, Tannenbaum, M, Prabhakar, G, Waksman, R, Corso, P, Wang, J, Fiocco, M, Wilson, Bh, Steigel, Rm, Chadwick, S, Zidar, F, Oswalt, J., Stone, Gregg W., Sabik, Joseph F., Serruys, Patrick W., Simonton, Charles A., Généreux, Philippe, Puskas, John, Kandzari, David E., Morice, Marie Claude, Lembo, Nichola, Brown, W. Morri, Taggart, David P., Banning, Adrian, Merkely, Béla, Horkay, Ferenc, Boonstra, Piet W., Van Boven, Ad J., Ungi, Imre, Bogáts, Gabor, Mansour, Samer, Noiseux, Nicola, Sabaté, Manel, Pomar, José, Hickey, Mark, Gershlick, Anthony, Buszman, Pawel, Bochenek, Andrzej, Schampaert, Erick, Pagé, Pierre, Dressler, Ovidiu, Kosmidou, Ioanna, Mehran, Roxana, Pocock, Stuart J., Kappetein, A. Pieter, for the EXCEL Trial Investigators:, [. . ., Antonio, Marzocchi, DI BARTOLOMEO, Roberto, ], . ., and Cardiothoracic Surgery

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Coronary Artery Disease, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, Coronary artery disease, 03 medical and health sciences, 0302 clinical medicine, Percutaneous Coronary Intervention, Randomized controlled trial, law, Internal medicine, medicine, Clinical endpoint, Drug-Eluting Stent, Humans, Everolimus, 030212 general & internal medicine, cardiovascular diseases, Coronary Artery Bypass, Aged, Female, Middle Aged, Drug-Eluting Stents, business.industry, Coronary Artery Bypa, Medicine (all), Percutaneous coronary intervention, General Medicine, medicine.disease, Surgery, Cardiac surgery, Everolimu, surgical procedures, operative, Bypass surgery, Conventional PCI, Cardiology, business, medicine.drug, Human
Abstract

BACKGROUND: Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. METHODS: We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. RESULTS: At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit, 4.0 percentage points; P=0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79 to 1.26; P=0.98 for superiority). The secondary end-point event of death, stroke, or myocardial infarction at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group (P

Published
2017

76. PRECISE-DAPT score for bleeding risk prediction in patients on dual or single antiplatelet regimens: insights from the GLOBAL LEADERS and GLASSY

Author

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

Published
2022
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77. Computing Methods for Composite Clinical Endpoints in Unprotected Left Main Coronary Artery Revascularization: A Post Hoc Analysis of the DELTA Registry

Author

Capodanno D., Gargiulo G., Buccheri S., Chieffo A., Meliga E., Latib A., Park S. -J., Onuma Y., Capranzano P., Valgimigli M., Narbute I., Makkar R. R., Palacios I. F., Kim Y. -H., Buszman P. E., Chakravarty T., Sheiban I., Mehran R., Naber C., Margey R., Agnihotri A., Marra S., Leon M. B., Moses J. W., Fajadet J., Lefevre T., Morice M. -C., Erglis A., Alfieri O., Serruys P. W., Colombo A., Tamburino C., Capodanno, Davide, Gargiulo, Giuseppe, Buccheri, Sergio, Chieffo, Alaide, Meliga, Emanuele, Latib, Azeem, Park, Seung Jung, Onuma, Yoshinobu, Capranzano, Piera, Valgimigli, Marco, Narbute, Inga, Makkar, Raj R., Palacios, Igor F., Kim, Young Hak, Buszman, Pawel E., Chakravarty, Tarun, Sheiban, Imad, Mehran, Roxana, Naber, Christoph, Margey, Ronan, Agnihotri, Arvind, Marra, Sebastiano, Leon, Martin B., Moses, Jeffrey W., Fajadet, Jean, Lefã¨vre, Thierry, Morice, Marie Claude, Erglis, Andrej, Alfieri, Ottavio, Serruys, Patrick W., Colombo, Antonio, Tamburino, Corrado, Cardiology, Capodanno, D., Gargiulo, G., Buccheri, S., Chieffo, A., Meliga, E., Latib, A., Park, S. -J., Onuma, Y., Capranzano, P., Valgimigli, M., Narbute, I., Makkar, R. R., Palacios, I. F., Kim, Y. -H., Buszman, P. E., Chakravarty, T., Sheiban, I., Mehran, R., Naber, C., Margey, R., Agnihotri, A., Marra, S., Leon, M. B., Moses, J. W., Fajadet, J., Lefevre, T., Morice, M. -C., Erglis, A., Alfieri, O., Serruys, P. W., Colombo, A., and Tamburino, C.

Subjects
Registrie, Male, Data Interpretation, Time Factors, Logistic Model, Time Factor, Endpoint Determination, left main, win ratio, Myocardial Infarction, Coronary Artery Disease, Kaplan-Meier Estimate, competing risk, Risk Assessment, Percutaneous Coronary Intervention, Risk Factors, Models, Drug-Eluting Stent, Humans, Registries, Coronary Artery Bypass, Propensity Score, Multivariate Analysi, Aged, Proportional Hazards Models, Andersen-Gill, Models, Statistical, Coronary Artery Bypa, Risk Factor, Drug-Eluting Stents, Markov Chain, Statistical, Middle Aged, weighted composite event(s), Cerebrovascular Disorders, Data Interpretation, Statistical, Female, Logistic Models, Markov Chains, Multivariate Analysis, Research Design, Treatment Outcome, Cardiology and Cardiovascular Medicine, Cerebrovascular Disorder, Proportional Hazards Model, Human
Abstract

Objectives The study sought to investigate the impact of different computing methods for composite endpoints other than time-to-event (TTE) statistics in a large, multicenter registry of unprotected left main coronary artery (ULMCA) disease. Background TTE statistics for composite outcome measures used in ULMCA studies consider only the first event, and all the contributory outcomes are handled as if of equal importance. Methods The TTE, Andersen-Gill, win ratio (WR), competing risk, and weighted composite endpoint (WCE) computing methods were applied to ULMCA patients revascularized by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at 14 international centers. Results At a median follow-up of 1,295 days (interquartile range: 928 to 1,713 days), all analyses showed no difference in combinations of death, myocardial infarction, and cerebrovascular accident between PCI and CABG. When target vessel revascularization was incorporated in the composite endpoint, the TTE (p = 0.03), Andersen-Gill (p = 0.04), WR (p = 0.025), and competing risk (p < 0.001) computing methods showed CABG to be significantly superior to PCI in the analysis of 1,204 propensity-matched patients, whereas incorporating the clinical relevance of the component endpoints using WCE resulted in marked attenuation of the treatment effect of CABG, with loss of significance for the difference between revascularization strategies (p = 0.10). Conclusions In a large study of ULMCA revascularization, incorporating the clinical relevance of the individual outcomes resulted in sensibly different findings as compared with the conventional TTE approach. In particular, using the WCE computing method, PCI and CABG were no longer significantly different with respect to the composite of death, myocardial infarction, cerebrovascular accident, or target vessel revascularization at a median of 3 years.

Published
2016

78. Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable polymer coronary stent (TARGET All Comers): a multicentre, open-label, randomised non-inferiority trial

Author

Lansky, A., Wijns, W., Xu, B., Kelbaek, H., Royen, N. van, Zheng, M., Morel, M.A., Knaapen, P., Slagboom, T., Johnson, T.W., Vlachojannis, G., Arkenbout, K.E., Holmvang, L., Janssens, L., Ochala, A., Brugaletta, S., Naber, C.K., Anderson, R., Rittger, H., Berti, S., Barbato, E., Toth, G.G., Maillard, L., Valina, C., Buszman, P., Thiele, H., Schachinger, V., Baumbach, A., Lansky, A., Wijns, W., Xu, B., Kelbaek, H., Royen, N. van, Zheng, M., Morel, M.A., Knaapen, P., Slagboom, T., Johnson, T.W., Vlachojannis, G., Arkenbout, K.E., Holmvang, L., Janssens, L., Ochala, A., Brugaletta, S., Naber, C.K., Anderson, R., Rittger, H., Berti, S., Barbato, E., Toth, G.G., Maillard, L., Valina, C., Buszman, P., Thiele, H., Schachinger, V., and Baumbach, A.

Abstract

Item does not contain fulltext, BACKGROUND: The FIREHAWK is a drug-eluting stent with a fully biodegradable sirolimus-containing polymer coating localised to recessed abluminal grooves on the stent surface. We investigated clinical outcomes with this targeted, low-dose, biodegradable polymer, sirolimus-eluting stent compared with XIENCE durable polymer, everolimus-eluting stents in an all-comers population. METHODS: The TARGET All Comers study was a prospective, multicentre, open-label randomised non-inferiority trial done at 21 centres in ten European countries. Patients with symptomatic or asymptomatic coronary artery disease and objective evidence of myocardial ischaemia who qualified for percutaneous coronary intervention were randomised 1:1 to undergo implantation of a FIREHAWK or XIENCE. Randomisation was web-based, with random block allocation and stratification by centre and ST elevation myocardial infarction. Outcome assessors were masked to treatment allocation, but treating physicians and patients were not. The primary endpoint was target lesion failure at 12 months, a composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation. The control event rate for XIENCE was assumed to be 7%, the non-inferiority margin was 3.5%, and the primary analysis was in the intention-to-treat population, censoring patients who did not have either an event before 365 days or contact beyond 365 days. Late lumen loss was the primary endpoint of an angiographic substudy designed to investigate the non-inferiority of the FIREHAWK compared with the XIENCE stent. This trial is registered with ClinicalTrials.gov, number NCT02520180. FINDINGS: From Dec 17, 2015, to Oct 14, 2016, 1653 patients were randomly assigned to implantation of the FIREHAWK (n=823) or XIENCE (n=830). 65 patients in the FIREHAWK group and 66 in the XIENCE group had insufficient follow-up data and were excluded from the analyses. At 12 months, target lesion failure occurred in 46 (6.1%)

Published
2018

79. Six months versus 12 months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction (DAPT-STEMI): randomised, multicentre, non-inferiority trial

Author

Kedhi, E, Fabris, E, Ent, M, Buszman, P, Birgelen, C, Roolvink, V, Zurakowski, A, Schotborgh, CE, Hoorntje, JCA, Eek, CH, Cook, S, Togni, M, Meuwissen, M, van Royen, N, Vliet, R, Wedel, H, Delewi, R, Zijlstra, Felix, Kedhi, E, Fabris, E, Ent, M, Buszman, P, Birgelen, C, Roolvink, V, Zurakowski, A, Schotborgh, CE, Hoorntje, JCA, Eek, CH, Cook, S, Togni, M, Meuwissen, M, van Royen, N, Vliet, R, Wedel, H, Delewi, R, and Zijlstra, Felix

Published
2018

80. Comparison of Investigator-Reported and Clinical Event Committee-Adjudicated Outcome Events in GLASSY.

Author

Leonardi, Sergio, Branca, Mattia, Franzone, Anna, McFadden, Eugene, Piccolo, Raffaele, Jüni, Peter, Vranckx, Pascal, Steg, Philippe Gabriel, Serruys, Patrick W, Benit, Edouard, Liebetrau, Christoph, Janssens, Luc, Ferrario, Maurizio, Zurakowski, Aleksander, Diletti, Roberto, Dominici, Marcello, Huber, Kurt, Slagboom, Ton, Buszman, Pawel, and Bolognese, Leonardo

Subjects
RESEARCH, STROKE, RESEARCH methodology, MYOCARDIAL infarction, MEDICAL cooperation, EVALUATION research, TREATMENT effectiveness, COMPARATIVE studies, HEMORRHAGE
Abstract

Background: Event adjudication by a clinical event committee (CEC) provides a standardized, independent outcome assessment. However, the added value of CEC to investigators reporting remains debated. GLASSY (GLOBAL LEADERS Adjudication Sub-Study) implemented, in a subset of the open-label, investigator-reported (IR) GLOBAL LEADERS trial, an independent adjudication process of reported and unreported potential outcome events (triggers). We describe metrics of GLASSY feasibility and efficiency, diagnostic accuracy of IR events, and their concordance with corresponding CEC-adjudicated events.Methods: We report the proportion of myocardial infarction, bleeding, stroke, and stent thrombosis triggers with sufficient evidence for assessment (feasibility) that were adjudicated as outcome events (efficiency), stratified by source (IR or non-IR). Using CEC-adjudicated events as criterion standard, we describe sensitivity, specificity, positive and negative predictive value, and global diagnostic accuracy of IR events. Using Gwet AC coefficient, we examine the concordance between IR- and corresponding CEC-adjudicated triggers. There was sufficient evidence for assessment for 2592 (98.3%) of 2636 triggers.Results: Overall, the adjudicated end point-to-trigger ratio was high and similar between IR- (88%) and non-IR-reported (87%) triggers. The global diagnostic accuracy and concordance between IR-reported and CEC-adjudicated outcome events was 0.70 (95% CI, 0.65-0.74) and 0.54 (95% CI, 0.45-0.62), respectively, for myocardial infarction; 0.77 (95% CI, 0.75-0.79) and 0.71 (95% CI, 0.68-0.74) for bleeding; 0.70 (95% CI, 0.62-0.79) and 0.59 (95% CI, 0.43-0.74) for stroke; 0.59 (95% CI, 0.52-0.66) and 0.39 (95% CI, 0.25-0.53) for stent thrombosis. For IR bleedings, the concordance with the CEC on type of events was generally weak.Conclusions: Implementing CEC adjudication in a pragmatic open-label trial with IR events is feasible and efficient. Our findings of modest global diagnostic accuracy for IR events and generally weak concordance between investigators and CEC support the role for CEC adjudication in such settings. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03231059. [ABSTRACT FROM AUTHOR]

Published
2021
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81. Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 1-year results of the SYNTAX II study

Author

Escaned, J., Collet, C., Ryan, N., Maria, G.L. De, Walsh, S., Sabate, M., Davies, J., Lesiak, M., Moreno, R., Cruz-Gonzalez, I., Hoole, S.P., West, N., Piek, J.J., Zaman, A., Fath-Ordoubadi, F., Stables, R.H., Appleby, C., Mieghem, N. van, Geuns, R.J.M. van, Uren, N., Zueco, J., Buszman, P., Iniguez, A., Goicolea, J., Hildick-Smith, D., Ochala, A., Dudek, D., Hanratty, C., Cavalcante, R., Kappetein, A.P., Taggart, D.P., Es, G.A. van, Morel, M.A., Vries, T. de, Onuma, Y., Farooq, V., Serruys, P.W., Banning, A.P., Escaned, J., Collet, C., Ryan, N., Maria, G.L. De, Walsh, S., Sabate, M., Davies, J., Lesiak, M., Moreno, R., Cruz-Gonzalez, I., Hoole, S.P., West, N., Piek, J.J., Zaman, A., Fath-Ordoubadi, F., Stables, R.H., Appleby, C., Mieghem, N. van, Geuns, R.J.M. van, Uren, N., Zueco, J., Buszman, P., Iniguez, A., Goicolea, J., Hildick-Smith, D., Ochala, A., Dudek, D., Hanratty, C., Cavalcante, R., Kappetein, A.P., Taggart, D.P., Es, G.A. van, Morel, M.A., Vries, T. de, Onuma, Y., Farooq, V., Serruys, P.W., and Banning, A.P.

Abstract

Contains fulltext : 182263.pdf (Publisher’s version ) (Open Access), Aims: To investigate if recent technical and procedural developments in percutaneous coronary intervention (PCI) significantly influence outcomes in appropriately selected patients with three-vessel (3VD) coronary artery disease. Methods and results: The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in patients with 3VD in 22 centres from four European countries. The SYNTAX-II strategy includes: heart team decision-making utilizing the SYNTAX Score II (a clinical tool combining anatomical and clinical factors), coronary physiology guided revascularisation, implantation of thin strut bioresorbable-polymer drug-eluting stents, intravascular ultrasound (IVUS) guided stent implantation, contemporary chronic total occlusion revascularisation techniques and guideline-directed medical therapy. The rate of major adverse cardiac and cerebrovascular events (MACCE [composite of all-cause death, cerebrovascular event, any myocardial infarction and any revascularisation]) at one year was compared to a predefined PCI cohort from the original SYNTAX-I trial selected on the basis of equipoise 4-year mortality between CABG and PCI. As an exploratory endpoint, comparisons were made with the historical CABG cohort of the original SYNTAX-I trial. Overall 708 patients were screened and discussed within the heart team; 454 patients were deemed appropriate to undergo PCI. At one year, the SYNTAX-II strategy was superior to the equipoise-derived SYNTAX-I PCI cohort (MACCE SYNTAX-II 10.6% vs. SYNTAX-I 17.4%; HR 0.58, 95% CI 0.39-0.85, P = 0.006). This difference was driven by a significant reduction in the incidence of MI (HR 0.27, 95% CI 0.11-0.70, P = 0.007) and revascularisation (HR 0.57, 95% CI 0.37-0.9, P = 0.015). Rates of all-cause death (HR 0.69, 95% CI 0.27-1.73, P = 0.43) and stroke (HR 0.69, 95% CI 0.10-4.89, P = 0.71) were similar. The rate of definite stent thrombosis w

Published
2017

82. Mortality following cardiovascular and bleeding events occurring beyond 1 year after coronary stenting: A secondary analysis of the Dual Antiplatelet Therapy (DAPT) Study.

Author

Hopkins J., McGarry T., Nygaard T., Pow T., Larkin T., Caulfield T., Stys T., Lee T., Mansouri V., Srinivas V., Gupta V., Marquardt W., Ballard W., Bachinsky W., Colyer W., Dillon W., Felten W., French W., Kuehl W., Nicholas W., Nicholson W., Phillips W., Khatib Y., Al-Saghir Y., Hawa Z., Masud Z., Jafar Z., Muller D., Meredith I., Rankin J., Worthley M., Jepson N., Thompson P., Hendriks R., Whitbourn R., Duffy S., Stasek J., Novobilsky K., Naplava R., Coufal Z., Vaquette B., Bressollette E., Teiger E., Coste P., Rihani R., Darius H., Bergmann M.W., Radke P., Sebastian P., Strasser R., Hoffmann S., Behrens S., Moebius-Winkler S., Rutsch W., Lupkovics G., Horvath I., Kancz S., Forster T., Koszegi Z., Devlin G., Hart H., Elliott J., Ormiston J., Abernathy M., Fisher N., Kay P., Harding S., Jaffe W., Hoffmann A., Sosnowski C., Trebacz J., Buszman P., Dobrzycki S., Kornacewicz-Jach Z., Iancu A.C., Ginghina C.D., Matei C., Dobreanu D., Bolohan F.R., Dorobantu M., Jacques A., Jain A., Bakhai A., Gershlick A., Adamson D., Newby D., Felmeden D., Purcell I., Edmond J., Irving J., De Belder M., Pitt M., Kelly P., O'Kane P., Clifford P., Suresh V., Secemsky E.A., Yeh R.W., Kereiakes D.J., Cutlip D.E., Cohen D.J., Steg P.G., Cannon C.P., Apruzzese P.K., D'Agostino R.B., Massaro J.M., Mauri L., Kaplan A., Ahmed A., Ahmed A.-H., Albirini A., Moreyra A., Rabinowitz A., Shroff A., Moak A., Jacobs A., Kabour A., Gupta A., Irimpen A., Rosenthal A., Taussig A., Ferraro A., Chhabra A., Pucillo A., Spaedy A., White A., Pratsos A., Shakir A., Ghitis A., Agarwal A., Chawla A., Tang A., Barker B., Bertolet B., Uretsky B., Erickson B., Rama B., McLaurin B., Dearing B., Negus B., Price B., Brott B., Bhambi B., Bowers B., Watt B., Donohue B., Hassel C.D., Croft C., Lambert C., O'Shaughnessy C., Shoultz C., Kim C., Caputo C., Nielson C., Scott C., Wolfe C., McKenzie C., Brachfeld C., Thieling C., Fisher D., Simon D., Churchill D., Dobies D., Eich D., Goldberg D., Griffin D., Henderson D., Kandzari D., Lee D., Lewis D., Mego D., Paniagua D., Rizik D., Roberts D., Safley D., Abbott D., Shaw D., Temizer D., Canaday D., Myears D., Westerhausen D., Ebersole D., Netz D., Baldwin D., Letts D., Harlamert E., Kosinski E., Portnay E., Mahmud E., Korban E., Hockstad E., Rivera E., Shawl F., Shamoon F., Kiernan F., Aycock G.R., Schaer G., Kunz G., Kichura G., Myers G., Pilcher G., Tadros G., Kaddissi G.I., Ramadurai G., Eaton G., Elsner G., Mishkel G., Simonian G., Piegari G., Chen H., Liberman H., Aronow H., Tamboli H.P., Dotani I., Marin J., Fleischhauer J.F., Leggett J., Mills J., Phillips J., Revenaugh J., Mann J.T., Wilson J., Pattanayak J., Aji J., Strain J., Patel J., Carr J., Moses J., Chen J.-C., Williams J., Greenberg J., Cohn J., Douglas J., Gordon J., Griffin J., Hawkins J., Katopodis J., Lopez J., Marshall J., Wang J., Waltman J., Saucedo J., Galichia J., McClure M., Kozina J., Stella J., Tuma J., Kieval J., Giri K., Ramanathan K., Allen K., Atassi K., Baran K., Khaw K., Clayton K., Croce K., Skelding K., Patel K., Garratt K., Harjai K., Chandrasekhar K., Kalapatapu K., Lin L., Dean L., Barr L., MacDonald L., Cannon L., Satler L., Gruberg L., Tami L., Bikkina M., Shah M., Atieh M., Chauhan M., Litt M., Unterman M., Lechin M., Zughaib M., Fisch M., Grabarczyk M., Greenberg M., Lurie M., Rothenberg M., Stewart M., Purvis M., Hook M., Leesar M., Buchbinder M., Weiss M., Guerrero M., Abu-Fadel M., Ball M., Chang M., Cunningham M., Del Core M., Jones M., Kelberman M., Lim M., Ragosta M., Rinaldi M., Rosenberg M., Savage M., Tamberella M., Kellett M., Vidovich M., Effat M., Mirza M.A., Khan M., Dib N., Laufer N., Kleiman N., Farhat N., Amjadi N., Schechtmann N., Bladuell N., Quintana O., Gigliotti O., Best P., Flaherty P., Hall P., Gordon P., Gurbel P., Ho P., Luetmer P., Mahoney P., Mullen P., Teirstein P., Tolerico P., Ramanathan P., Kerwin P., Lee P.V., Kraft P., Wyman R.M., Gonzalez R., Kamineni R., Dave R., Sharma R., Prashad R., Aycock R., Quesada R., Goodroe R., Magorien R., Randolph R., Bach R., Kettelkamp R., Paulus R., Waters R., Zelman R., Ganim R., Bashir R., Applegate R., Feldman R., Frankel R., Hibbard R., Jobe R., Jumper R., Maholic R., Siegel R., Smith R., Stoler R., Watson R., Wheatley R., Gammon R., Hill R., Sundrani R., Caputo R., Jenkins R., Stella R., Germanwala S., Hadeed S., Ledford S., Dube S., Gupta S., Davis S., Martin S., Waxman S., Dixon S., Naidu S., Potluri S., Cook S., Crowley S., Kirkland S., McIntyre S., Thew S., Lin S., Marshalko S., Guidera S., Hearne S., Karas S., Manoukian S., Rowe S., Yakubov S., Pollock S., Banerjee S., Allaqaband S., Choi S., Mulukutla S., Papadakos S., Bajwa T., Addo T., Schreiber T., Haldis T., Mathew T., Hopkins J., McGarry T., Nygaard T., Pow T., Larkin T., Caulfield T., Stys T., Lee T., Mansouri V., Srinivas V., Gupta V., Marquardt W., Ballard W., Bachinsky W., Colyer W., Dillon W., Felten W., French W., Kuehl W., Nicholas W., Nicholson W., Phillips W., Khatib Y., Al-Saghir Y., Hawa Z., Masud Z., Jafar Z., Muller D., Meredith I., Rankin J., Worthley M., Jepson N., Thompson P., Hendriks R., Whitbourn R., Duffy S., Stasek J., Novobilsky K., Naplava R., Coufal Z., Vaquette B., Bressollette E., Teiger E., Coste P., Rihani R., Darius H., Bergmann M.W., Radke P., Sebastian P., Strasser R., Hoffmann S., Behrens S., Moebius-Winkler S., Rutsch W., Lupkovics G., Horvath I., Kancz S., Forster T., Koszegi Z., Devlin G., Hart H., Elliott J., Ormiston J., Abernathy M., Fisher N., Kay P., Harding S., Jaffe W., Hoffmann A., Sosnowski C., Trebacz J., Buszman P., Dobrzycki S., Kornacewicz-Jach Z., Iancu A.C., Ginghina C.D., Matei C., Dobreanu D., Bolohan F.R., Dorobantu M., Jacques A., Jain A., Bakhai A., Gershlick A., Adamson D., Newby D., Felmeden D., Purcell I., Edmond J., Irving J., De Belder M., Pitt M., Kelly P., O'Kane P., Clifford P., Suresh V., Secemsky E.A., Yeh R.W., Kereiakes D.J., Cutlip D.E., Cohen D.J., Steg P.G., Cannon C.P., Apruzzese P.K., D'Agostino R.B., Massaro J.M., Mauri L., Kaplan A., Ahmed A., Ahmed A.-H., Albirini A., Moreyra A., Rabinowitz A., Shroff A., Moak A., Jacobs A., Kabour A., Gupta A., Irimpen A., Rosenthal A., Taussig A., Ferraro A., Chhabra A., Pucillo A., Spaedy A., White A., Pratsos A., Shakir A., Ghitis A., Agarwal A., Chawla A., Tang A., Barker B., Bertolet B., Uretsky B., Erickson B., Rama B., McLaurin B., Dearing B., Negus B., Price B., Brott B., Bhambi B., Bowers B., Watt B., Donohue B., Hassel C.D., Croft C., Lambert C., O'Shaughnessy C., Shoultz C., Kim C., Caputo C., Nielson C., Scott C., Wolfe C., McKenzie C., Brachfeld C., Thieling C., Fisher D., Simon D., Churchill D., Dobies D., Eich D., Goldberg D., Griffin D., Henderson D., Kandzari D., Lee D., Lewis D., Mego D., Paniagua D., Rizik D., Roberts D., Safley D., Abbott D., Shaw D., Temizer D., Canaday D., Myears D., Westerhausen D., Ebersole D., Netz D., Baldwin D., Letts D., Harlamert E., Kosinski E., Portnay E., Mahmud E., Korban E., Hockstad E., Rivera E., Shawl F., Shamoon F., Kiernan F., Aycock G.R., Schaer G., Kunz G., Kichura G., Myers G., Pilcher G., Tadros G., Kaddissi G.I., Ramadurai G., Eaton G., Elsner G., Mishkel G., Simonian G., Piegari G., Chen H., Liberman H., Aronow H., Tamboli H.P., Dotani I., Marin J., Fleischhauer J.F., Leggett J., Mills J., Phillips J., Revenaugh J., Mann J.T., Wilson J., Pattanayak J., Aji J., Strain J., Patel J., Carr J., Moses J., Chen J.-C., Williams J., Greenberg J., Cohn J., Douglas J., Gordon J., Griffin J., Hawkins J., Katopodis J., Lopez J., Marshall J., Wang J., Waltman J., Saucedo J., Galichia J., McClure M., Kozina J., Stella J., Tuma J., Kieval J., Giri K., Ramanathan K., Allen K., Atassi K., Baran K., Khaw K., Clayton K., Croce K., Skelding K., Patel K., Garratt K., Harjai K., Chandrasekhar K., Kalapatapu K., Lin L., Dean L., Barr L., MacDonald L., Cannon L., Satler L., Gruberg L., Tami L., Bikkina M., Shah M., Atieh M., Chauhan M., Litt M., Unterman M., Lechin M., Zughaib M., Fisch M., Grabarczyk M., Greenberg M., Lurie M., Rothenberg M., Stewart M., Purvis M., Hook M., Leesar M., Buchbinder M., Weiss M., Guerrero M., Abu-Fadel M., Ball M., Chang M., Cunningham M., Del Core M., Jones M., Kelberman M., Lim M., Ragosta M., Rinaldi M., Rosenberg M., Savage M., Tamberella M., Kellett M., Vidovich M., Effat M., Mirza M.A., Khan M., Dib N., Laufer N., Kleiman N., Farhat N., Amjadi N., Schechtmann N., Bladuell N., Quintana O., Gigliotti O., Best P., Flaherty P., Hall P., Gordon P., Gurbel P., Ho P., Luetmer P., Mahoney P., Mullen P., Teirstein P., Tolerico P., Ramanathan P., Kerwin P., Lee P.V., Kraft P., Wyman R.M., Gonzalez R., Kamineni R., Dave R., Sharma R., Prashad R., Aycock R., Quesada R., Goodroe R., Magorien R., Randolph R., Bach R., Kettelkamp R., Paulus R., Waters R., Zelman R., Ganim R., Bashir R., Applegate R., Feldman R., Frankel R., Hibbard R., Jobe R., Jumper R., Maholic R., Siegel R., Smith R., Stoler R., Watson R., Wheatley R., Gammon R., Hill R., Sundrani R., Caputo R., Jenkins R., Stella R., Germanwala S., Hadeed S., Ledford S., Dube S., Gupta S., Davis S., Martin S., Waxman S., Dixon S., Naidu S., Potluri S., Cook S., Crowley S., Kirkland S., McIntyre S., Thew S., Lin S., Marshalko S., Guidera S., Hearne S., Karas S., Manoukian S., Rowe S., Yakubov S., Pollock S., Banerjee S., Allaqaband S., Choi S., Mulukutla S., Papadakos S., Bajwa T., Addo T., Schreiber T., Haldis T., and Mathew T.

Abstract

Importance: Early cardiovascular and bleeding events after coronary stenting are associated with high risk of morbidity and mortality. Objective(s): To assess the prognosis of cardiovascular and bleeding events occurring beyond 1 year after coronary stenting. Design, Setting, and Participant(s): This secondary analysis is derived from data from the Dual Antiplatelet Therapy (DAPT) Study, a multi center trial involving 220 US and in ternational clinical sites from 11 countries. The study dateswere August 2009 to May 2014. Individuals who underwent coronary stenting and completed 12 months of thienopyridine plus aspirin therapy without ischemic or bleeding events remained on an aspirin regimen and were randomized to continued thienopyridine therapy vs placebo for 18 additional months. Individuals were then followed up for 3 additional months while receiving aspirin therapy alone. The analysis began in August 2015. Exposures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries [GUSTO] classification moderate or severe bleeding). Main Outcomes and Measures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (GUSTO classification moderate or severe bleeding). Death at 21 months after randomization (33 months after coronary stenting). Result(s): Intotal, 25 682 individuals older than 18 years with an indication for coronarystentingwere enrolled, and 11 648(meanage,61.3 years; 25.1%female)were randomized. After randomization, 478 individuals (4.1%) had 502 ischemic events (306 with myocardial infarction, 113 with stent thrombosis, and 83 with ischemic stroke), and 232 individuals (2.0%) had 235 bleeding events (155 with moderate and 80 with severe bleeding). Among individuals with ischemic events, 52(10.9%) died. The annualize

Published
2017

83. Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 1-year results of the SYNTAX II study

Author

Escaned, J, Collet, C, Ryan, N, De Maria, GL, Walsh, S, Sabate, M, Davies, J, Lesiak, M, Moreno, R, Cruz-Gonzalez, I, Hoole, SP, West, NE, Piek, JJ, Zaman, A, Fath-ordoubadi, F, Stables, RH, Appleby, C, van Mieghem, Nicolas, van Geuns, Robert Jan, Uren, N, Zueco, J, Buszman, P, Iniguez, A, Goicolea, J, Hildick-Smith, D, Ochala, A, Dudek, D, Hanratty, C, Cavalcante e Silva, Rafael, Kappetein, Arie-Pieter, Taggart, DP, Es, Gerrit-anne, Morel, Marie-Angele, de Vries, T (Ton), Onuma, Yoshinobu, Farooq, V, Serruys, PWJC (Patrick), Banning, AP, Escaned, J, Collet, C, Ryan, N, De Maria, GL, Walsh, S, Sabate, M, Davies, J, Lesiak, M, Moreno, R, Cruz-Gonzalez, I, Hoole, SP, West, NE, Piek, JJ, Zaman, A, Fath-ordoubadi, F, Stables, RH, Appleby, C, van Mieghem, Nicolas, van Geuns, Robert Jan, Uren, N, Zueco, J, Buszman, P, Iniguez, A, Goicolea, J, Hildick-Smith, D, Ochala, A, Dudek, D, Hanratty, C, Cavalcante e Silva, Rafael, Kappetein, Arie-Pieter, Taggart, DP, Es, Gerrit-anne, Morel, Marie-Angele, de Vries, T (Ton), Onuma, Yoshinobu, Farooq, V, Serruys, PWJC (Patrick), and Banning, AP

Published
2017

84. Assessment of quality of care of patients with ST-segment elevation myocardial infarction

Author

Hudzik, Bartosz, Budaj, Andrzej, Gierlotka, Marek, Witkowski, Adam, Wojakowski, Wojciech, Zdrojewski, Tomasz, Gil, Robert, Legutko, Jacek, Bartuś, Stanisław, Buszman, Paweł, Dudek, Dariusz, and Gąsior, Mariusz

Abstract

Aims: The 2017 European Society of Cardiology guidelines for the management of ST-elevation myocardial infarction recommended assessing quality of care to establish measurable quality indicators in order to ensure that every ST-elevation myocardial infarction patient receives the best possible care. We investigated the quality indicators of healthcare services in Poland provided to ST-elevation myocardial infarction patients.Methods and results: The Polish Registry of Acute Coronary Syndromes is a nationwide, multicentre, prospective study of acute coronary syndrome patients in Poland. For the purpose of assessing quality indicators, we included 8279 patients from the Polish Registry of Acute Coronary Syndromes hospitalised with ST-elevation myocardial infarction in 2018. Four hundred and eight of 8279 patients (4.9%) arrived at percutaneous coronary intervention centre by self-transport, 4791 (57.9%) arrived at percutaneous coronary intervention centre by direct emergency medical system transport, and 2900 (37.2%) were transferred from non-percutaneous coronary intervention facilities. Whilst 95.1% of ST-elevation myocardial infarction patients arriving in the first 12 h received reperfusion therapy, the rates of timely reperfusion were much lower (ranging from 39.4% to 55.0% for various ST-elevation myocardial infarction pathways). The median left ventricular ejection fraction was 46% and was assessed before discharge in 86.0% of patients. Four hundred and eighty-nine of 8279 patients (5.9%) died during hospital stay. Optimal medical therapy is prescribed in 50–85% of patients depending on various clinical settings. Only one in two ST-elevation myocardial infarction patients is enrolled in a cardiac rehabilitation program at discharge. No patient-reported outcomes were recorded in the Polish Registry of Acute Coronary Syndromes.Conclusions: The results of this study identified areas of healthcare system that require solid improvement. These include direct transport to percutaneous coronary intervention centre, timely reperfusion, guidelines-based medical therapy (in particular in patients with heart failure), referral to cardiac rehabilitation/secondary prevention programs. Also, there is a need for recording quality indicators associated with patient-reported outcomes.

Published
2020
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85. P2773Intraaortic balloon pump and 12-month mortality in cardiogenic shock AMI patients with unsuccessful and successful primary PCI - analysis from PL-ACS Registry

Author

Hawranek, M., primary, Pres, D., additional, Gasior, M., additional, Wojakowski, W., additional, Gil, R., additional, Legutko, J., additional, Witkowski, A., additional, Buszman, P., additional, Ochala, A., additional, Lekston, A., additional, Zembala, M., additional, Polonski, L., additional, Dudek, D., additional, and Gierlotka, M., additional

Published
2017
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86. THE ROLE OF FEMALE SEX IN THE CONTEMPORARY TREATMENT OF THE LEFT MAIN CORONARY ARTERY INSIGHTS FROM THE W-DELTA (WOMEN-DRUG ELUTING STENT FOR LEFT MAIN CORONARY ARTERY DISEASE) REGISTRY

Author

Buchanan GL, Chieffo A, Meliga E, Mehran R, Park SJ, Onuma Y, Capranzano P, Valgimigli M, Jegere S, Makkar R, Palacios IF, Kim YH, Buszman P, Charavarty T, Sheiban I, Naber C, Margey R, Agnihotri A, Marra S, Davide D, Leon M, Fajadet J, Lefevre T, Morice MC, Erglis A, Tamburino C, Serruys PW, Colombo A., ALFIERI , OTTAVIO, Buchanan, Gl, Chieffo, A, Meliga, E, Mehran, R, Park, Sj, Onuma, Y, Capranzano, P, Valgimigli, M, Jegere, S, Makkar, R, Palacios, If, Kim, Yh, Buszman, P, Charavarty, T, Sheiban, I, Naber, C, Margey, R, Agnihotri, A, Marra, S, Davide, D, Leon, M, Fajadet, J, Lefevre, T, Morice, Mc, Erglis, A, Tamburino, C, Alfieri, Ottavio, Serruys, Pw, and Colombo, A.

Published
2013

87. Acute respiratory failure and inflammatory response after out-of-hospital cardiac arrest: results of the Post-Cardiac Arrest Syndrome (PCAS) pilot study

Author

Czerwińska-Jelonkiewicz, Katarzyna, Grand, Johannes, Tavazzi, Guido, Sans-Rosello, Jordi, Wood, Alice, Oleksiak, Anna, Buszman, Piotr, Krysiński, Mateusz, Sionis, Alessandro, Hassager, Christian, and Stępińska, Janina

Abstract

Background: Although the lungs are potentially highly susceptible to post-cardiac arrest syndrome injury, the issue of acute respiratory failure after out-of-hospital cardiac arrest has not been investigated. The objectives of this analysis were to determine the prevalence of acute respiratory failure after out-of-hospital cardiac arrest, its association with post-cardiac arrest syndrome inflammatory response and to clarify its importance for early mortality.Methods: The Post-Cardiac Arrest Syndrome (PCAS) pilot study was a prospective, observational, six-centre project (Poland 2, Denmark 1, Spain 1, Italy 1, UK 1), studying patients resuscitated after out-of-hospital cardiac arrest of cardiac origin. Primary outcomes were: (a) the profile of organ failure within the first 72 hours after out-of-hospital cardiac arrest; (b) in-hospital and short-term mortality, up to 30 days of follow-up. Respiratory failure was defined using a modified version of the Berlin acute respiratory distress syndrome definition. Inflammatory response was defined using leukocytes (white blood cells), platelet count and C-reactive protein concentration. All parameters were assessed every 24 hours, from admission until 72 hours of stay.Results: Overall, 148 patients (age 62.9±15.27 years; 27.7% women) were included. Acute respiratory failure was noted in between 50 (33.8%) and 75 (50.7%) patients over the first 72 hours. In-hospital and short-term mortality was 68 (46.9%) and 72 (48.6%), respectively. Inflammation was significantly associated with the risk of acute respiratory failure, with the highest cumulative odds ratio of 748 at 72 hours (C-reactive protein 1.035 (1.001–1.070); 0.043, white blood cells 1.086 (1.039–1.136); 0.001, platelets 1.004 (1.001–1.007); <0.005). Early acute respiratory failure was related to in-hospital mortality (3.172, 95% confidence interval 1.496–6.725; 0.002) and to short-term mortality (3.335 (1.815–6.129); 0.0001).Conclusions: An inflammatory response is significantly associated with acute respiratory failure early after out-of-hospital cardiac arrest. Acute respiratory failure is associated with a worse early prognosis after out-of-hospital cardiac arrest.

Published
2020
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88. Left Main Stenting in Comparison With Surgical Revascularization: 10-Year Outcomes of the (Left Main Coronary Artery Stenting) LE MANS Trial.

Author

Buszman, Pawel E., Buszman, Piotr P., Banasiewicz-Szkróbka, Iwona, Milewski, Krzysztof P., Żurakowski, Aleksander, Orlik, Bartłomiej, Konkolewska, Magda, Trela, Błażej, Janas, Adam, Martin, Jack L., Kiesz, R. Stefan, and Bochenek, Andrzej

Abstract

Objectives This study has reported 10-year clinical follow-up of patients enrolled in the prospective, randomized LE MANS (Left Main Stenting) trial. Background The very long-term outcome after left main stenting in comparison with surgical revascularization remains unknown. Methods In this prospective, multicenter trial, we randomly assigned 105 patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease according to SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score to percutaneous coronary intervention (PCI) with stenting (n = 52) or coronary artery bypass grafting (CABG) (n = 53). Drug-eluting stents were implanted in 35%, whereas arterial grafts to the left anterior descending artery were utilized in 81%. Currently, the mean long-term follow-up was collected at 9.8 ± 1.0 years. Follow up for all-cause mortality is complete, whereas the incidence of major adverse cardiovascular and cerebral events (MACCE) was reported from 90% of patients. Ambulatory follow-up was completed in 46 (43.9%) patients. Results At 10 years, there was a trend toward higher ejection fraction in stenting when compared with surgery (54.9 ± 8.3% vs. 49.8 ± 10.3%; p = 0.07). The mortality (21.6% vs. 30.2%; p = 0.41) and MACCE (51.1% vs. 64.4%; p = 0.28) were statistically not different between groups; however, numerically the difference was in favor of stenting. Similarly, there was no difference in the occurrence of myocardial infarction (8.7 vs. 10.4%; p = 0.62), stroke (4.3 vs. 6.3%; p = 0.68), and repeated revascularization rates (26.1% vs. 31.3%; p = 0.64). The probability of very long-term survival up to 14 years was comparable between PCI and CABG (74.2% vs. 67.5%; p = 0.34; hazard ratio: 1.45, 95% confidence interval: 0.67 to 3.13); however, there was a trend toward higher MACCE-free survival in the PCI group (34.7% vs. 22.1%; p = 0.06; hazard ratio: 1.71, 95% confidence interval: 0.97 to 2.99). Conclusions In patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease, stenting offers numerically, but statistically nonsignificant, favorable long-term outcome up to 10 years in terms of safety and efficacy outcome measures, therefore, constitutes an alternative therapy for CABG. [ABSTRACT FROM AUTHOR]

Published
2016
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89. Guidelines on the management of stable angina pectoris: executive summary: The Task Force on the Management of Stable Angina Pectoris of the European Society of Cardiology

Author

Fox K, Garcia MA, Ardissino D, Buszman P, CAMICI , PAOLO, Crea F, Daly C, De Backer G, Hjemdahl P, Lopez Sendon J, Marco J, Morais J, Pepper J, Sechtem U, Simoons M, Thygesen K, Priori SG, Blanc JJ, Budaj A, Camm J, Dean V, Deckers J, Dickstein K, Lekakis J, McGregor K, Metra M, Osterspey A, Tamargo J, Zamorano JL, Andreotti F, Becher H, Dietz R, Fraser A, Gray H, Antolin RA, Huber K, Kremastinos DT, Maseri A, Nesser HJ, Pasierski T, Sigwart U, Tubaro M, Weis M., Fox, K, Garcia, Ma, Ardissino, D, Buszman, P, Camici, Paolo, Crea, F, Daly, C, De Backer, G, Hjemdahl, P, Lopez Sendon, J, Marco, J, Morais, J, Pepper, J, Sechtem, U, Simoons, M, Thygesen, K, Priori, Sg, Blanc, Jj, Budaj, A, Camm, J, Dean, V, Deckers, J, Dickstein, K, Lekakis, J, Mcgregor, K, Metra, M, Osterspey, A, Tamargo, J, Zamorano, Jl, Andreotti, F, Becher, H, Dietz, R, Fraser, A, Gray, H, Antolin, Ra, Huber, K, Kremastinos, Dt, Maseri, A, Nesser, Hj, Pasierski, T, Sigwart, U, Tubaro, M, and Weis, M.

Subjects
Male, medicine.medical_specialty, Cardiotonic Agents, medicine.medical_treatment, Placebo-controlled study, Revascularization, Coronary Angiography, Risk Assessment, law.invention, Angina Pectoris, Coronary artery disease, Electrocardiography, Pharmacotherapy, Randomized controlled trial, law, Diabetes mellitus, Internal medicine, medicine, Myocardial Revascularization, Humans, Myocardial infarction, Angioplasty, Balloon, Coronary, Coronary Artery Bypass, Medical History Taking, Referral and Consultation, Aged, Executive summary, business.industry, Clinical Laboratory Techniques, Middle Aged, medicine.disease, Cardiology, Exercise Test, Female, Stents, Cardiology and Cardiovascular Medicine, business
Abstract

Under the heading ‘Hypertension, diabetes, and other disorders’ on page 1358, the guidelines1 lean on the taskforce report on CVD prevention2 suggesting ‘considering a lower threshold for institution of pharmacological therapy for hypertension (130/85) for patients with established coronary heart disease (which would include patients with …

Published
2006

92. Impact of vessel size on angiographic and clinical outcomes of revascularization with biolimus-eluting stent with biodegradable polymer and sirolimus-eluting stent with durable polymer the LEADERS trial substudy

Author

Wykrzykowska, J. J., Serruys, P. W., Onuma, Y., de Vries, T., van Es, G. -A., Buszman, P., Linke, A., Ischinger, T., Klauss, V., Corti, R., Eberli, F., Wijns, W., Morice, M. -C., di Mario, C., van Geuns, R. J., Juni, P., Windecker, S., University of Zurich, Serruys, P W, and Cardiology

Subjects
long lesions, small vessels, biolimus-eluting stent, target vessel revascularization, sirolimus-eluting stent, 10209 Clinic for Cardiology, biodegradable polymer, Aged, Angioplasty, Balloon, Coronary, Cardiovascular Agents, Coronary Restenosis, Coronary Stenosis, Europe, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Proportional Hazards Models, Prosthesis Design, Risk Assessment, Severity of Illness Index, Sirolimus, Thrombosis, Time Factors, Treatment Outcome, Absorbable Implants, Coronary Angiography, Drug-Eluting Stents, Polymers, 610 Medicine & health, cardiovascular diseases, 2705 Cardiology and Cardiovascular Medicine
Abstract

ObjectivesWe assessed the impact of vessel size on outcomes of stenting with biolimus-eluting degradable polymer stent (BES) and sirolimus-eluting permanent polymer stent (SES) within a randomized multicenter trial (LEADERS).BackgroundStenting of small vessels might be associated with higher rates of adverse events.Methods“All-comer” patients (n = 1,707) were randomized to BES and SES. Post-hoc–stratified analysis of angiographic and clinical outcomes at 9 months and 1 year, respectively, was performed for vessels with reference diameter ≤2.75 mm versus >2.75 mm.ResultsOf 1,707 patients, 429 patients in the BES group with 576 lesions and 434 patients in the SES group with 557 lesions had only small vessels treated (50.6% of the patient cohort). In patients with small vessels there was no significant difference in overall major adverse cardiac events (MACE) rate (12.1% vs. 11.8%; p = 0.89) or target lesion revascularization (TLR) rate (9.6% vs. 7.4%; p = 0.26) between BES and SES. The MACE and TLR rates in the small-vessel patient population were higher than in the large-vessel population. The TLR rate was 9.6% versus 2.6%, and MACE rate was 12.1% versus 7.1% for small versus large vessels in the BES arm (TLR: hazard ratio [HR] = 3.724, p = 0.0013; MACE: HR = 1.720, p = 0.0412). In the SES arm, TLR was 7.4% versus 5.1%, and MACE was 11.8% versus 10.3% in small versus large vessels (TLR: HR = 1.435, p = 0.2594; MACE: HR = 1.149, p = 0.5546).ConclusionsPrevalence of small vessel disease is high in an “all-comer” population with higher TLR and MACE rates. The BES and SES seem equivalent in treatment outcomes of small vessels in this “all-comer” patient population.

Published
2009

93. Reduced risk of myocardial infarct and revascularization following coronary artery bypass grafting compared with percutaneous coronary intervention in patients with chronic kidney disease

Author

Charytan, David M., Desai, Manisha, Mathur, Maya, Stern, Noam M., Brooks, Maria M., Krzych, Lukasz J., Schuler, Gerhard C., Kaehler, Jan, Rodriguez-Granillo, Alfredo M., Hueb, Whady, Reeves, Barnaby C., Thiele, Holger, Rodriguez, Alfredo E., Buszman, Piotr P., Buszman, Paweł E., Maurer, Rie, and Winkelmayer, Wolfgang C.

Abstract

Coronary atherosclerotic disease is highly prevalent in chronic kidney disease (CKD). Although revascularization improves outcomes, procedural risks are increased in CKD, and unbiased data comparing coronary artery bypass grafting (CABG) and percutaneous intervention (PCI) in CKD are sparse. To compare outcomes of CABG and PCI in stage 3 to 5 CKD, we identified randomized trials comparing these procedures. Investigators were contacted to obtain individual, patient-level data. Ten of 27 trials meeting inclusion criteria provided data. These trials enrolled 3993 patients encompassing 526 patients with stage 3 to 5 CKD of whom 137 were stage 3b–5 CKD. Among individuals with stage 3 to 5 CKD, survival through 5 years was not different after CABG compared with PCI (hazard ratio [HR] 0.99, 95% confidence interval [CI] 0.67–1.46) or stage 3b–5 CKD (HR 1.29, CI 0.68–2.46). However, CKD modified the impact on survival free of myocardial infarction: it was not different between CABG and PCI for individuals with preserved kidney function (HR 0.97, CI 0.80–1.17), but was significantly lower after CABG in stage 3–5 CKD (HR 0.49, CI 0.29–0.82) and stage 3b-5 CKD (HR 0.23, CI 0.09–0.58). Repeat revascularization was reduced after CABG compared with PCI regardless, of baseline kidney function. Results were limited by unavailability of data from several trials and paucity of enrolled patients with stage 4–5 CKD. Thus, our patient-level meta-analysis of individuals with CKD randomized to CABG versus PCI suggests that CABG significantly reduces the risk of subsequent myocardial infarction and revascularization without affecting survival in these patients.

Published
2016
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94. Guidelines on the management of stable angino pectoris: executive summary

Author

Fox, K, Alonso Garcia, MA, Ardissino, D, Buszman, P, Camici, PG, Crea, F, Daly, C, de Backer, G, Hjemdahl, P, Lopez-Sendon, J, Marco, J, Morais, J, Pepper, J, Sechtem, U, Simoons, Maarten, Thygesen, K, Priori, SG, le Blanc, J-J, Budaj, A, Camm, AJ, Dean, V, Deckers, Jaap, Dickstein, K, Lekakis, J, McGregor, K, Metra, M, Osterspey, A, Tamargo, JL, Zamorano, JL, Andreotti, F, Bechner, H, Dietz, R, Fraser, AG, Gray, H, Hernandez Antolin, RA, Huber, K, Kremastinos, DT, Maseri, A, Nesser, HJ, pasierski, T, Sigwart, U, Tubaro, M, Weis, M, and Cardiology

Published
2006

96. A prospective, randomized, open-label trial of 6-month versus 12-month dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction: Rationale and design of the "DAPT-STEMI trial".

Author

Kedhi, Elvin, Fabris, Enrico, van der Ent, Martin, Kennedy, Mark W., Buszman, Pawel, von Birgelen, Clemens, Cook, Stéphane, Wedel, Hans, and Zijlstra, Felix

Abstract

Background: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention with second-generation drug eluting stents (DESs) is unclear. Because prolonged DAPT is associated with higher bleeding risk and health care costs, establishing optimal DAPT duration is of paramount importance. No other randomized controlled trials have evaluated the safety of shorter DAPT duration in ST-elevation myocardial infarction (STEMI) patients treated with second-generation DESs and latest P2Y12 platelet receptor inhibitors.Hypothesis: Six months of DAPT after Resolute Integrity stent implantation in STEMI patients is not inferior to 12 months of DAPT in clinical outcomes.Study Design: The Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation In ST-elevation Myocardial Infarction (DAPT-STEMI) trial is a randomized, multicenter, international, open-label trial designed to examine the safety (noninferiority) of 6-month DAPT after Resolute Integrity stent implantation in STEMI patients compared with 12-month DAPT. Event-free patients on DAPT at 6month will be randomized (1:1 fashion) between single (aspirin only) versus DAPT for an additional 6 months and followed until 2 years after primary percutaneous coronary intervention. The primary end point is a patient-oriented composite endpoint of all-cause mortality, any myocardial infarction, any revascularization, stroke, and major bleeding (net adverse clinical events [NACE]) at 18 months after randomization. To achieve a power of 85% for a noninferiority limit of 1.66, a total of 1100 enrolled patients are required.Summary: The DAPT-STEMI trial aims to assess in STEMI patients treated with second-generation DESs whether discontinuation of DAPT after 6 months of event-free survival is noninferior to routine 12-month DAPT. [ABSTRACT FROM AUTHOR]

Published
2017
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98. Coronary artery bypass graft versus percutaneous coronary intervention with drug-eluting stent implantation for diabetic patients with unprotected left main coronary artery disease: The D-DELTA registry

Author

Meliga, E. (Emanuele), Benedictis, M. (Mauro) de, Chieffo, A. (Alaide), Latib, A. (Azeem), Park, S.-J. (Seung-Jung), Kim, Y.-H. (Young-Hak), Onuma, Y. (Yoshinobu), Capranzano, P. (Piera), Jegere, S. (Sanda), Makkar, R.R. (Raj), Palacios, I.F. (Igor), Buszman, P. (Pawel), Bande, M. (Marta), Chakravarty, T. (Tarun), Mehran, R. (Roxana), Naber, C.K. (Christoph), Scrocca, I. (Innocenzo), Margey, R. (Ronan), Leon, M.B. (Martin), Moses, J.W. (Jeffrey), Fajadet, J. (Jean), Lefèvre, T. (Thierry), Morice, M-C. (Marie-Claude), Erglis, A. (Andrejs), Tamburino, C. (Corrado), Alfieri, O. (Ottavio), Conte, M.L., Serruys, P.W.J.C. (Patrick), Colombo, A. (Antonio), Meliga, E. (Emanuele), Benedictis, M. (Mauro) de, Chieffo, A. (Alaide), Latib, A. (Azeem), Park, S.-J. (Seung-Jung), Kim, Y.-H. (Young-Hak), Onuma, Y. (Yoshinobu), Capranzano, P. (Piera), Jegere, S. (Sanda), Makkar, R.R. (Raj), Palacios, I.F. (Igor), Buszman, P. (Pawel), Bande, M. (Marta), Chakravarty, T. (Tarun), Mehran, R. (Roxana), Naber, C.K. (Christoph), Scrocca, I. (Innocenzo), Margey, R. (Ronan), Leon, M.B. (Martin), Moses, J.W. (Jeffrey), Fajadet, J. (Jean), Lefèvre, T. (Thierry), Morice, M-C. (Marie-Claude), Erglis, A. (Andrejs), Tamburino, C. (Corrado), Alfieri, O. (Ottavio), Conte, M.L., Serruys, P.W.J.C. (Patrick), and Colombo, A. (Antonio)

Abstract

Aims: Data regarding the impact on clinical outcomes of PCI with DES implantation vs. CABG to treat unprotected left main coronary artery (ULMCA) disease in diabetic patients are still insufficient. The present study evaluated the short-term and long-term results of percutaneous and surgical revascularisation in diabetic patients with ULMCA disease in a large population. Methods and results: A total of 826 diabetic patients with ULMCA stenosis who received DES (n=520) or underwent CABG (n=306) were selected and analysed from the DELTA registry. In-hospital MACCE was significantly higher in the CABG group, mainly driven by a higher incidence of MI. At four-year follow-up, freedom from death and the composite endpoint of death, MI and cerebrovascular accident (CVA) was similar in the two treatment groups (CABG 87.4%, PCI 82.5%, p=0.124, and CABG 8

Published
2013
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99. Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable polymer coronary stent (TARGET All Comers): a multicentre, open-label, randomised non-inferiority trial

Author

Lansky, Alexandra, Wijns, William, Xu, Bo, Kelbæk, Henning, van Royen, Niels, Zheng, Ming, Morel, Marie-angèle, Knaapen, Paul, Slagboom, Ton, Johnson, Thomas W, Vlachojannis, Georgios, Arkenbout, Karin E, Holmvang, Lene, Janssens, Luc, Ochala, Andrzej, Brugaletta, Salvatore, Naber, Christoph K, Anderson, Richard, Rittger, Harald, Berti, Sergio, Barbato, Emanuele, Toth, Gabor G, Maillard, Luc, Valina, Christian, Buszman, Paweł, Thiele, Holger, Schächinger, Volker, and Baumbach, Andreas

Abstract

The FIREHAWK is a drug-eluting stent with a fully biodegradable sirolimus-containing polymer coating localised to recessed abluminal grooves on the stent surface. We investigated clinical outcomes with this targeted, low-dose, biodegradable polymer, sirolimus-eluting stent compared with XIENCE durable polymer, everolimus-eluting stents in an all-comers population.

Published
2018
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100. 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

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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