Search

Your search keyword '"Nordaby, Matias"' showing total 211 results
Start Over Author "Nordaby, Matias"
211 results on '"Nordaby, Matias"'

3. Time from admission to randomization and the effect of empagliflozin in acute heart failure: A post‐hoc analysis from EMPULSE.

Author

Ferreira, João Pedro, Blatchford, Jonathan P., Teerlink, John R., Kosiborod, Mikhail N., Angermann, Christiane E., Biegus, Jan, Collins, Sean P., Tromp, Jasper, Nassif, Michael E., Psotka, Mitchell A., Comin‐Colet, Josep, Mentz, Robert J., Brueckmann, Martina, Nordaby, Matias, Ponikowski, Piotr, and Voors, Adriaan A.

Abstract

Aims: Patients hospitalized for acute heart failure (HF) could be enrolled in EMPULSE (NCT04157751) upon haemodynamic stabilization and between 24 h and 5 days after hospital admission. The timing of treatment initiation may influence the efficacy and safety of drugs such as empagliflozin. The aim of this study was to evaluate patient characteristics, clinical events, and treatment effects according to time from admission to randomization. Methods and results: The EMPULSE population was dichotomized by median time from hospital admission to randomization (1–2 days vs. 3–5 days). The primary outcome was a hierarchical composite endpoint of time to all‐cause death, number of HF events, time to first HF event, and a ≥5‐point difference in Kansas City Cardiomyopathy Questionnaire total symptom score change from baseline after 90 days, analysed using the win ratio (WR) method. Patients randomized later (3–5 days, average time 3.9 days; n = 312) had a higher risk of experiencing clinical events than patients randomized earlier (1–2 days, average time 1.7 days; n = 215). The treatment effect favoured empagliflozin versus placebo in patients randomized later (3–5 days: WR 1.69, 95% confidence interval [CI] 1.26–2.25) but was attenuated in patients randomized earlier (1–2 days: WR 1.04, 95% CI 0.74–1.44) (interaction p = 0.029). A similar pattern was observed for the composite of HF hospitalization or cardiovascular death and all‐cause hospitalizations (interaction p < 0.1 for both). The reduction of N‐terminal pro‐B‐type natriuretic peptide levels was more pronounced with empagliflozin among patients randomized later than in patients randomized earlier (interaction p = 0.004). Conclusions: Among patients hospitalized for acute HF enrolled in EMPULSE, those randomized later after hospital admission (3–5 days) experienced greater clinical benefit with empagliflozin than those randomized earlier (1–2 days). These findings should be confirmed in future studies before clinical application. [ABSTRACT FROM AUTHOR]

Published
2024
Full Text
View/download PDF

4. Empagliflozin in the treatment of heart failure with reduced ejection fraction in addition to background therapies and therapeutic combinations (EMPEROR-Reduced): a post-hoc analysis of a randomised, double-blind trial

Author

Packer, M, Anker, S, Butler, J, Filippatos, G, Pocock, S, Zannad, F, Ferreira, JP, Brueckmann, M, George, J, Jamal, W, Welty, FK, Palmer, M, Clayton, T, Parhofer, KG, Pedersen, TR, Greenberg, B, Konstam, MA, Lees, KR, Carson, P, Doehner, W, Miller, A, Haas, M, Pehrson, S, Komajda, M, Anand, I, Teerlink, J, Rabinstein, A, Steiner, T, Kamel, H, Tsivgoulis, G, Lewis, J, Freston, J, Kaplowitz, N, Mann, J, Petrie, J, Perrone, S, Nicholls, S, Janssens, S, Bocchi, E, Giannetti, N, Verma, S, Zhang, J, Spinar, J, Seronde, M-F, Boehm, M, Merkely, B, Chopra, V, Senni, M, Taddi, S, Tsutsui, H, Choi, D-J, Chuquiure, E, La Rocca, HPB, Ponikowski, P, Juanatey, JRG, Squire, I, Januzzi, J, Pina, I, Bernstein, R, Cheung, A, Green, J, Kaul, S, Lam, C, Lip, G, Marx, N, McCullough, P, Mehta, C, Rosenstock, J, Sattar, N, Scirica, B, Shah, S, Wanner, C, Aizenberg, D, Cartasegna, L, Colombo Berra, F, Colombo, H, Fernandez Moutin, M, Glenny, J, Alvarez Lorio, C, Anauch, D, Campos, R, Facta, A, Fernandez, A, Ahuad Guerrero, R, Lobo Márquez, L, Leon de la Fuente, RA, Mansilla, M, Hominal, M, Hasbani, E, Najenson, M, Moises Azize, G, Luquez, H, Guzman, L, Sessa, H, Amuchástegui, M, Salomone, O, Perna, E, Piskorz, D, Sicer, M, Perez de Arenaza, D, Zaidman, C, Nani, S, Poy, C, Resk, J, Villarreal, R, Majul, C, Smith Casabella, T, Sassone, S, Liberman, A, Carnero, G, Caccavo, A, Berli, M, Budassi, N, Bono, J, Alvarisqueta, A, Amerena, J, Kostner, K, Hamilton, A, Begg, A, Beltrame, J, Colquhoun, D, Gordon, G, Sverdlov, A, Vaddadi, G, Wong, J, Coller, J, Prior, D, Friart, A, Leone, A, Vervoort, G, Timmermans, P, Troisfontaines, P, Franssen, C, Sarens, T, Vandekerckhove, H, Van De Borne, P, Chenot, F, De Sutter, J, De Vuyst, E, Debonnaire, P, Dupont, M, Pereira Dutra, O, Canani, LH, Vieira Moreira, MdC, de Souza, W, Backes, LM, Maia, L, De Souza Paolino, B, Manenti, ER, Saporito, W, Villaça Guimarães Filho, F, Franco Hirakawa, T, Saliba, LA, Neuenschwander, FC, de Freitas Zerbini, CA, Gonçalves, G, Gonçalves Mello, Y, Ascenção de Souza, J, Beck da Silva Neto, L, Bocchi, EA, Da Silveira, J, de Moura Xavier Moraes Junior, JB, de Souza Neto, JD, Hernandes, M, Finimundi, HC, Sampaio, CR, Vasconcellos, E, Neves Mancuso, FJ, Noya Rabelo, MM, Rodrigues Bacci, M, Santos, F, Vidotti, M, Simões, MV, Gomes, FL, Vieira Nascimento, C, Precoma, D, Helfenstein Fonseca, FA, Ribas Fortes, JA, Leães, PE, Campos de Albuquerque, D, Kerr Saraiva, JF, Rassi, S, Alves da Costa, FA, Reis, G, Zieroth, S, Dion, D, Savard, D, Bourgeois, R, Constance, C, Anderson, K, Leblanc, M-H, Yung, D, Swiggum, E, Pliamm, L, Pesant, Y, Tyrrell, B, Huynh, T, Spiegelman, J, Lavoie, J-P, Hartleib, M, Bhargava, R, Straatman, L, Virani, S, Costa-Vitali, A, Hill, L, Heffernan, M, Khaykin, Y, Ricci, J, Senaratne, M, Zhai, A, Lubelsky, B, Toma, M, Yao, L, McKelvie, R, Noronha, L, Babapulle, M, Pandey, A, Curnew, G, Lavoie, A, Berlingieri, J, Kouz, S, Lonn, E, Chehayeb, R, Zheng, Y, Sun, Y, Cui, H, Fan, Z, Han, X, Jiang, X, Tang, Q, Zhou, J, Zheng, Z, Zhang, X, Zhang, N, Zhang, Y, Shen, A, Yu, J, Ye, J, Yao, Y, Yan, J, Xu, X, Wang, Z, Ma, J, Li, Y, Li, S, Lu, S, Kong, X, Song, Y, Yang, G, Yao, Z, Pan, Y, Guo, X, Sun, Z, Dong, Y, Zhu, J, Peng, D, Yuan, Z, Lin, J, Yin, Y, Jerabek, O, Burianova, H, Fiala, T, Hubac, J, Ludka, O, Monhart, Z, Vodnansky, P, Zeman, K, Foldyna, D, Krupicka, J, Podpera, I, Busak, L, Radvan, M, Vomacka, Z, Prosecky, R, Cifkova, R, Durdil, V, Vesely, J, Vaclavik, J, Cervinka, P, Linhart, A, Brabec, T, Miklik, R, Bourhaial, H, Olbrich, H-G, Genth-Zotz, S, Kemala, E, Lemke, B, Böhm, M, Schellong, S, Rieker, W, Heitzer, T, Ince, H, Faghih, M, Birkenfeld, A, Begemann, A, Ghanem, A, Ujeyl, A, von Haehling, S, Dorsel, T, Bauersachs, J, Prull, M, Weidemann, F, Darius, H, Nickenig, G, Wilke, A, Sauter, J, Rauch-Kroehnert, U, Frey, N, Schulze, CP, König, W, Maier, L, Menzel, F, Proskynitopoulos, N, Ebert, H-H, Sarnighausen, H-E, Düngen, H-D, Licka, M, Stellbrink, C, Winkelmann, B, Menck, N, López-Sendón, JL, de la Fuente Galán, L, Delgado Jiménez, JF, Manito Lorite, N, Pérez de Juan Romero, M, Galve Basilio, E, Cereto Castro, F, González Juanatey, JR, Gómez, JJ, Sanmartín Fernández, M, Garcia-Moll Marimon, X, Pascual Figal, D, Bover Freire, R, Bonnefoy Cudraz, E, Jobbe Duval, A, Tomasevic, D, Habib, G, Isnard, R, Picard, F, Khanoyan, P, Dubois-Rande, J-L, Galinier, M, Roubille, F, Alexandre, J, Babuty, D, Delarche, N, Berneau, J-B, Girerd, N, Saxena, M, Rosano, G, Yousef, Z, Clifford, C, Arden, C, Bakhai, A, Boos, C, Jenkins, G, Travill, C, Price, D, Koenyves, L, Lakatos, F, Matoltsy, A, Noori, E, Zilahi, Z, Andrassy, P, Kancz, S, Simon, G, Sydo, T, Vorobcsuk, A, Kiss, RG, Toth, K, Szakal, I, Nagy, L, Barany, T, Nagy, A, Szolnoki, E, Chopra, VK, Mandal, S, Rastogi, V, Shah, B, Mullasari, A, Shankar, J, Mehta, V, Oomman, A, Kaul, U, Komarlu, S, Kahali, D, Bhagwat, A, Vijan, V, Ghaisas, NK, Mehta, A, Kashyap, J, Kothari, Y, TaddeI, S, Scherillo, M, Zacà, V, Genovese, S, Salvioni, A, Fucili, A, Fedele, F, Cosmi, F, Volpe, M, Mazzone, C, Esposito, G, Doi, M, Yamamoto, H, Sakagami, S, Oishi, S, Yasaka, Y, Tsuboi, H, Fujino, Y, Matsuoka, S, Watanabe, Y, Himi, T, Ide, T, Ichikawa, M, Kijima, Y, Koga, T, Yuda, S, Fukui, K, Kubota, T, Manita, M, Fujinaga, H, Matsumura, T, Fukumoto, Y, Kato, R, Kawai, Y, Hiasa, G, Kazatani, Y, Mori, M, Ogimoto, A, Inoko, M, Oguri, M, Kinoshita, M, Okuhara, K, Watanabe, N, Ono, Y, Otomo, K, Sato, Y, Matsunaga, T, Takaishi, A, Miyagi, N, Uehara, H, Takaishi, H, Urata, H, Kataoka, T, Matsubara, H, Matsumoto, T, Suzuki, T, Takahashi, N, Imamaki, M, Yoshitama, T, Saito, T, Sekino, H, Furutani, Y, Koda, M, Shinozaki, T, Hirabayashi, K, Tsunoda, R, Yonezawa, K, Hori, H, Yagi, M, Arikawa, M, Hashizume, T, Ishiki, R, Koizumi, T, Nakayama, K, Taguchi, S, Nanasato, M, Yoshida, Y, Tsujiyama, S, Nakamura, T, Oku, K, Shimizu, M, Suwa, M, Momiyama, Y, Sugiyama, H, Kobayashi, K, Inoue, S, Kadokami, T, Maeno, K, Kawamitsu, K, Maruyama, Y, Nakata, A, Shibata, T, Wada, A, Cho, H-J, Na, JO, Yoo, B-S, Choi, J-O, Hong, SK, Shin, J-H, Cho, M-C, Han, SH, Jeong, J-O, Kim, J-J, Kang, SM, Kim, D-S, Kim, MH, Llamas Esperon, G, Illescas Díaz, J, Fajardo Campos, P, Almeida Alvarado, J, Bazzoni Ruiz, A, Echeverri Rico, J, Lopez Alcocer, I, Valle Molina, L, Hernandez Herrera, C, Calvo Vargas, C, Padilla Padilla, FG, Rodriguez Briones, I, Chuquiure Valenzuela, EJJR, Aguilera Real, ME, Carrillo Calvillo, J, Alpizar Salazar, M, Cervantes Escárcega, JL, Velasco Sanchez, R, Al - Windy, N, van Heerebeek, L, Bellersen, L, Brunner-La Rocca, H-P, Post, J, Linssen, GCM, van de Wetering, M, Peters, R, van Stralen, R, Groutars, R, Smits, P, Yilmaz, A, Kok, WEM, Van der Meer, P, Dijkmans, P, Troquay, R, van Alem, AP, Van de Wal, R, Handoko, L, Westendorp, ICD, van Bergen, PFMM, Rensing, BJWM, Hoogslag, P, Kietselaer, B, Kragten, JA, den Hartog, FR, Alings, A, Danilowicz-Szymanowicz, L, Raczak, G, Piesiewicz, W, Zmuda, W, Kus, W, Podolec, P, Musial, W, Drelich, G, Kania, G, Miekus, P, Mazur, S, Janik, A, Spyra, J, Peruga, J, Balsam, P, Krakowiak, B, Szachniewicz, J, Ginel, M, Grzybowski, J, Chrustowski, W, Wojewoda, P, Kalinka, A, Zurakowski, A, Koc, R, Debinski, M, Fil, W, Kujawiak, M, Forys, J, Kasprzak, M, Krol, M, Michalski, P, Mirek-Bryniarska, E, Radwan, K, Skonieczny, G, Stania, K, Skoczylas, G, Madej, A, Jurowiecki, J, Firek, B, Wozakowska-Kaplon, B, Cymerman, K, Neutel, J, Adams, K, Balfour, P, Deswal, A, Djamson, A, Duncan, P, Hong, M, Murray, C, Rinde-Hoffman, D, Woodhouse, S, MacNevin, R, Rama, B, Broome-Webster, C, Kindsvater, S, Abramov, D, Barettella, M, Pinney, S, Herre, J, Cohen, A, Vora, K, Challappa, K, West, S, Baum, S, Cox, J, Jani, S, Karim, A, Akhtar, A, Quintana, O, Paukman, L, Goldberg, R, Bhatti, Z, Budoff, M, Bush, E, Potler, A, Delgado, R, Ellis, B, Dy, J, Fialkow, J, Sangrigoli, R, Ferdinand, K, East, C, Falkowski, S, Donahoe, S, Ebrahimi, R, Kline, G, Harris, B, Khouzam, R, Jaffrani, N, Jarmukli, N, Kazemi, N, Koren, M, Friedman, K, Herzog, W, Silva Enciso, J, Cheung, D, Grover-McKay, M, Hauptman, P, Mikhalkova, D, Hegde, V, Hodsden, J, Khouri, S, McGrew, F, Littlefield, R, Bradley, P, McLaurin, B, Lupovitch, S, Labin, I, Rao, V, Leithe, M, Lesko, M, Lewis, N, Lombardo, D, Mahal, S, Malhotra, V, Dauber, I, Banerjee, A, Needell, J, Miller, G, Paladino, L, Munuswamy, K, Nanna, M, McMillan, E, Mumma, M, Napoli, M, Nelson, W, O'Brien, T, Adlakha, A, Onwuanyi, A, Serota, H, Schmedtje, J, Paraschos, A, Potu, R, Sai-Sudhakar, C, Saltzberg, M, Sauer, A, Shah, P, Skopicki, H, Bui, H, Carr, K, Stevens, G, Tahirkheli, N, Tallaj, J, Yousuf, K, Trichon, B, Welker, J, Tolerico, P, Vest, A, Vivo, R, Wang, X, Abadier, R, Dunlap, S, Weintraub, N, Malik, A, Kotha, P, Zaha, V, Kim, G, Uriel, N, Greene, T, Salacata, A, Arora, R, Gazmuri, R, Kobayashi, J, Iteld, B, Vijayakrishnan, R, Dab, R, Mirza, Z, Marques, V, Nallasivan, M, Bensimhon, D, Peart, B, Saint-Jacques, H, Barringhaus, K, Contreras, J, Gupta, A, Koneru, S, Nguyen, V, Verma, Subodh, Dhingra, Nitish K, Butler, Javed, Anker, Stefan D, Ferreira, Joao Pedro, Filippatos, Gerasimos, Januzzi, James L, Lam, Carolyn S P, Sattar, Naveed, Peil, Barbara, Nordaby, Matias, Brueckmann, Martina, Pocock, Stuart J, Zannad, Faiez, and Packer, Milton

Published
2022
Full Text
View/download PDF

6. Comparison of Dabigatran Plus a P2Y12 Inhibitor With Warfarin-Based Triple Therapy Across Body Mass Index in RE-DUAL PCI

Author

De Caterina, Raffaele, Procopio, Antonio, Lopez Sendon, José-Luis, Raev, Dimitar, Mehta, Shamir R., Opolski, Grzegorz, Oldgren, Jonas, Steg, Philippe Gabriel, Hohnloser, Stefan H., Lip, Gregory Y.H., Kimura, Takeshi, Kleine, Eva, ten Berg, Jurriën M., Bhatt, Deepak L., Miede, Corinna, Nordaby, Matias, and Cannon, Christopher P.

Published
2020
Full Text
View/download PDF

7. Comparison of the Effect of Age (< 75 Versus ≥ 75) on the Efficacy and Safety of Dual Therapy (Dabigatran + Clopidogrel or Ticagrelor) Versus Triple Therapy (Warfarin + Aspirin + Clopidogrel or Ticagrelor) in Patients With Atrial Fibrillation After Percutaneous Coronary Intervention (from the RE-DUAL PCI Trial)

Author

ten Berg, Jurrien M., Steg, Philippe Gabriel, Bhatt, Deepak L., Hohnloser, Stefan H., de Veer, Anne, Nordaby, Matias, Miede, Corinna, Kimura, Takeshi, Lip, Gregory Y.H., Oldgren, Jonas, and Cannon, Christopher P.

Published
2020
Full Text
View/download PDF

11. Efficacy and Safety of Empagliflozin According to Background Diuretic Use in Heart Failure With Reduced Ejection Fraction

Author

Dhingra, Nitish K., primary, Verma, Subodh, additional, Butler, Javed, additional, Anker, Stefan D., additional, Ferreira, Joao Pedro, additional, Filippatos, Gerasimos, additional, Januzzi, James L., additional, Lam, Carolyn S.P., additional, Sattar, Naveed, additional, Zaremba-Pechmann, Liliana, additional, Böhm, Michael, additional, Nordaby, Matias, additional, Brueckmann, Martina, additional, Pocock, Stuart J., additional, Zannad, Faiez, additional, and Packer, Milton, additional

Published
2023
Full Text
View/download PDF

13. Mineralocorticoid receptor antagonist use and the effects of empagliflozin on clinical outcomes in patients admitted for acute heart failure: Findings from EMPULSE

Author

Ferreira, João Pedro, primary, Blatchford, Jonathan P., additional, Teerlink, John R., additional, Kosiborod, Mikhail N., additional, Angermann, Christiane E., additional, Biegus, Jan, additional, Collins, Sean P., additional, Tromp, Jasper, additional, Nassif, Michael E., additional, Psotka, Mitchell A., additional, Comin‐Colet, Josep, additional, Mentz, Robert J., additional, Brueckmann, Martina, additional, Nordaby, Matias, additional, Ponikowski, Piotr, additional, and Voors, Adriaan A., additional

Published
2023
Full Text
View/download PDF

15. Effect of Lesion Complexity and Clinical Risk Factors on the Efficacy and Safety of Dabigatran Dual Therapy Versus Warfarin Triple Therapy in Atrial Fibrillation After Percutaneous Coronary Intervention: A Subgroup Analysis From the REDUAL PCI Trial

Author

Berry, Natalia C., Mauri, Laura, Steg, Philippe Gabriel, Bhatt, Deepak L., Hohnloser, Stefan H., Nordaby, Matias, Miede, Corinna, Kimura, Takeshi, Lip, Gregory Y.H., Oldgren, Jonas, ten Berg, Jurriën M., and Cannon, Christopher P.

Published
2020
Full Text
View/download PDF

17. Antithrombotic therapy according to baseline bleeding risk in patients with atrial fibrillation undergoing percutaneous coronary intervention: applying the PRECISE-DAPT score in RE-DUAL PCI

Author

Costa, Francesco, Valgimigli, Marco, Steg, Philippe Gabriel, Bhatt, Deepak L, Hohnloser, Stefan H, Ten Berg, Jurrien M, Miede, Corinna, Nordaby, Matias, Lip, Gregory Y H, Oldgren, Jonas, Cannon, Christopher P, Costa, Francesco, Valgimigli, Marco, Steg, Philippe Gabriel, Bhatt, Deepak L, Hohnloser, Stefan H, Ten Berg, Jurrien M, Miede, Corinna, Nordaby, Matias, Lip, Gregory Y H, Oldgren, Jonas, and Cannon, Christopher P

Abstract

AIMS Patients with atrial fibrillation undergoing coronary intervention are at higher bleeding risk due to the concomitant need for oral anticoagulation and antiplatelet therapy. The RE-DUAL PCI trial demonstrated better safety with dual antithrombotic therapy (DAT: dabigatran 110 or 150 mg bid, clopidogrel or ticagrelor) compared to triple antithrombotic therapy (TAT: warfarin, clopidogrel or ticagrelor, and aspirin). We explored the impact of baseline bleeding risk based on the PRECISE-DAPT score for decision-making regarding DAT vs. TAT. METHODS AND RESULTS A score ≥25 points qualified high bleeding-risk (HBR). Comparisons were made for the primary safety endpoint ISTH major or clinically relevant non-major bleeding, and the composite efficacy endpoint of death, thromboembolic events, or unplanned revascularization, analyzed by time-to-event analysis. PRECISE-DAPT was available in 2,336/2,725 patients, and 37.9% were HBR. Compared to TAT, DAT with dabigatran 110 mg reduced bleeding risk both in non-HBR (HR 0.42, 95%CI, 0.31-0.57) and HBR (HR 0.70, 95%CI, 0.52-0.94), with a greater magnitude of benefit among non-HBR (Pint=0.02). DAT with dabigatran 150 mg vs. TAT reduced bleeding in non-HBR (HR 0.60, 95%CI, 0.45-0.80), with a trend toward less benefit in HBR patients (HR 0.92, 95%CI, 0.63-1.34, Pint=0.08). Risk of ischaemic events was similar on DAT with dabigatran (both 110 and 150 mg) vs. TAT in non-HBR and HBR patients (Pint=0.45 and Pint=0.56, respectively). CONCLUSIONS PRECISE-DAPT score appeared useful to identify AF patients undergoing PCI at further increased risk of bleeding complications, and may help clinicians identifying the antithrombotic regimen intensity with the best benefit-risk ratio in an individual patient.

Published
2022

18. Cardiovascular disease in the elderly: proceedings of the European Society of Cardiology - Cardiovascular Round Table

Author

Interne Geneeskunde Vasculaire, Circulatory Health, Lettino, Maddalena, Mascherbauer, Julia, Nordaby, Matias, Ziegler, André, Collet, Jean Philippe, Derumeaux, Geneviève, Hohnloser, Stefan H., Leclercq, Christophe, O'neill, Deirdre E., Visseren, Frank, Weidinger, Franz, Richard-Lordereau, Isabelle, Interne Geneeskunde Vasculaire, Circulatory Health, Lettino, Maddalena, Mascherbauer, Julia, Nordaby, Matias, Ziegler, André, Collet, Jean Philippe, Derumeaux, Geneviève, Hohnloser, Stefan H., Leclercq, Christophe, O'neill, Deirdre E., Visseren, Frank, Weidinger, Franz, and Richard-Lordereau, Isabelle

Published
2022

23. Safety, tolerability, pharmacodynamics and pharmacokinetics following once‐daily doses of BI 187004, an inhibitor of 11 beta‐hydroxysteroid dehydrogenase‐1, over 28 days in patients with type 2 diabetes mellitus and overweight or obesity

Author

Bianzano, Susanna, Nordaby, Matias, Plum‐Mörschel, Leona, Peil, Barbara, and Heise, Tim

Subjects
*TYPE 2 diabetes, *BLOOD sugar, *BODY mass index, *PHARMACOKINETICS, *PHARMACODYNAMICS, *CHILDHOOD obesity
Abstract

Aims: To study the oral 11 beta‐hydroxysteroid dehydrogenase‐1 (11β‐HSD1) inhibitor BI 187004 (NCT02150824), as monotherapy and in combination with metformin, versus placebo in patients with type 2 diabetes mellitus (T2DM) affected by overweight or obesity. Materials and Methods: This Phase II, randomized controlled trial investigated multiple rising doses of BI 187004 as monotherapy (Arm 1: 20, 80 or 240 mg) and in combination with metformin (Arm 2: 240 mg), in adults with T2DM and a body mass index of 28–40 kg/m2. Results: In total, 103 patients (Arm 1: n = 62, Arm 2: n = 41) were included in this study. BI 187004 was rapidly absorbed and exposure increased approximately dose‐dependently. Target engagement of 11β‐HSD1 was observed with near‐full inhibition of 11β‐HSD1 in the liver [decreased (5α‐tetrahydrocortisol + 5β‐tetrahydrocortisol)/tetrahydrocortisone ratio]; hypothalamic–pituitary–adrenal axis activation was also seen (increased total urinary corticosteroids). No clinically relevant changes from baseline with BI 187004 treatment were observed for bodyweight or meal tolerance test parameters, or in most efficacy endpoints testing glucose and lipid metabolism; a significant increase was observed in weighted mean plasma glucose (p <.05 for 80 and 240 mg BI 187004) but not fasting plasma glucose. Drug‐related adverse events were reported for 14 patients (22.6%) in Arm 1 and 10 patients (24.4%) in Arm 2, most frequently headache, diarrhoea, flushing and dizziness. A dose‐dependent increase in heart rate was seen with BI 187004 treatment. Conclusions: BI 187004 was generally well tolerated in patients with T2DM. Despite complete 11β‐HSD1 inhibition, no clinically relevant effects were observed with BI 187004. [ABSTRACT FROM AUTHOR]

Published
2023
Full Text
View/download PDF

24. Cardiovascular disease in the elderly: proceedings of the European Society of Cardiology—Cardiovascular Round Table

Author

Lettino, Maddalena, primary, Mascherbauer, Julia, additional, Nordaby, Matias, additional, Ziegler, André, additional, Collet, Jean Philippe, additional, Derumeaux, Geneviève, additional, Hohnloser, Stefan H, additional, Leclercq, Christophe, additional, O'Neill, Deirdre E, additional, Visseren, Frank, additional, Weidinger, Franz, additional, and Richard-Lordereau, Isabelle, additional

Published
2022
Full Text
View/download PDF

25. Empagliflozin in the treatment of heart failure with reduced ejection fraction in addition to background therapies and therapeutic combinations (EMPEROR-Reduced): a post-hoc analysis of a randomised, double-blind trial

Author

Verma, Subodh, primary, Dhingra, Nitish K, additional, Butler, Javed, additional, Anker, Stefan D, additional, Ferreira, Joao Pedro, additional, Filippatos, Gerasimos, additional, Januzzi, James L, additional, Lam, Carolyn S P, additional, Sattar, Naveed, additional, Peil, Barbara, additional, Nordaby, Matias, additional, Brueckmann, Martina, additional, Pocock, Stuart J, additional, Zannad, Faiez, additional, Packer, Milton, additional, Packer, M, additional, Anker, S, additional, Butler, J, additional, Filippatos, G, additional, Pocock, S, additional, Zannad, F, additional, Ferreira, JP, additional, Brueckmann, M, additional, George, J, additional, Jamal, W, additional, Welty, FK, additional, Palmer, M, additional, Clayton, T, additional, Parhofer, KG, additional, Pedersen, TR, additional, Greenberg, B, additional, Konstam, MA, additional, Lees, KR, additional, Carson, P, additional, Doehner, W, additional, Miller, A, additional, Haas, M, additional, Pehrson, S, additional, Komajda, M, additional, Anand, I, additional, Teerlink, J, additional, Rabinstein, A, additional, Steiner, T, additional, Kamel, H, additional, Tsivgoulis, G, additional, Lewis, J, additional, Freston, J, additional, Kaplowitz, N, additional, Mann, J, additional, Petrie, J, additional, Perrone, S, additional, Nicholls, S, additional, Janssens, S, additional, Bocchi, E, additional, Giannetti, N, additional, Verma, S, additional, Zhang, J, additional, Spinar, J, additional, Seronde, M-F, additional, Boehm, M, additional, Merkely, B, additional, Chopra, V, additional, Senni, M, additional, Taddi, S, additional, Tsutsui, H, additional, Choi, D-J, additional, Chuquiure, E, additional, La Rocca, HPB, additional, Ponikowski, P, additional, Juanatey, JRG, additional, Squire, I, additional, Januzzi, J, additional, Pina, I, additional, Bernstein, R, additional, Cheung, A, additional, Green, J, additional, Kaul, S, additional, Lam, C, additional, Lip, G, additional, Marx, N, additional, McCullough, P, additional, Mehta, C, additional, Rosenstock, J, additional, Sattar, N, additional, Scirica, B, additional, Shah, S, additional, Wanner, C, additional, Aizenberg, D, additional, Cartasegna, L, additional, Colombo Berra, F, additional, Colombo, H, additional, Fernandez Moutin, M, additional, Glenny, J, additional, Alvarez Lorio, C, additional, Anauch, D, additional, Campos, R, additional, Facta, A, additional, Fernandez, A, additional, Ahuad Guerrero, R, additional, Lobo Márquez, L, additional, Leon de la Fuente, RA, additional, Mansilla, M, additional, Hominal, M, additional, Hasbani, E, additional, Najenson, M, additional, Moises Azize, G, additional, Luquez, H, additional, Guzman, L, additional, Sessa, H, additional, Amuchástegui, M, additional, Salomone, O, additional, Perna, E, additional, Piskorz, D, additional, Sicer, M, additional, Perez de Arenaza, D, additional, Zaidman, C, additional, Nani, S, additional, Poy, C, additional, Resk, J, additional, Villarreal, R, additional, Majul, C, additional, Smith Casabella, T, additional, Sassone, S, additional, Liberman, A, additional, Carnero, G, additional, Caccavo, A, additional, Berli, M, additional, Budassi, N, additional, Bono, J, additional, Alvarisqueta, A, additional, Amerena, J, additional, Kostner, K, additional, Hamilton, A, additional, Begg, A, additional, Beltrame, J, additional, Colquhoun, D, additional, Gordon, G, additional, Sverdlov, A, additional, Vaddadi, G, additional, Wong, J, additional, Coller, J, additional, Prior, D, additional, Friart, A, additional, Leone, A, additional, Vervoort, G, additional, Timmermans, P, additional, Troisfontaines, P, additional, Franssen, C, additional, Sarens, T, additional, Vandekerckhove, H, additional, Van De Borne, P, additional, Chenot, F, additional, De Sutter, J, additional, De Vuyst, E, additional, Debonnaire, P, additional, Dupont, M, additional, Pereira Dutra, O, additional, Canani, LH, additional, Vieira Moreira, MdC, additional, de Souza, W, additional, Backes, LM, additional, Maia, L, additional, De Souza Paolino, B, additional, Manenti, ER, additional, Saporito, W, additional, Villaça Guimarães Filho, F, additional, Franco Hirakawa, T, additional, Saliba, LA, additional, Neuenschwander, FC, additional, de Freitas Zerbini, CA, additional, Gonçalves, G, additional, Gonçalves Mello, Y, additional, Ascenção de Souza, J, additional, Beck da Silva Neto, L, additional, Bocchi, EA, additional, Da Silveira, J, additional, de Moura Xavier Moraes Junior, JB, additional, de Souza Neto, JD, additional, Hernandes, M, additional, Finimundi, HC, additional, Sampaio, CR, additional, Vasconcellos, E, additional, Neves Mancuso, FJ, additional, Noya Rabelo, MM, additional, Rodrigues Bacci, M, additional, Santos, F, additional, Vidotti, M, additional, Simões, MV, additional, Gomes, FL, additional, Vieira Nascimento, C, additional, Precoma, D, additional, Helfenstein Fonseca, FA, additional, Ribas Fortes, JA, additional, Leães, PE, additional, Campos de Albuquerque, D, additional, Kerr Saraiva, JF, additional, Rassi, S, additional, Alves da Costa, FA, additional, Reis, G, additional, Zieroth, S, additional, Dion, D, additional, Savard, D, additional, Bourgeois, R, additional, Constance, C, additional, Anderson, K, additional, Leblanc, M-H, additional, Yung, D, additional, Swiggum, E, additional, Pliamm, L, additional, Pesant, Y, additional, Tyrrell, B, additional, Huynh, T, additional, Spiegelman, J, additional, Lavoie, J-P, additional, Hartleib, M, additional, Bhargava, R, additional, Straatman, L, additional, Virani, S, additional, Costa-Vitali, A, additional, Hill, L, additional, Heffernan, M, additional, Khaykin, Y, additional, Ricci, J, additional, Senaratne, M, additional, Zhai, A, additional, Lubelsky, B, additional, Toma, M, additional, Yao, L, additional, McKelvie, R, additional, Noronha, L, additional, Babapulle, M, additional, Pandey, A, additional, Curnew, G, additional, Lavoie, A, additional, Berlingieri, J, additional, Kouz, S, additional, Lonn, E, additional, Chehayeb, R, additional, Zheng, Y, additional, Sun, Y, additional, Cui, H, additional, Fan, Z, additional, Han, X, additional, Jiang, X, additional, Tang, Q, additional, Zhou, J, additional, Zheng, Z, additional, Zhang, X, additional, Zhang, N, additional, Zhang, Y, additional, Shen, A, additional, Yu, J, additional, Ye, J, additional, Yao, Y, additional, Yan, J, additional, Xu, X, additional, Wang, Z, additional, Ma, J, additional, Li, Y, additional, Li, S, additional, Lu, S, additional, Kong, X, additional, Song, Y, additional, Yang, G, additional, Yao, Z, additional, Pan, Y, additional, Guo, X, additional, Sun, Z, additional, Dong, Y, additional, Zhu, J, additional, Peng, D, additional, Yuan, Z, additional, Lin, J, additional, Yin, Y, additional, Jerabek, O, additional, Burianova, H, additional, Fiala, T, additional, Hubac, J, additional, Ludka, O, additional, Monhart, Z, additional, Vodnansky, P, additional, Zeman, K, additional, Foldyna, D, additional, Krupicka, J, additional, Podpera, I, additional, Busak, L, additional, Radvan, M, additional, Vomacka, Z, additional, Prosecky, R, additional, Cifkova, R, additional, Durdil, V, additional, Vesely, J, additional, Vaclavik, J, additional, Cervinka, P, additional, Linhart, A, additional, Brabec, T, additional, Miklik, R, additional, Bourhaial, H, additional, Olbrich, H-G, additional, Genth-Zotz, S, additional, Kemala, E, additional, Lemke, B, additional, Böhm, M, additional, Schellong, S, additional, Rieker, W, additional, Heitzer, T, additional, Ince, H, additional, Faghih, M, additional, Birkenfeld, A, additional, Begemann, A, additional, Ghanem, A, additional, Ujeyl, A, additional, von Haehling, S, additional, Dorsel, T, additional, Bauersachs, J, additional, Prull, M, additional, Weidemann, F, additional, Darius, H, additional, Nickenig, G, additional, Wilke, A, additional, Sauter, J, additional, Rauch-Kroehnert, U, additional, Frey, N, additional, Schulze, CP, additional, König, W, additional, Maier, L, additional, Menzel, F, additional, Proskynitopoulos, N, additional, Ebert, H-H, additional, Sarnighausen, H-E, additional, Düngen, H-D, additional, Licka, M, additional, Stellbrink, C, additional, Winkelmann, B, additional, Menck, N, additional, López-Sendón, JL, additional, de la Fuente Galán, L, additional, Delgado Jiménez, JF, additional, Manito Lorite, N, additional, Pérez de Juan Romero, M, additional, Galve Basilio, E, additional, Cereto Castro, F, additional, González Juanatey, JR, additional, Gómez, JJ, additional, Sanmartín Fernández, M, additional, Garcia-Moll Marimon, X, additional, Pascual Figal, D, additional, Bover Freire, R, additional, Bonnefoy Cudraz, E, additional, Jobbe Duval, A, additional, Tomasevic, D, additional, Habib, G, additional, Isnard, R, additional, Picard, F, additional, Khanoyan, P, additional, Dubois-Rande, J-L, additional, Galinier, M, additional, Roubille, F, additional, Alexandre, J, additional, Babuty, D, additional, Delarche, N, additional, Berneau, J-B, additional, Girerd, N, additional, Saxena, M, additional, Rosano, G, additional, Yousef, Z, additional, Clifford, C, additional, Arden, C, additional, Bakhai, A, additional, Boos, C, additional, Jenkins, G, additional, Travill, C, additional, Price, D, additional, Koenyves, L, additional, Lakatos, F, additional, Matoltsy, A, additional, Noori, E, additional, Zilahi, Z, additional, Andrassy, P, additional, Kancz, S, additional, Simon, G, additional, Sydo, T, additional, Vorobcsuk, A, additional, Kiss, RG, additional, Toth, K, additional, Szakal, I, additional, Nagy, L, additional, Barany, T, additional, Nagy, A, additional, Szolnoki, E, additional, Chopra, VK, additional, Mandal, S, additional, Rastogi, V, additional, Shah, B, additional, Mullasari, A, additional, Shankar, J, additional, Mehta, V, additional, Oomman, A, additional, Kaul, U, additional, Komarlu, S, additional, Kahali, D, additional, Bhagwat, A, additional, Vijan, V, additional, Ghaisas, NK, additional, Mehta, A, additional, Kashyap, J, additional, Kothari, Y, additional, TaddeI, S, additional, Scherillo, M, additional, Zacà, V, additional, Genovese, S, additional, Salvioni, A, additional, Fucili, A, additional, Fedele, F, additional, Cosmi, F, additional, Volpe, M, additional, Mazzone, C, additional, Esposito, G, additional, Doi, M, additional, Yamamoto, H, additional, Sakagami, S, additional, Oishi, S, additional, Yasaka, Y, additional, Tsuboi, H, additional, Fujino, Y, additional, Matsuoka, S, additional, Watanabe, Y, additional, Himi, T, additional, Ide, T, additional, Ichikawa, M, additional, Kijima, Y, additional, Koga, T, additional, Yuda, S, additional, Fukui, K, additional, Kubota, T, additional, Manita, M, additional, Fujinaga, H, additional, Matsumura, T, additional, Fukumoto, Y, additional, Kato, R, additional, Kawai, Y, additional, Hiasa, G, additional, Kazatani, Y, additional, Mori, M, additional, Ogimoto, A, additional, Inoko, M, additional, Oguri, M, additional, Kinoshita, M, additional, Okuhara, K, additional, Watanabe, N, additional, Ono, Y, additional, Otomo, K, additional, Sato, Y, additional, Matsunaga, T, additional, Takaishi, A, additional, Miyagi, N, additional, Uehara, H, additional, Takaishi, H, additional, Urata, H, additional, Kataoka, T, additional, Matsubara, H, additional, Matsumoto, T, additional, Suzuki, T, additional, Takahashi, N, additional, Imamaki, M, additional, Yoshitama, T, additional, Saito, T, additional, Sekino, H, additional, Furutani, Y, additional, Koda, M, additional, Shinozaki, T, additional, Hirabayashi, K, additional, Tsunoda, R, additional, Yonezawa, K, additional, Hori, H, additional, Yagi, M, additional, Arikawa, M, additional, Hashizume, T, additional, Ishiki, R, additional, Koizumi, T, additional, Nakayama, K, additional, Taguchi, S, additional, Nanasato, M, additional, Yoshida, Y, additional, Tsujiyama, S, additional, Nakamura, T, additional, Oku, K, additional, Shimizu, M, additional, Suwa, M, additional, Momiyama, Y, additional, Sugiyama, H, additional, Kobayashi, K, additional, Inoue, S, additional, Kadokami, T, additional, Maeno, K, additional, Kawamitsu, K, additional, Maruyama, Y, additional, Nakata, A, additional, Shibata, T, additional, Wada, A, additional, Cho, H-J, additional, Na, JO, additional, Yoo, B-S, additional, Choi, J-O, additional, Hong, SK, additional, Shin, J-H, additional, Cho, M-C, additional, Han, SH, additional, Jeong, J-O, additional, Kim, J-J, additional, Kang, SM, additional, Kim, D-S, additional, Kim, MH, additional, Llamas Esperon, G, additional, Illescas Díaz, J, additional, Fajardo Campos, P, additional, Almeida Alvarado, J, additional, Bazzoni Ruiz, A, additional, Echeverri Rico, J, additional, Lopez Alcocer, I, additional, Valle Molina, L, additional, Hernandez Herrera, C, additional, Calvo Vargas, C, additional, Padilla Padilla, FG, additional, Rodriguez Briones, I, additional, Chuquiure Valenzuela, EJJR, additional, Aguilera Real, ME, additional, Carrillo Calvillo, J, additional, Alpizar Salazar, M, additional, Cervantes Escárcega, JL, additional, Velasco Sanchez, R, additional, Al - Windy, N, additional, van Heerebeek, L, additional, Bellersen, L, additional, Brunner-La Rocca, H-P, additional, Post, J, additional, Linssen, GCM, additional, van de Wetering, M, additional, Peters, R, additional, van Stralen, R, additional, Groutars, R, additional, Smits, P, additional, Yilmaz, A, additional, Kok, WEM, additional, Van der Meer, P, additional, Dijkmans, P, additional, Troquay, R, additional, van Alem, AP, additional, Van de Wal, R, additional, Handoko, L, additional, Westendorp, ICD, additional, van Bergen, PFMM, additional, Rensing, BJWM, additional, Hoogslag, P, additional, Kietselaer, B, additional, Kragten, JA, additional, den Hartog, FR, additional, Alings, A, additional, Danilowicz-Szymanowicz, L, additional, Raczak, G, additional, Piesiewicz, W, additional, Zmuda, W, additional, Kus, W, additional, Podolec, P, additional, Musial, W, additional, Drelich, G, additional, Kania, G, additional, Miekus, P, additional, Mazur, S, additional, Janik, A, additional, Spyra, J, additional, Peruga, J, additional, Balsam, P, additional, Krakowiak, B, additional, Szachniewicz, J, additional, Ginel, M, additional, Grzybowski, J, additional, Chrustowski, W, additional, Wojewoda, P, additional, Kalinka, A, additional, Zurakowski, A, additional, Koc, R, additional, Debinski, M, additional, Fil, W, additional, Kujawiak, M, additional, Forys, J, additional, Kasprzak, M, additional, Krol, M, additional, Michalski, P, additional, Mirek-Bryniarska, E, additional, Radwan, K, additional, Skonieczny, G, additional, Stania, K, additional, Skoczylas, G, additional, Madej, A, additional, Jurowiecki, J, additional, Firek, B, additional, Wozakowska-Kaplon, B, additional, Cymerman, K, additional, Neutel, J, additional, Adams, K, additional, Balfour, P, additional, Deswal, A, additional, Djamson, A, additional, Duncan, P, additional, Hong, M, additional, Murray, C, additional, Rinde-Hoffman, D, additional, Woodhouse, S, additional, MacNevin, R, additional, Rama, B, additional, Broome-Webster, C, additional, Kindsvater, S, additional, Abramov, D, additional, Barettella, M, additional, Pinney, S, additional, Herre, J, additional, Cohen, A, additional, Vora, K, additional, Challappa, K, additional, West, S, additional, Baum, S, additional, Cox, J, additional, Jani, S, additional, Karim, A, additional, Akhtar, A, additional, Quintana, O, additional, Paukman, L, additional, Goldberg, R, additional, Bhatti, Z, additional, Budoff, M, additional, Bush, E, additional, Potler, A, additional, Delgado, R, additional, Ellis, B, additional, Dy, J, additional, Fialkow, J, additional, Sangrigoli, R, additional, Ferdinand, K, additional, East, C, additional, Falkowski, S, additional, Donahoe, S, additional, Ebrahimi, R, additional, Kline, G, additional, Harris, B, additional, Khouzam, R, additional, Jaffrani, N, additional, Jarmukli, N, additional, Kazemi, N, additional, Koren, M, additional, Friedman, K, additional, Herzog, W, additional, Silva Enciso, J, additional, Cheung, D, additional, Grover-McKay, M, additional, Hauptman, P, additional, Mikhalkova, D, additional, Hegde, V, additional, Hodsden, J, additional, Khouri, S, additional, McGrew, F, additional, Littlefield, R, additional, Bradley, P, additional, McLaurin, B, additional, Lupovitch, S, additional, Labin, I, additional, Rao, V, additional, Leithe, M, additional, Lesko, M, additional, Lewis, N, additional, Lombardo, D, additional, Mahal, S, additional, Malhotra, V, additional, Dauber, I, additional, Banerjee, A, additional, Needell, J, additional, Miller, G, additional, Paladino, L, additional, Munuswamy, K, additional, Nanna, M, additional, McMillan, E, additional, Mumma, M, additional, Napoli, M, additional, Nelson, W, additional, O'Brien, T, additional, Adlakha, A, additional, Onwuanyi, A, additional, Serota, H, additional, Schmedtje, J, additional, Paraschos, A, additional, Potu, R, additional, Sai-Sudhakar, C, additional, Saltzberg, M, additional, Sauer, A, additional, Shah, P, additional, Skopicki, H, additional, Bui, H, additional, Carr, K, additional, Stevens, G, additional, Tahirkheli, N, additional, Tallaj, J, additional, Yousuf, K, additional, Trichon, B, additional, Welker, J, additional, Tolerico, P, additional, Vest, A, additional, Vivo, R, additional, Wang, X, additional, Abadier, R, additional, Dunlap, S, additional, Weintraub, N, additional, Malik, A, additional, Kotha, P, additional, Zaha, V, additional, Kim, G, additional, Uriel, N, additional, Greene, T, additional, Salacata, A, additional, Arora, R, additional, Gazmuri, R, additional, Kobayashi, J, additional, Iteld, B, additional, Vijayakrishnan, R, additional, Dab, R, additional, Mirza, Z, additional, Marques, V, additional, Nallasivan, M, additional, Bensimhon, D, additional, Peart, B, additional, Saint-Jacques, H, additional, Barringhaus, K, additional, Contreras, J, additional, Gupta, A, additional, Koneru, S, additional, and Nguyen, V, additional

Published
2022
Full Text
View/download PDF

27. Dual antithrombotic therapy with dabigatran in patients with atrial fibrillation after percutaneous coronary intervention for ST-segment elevation myocardial infarction: a post hoc analysis of the randomised RE-DUAL PCI trial

Author

Zeymer, Uwe, primary, Leiva, Orly, additional, Hohnloser, Stefan H., additional, Steg, Philippe Gabriel, additional, Oldgren, Jonas, additional, Nickenig, Georg, additional, Gabor Kiss, Robert, additional, Ongen, Zeki, additional, Navarro Estrada, Jose, additional, Oude Ophuis, Ton, additional, Lip, Gregory Y.H., additional, Nordaby, Matias, additional, Miede, Corinna, additional, ten Berg, Jurrien M., additional, Bhatt, Deepak L., additional, and Cannon, Christopher P., additional

Published
2021
Full Text
View/download PDF

28. The effect of sex on the efficacy and safety of dual antithrombotic therapy with dabigatran versus triple therapy with warfarin after PCI in patients with atrial fibrillation (a RE-DUAL PCI subgroup analysis and comparison to other dual antithrombotic therapy trials)

Author

Eccleston, David S, Kim, Joseph M, Ten Berg, Jurien M, Steg, P Gabriel, Bhatt, Deepak L, Hohnloser, Stefan H, de Veer, Anne, Nordaby, Matias, Miede, Corinna, Kimura, Takeshi, Lip, Gregory Y H, Oldgren, Jonas, and Cannon, Christopher P

Subjects
Male, sex differences, Kardiologi, Clinical Investigations, Anticoagulants, Coronary Artery Disease, dual antithrombotic therapy, Dabigatran, Percutaneous Coronary Intervention, Fibrinolytic Agents, triple therapy, Atrial Fibrillation, Humans, Drug Therapy, Combination, Female, Cardiac and Cardiovascular Systems, Warfarin, Platelet Aggregation Inhibitors
Abstract

BACKGROUND: The RE-DUAL PCI trial demonstrated that in patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), dual therapy with dabigatran and a P2Y12 inhibitor, either clopidogrel or ticagrelor, reduced the risk of bleeding without an increased risk of thromboembolic events as compared to triple therapy with warfarin in addition to a P2Y12 inhibitor and aspirin. What remains unclear is whether this effect is consistent between males and females undergoing PCI.HYPOTHESIS: The reduction in risk of bleeding without increased risk of thromboembolic events with dual therapy with dabigatran and a P2Y12 inhibitor in comparison to triple therapy with warfarin, a P2Y12 inhibitor and aspirin is consistent in females and males.METHODS: The primary safety endpoint was the first International Society on Thrombosis and Hemostasis (ISTH) major bleeding event (MBE) or clinically relevant non-major bleeding event (CRNMBE). The efficacy endpoint was the composite of death, thromboembolic event (stroke, myocardial infarction, and systemic embolism) or unplanned revascularization. Cox proportional hazard regression analyses were applied to calculate corresponding hazard ratios and interaction p values for each endpoint.RESULTS: A total of 655 women and 2070 men were enrolled. The risk of major or CRNM bleeding was lower with both dabigatran 110 mg dual therapy and dabigatran 150 mg dual therapy compared with warfarin triple therapy in female and male patients (for 110 mg: females: HR 0.69, 95% CI 0.47-1.01, males: HR 0.46, 95% CI 0.37-0.59, interaction p value: 0.084 and for 150 mg: females HR 0.74, 95% CI 0.48-1.16, males HR 0.71, 95% CI 0.56-0.90, interaction p value: 0.83). There was also no detectable difference in the composite efficacy endpoint of death, thromboembolic events or unplanned revascularization between dabigatran dual therapy and warfarin triple therapy, with no statistically significant interaction between sex and treatment (interaction p values: 0.73 and 0.72, respectively).CONCLUSIONS: Consistent with the overall study results, the risk of bleeding was lower with dabigatran 110 mg and 150 mg dual therapy compared with warfarin triple therapy, and risk of thromboembolic events was comparable with warfarin triple therapy independent of the patient's sex.

Published
2021

29. Dual antithrombotic therapy with dabigatran in patients with atrial fibrillation after percutaneous coronary intervention for ST elevation myocardial infarction : results from the randomised RE-DUAL PCI trial.

Author

Zeymer, Uwe, Leiva, Orly, Hohnloser, Stefan H, Steg, Philippe Gabriel, Oldgren, Jonas, Nickenig, Georg, Gabor Kiss, Robert, Ongen, Zeki, Navarro Estrada, Jose, Oude Ophuis, Ton, Lip, Gregory Y H, Nordaby, Matias, Miede, Corinna, Ten Berg, Jurrien M, Bhatt, Deepak L, Cannon, Christopher P, Zeymer, Uwe, Leiva, Orly, Hohnloser, Stefan H, Steg, Philippe Gabriel, Oldgren, Jonas, Nickenig, Georg, Gabor Kiss, Robert, Ongen, Zeki, Navarro Estrada, Jose, Oude Ophuis, Ton, Lip, Gregory Y H, Nordaby, Matias, Miede, Corinna, Ten Berg, Jurrien M, Bhatt, Deepak L, and Cannon, Christopher P

Abstract

AIMS: To investigate the safety and efficacy of dabigatran dual therapy (110 or 150 mg twice daily, plus clopidogrel or ticagrelor) vs warfarin triple therapy in patients with atrial fibrillation undergoing PCI for ST elevation myocardial infarction (STEMI). METHODS AND RESULTS: In RE-DUAL PCI, 305 patients with STEMI were randomised to dabigatran 110 mg (n=113 versus 106 warfarin) or 150 mg (n=86 versus 84 warfarin). Primary endpoint was time to first major or clinically relevant non-major bleeding event (MBE/CRNMBE). The thrombotic endpoint was a composite of death, thromboembolic events, or unplanned revascularisation. In STEMI patients, dabigatran 110 mg (HR 0.39, 95% CI 0.20-0.74) and 150 mg (0.43, 0.21-0.89) dual therapy reduced the risk of MBE/CRNMBE versus warfarin triple therapy (p interaction vs all other patients = 0.31 and 0.16). Risk of thrombotic events, for dabigatran 110 mg (HR 1.61, 95% CI: 0.85-3.08) and 150 mg (0.56, 0.20-1.51) had p interactions of 0.20 and 0.33, respectively. For net clinical benefit, HRs were 0.74 (95% CI 0.46-1.17) and 0.49 (0.27-0.91) for dabigatran 110 and 150 mg (p interaction = 0.80 and 0.12). CONCLUSIONS: In patients after PCI for STEMI, dabigatran dual therapy had lower risks of bleeding events versus warfarin triple therapy with similar risks of thromboembolic events, supporting the use of dabigatran dual therapy even in patients with high thrombotic risk.

Published
2021
Full Text
View/download PDF

30. The effect of sex on the efficacy and safety of dual antithrombotic therapy with dabigatran versus triple therapy with warfarin after PCI in patients with atrial fibrillation (a RE-DUAL PCI subgroup analysis and comparison to other dual antithrombotic therapy trials)

Author

Eccleston, David S., Kim, Joseph M., ten Berg, Jurien M., Steg, P. Gabriel, Bhatt, Deepak L., Hohnloser, Stefan H., de Veer, Anne, Nordaby, Matias, Miede, Corinna, Kimura, Takeshi, Lip, Gregory Y. H., Oldgren, Jonas, Cannon, Christopher P., Eccleston, David S., Kim, Joseph M., ten Berg, Jurien M., Steg, P. Gabriel, Bhatt, Deepak L., Hohnloser, Stefan H., de Veer, Anne, Nordaby, Matias, Miede, Corinna, Kimura, Takeshi, Lip, Gregory Y. H., Oldgren, Jonas, and Cannon, Christopher P.

Abstract

Background The RE-DUAL PCI trial demonstrated that in patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), dual therapy with dabigatran and a P2Y12 inhibitor, either clopidogrel or ticagrelor, reduced the risk of bleeding without an increased risk of thromboembolic events as compared to triple therapy with warfarin in addition to a P2Y12 inhibitor and aspirin. What remains unclear is whether this effect is consistent between males and females undergoing PCI. Hypothesis The reduction in risk of bleeding without increased risk of thromboembolic events with dual therapy with dabigatran and a P2Y12 inhibitor in comparison to triple therapy with warfarin, a P2Y12 inhibitor and aspirin is consistent in females and males. Methods The primary safety endpoint was the first International Society on Thrombosis and Hemostasis (ISTH) major bleeding event (MBE) or clinically relevant non-major bleeding event (CRNMBE). The efficacy endpoint was the composite of death, thromboembolic event (stroke, myocardial infarction, and systemic embolism) or unplanned revascularization. Cox proportional hazard regression analyses were applied to calculate corresponding hazard ratios and interaction p values for each endpoint. Results A total of 655 women and 2070 men were enrolled. The risk of major or CRNM bleeding was lower with both dabigatran 110 mg dual therapy and dabigatran 150 mg dual therapy compared with warfarin triple therapy in female and male patients (for 110 mg: females: HR 0.69, 95% CI 0.47–1.01, males: HR 0.46, 95% CI 0.37–0.59, interaction p value: 0.084 and for 150 mg: females HR 0.74, 95% CI 0.48–1.16, males HR 0.71, 95% CI 0.56–0.90, interaction p value: 0.83). There was also no detectable difference in the composite efficacy endpoint of death, thromboembolic events or unplanned revascularization between dabigatran dual therapy and warfarin triple therapy, with no statistically significant interaction between sex and trea

Published
2021
Full Text
View/download PDF

31. The effect of sex on the efficacy and safety of dual antithrombotic therapy with dabigatran versus triple therapy with warfarin after PCI in patients with atrial fibrillation (a RE‐DUAL PCI subgroup analysis and comparison to other dual antithrombotic therapy trials)

Author

Eccleston, David S., primary, Kim, Joseph M., additional, ten Berg, Jurien M., additional, Steg, P. Gabriel, additional, Bhatt, Deepak L., additional, Hohnloser, Stefan H., additional, Veer, Anne, additional, Nordaby, Matias, additional, Miede, Corinna, additional, Kimura, Takeshi, additional, Lip, Gregory Y. H., additional, Oldgren, Jonas, additional, and Cannon, Christopher P., additional

Published
2021
Full Text
View/download PDF

32. Comparison of the Effect of Age (< 75 Versus >= 75) on the Efficacy and Safety of Dual Therapy (Dabigatran plus Clopidogrel or Ticagrelor) Versus Triple Therapy (Warfarin plus Aspirin plus Clopidogrel or Ticagrelor) in Patients With Atrial Fibrillation After Percutaneous Coronary Intervention (from the RE-DUAL PCI Trial)

Author

ten Berg, Jurrien M., Steg, Philippe Gabriel, Bhatt, Deepak L., Hohnloser, Stefan H., de Veer, Anne, Nordaby, Matias, Miede, Corinna, Kimura, Takeshi, Lip, Gregory Y. H., Oldgren, Jonas, and Cannon, Christopher P.

Subjects
Kardiologi, Cardiac and Cardiovascular Systems
Abstract

The RE-DUAL PCI trial reported that dabigatran dual therapy (110/150 mg twice daily, plus clopidogrel or ticagrelor) reduced bleeding events versus warfarin triple therapy (warfarin plus aspirin and Clopidogrel or ticagrelor) in patients with atrial fibrillation who underwent percutaneous coronary intervention, with noninferiority in composite thromboembolic events. In this prespecified analysis, risks of first major or clinically relevant norunajor bleeding event and composite end point of death, thromboembolic events, or unplanned revascularization were compared between dabigatran dual therapy and warfarin triple therapy in older (>= 75 years) and younger (< 75 years) patients, using Cox proportional hazard regression. Of 2,725 patients randomized to treatment, 1,026 (37.7 %) were categorized into older and 1,699 (623%) into younger age groups. Dabigatran 110 mg dual therapy lowered bleeding risk versus warfarin triple therapy in older (hazard ratio [HR] 0.67; 95% confidence interval [CI] 0.51 to 0.89) and younger patients (HR 0.40; 95% CI 0.30 to 0.54); interaction p value: 0.0125. Dabigatran 150 mg dual therapy lowered bleeding risk versus warfarin triple therapy in younger patients (HR 0.57; 95% CI 0.44 to 0.74), whereas no benefit could be observed in older patients (HR 1.21; 95% CI 0.83 to 1.77); interaction p value: 0.0013. For the thromboembolic end point, there was a trend for a higher risk with dabigatran 110 mg dual therapy in older patients, compared with warfarin triple therapy, whereas the risk was similar in younger patients. For dabigatran 150 mg dual therapy, the thromboembolic risk versus warfarin triple therapy was similar in older and younger patients. In conclusion, the benefits of dabigatran dual therapy differed in the 2 age groups, which may help dose selection when using dabigatran dual therapy. (C) 2019 The Authors. Published by Elsevier Inc.

Published
2020

33. Antithrombotic therapy according to baseline bleeding risk in patients with atrial fibrillation undergoing percutaneous coronary intervention : applying the PRECISE-DAPT score in RE-DUAL PCI.

Author

Costa, Francesco, Valgimigli, Marco, Steg, Philippe Gabriel, Bhatt, Deepak L, Hohnloser, Stefan H, Ten Berg, Jurrien M, Miede, Corinna, Nordaby, Matias, Lip, Gregory Y H, Oldgren, Jonas, Cannon, Christopher P, Costa, Francesco, Valgimigli, Marco, Steg, Philippe Gabriel, Bhatt, Deepak L, Hohnloser, Stefan H, Ten Berg, Jurrien M, Miede, Corinna, Nordaby, Matias, Lip, Gregory Y H, Oldgren, Jonas, and Cannon, Christopher P

Abstract

AIMS: Patients with atrial fibrillation undergoing coronary intervention are at higher bleeding risk due to the concomitant need for oral anticoagulation and antiplatelet therapy. The RE-DUAL PCI trial demonstrated better safety with dual antithrombotic therapy (DAT: dabigatran 110 or 150 mg bid, clopidogrel or ticagrelor) compared to triple antithrombotic therapy (TAT: warfarin, clopidogrel or ticagrelor, and aspirin). We explored the impact of baseline bleeding risk based on the PRECISE-DAPT score for decision-making regarding DAT vs. TAT. METHODS AND RESULTS: A score ≥25 points qualified high bleeding-risk (HBR). Comparisons were made for the primary safety endpoint ISTH major or clinically relevant non-major bleeding, and the composite efficacy endpoint of death, thromboembolic events, or unplanned revascularization, analyzed by time-to-event analysis. PRECISE-DAPT was available in 2,336/2,725 patients, and 37.9% were HBR. Compared to TAT, DAT with dabigatran 110 mg reduced bleeding risk both in non-HBR (HR 0.42, 95%CI, 0.31-0.57) and HBR (HR 0.70, 95%CI, 0.52-0.94), with a greater magnitude of benefit among non-HBR (Pint=0.02). DAT with dabigatran 150 mg vs. TAT reduced bleeding in non-HBR (HR 0.60, 95%CI, 0.45-0.80), with a trend toward less benefit in HBR patients (HR 0.92, 95%CI, 0.63-1.34, Pint=0.08). Risk of ischaemic events was similar on DAT with dabigatran (both 110 and 150 mg) vs. TAT in non-HBR and HBR patients (Pint=0.45 and Pint=0.56, respectively). CONCLUSIONS: PRECISE-DAPT score appeared useful to identify AF patients undergoing PCI at further increased risk of bleeding complications, and may help clinicians identifying the antithrombotic regimen intensity with the best benefit-risk ratio in an individual patient.

Published
2020
Full Text
View/download PDF

34. Dabigatran Dual Therapy Versus Warfarin Triple Therapy Post PCI in Patients With Atrial Fibrillation

Author

Steg, Philippe Gabriel, Ducrocq, Gregory, Bhatt, Deepak L, Hohnloser, Stefan H, Nordaby, Matias, Miede, Corinna, Lip, Gregory Y H, Oldgren, Jonas, Ten Berg, Jurriën M, Cannon, Christopher P, Steg, Philippe Gabriel, Ducrocq, Gregory, Bhatt, Deepak L, Hohnloser, Stefan H, Nordaby, Matias, Miede, Corinna, Lip, Gregory Y H, Oldgren, Jonas, Ten Berg, Jurriën M, and Cannon, Christopher P

Published
2020
Full Text
View/download PDF

35. Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention in Patients with Atrial Fibrillation With/Without a Proton Pump Inhibitor : A Pre-Specified Analysis of the RE-DUAL PCI Trial

Author

Nicolau, Jose C., Bhatt, Deepak L., Hohnloser, Stefan H., Kimura, Takeshi, Lip, Gregory Y. H., Miede, Corinna, Nordaby, Matias, Oldgren, Jonas, Steg, Philippe Gabriel, ten Berg, Jurrien M., Godoy, Lucas C., Cannon, Christopher P., Nicolau, Jose C., Bhatt, Deepak L., Hohnloser, Stefan H., Kimura, Takeshi, Lip, Gregory Y. H., Miede, Corinna, Nordaby, Matias, Oldgren, Jonas, Steg, Philippe Gabriel, ten Berg, Jurrien M., Godoy, Lucas C., and Cannon, Christopher P.

Abstract

Background and Objective In patients with atrial fibrillation following percutaneous coronary intervention, if a proton pump inhibitor is used, could that allow the use of warfarin triple therapy, or is there additional reduction in bleeding while using it with dual therapy? Methods The RE-DUAL PCI trial randomized 2725 patients with atrial fibrillation post-percutaneous coronary intervention to dabigatran dual therapy (110 or 150 mg twice daily, with clopidogrel or ticagrelor) or warfarin triple therapy (with clopidogrel or ticagrelor, and aspirin for 1-3 months). This prespecified subgroup analysis evaluated risks of a first major bleeding event or clinically relevant non-major bleeding event, all gastrointestinal bleeding, and a composite efficacy endpoint of all-cause mortality/thromboembolic event or unplanned revascularization according to baseline use of a proton pump inhibitor. Results Of 2678 analyzed patients, 1641 (61.3%) were receiving a proton pump inhibitor at baseline. Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interactionpvalues > 0.05). For gastrointestinal bleeding, no interaction was observed between study treatment and proton pump inhibitor use (interactionpvalues 0.84 and 0.62 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin triple therapy). Conclusions Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy, regardless of proton pump inhibitor use at baseline, in patients with atrial fibrillation who underwent percutaneous coronary intervention. Risk of the composite efficacy endpoint appeared to be similar for dabigatran dual therapy vs warfarin triple therapy in patients receiving/not receiving a proton pump

Published
2020
Full Text
View/download PDF

36. Effect of empagliflozin on exercise ability and symptoms in heart failure patients with reduced and preserved ejection fraction, with and without type 2 diabetes

Author

Abraham, William T, primary, Lindenfeld, JoAnn, additional, Ponikowski, Piotr, additional, Agostoni, Piergiuseppe, additional, Butler, Javed, additional, Desai, Akshay S, additional, Filippatos, Gerasimos, additional, Gniot, Jacek, additional, Fu, Michael, additional, Gullestad, Lars, additional, Howlett, Jonathan G, additional, Nicholls, Stephen J, additional, Redon, Josep, additional, Schenkenberger, Isabelle, additional, Silva-Cardoso, José, additional, Störk, Stefan, additional, Krzysztof Wranicz, Jerzy, additional, Savarese, Gianluigi, additional, Brueckmann, Martina, additional, Jamal, Waheed, additional, Nordaby, Matias, additional, Peil, Barbara, additional, Ritter, Ivana, additional, Ustyugova, Anastasia, additional, Zeller, Cordula, additional, Salsali, Afshin, additional, and Anker, Stefan D, additional

Published
2020
Full Text
View/download PDF

37. Kidney Function After Initiation And Discontinuation Of Empagliflozin (EMPA) In Heart Failure (HF) Patients (Pts) With And Without Type 2 Diabetes (T2D): Insights From The Emperial Trials

Author

Anker, Stefan D., primary, Ponikowski, Piotr, additional, Wanner, Christoph, additional, Pfarr, Egon, additional, Hauske, Sibylle, additional, Peil, Barbara, additional, Salsali, Afshin, additional, Ritter, Ivana, additional, Nordaby, Matias, additional, Koitka-Weber, Audrey, additional, Brueckmann, Martina, additional, Jamal, Waheed, additional, Lindenfeld, JoAnn, additional, and Abraham, William T., additional

Published
2020
Full Text
View/download PDF

38. Antithrombotic therapy according to baseline bleeding risk in patients with atrial fibrillation undergoing percutaneous coronary intervention: applying the PRECISE-DAPT score in RE-DUAL PCI

Author

Costa, Francesco, primary, Valgimigli, Marco, additional, Steg, Philippe Gabriel, additional, Bhatt, Deepak L, additional, Hohnloser, Stefan H, additional, Ten Berg, Jurrien M, additional, Miede, Corinna, additional, Nordaby, Matias, additional, Lip, Gregory Y H, additional, Oldgren, Jonas, additional, and Cannon, Christopher P, additional

Published
2020
Full Text
View/download PDF

40. TCT CONNECT-58 Evaluation of Antithrombotic Strategies Before and After the First Month of Therapy: Landmark Analysis of the RE-DUAL PCI Trial

Author

Bhatt, Deepak, primary, Steg, Philippe Gabriel, additional, Oldgren, Jonas, additional, Maeng, Michael, additional, Zeymer, Uwe, additional, Halvorsen, Sigrun, additional, Hohnloser, Stefan, additional, Lip, Gregory, additional, Kimura, Takeshi, additional, Nordaby, Matias, additional, Corinna, Miede, additional, Berg, Jurrien Ten, additional, Cannon, Christopher, additional, and Peterson, Benjamin, additional

Published
2020
Full Text
View/download PDF

41. Reply

Author

Maeng, Michael, primary, Bhatt, Deepak L., additional, Nordaby, Matias, additional, Miede, Corinna, additional, and Cannon, Christopher P., additional

Published
2020
Full Text
View/download PDF

43. Dabigatran dual therapy with ticagrelor or clopidogrel after percutaneous coronary intervention in atrial fibrillation patients with or without acute coronary syndrome: a subgroup analysis from the RE-DUAL PCI trial

Author

80359786, Oldgren, Jonas, Steg, Philippe Gabriel, Hohnloser, Stefan H, Lip, Gregory Y H, Kimura, Takeshi, Nordaby, Matias, Brueckmann, Martina, Kleine, Eva, ten Berg, Jurrien M, Bhatt, Deepak L, Cannon, Christopher P, 80359786, Oldgren, Jonas, Steg, Philippe Gabriel, Hohnloser, Stefan H, Lip, Gregory Y H, Kimura, Takeshi, Nordaby, Matias, Brueckmann, Martina, Kleine, Eva, ten Berg, Jurrien M, Bhatt, Deepak L, and Cannon, Christopher P

Abstract

Aims: After percutaneous coronary intervention (PCI) in patients with atrial fibrillation, safety and efficacy with dabigatran dual therapy were evaluated in pre-specified subgroups of patients undergoing PCI due to acute coronary syndrome (ACS) or elective PCI, and those receiving ticagrelor or clopidogrel treatment. Methods and results: In the RE-DUAL PCI trial, 2725 patients were randomized to dabigatran 110 mg or 150 mg with P2Y12 inhibitor, or warfarin with P2Y12 inhibitor and aspirin. Mean follow-up was 14 months, 50.5% had ACS, and 12% received ticagrelor. The risk of the primary endpoint, major or clinically relevant non-major bleeding event, was reduced with both dabigatran dual therapies vs. warfarin triple therapy in patients with ACS [hazard ratio (95% confidence interval), 0.47 (0.35–0.63) for 110 mg and 0.67 (0.50–0.90) for 150 mg]; elective PCI [0.57 (0.43–0.76) for 110 mg and 0.76 (0.56–1.03) for 150 mg]; receiving ticagrelor [0.46 (0.28–0.76) for 110 mg and 0.59 (0.34–1.04) for 150 mg]; or clopidogrel [0.51 (0.41–0.64) for 110 mg and 0.73 (0.58–0.91) for 150 mg], all interaction P-values >0.10. Overall, dabigatran dual therapy was comparable to warfarin triple therapy for the composite endpoint of death, myocardial infarction, stroke, systemic embolism, or unplanned revascularization, with minor variations across the subgroups, all interaction P-values >0.10. Conclusion: The benefits of both dabigatran 110 mg and 150 mg dual therapy compared with warfarin triple therapy in reducing bleeding risks were consistent across subgroups of patients with or without ACS, and patients treated with ticagrelor or clopidogrel.

Published
2019

44. Dabigatran Dual Therapy Versus Warfarin Triple Therapy in Atrial Fibrillation Post-PCI : Time in Therapeutic Range.

Author

Lip, Gregory Y H, Bhatt, Deepak L, Hohnloser, Stefan H, Kimura, Takeshi, Miede, Corinna, Nordaby, Matias, Oldgren, Jonas, Steg, Philippe Gabriel, Ten Berg, Jurriën M, Cannon, Christopher P, Lip, Gregory Y H, Bhatt, Deepak L, Hohnloser, Stefan H, Kimura, Takeshi, Miede, Corinna, Nordaby, Matias, Oldgren, Jonas, Steg, Philippe Gabriel, Ten Berg, Jurriën M, and Cannon, Christopher P

Published
2019
Full Text
View/download PDF

45. Dabigatran dual therapy with ticagrelor or clopidogrel after percutaneous coronary intervention in atrial fibrillation patients with or without acute coronary syndrome : a subgroup analysis from the RE-DUAL PCI trial

Author

Oldgren, Jonas, Steg, Philippe Gabriel, Hohnloser, Stefan H., Lip, Gregory Y. H., Kimura, Takeshi, Nordaby, Matias, Brueckmann, Martina, Kleine, Eva, ten Berg, Jurrien M., Bhatt, Deepak L., Cannon, Christopher P., Oldgren, Jonas, Steg, Philippe Gabriel, Hohnloser, Stefan H., Lip, Gregory Y. H., Kimura, Takeshi, Nordaby, Matias, Brueckmann, Martina, Kleine, Eva, ten Berg, Jurrien M., Bhatt, Deepak L., and Cannon, Christopher P.

Abstract

Aims After percutaneous coronary intervention (PCI) in patients with atrial fibrillation, safety and efficacy with dabigatran dual therapy were evaluated in pre-specified subgroups of patients undergoing PCI due to acute coronary syndrome (ACS) or elective PCI, and those receiving ticagrelor or clopidogrel treatment. Methods and results In the RE-DUAL PCI trial, 2725 patients were randomized to dabigatran 110 mg or 150 mg with P2Y12 inhibitor, or warfarin with P2Y12 inhibitor and aspirin. Mean follow-up was 14 months, 50.5% had ACS, and 12% received ticagrelor. The risk of the primary endpoint, major or clinically relevant non-major bleeding event, was reduced with both dabigatran dual therapies vs. warfarin triple therapy in patients with ACS [hazard ratio (95% confidence interval), 0.47 (0.35-0.63) for 110 mg and 0.67 (0.50-0.90) for 150 mg]; elective PCI [0.57 (0.43-0.76) for 110 mg and 0.76 (0.56-1.03) for 150 mg]; receiving ticagrelor [0.46 (0.28-0.76) for 110 mg and 0.59 (0.34-1.04) for 150 mg]; or clopidogrel [0.51 (0.41-0.64) for 110 mg and 0.73 (0.58-0.91) for 150 mg], all interaction P-values >0.10. Overall, dabigatran dual therapy was comparable to warfarin triple therapy for the composite endpoint of death, myocardial infarction, stroke, systemic embolism, or unplanned revascularization, with minor variations across the subgroups, all interaction P-values >0.10. Conclusion The benefits of both dabigatran 110 mg and 150 mg dual therapy compared with warfarin triple therapy in reducing bleeding risks were consistent across subgroups of patients with or without ACS, and patients treated with ticagrelor or clopidogrel.

Published
2019
Full Text
View/download PDF

46. Relationship of stroke and bleeding risk profiles to efficacy and safety of dabigatran dual therapy versus warfarin triple therapy in atrial fibrillation after percutaneous coronary intervention : An ancillary analysis from the RE-DUAL PCI trial

Author

Lip, Gregory Y. H., Mauri, Laura, Montalescot, Gilles, Ozkor, Mick, Vardas, Panagiotis, Steg, Philippe Gabriel, Bhatt, Deepak L., Hohnloser, Stefan H., Miede, Corinna, Nordaby, Matias, Brueckmann, Martina, Kreuzer, Joerg, Kimura, Takeshi, Oldgren, Jonas, ten Berg, Jurrien M., Cannon, Christopher P., Lip, Gregory Y. H., Mauri, Laura, Montalescot, Gilles, Ozkor, Mick, Vardas, Panagiotis, Steg, Philippe Gabriel, Bhatt, Deepak L., Hohnloser, Stefan H., Miede, Corinna, Nordaby, Matias, Brueckmann, Martina, Kreuzer, Joerg, Kimura, Takeshi, Oldgren, Jonas, ten Berg, Jurrien M., and Cannon, Christopher P.

Abstract

Background In the RE-DUAL PCI trial of patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI), dabigatran dual therapy (110 or 150 mg bid, plus clopidogrel or ticagrelor) reduced International Society on Thrombosis and Haemostasis bleeding events compared with warfarin triple therapy, with noninferiority in overall thromboembolic events. This analysis assessed outcomes in relation to patient bleeding and stroke risk profiles, based on the modified HAS-BLED and CHA(2)DS(2)-VASc scores. Methods The primary endpoint, major bleeding event (MBE) or clinically relevant nonmajor bleeding event (CRNMBE), was compared across study arms in patients categorized by modified HAS-BLED score 0-2 or >= 3. The composite endpoint of death, thromboembolic event, and unplanned revascularization rates was compared in patients categorized by CHA(2)DS(2)-VASc score 0-1, 2, or >= 3. Results Risk of MBE or CRNMBE was lower with dabigatran dual therapy (both doses) versus warfarin triple therapy, irrespective of modified HAS-BLED category (treatment-by-subgroup interaction P-value 0.584 and 0.273 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin). Risk of the composite thromboembolic endpoint was similar across CHA(2)DS(2)-VASc categories and consistent with overall study results (interaction P-value 0.739 and 0.075 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin). Higher HAS-BLED scores were associated with higher risks of bleeding in AF patients after PCI in a treatment-independent analysis. Conclusion Dabigatran dual therapy reduced bleeding events irrespective of bleeding risk category and demonstrated similar efficacy regardless of stroke risk category when compared with warfarin triple therapy.

Published
2019
Full Text
View/download PDF

47. Relationship of stroke and bleeding risk profiles to efficacy and safety of dabigatran dual therapy versus warfarin triple therapy in atrial fibrillation after percutaneous coronary intervention: An ancillary analysis from the RE-DUAL PCI trial

Author

Lip, Gregory Y.H., primary, Mauri, Laura, additional, Montalescot, Gilles, additional, Ozkor, Mick, additional, Vardas, Panagiotis, additional, Steg, Philippe Gabriel, additional, Bhatt, Deepak L., additional, Hohnloser, Stefan H., additional, Miede, Corinna, additional, Nordaby, Matias, additional, Brueckmann, Martina, additional, Kreuzer, Joerg, additional, Kimura, Takeshi, additional, Oldgren, Jonas, additional, ten Berg, Jurrien M., additional, and Cannon, Christopher P., additional

Published
2019
Full Text
View/download PDF

49. Dabigatran dual therapy with ticagrelor or clopidogrel after percutaneous coronary intervention in atrial fibrillation patients with or without acute coronary syndrome: a subgroup analysis from the RE-DUAL PCI trial

Author

Oldgren, Jonas, primary, Steg, Philippe Gabriel, additional, Hohnloser, Stefan H, additional, Lip, Gregory Y H, additional, Kimura, Takeshi, additional, Nordaby, Matias, additional, Brueckmann, Martina, additional, Kleine, Eva, additional, ten Berg, Jurrien M, additional, Bhatt, Deepak L, additional, and Cannon, Christopher P, additional

Published
2019
Full Text
View/download PDF

50. Uninterrupted anticoagulation with non‐vitamin K antagonist oral anticoagulants in atrial fibrillation catheter ablation: Lessons learned from randomized trials

Author

Cardoso, Rhanderson, primary, Willems, Stephan, additional, Gerstenfeld, Edward P., additional, Verma, Atul, additional, Schilling, Richard, additional, Hohnloser, Stefan H., additional, Okumura, Ken, additional, Nordaby, Matias, additional, Brouwer, Marc A., additional, and Calkins, Hugh, additional

Published
2018
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results