Ticagrelor alone vs. ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: TWILIGHT-ACS

被引：136

作者：

Baber, Usman ^{[1
,2
]}

Dangas, George ^{[2
]}

Angiolillo, Dominick Joseph ^{[3
]}

Cohen, David Joel ^{[4
]}

Sharma, Samin Kumar ^{[2
]}

Nicolas, Johny ^{[2
]}

Briguori, Carlo ^{[5
]}

Cha, Jin Yu ^{[2
]}

Collier, Timothy ^{[6
]}

Dudek, Dariusz ^{[7
]}

Dzavik, Vladimir ^{[8
]}

Escaned, Javier ^{[9
,10
]}

Gil, Robert ^{[11
]}

Gurbel, Paul ^{[12
]}

Hamm, Christian W. ^{[13
]}

Henry, Timothy ^{[14
]}

Huber, Kurt ^{[15
]}

Kastrati, Adnan ^{[16
]}

Kaul, Upendra ^{[17
]}

Kornowski, Ran ^{[18
]}

Krucoff, Mitchell ^{[19
]}

Kunadian, Vijay ^{[20
,21
]}

Marx, Steven Owen ^{[22
]}

Mehta, Shamir ^{[23
]}

Moliterno, David ^{[24
]}

Ohman, Erik Magnus ^{[19
]}

Oldroyd, Keith ^{[25
]}

Sardella, Gennaro ^{[26
]}

Sartori, Samantha ^{[2
]}

Shlofmitz, Richard ^{[27
]}

Steg, Philippe Gabriel ^{[28
]}

Weisz, Giora ^{[29
]}

Witzenbichler, Bernhard ^{[30
]}

Han, Ya-Ling ^{[31
]}

Pocock, Stuart ^{[6
]}

Gibson, Charles Michael ^{[32
]}

Mehran, Roxana ^{[2
]}

机构：

[1] Univ Oklahoma, Dept Cardiol, Hlth Sci Ctr, Oklahoma City, OK 73104 USA

[2] Mt Sinai Hosp, Zena & Michael A Wiener Cardiovasc Inst, Dept Cardiol, One Gustave L Levy Pl,Box 1030, New York, NY 10029 USA

[3] Univ Florida Shands, Dept Cardiol, Jacksonville, FL 32218 USA

[4] Univ Missouri, Dept Cardiol, Kansas City, MO 64110 USA

[5] Clin Mediterranea, Dept Cardiol, I-80122 Naples, NA, Italy

[6] London Sch Hyg & Trop Med, Dept Cardiol, Keppel St, London WC1E 7HT, England

[7] Jagiellonian Univ, Dept Cardiol 2, Med Coll, Swietej Anny 12, PL-31008 Krakow, Poland

[8] Univ Hlth Network, Peter Munk Cardiac Ctr, Dept Intervent Cardiol, Res & Innovat Intervent Cardiol & Cardiac Intens, 200 Elizabeth St, Toronto, ON M5G 2CA, Canada

[9] Hosp Clin San Carlos, Dept Cardiol, Inst Invest Sanitaria, Calle Prof Martin Lagos S-N, Madrid 28040, Spain

[10] Univ Complutense Madrid, Calle Prof Martin Lagos S-N, Madrid 28040, Spain

[11] Minist Interior & Adm, Ctr Postgrad Med Educ, Dept Invas Cardiol, Cent Clin Hosp, 137 Woloska Str, PL-02507 Warsaw, Poland

[12] Sinai Hosp Baltimore Syst, Dept Cardiol, Baltimore, MD 21215 USA

[13] Kerckhoff Clin, Dept Cardiol, Benekestrabe 2-8, D-61231 Bad Nauheim, Germany

[14] Christ Hosp, Dept Cardiol, Carl & Edyth Lindner Ctr Res & Educ, Cincinnati, OH 45219 USA

[15] Wilhelminenhospital, Dept Cardiol, Montleartstrabe 37, A-1160 Vienna, Austria

[16] Deutsch Herzzentrum Munich, Dept Cardiol, Lazarettstrabe 36, D-80636 Munich, Germany

[17] Batra Hosp & Med Res Ctr, Dept Cardiol, New Delhi 110062, India

[18] Rabin Med Ctr, Dept Cardiol, Zeev Jabutinsky Rd 39, IL-49100 Petah Tiqwa, Israel

[19] Duke Univ, Dept Cardiol, Med Ctr, Duke Clin Res Inst, Durham, NC 27710 USA

[20] Newcastle Univ, Fac Med Sci, Inst Cellular Med, Dept Cardiol, Freeman Rd, Newcastle Upon Tyne NE7 7DN, Tyne & Wear, England

[21] Newcastle Upon Tyne Hosp NHS Fdn Trust, Freeman Hosp, Cardiothorac Ctr, Dept Cardiol, Freeman Rd, Newcastle Upon Tyne NE7 7DN, Tyne & Wear, England

[22] Columbia Univ, Dept Cardiol, Med Ctr, New York, NY 10027 USA

[23] Hamilton Hlth Sci, Dept Cardiol, Hamilton, ON L8N 3Z5, Canada

[24] Univ Kentucky, Dept Cardiol, Lexington, KY 40506 USA

[25] Golden Jubilee Natl Hosp, West Scotland Heart & Lung Ctr, Dept Cardiol, Agamemnon St, Clydebank G81 4DY, Scotland

[26] Policlin Umberto & Univ, Dept Cardiol, I-00161 Rome, Italy

[27] St Francis Hosp, Dept Cardiol, 100 Port Washington Blvd, Roslyn, NY 11576 USA

[28] Grp Hosp BichatClaude Bernard, Dept Cardiol, 46 Rue Henri Huchard, F-75018 Paris, France

[29] Montefiore Med Ctr, Dept Cardiol, The Bronx, NY 10467 USA

[30] Helios Amper Klinikum, Dept Cardiol, Krankenhausstrabe 15, D-85221 Dachau, Germany

[31] Shenyang North Hosp, Dept Cardiol, Shenyang Shi, Liaoning Sheng, Peoples R China

[32] Beth Israel Deaconess Med Ctr, Dept Cardiol, Boston, MA 02215 USA

来源：

EUROPEAN HEART JOURNAL | 2020年 / 41卷 / 37期

关键词：

Acute coronary syndrome; Ticagrelor; Bleeding; DUAL ANTIPLATELET THERAPY; HIGH-RISK PATIENTS; ACUTE MYOCARDIAL-INFARCTION; PLATELET P2Y(12) RECEPTOR; ADENOSINE-DIPHOSPHATE; CARDIOVASCULAR EVENTS; CLOPIDOGREL; PCI; PRASUGREL; INHIBITION;

D O I：

10.1093/eurheartj/ehaa670

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Aims The aim of this study was to determine the effect of ticagrelor monotherapy on clinically relevant bleeding and major ischaemic events in relation to clinical presentation with and without non-ST elevation acute coronary syndromes (NSTE-ACS) among patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Methods and results We conducted a pre-specified subgroup analysis of The Ticagrelor With Aspirin or Alone in High Risk Patients After Coronary Intervention (TWILIGHT) trial, which enrolled 9006 patients with high-risk features undergoing PCI with DES. After 3 months of dual antiplatelet therapy (DAPT) with ticagrelor plus aspirin, 7119 adherent and event-free patients were randomized in a double-blind manner to ticagrelor plus placebo versus ticagrelor plus aspirin for 12 months. The primary outcome was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding while the composite of all-cause death, myocardial infarction (MI), or stroke was the key secondary outcome. Among patients with NSTE-ACS (n = 4614), ticagrelor monotherapy reduced BARC 2, 3, or 5 bleeding by 53% [3.6% vs. 7.6%; hazard ratio (HR) 0.47; 95% confidence interval (CI) 0.36-0.61; P < 0.001) and in stable patients (n = 2503) by 24% (4.8% vs. 6.2%; HR 0.76; 95% CI 0.54-1.06; P = 0.11; nominal P-int = 0.03). Rates of allcause death, MI, or stroke among those with (4.3% vs. 4.4%; HR 0.97; 95% CI 0.74-1.28; P = 0.84) and without (3.1% vs. 3.2%; HR 0.96; 95% CI 0.61-1.49; P = 0.85) NSTE-ACS were similar between treatment arms irrespective of clinical presentation (P-int = 0.96). Conclusion Among patients with or without NSTE-ACS who have completed an initial 3-month course of DAPT following PCI with DES, ticagrelor monotherapy reduced clinically meaningful bleeding events without increasing ischaemic risk as compared with ticagrelor plus aspirin. The benefits of ticagrelor monotherapy with respect to bleeding events were more pronounced in patients with NSTE-ACS. [GRAPHICS] .

引用

页码：3533 / 3545

页数：13

共 47 条

[1] Ticagrelor With or Without Aspirin in High -Risk Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention [J].

Angiolill, Dominick J. ;

Baber, Usman ;

Sartori, Samantha ;

Briguori, Carlo ;

Dangas, George ;

Cohen, David J. ;

Mehta, Shamir R. ;

Gibson, C. Michael ;

Chandiramani, Rishi ;

Huber, Kurt ;

Kornowski, Ran ;

Weisz, Giora ;

Kunadian, Vijay ;

Oldroyd, Keith G. ;

Han Ya-Ling ;

Kaul, Upendra ;

Witzenbichler, Bernhard ;

Dudek, Dariusz ;

Sardella, Gennaro ;

Escaned, Javier ;

Sharma, Samin ;

Shlofmitz, Richard A. ;

Collier, Timothy ;

Pocock, Stuart ;

Mehran, Roxana .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2020, 75 (19) :2403-2413

[2] International Expert Consensus on Switching Platelet P2Y12 Receptor-Inhibiting Therapies [J].

Angiolillo, Dominick J. ;

Rollini, Fabiana ;

Storey, Robert F. ;

Bhatt, Deepak L. ;

James, Stefan ;

Schneider, David J. ;

Sibbing, Dirk ;

So, Derek Y. F. ;

Trenk, Dietmar ;

Alexopoulos, Dimitrios ;

Gurbel, Paul A. ;

Hochholzer, Willibald ;

De Luca, Leonardo ;

Bonello, Laurent ;

Aradi, Daniel ;

Cuisset, Thomas ;

Tantry, Udaya S. ;

Wang, Tracy Y. ;

Valgimigli, Marco ;

Waksman, Ron ;

Mehran, Roxana ;

Montalescot, Gilles ;

Franchi, Francesco ;

Price, Matthew J. .

CIRCULATION, 2017, 136 (20) :1955-+

[3] In the presence of strong P2Y12 receptor blockade, aspirin provides little additional inhibition of platelet aggregation [J].

Armstrong, P. C. J. ;

Leadbeater, P. D. ;

Chan, M. V. ;

Kirkby, N. S. ;

Jakubowski, J. A. ;

Mitchell, J. A. ;

Warner, T. D. .

JOURNAL OF THROMBOSIS AND HAEMOSTASIS, 2011, 9 (03) :552-561

[4] Ticagrelor With or Without Aspirin After PCI The TWILIGHT Platelet Substudy [J].

Baber, Usman ;

Zafar, M. Urooj ;

Dangas, George ;

Escolar, Gines ;

Angiolillo, Dominick J. ;

Sharma, Samin K. ;

Kini, Annapoorna S. ;

Sartori, Samantha ;

Joyce, Lauren ;

Vogel, Birgit ;

Farhan, Serdar ;

Gurbel, Paul ;

Gibson, C. Michael ;

Fuster, Valentin ;

Mehran, Roxana ;

Badimon, Juan J. .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2020, 75 (06) :578-586

[5] Ticagrelor with aspirin or alone in high-risk patients after coronary intervention: Rationale and design of the TWILIGHT study [J].

Baber, Usman ;

Dangas, George ;

Cohen, David J. ;

Gibson, C. Michael ;

Mehta, Shamir R. ;

Angiolillo, Dominick J. ;

Pocock, Stuart J. ;

Krucoff, Mitchell W. ;

Kastrati, Adnan ;

Ohman, E. Magnus ;

Steg, Philippe Gabriel ;

Badimon, Juan ;

Zafar, M. Urooj ;

Chandrasekhar, Jaya ;

Sartori, Samantha ;

Aquino, Melissa ;

Mehran, Roxana .

AMERICAN HEART JOURNAL, 2016, 182 :125-134

[6] Time-Dependent Associations Between Actionable Bleeding, Coronary Thrombotic Events, and Mortality Following Percutaneous Coronary Intervention Results From the PARIS Registry [J].

Baber, Usman ;

Dangas, George ;

Chandrasekhar, Jaya ;

Sartori, Samantha ;

Steg, Philippe Gabriel ;

Cohen, David J. ;

Giustino, Gennaro ;

Ariti, Cono ;

Witzenbichler, Bernhard ;

Henry, Timothy D. ;

Kini, Annapoorna S. ;

Krucoff, Mitchell W. ;

Gibson, C. Michael ;

Chieffo, Alaide ;

Moliterno, David J. ;

Weisz, Giora ;

Colombo, Antonio ;

Pocock, Stuart ;

Mehran, Roxana .

JACC-CARDIOVASCULAR INTERVENTIONS, 2016, 9 (13) :1349-1357

[7] Long-Term Use of Ticagrelor in Patients with Prior Myocardial Infarction [J].

Bonaca, Marc P. ;

Bhatt, Deepak L. ;

Cohen, Marc ;

Steg, Philippe Gabriel ;

Storey, Robert F. ;

Jensen, Eva C. ;

Magnani, Giulia ;

Bansilal, Sameer ;

Fish, M. Polly ;

Im, Kyungah ;

Bengtsson, Olof ;

Ophuis, Ton Oude ;

Budaj, Andrzej ;

Theroux, Pierre ;

Ruda, Mikhail ;

Hamm, Christian ;

Goto, Shinya ;

Spinar, Jindrich ;

Nicolau, Jose Carlos ;

Kiss, Robert G. ;

Murphy, Sabina A. ;

Wiviott, Stephen D. ;

Held, Peter ;

Braunwald, Eugene ;

Sabatine, Marc S. ;

Morin, Suzanne ;

Dantzer, Emily ;

Acquilano, Dayle ;

McGuire, Rachael L. ;

Gannon, Joseph B. ;

Gershman, Elaine ;

Ahlbom, Ann Maxe ;

Boberg, Barbro ;

Abola, Maria Teresa ;

Ardissino, Diego ;

Aylward, Philip ;

Corbalan, Ramon ;

Dalby, Anthony ;

Diaz, Rafael ;

Hu, Dayi ;

Isaza, Daniel ;

Kamensky, Gabriel ;

Kiss, Robert ;

Kontny, Frederic ;

Lopez-Sendon, Jose ;

Medina, Felix ;

Montalescot, Gilles ;

Nicolau, Jose ;

Paolasso, Ernesto ;

Parkhomenko, Alexander .

NEW ENGLAND JOURNAL OF MEDICINE, 2015, 372 (19) :1791-1800

[8] High On-Treatment Platelet Reactivity After Prasugrel Loading Dose and Cardiovascular Events After Percutaneous Coronary Intervention in Acute Coronary Syndromes [J].

Bonello, Laurent ;

Pansieri, Michel ;

Mancini, Julien ;

Bonello, Roland ;

Maillard, Luc ;

Barnay, Pierre ;

Rossi, Philippe ;

Ait-Mokhtar, Omar ;

Jouve, Bernard ;

Collet, Frederic ;

Peyre, Jean Pascal ;

Wittenberg, Olivier ;

de Labriolle, Axel ;

Camilleri, Elise ;

Cheneau, Edouard ;

Cabassome, Elma ;

Dignat-George, Francoise ;

Camoin-Jau, Laurence ;

Paganelli, Franck .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2011, 58 (05) :467-473

[9] HEMORRHAGIC EVENTS DURING THERAPY WITH RECOMBINANT TISSUE-TYPE PLASMINOGEN-ACTIVATOR, HEPARIN, AND ASPIRIN FOR ACUTE MYOCARDIAL-INFARCTION - RESULTS OF THE THROMBOLYSIS IN MYOCARDIAL-INFARCTION (TIMI), PHASE-II TRIAL [J].

BOVILL, EG ;

TERRIN, ML ;

STUMP, DC ;

BERKE, AD ;

FREDERICK, M ;

COLLEN, D ;

FEIT, F ;

GORE, JM ;

HILLIS, LD ;

LAMBREW, CT ;

LEIBOFF, R ;

MANN, KG ;

MARKIS, JE ;

PRATT, CM ;

SHARKEY, SW ;

SOPKO, G ;

TRACY, RP ;

CHESEBRO, JH .

ANNALS OF INTERNAL MEDICINE, 1991, 115 (04) :256-265

[10] Aspirin-free strategies in cardiovascular disease and cardioembolic stroke prevention [J].

Capodanno, Davide ;

Mehran, Roxana ;

Valgimigli, Marco ;

Baber, Usman ;

Windecker, Stephan ;

Vranckx, Pascal ;

Dangas, George ;

Rollini, Fabiana ;

Kimura, Takeshi ;

Collet, Jean-Philippe ;

Gibson, C. Michael ;

Steg, Philippe Gabriel ;

Lopes, Renato D. ;

Gwon, Hyeon-Cheol ;

Storey, Robert F. ;

Franchi, Francesco ;

Bhatt, Deepak L. ;

Serruys, Patrick W. ;

Angiolillo, Dominick J. .

NATURE REVIEWS CARDIOLOGY, 2018, 15 (08) :480-496

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