Risk of intracranial hemorrhage with protease-activated receptor-1 antagonists

Stroke

Volumn 43, Issue 12, 2012, Pages 3189-3195

  Lee, Meng ^a   Saver, Jeffrey L ^c   Hong, Keun Sik ^d   Wu, Hsiu Chuan ^b   Ovbiagele, Bruce ^e  

^a CHANG GUNG UNIVERSITY COLLEGE OF MEDICINE   (Taiwan)

^b University of California ^*

^c UNIVERSITY OF CALIFORNIA   (United States)

^d Inje University College of Medicine   (South Korea)

^e MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

Author keywords

Acute coronary syndrome; Antiplatelet; Intracranial hemorrhage; Protease activated receptor 1 antagonists; Thrombin antagonists

Indexed keywords

ATOPAXAR; PLACEBO; PROTEINASE ACTIVATED RECEPTOR 1; VORAPAXAR;

ACUTE CORONARY SYNDROME; ARTICLE; BRAIN HEMORRHAGE; COCHRANE LIBRARY; CONFIDENCE INTERVAL; DATA ANALYSIS; EMBASE; HUMAN; INCIDENCE; MEDLINE; META ANALYSIS; PRIORITY JOURNAL; QUALITATIVE ANALYSIS; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK FACTOR; TREATMENT DURATION;

ACUTE CORONARY SYNDROME; HUMANS; IMINES; INCIDENCE; INTRACRANIAL HEMORRHAGES; LACTONES; PLACEBOS; PYRIDINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECEPTOR, PAR-1; RISK FACTORS; THROMBOSIS;

EID: 84870937888     PISSN: 00392499     EISSN: 15244628     Source Type: Journal    
DOI: 10.1161/STROKEAHA.112.670604     Document Type: Article

References (41)

1. Van de Werf F. Inhibitors of the platelet thrombin receptor: will they live up to their promises? Circulation. 2011;123:1833-1835.
2. Coughlin SR. Protease-activated receptors in hemostasis, thrombosis and vascular biology. J Thromb Haemost. 2005;3:1800-1814.
3. Angiolillo DJ, Capodanno D, Goto S. Platelet thrombin receptor antagonism and atherothrombosis. Eur Heart J. 2010;31:17-28.
4. Shah R. Protease-activated receptors in cardiovascular health and diseases. Am Heart J. 2009;157:253-262.
5. Kahn ML, Nakanishi-Matsui M, Shapiro MJ, Ishihara H, Coughlin SR. Protease-activated receptors 1 and 4 mediate activation of human platelets by thrombin. J Clin Invest. 1999;103:879-887.
6. Andersen H, Greenberg DL, Fujikawa K, Xu W, Chung DW, Davie EW. Protease-activated receptor 1 is the primary mediator of thrombin-stimulated platelet procoagulant activity. Proc Natl Acad Sci USA. 1999;96:11189-11193.
7. Diener HC, Bogousslavsky J, Brass LM, Cimminiello C, Csiba L, Kaste M, Leys D, Matias-Guiu J, Rupprecht HJ; MATCH investigators. Aspirin and clopidogrel compared with clopidogrel alone after recent ischaemic stroke or transient ischaemic attack in high-risk patients (MATCH): randomised, double-blind, placebo-controlled trial. Lancet. 2004;364:331-337.
8. Morrow DA, Braunwald E, Bonaca MP, Ameriso SF, Dalby AJ, Fish MP, Fox KA, Lipka LJ, Liu X, Nicolau JC, Ophuis AJ, Paolasso E, Scirica BM, Spinar J, Theroux P, Wiviott SD, Strony J, Murphy SA; TRA 2P-TIMI 50 Steering Committee and Investigators. Vorapaxar in the secondary prevention of atherothrombotic events. N Engl J Med. 2012;366:1404-1413.
9. O'Donoghue ML, Bhatt DL, Wiviott SD, Goodman SG, Fitzgerald DJ, Angiolillo DJ, Goto S, Montalescot G, Zeymer U, Aylward PE, Guetta V, Dudek D, Ziecina R, Contant CF, Flather MD; LANCELOT-ACS Investigators. Safety and tolerability of atopaxar in the treatment of patients with acute coronary syndromes: the lessons from antagonizing the cellular effects of Thrombin-Acute Coronary Syndromes Trial. Circulation. 2011;123:1843-1853.
10. Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009;151:264-9, W64.
11. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, McQuay HJ. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17:1-12.
12. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21:1539-1558.
13. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557-560.
14. Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions. West Sussex, UK: Cochrane Collaboration and John Wiley & Sons Ltd; 2008.
15. MANTEL N, HAENSZEL W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst. 1959;22:719-748.
16. Sterne JA, Egger M. Funnel plots for detecting bias in meta-analysis: guidelines on choice of axis. J Clin Epidemiol. 2001;54:1046-1055.
17. Goto S, Ogawa H, Takeuchi M, Flather MD, Bhatt DL; J-LANCELOT (Japanese-Lesson from Antagonizing the Cellular Effect of Thrombin) Investigators. Double-blind, placebo-controlled Phase II studies of the protease-activated receptor 1 antagonist E5555 (atopaxar) in Japanese patients with acute coronary syndrome or high-risk coronary artery disease. Eur Heart J. 2010;31:2601-2613.
18. Wiviott SD, Flather MD, O'Donoghue ML, Goto S, Fitzgerald DJ, Cura F, Aylward P, Guetta V, Dudek D, Contant CF, Angiolillo DJ, Bhatt DL; LANCELOT-CAD Investigators. Randomized trial of atopaxar in the treatment of patients with coronary artery disease: the lessons from antagonizing the cellular effect of Thrombin-Coronary Artery Disease Trial. Circulation. 2011;123:1854-1863.
19. Goto S, Yamaguchi T, Ikeda Y, Kato K, Yamaguchi H, Jensen P. Safety and exploratory efficacy of the novel thrombin receptor (PAR-1) antagonist SCH530348 for non-ST-segment elevation acute coronary syndrome. J Atheroscler Thromb. 2010;17:156-164.
20. Shinohara Y, Goto S, Doi M, Jensen P. Safety of the novel protease-activated receptor-1 antagonist vorapaxar in Japanese patients with a history of ischemic stroke. J Stroke Cerebrovasc Dis. 2012;21:318-324.
21. Tricoci P, Huang Z, Held C, Moliterno DJ, Armstrong PW, Van de Werf F, White HD, Aylward PE, Wallentin L, Chen E, Lokhnygina Y, Pei J, Leonardi S, Rorick TL, Kilian AM, Jennings LH, Ambrosio G, Bode C, Cequier A, Cornel JH, Diaz R, Erkan A, Huber K, Hudson MP, Jiang L, Jukema JW, Lewis BS, Lincoff AM, Montalescot G, Nicolau JC, Ogawa H, Pfisterer M, Prieto JC, Ruzyllo W, Sinnaeve PR, Storey RF, Valgimigli M, Whellan DJ, Widimsky P, Strony J, Harrington RA, Mahaffey KW; TRACER Investigators. Thrombin-receptor antagonist vorapaxar in acute coronary syndromes. N Engl J Med. 2012;366:20-33.
22. Becker RC, Moliterno DJ, Jennings LK, Pieper KS, Pei J, Niederman A, Ziada KM, Berman G, Strony J, Joseph D, Mahaffey KW, Van de Werf F, Veltri E, Harrington RA; TRA-PCI Investigators. Safety and tolerability of SCH 530348 in patients undergoing non-urgent percutaneous coronary intervention: a randomised, double-blind, placebo-controlled phase II study. Lancet. 2009;373:919-928.
23. Cohen DJ, Stolker JM, Wang K, Magnuson EA, Clark WM, Demaerschalk BM, Sam AD Jr, Elmore JR, Weaver FA, Aronow HD, Goldstein LB, Roubin GS, Howard G, Brott TG; CREST Investigators. Health-related quality of life after carotid stenting versus carotid endarterectomy: results from CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial). J Am Coll Cardiol. 2011;58:1557-1565.
24. Hong KS, Ali LK, Selco SL, Fonarow GC, Saver JL. Weighting components of composite end points in clinical trials: an approach using disability-adjusted life-years. Stroke. 2011;42:1722-1729.
25. Kim HC, Choi DP, Ahn SV, Nam CM, Suh I. Six-year survival and causes of death among stroke patients in Korea. Neuroepidemiology. 2009;32:94-100.
26. Cadilhac DA, Dewey HM, Vos T, Carter R, Thrift AG. The health loss from ischemic stroke and intracerebral hemorrhage: evidence from the North East Melbourne Stroke Incidence Study (NEMESIS). Health Qual Life Outcomes. 2010;8: In press.
27. Lee HY, Hwang JS, Jeng JS, Wang JD. Quality-adjusted life expectancy (QALE) and loss of QALE for patients with ischemic stroke and intracerebral hemorrhage: a 13-year follow-up. Stroke. 2010;41:739-744.
28. Sibon I, Orgogozo JM. Antiplatelet drug discontinuation is a risk factor for ischemic stroke. Neurology. 2004;62:1187-1189.
29. Broderick JP, Bonomo JB, Kissela BM, Khoury JC, Moomaw CJ, Alwell K, Woo D, Flaherty ML, Khatri P, Adeoye O, Ferioli S, Kleindorfer DO. Withdrawal of antithrombotic agents and its impact on ischemic stroke occurrence. Stroke. 2011;42:2509-2514.
30. García Rodríguez LA, Cea Soriano L, Hill C, Johansson S. Increased risk of stroke after discontinuation of acetylsalicylic acid: a UK primary care study. Neurology. 2011;76:740-746.
31. Ariesen MJ, Algra A, Warlow CP, Rothwell PM; Cerebrovascular Cohort Studies Collaboration (CCSC). Predictors of risk of intracerebral haemorrhage in patients with a history of TIA or minor ischaemic stroke. J Neurol Neurosurg Psychiatr. 2006;77:92-94.
32. Gregoire SM, Jäger HR, Yousry TA, Kallis C, Brown MM, Werring DJ. Brain microbleeds as a potential risk factor for antiplatelet-related intracerebral haemorrhage: hospital-based, case-control study. J Neurol Neurosurg Psychiatr. 2010;81:679-684.
33. Biffi A, Sonni A, Anderson CD, Kissela B, Jagiella JM, Schmidt H, Jimenez-Conde J, Hansen BM, Fernandez-Cadenas I, Cortellini L, Ayres A, Schwab K, Juchniewicz K, Urbanik A, Rost NS, Viswanathan A, Seifert-Held T, Stoegerer EM, Tomás M, Rabionet R, Estivill X, Brown DL, Silliman SL, Selim M, Worrall BB, Meschia JF, Montaner J, Lindgren A, Roquer J, Schmidt R, Greenberg SM, Slowik A, Broderick JP, Woo D, Rosand J; International Stroke Genetics Consortium. Variants at APOE influence risk of deep and lobar intracerebral hemorrhage. Ann Neurol. 2010;68:934-943.
34. Goldstein LB, Bushnell CD, Adams RJ, Appel LJ, Braun LT, Chaturvedi S, Creager MA, Culebras A, Eckel RH, Hart RG, Hinchey JA, Howard VJ, Jauch EC, Levine SR, Meschia JF, Moore WS, Nixon JV, Pearson TA; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Epidemiology and Prevention; Council for High Blood Pressure Research, Council on Peripheral Vascular Disease, and Interdisciplinary Council on Quality of Care and Outcomes Research. Guidelines for the primary prevention of stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2011;42:517-584.
35. Nüesch E, Trelle S, Reichenbach S, Rutjes AW, Tschannen B, Altman DG, Egger M, Jüni P. Small study effects in meta-analyses of osteoarthritis trials: meta-epidemiological study. BMJ. 2010;341:c3515.
36. Zhang T, Shen L, Hu L, He B. Optimal duration of dual-antiplatelet therapy following drug-eluting stent implantation: a meta-analysis. J Clin Pharmacol.
37. Tada T, Natsuaki M, Morimoto T, Furukawa Y, Nakagawa Y, Byrne RA, Kastrati A, Kadota K, Iwabuchi M, Shizuta S, Tazaki J, Shiomi H, Abe M, Ehara N, Mizoguchi T, Mitsuoka H, Inada T, Araki M, Kaburagi S, Taniguchi R, Eizawa H, Nakano A, Suwa S, Takizawa A, Nohara R, Fujiwara H, Mitsudo K, Nobuyoshi M, Kita T, Kimura T; CREDO-Kyoto PCI/CABG Registry Cohort-2 Investigators. Duration of dual antiplatelet therapy and long-term clinical outcome after coronary drugeluting stent implantation: landmark analyses from the CREDO-Kyoto PCI/CABG Registry Cohort-2. Circ Cardiovasc Interv. 2012;5:381-391.
38. Park SJ, Park DW, Kim YH, Kang SJ, Lee SW, Lee CW, Han KH, Park SW, Yun SC, Lee SG, Rha SW, Seong IW, Jeong MH, Hur SH, Lee NH, Yoon J, Yang JY, Lee BK, Choi YJ, Chung WS, Lim DS, Cheong SS, Kim KS, Chae JK, Nah DY, Jeon DS, Seung KB, Jang JS, Park HS, Lee K. Duration of dual antiplatelet therapy after implantation of drugeluting stents. N Engl J Med. 2010;362:1374-1382.
39. Chatterjee S, Sharma A, Mukherjee D. PAR-1 antagonists: current state of evidence. J Thromb Thrombolysis.
40. Capodanno D, Bhatt DL, Goto S, O'Donoghue ML, Moliterno DJ, Tamburino C, Angiolillo DJ. Safety and efficacy of protease-activated receptor-1 antagonists in patients with coronary artery disease: a meta-analysis of randomized clinical trials. J Thromb Haemost. 2012;10:2006-2015.
41. Earnshaw SR, Scheiman J, Fendrick AM, McDade C, Pignone M. Costutility of aspirin and proton pump inhibitors for primary prevention. Arch Intern Med. 2011;171:218-225.