Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study

American Heart Journal

Volumn 184, Issue , 2017, Pages 81-87

  Windecker, Stephan ^a,b   Tijssen, Jan ^b,c   Giustino, Gennaro ^d   Guimarães, Ana H C ^e   Mehran, Roxana ^d   Valgimigli, Marco ^a,b   Vranckx, Pascal ^b,f   Welsh, Robert C ^g   Baber, Usman ^d   van Es, Gerrit Anne ^b,e   Wildgoose, Peter ^h   Volkl, Albert A ^h   Zazula, Ana ⁱ   Thomitzek, Karen ^j   Hemmrich, Melanie ^j   Dangas, George D ^d  

^a UNIVERSITY OF BERN   (Switzerland)

^b European Cardiovascular Research Institute   (Netherlands)

^c ACADEMIC MEDICAL CENTER   (Netherlands)

^d MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^e CARDIALYSIS   (Netherlands)

^f Hartcentrum Hasselt   (Belgium)

^g UNIVERSITY OF ALBERTA   (Canada)

^h JANSSEN RESEARCH AND DEVELOPMENT   (United States)

ⁱ Bayer   (Brazil)

^j BAYER PHARMA AG   (Germany)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; RIVAROXABAN; ANTITHROMBOCYTIC AGENT; BLOOD CLOTTING FACTOR 10A INHIBITOR; TICLOPIDINE;

ADULT; ANTICOAGULANT THERAPY; ARTICLE; BLEEDING; CARDIOVASCULAR DISEASE; CAUSE OF DEATH; CEREBROVASCULAR ACCIDENT; CLINICAL OUTCOME; CLINICAL PROTOCOL; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DRUG EFFICACY; DRUG SAFETY; DUAL ANTIPLATELET THERAPY; EMBOLISM; FEMALE; HEART INFARCTION; HUMAN; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEW-ONSET ATRIAL FIBRILLATION; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTHETIC VALVE THROMBOSIS; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; STUDY DESIGN; TRANSCATHETER AORTIC VALVE IMPLANTATION; ANALOGS AND DERIVATIVES; AORTIC VALVE STENOSIS; CARDIOVASCULAR DISEASES; CLINICAL TRIAL; COMBINATION DRUG THERAPY; HEART VALVE DISEASES; MORTALITY; MYOCARDIAL INFARCTION; POSTOPERATIVE CARE; PROCEDURES; PULMONARY EMBOLISM; STROKE; THROMBOSIS; VENOUS THROMBOSIS;

AORTIC VALVE STENOSIS; ASPIRIN; CARDIOVASCULAR DISEASES; CAUSE OF DEATH; DRUG THERAPY, COMBINATION; EMBOLISM; FACTOR XA INHIBITORS; HEART VALVE DISEASES; HUMANS; MORTALITY; MYOCARDIAL INFARCTION; PLATELET AGGREGATION INHIBITORS; POSTOPERATIVE CARE; PULMONARY EMBOLISM; RIVAROXABAN; STROKE; THROMBOSIS; TICLOPIDINE; TRANSCATHETER AORTIC VALVE REPLACEMENT; VENOUS THROMBOSIS;

EID: 84998812103     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2016.10.017     Document Type: Article

References (30)

1. 1. Nko'mo, V.T., Gardin, J.M., Skelton, T.N., et al. Burden of valvular heart diseases: a population-based study. Lancet 368:9540 (2006), 1005–1011, 10.1016/S0140-6736(06)69208–8 [S0140-6736(06)69208-8 pii].
2. 2. Otto, C.M., Prendergast, B., Aortic-valve stenosis—from patients at risk to severe valve obstruction. N Engl J Med 371:8 (2014), 744–756, 10.1056/NEJMra1313875.
3. 3. Osnabrugge, R.L., Mylotte, D., Head, S.J., et al. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol 62:11 (2013), 1002–1012, 10.1016/j.jacc.2013.05.015 [S0735-1097(13)02079-2 pii].
4. 4. Thaden, J.J., Nkomo, V.T., Enriquez-Sarano, M., The global burden of aortic stenosis. Prog Cardiovasc Dis 56:6 (2014), 565–571, 10.1016/j.pcad.2014.02.006 [S0033–0620(14)00030–9 pii].
5. 5. Smith, C.R., Leon, M.B., Mack, M.J., et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 364:23 (2011), 2187–2198, 10.1056/NEJMoa1103510.
6. 6. Adams, D.H., Popma, J.J., Reardon, M.J., et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 370:19 (2014), 1790–1798, 10.1056/NEJMoa1400590.
7. 7. Leon, M.B., Smith, C.R., Mack, M., et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 363:17 (2010), 1597–1607, 10.1056/NEJMoa1008232.
8. 8. Vahanian, A., Alfieri, O., Andreotti, F., et al. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J 33:19 (2012), 2451–2496, 10.1093/eurheartj/ehs109 [ehs109 pii].
9. 9. Stortecky, S., Windecker, S., Stroke: an infrequent but devastating complication in cardiovascular interventions. Circulation 126:25 (2012), 2921–2924, 10.1161/CIRCULATIONAHA.112.149492.
10. 10. Van Mieghem, N.M., Schipper, M.E., Ladich, E., et al. Histopathology of embolic debris captured during transcatheter aortic valve replacement. Circulation 127:22 (2013), 2194–2201, 10.1161/CIRCULATIONAHA.112.001091.
11. 11. Makkar, R.R., Fontana, G., Jilaihawi, H., et al. Possible subclinical leaflet thrombosis in bioprosthetic aortic valves. N Engl J Med 373:21 (2015), 2015–2024, 10.1056/NEJMoa1509233.
12. 12. Lip, G.Y., Windecker, S., Huber, K., et al. Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary or valve interventions: a joint consensus document of the European Society of Cardiology Working Group on Thrombosis, European Heart Rhythm Association (EHRA), European Association of Percutaneous Cardiovascular Interventions (EAPCI) and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS) and Asia-Pacific Heart Rhythm Society (APHRS). Eur Heart J 35:45 (2014), 3155–3179, 10.1093/eurheartj/ehu298 ehu298 [pii].
13. 13. Rodes-Cabau, J., Dauerman, H.L., Cohen, M.G., et al. Antithrombotic treatment in transcatheter aortic valve implantation: insights for cerebrovascular and bleeding events. J Am Coll Cardiol 62:25 (2013), 2349–2359, 10.1016/j.jacc.2013.03.029 [S0735–1097(13)01401–0 pii].
14. 14. Webb, J., Rodes-Cabau, J., Fremes, S., et al. Transcatheter aortic valve implantation: a Canadian Cardiovascular Society position statement. Can J Cardiol 28:5 (2012), 520–528, 10.1016/j.cjca.2012.04.015 [S0828-282X(12)00201-2 pii].
15. 15. Holmes, D.R. Jr., Mack, M.J., Kaul, S., et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol 59:13 (2012), 1200–1254, 10.1016/j.jacc.2012.01.001 [S0735–1097(12)00002–2 pii].
16. 16. Nishimura, R.A., Otto, C.M., Bonow, R.O., et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 63:22 (2014), 2438–2488, 10.1016/j.jacc.2014.02.537 [S0735–1097(14)01280–7 pii].
17. 17. Ussia, G.P., Scarabelli, M., Mule, M., et al. Dual antiplatelet therapy versus aspirin alone in patients undergoing transcatheter aortic valve implantation. Am J Cardiol 108:12 (2011), 1772–1776, 10.1016/j.amjcard.2011.07.049 [S0002–9149(11)02431–3 pii].
18. 18. Holmes, D.R. Jr., Mack, M.J., Kaul, S., et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement: developed in collabration with the American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Failure Society of America, Mended Hearts, Society of Cardiovascular Anesthesiologists, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance. J Thorac Cardiovasc Surg 144:3 (2012), e29–e84, 10.1016/j.jtcvs.2012.03.001 [S0022-5223(12)00281-4 pii].
19. 19. Depta, J.P., Bhatt, D.L., New approaches to inhibiting platelets and coagulation. Annu Rev Pharmacol Toxicol 55 (2015), 373–397, 10.1146/annurev-pharmtox-010814-124438.
20. 20. Weitz, J.I., Insights into the role of thrombin in the pathogenesis of recurrent ischaemia after acute coronary syndrome. Thromb Haemost 112:5 (2014), 924–931, 10.1160/TH14-03-0265.
21. 21. Kubitza, D., Becka, M., Wensing, G., et al. Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939—an oral, direct Factor Xa inhibitor—after multiple dosing in healthy male subjects. Eur J Clin Pharmacol 61:12 (2005), 873–880, 10.1007/s00228-005-0043-5.
22. 22. Patel, M.R., Mahaffey, K.W., Garg, J., et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 365:10 (2011), 883–891, 10.1056/NEJMoa1009638.
23. 23. Buller, H.R., Prins, M.H., Lensin, A.W., et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 366:14 (2012), 1287–1297, 10.1056/NEJMoa1113572.
24. 24. Turpie, A.G., Lassen, M.R., Davidson, B.L., et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet 373:9676 (2009), 1673–1680, 10.1016/S0140–6736(09)60734–0 [S0140–6736(09)60734–0 pii].
25. 25. Mega, J.L., Braunwald, E., Wiviott, S.D., et al. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med 366:1 (2012), 9–19, 10.1056/NEJMoa1112277.
26. 26. Kappetein, A.P., Head, S.J., Genereux, P., et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol 60:15 (2012), 1438–1454, 10.1016/j.jacc.2012.09.001 [S0735–1097(12)04344–6 pii].
27. 27. Buller, H.R., Cohen, A.T., Davidson, B., et al. Idraparinux versus standard therapy for venous thromboembolic disease. N Engl J Med 357:11 (2007), 1094–1104, 10.1056/NEJMoa064247 [357/11/1094 pii].
28. 28. Mehran, R., Rao, S.V., Bhatt, D.L., et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation 123:23 (2011), 2736–2747, 10.1161/CIRCULATIONAHA.110.009449 [123/23/2736 pii].
29. 29. Popma, J.J., Adams, D.H., Reardon, M.J., et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol 63:19 (2014), 1972–1981, 10.1016/j.jacc.2014.02.556 [S0735–1097(14)01396-5 pii].
30. 30. Bayer, electronic Medicines Compendium (eMC); SPC Rivaroxaban Xarelto® Bayer, 1 July 2015. 2015.