Bivalirudin versus heparin in non-ST and ST-segment elevation myocardial infarction - A registry-based randomized clinical trial in the SWEDEHEART registry (the VALIDATE-SWEDEHEART trial)

American Heart Journal

Volumn 175, Issue , 2016, Pages 36-46

  Erlinge, David ^a   Koul, Sasha ^a   Eriksson, Peter ^b   Scherstén, Fredrik ^a   Omerovic, Elmir ^c   Linder, Rikard ^d   Östlund, Olof Petter ^e   Wallentin, Lars ^e   Fröbert, Ole ^f   James, Stefan ^e  

^a LUND UNIVERSITY   (Sweden)

^b UMEÅ UNIVERSITY   (Sweden)

^c Institute of Internal Medicine   (Sweden)

^d KAROLINSKA INSTITUTE   (Sweden)

^e UPPSALA UNIVERSITY   (Sweden)

^f Örebro University   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

CANGRELOR; HEPARIN; HIRULOG; PRASUGREL; TICAGRELOR; ANTICOAGULANT AGENT; BIVALIRUDIN; FIBRINOGEN RECEPTOR; HIRUDIN DERIVATIVE; PEPTIDE FRAGMENT; RECOMBINANT PROTEIN;

ADULT; AGED; ARTICLE; CONTROLLED STUDY; EVIDENCE BASED PRACTICE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; OPEN STUDY; OUTCOME ASSESSMENT; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; VALIDATION STUDY; ANTAGONISTS AND INHIBITORS; DOSE RESPONSE; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; ELECTROCARDIOGRAPHY; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; MULTIMODALITY CANCER THERAPY; NON-ST ELEVATED MYOCARDIAL INFARCTION; PROCEDURES; REGISTER; ST ELEVATION MYOCARDIAL INFARCTION; TREATMENT OUTCOME;

ADMINISTRATION, INTRAVENOUS; AGED; ANTICOAGULANTS; COMBINED MODALITY THERAPY; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; ELECTROCARDIOGRAPHY; FEMALE; HEPARIN; HIRUDINS; HUMANS; MALE; MIDDLE AGED; NON-ST ELEVATED MYOCARDIAL INFARCTION; OUTCOME AND PROCESS ASSESSMENT (HEALTH CARE); PEPTIDE FRAGMENTS; PERCUTANEOUS CORONARY INTERVENTION; PLATELET GLYCOPROTEIN GPIIB-IIIA COMPLEX; RECOMBINANT PROTEINS; REGISTRIES; ST ELEVATION MYOCARDIAL INFARCTION; TREATMENT OUTCOME;

EID: 84960086006     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2016.02.007     Document Type: Article

References (39)

1. Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC) P.G. Steg, S.K. James, and et al. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation Eur Heart J 33 20 2012 2569 2619
2. C.W. Hamm, J.P. Bassand, S. Agewall, and et al. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The task force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC) Eur Heart J 32 23 2011 2999 3054
3. P.T. O'Gara, F.G. Kushner, D.D. Ascheim, and et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines J Am Coll Cardiol 61 4 2013 485 510
4. H. Jneid, J.L. Anderson, R.S. Wright, and et al. 2012 ACCF/AHA focused update of the guideline for the management of patients with unstable angina/non-ST-elevation myocardial infarction (updating the 2007 guideline and replacing the 2011 focused update): A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines J Am Coll Cardiol 60 7 2012 645 681
5. G.W. Stone, B. Witzenbichler, G. Guagliumi, and et al. Bivalirudin during primary PCI in acute myocardial infarction N Engl J Med 358 21 2008 2218 2230
6. A.M. Lincoff, J.A. Bittl, R.A. Harrington, and et al. Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial JAMA 289 7 2003 853 863
7. G. Montalescot, P. Barragan, O. Wittenberg, and et al. Platelet glycoprotein IIb/IIIa inhibition with coronary stenting for acute myocardial infarction N Engl J Med 344 25 2001 1895 1903
8. G. Montalescot, U. Zeymer, J. Silvain, and et al. Intravenous enoxaparin or unfractionated heparin in primary percutaneous coronary intervention for ST-elevation myocardial infarction: The international randomised open-label ATOLL trial Lancet 378 9792 2011 693 703
9. A. Shahzad, I. Kemp, C. Mars, and et al. Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): An open-label, single centre, randomised controlled trial Lancet 384 9957 2014 1849 1858
10. G.W. Stone, B.T. McLaurin, D.A. Cox, and et al. Bivalirudin for patients with acute coronary syndromes N Engl J Med 355 21 2006 2203 2216
11. S.D. Wiviott, E. Braunwald, C.H. McCabe, and et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes N Engl J Med 357 20 2007 2001 2015
12. L. Wallentin, R.C. Becker, A. Budaj, and et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes N Engl J Med 361 11 2009 1045 1057
13. A. Kastrati, F.J. Neumann, S. Schulz, and et al. Abciximab and heparin versus bivalirudin for non-ST-elevation myocardial infarction N Engl J Med 365 21 2011 1980 1989
14. G.D. Dangas, A. Caixeta, R. Mehran, and et al. Frequency and predictors of stent thrombosis after percutaneous coronary intervention in acute myocardial infarction Circulation 123 16 2011 1745 1756
15. M. Koutouzis, B. Lagerqvist, S. James, and et al. Unfractionated heparin administration in patients treated with bivalirudin during primary percutaneous coronary intervention is associated lower mortality and target lesion thrombosis: A report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) Heart 97 18 2011 1484 1488
16. Y. Han, J. Guo, Y. Zheng, and et al. Bivalirudin vs heparin with or without tirofiban during primary percutaneous coronary intervention in acute myocardial infarction: The BRIGHT randomized clinical trial JAMA 313 13 2015 1336 1346
17. P.G. Steg, A. van 't Hof, C.W. Hamm, and et al. Bivalirudin started during emergency transport for primary PCI N Engl J Med 369 23 2013 2207 2217
18. S. Schulz, G. Richardt, K.L. Laugwitz, and et al. Prasugrel plus bivalirudin vs. clopidogrel plus heparin in patients with ST-segment elevation myocardial infarction Eur Heart J 35 34 2014 2285 2294
19. M. Valgimigli, E. Frigoli, S. Leonardi, and et al. Bivalirudin or unfractionated heparin in acute coronary syndromes N Engl J Med 373 11 2015 997 1009
20. P. Clemmensen, S. Wiberg, A. Van't Hof, and et al. Acute stent thrombosis after primary percutaneous coronary intervention: insights from the EUROMAX trial (European Ambulance Acute Coronary Syndrome Angiography) J Am Coll Cardiol Intv 8 1 Pt B 2015 214 220
21. G. Patti, V. Pasceri, L. D'Antonio, and et al. Comparison of safety and efficacy of bivalirudin versus unfractionated heparin in high-risk patients undergoing percutaneous coronary intervention (from the Anti-Thrombotic Strategy for Reduction of Myocardial Damage During Angioplasty-Bivalirudin vs Heparin study) Am J Cardiol 110 4 2012 478 484
22. C. Briguori, G. Visconti, A. Focaccio, and et al. Novel approaches for preventing or limiting events (Naples) III trial: randomized comparison of bivalirudin versus unfractionated heparin in patients at increased risk of bleeding undergoing transfemoral elective coronary stenting J Am Coll Cardiol Intv 8 3 2015 414 423
23. S. Bangalore, B. Toklu, A. Kotwal, and et al. Anticoagulant therapy during primary percutaneous coronary intervention for acute myocardial infarction: A meta-analysis of randomized trials in the era of stents and P2Y12 inhibitors BMJ 349 2014 g6419
24. M.S. Lauer, and R.B. D'Agostino Sr. The randomized registry trial - the next disruptive technology in clinical research? N Engl J Med 369 17 2013 1579 1581
25. O. Frobert, B. Lagerqvist, G.K. Olivecrona, and et al. Thrombus aspiration during ST-segment elevation myocardial infarction N Engl J Med 369 17 2013 1587 1597
26. O. Frobert, B. Lagerqvist, T. Gudnason, and et al. Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia (TASTE trial). A multicenter, prospective, randomized, controlled clinical registry trial based on the Swedish angiography and angioplasty registry (SCAAR) platform. Study design and rationale Am Heart J 160 6 2010 1042 1048
27. S. James, O. Frobert, and B. Lagerqvist Cardiovascular registries: A novel platform for randomised clinical trials Heart 98 18 2012 1329 1331
28. A.M. Galloe, L. Thuesen, H. Kelbaek, and et al. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: The SORT OUT II randomized trial JAMA 299 4 2008 409 416
29. K. Rasmussen, M. Maeng, A. Kaltoft, and et al. Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care (SORT OUT III): A randomised controlled superiority trial Lancet 375 9720 2010 1090 1099
30. L.O. Jensen, P. Thayssen, H.S. Hansen, and et al. Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: The Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV) Circulation 125 10 2012 1246 1255
31. E.H. Christiansen, L.O. Jensen, P. Thayssen, and et al. Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): A randomised non-inferiority trial Lancet 381 9867 2013 661 669
32. B. Raungaard, L.O. Jensen, H.H. Tilsted, and et al. Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI): A randomised non-inferiority trial Lancet 385 9977 2015 1527 1535
33. S.V. Rao, C.N. Hess, B. Barham, and et al. A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: The SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial J Am Coll Cardiol Intv 7 8 2014 857 867
34. C.N. Hess, S.V. Rao, D.F. Kong, and et al. Embedding a randomized clinical trial into an ongoing registry infrastructure: unique opportunities for efficiency in design of the Study of Access site For Enhancement of Percutaneous Coronary Intervention for Women (SAFE-PCI for Women) Am Heart J 166 3 2013 421 428
35. Authors/Task Force m S. Windecker, P. Kolh, and et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: The task force on myocardial revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Eur Heart J 35 37 2014 2541 2619
36. Annual report SWEDEHEART 2012 Scand Cardiovasc J 48 Suppl. 63 2014 2 133
37. G. Montalescot, A.W. van 't Hof, F. Lapostolle, and et al. Prehospital ticagrelor in ST-segment elevation myocardial infarction N Engl J Med 371 11 2014 1016 1027
38. S. Koul, P. Andell, A. Martinsson, and et al. A pharmacodynamic comparison of 5 anti-platelet protocols in patients with ST-elevation myocardial infarction undergoing primary PCI BMC Cardiovasc Disord 14 2014 189
39. D.L. Bhatt, G.W. Stone, K.W. Mahaffey, and et al. Effect of platelet inhibition with cangrelor during PCI on ischemic events N Engl J Med 368 14 2013 1303 1313