Comparison of bivalirudin and heparin in patients undergoing rotational atherectomy: A subanalysis of the randomised ROTAXUS trial

EuroIntervention

Volumn 10, Issue 4, 2014, Pages 458-465

  Akin, Ibrahim ^a   Khattab, Ahmed A ^b   Büttner, Heinz Joachim ^c   Toelg, Ralph ^a   Geist, Volker ^a   Neumann, Franz Josef ^c   Richardt, Gert ^a   Abdel Wahab, Mohamed ^a  

^a Segeberger Kliniken GmbH   (Germany)

^b UNIVERSITY OF BERN   (Switzerland)

^c UNIVERSITY HEART CENTER FREIBURG BAD KROZINGEN   (Germany)

Author keywords

Bivalirudin; Bleeding; Heparin; Myocardial infarction; Rotational atherectomy

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; CREATINE KINASE; CREATINE KINASE MB; FIBRINOGEN RECEPTOR ANTAGONIST; HEPARIN; HIRULOG; TROPONIN T; ANTICOAGULANT AGENT; ANTITHROMBIN; HIRUDIN DERIVATIVE; PEPTIDE FRAGMENT; RECOMBINANT PROTEIN;

AGED; ANGIOGRAPHY; ARTICLE; BLEEDING; BLOOD CLOTTING TIME; CONTROLLED STUDY; CORONARY ARTERY DISEASE; DISEASE SEVERITY; DRUG EFFICACY; DRUG FATALITY; DRUG INDUCED DISEASE; DRUG SAFETY; FEMALE; HEART INFARCTION; HEART LEFT VENTRICLE EJECTION FRACTION; HOSPITALIZATION; HUMAN; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; PACLITAXEL ELUTING CORONARY STENT; PERCUTANEOUS CORONARY INTERVENTION; RANDOMIZED CONTROLLED TRIAL; REVASCULARIZATION; ROTABLATOR; ROTATIONAL ATHERECTOMY; STENT THROMBOSIS; TARGET VESSEL REVASCULARISATION; VASCULAR ACCESS; VASCULAR CLOSURE DEVICE; ATHERECTOMY; CHEMICALLY INDUCED; COMPARATIVE STUDY; MIDDLE AGED; MYOCARDIAL INFARCTION; PROCEDURES; TREATMENT OUTCOME;

AGED; ANTICOAGULANTS; ANTITHROMBINS; ATHERECTOMY, CORONARY; CORONARY ARTERY DISEASE; FEMALE; HEMORRHAGE; HEPARIN; HIRUDINS; HUMANS; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; PEPTIDE FRAGMENTS; PERCUTANEOUS CORONARY INTERVENTION; RECOMBINANT PROTEINS; TREATMENT OUTCOME;

EID: 84930714951     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJV10I4A79     Document Type: Article

References (29)

1. Moussa I, Ellis SG, Jones M, Kereiakes DJ, McMartin D, Rutherford B, Mehran R, Collins M, Leon MB, Popma JJ, Russell ME, Stone GW. Impact of coronary culprit lesion calcium in patients undergoing paclitaxel-eluting stent implantation (a TAXUS-IV sub study). Am J Cardiol. 2005;96:1242-7.
2. Berenguer A, Mainar V, Bordes P, Valencia J, Gomez S, Lozano T. Incidence and predictors of restenosis after sirolimus-eluting stent implantation in high-risk patients. Am Heart J. 2005;150:536-42.
3. Smith SC Jr, Feldman TE, Hirshfeld JW Jr, Jacobs AK, Kern MJ, King SB 3rd, Morrison DA, O'Neill WW, Schaff HV, Whitlow PL, Williams DO, Antman EM, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions Writting Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention. ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). Circulation. 2006;113:156-75.
4. Lincoff AM, Bittl JA, Harrington RA, Feit F, Kleiman NS, Jackman JD, Sarembock IJ, Cohen DJ, Spriggs D, Ebrahimi R, Keren G, Carr J, Cohen EA, Betriu A, Desmet W, Kereiakes DJ, Rutsch W, Wilcox RG, de Feyter PJ, Vahanian A, Topol EJ; for the REPLACE-2 Investigators. 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. 2003;289:853-63.
5. Stone GW, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Dangas G, Wong SC, Kirtane AJ, Parise H, Mehran R; for the HORIZONS-AMI Trial Investigators. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med. 2008;358:2218-30.
6. Kastrati A, Neumann FJ, Mehilli J, Byrne RA, Iijima R, Büttner HJ, Khattab AA, Schulz S, Blankenship JC, Pache J, Minners J, Seyfarth M, Graf I, Skelding KA, Dirschinger J, Richardt G, Berger PB, Schömig A; for the ISAR-REACT-3 Trial Investigators. Bivalirudin versus unfractionated heparin during percutaneous coronary intervention. N Engl J Med. 2008;359:688-96.
7. Abdel-Wahab M, Richardt G, Büttner HJ, Toelg R, Geist V, Meinertz T, Schofer J, King L, Neumann FJ, Khattab AA. High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomised ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial. JACC Cardiovasc Interv. 2013;6:10-9.
8. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115:2344-51.
9. Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. Eur Heart J. 2007;28:2525-38.
10. Stone GW, McLaurin BT, Cox DA, Bertrand ME, Lincoff AM, Moses JW, White HD, Pocock SJ, Ware JH, Feit F, Colombo A, Aylward PE, Cequier AR, Darius H, Desmet W, Ebrahimi R, Hamon M, Rasmussen LH, Rupprecht HJ, Hoekstra J, Mehran R, Ohman EM; ACUITY Investigators. Bivalirudin for patients with acute coronary syndromes. N Engl J Med. 2006;355:2203-16.
11. Patti G, Pasceri V, D'Antonio L, D'Ambrosio A, Macri M, Dicuonzo G, Colonna G, Montinaro A, Di Sciascio G. 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. 2012;110:478-84.
12. Iijima R, Ndrepepa G, Mehilli J, Byrne RA, Schulz S, Neumann FJ, Richardt G, Berger PB, Schömig A, Kastrati A. Profile of bleeding and ischemic complications with bivalirudin and unfractionated heparin after percutaneous coronary intervention. Eur Heart J. 2009;30:290-6.
13. Kushner FG, Hand M, Smith SC Jr, King SB 3rd, Anderson JL, Antman EM, Bailey SR, Bates ER, Blankenship JC, Casey DE Jr, Green LA, Hochman JS, Jacobs AK, Krumholz HM, Morrison DA, Ornato JP, Pearle DL, Peterson ED, Sloan MA, Whitlow PL, Williams DO; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2009 Focused Updates: ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction (updating the 2004 Guideline and 2007 Focused Update) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention (updating the 2005 Guideline and 2007 Focused Update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2009;120:2271-306.
14. Bassand JP, Hamm CW, Ardissino D, Boersma E, Budaj A, Fernandez-Aviles F, Fox KA, Hasdai D, Ohman EM, Wallentin L, Wijns W; Task Force for Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes of European Society of Cardiology. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. Eur Heart J. 2007;28:1598-660.
15. Kinnaird TD, Stabile E, Mintz GS, Lee CW, Canos DA, Geworkian N, Pinnow EE, Kent KM, Pichard AD, Satler LF, Weissman NJ, Lindsay J, Fuchs S. Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary intervention. Am J Cardiol. 2003;92:930-5.
16. Moscucci M, Fox KA, Cannon CP, Klein W, Lopez-Sendon J, Montalescot G, White K, Goldberg RJ. Predictors of major bleeding in acute coronary syndromes: the Global Registry of Acute Coronary Events (GRACE). Eur Heart J. 2003;24:1815-23.
17. Rao SV, Jollis JG, Harrington RA, Granger CB, Newby LK, Armstrong PW, Moliterno DJ, Lindblad L, Pieper K, Topol EJ, Stamler JS, Califf RM. Relationship of blood transfusion and clinical outcomes in patients with acute coronary syndromes. JAMA. 2004;292:1555-62.
18. Spencer FA, Moscucci M, Granger CB, Gore JM, Goldberg RJ, Steg PG, Goodman SG, Budai A, Fitzgerald G, Fox KA; GRACE Investigators. Does comorbidity account for the excess mortality in patients with major bleeding in acute myocardial infarction? Circulation. 2007;116:2793-801.
19. Verheugt FW, Steinhubl SR, Hamon M, Darius H, Steg PG, Valgimigli M, Marso SP, Rao SV, Gershlick AH, Lincoff AM, Mehran R, Stone GW. Incidence, prognostic impact, and influence of antithrombotic therapy on access and nonaccess site bleeding in percutaneous coronary intervention. JACC Cardiovasc Interv. 2011;4;191-7.
20. Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardised bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011;123:2736-47.
21. Ndrepepa G, Schuster T, Hadamitzky M, Byrne RA, Mehilli J, Neumann FJ, Richardt G, Schulz S, Laugwitz KL, Massberg S, Schömig A, Kastrati A. Validation of the Bleeding Academic Research Consortium definition of bleeding in patients with coronary artery disease undergoing percutaneous coronary intervention. Circulation. 2012;125:1424-31.
22. Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Brigouri C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005;293:2126-30.
23. Miller WL, Garratt KN, Burritt MF, Lennon RJ, Reeder GS, Jaffe AS. Baseline troponin level: key to understanding the importance of post-PCI troponin elevations. Eur Heart J. 2006;27:1061-9.
24. Prasad A, Singh M, Lerman A, Lenon RJ, Holmes DR Jr, Rihal CS. Isolated elevation in troponin T after percutaneous coronary intervention is associated with higher long-term mortality. J Am Coll Cardiol. 2006;48:1765-70.
25. Abdelmeguid AE, Topol EJ. The myth of the myocardial 'infarctlet' during percutaneous coronary revascularization procedures. Circulation. 1996;94:3369-75.
26. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial infarction. Third universal definition of myocardial infarction. Eur Heart J. 2012;33:2551-67.
27. Kini A, Marmur JD, Kini S, Dangas G, Cocke TP, Wallenstein S, Brown E, Ambrose JA, Sharma SK. Creatine kinase-MB elevation after coronary intervention correlates with diffuse atherosclerosis, and low-to-medium level elevation has a benign clinical course: implications for early discharge after coronary intervention. J Am Coll Cardiol. 1999;34:663-71.
28. Cavusoglu E, Kini AS, Marmur JD, Sharma SK. Current status of rotational atherectomy. Catheter Cardiovasc Interv. 2004;62:485-98.
29. Kini A, Reich D, Marmur JD, Mitre CA, Sharma SK. Reduction in periprocedural enzyme elevation by abciximab after rotational atherectomy of type B2 lesions: results of the Rota ReoPro randomised trial. Am Heart J. 2001;142:965-9.