Impact of anticoagulation regimens on sheath management and bleeding in patients undergoing elective percutaneous coronary intervention in the STEEPLE trial

Catheterization and Cardiovascular Interventions

Volumn 73, Issue 3, 2009, Pages 319-325

  Gallo, Richard ^a   Steinhubl, Steven R ^b   White, Harvey D ^c   Montalescot, Gilles ^d  

^a MONTREAL HEART INSTITUTE   (Canada)

^b GEISINGER MEDICAL CENTER   (United States)

^c AUCKLAND CITY HOSPITAL   (New Zealand)

^d PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

Author keywords

Bleeding; Closure device; Enoxaparin; Percutaneous coronary intervention; Sheath size; Unfractionated heparin

Indexed keywords

ENOXAPARIN; FIBRINOGEN RECEPTOR ANTAGONIST; HEPARIN;

ADULT; AGED; ANTICOAGULATION; ARTICLE; BLEEDING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY BYPASS GRAFT; CORONARY ARTERY DISEASE; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; HUMAN; MAJOR CLINICAL STUDY; OUTCOME ASSESSMENT; PATIENT SAFETY; PERCUTANEOUS CORONARY INTERVENTION; RANDOMIZED CONTROLLED TRIAL; SHEATH REMOVAL; TREATMENT DURATION; TREATMENT RESPONSE;

AGED; ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; ANTICOAGULANTS; ENOXAPARIN; FEMALE; HEMORRHAGE; HUMANS; INJECTIONS, INTRAVENOUS; MALE; MIDDLE AGED; TREATMENT OUTCOME;

EID: 65549102277     PISSN: 15221946     EISSN: 1522726X     Source Type: Journal    
DOI: 10.1002/ccd.21764     Document Type: Article

References (25)

1. Smith SC Jr, Dove JT, Jacobs AK, Kennedy JW, Kereiakes D, Kern MJ, Kuntz RE, Popma JJ, Schaff HV, Williams DO, Gibbons RJ, Alpert JP, Eagle KA, Faxon DP, Fuster V, Gardner TJ, Gregoratos G, Russell RO, Smith SC Jr; American College of Cardiology; American Heart Association Task Force on Practice Guidelines. Committee to Revise the 1993 Guidelines for Percutaneous Transluminal Coronary Angioplasty. ACC/AHA guidelines of percutaneous coronary interventions (revision of the 1993 PTCA guidelines) - Executive summary. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (committee to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty). J Am Coll Cardiol 2001;37:2215-2239.
2. Moscucci M, Fox KA, Cannon CP, Klein W, López-Sendón 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;24:1815-1823.
3. Kuchulakanti PK, Satler LF, Suddath WO, Pichard AD, Kent KM, Pakala R, Canos DA, Pinnow EE, Rha SW, Waksman R. Vascular complications following coronary intervention correlate with long-term cardiac events. Catheter Cardiovasc Interv 2004; 62:181-185.
4. Exaire JE, Tcheng JE, Kereiakes DJ, Kleiman NS, Applegate RJ, Moliterno DJ; ELECT Investigators. Closure devices and vascular complications among percutaneous coronary intervention patients receiving enoxaparin, glycoprotein IIb/IIIa inhibitors, and clopidogrel. Catheter Cardiovasc Interv 2005;64:369-372.
5. Kinnaird TD, Stabile E, Mintz GS, Lee CW, Canos DA, Gevorkian 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 interventions. Am J Cardiol 2003;92:930-935.
6. 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;292:1555-1562.
7. Assali AR, Moustapha A, Sdringola S, Salloum J, Awadalla H, Saikia S, Ghani M, Hale S, Schroth G, Rosales O, Anderson HV, Smalling RW. The dilemma of success: Percutaneous coronary interventions in patients > or = 75 years of age-successful but associated with higher vascular complications and cardiac mortality. Catheter Cardiovasc Interv 2003;59:195-199.
8. Chiu JH, Bhatt DL, Ziada KM, Chew DP, Whitlow PL, Lincoff AM, Ellis SG, Topol EJ. Impact of female sex on outcome after percutaneous coronary intervention. Am Heart J 2004;148:998-1002.
9. Rothman MT. Drug insight: Bleeding after percutaneous coronary intervention-risks, measures and impact of anticoagulant treatment options. Nat Clin Pract Cardiovasc Med 2005;2:465-474.
10. Lincoff AM, Tcheng JE, Califf RM, Bass T, Popma JJ, Teirstein PS, Kleiman NS, Hattel LJ, Anderson HV, Ferguson JJ, Cabot CF, Anderson KM, Berdan LG, Musco MH, Weisman HF, Topol EJ. Standard versus low-dose weight-adjusted heparin in patients treated with the platelet glycoprotein IIb/IIIa receptor antibody fragment abciximab (c7E3 Fab) during percutaneous coronary revascularization. PROLOG Investigators. Am J Cardiol 1997;79:286-291.
11. Mandak JS, Blankenship JC, Gardner LH, Berkowitz SD, Aguirre FV, Sigmon KN, Timmis GC, Gilchrist IC, McIvor M, Resar J, Weiner BH, George BS, Talley JD, Lincoff AM, Tcheng JE, Califf RM, Topol EJ. Modifiable risk factors for vascular access site complications in the IMPACT II Trial of angioplasty with versus without eptifibatide. Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis. J Am Coll Cardiol 1998;31:1518-1524.
12. Zalc S, Lemos PA, Esteves A, Ribeiro EE, Horta P, Nicolau JC, Ramires JA, Cohen M, Martinez EE. Early ambulation and variability in anticoagulation during elective coronary stenting with a single intravenous bolus of low-dose, low-molecular weight heparin enoxaparin. J Invasive Cardiol 2006;18:45-48.
13. Blankenship JC, Hellkamp AS, Aguirre FV, Demko SL, Topol EJ, Califf RM. Vascular access site complications after percutaneous coronary intervention with abciximab in the Evaluation of c7E3 for the Prevention of Ischemic Complications (EPIC) trial. Am J Cardiol 1998;81:36-40.
14. Muller DW, Shamir KJ, Ellis SG, Topol EJ. Peripheral vascular complications after conventional and complex percutaneous coronary interventional procedures. Am J Cardiol 1992;69:63-68.
15. Konstance R, Tcheng JE, Wightman MB, Kelly LP, Moore A, Harrison JK, Sketch MH Jr. Incidence and predictors of major vascular complications after percutaneous coronary intervention in the glycoprotein IIb/IIIa platelet inhibitor era. J Interv Cardiol 2004;17:65-70.
16. Nikolsky E, Mehran R, Halkin A, Aymong ED, Mintz GS, Lasic Z, Negoita M, Fahy M, Krieger S, Moussa I, Moses JW, Stone GW, Leon MB, Pocock SJ, Dangas G. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: A meta-analysis. J Am Coll Cardiol 2004;44:1200-1209.
17. Ferguson JJ, Califf RM, Antman EM, Cohen M, Grines CL, Goodman S, Kereiakes DJ, Langer A, Mahaffey KW, Nessel CC, Armstrong PW, Avezum A, Aylward P, Becker RC, Biasucci L, Borzak S, Col J, Frey MJ, Fry E, Gulba DC, Guneri S, Gurfinkel E, Harrington R, Hochman JS, Kleiman NS, Leon MB, Lopez-Sendon JL, Pepine CJ, Ruzyllo W, Steinhubl SR, Teirstein PS, Toro-Figueroa L, White H; SYNERGY Trial Investigators. Enoxaparin vs unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: Primary results of the SYNERGY randomized trial. JAMA 2004;292:45-54.
18. 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; 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: 853-863.
19. Montalescot G, White HD, Gallo R, Cohen M, Steg PG, Aylward PE, Bode C, Chiariello M, King SB III, Harrington RA, Desmet WJ, Macaya C, Steinhubl SR; STEEPLE Investigators. Enoxaparin versus unfractionated heparin in elective percutaneous coronary intervention. N Engl J Med 2006;355:1006-1017.
20. Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators; Yusuf S, Mehta SR, Chrolavicius S, Afzal R, Pogue J, Granger CB, Budaj A, Peters RJ, Bassand JP, Wallentin L, Joyner C, Fox KA. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med 2006; 354:1464-1476.
21. Agostoni P, Biondi-Zoccai GG, de Benedictis ML, Rigattieri S, Turri M, Anselmi M, Vassanelli C, Zardini P, Louvard Y, Hamon M. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; Systematic overview and meta-analysis of randomized trials. J Am Coll Cardiol 2004;44:349-356.
22. Choussat R, Montalescot G, Collet JP, Vicaut E, Ankri A, Gallois V, Drobinski G, Sotirov I, Thomas D. A unique, low dose of intravenous enoxaparin in elective percutaneous coronary intervention. J Am Coll Cardiol 2002;40:1943-1950.
23. Popma JJ, Berger P, Ohman EM, Harrington RA, Grines C, Weitz JI. Antithrombotic therapy during percutaneous coronary intervention: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004;126(3,Suppl):576S-599S.
24. Sanborn TA, Gibbs HH, Brinker JA, Knopf WD, Kosinksi EJ, Roubin GS. A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty. J Invasive Cardiol 1999;11(Suppl B):6B-13B.
25. Kussmaul WG III, Buchbinder M, Whitlow PL, Aker UT, Heuser RR, King SB, Kent KM, Leon MB, Kolansky DM, Sandza JG Jr. Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: Results of a randomized trial of a novel hemostatic device. J Am Coll Cardiol 1995;25:1685-1692.