Reduction in vascular access site bleeding in sequential abciximab coronary intervention trials

Catheterization and Cardiovascular Interventions

Volumn 57, Issue 4, 2002, Pages 476-483

  Blankenship, James C ^a   Balog, Craig ^b   Sapp, Shelly K ^b   Califf, Robert M ^c   Lincoff, A Michael ^b   Tcheng, James E ^c   Topol, Eric J ^b  

^a GEISINGER MEDICAL CENTER   (United States)

^b LERNER RESEARCH INSTITUTE   (United States)

^c DUKE CLINICAL RESEARCH INSTITUTE   (United States)

Author keywords

Angioplasty; Bleeding; Complications; Stents; Vascular disease

Indexed keywords

ABCIXIMAB; HEPARIN; PLACEBO;

ADULT; AGED; ARTICLE; BLEEDING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; VASCULAR ACCESS;

AGED; ANTIBODIES, MONOCLONAL; ANTICOAGULANTS; BLOOD COAGULATION TESTS; BLOOD VESSEL PROSTHESIS IMPLANTATION; CATHETERS, INDWELLING; CLINICAL TRIALS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; IMMUNOGLOBULIN FAB FRAGMENTS; MALE; MIDDLE AGED; POSTOPERATIVE HEMORRHAGE; RETROSPECTIVE STUDIES; SEVERITY OF ILLNESS INDEX; STENTS;

EID: 0036895649     PISSN: 15221946     EISSN: None     Source Type: Journal    
DOI: 10.1002/ccd.10322     Document Type: Article

References (40)

1. Popma JJ, Satler LF, Pichard AD, Kent KM, Campbell A, Chuang YC, Clark C, Merritt AJ, Bucher TA, Leon MB. Vascular complications after balloon and new device angioplasty. Circulation 1993;88:1569-1578.
2. Waksman R, King SB, Douglas JS, Shen Y, Ewing H, Mueller L, Ghazzal ZMB, Weintraub WS. Predictors of groin complications after balloon and new-device coronary intervention. Am J Cardiol 1995;75:886-889.
3. Muller DWM, Shamir KJ, Ellis SG, Topol EJ. Peripheral vascular complications after conventional and complex percutaneous coronary interventional procedures. Am J Cardiol 1992;69:63-68.
4. Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, Belardi J, Sigwaart U, Colombo A, Goy JJ, van den Heuvel P, Delcan J, Morel M. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med 1994;331:489-495.
5. Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M. A randomized comparison of coronary stent placement and balloon angioplasty in the treatment of coronary artery disease. N Engl J Med 1994;331:496-501.
6. EPIC investigators. Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high risk coronary angioplasty. N Engl J Med 1994;330:956-961.
7. IMPACT II investigators. Randomised placebo-controlled trial of effect of eptifibitide on complications of percutaneous coronary intervention: IMPACT II. Lancet 1997;349:1422-1428.
8. CAPTURE investigators. Randomised placebo-controlled trial of abciximab before and during coronary intervention in refractory unstable angina: The CAPTURE study. Lancet 1997;349:1429-1435.
9. Brener SJ, Barr LA, Burchenal JEB, Katz S, George BS, Jones AA, Cohen ED, Gainey PC, White HJ, Cheek HB, Moses JW, Moliterno DJ, Effron MB, Topol EJ, RAPPORT investigators. Circulation 1998;98:734-741.
10. Schomig A, Neumann F-J, Kastrati A, Schuhlen H, Blasini R, Hadamitzky M, Walter H, Zitzmann-Roth E-M, Richardt G, Alt E, Schmitt C, Ulm K. A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents. N Engl J Med 1996;334:1084-1089.
11. EPILOG investigators. Platelet glycoprotein IIb/IIIa receptor blockade and low dose heparin during percutaneous coronary revascularization. N Engl J Med 1997;336:1689-1696.
12. EPISTENT investigators. Randomized placebo-controlled and balloon-angioplasty controlled trial to assess safety of coronary stenting with use of platelet glycoprotein IIb/IIIa blockade. Lancet 1998;352:87-92.
13. ESPRIT investigators. A randomised, placebo-controlled trial of a novel dosing regimen of eptifibatide in planned coronary stent implantation. Lancet 2000;356:2037-2044.
14. 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, for the PROLOG investigators. 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. Am J Cardiol 1997;79:286-291.
15. Turi ZG. Ooze you lose: Vascular closure in the IIb/IIIa inhibitor era. Cathet Cardiovasc Diagn 1999;47:148.
16. Cote AV, Berger PB, Holmes DR, Scott CG, Bell MR. Hemorrhagic and vascular complications after percutaneous coronary intervention with adjunctive abciximab. Mayo Clin Proc 2001;76:890-96.
17. Lincoff AM. Stent scrutiny. JAMA 2000;284:1839-1841.
18. Shrake KL. Comparison of major complication rates associated with four methods of arterial closure. Am J Cardiol 2000;85:1024-1025.
19. Baim DS, Knopf WD, Hinohara T, Schwarter DE, Schatz RA, Pinkerton CA, Cutlip DE, Fitzpatrick M, Ho KKL, Kuntz RE. Suture-mediated closure of the femoral access site after cardiac catheterization: Results of the suture to ambulate and discharge (STAND I and STAND II) trials. Am J Cardiol 2000;85:864-869.
20. Dangas G, Mehran R, Kokolis S, Feldman D, Satler LF, Pichard AD, Kent KM, Lansky AJ, Stone GW, Leon MB. Vascular complications after percutaneous coronary interventions following hemostasis with manual compresion versus arteriotomy closure devices. J Am Coll Cardiol 2001;38:638-641.
21. Chamberlin JR, Lardi AB, McKeever LS, Wang MH, Ramadurai G, Grunenwald P, Towne WP, Grassman ED, Leya FS, Lewis BE, Stein LH. Use of vascular sealing devices (VasoSeal and Perclose) versus assisted manual compression (Femostop) in transcatheter coronary interventions requiring abciximab (Reopro). Cathet Cardiovasc Intervent 1999;47:143-147.
22. Kahn ZM, Kumar M, Hollander G, Frankel R. Safety and efficacy of the Perclose device after diagnostic and interventional catheterizations in a large consecutive population. Cathet Cardiovasc Intervent 2002;55:1-7.
23. Carey D, Martin JR, Moore CA, Valentine MC, Nygaard TW. Complications of femoral artery closure devices. Cathet Cardiovasc Intervent 2001;52:3-7.
24. Pipkin W, Brophy C, Nesbit R, Mondy JS. Early experience with infectious complications of percutaneous femoral artery closure devices. J Vasc Surg 2000;32:205-208.
25. Duffin DC, Muhlestein JB, Allison SB, Home BD, Fowles RE, Sorenson SG, Revenaugh JR, Bair TL, Lappe DL. Femoral arterial puncture management after percutaenous coronary procedures: A comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invas Cardiol 2001;13:354-362.
26. Kim MH, Cha KW, Kim HJ, Kim SG, Kim JS. Primary stenting for acute myocardial infarction via the transradial approach: A safe and useful alternative to the transfemoral approach. J Invas Cardiol 2000;12:292-296.
27. George BS. Percutaneous radial approach: isn't it time we put it in its place? J Invas Cardiol 2000;12:297.
28. Brinker JA. Radial is not radical, but is it practical? Cathet Cardiovasc Intervent 2000;51:291-292.
29. Bovill EG, Terrin ML, Studm DC, Berke AD, Frederick M, Collen D, Feiit F, Gore JM, Hillis D, Lambrew CT, Leiboff R, Mann KG, Markis JE, Pratt CM, Sharkey SW, Sopko G, Tracey RP, Chesebro JH. Hemorrhagic events during therapy with recombinant tissue-type plasminogen activator. Ann Intern Med 1991;115:256-265.
30. Landefeld CS, Cook EF, Flatley M, Weisberg M, Goldman L. Identification and preliminary validation of predictors of major bleeding in hospitalized patients starting anticoagulant therapy. Am J Med 1987;82:703-771.
31. Friedman HZ, Cragg DR, Glazier SM, et al. Randomized prospective evaluation of prolonged versus abbreviated intravenous heparin therapy after coronary angioplasty. J Am Coll Cardiol 1994;24:1214-1219.
32. Blankenship JC, Hellkamp AS, Aguirre FV, Demko SL, Topol EJ, Califf RM, for the EPIC investigators. 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.
33. Mandak JS, Blankenship JC, Garner LH, Berkowitz SD, Aguirre FV, Sigmon KN, Timmis GC, Gilchrist IC, McIvor M, Talley JD, Weiner BH, George BS, Tcheng JE, Califf RM, Topol EJ. Modifiable risk factors for vascular access site complications in the IMPACT II trial of angioplasty with versus without eptifibitide. J Am Coll Cardiol 1998;31:1518-1524.
34. Rinder MR, Tamirisa PK, Taniuchi M, Kurz HI, Mumm K, Lasala JM. Safety and efficacy of suture-mediated closure after percutaneous coronary interventions. Cathet Cardiovasc Intervent 2001;54:146-151.
35. Amin FR, Yousufuddin M, Stables R, Shamin W, Al-Nasser F, Coats AJ, Clague J, Sigwart U. Femoral hemostasis after transcatheter therapeutic intervention: A prospective randomised study of the Angio-Seal device vs. the Femostop device. Int J Cardiol 2000;76:235-240.
36. Cox GS, Young JR, Gray BR, Grubb MW, Hertzer NR. Ultrasound-guided compression repair of postcatheterization pseudoaneurysms: Results of treatment of 100 cases. J Vasc Surg 1994;19:683-686.
37. Juran NB. Minimizing bleeding complications of percutaneous coronary intervention and glycoprotein IIb-IIIa antiplatelet therapy. Am Heart J 1999;138:S297-S306.
38. Bashore TM, Bates ER, Berger PB, Clark DA, Cusma JT, Dehmer GJ, Kern MJ, Laskey WK, O'Laughlin MP, Oesterle S, Popma JJ. Cardiac catheterization laboratory standards: A report of the American College of Cardiology Task Force on Clinical Expert Concensus Document. J Am Coll Cardiol 2001;37:2170-214.
39. Blankenship JC. Bleeding complications of glycoprotein IIb/IIIa receptor inhibitors. Am Heart J 1999;138:S287-S296.
40. Spector KS, Lawson WE. Optimizing safe femoral access during cardiac catheterization. Cathet Cardiovasc Intervent 2001;53:209-212.