Randomized multicenter comparison of conventional anticoagulation versus antiplatelet therapy in unplanned and elective coronary stenting. The full anticoagulation versus aspirin and ticlopidine (fantastic) study.
Bertrand, M. E.; Legrand, Victor; Boland, J.et al.
[en] BACKGROUND: Dual therapy with ticlopidine and aspirin has been shown to be as effective as or more effective than conventional anticoagulation in patients with an optimal result after implantation of intracoronary metallic stents. However, the safety and efficacy of antiplatelet therapy alone in an unselected population has not been evaluated. METHODS: Patients were randomized to conventional anticoagulation or to treatment with antiplatelet therapy alone. Indications for stenting were classified as elective (decided before the procedure) or unplanned (to salvage failed angioplasty or to optimize the results of balloon angioplasty). After stenting, patients received aspirin and either ticlopidine or conventional anticoagulation (heparin or oral anticoagulant). The primary end point was the occurrence of bleeding or peripheral vascular complications; secondary end points were cardiac events (death, infarction, or stent occlusion) and duration of hospitalization. RESULTS: In 13 centers, 236 patients were randomized to anticoagulation and 249 to antiplatelet therapy. Stenting was elective in 58% of patients and unplanned in 42%. Stent implantation was successfully achieved in 99% of patients. A primary end point occurred in 33 patients (13.5%) in the antiplatelet group and 48 patients (21%) in the anticoagulation group (odds ratio=0.6 [95% CI 0.36 to 0.98], P=0.03). Major cardiac-related events in electively stented patients were less common (odds ratio=0.23 [95% CI 0.05 to 0.91], P=0.01) in the antiplatelet group (3 of 123, 2.4%) than the anticoagulation group (11 of 111, 9.9%). Hospital stay was significantly shorter in the antiplatelet group (4.3+/-3.6 versus 6. 4+/-3.7 days, P=0.0001). CONCLUSIONS: Antiplatelet therapy after coronary stenting significantly reduced rates of bleeding and subacute stent occlusion compared with conventional anticoagulation.
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Bertrand, M. E.
Legrand, Victor ; Université de Liège - ULiège > Département des sciences cliniques > Cardiologie
Randomized multicenter comparison of conventional anticoagulation versus antiplatelet therapy in unplanned and elective coronary stenting. The full anticoagulation versus aspirin and ticlopidine (fantastic) study.
Publication date :
1998
Journal title :
Circulation
ISSN :
0009-7322
eISSN :
1524-4539
Publisher :
Lippincott Williams & Wilkins, United States - Maryland
Fischman DL, Leon MB, Bairn DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, Cleman M, Heuser R, Almond D, Teirstein P, Fish RD, Colombo A, Brinker J, Moses J, Shaknovich A, Hirschfeld J, Bailey S, Ellis S, Rake R, Goldberg S. 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.
Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emmanuelson H, Marco J, Legrand V, Materne P, Belardi J, Sigwart U, Colombo A, Goy JJ, van den Heuvel P, Delcan J, Morel MA. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med. 1994;331:489-495.
Colombo A, Hall P, Nakamura S, Almagor Y, Maiello L, Martini G, Gaglione A, Goldberg S, Tobis JM. Intracoronary stenting without anticoagulation accomplished with intravascular ultrasound guidance. Circulation. 1995;91:1676-1688.
Nakamura S, Hall P, Gaglione A, Tiecco F, Di Maggio M, Maiello L, Martini G, Colombo A. High pressure assisted coronary stent implantation accomplished without intravascular ultrasound guidance and subsequent anticoagulation. J Am Coll Cardiol. 1997;29:21-27.
Barragan P, Sainsous JB, Silvestri MA, Bouvier JL, Comet B, Simeoni JB, Charmasson C, Bremondy M. Ticlopidine and subcutaneous heparin as an alternative regimen following coronary stenting. Cathet Cardiovasc Diagn. 1994;32:133-138.
Ryan TJ, Baumann WB, Kennedy JW, Kereiakes DJ, King SP III, McCallister BD, Smith SC, Ullyot DJ. Guidelines for percutaneous transluminal coronary angioplasty: a report of the American Heart Association/American College of Cardiology task force on assessment of diagnostic and therapeutic cardiovascular procedures. Circulation. 1993;88: 2987-3007.
Hasdai D, Garratt KN, Holmes DR Jr, Berger P, Schwarz RS, Bell MR. Coronary angioplasty and intracoronary thrombolytics are of limited value in resolving early intracoronary stent thrombosis. J Am Coll Cardiol. 1996;28:361-367.
Mak K-H, Belli G, Ellis SG, Moliterno DJ. Subacute stent thrombosis: evolving issues and current concepts. J Am Coll Cardiol. 1996;27: 494-504.
Schömig A, Neumann FJ, Kastrati A, Schulen H, Blasini R, Hadamitzky M, Walter H, Zitzmann-Roth EM, 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.
Leon MB, Bairn DS, Gordon P, Giambotolomei A, Williams D, Diver DD, Senerchia C, Fitzpatrick M, Popma J, Kuntz RE. Clinical and angiographic results from the Stent Anticoagulation Regimen Study (STARS). Circulation. 1996;94(suppl I):I-685. Abstract.
Herrmann HC, Buchbinder M, Clemen MW, Fishman D, Goldberg S, Leon MB, Schatz RA, Tierstein P, Walker CM, Hirshfeld JW Jr. Emergent use of balloon-expandable coronary artery stenting for failed percutaneous transluminal coronary angioplasty. Circulation. 1992;86: 812-819.
Hall P, Nakamura S, Maiello L, Itoh A, Blengino S, Martini G, Ferraro M, Colombo A. A randomized comparison of combined ticlopidine and aspirin therapy versus aspirin therapy alone after successful intravascular ultrasound-guided stent implantation. Circulation. 1996;93: 215-222.
McTavish D, Faulds D, Goa KL. Ticlopidine: an updated review of its pharmacology and therapeutic use in platelet dependent disorders. Drugs. 1990;40:238-259.
Gregorini L, Marco J, Fajadet J, Bernies M, Cassagneau B, Brunel P, Bossi IM, Mannucci PM. Ticlopidine and aspirin pretreatment reduces coagulation and platelet activation during coronary dilation procedures. J Am Coll Cardiol. 1997;29:13-20.
