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JAMA. 2010 Sep 22;304(12):1339-49. doi: 10.1001/jama.2010.1320. Epub 2010 Aug 31.

Low-dose vs standard-dose unfractionated heparin for percutaneous coronary intervention in acute coronary syndromes treated with fondaparinux: the FUTURA/OASIS-8 randomized trial.

Collaborators (378)

Yusuf S, Steg PG, Jolly SS, Mehta SR, Diaz R, Avezum A, Widimsky P, Rupprecht HJ, Granger C, López-Sendón JL, Diaz R, Avezum A, Piegas LS, Bertrand O, Chrolavicius S, Eikelboom J, Jolly SS, Joyner C, Tanguay JF, Mehta S, Yusuf S, Widimsky P, Steg PG, Rupprecht HJ, Karatzas N, Keltai M, Xavier D, Di Pasquale G, Franzosi MG, ten Berg JM, Budaj A, Ruda M, Kim JH, López-Sendón JL, Uren N, Boden WE, Faxon D, Granger CB, Rao SV, Avezum, Piegas, Widimsky, Steg, Karatzas, Keltai, Budaj, Cannon CP, Anderson JL, DeMets D, Bassand JP, Weitz JL, King SB 3rd, Joyner C, Cohen EA, Czepiel A, Fodor G, Himbert D, Kalvach P, Massaro A, Radhakrishnan S, Sorokin E, Turazza F, Avezum, Piegas, Widimsky, Steg, Karatzas, Keltai, Budaj, Chrolavicius S, Meeks B, Lawrence M, Holmes E, Blake L, Pogue J, Afzal R, Yuan F, Gao P, Yang X, Laing S, Alvarez CA, Bassi F, Casali WP, Forti L, Gonzalez MA, Hasbani EG, Hominal MA, Hrabar AD, Licheri AJ, Macín SM, Meiriño A, Prado AD, Quiroga AR, Schygiel PO, Vega MM, Zapata GO, Andrade PB, Ardito WR, Costantini CR, Da Silva G, Dutra O, Furtado MV, Kormann A, Labrunie A, Maia LN, Manenti ER, Précoma DB, Rech RL, Saraiva JF, Doganov A, Draganov TI, Goranov GS, Grigorov GV, Manukov IH, Mazhdrakov GB, Petrov I, Velchev V, Bertrand OF, Brons S, Cieza TA, Goodhart DM, Kostuk W, Mehta SR, Radhakrishnan S, Zavitz MB, Bernat I, Cervinka P, Coufal Z, Herman J, Janota T, Kocka V, Malik J, Padour M, Pechman V, Vojacek J, Abergel H, Bonnet JL, Cattan SP, Champagne S, Cottin Y, de Labriolle A, Ducrocq G, Elbaz M, Esteve JB, Godin M, Grollier G, Lhermusier T, Lorgis L, Meneveau N, Quilici J, Schiele F, Teiger E, Tron C, Appel KF, Auer J, Blank RT, Bott MC, Buerke M, Butter C, Flachskampf FA, Gärtner S, Gauss S, Genth-Zotz S, Giannitsis E, Guenesli A, Hambrecht R, Haude M, Heissler S, Hoffmann S, Horacek T, Joost A, Kiehl C, Konstantinides S, Kruells-Muench J, Kulzer M, Lapp H, Lenk R, Menck N, Mittag M, Möbius-Winkler S, Möckel M, Nickenig G, Nienaber CA, Niethammer M, Radke PW, Schlitt A, Schmidt AE, Schroeter MR, Searle J, Stempfle HU, Strasser RH, Uhlemann M, Utech A, vom Dahl J, Werner N, Wittlinger T, Zotz RJ, Alexopoulos D, Demerouti E, Dimakouleas P, Georgiadou P, Georgopoulos GE, Goudevenos I, Iakovou I, Kremastinos D, Lazaris E, Mavronasiou E, Papachristidis A, Sbarouni E, Stefanadis C, Tsioufis C, Andreka P, Apró D, Csapó K, Csengo E, Edes I, Fogarassy G, Fontos G, Horváth I, Jambrik Z, Lupkovics G, Merkely B, Nagybaczoni B, Banker DN, Baxi HA, Behal S, Bhalani NC, Chandwani P, Deb S, Deshpande NV, Garipalli R, Hiremath JS, Jadhav MS, Kapoor VR, Kumar PR, Kumar S, Mahorkar UK, Mardikar HM, Mohanty A, Mutkure MR, Parikh KH, Patel TM, Patil CB, Pinto BO, Rao AM, Sawhney JP, Sethi S, Shah SC, Sinha N, Varghese K, Baduena L, Bovenzi F, Calabrese D, Campo G, Cavallini C, Chiodelli R, De Luca G, Lettino M, Morocutti G, Pantano P, Pier Camillo P, Pirelli S, Potenza A, Salvioni A, Terrosu P, Tomasi L, Uneddu F, Valgimigli M, Zanini R, Hersbach FM, Krasznai K, Michels HR, Rost IM, Smits PC, van der Ven J, Buszman PE, Dalkowski M, Dudek D, Jarzabek K, Jaworska K, Kardaszewicz P, Kokowicz P, Kopaczewski J, Kosior J, Kuklinska AM, Lenartowska L, Lewczuk J, Maciejewski P, Miekus P, Musial WY, Nowak T, Przewlocki T, Rynkiewicz A, Rzeszutko L, Starczewski PP, Szczeponek P, Szelemej R, Tracz W, Wlodarczak A, Wlodarczyk A, Wrzosek B, Zieba B, Zinka E, Berns SA, Boldueva S, Glebovskaya TD, Gordeev IG, Gruzdev A, Jukova N, Kalugina OA, Kokorin VA, Kruderg LK, Kruderg LK, Lapin OM, Markov VA, Osiev AG, Pershukov I, Popov NN, Shlyakhto EV, Staroverov I, Staroverov I, Syrkina AG, Vasilieva EU, Vorobyeva II, Zayashnikov SV, Zykov MV, Bae JH, Chae JK, Cho JM, Choe KH, Chung JW, Ha SI, Hong YJ, Jeong MH, Kim YK, Kim MH, Kim CJ, Kim SK, Kim YS, Kim JY, Ko JK, Kwon TG, Lee SH, Lee SW, Lee JU, Park SW, Pyun WB, Seo HS, Shin GJ, Song YB, Alvarez S, Barrio Nebreda MV, Bethencourt González A, Diego Nieto A, Domínguez A, Elorriaga AS, Fernandez-Vazquez F, Garcia-Rubira JC, Hernandez-Antolin RA, Hernández JM, Lopez-Otero D, Mainar V, Martin-Reyes R, Moreno R, Palacios JL, Rada I, Romo IA, Souto-Castro P, Balmain S, Baumbach A, Brown S, Forbes J, Gudmundsdottir I, Irving J, Kesavan S, Lim P, Banerjee S, Prashad R.

Abstract

CONTEXT:

The optimal unfractionated heparin regimen for percutaneous coronary intervention (PCI) in patients with non-ST-segment elevation acute coronary syndromes treated with fondaparinux is uncertain.

OBJECTIVE:

To compare the safety of 2 unfractionated heparin regimens during PCI in high-risk patients with non-ST-segment elevation acute coronary syndromes initially treated with fondaparinux.

DESIGN, SETTING, AND PARTICIPANTS:

Double-blind randomized parallel-group trial in 179 hospitals in 18 countries involving 2026 patients undergoing PCI within 72 hours, nested within a cohort of 3235 high-risk patients with non-ST-segment elevation acute coronary syndromes initially treated with fondaparinux enrolled from February 2009 to March 2010.

INTERVENTIONS:

Patients received intravenously either low-dose unfractionated heparin, 50 U/kg, regardless of use of glycoprotein IIb/IIIa (GpIIb-IIIa) inhibitors or standard-dose unfractionated heparin, 85 U/kg (60 U/kg with GpIIb-IIIa inhibitors), adjusted by blinded activated clotting time (ACT).

MAIN OUTCOME MEASURES:

Composite of major bleeding, minor bleeding, or major vascular access-site complications up to 48 hours after PCI. Key secondary outcomes include composite of major bleeding at 48 hours with death, myocardial infarction, or target vessel revascularization within day 30.

RESULTS:

The primary outcome occurred in 4.7% of those in the low-dose group vs 5.8% in the standard-dose group (odds ratio [OR], 0.80; 95% confidence interval [CI], 0.54-1.19; P = .27). The rates of major bleeding were not different but the rates of minor bleeding were lower with 0.7% in the low-dose group vs 1.7% in the standard-dose group (OR, 0.40; 95% CI, 0.16-0.97; P = .04). For the key secondary outcome, the rates for low-dose group were 5.8% vs 3.9% in the standard-dose group (OR, 1.51; 95% CI, 1.00-2.28; P = .05) and for death, myocardial infarction, or target vessel revascularization it was 4.5% for the low-dose group vs 2.9% for the standard-dose group (OR, 1.58; 95% CI, 0.98-2.53; P = .06). Catheter thrombus rates were very low (0.5% in the low-dose group and 0.1% in the standard-dose group, P = .15).

CONCLUSION:

Low-dose compared with standard-dose unfractionated heparin did not reduce major peri-PCI bleeding and vascular access-site complications.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT00790907.

PMID:
20805623
DOI:
10.1001/jama.2010.1320
[Indexed for MEDLINE]

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