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N Engl J Med. 2013 Jun 20;368(25):2377-84. doi: 10.1056/NEJMoa1114588.

Clopidogrel in infants with systemic-to-pulmonary-artery shunts.

Collaborators (573)

Trentadue J, Gutierrez D, Antoni D, Toledo R, Parodi WC, Guerrero R, Klinger D, Magliola R, Mazzucchelli MT, Moreno M, Bellani P, Couceiro C, Marantz P, Rosselot S, Benmaor L, Elorriaga MS, Peña G, Somoza F, Romero S, Barrea C, Sluysmans T, Nimbona G, Senga J, Moniotte S, Dessy H, Massin M, Milani SM, Mertens L, Gewillig M, Boshoff D, Eyskens B, De Wolf D, De Grote K, Panzer J, Santana MV, Miaiara MA, Santin J, Pontes SC Jr, Guerra AL, Dona TC, Paulista PP, Souza LC, Chaccur P, Pedra CA, Daudt NS, Horowitz E, Kozak MF, Kozak AC, Croti UA, Caneo LF, Afiune J, Succi FM, Hincapie MJ, Afiune CM, Diniz JD, de Faria GA, Pilla CB, Blacher C, Botta AM, Pereira CA, Luiz RO, Mulinari LA, Navarro F, Pimentel GK, Miyague N, Binotto C, Pelissari EC, Sandrini MK, Lenzi A, Maluf MA, Diógenes S, Carvalho AC, Stocco JC, Silva CM, Piante LS, Pereira CS, Trigueiro A, Pasqualucci P, Human D, Potts J, Kakadekar A, Koravangattu S, Chetaille P, Cote JM, Houde C, Delisle G, Jia B, Zhu B, Pan Y, Li S, Lv X, Luo Y, Zhang H, Zhuang J, Zeng R, Lei L, Shi C, Xie W, Wang JK, Wu MH, Hsieh KS, Lu WH, Sondergaard L, Reimers J, Helvind M, Shoeb MA, Desoky A, El Sayed MH, Moftah HM, Tynkkynen P, Sairanen H, Rautiainen P, Turanlahti M, Mildh L, Fraisse A, Blanc J, Metras D, Ghez O, Bonello B, Fouilloux V, Paoli F, Chantepie A, Poinsot J, Neuville P, Vaillant MC, Bergoend E, Michel-Behnke I, Billinger K, Berger F, Hacke P, Ewert P, Abedini M, Kanaan M, Yilmaz S, Paul T, Gravenhorst V, Dann G, Kramer HH, Hoffmann U, Reineker K, Entenmann A, Fischer G, Jung O, Dähnert I, Wörner C, Suchowerskyj P, Uhlemann F, Leischner K, Pross L, Kececioglu D, Schaeffler R, Kleideiter U, Fischer M, Kozlik-Feldmann R, Roemer U, Lang N, Nuebel J, Hess J, Balling G, de Winkel N, Cheung YF, Cheung EW, Cheng LC, Chau AK, Szatmari A, Ladanyi A, Rao N, Mannam G, Vyas S, Karmalkar M, Manohar K, Dharan BS, Sadiq A, Koneti NR, Swain S, Murthy KS, Koshy S, Anil S, Kurup R, Ranjit M, Kamath S, Gandhi D, Vanaki R, Kural V, Grover V, Gupta V, Agarwal R, Sekar R, Roy C, Rao S, Vaidyanathan B, Krishna K, Arun N, Supriya S, Xavier J, Bhat S, Joshi S, Sharma M, Suresh PV, Shah S, Mehta A, Manohari M, Rajappa S, Birk E, Berant M, Dagan T, Folgeman R, Bruckheimer E, Razon Y, Amir G, Tirosh N, Beer GB, Zuker N, Vidne BA, Frenkel G, Rotstein A, Stein R, De Zorzi A, Rinelli G, Brancaccio G, Padrini S, Carminati M, Micheletti A, Piazza L, Fesslova W, Rimini A, Pongiglione G, Pelegrini M, Frau F, Milanesi O, Maschietto N, Reffo E, Calabrò R, Russo MG, Caianello G, Morelli C, Ricci C, Palladino MT, Carrozza M, Esposito R, Picchio FM, Ragni L, Napoleone CP, Cameli D, Lee JR, Kwak JG, Park CS, Lee YO, Kandavello G, Radzi NA, Said RH, Maldonado R, Gutierrez M, Cruz DV, Roberto E, Hernández AB, Zabal C, Cervantes JL, Patiño EJ, García JA, Calderon J, Enríquez AJ, Miranda I, Ramirez S, Quibrera-Matienzo JA, Perez G, Palacios-Macedo A, Monroy E, Castañuelas V, Perez F, Tamariz O, Alarcón AV, Segura B, Bolio A, Garcia RM, Lozano A, Balderrabano N, Rodríguez-Hernández L, Lazo CC, Gonzalez J, Patiño Fde J, Dominguez CA, Helbing WA, Seem E, Holmstrom H, Birkeland S, Lindberg H, Kawalec W, Brodzikowska-Pytel A, Zuk M, Mirecka-Rola A, Werner B, Florianczyk T, Kucinska B, Sysa A, Ostrowska K, Jarosik P, Mazurek-Kula A, Bialkowski J, Baranowska A, Zeifert B, Chodor B, Fragata JI, Nogueira G, Trigo C, Abecasis LM, Anjos R, Ferreira R, Nogueira G, Areias JC, Baptista MJ, Gorbatykh Y, Sinelnikov Y, Leykekhmann A, Latypov A, Ivanov S, Krivoshchekov E, Volkova T, Kondratieva T, Yanulevich O, Shmakova N, Kulagina I, Kim A, Ryabtsev D, Rogova T, Lubomudrov V, Tsytko A, Duplyakov D, Goryachev V, Shorohov S, Kozeva I, Wong KY, Hong TT, Sriram S, Lawrenson J, De Decker R, Brown S, Bruwer AD, Harrisberg J, Karunagaran G, Cilliers A, Adams PE, Van Der Donck KM, Hoosen E, Nzimela A, López CM, Zunzunegui JL, Maroto E, Navarro N, Mora A, Riaño B, Moreno L, Vázquez Mdel C, Burgueros M, Guereta LG, Casares J, Merino C, Gómez E, Tejero MÁ, Cano A, Carrasco JI, Sanchez A, Núñez FR, Zavanella C, Marcos S, Sunnegardh J, Berggren H, Nygren A, Lundell B, Prakul C, Kritvikrom D, Kritvikrom D, Kanoknaphat C, Daubeney P, Slavik Z, Rowlinson G, Bu'lock F, Mathur S, Mulla H, Kudumula V, Raina S, Pateman A, Danton M, Richens T, Knight B, Weerasena NA, Blackburn M, Parry AJ, Martin R, Wilson D, Morgan G, Forsey J, Casey F, Murray J, Shah S, Morrison L, Boshkov LK, Martchenke J, Reller M, Hoffman TM, Schwartz R, Feltes T, Justino H, Ocampo E, Jefferies JL, Jones K, Ing F, Nugent A, Petit C, Fraser C, McVey S, Dinu B, Kay JD, Ivy D, Da Cruz E, O'Brien JE, Lofland GK, Swihart J, Tarrants M, Patel H, Newkumet K, Culbertson C, Reinhartz O, Pizarro C, Derby C, Rome JJ, Ravishankar C, Anderson T, Gleason M, Natrajan S, Rosenthal DN, Shin A, Roth S, Poole R, Tran M, Sullivan JE, Mascio CE, Austin E, Condurache C, Myers A, Recto M, Suttner D, Frazer J, Lane B, Knight G, Teitel DF, Moore P, Tacy T, Aluquin V, Stokes J, Sturgis S, Johnson G, Watts H, Myers J, McMonagle A, Clark J, Jones J, Manbachi R, Porter P, Shaner M, Van Bergen A, Husayni T, Nguyen N, Sajan I, Thompson JA, Callahan P, Charpie JR, Armstrong AK, Gajarski RJ, Aiyagari R, Covitz W, Cnota JF, Crawford K, Dobrolet NC, Nieves JA, Forbus GA, Atz A, Huhta J, Sieasman JW, Emmanuel PJ, Quintessenza J, Chai P, Jacobs J, Lizarralde J, Boston U, Myers JL, Lutterman J, Gilbert C, Cabrera A, Mathis C, Tugertimur A, Nykanen DG, Camitta MG, Anderson P, Rhodes J, Li J, Barker P, Miller S, Milazzo A, Scholz T, Pardini B, Pierick T, Mahle WT, Simsic J, Kanter K, Kirshbom P, Kogon B, Bajaj T, Huckaby J, Pugsley L, Spainhour C, Dieleman L, Jensen D, Giannopoulos H, Wilkey S, Lamphier C, Rhodes J, Dukes SA, Bond J, Siu B, Schutte D, Turner D, Walters H, Delius R, McGivern J, Sullivan N, Storie K, Kennedy K, Forbes T, Srinath G, Kumar A, Parikh S, Berger JT, Cross RR, Heath DM, Odegard K, Jenkins K, DiNardo J, Connor J, Maltz L, Taylor M, Christian KG, Liske MR, Shalaby TM, Arnold JM, Leizorovicz A, Danielson L, Michelson A, Sanders SS, Wessel DL, Berger F, Brown S, Feltes T, Fraisse A, Li JS, Medrano C, Mertens L, Mulinari LA, Palacios-Macedo A, Newburger JW, Rao S, Newburger JW, Berger F, Brown S, Dunbar-Masterson C, Feltes T, Fraisse A, Geva J, Medrano C, Mertens L, Mulinari LA, Palacios-Macedo A, Rao S.

Author information

  • 1Children's National Medical Center, Washington, DC 20010, USA. dwessel@childrensnational.org

Abstract

BACKGROUND:

Infants with cyanotic congenital heart disease palliated with placement of a systemic-to-pulmonary-artery shunt are at risk for shunt thrombosis and death. We investigated whether the addition of clopidogrel to conventional therapy reduces mortality from any cause and morbidity related to the shunt.

METHODS:

In a multicenter, double-blind, event-driven trial, we randomly assigned infants 92 days of age or younger with cyanotic congenital heart disease and a systemic-to-pulmonary-artery shunt to receive clopidogrel at a dose of 0.2 mg per kilogram of body weight per day (467 infants) or placebo (439 infants), in addition to conventional therapy (including aspirin in 87.9% of infants). The primary efficacy end point was a composite of death or heart transplantation, shunt thrombosis, or performance of a cardiac procedure due to an event considered to be thrombotic in nature before 120 days of age.

RESULTS:

The rate of the composite primary end point did not differ significantly between the clopidogrel group (19.1%) and the placebo group (20.5%) (absolute risk difference, 1.4 percentage points; relative risk reduction with clopidogrel, 11.1%; 95% confidence interval, -19.2 to 33.6; P=0.43), nor did the rates of the three components of the composite primary end point. There was no significant benefit of clopidogrel treatment in any subgroup, including subgroups defined by shunt type. Clopidogrel recipients and placebo recipients had similar rates of overall bleeding (18.8% and 20.2%, respectively) and severe bleeding (4.1% and 3.4%, respectively).

CONCLUSIONS:

Clopidogrel therapy in infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary-artery shunt, most of whom received concomitant aspirin therapy, did not reduce either mortality from any cause or shunt-related morbidity. (Funded by Sanofi-Aventis and Bristol-Myers Squibb; ClinicalTrials.gov number, NCT00396877.).

PMID:
23782178
[PubMed - indexed for MEDLINE]
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