Effect of 48-h intravenous trimetazidine on short- and long-term outcomes of patients with acute myocardial infarction, with and without thrombolytictherapy - A double-blind, placebo-controlled, randomized trial
F. Aldor,erd,gaul,kuhn,leisch,lenzhofer,mlczoch,peschorn,tiso,block,balthazar,beys,bladt,bruyneel,debacker,derbaudrenghien,dierickx,elallaf,fautsch,francois,henuzet,kornitzer,leone,prihadi,renard,tremblay,cagan,dvorak,heinc,jirmar,kana,klapal,lupinek,pidrman,rybka,semrad,smid,spinar,svitil,zeman,hardt,horgan,o'Callaghan,sullivan,taaffe,walsh,aalto,eloranta,hussi,kala,kohvakka,korpilahti,koskelainen,lindstrom,linna,pietila,raasakka,saari,saarinen,savola,aboukhalil,adams,aliot,andre,apffel,baradat,barreau,basin,bassand,baudet,baudier,bayo,beaufils,beltran,"ben Ahmed",bergere,berthou,berzin,bessede,blanc,bollaert,bolte,boschat,boulenc,boumal,bourdon,bouthillier,bragrad,"brandt, Cm",brehier,cami,carette,cattan,cavallaro,cazaugade,chassevent,chareyre,chaussinand,choux,citron,coisne,colin,combe,convert,cornaert,cornuau,cotel,coudray,damiani,daubeze,dechamboux,degand,delabrouille,dellinger,deluze,demarcq,dennetiere,dewilde,dickele,d'Hautefeuille,d'Ivernois,dreyfuss,dubois,duc,dujardin,dulhoste,elaerts,elattare,fadel,fagart,faitg,fernandez,fruchaud,funck,gabrielle,gaillemin,gallel,galley,galloux,gateau,gauthier,gerin,geslin,godin,goldstein,gottwalles,goralski,grollier,guerin,guignon,guillemin,gully,guy,hannebicque,heiligenstein,hertault,hiltger,jacques,janin-manificat,jarry,joussen,julien,julliard,katz,ketelers,khalife,lafont,lagorce,landas,lanfranchi,lapandry,lapeysonnie,larque,larroque,lassabe,lemetayer,lepine,"leroy et al., Effect of 48-h intravenous trimetazidine on short- and long-term outcomes of patients with acute myocardial infarction, with and without thrombolytictherapy - A double-blind, placebo-controlled, randomized trial, EUR HEART J, 21(18), 2000, pp. 1537-1546
Aims To compare the effect of trimetazidine (TMZ) versus placebo administer
ed during the acute phase of myocardial infarction on long- and short-term
mortality.
Methods and Results EMIP-FR (European Myocardial Infarction Project-Free Ra
dicals) was a prospective, double-blind, European multicentre trial in whic
h 19 725 patients, presenting symptoms of acute myocardial infarction withi
n the previous 24 h were randomized. Stratification was according to thromb
olytic therapy (56%) or not (44%). An intravenous bolus injection of trimet
azidine (40 mg) was given just before or simultaneously with thrombolysis,
followed by continuous infusion (60 mg . 24 h(-1)) for 48 h. Overall, no di
fference was found between trimetazidine and placebo for the main end-point
, short-term (35-day) mortality, (P=0.98) in an intention-to-treat analysis
. This was the result of opposing trends in the two strata. Thrombolysed pa
tients showed a tendency towards more short-term deaths with trimetazidine,
compared to placebo (trimetazidine: 11.3%, placebo: 10.5%, P=0.15) and non
-thrombolysed patients the converse (trimetazidine: 14.0%, placebo: 15.1%,
P=0.14). In a perprotocol analysis the beneficial effect of trimetazidine f
ar non-thrombolysed patients became statistically significant (trimetazidin
e: 13.3%, placebo: 15.1%, P=0.027).
Conclusion Trimetazidine does not reduce mortality in patients undergoing t
hrombolytic therapy; however, it might have some beneficial effect for non-
thrombolysed patients. (Eur Heart J 2000; 21: 1537-1546) (C) 2000 The Europ
ean Society of Cardiology.