PMID- 28506937
OWN - NLM
STAT- MEDLINE
DCOM- 20180522
LR  - 20180522
IS  - 1969-6213 (Electronic)
IS  - 1774-024X (Linking)
VI  - 13
IP  - 5
DP  - 2017 Aug 4
TI  - Bivalirudin infusion to reduce ventricular infarction: the open-label, randomised 
      Bivalirudin Infusion for Ventricular InfArction Limitation (BIVAL) study.
PG  - e540-e548
LID - EIJ-D-17-00307 [pii]
LID - 10.4244/EIJ-D-17-00307 [doi]
AB  - AIMS: The aim of the study was to investigate whether bivalirudin versus 
      unfractionated heparin (UFH) reduces infarct size (IS) for primary percutaneous 
      coronary intervention (PPCI) in large acute myocardial infarction (AMI). METHODS 
      AND RESULTS: This multicentre open-label trial randomised 78 patients undergoing 
      PPCI for large AMI to bivalirudin or UFH. The primary endpoint was IS, assessed 
      by cardiac magnetic resonance (CMR) five days after PPCI. Secondary endpoints 
      included index of microcirculatory resistance (IMR), CMR-assessed microvascular 
      obstruction (MVO) and ejection fraction, and biomarkers for thrombin activity and 
      cell injury. No difference was observed in mean IS at five days (25.0+/-19.7 g for 
      bivalirudin vs. 27.1+/-20.7 g for UFH; p=0.75). Early MVO was numerically lower 
      with bivalirudin (5.3+/-5.8 g vs. 7.7+/-6.3 g; p=0.17), with no significant 
      difference in ejection fraction at 90 days (54.6+/-12.0% vs. 49.1+/-12.1%; p=0.11). 
      In the biomarkers, thrombin-antithrombin complexes were reduced by 4.8 ug/L over 
      the first day for bivalirudin versus an increase of 1.9 ug/L in the heparin arm 
      (p=0.0003). Acute IMR was lower (43.5+/-21.6 vs. 68.7+/-35.8 mmHgxs, respectively; 
      p=0.014). In a planned interim analysis, an approximate 11% reduction in IS was 
      observed with bivalirudin; the trial was discontinued for futility. CONCLUSIONS: 
      This study did not achieve its primary endpoint of significant infarct size 
      reduction in PPCI by prolonged bivalirudin infusion compared to UFH, even though 
      complete thrombin inhibition was achieved in the acute phase, with a lower 
      myocardial microcirculation resistance at the end of the procedure.
FAU - van Geuns, Robert Jan
AU  - van Geuns RJ
AD  - Erasmus MC, Rotterdam, the Netherlands.
FAU - Sideris, Georgios
AU  - Sideris G
FAU - Van Royen, Niels
AU  - Van Royen N
FAU - El Mahmoud, Rami
AU  - El Mahmoud R
FAU - Diletti, Roberto
AU  - Diletti R
FAU - Bal Dit Sollier, Claire
AU  - Bal Dit Sollier C
FAU - Garot, Jerome
AU  - Garot J
FAU - Van Der Hoeven, Nina W
AU  - Van Der Hoeven NW
FAU - Cortese, Bernardo
AU  - Cortese B
FAU - Ding, Li
AU  - Ding L
FAU - Lechthaler, Ilknur
AU  - Lechthaler I
FAU - Deliargyris, Efthymios N
AU  - Deliargyris EN
FAU - Anthopoulos, Prodromos
AU  - Anthopoulos P
FAU - Drouet, Ludovic
AU  - Drouet L
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20170804
PL  - France
TA  - EuroIntervention
JT  - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on 
      Interventional Cardiology of the European Society of Cardiology
JID - 101251040
RN  - 0 (Anticoagulants)
RN  - 0 (Antithrombins)
RN  - 0 (Hirudins)
RN  - 0 (Peptide Fragments)
RN  - 0 (Platelet Aggregation Inhibitors)
RN  - 0 (Recombinant Proteins)
RN  - 9005-49-6 (Heparin)
RN  - TN9BEX005G (bivalirudin)
SB  - IM
MH  - Aged
MH  - Anticoagulants/therapeutic use
MH  - Antithrombins/*therapeutic use
MH  - Female
MH  - Heart Ventricles/*drug effects/physiopathology
MH  - Heparin/therapeutic use
MH  - Hirudins
MH  - Humans
MH  - Infarction/*drug therapy
MH  - Male
MH  - Microcirculation/drug effects
MH  - Middle Aged
MH  - Myocardial Infarction/drug therapy
MH  - Peptide Fragments/*therapeutic use
MH  - Percutaneous Coronary Intervention/methods
MH  - Platelet Aggregation Inhibitors/*therapeutic use
MH  - Recombinant Proteins/therapeutic use
MH  - Treatment Outcome
EDAT- 2017/05/17 06:00
MHDA- 2018/05/23 06:00
CRDT- 2017/05/17 06:00
PHST- 2017/05/17 06:00 [pubmed]
PHST- 2018/05/23 06:00 [medline]
PHST- 2017/05/17 06:00 [entrez]
AID - EIJ-D-17-00307 [pii]
AID - 10.4244/EIJ-D-17-00307 [doi]
PST - epublish
SO  - EuroIntervention. 2017 Aug 4;13(5):e540-e548. doi: 10.4244/EIJ-D-17-00307.