PMID- 23182947
OWN - NLM
STAT- MEDLINE
DCOM- 20130830
LR  - 20151119
IS  - 1969-6213 (Electronic)
IS  - 1774-024X (Linking)
VI  - 8
IP  - 9
DP  - 2013 Jan 22
TI  - A randomised study of dabigatran in elective percutaneous coronary intervention 
      in stable coronary artery disease patients.
PG  - 1052-60
LID - 20120717-08 [pii]
LID - 10.4244/EIJV8I9A162 [doi]
AB  - AIMS: Patients receiving long-term anticoagulant treatment with dabigatran may 
      need to undergo a percutaneous coronary intervention (PCI). We studied markers of 
      coagulation activation during elective PCI in patients using dabigatran in order 
      to investigate whether coagulation activation upon balloon inflation and stenting 
      is suppressed by dabigatran without additional heparin treatment. METHODS AND 
      RESULTS: This phase IIa, exploratory, multicentre, randomised, open-label study 
      included 50 stable patients having an elective PCI. Patients on standard dual 
      antiplatelet therapy (DAPT) were randomised (2:2:1) to either pre-procedural 
      dabigatran 110 mg BID (n=19) or 150 mg BID (n=21), as compared to standard 
      intraprocedural unfractionated heparin (UFH) (n=10). Following PCI, a significant 
      increase in the levels of prothrombin fragment 1+2 (F1+2) in the combined 
      dabigatran group was observed compared to the level just before the start of PCI 
      (159.1 [1.4] pmol/l; geometric mean [gSD]). Levels at 0.5, 1.0, 1.5 and 2 hrs 
      after the start of PCI ranged from 193.5 (1.4) to 270.6 pmol/l (1.7); (p-value 
      for paired analysis=0.015, 0.022, 0.2342, 0.0379, respectively). Also, 
      thrombin-antithrombin (TAT) complexes were increased significantly in the 
      combined dabigatran group compared to pre-PCI levels (4.2 [2.2] ug/l). Levels 
      ranged from 5.2 (2.5) to 8.5 (2.3) (p=0.0497, 0.0343, 0.005 and 0.1628, 
      respectively). In contrast, in the control group of patients treated with UFH, no 
      increase was observed in F1+2 and TAT complexes during PCI. Five out of 40 
      (12.5%) patients required bail-out anticoagulation in the dabigatran group, of 
      whom four experienced a procedural myocardial infarction (MI), versus one out of 
      10 in the UFH group, who had a stent thrombosis without MI prior to the 
      study-PCI. One minor access-site bleeding occurred in the dabigatran group. 
      CONCLUSIONS: Dabigatran treatment (110 mg or 150 mg BID) may not provide 
      sufficient anticoagulation during PCI. EudraCT. No: 2007-007536-25.
FAU - Vranckx, Pascal
AU  - Vranckx P
AD  - Department of Cardiac Intensive Care & Interventional Cardiology, Hartcentrum, 
      Hasselt, Belgium.
FAU - Verheugt, Freek W A
AU  - Verheugt FW
FAU - de Maat, Moniek P
AU  - de Maat MP
FAU - Ulmans, Victor A W M
AU  - Ulmans VA
FAU - Regar, Evelyn
AU  - Regar E
FAU - Smits, Peter
AU  - Smits P
FAU - ten Berg, Jurrien M
AU  - ten Berg JM
FAU - Lindeboom, Wietze
AU  - Lindeboom W
FAU - Jones, Russel L
AU  - Jones RL
FAU - Friedman, Jeffrey
AU  - Friedman J
FAU - Reilly, Paul
AU  - Reilly P
FAU - Leebeek, Frank W G
AU  - Leebeek FW
LA  - eng
SI  - ClinicalTrials.gov/NCT00818753
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
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 (Antithrombins)
RN  - 0 (Benzimidazoles)
RN  - 0 (Pyridines)
RN  - I0VM4M70GC (Dabigatran)
SB  - IM
MH  - Administration, Oral
MH  - Aged
MH  - Antithrombins/administration & dosage/pharmacology/*therapeutic use
MH  - Benzimidazoles/administration & dosage/pharmacology/*therapeutic use
MH  - Blood Coagulation/drug effects
MH  - Coronary Artery Disease/*therapy
MH  - Coronary Thrombosis/*prevention & control
MH  - Dabigatran
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Percutaneous Coronary Intervention/*methods
MH  - Pyridines/administration & dosage/pharmacology/*therapeutic use
MH  - Treatment Outcome
EDAT- 2012/11/28 06:00
MHDA- 2013/08/31 06:00
CRDT- 2012/11/28 06:00
PHST- 2012/11/28 06:00 [entrez]
PHST- 2012/11/28 06:00 [pubmed]
PHST- 2013/08/31 06:00 [medline]
AID - 20120717-08 [pii]
AID - 10.4244/EIJV8I9A162 [doi]
PST - ppublish
SO  - EuroIntervention. 2013 Jan 22;8(9):1052-60. doi: 10.4244/EIJV8I9A162.