PMID- 25925992
OWN - NLM
STAT- MEDLINE
DCOM- 20160614
LR  - 20200225
IS  - 2567-689X (Electronic)
IS  - 0340-6245 (Print)
IS  - 0340-6245 (Linking)
VI  - 114
IP  - 2
DP  - 2015 Aug
TI  - Peri-procedural use of rivaroxaban in elective percutaneous coronary intervention 
      to treat stable coronary artery disease. The X-PLORER trial.
PG  - 258-67
LID - 10.1160/TH15-01-0061 [doi]
AB  - Patients on rivaroxaban requiring percutaneous coronary intervention (PCI) 
      represent a clinical conundrum. We aimed to investigate whether rivaroxaban, with 
      or without an additional bolus of unfractionated heparin (UFH), effectively 
      inhibits coagulation activation during PCI. Stable patients (n=108) undergoing 
      elective PCI and on stable dual antiplatelet therapy were randomised (2:2:2:1) to 
      a short treatment course of rivaroxaban 10 mg (n=30), rivaroxaban 20 mg (n=32), 
      rivaroxaban 10 mg plus UFH (n=30) or standard peri-procedural UFH (n=16). Blood 
      samples for markers of thrombin generation and coagulation activation were drawn 
      prior to and at 0, 0.5, 2, 6-8 and 48 hours (h) after start of PCI. In patients 
      treated with rivaroxaban (10 or 20 mg) and patients treated with rivaroxaban plus 
      heparin, the levels of prothrombin fragment 1 + 2 at 2 h post-PCI were 0.16 [0.1] 
      nmol/l (median) [interquartile range, IQR] and 0.17 [0.2] nmol/l, respectively. 
      Thrombin-antithrombin complex values at 2 h post-PCI were 3.90 [6.8]microg/l and 3.90 
      [10.1] microg/l, respectively, remaining below the upper reference limit (URL) after 
      PCI and stenting. This was comparable to the control group of UFH treatment 
      alone. However, median values for thrombin-antithrombin complex passed above the 
      URL with increasing tendency, starting at 2 h post-PCI in the UFH-alone arm but 
      not in rivaroxaban-treated patients. In this exploratory trial, rivaroxaban 
      effectively suppressed coagulation activation after elective PCI and stenting.
FAU - Vranckx, P
AU  - Vranckx P
FAU - Leebeek, F W G
AU  - Leebeek FW
FAU - Tijssen, J G P
AU  - Tijssen JG
FAU - Koolen, J
AU  - Koolen J
FAU - Stammen, F
AU  - Stammen F
FAU - Herman, J-P R
AU  - Herman JP
FAU - de Winter, R J
AU  - de Winter RJ
FAU - van T Hof, A W J
AU  - van T Hof AW
FAU - Backx, B
AU  - Backx B
FAU - Lindeboom, W
AU  - Lindeboom W
FAU - Kim, S-Y
AU  - Kim SY
FAU - Kirsch, B
AU  - Kirsch B
FAU - van Eickels, M
AU  - van Eickels M
FAU - Misselwitz, F
AU  - Misselwitz F
FAU - Verheugt, F W A
AU  - Verheugt FW
AD  - Prof. Freek W. A. Verheugt MD, PhD, Department of Cardiology, Heartcenter, 
      Oosterpark 9, AC Amsterdam 1091, the Netherlands, Tel.: + 31 20 5993421, Fax: +31 
      20 5993997, E-mail: f. w. a.verheugt@olvg.nl.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20150430
PL  - Germany
TA  - Thromb Haemost
JT  - Thrombosis and haemostasis
JID - 7608063
RN  - 0 (Anticoagulants)
RN  - 0 (Biomarkers)
RN  - 0 (Factor Xa Inhibitors)
RN  - 0 (Fibrinolytic Agents)
RN  - 0 (Peptide Fragments)
RN  - 0 (Platelet Aggregation Inhibitors)
RN  - 0 (antithrombin III-protease complex)
RN  - 0 (prothrombin fragment 1.2)
RN  - 9000-94-6 (Antithrombin III)
RN  - 9001-26-7 (Prothrombin)
RN  - 9005-49-6 (Heparin)
RN  - 9NDF7JZ4M3 (Rivaroxaban)
RN  - EC 3.4.- (Peptide Hydrolases)
RN  - EC 3.4.21.5 (Thrombin)
SB  - IM
CIN - Thromb Haemost. 2015 Aug;114(2):214-6. PMID: 25995026
MH  - Aged
MH  - Anticoagulants/therapeutic use
MH  - Antithrombin III/analysis
MH  - Biomarkers/blood
MH  - Coronary Disease/*surgery
MH  - Drug Therapy, Combination
MH  - Elective Surgical Procedures
MH  - Factor Xa Inhibitors/administration & dosage/*therapeutic use
MH  - Female
MH  - Fibrinolytic Agents/therapeutic use
MH  - Heparin/therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Peptide Fragments/analysis
MH  - Peptide Hydrolases/analysis
MH  - *Percutaneous Coronary Intervention
MH  - Platelet Aggregation Inhibitors/therapeutic use
MH  - Postoperative Care
MH  - Postoperative Complications/blood/*prevention & control
MH  - Prothrombin/analysis
MH  - Risk Factors
MH  - Rivaroxaban/administration & dosage/*therapeutic use
MH  - Single-Blind Method
MH  - Stents
MH  - Thrombin/biosynthesis
MH  - Thrombosis/blood/*prevention & control
PMC - PMC6374984
OTO - NOTNLM
OT  - Anticoagulation
OT  - coronary artery disease
OT  - rivaroxaban
OT  - thrombosis
COIS- Conflicts of interest Pascal Vranckx has received research grants from Bayer 
      Health-Care, Boehringer Ingelheim and Daiichi Sankyo; honoraria for advisory 
      board and lectures from BMS-Pfizer. Freek W. A. Verheugt has received honoraria 
      for consulting and speaking from Bayer HealthCare, Boehringer Ingelheim, 
      BMS/Pfizer and Daiichi Sankyo. So-Young Kim, Bodo Kirsch, Martin van Eickels and 
      Frank Misselwitz report being employees of Bayer HealthCare. No other potential 
      conflict of interest relevant to this article was reported.
EDAT- 2015/05/01 06:00
MHDA- 2016/06/15 06:00
PMCR- 2019/02/14
CRDT- 2015/05/01 06:00
PHST- 2015/01/21 00:00 [received]
PHST- 2015/03/04 00:00 [accepted]
PHST- 2015/05/01 06:00 [entrez]
PHST- 2015/05/01 06:00 [pubmed]
PHST- 2016/06/15 06:00 [medline]
PHST- 2019/02/14 00:00 [pmc-release]
AID - 15-01-0061 [pii]
AID - 10.1160/TH15-01-0061 [doi]
PST - ppublish
SO  - Thromb Haemost. 2015 Aug;114(2):258-67. doi: 10.1160/TH15-01-0061. Epub 2015 Apr 
      30.