Peri-procedural use of rivaroxaban in elective percutaneous coronary intervention to treat stable coronary artery disease. The X-PLORER trial.
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]µg/l and 3.90 [10.1] µg/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.
P
P
Vranckx
F W G
FW
Leebeek
J G P
JG
Tijssen
J
J
Koolen
F
F
Stammen
J-P R
JP
Herman
R J
RJ
de Winter
A W J
AW
van T Hof
B
B
Backx
W
W
Lindeboom
S-Y
SY
Kim
B
B
Kirsch
M
M
van Eickels
F
F
Misselwitz
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.
F W A
FW
Verheugt
D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D000990:Antithrombin III / Q000032:analysis; D015415:Biomarkers / Q000097:blood; D003327:Coronary Disease / Q000601:surgery*; D004359:Drug Therapy, Combination; D017558:Elective Surgical Procedures; D065427:Factor Xa Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000032:analysis; D010447:Peptide Hydrolases / Q000032:analysis; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011182:Postoperative Care; D011183:Postoperative Complications / Q000097:blood / Q000517:prevention & control*; D011516:Prothrombin / Q000032:analysis; D012307:Risk Factors; D000069552:Rivaroxaban / Q000008:administration & dosage / Q000627:therapeutic use*; D016037:Single-Blind Method; D015607:Stents; D013917:Thrombin / Q000096:biosynthesis; D013927:Thrombosis / Q000097:blood / Q000517:prevention & control*
D000925:Anticoagulants; D015415:Biomarkers; D065427:Factor Xa Inhibitors; D005343:Fibrinolytic Agents; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; C046193:antithrombin III-protease complex; C045879:prothrombin fragment 1.2; D000990:Antithrombin III; D011516:Prothrombin; D006493:Heparin; D000069552:Rivaroxaban; D010447:Peptide Hydrolases; D013917:Thrombin
Anticoagulation; coronary artery disease; rivaroxaban; thrombosis