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Initial experience with factor-Xa inhibition in percutaneous coronary intervention: the XaNADU-PCI Pilot.

Publication ,  Journal Article
Alexander, JH; Dyke, CK; Yang, H; Becker, RC; Hasselblad, V; Zillman, LA; Kleiman, NS; Hochman, JS; Berger, PB; Cohen, EA; Lincoff, AM ...
Published in: J Thromb Haemost
February 2004

BACKGROUND: Direct factor (F)Xa inhibition is an attractive method to limit thrombotic complications during percutaneous coronary intervention (PCI). OBJECTIVES: To investigate drug levels achieved, effect on coagulation markers, and preliminary efficacy and safety of several doses of DX-9065a, an intravenous, small molecule, direct, reversible FXa inhibitor during PCI. PATIENTS AND METHODS: Patients undergoing elective, native-vessel PCI (n = 175) were randomized 4 : 1 to open-label DX-9065a or heparin in one of four sequential stages. DX-9065a regimens in stages I-III were designed to achieve concentrations of > 100 ng mL-1, > 75 ng mL-1, and > 150 ng mL-1. Stage IV used the stage III regimen but included patients recently given heparin. RESULTS: At 15 min median (minimum) DX-9065a plasma levels were 192 (176), 122 (117), 334 (221), and 429 (231) ng mL-1 in stages I-IV, respectively. Median whole-blood international normalized ratios (INRs) were 2.6 (interquartile range 2.5, 2.7), 1.9 (1.8, 2.0), 3.2 (3.0, 4.1), and 3.8 (3.4, 4.6), and anti-FXa levels were 0.36 (0.32, 0.38), 0.33 (0.26, 0.39), 0.45 (0.41, 0.51), and 0.62 (0.52, 0.65) U mL-1, respectively. Stage II enrollment was stopped (n = 7) after one serious thrombotic event. Ischemic and bleeding events were rare and, in this small population, showed no clear relation to DX-9065a dose. CONCLUSIONS: Elective PCI is feasible using a direct FXa inhibitor for anticoagulation. Predictable plasma drug levels can be rapidly obtained with double-bolus and infusion DX-9065a dosing. Monitoring of DX-9065a may be possible using whole-blood INR. Direct FXa inhibition is a novel and potentially promising approach to anticoagulation during PCI that deserves further study.

Duke Scholars

Published In

J Thromb Haemost

DOI

ISSN

1538-7933

Publication Date

February 2004

Volume

2

Issue

2

Start / End Page

234 / 241

Location

England

Related Subject Headings

  • Thrombosis
  • Propionates
  • Postoperative Complications
  • Pilot Projects
  • Naphthalenes
  • Middle Aged
  • Male
  • Intraoperative Care
  • International Normalized Ratio
  • Humans
 

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Alexander, J. H., Dyke, C. K., Yang, H., Becker, R. C., Hasselblad, V., Zillman, L. A., … XaNADU-PCI PILOT Investigators, . (2004). Initial experience with factor-Xa inhibition in percutaneous coronary intervention: the XaNADU-PCI Pilot. J Thromb Haemost, 2(2), 234–241. https://doi.org/10.1111/j.1538-7933.2004.00594.x
Alexander, J. H., C. K. Dyke, H. Yang, R. C. Becker, V. Hasselblad, L. A. Zillman, N. S. Kleiman, et al. “Initial experience with factor-Xa inhibition in percutaneous coronary intervention: the XaNADU-PCI Pilot.J Thromb Haemost 2, no. 2 (February 2004): 234–41. https://doi.org/10.1111/j.1538-7933.2004.00594.x.
Alexander JH, Dyke CK, Yang H, Becker RC, Hasselblad V, Zillman LA, et al. Initial experience with factor-Xa inhibition in percutaneous coronary intervention: the XaNADU-PCI Pilot. J Thromb Haemost. 2004 Feb;2(2):234–41.
Alexander, J. H., et al. “Initial experience with factor-Xa inhibition in percutaneous coronary intervention: the XaNADU-PCI Pilot.J Thromb Haemost, vol. 2, no. 2, Feb. 2004, pp. 234–41. Pubmed, doi:10.1111/j.1538-7933.2004.00594.x.
Alexander JH, Dyke CK, Yang H, Becker RC, Hasselblad V, Zillman LA, Kleiman NS, Hochman JS, Berger PB, Cohen EA, Lincoff AM, Saint-Jacques H, Chetcuti S, Burton JR, Buergler JM, Spence FP, Shimoto Y, Robertson TL, Kunitada S, Bovill EG, Armstrong PW, Harrington RA, XaNADU-PCI PILOT Investigators. Initial experience with factor-Xa inhibition in percutaneous coronary intervention: the XaNADU-PCI Pilot. J Thromb Haemost. 2004 Feb;2(2):234–241.
Journal cover image

Published In

J Thromb Haemost

DOI

ISSN

1538-7933

Publication Date

February 2004

Volume

2

Issue

2

Start / End Page

234 / 241

Location

England

Related Subject Headings

  • Thrombosis
  • Propionates
  • Postoperative Complications
  • Pilot Projects
  • Naphthalenes
  • Middle Aged
  • Male
  • Intraoperative Care
  • International Normalized Ratio
  • Humans