The Angiomax Peripheral Procedure Registry of Vascular Events Trial (APPROVE): In-hospital and 30-day results

David Allie, Patrick Hall, Nicolas W. Shammas, Robert Safian, John R. Laird, John J. Young, Ajay Virmani

Research output: Contribution to journalArticle

37 Scopus citations

Abstract

Background - High-risk patient characteristics and complexity of percutaneous peripheral intervention (PPI) procedures suggest a need for predictable and reliable anticoagulation. We undertook this study to assess the safety and efficacy of bivalirudin as the procedural anticoagulant in patients undergoing PPI of the renal, iliac, or femoral artery. Methods - This was a prospective, open-label, single arm study in patients undergoing PPI of the renal, iliac, or femoral vessels to assess bivalirudin as the sole procedural anticoagulant (0.75 mg/kg bolus/1.75 mg/kg/hr infusion). The primary endpoint was procedural success defined as residual stenosis ≤ 20%. Secondary endpoints included ischemic events (death, myocardial infarction, unplanned revascularization, and amputation), and bleeding complications, as well as ACT values and times to sheath removal, ambulation, and discharge. Results - 505 patients were enrolled at 26 sites. Procedural success was achieved in 95.0% of patients. Ischemic events were low (1.4%) and similar between vessel types. Protocol-defined major hemorrhage and TIMI major hemorrhage rates were 2.2% and 0.4%, respectively. Mean ACTs were similar among treatment groups (renal 353.8 seconds(s); iliac 335.9s, femoral, 343.5s). Conclusion - Bivalirudin provided consistent anticoagulation and similar outcomes in all vessel types treated at the dose tested. Ischemic and bleeding event rates were low, demonstrating the safe use of bivalirudin as a procedural anticoagulant in PPI.

Original languageEnglish (US)
Pages (from-to)651-656
Number of pages6
JournalJournal of Invasive Cardiology
Volume16
Issue number11
StatePublished - Nov 2004
Externally publishedYes

Keywords

  • Anticoagulation
  • Femoral artery
  • Iliac artery
  • Percutaneous peripheral intervention
  • Renal intervention
  • Unfractionated heparin

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Allie, D., Hall, P., Shammas, N. W., Safian, R., Laird, J. R., Young, J. J., & Virmani, A. (2004). The Angiomax Peripheral Procedure Registry of Vascular Events Trial (APPROVE): In-hospital and 30-day results. Journal of Invasive Cardiology, 16(11), 651-656.