Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention (PCI) Patients, an International Randomized Evaluation (STEEPLE)

Summary

The purpose of this study is to evaluate the efficacy and safety of intravenous enoxaparin versus intravenous unfractionated heparin (UFH) in patients undergoing non-emergent PCI, as assessed by measuring the incidence of non-coronary artery bypass graft (CABG) major and minor bleeding.

Timeline

Start

2004-01

Primary completion

2005-09

Completion

2005-09

Outcome

Mixed primary results

paper Enoxaparin at a dose of 0.5 mg per kilogram was associated with a significant reduction in the rate of non-CABG-related bleeding PMID 16957147 ↗

paper but the higher enoxaparin dose was not (6.5% vs. 8.5%; absolute difference, -2.0; 95% CI, -4.0 to 0.0; P=0.051). PMID 16957147 ↗

Publications

• Results Montalescot G, White HD, Gallo R, Cohen M, Steg PG, Aylward PE, Bode C, Chiariello M, King SB 3rd, Harrington RA, Desmet WJ, Macaya C, Steinhubl SR; STEEPLE Investigators. Enoxaparin versus unfractionated heparin in elective percutaneous coronary intervention. N Engl J Med. 2006 Sep 7;355(10):1006-17. doi: 10.1056/NEJMoa052711.
• Results Montalescot G, Cohen M, Salette G, Desmet WJ, Macaya C, Aylward PE, Steg PG, White HD, Gallo R, Steinhubl SR; STEEPLE Investigators. Impact of anticoagulation levels on outcomes in patients undergoing elective percutaneous coronary intervention: insights from the STEEPLE trial. Eur Heart J. 2008 Feb;29(4):462-71. doi: 10.1093/eurheartj/ehn008.
• White HD, Aylward PE, Gallo R, Bode C, Steg G, Steinhubl SR, Montalescot G; STEEPLE Investigators. Hematomas of at least 5 cm and outcomes in patients undergoing elective percutaneous coronary intervention: insights from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial. Am Heart J. 2010 Jan;159(1):110-6. doi: 10.1016/j.ahj.2009.10.034.
• Montalescot G, Gallo R, White HD, Cohen M, Steg PG, Aylward PE, Bode C, Chiariello M, King SB 3rd, Harrington RA, Desmet WJ, Macaya C, Steinhubl SR; STEEPLE Investigators. Enoxaparin versus unfractionated heparin in elective percutaneous coronary intervention 1-year results from the STEEPLE (SafeTy and efficacy of enoxaparin in percutaneous coronary intervention patients, an international randomized evaluation) trial. JACC Cardiovasc Interv. 2009 Nov;2(11):1083-91. doi: 10.1016/j.jcin.2009.08.016.
• White HD, Gallo R, Cohen M, Steg PG, Aylward PE, Bode C, Steinhubl S, Montalescot G. The use of intravenous enoxaparin in elective percutaneous coronary intervention in patients with renal impairment: results from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial. Am Heart J. 2009 Jan;157(1):125-31. doi: 10.1016/j.ahj.2008.08.019. Epub 2008 Nov 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enoxaparin sodium	Other / unclassified	0.5 mg/kg	Intravenous
Subject	Enoxaparin sodium	Other / unclassified	0.75 mg/kg	Intravenous

Indications

No indication recorded.