A randomized study comparing same-day home discharge and abciximab bolus only to overnight hospitalization and abciximab bolus and infusion after transradial coronary stent implantation

Circulation. 2006 Dec 12;114(24):2636-43. doi: 10.1161/CIRCULATIONAHA.106.638627. Epub 2006 Dec 4.

Abstract

Background: Systematic use of coronary stents and optimized platelet aggregation inhibition has greatly improved the short-term results of percutaneous coronary interventions. Transradial percutaneous coronary interventions have been associated with a low risk of bleeding complications. It is unknown whether moderate- and high-risk patients can be discharged safely the same day after uncomplicated transradial percutaneous coronary interventions.

Methods and results: We randomized 1005 patients after a bolus of abciximab and uncomplicated transradial percutaneous coronary stent implantation either to same-day home discharge and no infusion of abciximab (group 1, n=504) or to overnight hospitalization and a standard 12-hour infusion of abciximab (group 2, n=501). The primary composite end point of the study was the 30-day incidence of any of the following events: death, myocardial infarction, urgent revascularization, major bleeding, repeat hospitalization, access site complications, and severe thrombocytopenia. The noninferiority of same-day home discharge and bolus of abciximab only compared with overnight hospitalization and abciximab bolus and infusion was evaluated. Two thirds of patients presented with unstable angina and approximately 20% presented with high-risk acute coronary syndrome prior to the procedure. The incidence of the primary end point was 20.4% in group 1 and 18.2% in group 2 (P=0.017 for noninferiority) with a troponin T-based definition of myocardial infarction; the incidence of the primary end point was 11.1% in group 1 and 9.6% in group 2 (P=0.0004 for noninferiority) with a creatinine kinase myocardial band-based definition of myocardial infarction. No death occurred. Rate of major bleeding in both groups was extremely low at 0.8% and 0.2%, respectively. From 504 patients randomized in group 1, 88% were discharged home the same day.

Conclusions: Our data suggest that same-day home discharge after uncomplicated transradial coronary stenting and bolus only of abciximab is not clinically inferior, in a wide spectrum of patients, to the standard overnight hospitalization and a bolus followed by a 12-hour infusion. This novel approach offers a safe strategy for same-day home discharge after uncomplicated coronary intervention.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abciximab
  • Aged
  • Ambulatory Surgical Procedures*
  • Angioplasty, Balloon, Coronary / methods*
  • Antibodies, Monoclonal / administration & dosage*
  • Electrocardiography
  • Female
  • Hospitalization
  • Humans
  • Immunoglobulin Fab Fragments / administration & dosage*
  • Male
  • Middle Aged
  • Platelet Aggregation Inhibitors / administration & dosage*
  • Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors*
  • Radial Artery
  • Stents*
  • Troponin T / blood

Substances

  • Antibodies, Monoclonal
  • Immunoglobulin Fab Fragments
  • Platelet Aggregation Inhibitors
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Troponin T
  • Abciximab