Routine upfront abciximab versus standard periprocedural therapy in patients undergoing primary percutaneous coronary intervention for cardiogenic shock: The PRAGUE-7 Study. An open randomized multicentre study.

Abstract

BACKGROUND:

The outcome of acute myocardial infarction (AMI) complicated with cardiogenic shock is poor. The aim of this study was to analyse, whether upfront abciximab administration could improve the outcomes of cardiogenic shock.

METHODS:

This multicentre open trial randomized 80 patients with AMI complicated by cardiogenic shock expected to undergo primary PCI into group A (routine upfront-pre-procedural-abciximab bolus followed by 12-h abciximab infusion) and group B (standard therapy). The study primary objective was 30-day combined outcome (death/reinfarction/stroke/new severe renal failure).

RESULTS:

PCI was technically successful in 90% (A) versus 87.5% (B) patients. Abciximab was used in 100% (A) versus 35% (B). The primary endpoint occurred in 17 group A patients (42.5%) and 11 group B patients (27.5%, P = 0.24). Ejection fraction among survivors after 30 days was 44 ± 11% (A) versus 41 ± 12% (B, P = 0.205). Major bleeding occurred in 17.5% (A) versus 7.5% (B, P = 0.310). No differences (A versus B) were found in TIMI-flow and MBG after PCI.

CONCLUSIONS:

This study did not show any benefit from routine pre-procedural abciximab when compared with a selective abciximab use during the intervention in patients with cardiogenic shock undergoing primary PCI. However, small sample size of the trial preclude any definitive conclusion, a larger prospective, randomized, multicentered trial is needed.

• Authors: Petr Tousek, Richard Rokyta, Jitka Tesarova, Radek Pudil, Jan Belohlavek, Josef Stasek, Filip Rohac, Petr Widimsky
• Journal: Acute cardiac care (Acute Card Care) Vol. 13 Issue 3 Pg. 116-22 (Sep 2011) ISSN: 1748-295X [Electronic] England
• PMID: 21526919 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

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

Topics

• Abciximab
• Aged
• Angioplasty, Balloon, Coronary (methods)
• Antibodies, Monoclonal (administration & dosage)
• Czech Republic
• Female
• Humans
• Immunoglobulin Fab Fragments (administration & dosage)
• Male
• Middle Aged
• Myocardial Infarction (complications, drug therapy, mortality, pathology)
• Platelet Aggregation Inhibitors (administration & dosage)
• Platelet Glycoprotein GPIIb-IIIa Complex (antagonists & inhibitors)
• Prospective Studies
• Shock, Cardiogenic (complications, drug therapy, mortality, pathology)
• Stroke Volume
• Survival Analysis
• Treatment Outcome