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.

Keywords::

• Abciximab
• acute myocardial infarction
• cardiogenic shock
• outcome
• primary percutaneous coronary intervention

Acknowledgements

ClinicalTrial.gov Identifier: NCT 00420030.

This work was supported by Eli Lilly (supply of ReoPro^R for the study patients); and by the Charles University Prague Research Project no. MSM 0021620817 awarded by the Ministry of Education, Youth, and Physical Education of the Czech Republic.

The authors should like to thank all other interventional cardiologists cooperating at this trial: Viktor Kocka, Tomas Budesinsky, Libor Lisa, Jan Pesek, Jiri Koza, Ivo Bernat, Jan Horak, Stanislav Simek. The authors should like to acknow ledge also Dr Marek Maly for the statistic support during preparation of this manuscript.

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.