PRAGUE-7 - PRAGUE-7

Aug 31, 2009
Font Size
A
A
A
Trial Sponsor:
Eli Lilly and the Ministry of Education, Youth, and Physical Education of the Czech Republic
Date Presented:
01/01/2009
Date Published:
01/01/2011
Date Updated:
08/31/2009
Original Posted Date:
08/31/2009
References

Description:

The goal of the trial was to evaluate the effect of routine upfront use of the GP IIb/IIIa inhibitor abciximab compared with standard peri-procedural abciximab therapy among patients with cardiogenic shock undergoing primary percutaneous coronary intervention (PCI).

Study Design

Patients Enrolled: 80
Mean Follow Up: 30 days
Mean Patient Age: Mean age 66 years

Patient Populations:

Evolving acute MI with indications for urgent coronary angiography and clinical signs of cardiogenic shock, including incompletely developed shock

Exclusions:

Contraindications for the use of abciximab, severe valvular disease, mechanical or other cause of shock, and preadmission administration of >10,000 IU of heparin in the previous 6 hours

Primary Endpoints:

Death, reinfarction, stroke, or new renal failure by 30 days

Secondary Endpoints:

Left ventricular ejection fraction (LVEF) assessed by echocardiography on day 30, major bleeding complications, post-PCI myocardial blush grade and TIMI flow grade

Drug/Procedures Used:

Patients were randomized in an open-label manner to routine upfront use of abciximab bolus followed by immediate PCI and a 12 hour abciximab infusion (n = 40) or standard therapy with optional abciximab administration during PCI (n = 40). Patients in both groups were to receive standard antithrombotic and anticoagulant treatment and coronary angiography.

Principal Findings:

PCI was technically successful in 90% of the upfront abciximab group and 88% of usual care group. Per protocol, abciximab was used in all patients in the upfront group and 35% of the usual care group. One-quarter of patients received cardiopulmonary resuscitation and 46% were on mechanical ventilation.

There was no difference in the primary endpoint of death, reinfarction, stroke, or new renal failure by 30 days between the groups (42% of the upfront abciximab group and 27% of the usual care group, p=0.24). The mortality rate during the hospitalization was high in both groups, with no differences between the treatment arms (37% vs 32%, respectively, p=0.82). Among survivors at 30 days, ejection fraction was 44 ±11% in the upfront abciximab group vs. 41 ±12% in the usual care group (p=0.205). Major bleeding occurred in 17.5% of the upfront abciximab group as compared with 7.5% of the usual care group (p=0.310) and stroke in 2.5% and 5%, respectively. There were no differences in post-PCI TIMI flow grade (mean 2.6 in each group) or in myocardial blush grade (mean 2.3 in each group).

Interpretation:

Among patients with cardiogenic shock undergoing primary PCI, routine upfront use of the GP IIb/IIIa inhibitor abciximab was not associated with a difference in the composite endpoint of death, reinfarction, stroke, or new renal failure by 30 days compared with standard therapy with optional abciximab administration during PCI.

The trial was very small (n=80) and likely underpowered to detect all but a very large difference in event rates between the groups. In addition, one-third of patients in the usual care group received abciximab during the PCI, which would make it harder to detect a difference between the groups. The outcome of patients with MI complicated by cardiogenic shock is very poor, as evidenced by the high mortality rate in the study of approximately one-third of patients during the index hospitalization, despite a relatively high procedural success with PCI. Given the non-statistically higher frequency of major bleeding with upfront use of abciximab without an impact on clinical outcomes, angiographic measures or LVEF, routine upfront use of abciximab in this complicated cohort of patients was not a beneficial treatment strategy.

References:

Tousek P, Rokyta R, Tesarova J, et al. 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. Acute Card Care. 2011 Sep;13(3):116-22.

Presented by Dr. Petr Widimsky at the European Society of Cardiology Congress, Barcelona, Spain, August 2009.

Keywords: Stroke, Platelet Aggregation Inhibitors, Respiration, Artificial, Cardiopulmonary Resuscitation, Coronary Disease, Immunoglobulin Fab Fragments, Percutaneous Coronary Intervention, Shock, Cardiogenic, Renal Insufficiency, Coronary Angiography, Platelet Glycoprotein GPIIb-IIIa Complex


< Back to Listings