Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI

Marco Valgimigli

Status and phase: Unknown; Phase 4

Conditions: Myocardial Infarction

Treatments: Other: abciximab and Sirolimus eluting stent; Other: tirofiban and bare metal stent; Other: abciximab followed by implantation of bare metal stent; Other: tirofiban and sirolimus-eluting stent

Study type: Interventional

Funder types: Other

Identifiers

NCT00229515

TSES-02-III

Details and patient eligibility

About

The purpose of this study is to determine which from the four combinations tirofiban+sirolimus eluting stent (SES), tirofiban+bare metal stent (BMS), abciximab+SES, abciximab+BMS is the possible gold standard treatment for ST-segment elevation myocardial infarction in terms of efficacy and cost-efficacy.

Full description

The combination abciximab plus bare metal stent (BMS) is currently considered the standard therapy for AMI. The use of sirolimus eluting stent (SES) is related to a reduction of the need for urgent target vessel revascularization (TVR). With current acquisition prices for abciximab and SES, replacing abciximab with tirofiban, administered as a single high-dose bolus (SHDB) regimen, is a promising strategy that would preserve financial resources. In a recent study the combination tirofiban and SES resulted to be associated to an overall lower major adverse cardiovascular events (MACE) rate with respect to the abciximab plus BMS. However, since no conclusion can be drawn yet regarding the relative contribution of a specific GP IIb/IIIa inhibitor or a stent type with respect to the other, the combination of abciximab and SES may be associated to an even lower event rate with respect to SHDB tirofiban and SES, thus offsetting the higher initial cost.

Comparison(s): four strategies (SHDB tirofiban + BMS, SHDB tirofiban + SES, abciximab + BMS, abciximab + SES) are compared to determine the possible gold standard treatment for ST-segment elevation myocardial infarction in terms of efficacy and cost-efficacy.

Enrollment: 744 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ST segment elevation myocardial infarction
• Schedule for primary percutaneous coronary intervention
• Informed consent

Exclusion criteria

• Administration of fibrinolytic or any GP IIb/IIIa inhibitors for the treatment of current acute myocardial infarction or within 1 month before it
• History of bleeding diathesis or allergy to the studies drug
• Major surgery within 30 days
• Limited life expectancy, e.g. neoplasms, others
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

744 participants in 4 patient groups

1

Active Comparator group

Description:

Patients will receive abciximab infusion at standard regimen prior undergoing percutaneous coronary intervention for STEMI followed by BMS implantation in the culprit lesion

Treatment:

Other: abciximab followed by implantation of bare metal stent

2

Experimental group

Description:

Abciximab followed by implantation of sirolimus-eluting stent in the culprit lesion

Treatment:

Other: abciximab and Sirolimus eluting stent

3

Experimental group

Description:

tirofiban infusion followed by bare metal stent implantation

Treatment:

Other: tirofiban and bare metal stent

4

Experimental group

Description:

tirofiban and sirolimus-eluting stent

Treatment:

Other: tirofiban and sirolimus-eluting stent