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

Conditions

Myocardial Infarction

Keywords

Myocardial infarction, Revascularization, Stent, ST segment elevation

Brief summary

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.

Detailed 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.

Garg S, Sarno G, Serruys PW, Rodriguez AE, Bolognese L, Anselmi M, De Cesare N, Colangelo S, Moreno R, Gambetti S, Monti M, Bristot L, Bressers M, Garcia-Garcia HM, Parrinello G, Campo G, Valgimigli M, STRATEGY and MULTISTRATEGY Investigators.

2011-01-01105 citations

10.1016/j.jcin.2010.09.017

Comparison of angioplasty with infusion of tirofiban or abciximab and with implantation of sirolimus-eluting or uncoated stents for acute myocardial infarction: the MULTISTRATEGY randomized trial.

Valgimigli M, Campo G, Percoco G, Bolognese L, Vassanelli C, Colangelo S, de Cesare N, Rodriguez AE, Ferrario M, Moreno R, Piva T, Sheiban I, Pasquetto G, Prati F, Nazzaro MS, Parrinello G, Ferrari R, Multicentre Evaluation of Single High-Dose Bolus Tirofiban vs Abciximab With Sirolimus-Eluting Stent or Bare Metal Stent in Acute Myocardial Infarction Study (MULTISTRATEGY) Investigators.

2008-03-30187 citations

10.1001/jama.299.15.joc80026

Interventions

OTHERabciximab followed by implantation of bare metal stent

Patients will receive infusion of abciximab at standard regimen before undergoing intervention for STEMI and then bare metal stent implantation in the culprit lesion

OTHERabciximab and Sirolimus eluting stent

Patients will receive abciximab infusion at standard regimen followed by implantation of sirolimus-eluting stent in the culprit lesion

OTHERtirofiban and bare metal stent

Patients will receive tirofiban infusion at high loading dose followed by standard infusion for 18-24 hours and subsequently they will be treated with bare metal stent implantation

OTHERtirofiban and sirolimus-eluting stent

Patients will receive tirofiban infusion at high loading dose followed by standard infusion for 18-24 hours and subsequently they will be treated with sirolimus-eluting stent implantation

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
The evaluation of the degree of ST-segment resolution after the mechanical intervention.	90 minutes after last balloon inflation
The cumulative rate of death for any cause, reinfarction and target vessel revascularisation	8 months

Secondary

Measure	Time frame
stent thrombosis according to the ARC classification	any time during follow-up
Death, recurrent acute myocardial infarction, target vessel revascularization and target lesion revascularisation, considered separately or in combination.	at any time during follow-up
bleeding rate defined according to different classifications including TIMI, Acuity, GUSTO and Steeple.	at 30 days, 1 year, 3 and 5 years
the degree of cumulative or single lead ST segment resolution at time frames different from the primary endpoint. the degree of residual ST segment elevation.	immediately after intervention, at 90 minutes and at discharge
The evaluation of the cost-effectiveness of the involved experimental treatments.	8 months, 1,3 and 5 years

Countries

Italy

Outcome results

None listed