High-dose bolus tirofiban and sirolimus eluting stent versus abiciximab and bare metal stent in acute myocardial infarction (STRATEGY) study--protocol design and demography of the first 100 patients.
BACKGROUND
Primary bare metal stenting and abciximab infusion are currently considered the best available reperfusion strategy for acute ST-segment elevation myocardial infarction (STEMI). Sirolimus eluting stents (SES), compared to bare metal stent (BMS), greatly reduce the incidence of binary restenosis and target vessel revascularisation (TVR), but their use on a routine basis results in a significant increase in medical costs. With current European list prices, the use of tirofiban instead of abciximab would save enough money to absorb the difference between SES and BMS.


OBJECTIVE
To assess whether in patients with STEMI the combination of SES with high dose bolus (HDB) tirofiban results in a similar incidence of major cardiovascular events (MACE) but in a lower binary restenosis rate after six months compared to BMS and abciximab.


RESULTS
160 patients are required to satisfy the primary composite end-point, including MACE and binary restenosis. The study is ongoing: the current paper focuses on the methodology and demography of the first 100 patients so far enrolled. Patients randomised to HDB tirofiban (n = 50, mean age: 62 +/- 12, 40 males) and abciximab (n = 50, mean age: 63 +/- 12, 38 males) do not differ for medical history, presentation profile, medications at discharge, angiographic profile and creatine-kinase MB-fraction at peak.


CONCLUSIONS
The results of the trial will be available by the end of 2004: they will be crucial for the cardiologists to know whether the gold standard for AMI treatment should be reconsidered after the introduction of SES into the clinical practice.
Valgimigli
Marco
M
University of Ferrara, Cardiovascular Institute, Arcispedale S. Anna Hospital, C.rso Giovecca 203, 44100 Ferrara, Italy. vlgmrc@unife.it
Percoco
Gianfranco
G
Cicchitelli
Giordano
G
Ferrari
Fabrizio
F
Barbieri
Dario
D
Ansani
Lucia
L
Guardigli
Gabriele
G
Parrinello
Giovanni
G
Malagutti
Patrizia
P
Soukhomovskaia
Olga
O
Bettini
Alessandro
A
Campo
Gianluca
G
Ferrari
Roberto
R
D000077284:Abciximab; D000911:Antibodies, Monoclonal / Q000191:economics / Q000627:therapeutic use*; D002985:Clinical Protocols; D023903:Coronary Restenosis / Q000517:prevention & control; D004343:Drug Implants / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D004562:Electrocardiography; D005260:Female; D005544:Forecasting; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000191:economics / Q000627:therapeutic use*; D007267:Injections; D007558:Italy; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000188:drug therapy*; D010974:Platelet Aggregation / Q000187:drug effects; D020123:Sirolimus / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D015607:Stents / Q000191:economics / Q000706:statistics & numerical data*; D013997:Time Factors; D000077466:Tirofiban; D016896:Treatment Outcome; D014443:Tyrosine / Q000008:administration & dosage* / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use*
D000911:Antibodies, Monoclonal; D004343:Drug Implants; D007140:Immunoglobulin Fab Fragments; D014443:Tyrosine; D000077466:Tirofiban; D020123:Sirolimus; D000077284:Abciximab