The additive value of tirofiban administered with the high-dose bolus in the prevention of ischemic complications during high-risk coronary angioplasty: the ADVANCE Trial.
OBJECTIVE
We sought to determine the safety and efficacy of high-dose bolus (HDB) tirofiban in high-risk patients undergoing percutaneous coronary intervention (PCI).


BACKGROUND
The use of HDB tirofiban in the catheterization laboratory is controversial. In particular, in patients with acute coronary syndromes undergoing PCI, there is no evidence that tirofiban administered in the catheterization laboratory is superior to heparin alone. This finding probably reflects the suboptimal platelet inhibition when tirofiban is employed at RESTORE (Randomized Efficacy Study of Tirofiban for Outcomes and Restenosis) regimen.


METHODS
A total of 202 patients (mean age 69 +/- 8 years; 137 males [68%]) undergoing high-risk PCI, pretreated with thienopyridines, were consecutively randomized to HDB tirofiban (25 microg/kg/3 min, and infusion of 0.15 microg/kg/min for 24 to 48 h) or placebo immediately before the procedure and then followed for a median time of 185 days (range 45 to 324 days) for the occurrence of the primary composite end point of death, myocardial infarction, target vessel revascularization (TVR), and bailout use of glycoprotein (GP) IIb/IIIa inhibitors.


RESULTS
The cumulative incidence of the primary end point was 35% and 20% in placebo and HDB tirofiban groups, respectively (hazard ratio 0.51, 95% confidence interval 0.29 to 0.88; p = 0.01). This difference was mainly due to the reduction of myocardial infarction and bailout use of GP IIb/IIIa inhibitors, with no significant effect on TVR or death. The safety profile did not differ between tirofiban and placebo.


CONCLUSIONS
The use of tirofiban, when administered at HDB, is safe and significantly reduces the incidence of ischemic/thrombotic complications during high-risk PCI.
Valgimigli
Marco
M
Department of Cardiology, University of Ferrara, Ferrara, Italy. vlgmrc@unife.it
Percoco
Gianfranco
G
Barbieri
Dario
D
Ferrari
Fabrizio
F
Guardigli
Gabriele
G
Parrinello
Giovanni
G
Soukhomovskaia
Olga
O
Ferrari
Roberto
R
D000208:Acute Disease; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000925:Anticoagulants / Q000008:administration & dosage; D015415:Biomarkers / Q000097:blood; D023921:Coronary Stenosis / Q000453:epidemiology / Q000628:therapy; D003402:Creatine Kinase / Q000097:blood; D052279:Creatine Kinase, MB Form; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006493:Heparin / Q000008:administration & dosage; D006801:Humans; D007431:Intraoperative Complications / Q000453:epidemiology / Q000209:etiology* / Q000517:prevention & control*; D007527:Isoenzymes / Q000097:blood; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000453:epidemiology / Q000209:etiology* / Q000517:prevention & control*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D015995:Prevalence; D012307:Risk Factors; D013577:Syndrome; D000077466:Tirofiban; D016896:Treatment Outcome; D019210:Troponin I / Q000097:blood; D014443:Tyrosine / Q000008:administration & dosage* / Q000031:analogs & derivatives*
D000925:Anticoagulants; D015415:Biomarkers; D007527:Isoenzymes; D010975:Platelet Aggregation Inhibitors; D019210:Troponin I; D014443:Tyrosine; D006493:Heparin; D003402:Creatine Kinase; D052279:Creatine Kinase, MB Form; D000077466:Tirofiban