CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY
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
Marco Valgimigli, MD* ,*,
Gianfranco Percoco, MD*,
Dario Barbieri, MD*,
Fabrizio Ferrari, MD*,
Gabriele Guardigli, MD*,
Giovanni Parrinello, PhD ,
Olga Soukhomovskaia, MD* and
Roberto Ferrari, MD, PhD*
* Department of Cardiology, University of Ferrara, Ferrara, Italy
Cardiovascular Research Centre, Salvatore Maugeri Foundation, IRCCS Gussago (BS), Gussago, Italy
Medical Statistics Unit, University of Brescia, Brescia, Italy
Manuscript received January 28, 2004;
revised manuscript received February 24, 2004,
accepted March 2, 2004.
* Reprint requests and correspondence: Dr. Marco Valgimigli, Chair of Cardiology, University of Ferrara, Cardiovascular Institute, Arcispedale S. Anna Hospital, C.rso Giovecca 203, 44100 Ferrara, Italy.
vlgmrc{at}unife.it
OBJECTIVES: 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 µg/kg/3 min, and infusion of 0.15 µg/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.
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Abbreviations and Acronyms
| | ACS | = acute coronary syndrome | | ACT | = activated clotting time | | CK | = creatine kinase | | GP | = glycoprotein | | HDB | = high-dose bolus | | MI | = myocardial infarction | | PCI | = percutaneous coronary intervention | | TVR | = target vessel revascularization |
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