21 research outputs found
High-dose bolus tirofiban and sirolimus-eluting stent versus abciximab and bare metal stent in acute myocardial infarction (STRATEGY) study
none9Summary. 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.
Aim: 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.
Methods and 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.noneVALGIMIGLI M; PERCOCO G; CICCHITELLI G; MALAGUTTI P; CAMPO G; FERRARI F; BARBIERI D; ANSANI L; R. FERRARIValgimigli, M; Percoco, G; Cicchitelli, G; Malagutti, P; Campo, Gianluca Calogero; Ferrari, F; Barbieri, D; Ansani, L; Ferrari, Robert
Health care costs for heart failure in Marche region [Analisi dei costi sanitari per lo scompenso cardiaco nella regione Marche]
Hydroxyl radical generation, levels of tumor necrosis factor-alpha, and progression to heart failure after acute myocardial infarction
OBJECTIVES We used acetylsalicylic acid (ASA) as a probing agent to quantify hydroxyl radical (˙OH) in
Controls and patients with coronary artery disease and to prospectively investigate ˙OH
production in patients with myocardial infarction (MI) complicated by heart failure (HF).
BACKGROUND Oxidative stress status (OSS) is a mechanism for transition to HF in experimental heart injury
models, but evidence for its causal role in humans is still limited.
METHODS Thirty healthy subjects (Controls), 12 patients with stable angina (Group 1), and 74 patients
with ST-segment elevation MI (Group 2) were enrolled. A dose of 250 mg Flectadol was
given intravenously before each blood collection to determine the 2,3-dihydroxybenzoic
acid/salicylic acid (DHBA/SA) ratio. We also quantified vitamin E and coenzyme Q10 to
monitor antioxidant reserve, as well as tumor necrosis factor (TNF)-alpha, TNF-soluble
receptors, interleukin (IL)-6, and IL-1ra to assess inflammatory status. All measurements
were repeated at month 6 in Group 2.
RESULTS There were no differences between Controls and Group 1. Group 2 showed increased ˙OH
production, peaking at 24 h, whereas vitamin E and coenzyme Q10 progressively declined.
Group 2 patients developing HF during hospitalization (Group 2Bi) presented with an
increase of both ˙OH production at discharge and inflammatory status, as compared with
patients without HF (Group 2Ai), persisting at month 6 in post-MI patients with HF
(Group 2Bii).
CONCLUSIONS We found a distinct pattern of ˙OH generation in post-MI patients who show progression to
HF. The interplay between OSS and inflammatory status should be targeted as a possible
mechanism of progression to post-MI left ventricular dysfunction. (J Am Coll Cardiol
2004;43:2000–8) © 2004 by the American College of Cardiology Foundatio
Tirofiban and sirolimus-eluting stent vs abciximab and bare-metal stent for acute myocardial infarction: a randomized trial
CONTEXT: Bare-metal stenting with abciximab pretreatment is currently considered a reasonable reperfusion strategy for acute ST-segment elevation myocardial infarction (STEMI). Sirolimus-eluting stents significantly reduce the need for target-vessel revascularization (TVR) vs bare-metal stents but substantially increase procedural costs. At current European list prices, the use of tirofiban instead of abciximab would absorb the difference in cost between stenting with sirolimus-eluting vs bare-metal stents. OBJECTIVE: To evaluate the clinical and angiographic impact of single high-dose bolus tirofiban plus sirolimus-eluting stenting vs abciximab plus bare-metal stenting in patients with STEMI. DESIGN, SETTING, AND PATIENTS: Prospective, single-blind, randomized controlled study (Single High Dose Bolus Tirofiban and Sirolimus Eluting Stent vs Abciximab and Bare Metal Stent in Myocardial Infarction [STRATEGY]) of 175 patients (median age, 63 [interquartile range, 55-72] years) presenting to a single referral center in Italy with STEMI or presumed new left bundle-branch block and randomized between March 6, 2003, and April 23, 2004. INTERVENTION: Single high-dose bolus tirofiban regimen plus sirolimus-eluting stenting (n = 87) vs standard-dose abciximab plus bare-metal stenting (n = 88). MAIN OUTCOME MEASURES: The primary end point was a composite of death, nonfatal myocardial infarction, stroke, or binary restenosis at 8 months. Secondary outcomes included freedom, at day 30 and month 8, from major cardiac or cerebrovascular adverse events (composite of death, reinfarction, stroke, and repeat TVR). RESULTS: Cumulatively, 14 of 74 patients (19%; 95% confidence interval [CI], 10%-28%) in the tirofiban plus sirolimus-eluting stent group and 37 of 74 patients (50%; 95% CI, 44%-56%) in the abciximab plus bare-metal stent group reached the primary end point (hazard ratio, 0.33; 95% CI, 0.18-0.60; P<.001 [P<.001 by Fischer exact test]). The cumulative incidence of death, reinfarction, stroke, or TVR was significantly lower in the tirofiban plus sirolimus-eluting stent group (18%) vs the abciximab plus bare-metal stent group (32%) (hazard ratio, 0.53; 95% CI, 0.28-0.92; P = .04), predominantly reflecting a reduction in the need for TVR. Binary restenosis was present in 6 of 67 (9%; 95% CI, 2%-16%) and 24 of 66 (36%; 95% CI, 26%-46%) patients in the tirofiban plus sirolimus-eluting stent and abciximab plus bare-metal stent groups, respectively (P = .002). CONCLUSION: Tirofiban-supported sirolimus-eluting stenting of infarcted arteries holds promise for improving outcomes while limiting health care expenditure in patients with myocardial infarction undergoing primary intervention
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.
AIM:
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.
METHODS AND 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