Context Abciximab infusion and uncoated-stent implantation
is a complementary treatment strategy to reduce major adverse
cardiac events in patients undergoing angioplasty for ST-segment
elevation myocardial infarction (STEMI). It is uncertain whether
there may be similar benefits in replacing abciximab with high-dose
bolus tirofiban. Similarly, the use of drug-eluting stents in
this patient population is currently discouraged because of
conflicting results on efficacy reported in randomized trials
and safety concerns reported by registries.
Objective To evaluate the effect of high-dose bolus tirofiban
and of sirolimus-eluting stents as compared with abciximab infusion
and uncoated-stent implantation in patients with STEMI undergoing
percutaneous coronary intervention.
Design, Setting, and Patients An open-label, 2 x 2
factorial trial of 745 patients presenting with STEMI or new
left bundle-branch block at 16 referral centers in Italy, Spain,
and Argentina between October 2004 and April 2007.
Interventions High-dose bolus tirofiban vs abciximab infusion
and sirolimus-eluting stent vs uncoated stent implantation.
Main Outcome Measures For drug comparison, at least 50%
ST-segment elevation resolution at 90 minutes postintervention
with a prespecified noninferiority margin of 9% difference (relative
risk, 0.89); for stent comparison, the rate of major adverse
cardiac events, defined as the composite of death from any cause,
reinfarction, and clinically driven target-vessel revascularization
within 8 months.
Results ST-segment resolution occurred in 302 of 361 patients
(83.6%) who had received abciximab infusion and 308 of 361 (85.3%)
who had received tirofiban infusion (relative risk, 1.020; 97.5%
confidence interval, 0.958-1.086;
P < .001 for
noninferiority). Ischemic and hemorrhagic outcomes were similar
in the tirofiban and abciximab groups. At 8 months, major adverse
cardiac events occurred in 54 patients (14.5%) with uncoated
stents and 29 (7.8%) with sirolimus stents (
P = .004),
predominantly reflecting a reduction of revascularization rates
(10.2% vs 3.2%). The incidence of stent thrombosis was similar
in the 2 stent groups.
Conclusions In patients with STEMI undergoing percutaneous
coronary intervention, compared with abciximab, tirofiban therapy
was associated with noninferior resolution of ST-segment elevation
at 90 minutes following coronary intervention, whereas sirolimus-eluting
stent implantation was associated with a significantly lower
risk of major adverse cardiac events than uncoated stents within
8 months after intervention.
Trial Registration clinicaltrials.gov Identifier:
NCT00229515 相似文献