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Assoc. Prof. Marco Valgimigli,
We sought to investigate the three year outcomes of the first randomized trial which evaluated a strategy of sirolimus-eluting stent (SES) implantation in STEMI patients.
Presenter report: Valgimigli, Marco, Ferrara, (Italy) View the slides The design of the study has been previously reported.
Briefly, patients with STEMI were randomly assigned before obtaining initial angiogram to single high dose bolus tirofiban infusion (SHDB, 25 μg/kg/3 min and 0.15 μg/Kg/min for18-24 hours) followed by SES implantationm or abciximab (bolus of 0.25 mg/Kg/3-min with 0.125 mg/Kg/min for12-hour) and bare metal stent (BMS) implantation.
Between March 6, 2003, and April 23, 2004, 175 patients with STEMI were included. Overall, 74 (85%) patients in the tirofiban-SES and 77 (88%) in the abciximab-BMS arm received the protocol-mandated treatment combination. Patients were considered for 6-month angiographic follow-up if protocol-mandated PCI had been attempted. The primary end-point , evaluated at 8 months after randomization, was freedom from death, nonfatal MI, stroke, and binary restenosis. Patients were scheduled to undergo clinical follow-up at 30 days and then every six months from enrolment until five years. All deaths were considered cardiac unless an unequivocal non-cardiac cause could be established.
A definite diagnosis of myocardial infarction after normalisation of cardiac markers was made if there was documentation of new abnormal Q waves (according to the Minnesota code) or a confirmed elevation above upper limit of normal of CK/CK-MB or troponin I or T in at least one blood sample. Stent thrombosis (ST) has been classified according to the recently proposed Academic Research Consortium (ARC) classification.
As previously reported, both groups had similar baseline clinical and angiographic characteristics, procedural factors -with the sole exception of a smaller nominal stent diameter in the SES group- and 30-days results. Whereas mean duration of dual antiplatelet treatment tended to be longer in the tirofiban-SES arm (182±92 days vs. 155±105 days in the abciximab+BMS group; p=0.073), 80 and 100% of patients in both groups discontinued thienopyridines after 250 and 360 days, respectively. Of note, five patients restarted clopidogrel on top of aspirin between the second and third year of follow-up due to preference of the treating physician. Medications at follow-up did not differ between study groups. Complete follow-up information up to 1100 days was available for all patients. At 3 years, the primary endpoint, including death, reinfarction, cerebrovascular accident or binary restenosis remained lower in the tirofiban+SES group (29% vs. 49%; p=0.008). The cumulative incidence of MACE (death, myocardial infarction or target vessel revascularization) trended lower in the tirofiban-SES (28.7% vs. 40.9%; HR 0.64 [95% CI: 0.39-1.07]; p=0.089). All cause mortality and the composite of death or MI was similar in the tirofiban-SES (16.0% and 19.5%) vs. the abciximab-BMS group (14.7%, p=0.85; and 22.7%, p=0.57, respectively), while the need for TVR remained markedly reduced (10.3% vs. 25.0%; HR 0.38 [95% CI: 0.18-0.89]; p=0.01) in the tirofiban-SES group.
The cumulative incidence of definite, probable or possible ST were 5.7% vs. 6.8% in the tirofiban-SES and abciximab-BMS group, respectively (HR 0.84 [95% CI: 0.25-2.7]; p=0.76.
Among patients who were alive at 12 months, the cumulative incidence of death or non-fatal MI at 3 years was 8.7% in the tirofiban-SES and 7.5% in the abciximab-BMS group (p=0.78 at log rank test)
We conclude that at 3-year follow-up, a strategy of SES implantation in patients undergoing treatment for STEMI remained superior in terms of reintervention in the infarcted artery compared to traditional BMS, with no safety concerns.
Clinical Trial Update I