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TRUE: Sirolimus-eluting stent safe, effective after four years

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Patients who had sirolimus-eluting stents implanted following bare metal stent in-stent restenosis had low target lesion revascularization and a <1% incidence of stent thrombosis per year at four-year follow-up, study findings indicated.

The results confirmed the long-term benefits of drug-eluting stents after several reports involving late stent thrombosis beyond the traditional nine-month time frame raised concerns that beneficial treatment effects may wane in the years following implantation.

Researchers followed 244 consecutive patients who were treated with sirolimus-eluting stents for bare metal stent restenosis out to four years, observing major adverse cardiac events including death from any cause, nonfatal reinfarction and ischemia-driven target lesion revascularization. All patients were assigned to combined antiplatelet therapy with at least 100 mg of aspirin daily and ticlopidine 500 mg daily (or clopidogrel 75 mg daily) at least 48 hours prior to sirolimus-eluting stent implantation and continued for at least six months following the procedure. Mean dual antiplatelet duration was 341 days, with 168 patients (69%) assigned to therapy for at least 12 months and 24 patients (10%) for 24 months.

The researchers determined that the cumulative event-free survival rate was 80.3%, with eight patients experiencing nonfatal MI (3.2%) and 27 patients experiencing target lesion revascularization (11.1%). Eleven patients experienced cardiac death (4.5%). Definite stent thrombosis occurred in five patients (2%), with possible stent thrombosis occurring in an additional two patients (0.8%) who were aged 85 and 89 years. Cumulative rates for stent thrombosis (0.70% per year) and very late stent thrombosis (0.57%) were on par with rates observed in several other registries and a meta-analysis, according to the researchers. Additionally, diabetes remained an independent negative predictor of freedom from target-lesion revascularization (OR=0.38; 95% CI, 0.20-0.71) and major adverse cardiac events (OR=0.38; 95% CI, 0.20-0.71).

“Except for one patient who was [assigned to] aspirin and clopidogrel at the time of the event, all patients interrupted clopidogrel more than one month before the event,” the researchers wrote. “To our knowledge, this registry is the largest series of patients treated with sirolimus-eluting stents for in-stent restenosis lesions in a real-world scenario with no exclusion criteria concerning patients’ clinical status as well as angiographic criteria and followed-up in a long-term format.”

Liistro F. J Am Coll Cardiol. 2010;55:613-616.

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