Why the study?
Does a sirolimus-eluting coronary stent reduce MACE compared to a paclitaxel-eluting coronary stent in patients with STEMI, NSTEMI, or angina?
Does a sirolimus-eluting coronary stent reduce MACE compared to a paclitaxel-eluting coronary stent in patients with STEMI, NSTEMI, or angina?
Sirolimus-eluting and paclitaxel-eluting stents demonstrate similar long-term safety and efficacy at 5 years with no significant difference in MACE or stent thrombosis.
Sirolimus-eluting stents offer no advantage over paclitaxel-eluting stents; confirms comparable 5-year safety and efficacy in ACS or angina.
OBJECTIVE: Millions of patients were treated with the sirolimus-eluting Cypher™ and the paclitaxel-eluting Taxus™ coronary stents with potential late-occurring increase in event rates. Therefore, the long-term outcome follow-up is of major clinical interest. DESIGN: In total, 2.098 unselected patients with ST-segment elevation myocardial infarction (STEMI), non-STEMI, stable or unstable angina pectoris were randomized to receive Cypher™ (n = 1.065) or Taxus™ (n = 1.033) stents and were followed for 5 years. RESULTS: The primary end-point; the composite of cardiac death, myocardial infarction and target vessel revascularization (major adverse cardiac event, MACE), occurred in 467 patients (22.3%); Cypher™ n = 222 (20.8%), Taxus™ n = 245 (23.7%), ns. Definite and probable stent thrombosis occurred in 107 patients (5.1%); Cypher™ n = 51 (4.8%), Taxus™ n = 56 (5.4%), ns. No statistically significant differences were found in the elements of the primary end-point or in other secondary end-points between the two stent groups. After one year, the annual rates of stent thrombosis and MACE remained constant. CONCLUSIONS: During 5-year follow-up, the Cypher™ and the Taxus™ coronary stents had similar clinical outcome with no signs of increasing rates of adverse events over time.
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Bligaard et al. (2014) studied this question.
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