No differences in clinical outcome between sirolimus- and paclitaxel-eluting stents in ‘real world’ setting

Results of the SORT OUT II trial, which reflected everyday clinical practice, revealed no significant difference in clinical outcome among patients undergoing PCI who received either sirolimus-eluting or paclitaxel-eluting coronary stents. Clinicians have keenly welcomed the evolution of percutaneous coronary intervention (PCI) owing to reduction in rates of restenosis. This evolution has seen progression from the initial use of balloon angioplasty, to coronary stents and most recently drug-eluting coronary stents. The approved use of drug-eluting stents has been based on relatively small trials and on selected patients, yet the results from such studies may not accurately reflect the clinical situation for unselected patients in routine practice. While the rate of unwanted events may be low, different stents may still produce important differences in clinical event rates that can only be detected by direct comparison using large, randomised samples. The SORT OUT II randomized trial compared the efficacy and safety of sirolimus-eluting and paclitaxel-eluting stents — the first two commercially available drug-eluting stents. The study was designed to reflect everyday clinical practice by attempting to include unselected patients and by specifically using only symptom-driven clinical end points. The primary end point was a composite clinical end point of major adverse cardiac event (cardiac death, acute myocardial infarction, target lesion revascularisation, or target vessel revascularisation). The secondary end points included individual components of all-cause mortality, and stent thrombosis. Consecutive patients undergoing PCI with the planned use of a drug-eluting stent were enrolled into the study. A total of 2098 patients (mean age 63.6 years) treated with PCI and randomised to receive either a sirolimus-eluting stent (n = 1065) or paclitaxel-eluting stent (n = 1033) were included in this randomised, blinded trial. The results revealed no significant difference between the sirolimus- and paclitaxel-eluting stents with regard to major adverse cardiac events (9.3% versus 11.2%; hazard ratio, 0.83; p=0.16). Nor were significant differences observed in any of the secondary end points for the two drug-eluting stents. This effect was consistent regardless of whether patients with diabetes who underwent scheduled repeat angiography were included in the analyses or not. However, the authors point out that insufficient study power may have compromised their results. “This equivalence may have resulted from a truly negligible difference in the effectiveness and safety of the stents in everyday clinical practice, but it also may be due to insufficient study power,” they stated. They concluded that the results of the study revealed no significant differences in clinical outcomes between the sirolimus-eluting and paclitaxel-eluting coronary stents among patients undergoing PCI. Reference...