Abizaid (p < 0.0001) between the CYPHER stent and bare metal control stent for all clinical event endpoints were sustained at 3-years. Furthermore, when these results are compared with the 9m follow-up data, SIRIUS demonstrates that the clinical beneﬁt of CYPHER stent over bare metal stents increases from 9 to 12 months (by an average of 24%) and this remains virtually unchanged at 3 years with no evidence of late “catch-up” in restenosis (Moses et al 2003). Comparative trials More recently, we have had the opportunity to compare the SES and paclitaxel drug-eluting stents (PES) following the presentation of data from a total of ten head-to-head trials (Table 1). ISAR-DESIRE was the ﬁrst randomized trial to show that drug-eluting stents provide results superior to those achieved with standard percutaneous transluminal coronary angioplasty (PTCA) in the treatment of in-stent restenosis. Secondary analysis also suggests an advantage of SES over PES in terms of clinical restenosis rates in this indication (SES: 14.3%, PES: 21.7%) (Kastrati et al 2005a). Results from SIRTAX, a Swiss study involving 1005 patients, revealed that when compared with TAXUS, the CYPHER stent had signiﬁcantly lower rates of death, myocardial infarction (MI), or target lesion revascularization (TLR) at 9 months – the composite primary endpoint (6.2% vs 10.8%, p < 0.009). What makes these ﬁndings all the more impressive is the fact that SIRTAX is an “all-comers” trial with a very complex patient population which included those with acute coronary syndromes, chronic total occlusions and bifurcation lesions (Windecker et al 2005). Following the pattern set by earlier comparisons of drug- eluting stents, diabetic patients treated in ISAR-DIABETES trial, revealed CYPHER to have a signiﬁcantly superior suppression of neointimal hyperplasia, as measured by both in-stent and in-segment late lumen loss (Dibra et al 2005). This ﬁnding corresponds to a signiﬁcant reduction in restenosis rates (16.5% in-segment restenosis in the paclitaxel group versus 6.9% in the sirolimus group) and a much lower need for repeat intervention with CYPHER stent. Target lesion revascularization rates were 12.0% and 6.4% for the pacli- taxel and sirolimus groups respectively (Dibra et al 2005). The results from the REALITY trial show no signiﬁcant differences in the primary end point of binary restenosis at 8 months among the 1386 patients treated with either the CYPHER or the TAXUS. Late loss and diameter stenosis were signiﬁcantly less in the CYPHER-treated patients, but this did not translate into differences in the secondary end points of target lesion and target vessel revascularizations at one year. The composite end point of cardiac death, MI, coronary artery bypass grafting (CABG), or repeat percutane- ous coronary intervention (PCI) (MACE) at one year was no different between the two groups. REALITY also does not settle the question of stent thrombosis, which trended higher in the Taxus-treated patients (Morice et al 2006). The issue of stent thrombosis is discussed below. Similarly, TAXI, a prospective randomized comparison between PES and SES in the real world of interventional cardiology conﬁrmed that the high success rate obtained with both stents in randomized trials can be replicated in routine clinical practice. A total of 202 patients were enrolled into the study. One hundred patients were treated with a PES and 102 received an SES. Target lesion revascularisation rates were low in both groups: 1% with paclitaxel and 3% with sirolimus. The investigators acknowledged that in this small group of patients they were unable to show any advantage of one stent over the other (Goy et al 2005). ISAR-SMART 3 involved a total of 360 patients undergo- ing PCI for de novo lesions in native coronary arteries with a diameter of <2.80 mm. They were randomly assigned to receive either an SES or a PES. The primary endpoint was in-stent late luminal loss, the primary endpoint, was 0.32 mm, which was greater than that in the SES group, failing to show non-inferiority of the PES to the SES. Angiographic resteno- sis was reported in 19.0% of the PES cohort as compared with 11.4% in those treated with the SES. Similarly, target lesion revascularization rates were 14.7% and 6.6% for the paclitaxel and sirolimus groups respectively (Mehilli et al 2006). Conducted at Cordoba and Las Palmas in Spain, the CORPAL trial evaluated 1182 lesions in 910 patients identi- ﬁed as being at high risk for restenosis. Consecutive patients with documented myocardial ischemia secondary to coronary lesions were randomized to either SES or PES. There were no signiﬁcant differences in terms of immediate or 1-month follow-up. However, late evaluation (15 ± 8 months) did reveal differences in terms of restenosis rates (15% vs 23% for SES and PES respectively, and target lesion revascular- ization (4% vs 7%) (Suarez de Lezo et al 2005). Data from the multi-centre, prospective, randomized controlled LONG-DES II trial revealed that patients treated with SES had signiﬁcantly less in-stent late loss than those treated with paclitaxel-eluting stents (0.05 ± 0.22 mm vs 0.25 ± 0.35 mm). Major adverse cardiac event rates were 3% for sirolimus vs 10.3% for paclitaxel (Hong et al 2006). 194 Vascular Health and Risk Management 2007:3(2)