Bosiers et al may inﬂuence outcomes depending on the vascular bed treated, thus, below are presented results subdivided into anatomic regions. Lower limb arteries Femoropopliteal vasculature The investigators of the SIROCCO trial (SIROlimus Coated COrdis Self-expandable Stent), were the ﬁrst to publish the outcomes following use of sirolimus-eluting (SES) stents in the infrainguinal vasculature. This double-blind RCT evalu- ated the efﬁcacy of sirolimus-eluting self-expanding nitinol stents versus the same commercially available bare metal stents (SMART®, Cordis. Miami, FL, USA) in the super- ﬁcial femoral artery (SFA) (Duda et al 2002, 2005, 2006). The study was performed in 2 phases. After interim analysis of SIROCCO I revealed a high fracture rate, it was decided to reduce the maximal allowed lesion length from 20 cm to 14.5 cm in order to decrease the number of stents implanted from 3 to 2 in an attempt to avoid stent fractures (Duda et al 2002). In total, 93 patients with occlusions or stenoses (aver- age lesion length 8.3 cm) at the level of the SFA were included. The sirolimus-eluting SMART® stent was implanted in 47 and the bare SMART® nitinol stent in 46 patients. (Duda et al 2006) Both groups were followed for a mean of 24 months and no signiﬁcant differences were observed in either the peak velocity ratios (PVR), nor ankle-brachial index (ABI). At 24 months, the in-stent restenosis rate as measured by duplex ultrasound was not signiﬁcantly different between the sirolimus and the bare metal stent group, being 22.9% versus 21.1%, respectively. The target lesion revasculariza- tion (TLR) was 6% in the sirolimus group and 13% in the bare stent group. Higher values were found for target vessel revascularization (TVR): 13% and 22%, respectively. (Duda et al 2006) In both groups at 24 months, no amputations were performed as a result of complications from stenting. The SIROCCO-investigators concluded that the study provided objective evidence supporting the safety and efﬁcacy of drug- eluting and bare metal self-expanding nitinol SMART® stents in patients with chronic limb ischemia (CLI) and TASC C SFA lesions. They stated that no signiﬁcant difference could be found between the bare and the sirolimus-eluting SMART® stents, because the restenosis rate in the bare stent group was unexpectedly low (Duda et al 2002, 2005, 2006). To date, SIROCCO is the only completed RCT that has published results showing the utility of DES in the femoro- popliteal (FP) vasculature. At the preparation of this manu- script, 2 further clinical trials investigating the efﬁcacy of different types of DES for the treatment of FP atherosclerotic 554 occlusive disease are in the process of completing patient enrollment. It is hoped that publication of these ongoing trials will clarify whether DES are in fact superior to bare metal stents (BMS) in the FP area. The ﬁrst trial from Abbott Vascular Inc (Santa Clara, CA, USA) has completed enrollment of 100 patients. Known as the STRIDES trial (SFA Treatment with Drug-Eluting Stents Study), this is a European prospective non-randomized con- trolled trial that aims to evaluate the safety and performance of the DYNALINK-E® Everolimus-Eluting Peripheral Stent System in above-knee (AK) FP de novo or restenotic lesions. The maximal length of lesion treated is 17 cm. The second trial, the ZILVER® PTX™ paclitaxel-eluting stent study from Cook Inc (Bloomington, IN, USA) is also completing enroll- ment. In this study, the safety and efﬁcacy of the ZILVER® PTX™ stent is being evaluated in the AK FP vasculature for lesions up to 28 cm in length. This study has 2 components, the ﬁrst being a randomized investigational device exemption (IDE) trial that compares 240 ZILVER® PTX™ patients with 240 control patients. The control patients undergo percutane- ous transluminal angioplasty (PTA) followed by placement of ZILVER® BMS for procedural failures. The second phase is a Global Registry evaluating an extra 760 ZILVER® PTX™, thus, giving a total of 1000 patients who will have received the paclitaxel-coated ZILVER® stents for FP lesions. At the 2007 International Symposium on Endovascular Therapies (ISET) meeting in Miami (http://www.iset.org/), Michael Dake presented an interim report for the IDE-phase, on behalf of the ZILVER® PTX™ investigators. Data on the ﬁrst 60 patients enrolled in the trial were presented. Twenty-eight patients were assigned to the ZILVER® PTX™ group and 32 to the PTA control group. The mean follow-up duration was 9 months (range 6–18 months). Based on this preliminary data set, Dake concluded that the use of DES in AK FP lesions did not result in any safety concerns. The event-free survival was 89% in the ZILVER® PTX™ versus 91% in the PTA groups. Stent safety at 6 months was evaluated by plain X-ray, which showed no stent fractures in any of the implanted stents, and IVUS which did not reveal aneurysm formation or strut malapposition. Taking into account acute treatment failure, the investigators found a higher 9-month primary patency rate in the patients assigned to the ZILVER® PTX™ treatment (90%) in comparison to the PTA control group (52%). Stent effectiveness as evaluated by prelimi- nary results in this analysis leads us to anticipate an equally encouraging ﬁnal trial outcome. These 2 landmark DES trials are of utmost importance for the endovascular community because positive results could Vascular Health and Risk Management 2008:4(3)