Zotarolimus-eluting stent utilization in small-vessel coronary artery disease (ZEUS)

Abstract

The role of the second-generation zotarolimus-eluting stent RESOLUTE in small-vessel coronary artery disease is unclear. The aim of this study was examine the angiographic results of RESOLUTE in de novo coronary lesions of ≥50 % diameter stenosis in target vessels ≤2.5 mm. From August 2008 to April 2010, 142 symptomatic patients with 159 lesions who fitted the inclusion criteria were treated with RESOLUTE. The mean age of patients was 66 ± 10 years, with male predominance (66 %). Diabetes mellitus was found in 62 (43.7 %) patients, whereas multivessel disease was observed in 105 (73.9 %). The mean stent size and length used were 2.33 ± 0.13 and 22 ± 8 mm, respectively. Follow-up angiography was performed on 143 (89.9 %) lesions in 127 (89.4 %) patients at a mean of 10.3 ± 3.6 months. Angiographic restenosis was found in 9 (6.3 %) lesions; the late loss was 0.26 ± 0.34 mm. At 1-year follow-up there were four cardiovascular deaths, two nonfatal myocardial infarctions, and six repeated revascularizations. The resultant major adverse cardiac event rate was 8.5 %. The use of RESOLUTE to treat small-vessel disease is associated with good clinical and angiographic outcomes at 1 year.

Comparison of Long-Term Outcomes in Real-World Patients Between Resolute Zotarilumus-Eluting and Paclitaxel-Eluting Stents in Small Vessel

“…The R-ZES is a second-generation device that has been studied in international small vessel trials. 8,18 Caputo et al 8 showed that the 2-year clinical outcomes after implantation of the second-generation R-ZES in patients with small vessels were similar to those in patients with larger vessels. There was no significant difference in target lesion failure (10.1% vs 8.7%; P = .54) at 2 years.…”

“…Angiographic restenosis was found in 9 (6.3%) lesions, and the rate of major adverse cardiac events was 8.5%. 18 More recently, the ENDEA-VOR IV randomized controlled trial (of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions), 19 which assessed the outcomes after implantation of E-ZES and PES in patients with single de novo coronary lesions, showed that E-ZES and PES were associated with similar TLR (7.7% vs 8.6%, P ¼ .70) and TVR (17.2% vs 21.1%, P ¼ .061) rates; however, the incidence of cardiac death or MI was lower with E-ZES (6.4% vs 9.1%, P ¼ 0.048), primarily driven by a lower rate of target vessel MI with E-ZES (2.6% vs. 6.0%, P ¼ .002). Although overall definite/probable stent thrombosis rates were similar between stents (1.3% vs 2%, p ¼ 0.42), rates of very late stent thrombosis (0.4% vs. 1.8%, P ¼ .012) and late MI events (1.3% vs. 3.5%, P ¼ .008) were significantly lower with E-ZES compared with PES.…”

A novel ultrasound controlled paclitaxel releasing balloon catheter versus plain balloon catheter in the treatment of small coronary vessel stenosis: study protocol of a randomized controlled clinical trial (Vasoguard I Trial)

“…Promising results have been shown of DCB in the intervention of SVD, in-stent restenosis (ISR), and some other special coronary lesions. The PEPCAD I study [13,33] was the rst trial to assess the performance of a DCB in a high risk patient population with small coronary vessel disease, one hundred and eighteen patients with a target vessel diameter of 2.25-2.8 mm were treated by paclitaxel coated balloons (PCB), LLL in the 6 month angiographic follow-up and MACE rate in the 12 month clinical follow-up are both promising and are not inferior to the results of DES for SVD reported by other studies [34][35][36][37][38]. In BELLO study [17], which is the rst long-term follow-up RCT comparing PCB with paclitaxel eluting stent for SVD, PCB showed signi cant lower LLL in the 6 month angiographic follow-up and a tendency towards lower incidence of MACE during 2 year clinical follow-up compared to DES.…”

Impact of catheter size on reliability of quantitative coronary angiographic measurements (comparison of 4Fr and 6Fr catheters)

“…Koning et al [3] showed that 6Fr and 7Fr Mallinckrodt Softouch catheters satisfy the acceptance criteria for QCA calibration procedures, in that the average difference between the angiographically measured and true diameters is smaller than 3.5 % and the pooled standards of the measured diameters are on the order of 0.1 mm or lower [4]. Accurate and precise QCA analysis is necessary in evaluating acute gain and late loss after percutaneous coronary intervention (PCI) [5], or disease progression [6,7] especially in multicenter trials [8]. However, the Abstract To evaluate the feasibility of catheter down sizing for QCA, the reliability of a 4Fr catheter as a calibration device was evaluated.…”