Comparison of Zotarolimus-Eluting Stents With Sirolimus-Eluting and Paclitaxel-Eluting Stents

Abstract

Background— As a substudy of the large, randomized ZEST (Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent with Sirolimus-Eluting and PacliTaxel-Eluting Stent for Coronary Lesions) trial comparing first- and second-generation drug-eluting stents, we evaluated intimal hyperplasia (IH) and vascular changes using volumetric intravascular ultrasound analysis. Methods and Results— Complete angiographic and volumetric intravascular ultrasound data immediately after stenting and at 9-month follow-up were available in 162 patients with 183 lesions: 61 sirolimus-eluting stents (SES), 64 paclitaxel-eluting stents (PES), and 58 zotarolimus-eluting stents (ZES). External elastic membrane, stent, lumen, and peristent plaque volumes (external elastic membrane minus stent) were normalized by stent length. Percent IH volumes were calculated as [IH volume/stent volume]×100, %. Reduction of minimal luminal area) was greater in PES than SES (−1.4±1.5 mm 2 versus −0.7±0.9 mm 2 , P =0.003), whereas minimal luminal area change in ZES was not significantly different from SES (−1.2±1.0 mm 2 versus −0.7±0.9 mm 2 , P =0.055). Percent IH volume was less in SES compared with PES (9.8±6.0% versus 17.5±11.2%, P =0.002) or with ZES (9.8±6.0% versus 18.2±7.6%, P =0.005). Comparing ZES versus PES, there were no significant differences in %IH volume (17.5±11.2% versus 18.2±7.6%, P =0.779) or changes in normalized lumen volume (−1.2±1.3 mm 2 versus −1.1±0.8 mm 2 , P =0.452). Late stent malapposition was identified in 8 (13%) SES and 2 (3%) PES but in no ZES ( P =0.050). Angiographic restenosis was detected in 6 lesions (3 PES and 3 ZES). Conclusions— The degree of neointimal growth in ZES was similar to that in PES but less than that in SES. ZES had no late stent malappositions. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00418067.