A randomized, controlled, multi-center trial comparing the safety and efficacy of zotarolimus-eluting and paclitaxel-eluting stents in de novo lesions in coronary arteries: Final results of the ZoMaxx II trial

A randomized, controlled, multicenter trial to evaluate the safety and efficacy of Zotarolimus‐ vs. Paclitaxel‐eluting stents in de novo occlusive lesions in coronary arteries: Five‐year results from the ZOMAXX I trial

“…Although the differences in TLR did not reach statistical significance, a sufficient trend was identified, which suggested that the antiproliferative capacity of ZoMaxx was inferior to Taxus during the first year. This same trend was demonstrated in the ZoMaxx II trial, which, although terminated early, also showed a near‐doubling of TLR after 9 months (4.1 vs. 2.5% in 1,099 patients) . It is noteworthy that for both ZoMaxx and Taxus in the ZoMaxx I trial, TLR was eventually required in ≤3% of patients over the ensuing 5‐year period.…”

“…The observed incidence of stent thrombosis over 5 years was nominally lower for ZoMaxx when compared with Taxus, whether defined prospectively within the protocol (ZoMaxx 0.5% vs. Taxus 2.5%; P = 0.12) or retrospectively by the ARC (ZoMaxx 1.5% vs. Taxus 3.0%; P = 0.34). This trend was not evident within the usual reporting period of 1 year , but became apparent after a full 5 years of follow‐up. Some have suggested that DES that generate more modest inhibition of neointimal hyperplasia might also generate less thrombosis in the long term, and that the PC coating is exceptionally biocompatible and nonthrombogenic .…”

Clinical outcomes of zotarolimus-eluting stents versus the first generation sirolimus-eluting stents and paclitaxel-eluting stents: A meta-analysis of randomized trials

“…However, the long-term safety of the two DESs has been questioned by recent studies and a meta-analysis of randomized trials have reported increased rates of late stent thrombosis and late-occurring death or myocardial infarction (MI) compared with BMS [2]. To fill this gap, we performed a meta-analysis with 9 publications resulted from 6 randomized clinical trials (ENDEAVOR III, ENDEAVOR IV, ISAR-TEST-2, ZoMaxx II, SORT OUT III and ZEST) [3][4][5][6][7][8][9][10][11]. Emerged large randomized trials have investigated the clinical outcomes of ZES, SES and PES and the results were inconsistent.…”

“…The study population of ENDEAVOR III [3,10], ENDEAVOR IV [4,5,9], ISAR-TEST-2 [7] and ZoMaxx II [11] were consecutive patients aged 18 years or older with symptomatic ischemic heart disease due to de novo stenotic lesions in native coronary arteries. Study population of SORT OUT III [6] and ZEST [8] were aged 18 years or older, had chronic stable coronary artery disease or acute coronary syndromes, and had at least one target lesion, defined as a lesion needing treatment with a drug-eluting stent.…”