Initial results of the quanam drug eluting stent (QuaDS-QP-2) registry (BARDDS) in human subjects

Thirty-two patients presenting with varied coronary syndromes and anatomy w ere treated with a new coronary multisleeve drug delivery coronary stem (Qu aDS-QP-2) containing up to 4,000 mug of a taxol-derived lipophilic microtub ule inhibitor (QP2). The device was successfully implanted in 32 patients w ho have been followed for up to 2 years. Twenty-five patients have undergon e stress ECHO or SPECT Thallium and all are currently asymptomatic. Thirtee n patients have already been restudied angiographically, by IVUS and/or by SPECT Thallium testing and are detailed in this report. Angiographic, IVUS, and SPECT Thallium have been controlled at a mean of 11.2 months (range, 6 -15 months) in this 13-patient cohort. Although all 13 QuaDS-QP-2 (QDES) st ents were angiographically and IVUS patent, two reinterventions have been r equired in the 32-patient study group thus far, both relate to either new d isease or to distal, small-vessel disease beyond the stent. There was no ev idence of significant proliferation in the QDES devices. On the basis of th is preliminary data and a European pilot study, a controlled randomized tri al (SCORE) is currently in progress in western Europe. (C) 2001 Wiley-Liss, Inc.