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Initial results of the quanam drug eluting stent (QuaDS‐QP‐2) registry (BARDDS) in human subjects
Author(s) -
de la Fuente Luis M.,
Miano Jorge,
Mrad Jorge,
Penaloza Eduardo,
Yeung Alan C.,
Eury Robert,
Froix Michael,
Fitzgerald Peter J.,
Stertzer Simon H.
Publication year - 2001
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.1207
Subject(s) - medicine , asymptomatic , stent , thallium , coronary artery disease , intravascular ultrasound , cohort , drug eluting stent , radiology , restenosis , cardiology , inorganic chemistry , chemistry
Thirty‐two patients presenting with varied coronary syndromes and anatomy were treated with a new coronary multisleeve drug delivery coronary stent (QuaDS‐QP‐2) containing up to 4,000 μg of a taxol‐derived lipophilic microtubule inhibitor (QP2). The device was successfully implanted in 32 patients who have been followed for up to 2 years. Twenty‐five patients have undergone stress ECHO or SPECT Thallium and all are currently asymptomatic. Thirteen 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) stents were angiographically and IVUS patent, two reinterventions have been required in the 32‐patient study group thus far, both relate to either new disease or to distal, small‐vessel disease beyond the stent. There was no evidence of significant proliferation in the QDES devices. On the basis of this preliminary data and a European pilot study, a controlled randomized trial (SCORE) is currently in progress in western Europe. Cathet Cardiovasc Intervent 2001;53:480–488. © 2001 Wiley‐Liss, Inc.