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 were treated with a new coronary multisleeve drug delivery coronary stent (QuaDS-QP-2) containing up to 4,000 microg 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.
de la Fuente
L M
LM
Instituto de Diagnostico de Buenos Aires, Buenos Aires, Argentina. mifitte@yahoo.com
Miano
J
J
Mrad
J
J
Penaloza
E
E
Yeung
A C
AC
Eury
R
R
Froix
M
M
Fitzgerald
P J
PJ
Stertzer
S H
SH
D000328:Adult; D000368:Aged; D000792:Angiography; D015331:Cohort Studies; D003327:Coronary Disease / Q000000981:diagnostic imaging; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015918:Infusion Pumps, Implantable; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012042:Registries; D015607:Stents; D015899:Tomography, Emission-Computed, Single-Photon; D018084:Ultrasonography, Interventional