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

Catheter Cardiovasc Interv. 2001 Aug;53(4):480-8. doi: 10.1002/ccd.1207.

Abstract

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.

MeSH terms

  • Adult
  • Aged
  • Angiography
  • Cohort Studies
  • Coronary Disease / diagnostic imaging
  • Female
  • Follow-Up Studies
  • Humans
  • Infusion Pumps, Implantable*
  • Male
  • Middle Aged
  • Recurrence
  • Registries*
  • Stents*
  • Tomography, Emission-Computed, Single-Photon
  • Ultrasonography, Interventional