7-hexanoyltaxol-eluting stent for prevention of neointimal growth: an intravascular ultrasound analysis from the Study to COmpare REstenosis rate between QueST and QuaDS-QP2 (SCORE).
BACKGROUND
Inhibition of neointimal tissue growth has been demonstrated in preliminary human feasibility studies with a stent-based polymer sleeve delivering 7-hexanoyltaxol. The Study to COmpare REstenosis rate between QueST and QuaDS-QP2 (SCORE) trial is a human, randomized, multicenter trial comparing 7-hexanoyltaxol (QP2)-eluting stents (qDES) with bare metal stents (BMS) in the treatment of de novo coronary lesions. The purpose of this substudy was to evaluate the acute expansion property and long-term neointimal responses of qDES compared with BMS as assessed by intravascular ultrasound (IVUS).


RESULTS
A total of 122 (qDES 66, BMS 56) patients were enrolled into the IVUS substudy. All IVUS images (immediately after the procedure and at 6-month follow-up) were analyzed at an independent core laboratory in a blind manner. At baseline, qDES achieved stent expansion similar to BMS. At follow-up, qDES showed reduced neointimal growth by 70% at the tightest cross section and by 68% over the stented segment (P<0.0001 for both), resulting in a significantly larger lumen in qDES than in BMS. Unlike intracoronary brachytherapy, there was no evidence of negative edge effects, unhealed dissections, or late stent-vessel wall malapposition over the stented and adjacent references segments in either group.


CONCLUSIONS
Detailed IVUS analysis revealed that qDES had comparable acute mechanical and superior long-term biological effects to BMS. Although the long-term benefits and limitations of this technology require further investigation, the reduction in neointimal thickenings demonstrated that local delivery of 7-hexanoyltaxol through polymer sleeves augments conventional mechanical treatment of atherosclerotic disease.
D019917:Blood Vessel Prosthesis Implantation; D001952:Bridged-Ring Compounds / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000601:surgery; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000601:surgery; D004343:Drug Implants / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015607:Stents / Q000009:adverse effects; D013995:Time; D016896:Treatment Outcome; D017539:Tunica Intima / Q000187:drug effects*; D018084:Ultrasonography, Interventional
D001952:Bridged-Ring Compounds; D004343:Drug Implants; C434083:7-hexanoyltaxol