Clinical trials in restenosis with 7-hexanoyltaxol and paclitaxel-eluting stents

Restenosis rates are lower with stent implantation than with balloon angioplasty. Nevertheless, even with the use of stenting, restenosis still occurs in approximately a third of patients with diabetes, small coronary vessels and long lesions. Animal studies with paclitaxel (Taxol, Bristol-Myers Squibb)-eluting stents, mainly in endothelium-denuded normal vessels, have shown that although paclitaxel reduces restenosis in the short-term, this may only delay rather than prevent restenosis. In clinical trials, stents eluting the paclitaxel derivative, 7-hexanoyltaxol, or paclitaxel without a polymer, also delay rather than prevent restenosis. Slowing the release of paclitaxel with a polymer base in the TAXUS trade mark series of clinical trials reduced the revascularization rate at 12 months, indicating that polymer-based paclitaxel is effective for longer periods of time. Further follow-up is necessary to determine whether polymer-based release of paclitaxel represents a longer delay or prevention of restenosis. To date, paclitaxel is showing promise as an eluting agent to prevent restenosis associated with stenting.