Release profiles in drug-eluting stents: issues and uncertainties.

This review presents the current data on drug release from drug-eluting stents and the effects of the release profiles on animal and human data for coronary stenosis. Data for the two most important drugs, sirolimus (rapamycin) and paclitaxel, are presented, the polymers used are described and the observed release profiles are discussed for various polymer carriers. The current literature on the tissue compatibility of the polymers commonly used in drug-eluting stents is also discussed. The range of release rates from stents studied to date is limited for sirolimus, but somewhat broader for paclitaxel. Animal and human data comparing the different release profiles are limited to about 6 months for animals and 2-4 years for humans. From the data available, it appears that for both sirolimus and paclitaxel, a slow-releasing drug-eluting stent leads to slightly more favorable angiographic outcomes than more rapid release. Most of the complications arising from the use of drug-eluting stents are attributed to incomplete healing; one possible clinical consequence of this delay in healing is that anti-platelet therapy needs to be maintained over a much longer period than is the case for bare metal stents.