[Treatment of lesions with a high risk of stenosis. Comparative study in 300 patients of rapamycin- and Paclitaxel-eluting polymer-based stents, and bare metal stents].
OBJECTIVE
Rapamycin- and taxol-eluting stents have been shown to reduce restenosis, but there are no large-scale studies of their usefulness in lesions with a high risk of restenosis, or of the relative merits of the two devices. This prospective study compared their safety and efficacy in lesions with a high risk of restenosis.


METHODS
We included consecutive patients with lesions to treat that met at least one of the following criteria: a) in-stent restenosis; b) diffuse (>20 mm) restenosis; c) small vessel (< or =2.5 mm) restenosis; or d) total occlusion. Patients received different devices along three consecutive study periods: bare metal (conventional) stents, sirolimus-eluting (rapamycin) stents and paclitaxel-eluting (taxol) stents.


RESULTS
One hundred patients in each group were included, for a total of 300 patients. In the sirolimus group, after 8.5+/-2 months of follow-up, there were 2 late thromboses (2%) and only 1 patient (1%) required target lesion revascularization. In the paclitaxel group 2 patients (2%) had in-hospital stent thrombosis (1 acute, 1 subacute), and after 9+/-2.5 months of follow-up only 1 patient (1%) needed target lesion revascularization. In the conventional group, after 8+/-2 months of follow-up, there was 1 subacute thrombosis (1%) and 15 patients (15%) had clinical restenosis requiring target lesion revascularization. Event-free survival curves were significantly better with drug-eluting stents (P<.01 vs conventional stents).


CONCLUSIONS
Rapamycin- and taxol-eluting stents were safe for lesions with a high risk of restenosis. These stents were associated with a lower rate of target lesion revascularization during follow-up compared to bare metal stents.
de la Torre Hernández
José M
JM
Unidad de Hemodinámica y Cardiología Intervencionista, Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain. hemodinaica@humv.es
Sainz Laso
Fermín
F
Ruisánchez
Cristina
C
Zueco
Javier
J
Figueroa
Alvaro
A
Colman
Thierry
T
D023903:Coronary Restenosis / Q000517:prevention & control*; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011108:Polymers; D011446:Prospective Studies; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents
D011108:Polymers; D017239:Paclitaxel; D020123:Sirolimus