Local delivery of enoxaparin to decrease restenosis after stenting: Results of initial multicenter trial - Polish-American local lovenox NIR assessment study (The POLONIA study)

Background-Enoxaparin inhibits smooth muscle cell proliferation in experime ntal models. Intimal hyperplasia has been found to be the principal cause o f restenosis after coronary stent implantation. We sought to determine whet her the intramural delivery of enoxaparin before stenting of de novo lesion s decreases restenosis. Methods and Results-One hundred patients who were undergoing stenting were randomly assigned to either local administration of enoxaparin during predi lation with reduced systemic heparinization or stenting with standard, syst emic heparinization. All patients were treated with the same type of stent (NIR). The primary study end point was late luminal loss. The secondary end points were major adverse cardiac events, target lesion revascularization, and angiographic restenosis at 6 months. Angiographic follow-up at 6 month s was completed in all except 1 patient. Late luminal loss was reduced to 0 .76+/-0.42 mm in the local enoxaparin delivery group versus 1.07+/-0.49 mm in the systemic heparinization group (P<0.001). Restenosis, using a binary definition, occurred in 10% of patients in the enoxaparin group and in 24% of patients in the systemic heparinization group (P<0.05). Target lesion re vascularization rates occurred in 8% of the enoxaparin group and 22% of the systemic heparinization group (P<0.05). There were no deaths and no emerge nt CABGs were performed. The only subacute stent closure and non-Q-wave inf arction occurred in a patient assigned to the systemic heparinization group . Conclusions-This is the first prospective randomized trial in which the loc al delivery of a drug, enoxaparin, resulted in significant reduction in lat e luminal loss and restenosis after stent implantation in de novo coronary lesions.