Michael D. Dake

Publication Details

  • Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: two-year follow-up from the Zilver PTX randomized and single-arm clinical studies. Journal of the American College of Cardiology Dake, M. D., Ansel, G. M., Jaff, M. R., Ohki, T., Saxon, R. R., Smouse, H. B., Snyder, S. A., O'Leary, E. E., Tepe, G., Scheinert, D., Zeller, T. 2013

    Abstract:

    OBJECTIVE: A prospective, multinational randomized controlled trial (RCT) and a complementary single-arm study evaluated the 2-year safety and effectiveness of a paclitaxel-coated drug-eluting stent (DES) in patients with superficial femoral artery (SFA) lesions. The RCT compared the DES to percutaneous transluminal angioplasty (PTA) and provisional bare metal stent (BMS) placement. BACKGROUND: Local drug delivery for SFA lesions has been investigated with the intent of limiting restenosis similarly to DES for the coronary arteries. One-year outcomes of DES in the SFA are promising but longer-term benefits have not been established. METHODS: In the RCT, patients were randomly assigned to primary DES (n=236) or PTA (n=238). Acute PTA failure occurred in 120 patients, who underwent secondary randomization to DES (n=61) or BMS (n=59). The single-arm study enrolled 787 patients with DES treatment. RESULTS: Compared with the control group, the primary DES group demonstrated significantly superior 2-year event-free survival (86.6% versus 77.9%; p=0.02) and primary patency (74.8% versus 26.5%; p<0.01). In addition, the provisional DES group exhibited superior 2-year primary patency compared with the provisional BMS group (83.4% versus 64.1%; p<0.01) and achieved higher sustained clinical benefit (83.9% versus 68.4%; p=0.05). The 2-year freedom from target lesion revascularization with primary DES was 80.5% in the single-arm study and 86.6% in the RCT. CONCLUSIONS: The 2-year outcomes with the paclitaxel-eluting stent support its sustained safety and effectiveness in patients with femoropopliteal arterial disease, including the long-term superiority of the DES to PTA and to provisional BMS.

    View details for PubMedID 23583245

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