Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the zilver PTX randomized and single-arm clinical studies

Michael D. Dake, Gary M. Ansel, Michael R. Jaff, Takao Ohki, Richard R. Saxon, H. Bob Smouse, Scott A. Snyder, Erin E. O'Leary, Gunnar Tepe, Dierk Scheinert, Thomas Zeller

Research output: Contribution to journalArticlepeer-review

271 Scopus citations

Abstract

Objectives 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 lesions. The RCT compared the DES with percutaneous transluminal angioplasty (PTA) and provisional bare-metal stent (BMS) placement. Background Local drug delivery for superficial femoral artery lesions has been investigated with the intent of limiting restenosis similarly to DES for the coronary arteries. One-year outcomes of DES in the superficial femoral artery are promising, but longer-term benefits have not been established. Methods In the RCT, patients were randomly assigned to primary DES implantation (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) placement. 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% vs. 77.9%, p = 0.02) and primary patency (74.8% vs. 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% vs. 64.1%, p < 0.01) and achieved higher sustained clinical benefit (83.9% vs. 68.4%, p = 0.05). Two-year freedom from target lesion revascularization with primary DES placement was 80.5% in the single-arm study and 86.6% in the RCT. Conclusions Two-year outcomes with the paclitaxel-eluting stent support its sustained safety and effectiveness in patients with femoropopliteal artery disease, including the long-term superiority of the DES to PTA and to provisional BMS placement. (Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery; NCT00120406; Zilver® PTX™ Global Registry; NCT01094678).

Original languageEnglish (US)
Pages (from-to)2417-2427
Number of pages11
JournalJournal of the American College of Cardiology
Volume61
Issue number24
DOIs
StatePublished - Jun 18 2013
Externally publishedYes

Keywords

  • angioplasty
  • drug-eluting stent(s)
  • paclitaxel-eluting stent(s)
  • peripheral arterial disease

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Fingerprint

Dive into the research topics of 'Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the zilver PTX randomized and single-arm clinical studies'. Together they form a unique fingerprint.

Cite this