Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: Twelve-month zilver PTX randomized study results

Michael D. Dake, Gary M. Ansel, Michael R. Jaff, Takao Ohki, Richard R. Saxon, H. Bob Smouse, Thomas Zeller, Gary S. Roubin, Mark W. Burket, Yazan Khatib, Scott A. Snyder, Anthony O. Ragheb, J. King White, Lindsay S. Machan

Research output: Contribution to journalArticle

412 Citations (Scopus)

Abstract

Background-Sustained benefits of drug-eluting stents in femoropopliteal arteries have not been demonstrated. This prospective, multinational, randomized study was designed to compare the 12-month safety and effectiveness of a polymer-free, paclitaxel-coated nitinol drug-eluting stent (DES) with percutaneous transluminal angioplasty (PTA) and provisional bare metal stent (BMS) placement in patients with femoropopliteal peripheral artery disease. Methods and Results-Patients were randomly assigned to primary DES implantation (n=236) or PTA (n=238). Demographics and lesion characteristics were similar between groups (eg, average lesion length, approximately 65±40 mm). One hundred twenty patients had acute PTA failure and underwent secondary random assignment to provisional DES (n=61) or BMS (n=59). Primary end points were the 12-month rates of event-free survival and patency in the primary DES and PTA groups. Compared with the PTA group, the primary DES group exhibited superior 12-month event-free survival (90.4% versus 82.6%; P=0.004) and primary patency (83.1% versus 32.8%; P<0.001), satisfying the primary hypotheses. In the secondary evaluations, (1) the primary DES group exhibited superior clinical benefit compared with the PTA group (88.3% versus 75.8%; P<0.001), (2) the provisional DES group exhibited superior primary patency (89.9% versus 73.0%; P=0.01) and superior clinical benefit (90.5% and 72.3%, P=0.009) compared with the provisional BMS group, and (3) the stent fracture rate (both DES and BMS) was 0.9% (4/457). Conclusions-Femoropopliteal peripheral artery disease treatment with the paclitaxel-eluting stent was associated with superior 12-month outcomes compared with PTA and provisional BMS placement. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00120406.

Original languageEnglish (US)
Pages (from-to)495-504
Number of pages10
JournalCirculation: Cardiovascular Interventions
Volume4
Issue number5
DOIs
StatePublished - Oct 1 2011
Externally publishedYes

Fingerprint

Drug-Eluting Stents
Balloon Angioplasty
Paclitaxel
Stents
Angioplasty
Metals
Peripheral Arterial Disease
Disease-Free Survival
Polymers
Arteries
Demography
Clinical Trials
Safety

Keywords

  • Angioplasty
  • Drug-eluting stent
  • Paclitaxel-eluting stent
  • Peripheral vascular disease

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease : Twelve-month zilver PTX randomized study results. / Dake, Michael D.; Ansel, Gary M.; Jaff, Michael R.; Ohki, Takao; Saxon, Richard R.; Smouse, H. Bob; Zeller, Thomas; Roubin, Gary S.; Burket, Mark W.; Khatib, Yazan; Snyder, Scott A.; Ragheb, Anthony O.; White, J. King; Machan, Lindsay S.

In: Circulation: Cardiovascular Interventions, Vol. 4, No. 5, 01.10.2011, p. 495-504.

Research output: Contribution to journalArticle

Dake, MD, Ansel, GM, Jaff, MR, Ohki, T, Saxon, RR, Smouse, HB, Zeller, T, Roubin, GS, Burket, MW, Khatib, Y, Snyder, SA, Ragheb, AO, White, JK & Machan, LS 2011, 'Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: Twelve-month zilver PTX randomized study results', Circulation: Cardiovascular Interventions, vol. 4, no. 5, pp. 495-504. https://doi.org/10.1161/CIRCINTERVENTIONS.111.962324
Dake, Michael D. ; Ansel, Gary M. ; Jaff, Michael R. ; Ohki, Takao ; Saxon, Richard R. ; Smouse, H. Bob ; Zeller, Thomas ; Roubin, Gary S. ; Burket, Mark W. ; Khatib, Yazan ; Snyder, Scott A. ; Ragheb, Anthony O. ; White, J. King ; Machan, Lindsay S. / Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease : Twelve-month zilver PTX randomized study results. In: Circulation: Cardiovascular Interventions. 2011 ; Vol. 4, No. 5. pp. 495-504.
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abstract = "Background-Sustained benefits of drug-eluting stents in femoropopliteal arteries have not been demonstrated. This prospective, multinational, randomized study was designed to compare the 12-month safety and effectiveness of a polymer-free, paclitaxel-coated nitinol drug-eluting stent (DES) with percutaneous transluminal angioplasty (PTA) and provisional bare metal stent (BMS) placement in patients with femoropopliteal peripheral artery disease. Methods and Results-Patients were randomly assigned to primary DES implantation (n=236) or PTA (n=238). Demographics and lesion characteristics were similar between groups (eg, average lesion length, approximately 65±40 mm). One hundred twenty patients had acute PTA failure and underwent secondary random assignment to provisional DES (n=61) or BMS (n=59). Primary end points were the 12-month rates of event-free survival and patency in the primary DES and PTA groups. Compared with the PTA group, the primary DES group exhibited superior 12-month event-free survival (90.4{\%} versus 82.6{\%}; P=0.004) and primary patency (83.1{\%} versus 32.8{\%}; P<0.001), satisfying the primary hypotheses. In the secondary evaluations, (1) the primary DES group exhibited superior clinical benefit compared with the PTA group (88.3{\%} versus 75.8{\%}; P<0.001), (2) the provisional DES group exhibited superior primary patency (89.9{\%} versus 73.0{\%}; P=0.01) and superior clinical benefit (90.5{\%} and 72.3{\%}, P=0.009) compared with the provisional BMS group, and (3) the stent fracture rate (both DES and BMS) was 0.9{\%} (4/457). Conclusions-Femoropopliteal peripheral artery disease treatment with the paclitaxel-eluting stent was associated with superior 12-month outcomes compared with PTA and provisional BMS placement. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00120406.",
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T1 - Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease

T2 - Twelve-month zilver PTX randomized study results

AU - Dake, Michael D.

AU - Ansel, Gary M.

AU - Jaff, Michael R.

AU - Ohki, Takao

AU - Saxon, Richard R.

AU - Smouse, H. Bob

AU - Zeller, Thomas

AU - Roubin, Gary S.

AU - Burket, Mark W.

AU - Khatib, Yazan

AU - Snyder, Scott A.

AU - Ragheb, Anthony O.

AU - White, J. King

AU - Machan, Lindsay S.

PY - 2011/10/1

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N2 - Background-Sustained benefits of drug-eluting stents in femoropopliteal arteries have not been demonstrated. This prospective, multinational, randomized study was designed to compare the 12-month safety and effectiveness of a polymer-free, paclitaxel-coated nitinol drug-eluting stent (DES) with percutaneous transluminal angioplasty (PTA) and provisional bare metal stent (BMS) placement in patients with femoropopliteal peripheral artery disease. Methods and Results-Patients were randomly assigned to primary DES implantation (n=236) or PTA (n=238). Demographics and lesion characteristics were similar between groups (eg, average lesion length, approximately 65±40 mm). One hundred twenty patients had acute PTA failure and underwent secondary random assignment to provisional DES (n=61) or BMS (n=59). Primary end points were the 12-month rates of event-free survival and patency in the primary DES and PTA groups. Compared with the PTA group, the primary DES group exhibited superior 12-month event-free survival (90.4% versus 82.6%; P=0.004) and primary patency (83.1% versus 32.8%; P<0.001), satisfying the primary hypotheses. In the secondary evaluations, (1) the primary DES group exhibited superior clinical benefit compared with the PTA group (88.3% versus 75.8%; P<0.001), (2) the provisional DES group exhibited superior primary patency (89.9% versus 73.0%; P=0.01) and superior clinical benefit (90.5% and 72.3%, P=0.009) compared with the provisional BMS group, and (3) the stent fracture rate (both DES and BMS) was 0.9% (4/457). Conclusions-Femoropopliteal peripheral artery disease treatment with the paclitaxel-eluting stent was associated with superior 12-month outcomes compared with PTA and provisional BMS placement. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00120406.

AB - Background-Sustained benefits of drug-eluting stents in femoropopliteal arteries have not been demonstrated. This prospective, multinational, randomized study was designed to compare the 12-month safety and effectiveness of a polymer-free, paclitaxel-coated nitinol drug-eluting stent (DES) with percutaneous transluminal angioplasty (PTA) and provisional bare metal stent (BMS) placement in patients with femoropopliteal peripheral artery disease. Methods and Results-Patients were randomly assigned to primary DES implantation (n=236) or PTA (n=238). Demographics and lesion characteristics were similar between groups (eg, average lesion length, approximately 65±40 mm). One hundred twenty patients had acute PTA failure and underwent secondary random assignment to provisional DES (n=61) or BMS (n=59). Primary end points were the 12-month rates of event-free survival and patency in the primary DES and PTA groups. Compared with the PTA group, the primary DES group exhibited superior 12-month event-free survival (90.4% versus 82.6%; P=0.004) and primary patency (83.1% versus 32.8%; P<0.001), satisfying the primary hypotheses. In the secondary evaluations, (1) the primary DES group exhibited superior clinical benefit compared with the PTA group (88.3% versus 75.8%; P<0.001), (2) the provisional DES group exhibited superior primary patency (89.9% versus 73.0%; P=0.01) and superior clinical benefit (90.5% and 72.3%, P=0.009) compared with the provisional BMS group, and (3) the stent fracture rate (both DES and BMS) was 0.9% (4/457). Conclusions-Femoropopliteal peripheral artery disease treatment with the paclitaxel-eluting stent was associated with superior 12-month outcomes compared with PTA and provisional BMS placement. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00120406.

KW - Angioplasty

KW - Drug-eluting stent

KW - Paclitaxel-eluting stent

KW - Peripheral vascular disease

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