Infrapopliteal Drug-Eluting Angioplasty Versus Stenting - IDEAS

Sep 17, 2014
Font Size
A
A
A
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
University of Patras, Greece
Date Published:
01/01/2014
Date Updated:
09/17/2014
Original Posted Date:
09/17/2014
References

Description:

The current trial sought to compare outcomes among patients undergoing drug-eluting stent (DES) versus paclitaxel-coated balloon (PCB) angioplasty for infrapopliteal arterial disease.

Hypothesis:

PCB angioplasty would be superior to DES for angiographic outcomes in patients with long-segment infrapopliteal disease.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Angiographically documented infrapopliteal disease
  • Rutherford category of peripheral arterial disease between class 3 and 6
  • Lesion length between 70 and 220 mm
  • Lesions situated in the proximal, mid, and mid to distal segments of the tibial vessels

    Number of enrollees: 50
    Duration of follow-up: 6 months
    Mean patient age: 71 years
    Percentage female: 24%
    New York Heart Association class: 56.5%

Exclusions:

  • Distal arterial occlusive disease compromising below-the-ankle runoff of the target vessel to be treated (e.g., blocked dorsalis pedis in case of anterior tibial artery treatment or occluded plantar arteries in case of posterior tibial artery treatment)

Primary Endpoints:

  • Angiographic restenosis >50% (binary) of the target lesion at 6 months

Secondary Endpoints:

  • Technical success defined as the absence of flow-limiting dissection and no significant residual stenosis by visual estimate
  • Immediate post-procedure stenosis
  • Late lumen loss at 6 months
  • Post-procedure complications
  • Target vessel revascularization at 6 months
  • Limb salvage at 6 months

Drug/Procedures Used:

All procedures were performed with antegrade access via the common femoral artery. 6 Fr sheath was inserted and 5,000 units of UFH were administered. Patients with infrapopliteal arterial disease and lesion length >70 mm were randomized in a 1:1 fashion to receive either angioplasty with PCB or DES placement. The PCB under investigation was the IN.PACT Amphirion (Medtronic, Brescia, Italy), which was available in sizes with 3-4 mm diameters and 40-120 mm lengths. DES used included zotarolimus-eluting, sirolimus-eluting, and everolimus-eluting stents.

After the device was deployed (DES) or inflated (PCB), a second angiogram was performed. In the case of residual stenosis, a further prolonged dilation was performed in both groups and a final angiogram was acquired. In the PCB group, the inflation time was 1 minute. In the DES group, inflation time was 20 seconds.

Concomitant Medications:

Dual antiplatelet therapy for 6 months

Principal Findings:

A total of 50 patients were randomized at a single center, 25 to PCB (25 vessels) and 25 to DES (30 vessels). Baseline characteristics were fairly similar between the two arms. Approximately 70% had diabetes, 30% were smokers, and 28% had concomitant coronary artery disease. About 66% also had inflow iliofemoral disease. Nearly 18% of treated lesions were total occlusions, with baseline mean lesion length of nearly 140 mm. Nearly 50% had evidence of nonhealing wounds. Target vessel was anterior tibial artery in 51%, posterior tibial artery in 26%, and peroneal artery in the rest. Technical success was 96% in the PCB arm and 100% in the DES arm.

Immediate residual post-procedure stenosis was significantly lower in DES versus PCB arms (9.6% vs. 24.8%, p < 0.0001). Similarly, binary restenosis (≥50%) was lower (28% vs. 57.8%, p = 0.046). Late lumen loss at 6 months was similar in both groups (1.35 mm vs. 1.15 mm, p = 0.64). Target lesion revascularization (TLR) (13.3% vs. 7.7%, p = 0 .65), total occlusion (15.8% vs. 20%, p = 0.72), and amputation rates (1 vs. 2, p = 1.0) were similar between the DES and PCB arms. The investigators believed that both amputations in the DES arm were due to stent thrombosis, but no angiographic evidence was available. There was no difference in symptomatic benefit or wound healing between the two arms. No cases of stent fracture were reported.

Interpretation:

The results of this small single-center trial indicate that DES is superior to PCB for immediate angiographic appearance and 6-month binary stenosis in patients with long infrapopliteal arterial lesions. However, TLR and occlusion rates, as well as wound healing rates were similar. In addition, DES may carry a risk of acute stent thrombosis resulting in amputations.

These results are interesting, since traditionally infrapopliteal lesions have been treated with balloon angioplasty alone, with recent interest in the use of coronary DES. PCBs have shown promise in iliofemoral lesions; this and other similar smaller trials suggest a role for PCB in infrapopliteal lesions as well.

References:

Siablis D, Kitrou PM, Spiliopoulos S, Katsanos K, Karnabatidis D. Paclitaxel-coated balloon angioplasty versus drug-eluting stenting for the treatment of infrapopliteal long-segment arterial occlusive disease: the IDEAS randomized controlled trial. JACC Cardiovasc Interv 2014;7:1048-56.

Editorial: Micari A, Vadalà G. David Versus Goliath: The First Round. JACC Cardiovasc Interv 2014;7:1057-9.

Keywords: Polychlorinated Biphenyls, Coronary Artery Disease, Drug-Eluting Stents, Femoral Artery, Sirolimus, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Paclitaxel, Thrombosis, Research Personnel, Wound Healing, Tibial Arteries, Diabetes Mellitus


< Back to Listings