Drug-Eluting Balloons Lower TLR in Diabetics with Critical Limb Ischemia

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Compared with angioplasty using uncoated balloons, paclitaxel-eluting balloons reduce restenosis by almost one-third at 1 year in patients with diabetes and critical limb ischemia (CLI). However, according to findings reported online June 24, 2013, ahead of print in Circulation, limb salvage rates are no different between the 2 treatments.

Initial results of the Drug-Eluting Balloon in peripherAl InTErvention for Below the Knee Angioplasty Evaluation (DEBATE BTK) trial were presented in November 2011 at the Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco, CA.

For DEBATE BTK, researchers led by Francesco Liistro, MD, of San Donato Hospital (Arezzo Italy), randomized 132 patients with diabetes and CLI (n = 158 infrapopliteal lesions) at their institution to treatment with uncoated balloon angioplasty (n = 67) or the Amphirion In.Pact paclitaxel-eluting balloon (n = 65; Medtronic, Santa Rosa, CA) from November 2010 through October 2011.

Baseline characteristics were similar between the 2 groups. Ten percent of patients in each arm were on chronic dialysis and the majority had 0-1 patent tibial arteries at baseline.

There were no adverse events in hospital, with 8 deaths occurring during follow-up. Rates of cardiac and noncardiac death in the 2 groups were similar, with 1 case of DES bailout stenting performed in each arm. Angiographic follow-up was obtained in 111 out of 124 patients alive at 1 year.

Drug-Eluting Balloons Reduce Restenosis

At 12 months, major amputations were low and similar between groups, while other clinical and angiographic outcomes, including binary in-segment restenosis (primary endpoint), were improved with drug-eluting balloons (table 1).

Table 1. DEBATE BTK: Clinical and Angiographic Outcomes at 12 Months


Drug-Eluting Balloon
(n = 65)

Uncoated Balloon Angioplasty
(n = 67)

P Value





Major Amputation




Major Adverse Eventsa




Rutherford Class Category

0.90 ± 1.8

2.0 ± 2.3


Binary In-segment Restenosis



< 0.001





Complete Index Ulcer Healing




Vessel Occlusion



< 0.001

a Major adverse events = death, major amputation, TLR, and Rutherford class ≥4.

Time to index ulcer healing was also shorter in the drug-eluting balloon group (4.4 months vs. 5.2 months; P = 0.01).

The authors highlight that the relative risk reduction for 12-month restenosis with drug-eluting balloons was 64%. “This advantage was irrespective of lesion length, revascularization technique and baseline vessel conditions,” they add. “Moreover, the high frequency of angiographic follow-up and the very low rate of bail-out treatment with drug-eluting stents ensure the reliability of our results.”

However, the researchers caution that treatment with drug-eluting balloons did not translate into a higher rate of limb salvage, a result that may stem from 2 main factors:

  • Patients were enrolled only after successful wiring of the target vessel, and therefore, the rate of major amputation cannot be compared with that from studies employing intention-to-treat protocols.
  • The study group established a dedicated multidisciplinary team providing wound care and continuous surveillance of the foot lesion and vessel patency, including fast-track angiography and reintervention when clinically needed. Thus, the overall rate of limb loss was rare.

As such, Dr. Liistro and colleagues stress, “Large multicenter randomized trials will be needed to assess whether the increased patency of limb arteries afforded by [drug-eluting balloons] promotes clear improvement in limb salvage and survival.”

DEB Called Current ‘Gold Standard’

In an e-mail communication with TCTMD, Bruno Scheller, MD, of the University of Saarland (Homburg, Germany), noted that paclitaxel urea-coated balloons such as Amphirion In.Pact have the broadest clinical evidence in peripheral arteries. “I would consider it as the current gold standard for peripheral interventions,” Dr. Scheller said. “Furthermore, this coating is one of the two aiming for FDA approval.”

He agreed that limb salvage rates were low. However, “the study was not powered for clinical endpoints,” Dr. Scheller stressed, noting, that “[drug-eluting balloons] led to a significant improvement in ulcer healing (faster and more complete). Furthermore, quality of life seems to be improved as reflected in the distribution of Rutherford classes.”

Dr. Scheller added that DES and drug-eluting balloons may compare well for short below-the-knee lesions. “However, in long diffuse BTK lesions, [drug-eluting balloons] will be the best strategy instead of full-metal jacket with DES,” he said.

Overall, “[drug-eluting balloons] show significant clinical benefits in different vessel areas, especially in such high-risk populations as studied in this trial,” Dr. Scheller said. “This benefit was independent from lesion length and procedural factors. The need for stents was extremely low, supporting the ‘DEB only’ concept of leaving nothing behind.”

Study Details

All patients had stenosis or occlusion ≥ 40 mm of at least 1 tibial vessel with distal runoff to the foot. Interventions were performed mainly by an antegrade approach. All patients were taking aspirin 100 mg daily. After sheath insertion, 70 IU/Kg heparin was administered. Post-intervention dual antiplatelet therapy with aspirin 100 mg and clopidogrel 75 mg once daily was given at least for 4 weeks and 100 mg aspirin was given daily thereafter.


Liistro F, Porto I, Angioli P, et al. Drug-Eluting Balloon in peripherAl InTErvention for Below the Knee Angioplasty Evaluation (DEBATE BTK): A randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013; Epub ahead of print.



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  • The study was performed without any industry financial support.
  • Dr. Liistro reports no relevant conflicts of interest.
  • Dr. Scheller reports being a shareholder of InnoRa GmbH (Berlin, Germany), a company responsible for the preclinical and first clinical studies of this specific drug-eluting balloon.