August 31, 2026Journal of the American College of CardiologyOpen Access

Drug-Eluting Balloon Versus Standard Balloon Angioplasty for Infrapopliteal Arterial Revascularization in Critical Limb Ischemia

Q: What is the clinical evidence from this study?

Study design: RCT. Population: critical limb ischemia (CLI) (n=358). Intervention: IN.PACT Amphirion drug-eluting balloons (IA-DEB) vs. percutaneous transluminal angioplasty (PTA). Primary outcome: clinically driven target lesion revascularization (CD-TLR) (p=0.291).

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Key result

IN.PACT Amphirion drug-eluting balloon fails to improve target lesion revascularization over standard angioplasty.

P=0.291
n=358

Why the study?

Does drug-eluting balloon angioplasty reduce clinically driven target lesion revascularization and late lumen loss compared to standard percutaneous transluminal angioplasty in patients with critical limb ischemia?

Population

n=358 patients with critical limb ischemia (CLI) undergoing infrapopliteal arterial revascularization

Comparison

Drug-eluting balloons (IN.PACT Amphirion) vs Standard percutaneous transluminal angioplasty

Design

RCT, randomized 2:1

Follow-up

12 months

Authors

TZThomas ZellerUniversitäts-Herzzentrum Freiburg-Bad Krozingen IBIris BaumgärtnerUniversity Hospital of Bern DSDierk ScheinertUniversity Hospital Leipzig

Discussion

Member takes

Key expert perspectives

Captured external expert commentary on this paper, strongest first. Original sources are linked where available.

RWRon WaksmanEditor in Chief, Cardiovascular Revascularization Medicine

“a technology that works for the SFA may not be as effective and safe for popliteal and tibial narrowing, as was shown in the IN.PACT DEEP study”

Cardiovascular Revascularization MedicineEditorial

Implication

In patients with critical limb ischemia, drug-eluting balloons showed comparable efficacy to standard angioplasty but a trend toward increased major amputations.

Key Points

To evaluate the efficacy and safety of IN.PACT Amphirion drug-eluting balloons compared with standard percutaneous transluminal angioplasty for infrapopliteal arterial revascularization in patients with critical limb ischemia.
Conducted a prospective, multicenter randomized controlled trial (NCT00941733) assigning 358 patients with critical limb ischemia 2:1 to IN.PACT Amphirion drug-eluting balloons or standard percutaneous transluminal angioplasty.
Assessed two coprimary efficacy endpoints through 12 months: clinically driven target lesion revascularization and late lumen loss, analyzed by independent angiographic and wound core laboratories.
Evaluated a composite primary safety endpoint through 6 months consisting of all-cause mortality, major amputation, and clinically driven target lesion revascularization.
Coprimary efficacy endpoints showed no significant difference between the drug-eluting balloon and standard angioplasty arms: clinically driven target lesion revascularization occurred in 9.2% versus 13.1% (p = 0.291) and late lumen loss was 0.61 ± 0.78 mm versus 0.62 ± 0.78 mm (p = 0.950).
The primary safety composite endpoint at 6 months met noninferiority criteria, occurring in 17.7% of the drug-eluting balloon group compared to 15.8% of the standard angioplasty group (p = 0.021 for noninferiority).
A safety signal for major amputations through 12 months emerged, showing higher amputation rates in the drug-eluting balloon group than the standard angioplasty group (8.8% vs. 3.6%; p = 0.080).

Study Design

Type

RCT (n=358)

Randomization

2:1

Multicenter

Yes

Structured PICO

Population

358 patients with critical limb ischemia requiring infrapopliteal arterial revascularization, followed for 12 months.

Intervention

Drug-eluting balloons (IN.PACT Amphirion)

Comparator

Standard percutaneous transluminal angioplasty (PTA)

Outcome

Coprimary efficacy endpoints through 12 months: clinically driven target lesion revascularization (CD-TLR) and late lumen loss (LLL). Primary safety endpoint through 6 months: composite of all-cause mortality, major amputation, and CD-TLR.composite

Main Result

Absolute Event Rate: 9.2% vs 13.1%

p-value: p=0.291

In patients with critical limb ischemia, drug-eluting balloons showed comparable efficacy to standard angioplasty but a trend toward increased major amputations.

Cite This Study

Zeller et al. (2014) conducted an RCT in critical limb ischemia (CLI) (n=358). IN.PACT Amphirion drug-eluting balloons (IA-DEB) vs. percutaneous transluminal angioplasty (PTA) was evaluated on clinically driven target lesion revascularization (CD-TLR) (p=0.291). IN.PACT Amphirion drug-eluting balloons showed comparable efficacy to standard angioplasty for target lesion revascularization (9.2% vs 13.1%; P=0.291) but trended toward increased major amputations.

synapsesocial.com/papers/6a95efba300fdfe30a98b4f2 https://doi.org/10.1016/j.jacc.2014.06.1198

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Implication

In patients with critical limb ischemia, drug-eluting balloons showed comparable efficacy to standard angioplasty but a trend toward increased major amputations.

Drug-Eluting Balloon Versus Standard Balloon Angioplasty for Infrapopliteal Arterial Revascularization in Critical Limb Ischemia

Discussion

Member takes

Key expert perspectives

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Drug-Eluting Balloon Versus Standard Balloon Angioplasty for Infrapopliteal Arterial Revascularization in Critical Limb Ischemia

Discussion

Member takes

Key expert perspectives

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

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