What is the clinical evidence from this study?

Study design: RCT. Population: Superficial femoral artery in-stent restenosis and chronic limb ischemia (n=119). Intervention: Drug-coated balloon angioplasty (DCBA) vs. Standard balloon angioplasty (POBA). Primary outcome: Recurrent in-stent restenosis assessed by ultrasound at 6 months (p=0.002).

What does this research mean for the field?

Drug-coated balloon angioplasty significantly reduces recurrent restenosis and improves clinical outcomes compared to standard balloon angioplasty in patients with superficial femoral artery in-stent restenosis, without an apparent difference in safety. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To assess the efficacy of drug-coated balloon angioplasty versus standard balloon angioplasty for preventing restenosis in patients with superficial femoral artery in-stent restenosis.

July 9, 2026Circulation

Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis

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Key result

DCB cuts recurrent in-stent restenosis ~66% vs. standard balloon angioplasty at 6 months.

P=0.002
n=119

Why the study?

Does drug-coated balloon angioplasty reduce recurrent in-stent restenosis in patients with superficial femoral artery in-stent restenosis compared to standard balloon angioplasty?

Population

119 patients with superficial femoral artery in-stent restenosis and chronic limb ischemia across 5 German…

Comparison

Drug-coated balloon angioplasty (DCBA) vs Standard balloon angioplasty (POBA)

Design

RCT, prospectively randomized

Follow-up

12 months

Authors

HKHans KrankenbergSana Kliniken Duisburg TTThilo TüblerUniversität Hamburg MIMaja IngwersenJena University Hospital

Discussion

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Implication

Drug-coated balloon angioplasty significantly reduces recurrent restenosis and improves clinical outcomes compared to standard balloon angioplasty for superficial femoral artery in-stent restenosis.

Key Points

To assess the efficacy of drug-coated balloon angioplasty versus standard balloon angioplasty for preventing restenosis in patients with superficial femoral artery in-stent restenosis.
Prospectively randomized trial with 119 patients from 5 German clinical sites
Patients assigned to DCBA (n=62) or POBA (n=57)
Follow-up conducted at 6 and 12 months using clinical assessments and duplex ultrasound.
Recurrent in-stent restenosis at 6 months was 15.4% in DCBA versus 44.7% in POBA (P=0.002)
Freedom from target lesion revascularization was 96.4% in DCBA compared to 81.0% in POBA at 6 months (P=0.0117)
At 12 months, clinical improvement was observed in 77.8% of DCBA patients versus 52.3% of POBA patients (P=0.015).

Study Design

Type

RCT (n=119)

Randomization

randomized

Multicenter

Yes

Structured PICO

Does drug-coated balloon angioplasty reduce recurrent in-stent restenosis in patients with superficial femoral artery in-stent restenosis compared to standard balloon angioplasty?

Population

119 patients with superficial femoral artery in-stent restenosis and chronic limb ischemia, followed for 12 months.

Intervention

Drug-coated balloon angioplasty (DCBA)

Comparator

Standard balloon angioplasty (POBA)

Outcome

Recurrent in-stent restenosis assessed by ultrasound at 6 monthssurrogate

Main Result

Absolute Event Rate: 15.4% vs 44.7%

p-value: p=0.002

Drug-coated balloon angioplasty significantly reduces recurrent restenosis and improves clinical outcomes compared to standard balloon angioplasty for superficial femoral artery in-stent restenosis.

Cite This Study

Krankenberg et al. (2015) conducted an RCT in Superficial femoral artery in-stent restenosis and chronic limb ischemia (n=119). Drug-coated balloon angioplasty (DCBA) vs. Standard balloon angioplasty (POBA) was evaluated on Recurrent in-stent restenosis assessed by ultrasound at 6 months (p=0.002). Drug-coated balloon angioplasty significantly reduced recurrent in-stent restenosis at 6 months compared to standard balloon angioplasty (15.4% vs 44.7%, P=0.002).

synapsesocial.com/papers/6a501047005270d31ee7fc2f https://doi.org/10.1161/circulationaha.115.017364

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Implication

Drug-coated balloon angioplasty significantly reduces recurrent restenosis and improves clinical outcomes compared to standard balloon angioplasty for superficial femoral artery in-stent restenosis.

Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Also Consider

Also Consider