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October 14, 2026Frontiers in Cardiovascular MedicineOpen Access

Scoring balloon versus plain balloon vessel preparation before drug-coated balloon angioplasty for femoropopliteal atherosclerotic occlusive disease: a two-centre retrospective cohort study

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Key result

Plain balloon angioplasty before DCB linked to ~5-fold higher vessel dissection odds vs scoring balloons.

OR 5.00
95% CI 1.91-13.06
P=0.001
n=126

Figures

Why the study?

Optimal vessel preparation before DCB angioplasty in femoropopliteal atherosclerotic occlusive disease remains counteracted by dissection and recoil, motivating an evaluation of scoring balloon versus plain balloon preparation.

Does scoring balloon vessel preparation before drug-coated balloon angioplasty reduce target vessel dissection and improve 12-month patency compared with plain balloon preparation in patients with femoropopliteal atherosclerotic complete occlusive disease?

Key Points

To evaluate whether vessel preparation with a scoring balloon improves immediate procedural outcomes and mid-term patency compared with a plain balloon prior to drug-coated balloon angioplasty in femoropopliteal atherosclerotic occlusive disease.
Retrospective review of patients with femoropopliteal occlusive disease undergoing drug-coated balloon angioplasty between 2022 and 2025 across two tertiary centers.
A 1:1 propensity score matching method was applied to balance baseline demographics and lesion characteristics, resulting in 63 patients in the plain balloon group and 63 patients in the scoring balloon group (initial cohort N=205).
Assessed target vessel dissection as the primary endpoint, alongside secondary endpoints including bailout stenting, procedural complications, ankle-brachial index, 12-month primary patency, and clinically driven target vessel revascularization.
Target vessel dissection occurred in 49.2% of the plain balloon group versus 17.5% of the scoring balloon group (OR: 5.00, 95% CI: 1.91–13.06, p = 0.001; RR: 2.82, 95% CI: 1.58–5.04).
Bailout stenting was required in 31.7% of the plain balloon group compared with 9.5% of the scoring balloon group (OR: 3.80, 95% CI: 1.42–10.17, p = 0.008; RR: 3.33, 95% CI: 1.39–8.01).
No significant differences occurred for procedural complications (6.3% vs 3.2%, OR: 2.00, 95% CI: 0.37–10.92, p = 0.424), 12-month primary patency (87.3% vs 88.9%, HR: 1.18, 95% CI: 0.44–3.22, p = 0.739), or 12-month freedom from clinically driven target vessel revascularization (88.9% vs 93.7%, HR: 1.83, 95% CI: 0.52–6.47, p = 0.348).

Study Design

Type

Cohort (n=126)

Blinding

Blinded image review by two senior vascular surgeons

Multicenter

Yes

Structured PICO

Does scoring balloon vessel preparation before drug-coated balloon angioplasty reduce target vessel dissection and improve 12-month patency compared with plain balloon preparation in patients with femoropopliteal atherosclerotic complete occlusive disease?

P

Population

126 propensity-matched adults (63 pairs from an initial 205-patient cohort; mean age ~76.6 years, 25.4% female) with unilateral complete femoropopliteal atherosclerotic occlusive disease (Rutherford categories 3-6) undergoing drug-coated balloon angioplasty at two tertiary centers in China, followed for 12 months.

E

Exposure

Scoring balloon (D-Kutting, DK Medtech, China) vessel preparation followed by therapeutic dilation with a paclitaxel drug-coated balloon (Lutonix, Bard, USA), plus dual antiplatelet therapy (aspirin 100 mg/day and clopidogrel 75 mg/day for ≥3 days prior and ≥6 months post-procedure, followed by long-term single antiplatelet therapy).

C

Comparator

Plain balloon (Cordis, USA) sequential vessel preparation (smaller to larger diameters) followed by the same Lutonix drug-coated balloon (Bard, USA) and identical antiplatelet regimen.

O

Outcome

Any target vessel dissection (comprising mild Type B [<1/3 lumen diameter] and severe Type C [≥1/3 lumen diameter] angiographic dissection according to the Kobayashi system), assessed on intraoperative angiography after vessel preparation and before DCB inflation by two independent blinded senior vascular surgeons.surrogate

Main Result

Odds Ratio: 5 (95% CI 1.91–13.06)

Absolute Event Rate: 17.5% vs 49.2%

Absolute Risk Reduction: 32%

p-value: p=0.001

In complete femoropopliteal occlusions treated with drug-coated balloon angioplasty, scoring balloon vessel preparation significantly reduces acute target vessel dissection and bailout stenting compared with plain balloon preparation, though without significant differences in 12-month patency or revascularization.

Limitations

Non-random retrospective treatment allocation with potential residual confounding by indication (center, operator, and calendar-period variables not in the propensity model)
Kobayashi classification grades dissection by width and does not directly quantify flow impairment, morphology, or length, with no intravascular imaging available
Small propensity-matched sample size (63 pairs) with few complications and limited 12-month events, resulting in imprecise mid-term estimates
Lack of data on death, major amputation, wound healing, and symptom improvement, and use of CTA surveillance rather than duplex ultrasound
Findings restricted to specific devices (D-Kutting scoring balloon and Lutonix DCB)
Non-random treatment allocation reflecting lesion characteristics, operator experience, and device availability, with residual confounding by indication (centre, operator, and calendar-period not included in PSM)
Kobayashi classification grades dissection by width only and does not quantify flow impairment, length, or lumen compromise, and intravascular imaging was unavailable
Small matched sample size (63 pairs) with few complications and limited 12-month events, leading to wide confidence intervals and imprecise estimates for safety, patency, and revascularisation
Death, major amputation, wound healing, and symptom-improvement variables were unavailable, and CTA surveillance differs from duplex ultrasound strategies
Findings are specific to the D-Kutting scoring balloon and Lutonix DCB platforms

Ask about this paper

Answers are grounded in this paper and cite their sources.

Implication

Scoring balloon preparation may reduce acute dissections in femoropopliteal DCB angioplasty; leaves open whether randomized trials will confirm long-term benefits.

Abstract

Background Optimal vessel preparation before drug-coated balloon (DCB) angioplasty in femoropopliteal atherosclerotic occlusive disease remains counteracted by dissection and recoil. We evaluated whether scoring balloon (SB) vessel preparation improves procedural immediate effect and mid-term outcomes compared with plain balloon (PB). Methods Patients with femoropopliteal occlusive disease undergoing DCB angioplasty following SB or PB preparation (2022-2025) across two tertiary centers were reviewed. 1:1 propensity score matching (PSM) was implemented. Primary endpoint was target vessel dissection. Secondary endpoints included bailout stenting, procedural complications, ankle-brachial index (ABI), 12-month primary patency, and freedom from clinically driven target vessel revascularisation (CD-TVR). Results After matching, 63 patients were in each group. Target vessel dissection occurred in 49.2% of Group PB and 17.5% of Group SB (OR: 5.00, 95% CI: 1.91–13.06, p = 0.001). For Groups PB and SB, bailout stenting rates were 31.7% and 9.5%, respectively (OR: 3.80, 95% CI: 1.42–10.17; p = 0.008). Procedural complication rates were 6.3% and 3.2% (OR: 2.00, 95% CI: 0.37–10.92; p = 0.424). 12-month primary patency were 87.3% and 88.9% (HR: 1.18, 95% CI: 0.44–3.22; p = 0.739). 12-month freedom from CD-TVR were 88.9% and 93.7% (HR: 1.83, 95% CI: 0.52–6.47; p = 0.348). Conclusion In this propensity-matched cohort, SB vessel preparation before DCB angioplasty was associated with lower rates of target vessel dissection and bailout stenting than PB. No statistically significant difference in the prespecified procedural complications, 12-month patency or CD-TVR was observed.

Discussion

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Cite This Study

Qi et al. (2026) conducted a cohort in Femoropopliteal atherosclerotic complete occlusive disease (n=126). Scoring balloon (D-Kutting) vessel preparation before drug-coated balloon (Lutonix) angioplasty vs. Plain balloon (Cordis) vessel preparation before drug-coated balloon (Lutonix) angioplasty was evaluated on Target vessel dissection (any mild Type B or severe Type C angiographic dissection per Kobayashi classification) (OR 5.00, 95% CI 1.91-13.06, p=0.001). Scoring balloon vessel preparation before DCB angioplasty was associated with lower target vessel dissection than plain balloon preparation (17.5% vs 49.2%; OR 5.00, 95% CI 1.91-13.06, p=0.001).

synapsesocial.com/papers/6aee6b6871a759480622094f https://doi.org/10.3389/fcvm.2026.1975976

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