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The "DEBELLUM"--lower limb multilevel treatment with drug eluting balloon--randomized trial: 1-year results
F Fanelli1, A Cannavale, M Corona
1Unit of Vascular and Interventional Radiology Department of Radiological Sciences "Sapienza" University of Rome, Rome, Italy - fabrizio.fanelli@uniroma1.it.
Insights
Drug-eluting balloons (DEB) significantly reduced restenosis and major adverse events compared to conventional angioplasty in lower limb arterial disease. DEB therapy offers improved clinical outcomes for patients with femoropopliteal and infrapopliteal lesions.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Biomedical Engineering
Background:
- Peripheral artery disease (PAD) affects lower limb circulation, leading to claudication and critical limb ischemia.
- Femoropopliteal and infrapopliteal lesions often require revascularization to restore blood flow.
- Drug-eluting balloons (DEB) offer a potential alternative to conventional angioplasty for treating PAD.
Purpose of the Study:
- To report 12-month clinical outcomes of the DEBELLUM randomized trial comparing DEB and conventional angioplasty.
- To evaluate the efficacy of DEB in reducing restenosis and improving limb salvage in patients with femoropopliteal and infrapopliteal disease.
Main Methods:
- A randomized trial involving 50 patients with symptomatic lower limb PAD.
- Patients were assigned to either drug-eluting balloon (DEB) or conventional angioplasty (PTA) treatment.
- Lesions in the femoropopliteal (SFA) and infrapopliteal (BTK) regions were treated, with primary stenting allowed in the SFA.
Main Results:
- DEB treatment resulted in significantly lower late lumen loss (LLL) compared to PTA (0.64 mm vs. 1.81 mm, P=0.01).
- The target lesion revascularization (TLR) rate was lower in the DEB group (12.2%) versus the PTA group (35.3%, P<0.05).
- DEB showed a trend towards reduced amputation rates (4% vs. 12%) and significantly fewer major adverse events (24% vs. 60%, P<0.05).
Conclusions:
- The 12-month outcomes confirm the 6-month findings, demonstrating the effectiveness of DEB.
- In.Pact DEB balloons are efficient in reducing restenosis rates in femoropopliteal and infrapopliteal interventions.
- DEB therapy represents a valuable option for improving clinical outcomes in patients with lower limb PAD.
Aim:
The aim of the present paper was to make a report of the 12-month clinical outcomes of the DEBELLUM (Drug-Eluting-Balloon-Evaluation-for-Lower-Limb- mUltilevel-treatMent) randomized trial.
Methods:
From September 2010 to March 2011, 50 patients were randomized between drug eluting balloon (DEB, N.=25) and conventional angioplasty balloon (PTA, N.=25). Patients were symptomatic for claudication and critical limb ischemia, with de novo stenosis or occlusion in the femoropopliteal (SFA) and infrapopliteal (BTK) region. Only in the SFA primary stenting was allowed and postdilatation performed with DEB or PTA depending on the assigned group.
Results:
One hundred and twenty-two lesions were treated: 92 (75.4%) SFA, 30 (24.6%) BTK. Twenty (40%) patients presented multilevel concomitant femoropopliteal and infra-popliteal lesions. Late lumen loss (LLL) was 0.64±0.9 mm in DEB group vs. 1.81±0.1 mm in the control group (P=0.01). In non-stented segment LLL was 0.63±0.9 mm (DEB) vs. 1.70±0.6 mm (PTA), P<0.01. In the stent subgroup was LLL 0.65±0.2 mm (DEB) vs. 1.91±0.3 mm (PTA), P<0.01. In the femoropopliteal region the overall LLL was 0.61±0.8 mm for DEB vs. 1.84±0.3 mm for PTA (P=0.02). BTK the overall LLL was 0.66±0.9 mm (DEB) vs. 1.69±0.5 mm (PTA) (P=0.03). The overall TLR was 12.2% for DEB and 35.3% for PTA (P<0.05). Amputation rate was 4% (DEB) vs. 12% (PTA), P=0.36. Thrombosis was 4% (DEB) vs. 8% (PTA), P≥0.05. Major adverse events 24% (DEB) vs. 60% (PTA), P<0.05. ABI improved more in the DEB group: 0.81±0.3 vs. 0.68±0.13 (P=0.02). Fontaine stage increased (from II b to I) 80% DEB vs. 56% PTA (P<0.05).
Conclusion:
Results confirm and reinforce initial 6-month outcomes. In.Pact DEB balloons can be considered efficient to reduce restenosis rate.
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