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Drug coated balloons in BTK - just too early?
1Vascular and Interventional Unit, Department of Radiological Sciences, Sapienza University of Rome, Rome, Italy - fabrizio.fanelli@uniroma1.it.
Insights
Drug-coated balloons (DCB) showed no superiority over standard angioplasty for below-the-knee arterial disease. Higher amputation rates were observed with DCB, necessitating further investigation into these safety concerns.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Devices
Background:
- Infra-popliteal arterial disease presents treatment challenges due to multi-vessel atherosclerosis.
- Drug-coated balloons (DCB) have shown promise in femoro-popliteal interventions.
- Their application in below-the-knee (BTK) interventions is under scrutiny.
Purpose of the Study:
- To evaluate the efficacy and safety of drug-coated balloons (DCB) compared to standard percutaneous transluminal angioplasty (PTA) in below-the-knee (BTK) arterial disease.
- To investigate the reasons behind the conflicting results observed in different studies.
Main Methods:
- The IN.PACT Deep trial, a large randomized trial, compared In.Pact DCB against standard PTA.
- Patient outcomes, including amputation rates, were assessed.
Main Results:
- The IN.PACT Deep trial failed to demonstrate the superiority of DCB over PTA for BTK interventions.
- A significantly higher amputation rate was observed in the DCB group (8.8%) compared to the PTA group (3.6%).
Conclusions:
- Current evidence does not support the routine use of DCB for BTK arterial disease.
- Further research is required to understand the safety concerns and variability in outcomes across studies.
Abstract:
Patients with infra-popliteal arterial disease are generally considered challenging due to the usual presence of multi-vessel atherosclerotic disease. Several treatment options have been used by different authors but none of them can be considered ideal. In the last few years drug coated balloons have gained popularity especially due to the extraordinary results in the femoro-popliteal region. Following the great success, phisicians started to use this promising device also in the below-the-knee (BTK) region. The initial enthusiasm correlated to some studies is not confirmed by the largest randomized trial, IN.PACT Deep, comparing In.Pact DCB vs. standard PTA. This trial failed completely to show the superiority of DCB.The negative outcome was mainly correlated to safety issues with an amputation rate higher for the drug coated balloon when compared to the conventional balloon (8.8% DCB vs 3.6% PTA, p=0.08). A thorough evaluation has been performed to justify these negative outcomes, given the good results reported by other studies. But nowadays is still difficult to find a clear explanation. Especially for this negative outcome and for the big difference, in term of results, beteween the different studies in the BTK region and also betwenn the above and below the knee regions more trials are mandatory.