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Published on: February 5, 2021
Drug coated balloons below-the-knee: just too early?
Fabrizio Fanelli1, Alessandro Cannavale
1Vascular and Interventional Unit, Department of Radiological Sciences, "Sapienza" University of Rome, Rome, Italy - fabrizio.fanelli@uniroma1.it.
Insights
Drug-coated balloons (DCBs) showed no superiority over standard angioplasty for below-the-knee arterial disease. The IN.PACT Deep trial found higher amputation rates with DCBs, necessitating further research.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Devices
Background:
- Infrapopliteal arterial disease presents treatment challenges due to multivessel involvement.
- Drug-coated balloons (DCBs) have shown promise in femoro-popliteal interventions.
- Physicians have explored DCB use in the below-the-knee (BTK) region.
Purpose of the Study:
- To evaluate the efficacy and safety of drug-coated balloons (DCBs) compared to standard percutaneous transluminal angioplasty (PTA) in the below-the-knee (BTK) region.
- To investigate the outcomes of the IN.PACT Deep trial, a large randomized trial comparing DCB to PTA for BTK disease.
Main Methods:
- A randomized trial (IN.PACT Deep) comparing In.Pact DCB to standard PTA for infrapopliteal arterial disease.
- Analysis of amputation rates and other safety and efficacy endpoints.
Main Results:
- The IN.PACT Deep trial did not demonstrate the superiority of DCB over standard PTA.
- Higher amputation rates were observed in the DCB group (8.8%) compared to the PTA group (3.6%).
- The trial failed to confirm the initial enthusiasm for DCBs in the BTK region due to safety concerns.
Conclusions:
- Current evidence does not support the routine use of DCBs over standard PTA for below-the-knee arterial disease.
- Significant discrepancies exist between studies evaluating DCBs in the BTK region.
- Further trials are essential to clarify the role and safety of DCBs in infrapopliteal interventions.
Abstract:
Patients with infrapopliteal arterial disease are generally considered challenging due to the usual presence of multivessel 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, physicians 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 to standard PTA. This trial failed completely to show the superiority of drug coated balloon (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 it is still difficult to find a clear explanation. Especially for this negative outcome and for the big difference, in term of results, between the different studies in the BTK region and also between the above and below the knee regions more trials are mandatory.
