Drug eluting balloon (DEB) is a percutaneous coronary intervention (PCI) technique that delivers antiproliferative drugs directly to the site of blocked arteries. Its main objective is to prevent re-blockage or restenosis after angioplasty. DEB is proving to be an effective alternative to drug eluting stents for certain patients and clinical scenarios.
What is a Drug Eluting Balloon?
A DEB is a standard angioplasty balloon coated with an antiproliferative drug, usually paclitaxel. When the balloon is inflated at the site of the blockage, the drug is transferred to the arterial walls. The drug is designed to prevent excessive scarring and new cell growth that can cause re-narrowing or restenosis after balloon angioplasty. DEBs were developed to address the drawbacks of bare metal stents and drug eluting stents.
Mechanism of Action
When inflated, the DEB delivers a single dose of an antiproliferative drug - usually paclitaxel - to the treatment area. Paclitaxel works by interfering with cell division and preventing excessive smooth muscle cell proliferation which is the main cause of restenosis post-angioplasty. By delivering the drug directly to the vessel wall where it is needed most, very high concentrations can be achieved locally with minimal systemic exposure. This leads to effective inhibition of restenosis with a better safety profile.
Clinical Trials and Effectiveness
Several randomized clinical trials have shown Drug Eluting Balloons to be as effective as drug eluting stents in reducing restenosis rates for certain patient subsets. Some of the key trials include:
- PEPCAD I Trial (2011): Showed similar luminal diameters and restenosis rates between DEB and drug eluting stent at 9 months follow up in de-novo coronary lesions.
- BELLO Trial (2013): Found comparable efficacy and safety outcomes between DEB and everolimus eluting stent for de-novo femoral-popliteal artery disease at 12 months.
- IN.PACT SFA Trial (2014): Demonstrated significantly lower rates of target lesion revascularization with DEB versus plain balloon angioplasty at 24 months in treating superficial femoral and proximal popliteal arteries.
- ILLUMENATE EU Trial (2017): Showed non-inferiority of DEB versus drug eluting stent for small vessel coronary artery disease (reference vessel diameter <2.5mm) at one year.
Overall, DEBs have emerged as an effective alternative to drug eluting stents for certain patient subsets like small vessel disease, long lesions, bifurcation lesions, transplant vascular disease, and peripheral vascular disease.
Advantages over Drug Eluting Stents
DEBs offer some practical advantages over drug eluting stents:
- No permanent implant: As DEBs do not leave any permanent implant, they eliminate concerns about stent fracture or late stent thrombosis.
- Easier intervention in complex cases: DEBs allow for easier navigation and treatment in complex coronary lesions involving multiple folds, tortuous vessels, or bifurcation lesions where stenting can be challenging.
- Safer in peripheral interventions: For vessel below the knee, avoid issues like stent fracture seen with peripheral stents. DEBs cause less vessel injury.
- Lower risk of restenosis in small vessels: DEBs are proving more effective than DES in small vessel coronary artery disease (<2.5mm) where strut coverage is an issue with stents.
- Potentially lower costs: Absence of a permanent implant can reduce total costs involved in longer term patient follow up and repeat procedures.
However, the main limitations are the need for a higher number of target vessel revascularization compared to DES and the short drug effect after a single drug application.
Ongoing Studies and Future Potential
Research into DEBs is ongoing to address some of the current limitations and further expand their applications:
- Studies testing DEBs with longer acting drugs like sirolimus or everolimus to extend the drug effect duration beyond initial treatment.
- Trials evaluating whether DEB benefits are sustained beyond 1-2 years as seen with new generation DES.
- Exploring DEB use for complex coronary lesions currently treated with stents like chronic total occlusions.
- Investigating DEBs for below-the-knee infrapopliteal angioplasty in critical limb ischemia patients.
- Developing DEB coatings with combined drug regimens or adjunct imaging/diagnostic modalities.
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