From the Guidelines
Paclitaxel on angioplasty balloons works by being rapidly transferred to the arterial wall during balloon inflation to prevent restenosis after angioplasty procedures. When the drug-coated balloon is inflated against the narrowed artery, the lipophilic paclitaxel molecules quickly penetrate the vessel wall where they bind to microtubules in smooth muscle cells, as supported by the concept that highly lipophilic drugs can be effectively delivered with short contact times between the balloon and the vessel wall 1. This binding prevents cell division by stabilizing microtubules in their polymerized state, inhibiting the normal breakdown of microtubules during cell division. The anti-proliferative effect suppresses neointimal hyperplasia (excessive tissue growth) that typically causes restenosis following angioplasty.
Some key points to consider when using paclitaxel-coated balloons include:
- The typical dose ranges from 2-3 μg/mm² of balloon surface area
- The balloon inflation typically lasts 30-60 seconds to ensure adequate drug transfer
- This approach is particularly valuable in peripheral artery disease, small vessels, in-stent restenosis, and areas where leaving a permanent implant is undesirable
- However, it's crucial to weigh the benefits against the potential risks, including a possible increase in long-term mortality rates among patients with peripheral artery disease treated with paclitaxel-coated balloons and paclitaxel-eluting stents, as noted by the FDA warning letter in 2019 1.
Given the most recent evidence from 2023, the use of paclitaxel-coated balloons is recommended for improving patency when compared to conventional balloon angioplasty, despite the need for continued surveillance and discussion of the risks and benefits with patients 1.
From the Research
Mechanism of Paclitaxel-Eluting Balloons
- Paclitaxel-eluting balloons work by releasing the drug paclitaxel, which inhibits cell division and prevents the proliferation of smooth muscle cells, thereby reducing the occurrence of restenosis 2, 3, 4.
- The use of paclitaxel-eluting balloons has been shown to be effective in reducing restenosis rates compared to balloon angioplasty alone 2, 3.
- Paclitaxel-eluting balloons have also been compared to paclitaxel-eluting stents, with some studies showing similar or superior outcomes for the balloons 2, 3.
Clinical Outcomes
- Clinical outcomes for paclitaxel-eluting balloons have been evaluated in several studies, with results showing favorable outcomes in terms of patency rates and reduced target lesion revascularization 5, 6.
- However, some studies have raised concerns about the potential for increased long-term mortality with the use of paclitaxel-coated devices, although this has not been consistently shown across all studies 6.
- Predictive risk factors for restenosis have been identified, including factors such as vessel diameter, lesion length, and patient characteristics 5.
Comparison to Other Treatments
- Paclitaxel-eluting balloons have been compared to other treatments, including paclitaxel-eluting stents and plain old balloon angioplasty, with varying results 2, 3, 5, 6.
- The choice of treatment may depend on various factors, including patient characteristics, lesion characteristics, and operator preference 5.