Latest Findings on Drug-Coated Balloons for PAD and CAD Treatment
Drug-coated balloons (DCBs) have emerged as an effective treatment option for both peripheral artery disease (PAD) and coronary artery disease (CAD), particularly for in-stent restenosis (ISR) and in cases where leaving a permanent implant is undesirable. 1
Drug-Coated Balloons in Peripheral Artery Disease (PAD)
DCBs coated with paclitaxel have demonstrated significantly improved patency rates compared to conventional balloon angioplasty in multiple prospective randomized trials for PAD treatment 1
In the 2024 ACC/AHA guidelines, trials assessing drug-eluting stents and DCBs for PAD revascularization generally recommend dual antiplatelet therapy (DAPT) for 2-6 months after the procedure 1
The FDA issued a warning in 2019 about a possible increase in long-term mortality rates among PAD patients treated with paclitaxel-coated balloons compared to patients treated with non-coated balloons, recommending continued surveillance and discussion of risks and benefits with patients 1
Despite this warning, the FDA has allowed continued use of paclitaxel-coated balloons per current standard of care, recognizing their clinical benefits in maintaining vessel patency 1
For dialysis access maintenance, DCBs have shown superior patency rates compared to conventional angioplasty, with primary patency rates at 6-12 months of 38-63% 1
Drug-Coated Balloons in Coronary Artery Disease (CAD)
For coronary in-stent restenosis (ISR), network meta-analyses comparing various treatment options have shown that drug-eluting stents (DES) are associated with the lowest rates of restenosis and target-vessel revascularization, with everolimus-eluting stents showing the best efficacy 1
DCBs are recommended as a reasonable alternative for ISR treatment, particularly when additional stent layers are undesirable 1, 2
The 2021 ACC/AHA/SCAI guidelines state that in patients with ISR who have an indication for revascularization, it is reasonable to perform repeat PCI with a DES or DCB if anatomic factors are appropriate 1
The advantages of DCBs over direct stent approaches include potentially reduced restenosis rates in indications where DES show limited efficacy, reduction of DAPT duration (especially in patients with contraindications for prolonged DAPT), and leaving no permanent implant 3, 2
Clinical Outcomes and Safety
A comprehensive meta-analysis of 45 randomized trials comparing DCBs with conventional revascularization strategies found no significant difference in mortality between DCB and conventionally treated patients (5.9% vs 5.7%) 2
The same meta-analysis showed that DCBs significantly reduced the rate of target lesion revascularization (TLR), with larger benefits observed in PAD patients and compared to balloon-only angioplasty 2
For coronary applications, DCB angioplasty with provisional spot-stenting in case of severe dissections may be beneficial in complex lesions, bifurcations, or in patients with contraindications for DES 4
In the European guidelines, drug-eluting balloons are recommended (Class IIa, Level B) for the treatment of in-stent restenosis after prior bare metal stent (BMS) implantation 1
Practical Considerations and Future Directions
Proper lesion preparation is crucial for effective DCB therapy to facilitate drug delivery, typically including conventional angioplasty before DCB application 3
In more complex lesions, additional treatments and imaging or functional measurements are helpful to optimize outcomes 3
Emerging applications for DCBs include treatment of de novo lesions in small coronary vessels, bifurcation lesions, long lesions, and cerebrovascular applications 4, 5
The concept of "leaving nothing behind" with DCBs allows for vascular restoration with potential plaque regression instead of neo-atherosclerosis that can occur with permanent implants 3, 5
Cautions and Limitations
The FDA warning about increased mortality with paclitaxel-coated devices requires careful patient selection and informed consent 1
Not all DCBs are equally effective - clinical outcomes vary based on the specific coating technology and drug delivery mechanism 6, 4
For recurrent ISR with multiple stent layers, or in patients not suitable for additional stenting or bypass surgery, vascular brachytherapy remains a reasonable option 1