Drug-Coated Balloons for PAD and CAD Treatment

Introduction to Drug-Coated Balloons

The American College of Cardiology and the American College of Radiology suggest that 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, 2, 3

DCBs coated with paclitaxel have demonstrated significantly improved patency rates compared to conventional balloon angioplasty in multiple prospective randomized trials for PAD treatment, with the American College of Radiology citing improved outcomes 2, 3
The American College of Cardiology recommends dual antiplatelet therapy (DAPT) for 2-6 months after DCB procedure for PAD revascularization, based on 2024 ACC/AHA guidelines 4, 5
The FDA has issued a warning about a possible increase in long-term mortality rates among PAD patients treated with paclitaxel-coated balloons, recommending continued surveillance and discussion of risks and benefits with patients, as reported in the Journal of the American College of Radiology 2
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%, according to the American College of Radiology 2, 3

For coronary in-stent restenosis (ISR), the American College of Cardiology suggests that 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, 6
The American College of Cardiology recommends DCBs as a reasonable alternative for ISR treatment, particularly when additional stent layers are undesirable, based on the 2021 ACC/AHA/SCAI guidelines 1, 6
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, as suggested by the American College of Cardiology 1, 6

The European Society of Cardiology recommends drug-eluting balloons (Class IIa, Level B) for the treatment of in-stent restenosis after prior bare metal stent (BMS) implantation, as stated in the European Heart Journal 7

The FDA warning about increased mortality with paclitaxel-coated devices requires careful patient selection and informed consent, according to the Journal of the American College of Radiology 2
For recurrent ISR with multiple stent layers, or in patients not suitable for additional stenting or bypass surgery, vascular brachytherapy remains a reasonable option, as suggested by the American College of Cardiology and Circulation 1, 8