Cliff Shearman, Giovanni Torsello and Theodosios Bisdas
What do you think are the biggest challenges treating peripheral arterial disease?
Cliff Shearman (CS): The lack of understanding of the disease processes and factors influencing progression. At present, we only have tools to modify the condition at the end stages, eg. critical limb ischaemia. There has been no high quality evidence produced in this area compared for instance with carotid and aortic aneurysm disease, which means that current therapies are based more on personal bias rather than evidence.
Giovanni Torsello (GT) and Theodosios Bisdas (TB): We now have in our armamentarium a number of different materials and devices to treat peripheral arterial disease. The majority of those devices have shown excellent results in well-designed randomised controlled trials including patients with TASC A and B lesions and Rutherford categories 1 to 4. However, the literature is lacking on evidence about the safety and efficacy of those technologies in more challenging populations, namely patients with long occlusions, critical limb ischaemia, severe calcification and dialysis. These patients are typically excluded in the majority of randomised controlled trials and remain the biggest challenges that physicians are facing treating peripheral arterial disease. Last but not least, the financial burden of using all these new technologies in our tax- and insurance-funded healthcare systems without any evidence about cost-effectiveness is probably the biggest challenge for physicians.
What are the main challenges around the use of drug-coated balloons in the superficial femoral artery and their durability?
CS: The lack of convincing clinical evidence such as reduction in symptoms or avoidance of amputation in treated patients compared to those managed conventionally. Unless these data are available, it is impossible to draw any views on the cost-effectiveness of the devices. The cost will be a major factor even if benefit is demonstrated.
GT/TB: The introduction of drug-coated balloons in the femoropopliteal lesions has the potential to change the paradigm of treatment in patients with peripheral arterial disease. The two-year results from prospective, randomised controlled trials demonstrated continued superiority of the drug-coated balloon over percutaneous transluminal angioplasty and a very encouraging reduction in the need for reinterventions after local delivery of paclitaxel. However, further assessment of the durability of drug-coated balloons in de novo lesions is mandatory considering the surprising catch-up phenomenon of percutaneous transluminal angioplasty over drug-coated balloons at three years after treatment of in-stent restenosis in diabetics (DEBATE-ISR). Furthermore, all randomised controlled trials demonstrate superiority of drug-coated balloons over percutaneous transluminal angioplasty for short- to intermediate-length lesions, but the benefit of drug-coated balloons for longer lesions (>18cm) and more complex lesion subsets, namely severely calcified lesions and thrombus-containing lesions, has not been proven.
Is there a consensus in relation to drug-coated balloons vs. stents?
CS: The disappointing long-term results with drug-eluting stents have prompted drug-coated balloons with the concept of “leaving nothing behind”. I think there is scepticism about the drug penetration into diseased atherosclerotic arteries (compared to most of the validation work in animal arteries) and again lack of convincing clinical evidence of benefit. My impression is that this will be a short-lived therapy.
GT/TB: We have an increased number of evidence as to the effectiveness of both drug-coated balloons and stents in symptomatic femoropopliteal arterial disease, but no direct comparison exists. At present, there are no algorithms for using the one or the other treatment option. A consensus including all involved specialties (vascular surgeons, cardiologists, radiologists) about drug-eluting technologies would be of great importance and would guide decision-making among vascular specialists.
Join the discussion of these and more topics in the peripheral arterial field at the CX Peripheral Arterial Challenges Day on Tuesday 26 April, Olympia Grand, London, UK
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