Drug-Coated Balloon Use Must Be Individualized to Our Patients

Can you share your reaction to the Katsanos meta-analysis¹?

The studies used in Dr. Katsanos’ meta-analysis were very different. The meta-analysis was based on study-level data, not patient-level data and, therefore, there are certainly confounding issues involved. That being said, the FDA studied the data and determined similar findings as Dr. Katsanos, indicating a signal for increased mortality.² The reason for this signal is not known, but a signal is there. At this time, the FDA is not launching a new study, due to the cost, but has put limitations on the use of the product. Patients with a low intrinsic risk and low recurrence risk (patients with a TASC A or B type lesion), should be treated with plain old balloon angioplasty (POBA) after atherectomy. The key is long-term follow-up of each patient. Patients must adhere to follow-up visit plan. For patients with a high recurrence risk, offer whatever available treatment keeps them symptom free and does not incur more of a risk with an interventional procedure, which also incurs a greater monetary cost to the healthcare system overall. I think the meta-analysis is flawed. It is flawed in several different statistical areas and in combining different studies with different variables. Despite the flaws, however, there was a signal toward mortality and until it is absolutely proven not to be true, we are better erring on the side of caution.

Will your practice change in light of the data that have come forward?

Mine has not. Early on, right after Society of Interventional Radiology (SIR) conference, the hospital’s administration made a decision to put on hold any use of drug-coated balloons. I had a patient that came in the very next day with a severe toe wound (Rutherford 5). His occlusion went from the popliteal into the trifurcation. I knew of nothing else that I could use to keep it open except a drug-coated device; otherwise, the patient would have ended up requiring an amputation. Fortunately, the hospital reversed its decision. The administration developed a separate consent form for these patients. The physician verbally consents the patient in front of a witness (usually the cath lab nurse). The patient is informed of the meta-analysis with a signal toward late increased mortality with the use of paclitaxel-coated devices. I use this consent form with patients that have severe, complex lesions (Rutherford 4 and 5), and a high recurrence risk. I also discuss this option with patients that have moderately complex lesions, if calcification is present and the lesion length reaches 8-10 cm. These patients have a high chance of needing re-intervention within a short period of time. I have them consent for possible drug-eluting device use and will dictate that into my patient notes. Obviously, hospitals are afraid of late legal action, but I think this is how we have to handle this issue for now.

Can you tell us more about your consent process?

The consent process is mentioned in every operative note. There is a basic consent form, but in the operative note, I have a brief indicator that the patient and I have had the consent discussion. I will also have a witness present when I inform the patient of the possible mortality signal and obtain their consent. Patient safety is of utmost importance, but I remember what it was like for patients before the use of paclitaxel-coated devices. Bare-metal stents put in patients with long, complex lesions have significantly higher rates of target lesion revascularization (TLR). Especially for diabetic patients or patients that continue to smoke, the primary patency rate was 25% at the end of one year. These patients repeatedly required revascularization with very little treatment strategy for in-stent restenosis. These were dark ages, in my opinion. With the introduction of drug-coated stents and drug-coated balloons, I manage these patients, especially if I surveil them very closely every 6 months. Patient management includes an ultrasound of the treated area or, if an area of focal in-stent restenosis is evident, we take the patient to the lab and put in a little balloon, and the patient is good for another year or so. Drug-coated devices changed my practice drastically.

Do you think there is a full understanding of the severity of critical limb ischemia (CLI) and the disease process?

Yes, I think the FDA has a full understanding of the severity of CLI and the disease process. Their response to the indicated signal was appropriate. The FDA stated that these devices were not being taken off the market. The need for drug-coated devices is strong in certain cases, but the true reality and severity of the late signal on mortality needs to be determined.

Do you think the role of atherectomy will change?

Atherectomy helps prepare lesions in the vessels for a much better long-term result. Atherectomy is here to stay. The debulking aspect of Jetstream (Boston Scientific), as well as TurboHawk (Medtronic), is extremely beneficial. There is also a new debulking device by Avinger, Pantheris, that is helpful. No, the role of atherectomy will not change.

Any final thoughts?

The FDA had a measured response. They didn’t give a green light to doctors for use of a drug-coated device on every patient, but they didn’t take the products off the market, either. Any device used should be chosen based on the morphology and complexity of the lesion. I hope within the next 2-4 years the reason for the appearance of this late signal of mortality will be determined and if it was a flawed situation that will be told also. 

Disclosure: Dr. Beasley reports that he is a consultant or an advisory board member for BD, Boston Scientific, Cook Medical, CSI, Medtronic, Philips/Spectranetics, and Terumo.

Dr. Bob Beasley can be contacted at bbeaz@aol.com.

REFERENCES

1. Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc. 2018 Dec 18; 7(24): e011245.

2. FDA Executive Summary. Circulatory System Devices Panel Meeting. Section 3.2. June 19 and 20, 2019. Available online at https://www.fda.gov/media/127698/download. Accessed June 20, 2019.