Choose your Region

Are you sure you want to proceed?

You will be leaving the Cook Medical website that you were viewing and going to a Cook Medical website for another region or country. Not all products are approved in all regulatory jurisdictions. The product information on these websites is intended only for licensed physicians and healthcare professionals.

Peripheral Intervention

The Paclitaxel Decision

An interview with Dr. Eric Secemsky

Dr. Eric A. Secemsky

Eric A. Secemsky, MD, MSc, RPVI, FACC, FAHA, FSCAI, FSVM
Director of Vascular Intervention, Beth Israel Deaconess Medical Center Section Head, Interventional Cardiology and Vascular Research, Smith Center for Outcomes Research
Assistant Professor of Medicine, Harvard Medical School

On July 11, 2023, the FDA reversed a decision outlined in a controversial 2019 letter on the potential increase in all-cause mortality when using paclitaxel-coated devices compared with non-drug-coated devices to treat peripheral arterial disease (PAD) in the femoropopliteal artery.

In the updated letter, the FDA stated “the data does not support an excess mortality risk for paclitaxel-coated devices.” Physicians around the world celebrated the FDA’s conclusion that these devices are safe and effective for patients suffering from PAD.

Dr. Eric Secemsky, a primary investigator on SAFE-PAD (Safety Assessment of Femoropopliteal Endovascular Treatment with Paclitaxel-Coated Devices),1 played an important role in helping bring these lifesaving devices back to the shelves.

We recently spoke to Dr. Secemsky about the fallout and subsequent turnabout regarding this important technology.

How will the FDA’s updated letter positively impact patients?

Many of us practicing in the vascular space, particularly in the US, felt confident that there were no safety concerns with these devices. Obviously, any suspicion leads to caution among the general group of operators because our patients are always the priority. The FDA is charged with protecting the safety of our patients in the US from a regulatory standpoint, and they now agree that there is no clear evidence of safety issues with paclitaxel-coated devices. That is a stamp of approval that was needed for us to move back to our routine practice and deliver the best care for our patients.

A notable impact of the FDA’s decision is that it allows other non-US regulatory bodies to consider similar endorsements for more routine use of these devices. Hopefully now every patient can benefit from this technology no matter where they live.

What was your role in researching paclitaxel and its long-term impact?

I got involved very early after the Katsanos meta-analysis came out. Our research center in Boston (Smith Center for Outcomes Research) had put out two papers1,2 using real-world evidence from a claims registry that demonstrated no reproducibility of that harm signal with these devices.

Two things resulted from these publications. First, this was an early example of long-term safety of these devices and demonstrated to the FDA how real-world evidence can be used adjunctively to help understand the safety concern that was seen in the Katsanos meta-analysis. Second, it gave me an opportunity to become more involved in evaluating the safety of these devices, including participation at the June 2019 FDA advisory meeting and developing the real-world evidence pathway to allow these devices to remain available in the US.

After the FDA panel, my partner Dr. Robert Yeh and I were asked to design and conduct a longitudinal surveillance mechanism using real-world evidence, which became the SAFE-PAD study. This was designed in collaboration with the FDA and provides biannual updates on the safety of these devices.

Why were you so active in working alongside the FDA?

As a practicing vascular interventionalist, I only knew how to practice in a world where I had drug-eluting stents and drug-coated balloons. My procedures felt incomplete not having these devices available for my patients. So, I wanted to get involved and understand the signal better because it was impacting my patients and my clinical practice. No one knew exactly who I was when I started publishing these papers. When I got the FDA’s attention, they started paying attention to some of the work that I was doing. One thing led to another. But, in the end, I’m a practicing clinician who cares about my patients, and I thought this was a critically important topic for something that deeply affects each of them.

What role did you see industry play in the paclitaxel update?

I think that industry partners—and Cook being at the front of them—really had a dramatic impact on how the paclitaxel pathway moved forward after the Katsanos analysis. This was a wonderful demonstration of how industry can work together to advocate for patient care. And that is exactly what the FDA wanted from industry. It was wonderful to see all of our industry partners we work with every day come together and put their competitiveness aside so that the patient remained at the center of the conversation. This was definitely one of the biggest positives to come out of the paclitaxel situation.

How did it help you as a physician when Cook analyzed our data and provided entire datasets?

I remember being with Cook at Charing Cross when the paclitaxel decision tool went live. I was immediately impressed with how Cook was willing to be so public and transparent with their data. Especially because we knew that the Zilver® PTX® trial was so complicated because of the randomization scheme.

In the 2019 letter, the FDA determined that only high-risk patients should be treated with paclitaxel-coated devices. Clinicians didn’t have a tool to identify those patients, so we were kind of lost. Cook stepped in with the novel prediction model that allowed us to discern who’s a good candidate for a paclitaxel device. I believe it helped physicians and Cook, who showed it’s a company that’s data-driven and doing things in the patient’s best interest.

Now that we can use paclitaxel more liberally again, the prediction model reminds me who’s at higher risk for a repeat event, enabling me to optimize my therapy and think about post-procedure care and monitoring. It also helps patients to be more aware of their own risks and benefits with the therapy. The prediction model gives real-world numbers based on the complexity of their disease and comorbidities.

For physicians who are still hesitant about paclitaxel, what level of data do you think they need to make them more comfortable?

Physicians who previously used paclitaxel-coated devices but stopped using them after the FDA letter should be comforted by the resounding amount of safety data that is now available. The data supports the safety of these devices exceeds five years, which is the farthest point that the Katsanos meta-analysis covered. For instance, we now have data out to eight years in SAFE-PAD. And we have additional demonstrations—both in randomized trials and observational studies—that show these devices are safe. The stamp of approval from the FDA further cements that this was a blip in the data and not a true causal relationship between paclitaxel and survival.

The other physician group that exists is the never-believers. They didn’t use drug therapy before Katsanos, and that gave them further reason not to use it. But I would remind them that there really are no other peripheral vascular devices that have as much randomized trial data as paclitaxel-coated devices. We use so many devices in our daily practice that are approved on single-arm trials or less, and we make many decisions based on anecdotal data. So, if you look at the totality of data for drug-coated devices, there is a continuous demonstration of patient benefit, not just binary stenosis on ultrasound, but reduction in clinical events that favors a patient outcome that should really resonate with anyone who’s truly thinking about their patients.

Where do you see the future of a drug coating other than paclitaxel?  

We have not seen paclitaxel succeed below the knee yet. Maybe it’s the therapeutic agent and not how the agent’s being delivered. Or it could be the disease state that’s confounding this issue. Balloons with limus preparations below the knee have shown promise. Hopefully they will provide a pathway forward where paclitaxel has not been successful yet, at least not on a large scale.


  1. Secemsky EA, Shen C, Schermerhorn M, et al. Longitudinal assessment of safety of femoropopliteal endovascular treatment with paclitaxel-coated devices among Medicare beneficiaries: the SAFE-PAD study. JAMA Intern Med. 2021 Aug 1;181(8):1071-1080. doi: 10.1001/jamainternmed.2021.2738. 
  2. Secemsky EA, Schermerhorn M, Carroll BJ, et al. Readmissions after revascularization procedures for peripheral arterial disease: a nationwide cohort study. Ann Intern Med. 2018 Jan 16;168(2):93-99. doi: 10.7326/M17-1058.