FDA update: Paclitaxel-coated devices for PAD cleared of excess mortality risk, proven safe and effective


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Data on hundreds of thousands of patients who have received lower limb endovascular treatment provide confidence in paclitaxel safety. This central message from a Boston Scientific symposium at the recent Leipzig Interventional Course (LINC 2023; 6–9 June, Leipzig, Germany) was delivered a month before the US Food and Drug Administration (FDA) removed restrictions on use of paclitaxel in peripheral arterial disease (PAD) treatment.

The LINC 2023 symposium—moderated by Marianne Brodmann (University of Graz, Graz, Austria) and Koen Deloose (AZ Sint-Blasius, Dendermonde, Belgium)—saw various speakers outline existing and new data concerning the use of the Eluvia drug-eluting stent (DES) and the Ranger drug-coated balloon (DCB) in the superficial femoral artery (SFA), including four-year data from the Ranger II SFA randomised controlled trial (RCT) and several registries.

The role of RCTs in shaping clinical practice

Brodmann opened the session with a presentation on RCT data, which she described as “the pinnacle of proof”, stressing their importance in proving device performance against standard of care, and in shaping clinical guidelines.

The first RCT discussed was the Ranger II SFA RCT that assessed the Ranger DCB versus standard percutaneous transluminal angioplasty (PTA). In this single-blind, superiority trial, 376 patients were randomised 3:1.

Brodmann shared long-term follow-up results, revealing specifically three-year patency and four-year clinical safety results. The investigators “demonstrated outstanding three-year primary patency of 77% for the [Ranger] DCB and four-year freedom from clinically driven target lesion revascularisation [CD-TLR] which is greater than [that] reported in other DCB studies previously published,” she summarised.

Aside from the Ranger II results, Brodmann also informed the LINC 2023 audience about three other RCTs—COMPARE, IMPERIAL and EMINENT— and relayed their positive outcomes.

COMPARE showed similar primary patency between the low-dose Ranger and the high-dose IN.PACT DCB (Medtronic), the presenter outlined, while IMPERIAL demonstrated superior primary patency for Eluvia over Zilver PTX (Cook Medical) at 12 months, a “significant” TLR advantage at 24 months and similar safety outcomes out to five years. Brodmann continued that, in the EMINENT RCT, the Eluvia DES showed superiority in terms of efficacy compared to bare metal stents (BMS) and is the first and only DES to do so in SFA intervention.

Real-world evidence: Registries complement, and do not replace RCTs

Giovanni Torsello (St Franziskus Hospital, Münster, Germany) then shared real-world evidence on the Eluvia DES. “The real-world data are consistent with RCT results for Eluvia DES despite markedly increased lesion complexity and patient comorbidities,” he remarked.

Torsello spoke on several registries studying the Eluvia DES, including Auckland, DESAFINADO, Regal, and Münster. The studies all demonstrated around 90% primary patency for the Eluvia DES at 12 months despite often involving long lesions and high patient comorbidity. According to Torsello, the available registry data “provide more evidence and more confidence that the Eluvia RCT results are generalisable and repeatable”.

Osamu Iida (Osaka Police Hospital, Cardiovascular Division, Osaka, Japan) then shared real-world data on drug-eluting therapies from Japan, concluding that they “provide more evidence of Eluvia DES and Ranger DCB successful outcomes”.

The presenter outlined that in the CAPSICUM registry (1,097 patients), three-year follow-up showed acceptable restenosis rates for the Eluvia DES, and decreasing annual event rates for restenosis, re-occlusion and stent thrombosis.

Iida also addressed the CAPRICORN propensity-matched cohort (1,456 patients), which demonstrated significantly lower one-year restenosis rates for the Eluvia DES versus the IN.PACT DCB. He noted that this was the first study to demonstrate superiority of DES over DCB in real-world practice.

Finally, Iida shared that the PROSPECT MONSTER study (581 patients) showed that the low-dose Ranger DCB performed similarly to the high-dose IN.PACT DCB. This result was also observed in the COMPARE RCT, as Brodmann had previously noted.

Big data from big databases—PTX safety

Yann Gouëffic (Groupe Hospitalier Paris Saint Joseph, Paris, France) addressed the topic of paclitaxel safety with an overview of studies that included more than 180,000 patients, such as SWEDEPAD, VOYAGER PAD, and SAFE-PAD. He detailed that these studies all refute the findings of the 2018 Katsanos meta-analysis, by showing no difference in mortality between patients treated with either a drug-coated device or a non-drug-coated device. He closed by introducing the DETECT study, based on French national healthcare data. This study includes ~260,000 patients and, as reported by Gouëffic, it confirmed the conclusion on paclitaxel safety. The final analysis is expected later this year.

On 11 July, soon after LINC 2023, the US Food and Drug Administration (FDA) updated its guidance on the use of paclitaxel-coated devices to treat PAD, determining that additional long-term clinical data from the pivotal RCTs do not support an excess mortality risk for paclitaxel-coated devices.1

In a Boston Scientific statement released following the FDA announcement, chief medical officer Michael Jaff commented that the update recognises the safety and efficacy of devices such as Eluvia and Ranger, “both of which have demonstrated excellent safety profiles and very low revascularisation rates in the hundreds and thousands of patients treated worldwide with these devices”.2

The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) added to the subject in an online editorial dated 12 July, underscoring that re-analysis of old data and new outcomes data do not support a link between paclitaxel-coated balloons and paclitaxel-eluting stents and mortality. On this basis, CIRSE encourages the use of these devices for treating PAD in femoropopliteal disease, relying on their published efficacy.3


  1. UPDATE: Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality – Letter to Health Care Providers | FDA
  2. News Releases – Boston Scientific: Boston Scientific Position on FDA Update About Use of Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease
  3. Müller-Hülsbeck S, Fanelli F, Haage P, et al. Re-analysis of old data and new outcomes data do not support a link between paclitaxel-coated balloons and paclitaxel-eluting stents and mortality: these devices should be used in PAD (peripheral arterial disease) treatment in femoropopliteal disease on the basis of their published efficacy. Cardiovasc Intervent Radiol. 2023;46:977–980. https://doi.org/10.1007/s00270-023-03507-w

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