UK's MHRA Offers Split Recs on Paclitaxel-Coated Devices in PAD

Patrice Wendling

June 05, 2019

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is cautioning physicians against the routine use of paclitaxel drug-coated balloons (DCB) or drug-eluting stents (DES) to treat intermittent claudication but suggests the devices may still be an option in critical limb ischemia.

The action follows widespread concern over a late mortality signal associated with use of the devices for femoropopliteal disease reported late last year in the controversial Katsanos meta-analysis.

The MHRA formed an independent Expert Advisory Group (EAG) in response to those concerns, which recently concluded that the "statistical analysis in the Katsanos paper is robust," and that there is "a possible dose-dependent effect of the use of paclitaxel coated/eluting devices on mortality although no scientific or clinical explanation is currently available."

In a June 3 statement closely aligned with the EAG recommendations, the MHRA told physicians not to use paclitaxel DCBs or DES in the "routine treatment of patients with intermittent claudication until further notice, as the potential mortality risk generally outweighs the benefits."

The use of paclitaxel DCBs and DES in patients with critical limb ischemia, however, "remains an appropriate option in accordance with NICE guidance, as the benefits may outweigh the risks. This is because these patients generally have a higher risk of irreversible ischemic damage resulting from restenosis, and a lower life expectancy," the statement says.

The MHRA also recommended enhanced patient follow-up if the devices are to be used and called on patients, carers, and healthcare professionals to report any device-related safety complication or adverse event via its Yellow Card scheme.

A formal PCR statement on the controversial devices, presented at last month's Congress of the European Association of Percutaneous Cardiovascular Intervention (EuroPCR) 2019, said the Katsanos meta-analysis serves as a "wake-up call." However, "pending the availability of more conclusive data, there is currently no strong evidence to justify changing clinical practice and clinicians should continue to use best judgment in the use of paclitaxel-based DCBs."

The US Food and Drug Administration (FDA) warned physicians in a March letter that "alternative treatment options should generally be used for most patients" after initial findings of its own review showed about a 50% increase in mortality with paclitaxel-coated devices in three trials with 5-year follow-up data.

Further insights are expected from an industry-wide patient level and DCB-only pooled analysis to be presented at an upcoming FDA advisory committee meeting June 19 and 20.

The UK's EAG and the PCR statement were in agreement, however, that currently suspended randomized controlled trials involving paclitaxel-coated devices should resume enrollment. The European BASIL-3 and SWEDEPAD trials halted enrollment just days after publication of the Katsanos meta-analysis.

The SWEDEPAD trialists, however, recently announced they've decided to "investigate the possibilities of resuming inclusion in SWEDEPAD" following the recommendation of its security committee to do so after its own analysis of the data failed to support the conclusion of Katsanos et al.

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