ATLANTA — Paclitaxel-coated devices for femoropopliteal artery revascularization weren’t related to any excess mortality risk in the newest update from Medicare data.
The danger of death from any cause, if anything, trended barely lower (hazard ratio 0.98, 95% CI 0.96-0.99) with paclitaxel-eluting stents or -coated balloons compared with bare metal stent or percutaneous transluminal angioplasty (PTA) during a median follow-up of three.52 years in greater than 160,000 individuals, reported Eric A. Secemsky, MD, MSc, of Beth Israel Deaconess Medical Center in Boston.
Weighted cumulative mortality in as much as 6.31 years of follow-up occurred in 62.5% of patients treated with paclitaxel-coated devices versus 63.6% with non-coated devices, which met non-inferiority criteria, he said on the Society for Cardiovascular Angiography and Interventions (SCAI) annual meeting. The findings were published concurrently in a research letter in Circulation: Cardiovascular Interventions.
The outcomes largely match earlier data from the identical cohort within the SAFE-PAD study at 2 years and a lot of other smaller observational cohorts.
“We have been coping with this within the peripheral space since December 2018, when this meta-analysis was presented,” Secemsky noted on the SCAI featured clinical research session. That meta-analysis of randomized trials suggested a 68% relative jump in mortality with paclitaxel devices for peripheral artery disease (PAD) at 2 years and 93% at 4 to five years, albeit based on just three trials at that time with lower than 1,000 patients.
FDA’s response, recommending only cautious use of paclitaxel-coated devices for PAD, has left the sector in “limbo” ever since, Secemsky said.
“We’ve not been in a position to replicate that signal of harm in any of the following studies which have come out,” he concluded. “It’s about time that we revisit probably the most recent regulatory communications about paclitaxel-coated peripheral devices.”
SCAI session panelist Herb D. Aronow, MD, MPH, of Henry Ford Health in Royal Oak, Michigan, agreed.
“It’s clear that a randomized trial isn’t going to occur,” he said. “It doesn’t look like the information can get any higher than what you only presented … Really, this can be a very sophisticated evaluation you have done, and I feel it’s as convincing as anything. My conclusion as an operator is, it is time to move on.”
Secemsky noted that his conversations with FDA suggest the agency is able to move on too, but remains to be waiting on one final piece of information, an updated patient-level meta-analysis sponsored by industry.
“In point of fact, I feel a few of the pressure goes to have to come back from us,” he said. The multi-society response on the FDA advisory panel in 2019 on this issue “made a big impact on the time, and I feel it is time for us to do something like that.”
The SAFE-PAD study included all 168,553 Medicare fee-for-service beneficiaries who had femoropopliteal artery revascularization from April 2015 through December 2018 with a drug-eluting stent, drug-coated balloon, bare metal stent, or PTA. Patients needed to have been enrolled in Medicare for no less than a yr prior to the procedure, to determine comorbidities.
Not one of the prespecified subgroups showed harm from paclitaxel-coated device use, including low-risk patients, those with critical limb ischemia or not, those with stents implanted, or those that only had balloon angioplasty.
Instrumental variable analyses were likewise consistent with the general results.
A falsification evaluation turned up “negligible” associations with acute myocardial infarction, heart failure, and pneumonia, further supporting the robust results of the most important evaluation.
While it was essential to substantiate lack of risk within the healthiest patients, SCAI president and session co-moderator Timothy Henry, MD, of The Christ Hospital in Cincinnati, noted that it’s plausible to imagine that use of those devices could actually end in a mortality profit within the sickest patients, like those with critical limb ischemia (CLI), for whom treatment should improve activity and thus survival. He pointed to the subgroup evaluation by which the CLI patients had an HR 0.96 (95% CI 0.95-0.98) for mortality with paclitaxel-coated devices.
It’s price revisiting once the dust settles, Secemsky agreed.
Secemsky disclosed funding from the National Heart, Lung, and Blood Institute, Harvard Medical School and the University of California San Francsico, grants to his institution from AstraZeneca, BD, Boston Scientific, Cook, CSI, Laminate Medical, Medtronic, and Philips, and consulting or speaking fees from Abbott, BD, Bayer, Boston Scientific, Cook, CSI, Inari, Janssen, Medtronic, and Philips.