The Society for Cardiovascular Angiography and Interventions (SCAI) weighed in on the ongoing debate regarding the long-term safety of paclitaxel-coated balloons and stents on Jan. 25, largely agreeing with the FDA’s stance that the benefits of such devices appear to outweigh the risks until more information becomes available.
The questions surrounding these devices stemmed from a meta-analysis published in the Journal of the American Heart Association in December, which concluded patients treated with paclitaxel devices for femoropopliteal artery disease experienced significantly higher rates of mortality at two and five years of follow-up compared to a control group treated with uncoated devices. Relative increases in mortality associated with the drug-coated balloons (DCBs) or drug-eluting stents (DES) reached 68 percent at two years and 93 percent at five years. There were no significant differences in death rates at one year of follow-up.
“Experts from the SCAI Vascular Disease Council have reviewed this meta-analysis and have concluded that the methods are appropriate and within constraints of trial-level meta-analysis,” SCAI’s statement read. “However, it is important to note that SCAI believes the associations are hypothesis-generating and require further investigation with patient-level data.”
Specific limitations of the meta-analysis, according to SCAI, include there being no mechanistic explanation for the findings, a lack of patient-level data to adjust for clinical and angiographic differences, and only 12 of the 28 included trials reporting data beyond one year and only three reporting data out to five years.
Still, the study caught the attention of the FDA, which announced on Jan. 17 it was going to investigate the potential safety signal of paclitaxel-coated balloons and paclitaxel-eluting stents for the treatment of peripheral artery disease.
Last week, several investigators from device trials responded to the concerns raised by the meta-analysis with patient-level data from their respective studies. Those presentations, which occurred at the Leipzig Interventional Course, revealed the following, according to SCAI:
- Five-year mortality rates were statistically similar between 1,837 people treated with the In.Pact Admiral DCB and those receiving plain balloon angioplasty (9.3 percent vs. 11.2 percent, respectively, p-value=0.399).
- Randomized three-year data from 105 patients showed no significant difference in all-cause mortality between the Ranger SFA DCB and a control group (13.8 percent vs. 10.7 percent).
- Five-year rates of all-cause mortality weren’t significantly different among the 479 patients randomized to be treated with the Zilver PTX DES or a control group (18.7 percent vs. 17.6 percent, p=0.53).
- Three-year data from both randomized and nonrandomized trials showed there were no significant differences in death rates between 2,351 patients treated with the Stellarex DCB or 170 patients in a control group (7.9 percent vs. 9.9 percent, p=0.78).
- Five-year data from 1,189 patients in the Levant 2 trial showed no statistically significant difference in all-cause mortality between patients treated with the Lutonix DCB or a control device (14.1 percent vs. 10.6 percent, p=0.22).
“We expect further details from these meta-analyses to be examined in peer reviewed journals in the near future,” SCAI said in its statement. “Additional patient-level analyses are underway by FDA, independent physicians, and industry, and SCAI is closely monitoring this evolving situation.”
SCAI president David A. Cox, MD, said the organization “concurs” with the FDA that the benefits of paclitaxel-coated balloons and stents “continue to outweigh any potential risks.”
“However, we strongly encourage our members to discuss the findings of the meta-analysis with their patients and to report any safety concerns to FDA,” Cox said.
Any adverse events or safety concerns suspected with the devices can be reported through the FDA’s MedWatch program.