Amid concerns about a potential link between paclitaxel devices and heightened long-term mortality rates, Medtronic (NYSE:MDT) and other device-makers doubled down on their products’ safety at this year’s Leipzig Interventional Course in Germany.
Medtronic presented a patient-level survival analysis that included 1,837 patients enrolled in its In.Pact Admiral clinical program.
The analysis assessed all-cause mortality across the program, including device- or procedure-related death through five years and paclitaxel-related events through 12 months.
Medtronic noted that at five years, there was no statistically significant difference in all-cause mortality between the In.Pact Admiral drug-coated balloon and plain balloon angioplasty groups.
The company added that there was no correlation between paclitaxel dose and long-term survival.
“This independently adjudicated analysis includes 1,837 patients treated with IN.PACT Admiral and followed long-term,” presenter Dr. Peter Schneider said in prepared remarks. “In contrast to a recently published summary-level meta-analysis-which included 28 trials with different devices, designs, levels of monitoring, and follow-up periods-the findings from this study showed neither paclitaxel use, nor dose had any effect on mortality at five years.”
“In light of recent discussions around the safety of paclitaxel-coated and -eluting technologies, it’s now more important than ever for Medtronic and our industry peers to be forthcoming with all our clinical data,” VP & GM of Medtronic’s peripheral biz, Mark Pacyna, added. “The evidence presented today at LINC underscores our ongoing commitment to patient safety, improved long-term outcomes, and data transparency.”
Boston Scientific’s peripheral interventions president: “The data will be there” to support paclitaxel devices
Focusing on diabetic patients in the company’s Imperial clinical trial, researchers found a statistically significant difference in target lesion revascularization rates for Eluvia versus Cook Medical’s Zilver PTX device – 3.7% compared to 13.6%, respectively.
“That’s a pretty large difference; that’s a 70% reduction in the rate for Eluvia versus the Zilver PTX. So if you think about that from a patient perspective, diabetic patients who receive an Eluvia have a 70% reduction of the need for a repeat intervention at one year. That’s a dramatic treatment effect,” Jeff Mirviss, SVP & president of Boston Scientific’s peripheral interventions unit, told Drug Delivery Business News.
Investigators also reported a nine-fold reduction in the rate of stent thrombosis for diabetic patients treated with Eluvia compared to those treated with Zilver PTX.
“These results that we’ve put up with Eluvia have been very consistent from trial to trial and dataset to dataset. And I think that’s very important for physicians. When they select a device, it’s [about] that reliability and consistency and performance, and I’m happy to say that Eluvia can fall under that category with all of the data that we put up,” Mirviss said.
“What’s new about the diabetic data is many physicians look to the diabetic patient as complex patient that is typically difficult to treat and, to generalize it, has worse outcomes than non-diabetic patients,” he added. “But I think what we’re seeing with Eluvia is that I believe it will give physicians confidence that Eluvia is an excellent first choice for their diabetic patients, because the data, both safety and efficacy, is so strong and so consistent with the overall dataset.”
Also at LINC, researchers reported three year follow-up data for the Compare trial, a head-to-head study comparing Boston Scientific’s Ranger drug-coated balloon with Medtronic’s In.Pact Admiral DCB.
Despite that Ranger has half the dose of paclitaxel compared to In.Pact, Mirviss said the two devices had equivalent efficacy results in terms of primary patency.
He also noted that the devices sported safety profiles that were in line with previously-reported mortality data.
Commenting on the meta-analysis published earlier this month linking late-term mortality concerns with paclitaxel devices, Mirviss pointed out that its Eluvia device stands out from other technologies due to its design.
“All of the other devices, including the Zilver PTX stent, have a coating where the coating comes off to deliver the drug. Eluvia is an eluting technology, with a polymer that has the drug incorporated in it so that the coating does not come off,” he explained, adding that Eluvia was not included in the meta-analysis.
Mirviss praised the FDA’s letter to doctors, saying that the company was pleased that the agency “made a strong statement that indicated that the benefits continue to outweigh the risks.”
“I believe that they have all the patient-level data from the companies, so I believe that will give physicians a lot of confidence and support for what has clearly been demonstrated to be a more effective treatment modality with drug-eluting technologies versus bare technologies,” he said.
“Our view is with further analysis, patient-level data, which was not used in the meta-analysis, I think what we will see is that there is a very important role for drug-eluting technologies, and that over time, it will be shown to be safe and quite effective,” Mirviss said. “I think that this meta-analysis has raised important questions that we need to clarify, but I believe that the data will be there to reinforce the safe and effective use of paclitaxel.”