(HealthNewsDigest.com) – The Cardiovascular Research Technologies meeting serves as a global leader in interventional cardiology conferences. This year, in 2019, the conference took place on March 2-5 in Washington, D.C. and featured a Drug-Coated Balloon Mortality Town Hall, which included a panel of stakeholders and experts who examined the latest data on all-cause mortality related to paclitaxel-coated devices.
What Is Paclitaxel?
Paclitaxel, available under the brand name Taxol, is a chemotherapy drug formulated to slow or stop cancer growth. It’s been used since 2003 as a coating for coronary stents used to prevent restenosis, and more recently, in the last decade, its use has widened as a coating for peripheral stents and balloons. But this form of therapy might not be safe for patient use a new study has found.
Recently, the Food and Drug Administration, in response to a study published in the December 2018 issue of the Journal of the American Heart Association, sent out a letter to physicians alerting them to the risks of these devices and asserted that it believed the risks involved outweighed any benefits the devices could have for patients.
The Society for Cardiovascular Angiography and Interventions Foundation agreed with the FDA’s assertion and advised doctors to inform patients of the risk of therapy involving paclitaxel-coated devices.
Why and How the Panel Voted
A meta-analysis was published in December 2018, which found a 68% increase in risk of mortality at two years in patients who received paclitaxel drug-coated balloons and drug-eluting stents placed in lower-limb arteries when compared to controls. The increase in mortality seemed to get worseat five years, with up to a 93 percent higher relative risk recorded.
The panelists voted whether there is a safety signal with these devices and stents that are used as a therapy option forpatients peripheral artery disease. According to a report from MedPage Today,this is how the vote panned out: “Ten of the 14 panelists voted that, yes, such a signal exists after considering the totality of the data presented by industry and academic researchers throughout the day at the CRT meeting here. The other four responded with “I don’t know.”
What Caused the Confusion?
The uncertainty about the safety signal comes from investigative data presented by different groups. The session moderator Jeffrey Popma, MD, admitted he was not sure of the meta-analysis’ data and couldn’t decide whether a safety signal really exists. Popma attributed his uncertainty not to erroneous statistical work from researchers but to an underlying structure of data that may be incorrect.
Issues with trials included in the meta-analysis ranged from lack of medication protocol, failed follow-up and various cross-overs. But some panel members took the mortality rate to mean that there is a thethe vote was not quite split at 8 to 6.Then, a near-unanimous vote was cast on whethermedical providers should inform their patients about the paclitaxel devices controversy before committing to a procedure involving it – only one “I don’t know” vote was recorded.
During the CRT Town Hall session, industry reps who were in attendance were called upon to present patient data from their related research programs that showed no increase in deaths when paclitaxel devices were used and the majority of the panel voted for a statistically robust pooled analysis of data for further study. Another group, VIVA Physicians, announced its plan to complete its own meta-analysis of the available patient data.
Further Research is Needed
Mehdi Shishehbor, DO, FSCAI, director of the Cardiovascular Interventional Center and co-director of the Vascular Center at University Hospitals Harrington Heart and Vascular Institute, Cleveland, Ohio believes, unlike the FDA, that the benefits of paclitaxel devices outweigh the risks.
Dr. Shishehborbelieves that it will take additionaldata to determine if there is truly a safety issue at stake. “We will see a lot of new information and papers coming out on this in the first quarter of 2019. There will be more studies looking for these safety signals,” he said.
Dr. Aloke Finn, Medical Director and Chief of Research at CVPath Institute in Gaithersburg, Maryland,hypothesized that mortality can be explained by poor delivery of the drug:
“DCB drug delivery is inefficient because most of the paclitaxel does not make it to the target site and is lost in the body. Overall, total doses of DCBs to the patient is much lower than required to cause paclitaxel toxicity,” saidFinn. “We must look for other causes.”