KINGSPORT, TN (WJHL) – A little more than a year after Wellmont CVA Heart Institute became one of a limited number of sites across the country offering patients a first-of-its-kind dissolving stent to help treat coronary artery disease, the maker of that device has stopped sales and Wellmont has returned its remaining stents.
While Abbott reports the decision was due to low sales, the move comes six months after the Food and Drug Administration started investigating concerns about an increased rate of major adverse cardiac events.
Despite recent developments, Wellmont CVA Heart Institute Clinical Research Medical Director Dr. Chris Metzger said there are no safety concerns for any of the more than 100 patients in our area who received the stent.
“This is not a buzz for alarm,” Dr. Metzger said. “You don’t have a bad stent or a stent that’s on recall.”
During clinical trials for the Absorb stent, Wellmont called itself one of the top enrollers of patients in the country. The stent opens arteries, but unlike traditional ones made out of mesh-wire slowly disappears as arteries become strong enough to stay open on their own.
Dr. Metzger said although Wellmont participated in the clinical trials and implanted a limited number of stents on patients, he is not aware of any adverse cardiac events like cardiac deaths, heart attacks or the need for additional procedures, because Wellmont doctors followed the proper instructions when implanting the medical device and did not implant them on small arteries.
“It was not as good as the best stent in the world in the terms of a small increase in a number of increased heart attacks or the stent clotting off,” he said. “Honestly, it’s a good stent provided you put it in correctly.”
Wellmont announced its participation in the breakthrough technology in July 2016. The FDA announced its approval of the stent on the same day.
By March 2017, the FDA sent a letter to health care providers telling them the agency was investigating an increased rate of major adverse cardiac events and an increased rate of developing blood clots compared to the alternative metallic stent. In its letter, the FDA urged health care providers to follow the manufacturer’s instructions for the use of the product.
“The FDA’s initial review of two-year data from the BS pivotal clinical study shows an 11 percent rate of major adverse cardiac events in patients treated with the BVS at two years, compared with 7.9 percent in patients treated with the already-approved Abbott Vascular’s metallic XIENCE drug-eluting stent,” the FDA letter said. “This study also shows a 1.9 percent rate of developing blood clots within the BVS versus 0.8 percent within the XIENCE stent at 2 years.”
Later that month, in light of concerns, Abbott limited the stent’s use in Europe before ending sales of the stent last month.
“Due to low commercial sales, Abbott will stop selling the first-generation bioresorbable Absorb coronary stent,” the company said in a statement. “We pioneered bioresorbable technology because we believe it offers patients the possibility of life without permanent metallic implants, and we will continue work on a next generation bioresorbable device. We’ll also continue to follow implanted patients in existing Absorb clinical trials. We’re dedicated to developing treatments that help patients with vascular and other heart diseases live their fullest lives.”
Wellmont said it recently sent the Absorb stent back to the manufacturer.
“I honestly do not remember the last one that we’ve implanted,” Dr. Metzger said.
He says he does not believe any of the patients who received the stent from Wellmont have any reason to be concerned.
“I do not believe that they are in any increased concern if they got the bioresorbable stent compared to the regular stent,” he said.
While Abbott stopped sales of the stent, an FDA spokesperson told us the agency is continuing to monitor the number of adverse events.
“At this time, although the observed rates of major adverse cardiac events are higher in patients treated with the BVS compared with the Xience stent (a metallic stent that Abbott also manufacturers), the event rates remain relatively low, and we believe may be lowered by particular attention to recommendations on vessel size and implantation methods already included in the labeling, as this could positively impact BVS clinical performance,” a FDA spokesperson said. “The FDA is working with Abbott Vascular, Inc. to better understand the cause(s) of the higher cardiac event and device thrombosis rates in patients treated with BVS compared to the XIENCE stent. For example, we know that BVS implantation in small coronary arteries is associated with increased cardiac event rates, and this awareness is specifically reflected in the BVS physician labeling—physicians should select appropriately sized coronary arteries for BVS use. In addition, preliminary data suggest that there is an increased risk of late events when the BVS is not fully apposed to the vessel wall during the implant procedure.”
An Abbott spokesperson said when implemented in appropriately sized vessels and when instructions are followed, the results for the Absorb stent are comparable to the leading metallic stent. The company added when the FDA approved the stent some doctors were using an outdated technique and needed comprehensive training.Copyright WJHL 2017. All rights reserved.