Updated to include a statement from an Abbott spokesperson.
Abbott‘s (NYSE:ABT) bioresorbable scaffold has been plagued with a myriad of troubling data, including a study that showed that the device is associated with an increase in thrombosis and target lesion failure. In April, Abbott restricted use of the Absorb devices to clinical registry studies.
In response to widespread criticism of the technology, the EuroPCR team released a statement this week defending bioresorbable stents as “an important option to optimise outcomes in patients whose needs are not adequately met with current devices.”
“We think it’s important to make a statement because of the need to continue to develop this approach for the future, supporting the concept of a stent that disappears in patients with 30, 40, and even 50 years of life expectancy after undergoing a procedure,” EuroPCR 2017 course director Dr. William Wijns said in prepared remarks. “The ideal of a stent that does its job and disappears is a valuable long-term goal, especially in young patients with long life-expectancy.”
The team noted that current bioresorbable scaffolds are 1st-generation devices and acknowledged that the technology has significant mechanical limitations compared to available thin strut metallic drug-eluting stents.
Abbott’s Absorb bioresorbable vascular scaffold is the only available bioresorbable stent that has been evaluated in randomized, controlled trials with medium term follow-up. Despite the fact that clinical outcomes didn’t compare to those obtained with drug-eluting stents, course director Jean Fajadet said that post-hoc analysis according to vessel size and adequate procedural technique demonstrated mitigation of scaffold thrombosis.
“Encouraging results for several 1st- and 2nd-generation polymeric and metallic (magnesium-based) BRS devices currently being evaluated have been presented during EuroPCR 2017,” Wijns said.
However, he added that observational studies of bioresorbable stents have suffered due to small study populations and short-term follow-up
“Until the concerns about bioresorbable stents can be assuaged, current-generation BRS should not be preferred to metallic drug-eluting stents in routine clinical practice,” Wijns said.
The EuroPCR team said that interventional physicians should “protect the potential of BRS as an innovation by avoiding its use in situations where poor results might be predicted.”
“Post-marketing registries are being initiated in Europe to monitor implantation technique for the Absorb dissolving stent. Analyses of Absorb trials from around the world have demonstrated that optimal implantation technique results in outcomes comparable to the best-in-class metallic drug eluting stent, with the added feature of leaving no metal behind once it dissolves (presented at TCT, CRT, ACC),” a spokesperson for Abbott said in an email. “The objective of the EU registries is similar to post-approval observational studies and training being conducted in other parts of the world. The vast majority of hospitals that use Absorb currently in Europe will continue to be able to implant Absorb as part of the registries.”
Correction: An earlier version of the story stated that Abbott pulled the Absorb stent from European markets. This has been corrected to reflect that the device is still available through clinical registry studies.
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