A new study highlights the potential risk of blood clots with bioresorbable vascular scaffold (BVS). The findings come only days after the FDA announced that it is investigating the health risks associated with the heart implants.
Researchers from The Netherlands warn that using BVS implants for percutaneous coronary intervention appear to increase the risk of blood clots, when compared to drug-eluting metallic stents used for the same purpose. The findings were published in the New England Journal of Medicine on March 29.
Bioresorbable vascular scaffolds (BVS) are surgical implant used to open coronary arteries blocked by plaque, increasing blood flow to the heart. The device is implanted during an angioplasty procedure, and is designed to eventually dissolve and be absorbed by the body.
On March 18, the FDA issued a letter to healthcare providers announcing that the agency has launched an investigation into safety issues with Abbott Vascular’s Absorb G1 Bioresorbably Vascular Scaffold. According to the FDA, approximately 11% of Absorb G1 BVS recipients have suffered major adverse cardiac events.
The findings of this new study appear to confirm those concerns.
Researchers evaluated data on 1,895 patients who either received a bioresorbable vascular scaffold or a metallic stent. The study followed up on those patients for 707 days.
In addition to slightly increased risks of heart attacks and revascularization among BVS recipients, researchers found that those patients suffered nearly four times the rate of device thrombosis compared to those who were implanted with traditional stents.
The researchers found other problems with BVS implants as well.
“Scaffold implantation was associated with a longer procedure time, more use of contrast material, and a lower likelihood of receiving the assigned device than was stent implantation,” the researchers warned. “These findings attest to delivery challenges associated with scaffold implantation.”
Their study is not the only one to raise questions about the safety of the heart implants.
Abbott’s BVS was approved by the FDA in July 2016. However, according to the FDA letter, two-year data from a clinical trial, known as ABSORB III, used to convince the FDA to approve the device, indicates a much higher rate of heart problems than expected. Initially, the FDA approved the device looking at only one year of clinical trial data.
The FDA notes that patients who receive coronary stents are required to take dual antiplatelet therapy, typically a combination of aspirin and Plavix, or a similar blood thinner. The agency indicates that most patients who developed blood clots within a year or being implanted with the BVS had discontinued the drug therapy.
While the FDA continues its investigation, it is advising health care providers to closely follow instructions on selecting heart vessels for BVS implants; to warn patients to be aware of any symptoms of heart problems and immediately seek medical attention; to advise patients to stick to their dual antiplatelet therapy; and to report any BVS-related adverse events to the FDA’s MedWatch adverse event reporting program.