Bioresorbable vascular scaffolds (BVS) appear to offer a safe, innovative therapy for those difficult-to-treat patients who experience in-stent restenosis (ISR), according to a new multicenter study conducted in Europe.
Results of the research were published online August 30 in JACC: Cardiovascular Interventions.
“First, BVS seem to represent a safe novel therapeutic strategy for patients with ISR,” wrote lead author was Fernando Alfonso, with the Hospital Universitario de La Princesa in Madrid, and coauthors. “Second, BVS constitute an effective new therapeutic modality in this challenging anatomic setting. … Third, late angiographic findings after BVS implantation were favorable.
“Fourth, BVS seem to be equally effective for patients with bare-metal stent ISR and drug-eluting stent ISR. … Fifth, in patients with ISR the results obtained with BVS are very similar to those achieved with drug-eluting balloons (DEB).”
The researchers cautioned that their findings warrant cautious interpretation as the study sample was small. The patient group comprised 141 patients from 19 Spanish university centers enrolled in the study between April 2014 and December 2015. The 141 patients were treated with BVS for either bare-metal stent-ISR or drug-eluding stent ISR.
Patients who had angina or objective signs of ischemia who presented with ISR (more than 50 percent diameter stenosis on visual assessment) qualified to participate.
“Patients with multiple previous interventions (including stents) in the target lesions were eligible,” the team wrote.
Follow up evaluations took place at six to nine months or earlier, if earlier assessment was clinically indicated.
“The results of the current study suggest that BVS are safe and effective in patients with ISR,” wrote Alfonso et al. “In addition, our findings indicate that in this challenging anatomic scenario, the late angiographic and clinical outcomes of BVS are similar to those obtained with DEB but remain poorer than those achieved with EES.”
Only randomized, controlled trials will be able to confirm the relative value of these different approaches to therapy for patients with in-stent restenosis.