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BVS linked to higher risk for very late device thrombosis vs. EES
Bioresorbable vascular scaffolds appear to be associated with a higher risk for very late device thrombosis between 1 and 2 years after implantation vs. everolimus-eluting stents, according to recent findings.
In a meta-analysis, researchers identified 24 reported trials comparing Absorb BVS (Abbott Vascular) with EES, as well as single-arm registries assessing either device, with clinical outcomes at 2 years after implantation. Also identified were 2-year results from the ABSORB Japan trial, which was presented at the European Society of Cardiology meeting Aug. 29.
From these studies, the researchers extracted randomized controlled trials and observational studies comparing the impact of BVS and EES on stent/scaffold thrombosis and/or target lesion failure. Additionally, studies assessing BVS or EES as a single-arm design that included stent/scaffold thrombosis or TLF outcomes at 2 years were included to calculate the estimated incidence rates of stent/scaffold thrombosis and TLF between 1 and 2 years after implantation.
Of the 24 trials (BVS, n = 2,567; EES, n = 19,806), seven comparative studies (three randomized and four observational) were used to compare the stent/scaffold thrombosis risk of BVS vs. EES, and 17 single-arm studies were used to estimate the pooled incidence rates of stent/scaffold thrombosis and TLF.
Thrombosis risk
The researchers found that, between 1 and 2 years, the BVS group had a numerically higher risk for very late stent/scaffold thrombosis vs. the EES group (OR = 2.03; 95% CI, 0.62-6.71), but this difference was not statistically significant between groups. However, the increased risk for stent/scaffold thrombosis with the BVS vs. EES reached significance during the entire 2-year follow-up (OR = 2.08; 95% CI, 1.02-4.26). Comparisons of TLF risk between BVS and EES were neutral, both between 1 and 2 years and for the duration of 2-year follow-up.
The pooled incidence rates of very late stent/scaffold thrombosis between 1 and 2 years were higher in the BVS group vs. the EES group (0.24%; 95% CI, 0.022-0.608 vs. 0.003%; 95% CI, 0-0.028). Pooled incidence rates for TLF were similar between the BVS and EES groups (BVS, 1.88%; 95% CI, 1.3-2.55; EES, 1.78%; 95% CI, 1.17-2.49), the researchers wrote.
Throughout the entire 2-year follow-up, the pooled incidence rate of stent/scaffold thrombosis was higher in the BVS group vs. the EES group (1.43%; 95% CI, 0.67-2.41 vs. 0.56%; 95% CI, 0.43-0.7). The pooled incidence rate of TLF throughout the 2-year follow-up was similar between the BVS and EES groups (BVS, 7.9%; 95% CI, 6.26-9.69; EES, 7.49%; 95% CI, 5.86-9.29), according to the researchers.
Maintain scrutiny
In a related editorial, Fernando Alfonso, MD, PhD, and Javier Cuesta, MD, of the department of cardiology, Hospital Universitario de la Princesa, Universidad Autónoma de Madrid, wrote that newer-generation BVS are expected to overcome many of the current issues with late stent/scaffold thrombosis.
“New-generation polymeric BVS, with thinner struts, enhanced expansile capability, and improved resorption kinetics will soon be available. These iterations are expected to overcome most of the limitations encountered by first-generation BVS,” the authors wrote. “However, we should learn our lessons and maintain close critical scrutiny on the clinical performance of these novel devices.” – by Jennifer Byrne
Disclosure: One researcher reports being an advisory board member of and receiving research grants from Abbott Vascular. Another researcher reports serving as an education consultant for Boston Scientific Corp. Alfonso and Cuesta report no relevant financial disclosures.