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Adverse event rates higher with BVS vs. EES at 2 years
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Target lesion failure and device thrombosis were more common at 2 years in patients who underwent revascularization with a bioresorbable vascular scaffold compared with a metallic everolimus-eluting stent, according to data from a recent meta-analysis.
Compared with metallic EES, the Absorb BVS (Abbott Vascular) was associated with a higher 2-year RR for the device-oriented composite endpoint of TLF — cardiac mortality, target vessel-related MI or ischemia-driven target lesion revascularization (9.4% vs. 7.4%; RR = 1.29; 95% CI, 1.08-1.56).
Results indicated that increased rates of target vessel-related MI (5.8% vs. 3.2%; RR = 1.68; 95% CI, 1.29-2.19) and ischemia-driven TLR (5.3% vs. 3.9%; RR = 1.4; 95% CI, 1.09-1.8) largely accounted for this difference in the device-oriented composite endpoint. Cardiac mortality, however, did not differ with BVS vs. EES at 2 years (1.1% vs. 1.3%; RR = 0.97; 95% CI, 0.59-1.59), Ziad A. Ali, MD, DPhil, assistant professor, associate director of translational medicine and Victoria and Esther Aboodi Cardiology Researcher at Columbia University Medical Center/NewYork-Presbyterian Hospital, and colleagues wrote.
The safety endpoint of device thrombosis was also higher with BVS than with EES at 2 years (2.3% vs. 0.7%; RR = 3.35; 95% CI, 1.96-5.72), according to the data.
The meta-analysis included seven trials — ABSORB II, ABSORB Japan, ABSORB China, ABSORB III, EVERBIO II, TROF II and AIDA — that included 5,583 patients who were randomly assigned to BVS (n = 3,261) or EES (n = 2,322). The researchers also used individual patient data from the four ABSORB trials (n = 3,389) for landmark and subgroup analyses.
In the landmark analysis between 1 and 2 years, BVS, compared with EES, was associated with a higher rate of the device-oriented composite endpoint (3.3% vs. 1.9%; RR = 1.64; 95% CI, 1.03-2.61), which was driven by increased target vessel-related MI (1.3% vs. 0.3%; RR = 3.68; 95% CI, 1.3-10.43), and a higher rate of device thrombosis (0.5% vs. 0%; P < .0001).
Multivariable analysis of pooled data from the four ABSORB trials showed that treatment group — BVS or EES — was an independent predictor of the 2-year cumulative device-oriented composite endpoint, device thrombosis, the patient-oriented composite endpoint (all-cause mortality, all MI or all revascularization), MI and target vessel-related MI, but not ischemia-driven TLR.
The researchers also observed significant interactions between device type and baseline American College of Cardiology/American Heart Association lesion classification, target vessel and degree of calcification for the 2-year device-oriented composite endpoint.
Additionally, multivariable analysis also indicated that preprocedure coronary angiography reference vessel diameter less than 2.25 mm was an independent predictor of the device-oriented composite endpoint, the patient-oriented composite endpoint, MI, target-vessel MI, ischemia-driven TLR and device thrombosis in patients treated with BVS.
Despite their findings, the researchers highlighted several study limitations.
“These analyses were not corrected for multiplicity, however, and should thus be considered hypothesis-generating, given the large number of subgroups examined,” they wrote. “Second, many high-risk patients and complex lesions were excluded from the ABSORB randomized trials. Dedicated studies are required to assess the performance of BVS in these scenarios.”
The researchers also noted that BVS was used for the first time by most of the study investigators and that BVS was not implanted with what would now be considered the optimal technique in the early ABSORB trials.
“Long-term follow-up from this and other large-scale studies is necessary to assess whether BVS risks continue to increase beyond 2 years, and whether BVS benefits emerge after complete device bioresorption and restoration of vascular homeostasis (around 3 years),” they wrote. “Identification of such benefits will require large studies and follow-up for 7 to 10 years after device implant, which is being done in ABSORB IV.” – by Melissa Foster
Disclosures: The study was sponsored by Abbott Vascular. Ali reports receiving grants and personal fees from Cardiovascular Systems Inc. and St. Jude Medical, and personal fees from Acist Medical. Please see the study for all other authors’ relevant financial disclosures.
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