ABSORB IV: Long-Term Outcomes Show Higher Rates of TLF With BVS vs. CoCR-EES
The long-term follow-up of the ABSORB IV trial showed that the absolute five-year rate of target lesion failure (TLF) was 3% greater with the Absorb bioresorbable vascular scaffolds (BVS) compared with the cobalt-chromium-based Xience drug-eluting stent (CoCr-EES), according to results presented at EuroPCR 2023 in Paris, France, and simultaneously published May 17 in JACC.
The ABSORB IV trial was a large-scale, blinded, international randomized trial of 2,604 patients with stable or acute coronary syndromes at 147 sites that compared the BVS implanted with improved techniques against the CoCr-EES. The primary outcome of TLF (cardiac death, target vessel myocardial infarction [MI], ischemia-driven target lesion revascularization [ID-TLR]) at 30 days for BVS vs. Xience was 5.0% vs. 3.7% (p for noninferiority = 0.02, p for superiority = 0.11).
In the present analysis, Gregg W. Stone, MD, FACC, et al., showed that TLF had occurred in 17.5% of patients assigned to BVS and 14.5% of patients assigned to CoCr-EES at five years (p=0.03), driven by higher rates of target-vessel MI and ID-TLR in the BVS cohort. The rates of cardiac death and all-cause death were similar in both cohorts at five years. No significant differences were seen for the rates of target vessel failure, major adverse cardiovascular events or PoCE, or in the rate of device thrombosis (1.7% vs. 1.1% in the BVS and CoCr-EES patients, respectively; hazard ratio [HR], 1.65; p=0.15).
Angina recurred within five years in 53% of patients assigned to BVS, with similar results in patients with CoCr-EES at 53.3% (HR, 0.97; p=0.63).
In a landmark analysis, TLF and device thrombosis rates were higher with BVS compared with CoCr-EES within the first three years, with absolute increments of 3% and 1% respectively, and then similar between years three and five. Quality of life measures were similar with both devices over the five-year follow-up.
The authors note that “more than half of patients developed recurrent anginal or anginal equivalent symptoms within five years at some time after PCI” and that further research is warranted to “examine the extent to which microvascular disease and vasospasm contribute to the high rate of recurrent symptoms after PCI in patients with obstructive coronary artery disease."
Keywords: Infarction, Thrombosis, Ischemia, Acute Coronary Syndrome, Vascular Diseases, Myocardial Ischemia, Angina Pectoris, Percutaneous Coronary Intervention, Follow-Up Studies, Absorbable Implants, Quality of Life, Cobalt, Chromium, Drug-Eluting Stents, Coronary Artery Disease, ACC International
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