Outcomes With the Absorb Bioresorbable Scaffold

Study Questions:

What is the safety and efficacy of bioresorbable vascular scaffolds (BVS) as compared to drug-eluting stents within the first year after implantation?

Methods:

The investigators did a patient-level pooled meta-analysis of four randomized trials in which 3,389 patients with stable coronary artery disease or a stabilized acute coronary syndrome were enrolled at 301 academic and medical centers in North America, Europe, and the Asia-Pacific region. These patients were randomly assigned to the everolimus-eluting Absorb BVS (n = 2,164) or the Xience cobalt-chromium everolimus-eluting stent (CoCr-EES; n = 1,225). The primary endpoints were the 1-year relative rates of the patient-oriented composite endpoint (all-cause mortality, all myocardial infarction, or all revascularization) and the device-oriented composite endpoint of target lesion failure (cardiac mortality, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization). All analyses were by intention to treat.

Results:

The summary treatment effect for the 1-year relative rates of the patient-oriented composite endpoint did not differ significantly between BVS and CoCr-EES (relative risk [RR], 1.09; 95% confidence interval [CI], 0.89–1.34; p = 0.38). Similarly, the 1-year relative rates of the device-oriented composite endpoint did not differ between the groups (RR, 1.22; 95% CI, 0.91–1.64; p = 0.17). Target vessel-related myocardial infarction was increased with BVS compared with CoCr-EES (RR, 1.45; 95% CI, 1.02–2.07; p = 0.04), due in part to nonsignificant increases in periprocedural myocardial infarction and device thrombosis with BVS (RR, 2.09; 95% CI, 0.92–4.75; p = 0.08). The relative rates of all-cause and cardiac mortality, all myocardial infarction, ischemia-driven target lesion revascularization, and all revascularization did not differ between BVS and CoCr-EES. Results were similar after multivariable adjustment for baseline imbalances, and were consistent across most subgroups and in sensitivity analysis when two additional randomized trials with <1 year of follow-up were included.

Conclusions:

The authors concluded that BVS did not lead to different rates of composite patient-oriented and device-oriented adverse events at 1-year follow-up compared with CoCr-EES.

Perspective:

This patient-level, pooled meta-analysis reports that the overall relative rates of composite patient-oriented and device-oriented adverse events did not differ significantly between the Absorb BVS and the Xience CoCr-EES stents at 1-year follow-up. Target vessel-related myocardial infarction was more common with BVS than with CoCr-EES, although rates of all myocardial infarction, cardiac mortality, and all-cause mortality did not differ between the groups. Revascularization at 1 year was also similar between the two devices. These findings would support the safety and effectiveness of BVS use at 1 year for patients with stable coronary artery disease and stabilized acute coronary syndromes. However, the ultimate benefit–risk assessment of BVS as compared with metallic drug-eluting stents awaits the 5-year results from ongoing large-scale trials, especially the ABSORB IV trial.

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Interventions and ACS, Interventions and Coronary Artery Disease

Keywords: Acute Coronary Syndrome, Chromium, Cobalt, Coronary Artery Disease, Drug-Eluting Stents, Ischemia, Myocardial Infarction, Myocardial Revascularization, Risk Assessment, Stents, Thrombosis


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