Key result
Everolimus-eluting bioresorbable scaffolds yielded a higher 5-year rate of device-oriented clinical events than metallic stents in STEMI patients (13.2% vs 7.6%; HR 1.87, 95% CI 0.94-3.44, p=0.071).
Why the study?
To compare five-year clinical outcomes between an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent in STEMI patients.
Does an everolimus-eluting bioresorbable scaffold improve long-term clinical outcomes compared to an everolimus-eluting metallic stent in STEMI patients?
Observational (n=470)
Does an everolimus-eluting bioresorbable scaffold improve long-term clinical outcomes compared to an everolimus-eluting metallic stent in STEMI patients?
Hazard Ratio: 1.87 (95% CI 0.94–3.44)
Absolute Event Rate: 13.2% vs 7.6%
p-value: p=0.071
In STEMI patients, the use of everolimus-eluting bioresorbable scaffolds is associated with a higher 5-year risk of device-oriented adverse events and device thrombosis compared to everolimus-eluting metallic stents.
BRS associated with higher 5-year DOCE than EES in STEMI; leaves open confirmation in prospective randomized data.
AIMS: The aim of this study was to compare five-year clinical outcomes between an everolimus-eluting bioresorbable scaffold (BRS) and an everolimus-eluting metallic stent (EES) in STEMI patients. METHODS AND RESULTS: This observational and retrospective study included 235 consecutive STEMI patients treated with BRS, compared with 235 STEMI patients treated with EES from the EXAMINATION trial, by applying propensity score matching. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction and target lesion revascularisation at five-year follow-up. Device thrombosis, according to the ARC criteria, was also evaluated. Optical coherence tomography (OCT) analysis was also performed at five years in event-free BRS patients. The cumulative incidence of five-year DOCE was higher in the BRS group as compared to the EES group (13.2% vs 7.6%, HR 1.87, 95% CI: 0.94-3.44, p=0.071), mainly driven by a higher rate of TLR (7.6% vs 1.7%, HR 1.15, 95% CI: 0.44-2.30, p=0.004). The five-year definite BRS thrombosis rate was also higher as compared to EES (4.2% vs 1.2%, HR 3.49, 95% CI: 0.95-12.82, p=0.054). OCT analysis showed a high incidence of neoatherosclerosis in the BRS group. CONCLUSIONS: The five-year event risk was higher with BRS versus EES in STEMI. This suggests that the probability of obtaining favourable results at very long-term follow-up is low. Whether better results will be obtained with new-generation BVS remains to be determined.
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Brugaletta et al. (2020) conducted an observational in ST-segment elevation myocardial infarction (n=470). Everolimus-eluting bioresorbable scaffold (BRS) vs. Everolimus-eluting metallic stent (EES) was evaluated on Device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction and target lesion revascularisation (HR 1.87, 95% CI 0.94-3.44, p=0.071). Everolimus-eluting bioresorbable scaffolds yielded a higher 5-year rate of device-oriented clinical events than metallic stents in STEMI patients (13.2% vs 7.6%; HR 1.87, 95% CI 0.94-3.44, p=0.071).
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