Key result
The Absorb bioresorbable scaffold resulted in a minimum flow area of 5.13 mm2 compared to 6.30 mm2 with the Xience metallic stent at 12 months (P=0.06), and noninferiority could not be evaluated.
Why the study?
Implantation of a bioresorbable scaffold during STEMI represents a novel strategy without intravascular metal, but 12-month healing responses compared to standard metallic drug-eluting stents needed investigation.
Does an everolimus-eluting bioresorbable scaffold improve minimum flow area at 12 months compared to an everolimus-eluting metallic stent in patients with STEMI undergoing primary PCI?
RCT (n=66)
Open-label
1:1
Does an everolimus-eluting bioresorbable scaffold improve minimum flow area at 12 months compared to an everolimus-eluting metallic stent in patients with STEMI undergoing primary PCI?
Absolute Event Rate: 5.13% vs 6.3%
p-value: p=0.06
In patients with STEMI, a bioresorbable scaffold did not show noninferiority for minimum flow area at 12 months compared to a metallic DES, though both showed good stent healing.
BRS failed to demonstrate noninferiority versus metallic DES for minimum flow area in STEMI; challenges routine adoption and supports further device refinement trials.
BACKGROUND: Primary percutaneous coronary intervention with implantation of a metallic drug-eluting stent (DES) is the standard treatment for patients presenting with ST-elevation myocardial infarction (STEMI). Implantation of a bioresorbable scaffold (BRS) during STEMI represents a novel strategy without intravascular metal. OBJECTIVE: The aim of the study was to investigate 12-month healing response in an STEMI population after implantation of either the Absorb BRS or Xience DES (Abbott Vascular, USA). METHODS: The present trial was a prospective, randomized, controlled, nonblinded, noninferiority study with planned inclusion of 120 patients with STEMI. Patients were randomly assigned 1:1 to treatment with Absorb BRS or Xience DES. Implantation result and healing response were evaluated by angiography and optical coherence tomography (OCT) at baseline and 12-month follow-up. The primary endpoint was minimum flow area (MFA) assessed at 12 months. Coronary stent healing index (CSHI) was calculated from OCT images. RESULTS: Out of 66 included patients, 58 had follow-up OCT after 12 months, and 49 entered matched analysis. One death occurred in each group; none were stent-related. MFA was 5.13 ± 1.70 mm2 (95% CI, 4.44-5.82) in the BRS group compared with 6.30 ± 2.49 mm2 (95% CI, 5.22-7.37) (P = 0.06) in the DES group. Noninferiority could not be evaluated. CSHI for both groups had a median score of 3. CONCLUSION: The DES group performed numerically better in primary and secondary endpoints, but the CSHI showed good stent healing in both groups.
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Eriksen et al. (2022) conducted an RCT in ST-segment elevation myocardial infarction (STEMI) (n=66). Absorb bioresorbable scaffold (BRS) vs. Xience everolimus-eluting metallic stent (DES) was evaluated on minimum flow area (MFA) assessed at 12 months (p=0.06). The Absorb bioresorbable scaffold resulted in a minimum flow area of 5.13 mm2 compared to 6.30 mm2 with the Xience metallic stent at 12 months (P=0.06), and noninferiority could not be evaluated.
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