Everolimus-eluting bioresorbable scaffold versus everolimus-eluting metallic stent in primary percutaneous coronary intervention of ST-segment elevation myocardial infarction: a randomized controlled trial

Abstract

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.

Long-term multimodality imaging follow-up of ST-segment elevation myocardial infarction patients treated with bioresorbable vascular scaffold: advantages and challenges

“…Results are presented in Fig. 5, and in detail in previous publication [12]. Reference area measured by MSCT was numerically lower than that measured by OCT with a mean (±SD) difference of 0.95 (±2.64 mm², P = 0.10).…”

“…Each patient had a mean (±SD) of 1.2 (±0.4) BRS implanted with nominal stent length and diameter of 22 (±1.5) mm and 3.1 (±0.3) mm, respectively. Full description of baseline characteristics and procedural details can be found in our previous publication [12].…”

“…We present data from long-term multimodality imaging with angiography, OCT, echocardiography and MSCT at 12 months, and repeated MSCT at 36 months after BRS implantation. The inclusion and exclusion criteria of the main study and details of BRS implantation are described earlier [12]. Briefly, this study randomized STEMI patients to percutaneous coronary intervention (PCI) with DES or BRS.…”

“…We aimed to see whether MSCT is useful in long-term follow-up of nonmetallic BRS in a larger cohort. In our study ‘Everolimus-eluting bioresorbable scaffold versus everolimus-eluting metallic stent in primary percutaneous intervention of ST-segment elevation myocardial infarction (STEMI): a randomized controlled trial’ (BRS in STEM) [12], we have a predefined long-term follow-up with MSCT at 12 and 36 months post STEMI. We used echocardiography, coronary angiography, and OCT as references for MSCT, and to establish a landmark at 12 months for further follow-up by MSCT.…”