Abstract
PurposeData regarding vessel healing by optical coherence tomography (OCT) after everolimus-eluting bioresorbable scaffolds (BRS) or everolimus-eluting metallic stent (EES) implantation in acute myocardial infarction (AMI) patients is scarce. We compared OCT findings after BRS or EES implantation in patients with AMI enrolled in a randomized trial.MethodsIn ISAR-Absorb MI, AMI patients were randomized to BRS or EES implantation, with 6–8 month angiographic follow-up. This analysis includes patients who underwent OCT during surveillance angiography. Tissue characterization was done using grey-scale signal intensity analysis. The association between OCT findings and target lesion failure (TLF) at 2 years was investigated.ResultsOCT was analyzed in 103 patients (2237 frames, 19,827 struts) at a median of 216 days post-implantation. Of these, 70 were treated with BRS versus 32 with EES. Pre-(92.8 vs. 68.7%, p = 0.002) and post-dilation (51.4 vs. 12.5%, p < 0.001) were more common in BRS as compared to EES. Strut coverage was higher in BRS vs. EES (97.5% vs. 90.9%, p < 0.001). Mean neointimal thickness was comparable in both groups [85.5 (61.9, 124.1) vs. 69.5 (32.7, 127.5) µm, respectively, p = 0.20]. Mature neointimal regions were numerically more common in BRS (43.0% vs. 24.6%; p = 0.35); this difference was statistically significant in ST-elevation myocardial infarction patients (40.9% vs. 21.1%, p = 0.03).At two-years, 8 (7.8%) patients experienced TLF. Mean neointimal area [0.61 (0.21, 1.33) vs. 0.41 (0.11, 0.75) mm2, p = 0.03] and mean neointimal coverage [106.1 (65.2, 214.8) vs. 80.5 (53.5, 122.1) µm, p < 0.01] were higher, with comparable tissue maturity, in lesions with versus without TLF.ConclusionsIn selected patients who underwent OCT surveillance 6–8 months after coronary intervention for AMI with differing implantation characteristics depending on the device type used, vessel healing was more advanced in BRS compared with EES, particularly in the STEMI subgroup.
Highlights
Everolimus-eluting bioresorbable scaffolds (BRS) were designed with the intention of overcoming the long-term limitations of conventional metallic drug eluting stents (DES) [1]
Randomized clinical trials have shown significantly higher rates of target lesion failure and device thrombosis with the everolimus-eluting BRS as compared to conventional stents at mid- and long-term follow-up [2, 3], one area where BRS may offer an advantage over metallic stents is the setting of ST-elevation myocardial infarction (STEMI)
Mature region of interest (ROI) were numerically more common in BRS compared to eluting metallic stent (EES) (43.0% vs. 24.6%; p = 0.35); this difference was statistically significant in STEMI subgroup (40.9% vs. 21.1%, p = 0.03) (Fig. 4)
Summary
Everolimus-eluting bioresorbable scaffolds (BRS) were designed with the intention of overcoming the long-term limitations of conventional metallic drug eluting stents (DES) [1]. The technology aims to provide temporary mechanical scaffolding with anti-proliferative drug release in the early period after implantation, with slow resorption thereafter to eliminate any nidus for late stent failure as seen with DES, caused by restenosis or stent thrombosis. Randomized clinical trials have shown significantly higher rates of target lesion failure and device thrombosis with the everolimus-eluting BRS as compared to conventional stents at mid- and long-term follow-up [2, 3], one area where BRS may offer an advantage over metallic stents is the setting of ST-elevation myocardial infarction (STEMI). Neither trial was adequately powered to assess clinical outcomes, a meta-analysis of individual patient data from these two trials showed comparable clinical outcomes in the BRS and EES groups at follow-up, this analysis was impacted by limited power [2]
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