Background: The purpose of a bioresorbable scaffold (BRS) is to provide radial support during coronary healing. In this study, coronary artery healing after optical coherence tomography (OCT)- versus angiography-guided magnesium BRS (MBRS) implantation in patients with non-ST-segment-elevation myocardial infarction (NSTEMI) is compared. Methods: 75 patients were randomized 1:1 to OCT- or angiography-guided implantation of a MBRS with protocolled pre- and post-dilation. In the OCT-guided group, prespecified criteria indicating additional intervention were (1) scaffold under-expansion, (2) strut malapposition, (3) edge dissection, and (4) residual stenosis at distal or proximal reference segments. The primary endpoint was OCT-derived healing stage at 6 months. Results: At 6 months, there was no difference in average healing stage between OCT- and angiography-guided intervention (4.6 [interquartile range (IQR): 4.5–4.7] versus 4.5 [IQR: 4.3–4.7]; p = 0.54). The MBRSs were completely resolved in 77.0% [IQR: 68.5–85.5] versus 76.5% [IQR: 67.9–85.5]; (p = 0.97). Minimal lumen area (MLA) was reduced at 6 months in both the OCT- (32.3%; p < 0.01) and the angiography-guided group (21.3%; p < 0.01), however OCT-guided implantation was associated with a greater reduction of total lumen volume (−27.1 ± 32.5 mm3 versus −5.0 ± 32.9 mm3; p < 0.01) and MLA (−2.3 ± 1.6 mm2 vs. −1.4 ± 1.4 mm2; p = 0.02). Conclusions: In NSTEMI patients, OCT-guidance with protocolled pre- and post-dilation of MBRS implantation showed similar healing pattern at 6 months compared to angiography-guidance alone. Clinical trial registration: The Coronary Artery Healing Process after Optical Coherence Tomography Guided Percutaneous Coronary Intervention with Magmaris Bioresorbable Scaffold in Patients with Non-ST-Segment-Elevation Myocardial Infarction: (HONEST) trial is registered with ClinicalTrials.gov, NCT03016624.
Bibliografisk noteFunding Information:
AM has received research grant from Abbott Vascular and Boston Scientific. Consultant for Boston Scientific and Philips. JFL has received speakers fee from Biotronik, Boston Scientific, Abbott Vascular, Biosensors, Therumo, and St. Jude Medical. LOJ has received research grants to her institution from Biotronik, Biosensors and Terumo and honoraria from Biotronik. COF, LA, MN, MH, KNH, JE, OA, KTV, ABJ, and HSH declare that they have no conflicts of interest.