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Second generation, sirolimus‐eluting, bioresorbable Tyrocore scaffold implantation in patients with ST‐segment elevation myocardial infarction: Baseline OCT and 30‐day clinical outcomes – A FANTOM STEMI pilot study
Author(s) -
Koltowski Lukasz,
Tomaniak Mariusz,
Ochijewicz Dorota,
Maksym Jakub,
Roleder Tomasz,
Zaleska Martyna,
Proniewska Klaudia,
Opolski Grzegorz,
Kochman Janusz
Publication year - 2020
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.28414
Subject(s) - medicine , myocardial infarction , percutaneous coronary intervention , clinical endpoint , conventional pci , cardiology , surgery , clinical trial
Background There is paucity of data on acute performance of Fantom (REVA Medical, CA), a second generation sirolimus‐eluting bioresorbable scaffold (BRS), in ST‐segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention. The aim of this study was to evaluate safety and efficacy of the Fantom BRS in the acute setting of STEMI characterized by thrombogenic milieu. Methodology Ten STEMI patients treated with a sirolimus‐eluting Fantom BRS were enrolled into prospective, observational study. The scaffold sizing, positioning, and optimization were optical coherence tomography (OCT) guided. The primary end‐point was the device‐oriented composite endpoint (DOCE), additionally angiographic and OCT analysis were performed. Results The primary‐end point, defined as DOCE, did not occur in any patient within the 30‐day follow‐up. The procedural and angiographic success rates were both 100%, there was no case of scaffold thrombosis, target lesion revascularization nor death. In QCA, an in‐device minimum lumen diameter was 2.89 ± 0.24 mm and the residual diameter stenosis was 3.56 ± 3.17%. OCT revealed an incomplete scaffold apposition in five patients with an average of seven malapposed struts per scaffold and mean distance of 120 ± 30 μm. There was no proximal edge dissection, the distal edge dissection was recorded in one patient. Conclusions This is the first pilot study evaluating safety and efficacy of the Fantom BRS, a second generation fully bioresorbable coronary scaffold, in STEMI patients undergoing primary PCI with OCT guidance. Fantom BRS showed adequate safety and efficacy in the acute 30‐day angiographic, OCT, and clinical follow‐up.