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FIRST SERIAL 12- AND 24-MONTH OPTICAL COHERENCE TOMOGRAPHY ASSESSMENT OF STEMI PATIENTS AFTER THE GENERATION OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD IMPLANTATION
126 JACC March 21, 2017 Volume 69, Issue 11
Acute and Stable Ischemic Heart Disease FIRST SERIAL 12- AND 24-MONTH OPTICAL COHERENCE TOMOGRAPHY ASSESSMENT OF STEMI PATIENTS AFTER THE GENERATION OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD IMPLANTATION Poster Contributions Poster Hall, Hall C Friday, March 17, 2017, 3:45 p.m.-4:30 p.m. Session Title: Coronary Angiography, Intra-Vascular Imaging, Revascularization and Outcomes Abstract Category: 2. Acute and Stable Ischemic Heart Disease: Clinical Presentation Number: 1166-334 Authors: Lukasz Koltowski, Janusz Kochman, Mariusz Tomaniak, Arkadiusz Pietrasik, Klaudia Proniewska, Jacek Jakala, Adam Rdzanek, Krzysztof Filipiak, Grzegorz Opolski, Medical University of Warsaw, Warsaw, Poland
Background: The everolimus-eluting bioresorbable vascular scaffold (BVS) is a new technology that was designed to alleviate some of the drawbacks of metallic drug eluting stents (DES). Methods: The aim of the study was to evaluate the vascular healing pattern and device performance using the OCT over the second year after BVS implantation. BVS was implanted during the primary percutaneous coronary intervention in consecutive STEMI patients. A 12- and 24-months OCT follow-up has been scheduled as part of the study protocol. In 14 patients the corresponding 12- and 24-month OCT follow-up was available and evaluated. The OCT analysis was performed at 1 mm longitudinal intervals. For the 5-mm proximal and distal edges as well as at the 2-mm margins of the scaffold the edge vascular restenosis was assessed in a frame-by-frame fashion. The following OCT parameters were evaluated: lumen and scaffold area, strut malapposition and neointimal thickness.
Results: Between 12 and 24 months after BVS implantation a significant increase in the mean neointimal thickness of 89μm was recorded. Despite that, the minimum and mean lumen was not diminished, which could likely be explained by the concomitant enlargement of the mean and minimal scaffold area. No late malapposition or device failures were reported during the observation period. Conclusions: The vascular response to the BVS implanted in STEMI patients evaluated with OCT between 12- and 24-months confirmed safety and efficacy of the device.
Variable Minimum lumen area (mm2) Mean lumen area (mm2) Mean scaffold area (mm2) Minimum scaffold area (mm2) Malapposition distance (mm) Malapposition distance (mm) Mean neointima thickness (μm)
Optical coherence tomography analysis (scaffold level) 12 M FU n = 14 24 M FU n = 14 4.85 ± 1.91 4.26 ± 1.52 6.72 ± 1.58 6.5 ± 1.57 8.82 ± 1.53 9.49 ± 1.89 7.00 ± 1.58 6.41 ± 2.45 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 203 (181-251) 292 (248 - 325)
p-value 0.0552 0.5016 0.0166 0.2744
0.0006
Acute and Stable Ischemic Heart Disease FIRST SERIAL 12- AND 24-MONTH OPTICAL COHERENCE TOMOGRAPHY ASSESSMENT OF STEMI PATIENTS AFTER THE GENERATION OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD IMPLANTATION Poster Contributions Poster Hall, Hall C Friday, March 17, 2017, 3:45 p.m.-4:30 p.m. Session Title: Coronary Angiography, Intra-Vascular Imaging, Revascularization and Outcomes Abstract Category: 2. Acute and Stable Ischemic Heart Disease: Clinical Presentation Number: 1166-334 Authors: Lukasz Koltowski, Janusz Kochman, Mariusz Tomaniak, Arkadiusz Pietrasik, Klaudia Proniewska, Jacek Jakala, Adam Rdzanek, Krzysztof Filipiak, Grzegorz Opolski, Medical University of Warsaw, Warsaw, Poland
Background: The everolimus-eluting bioresorbable vascular scaffold (BVS) is a new technology that was designed to alleviate some of the drawbacks of metallic drug eluting stents (DES). Methods: The aim of the study was to evaluate the vascular healing pattern and device performance using the OCT over the second year after BVS implantation. BVS was implanted during the primary percutaneous coronary intervention in consecutive STEMI patients. A 12- and 24-months OCT follow-up has been scheduled as part of the study protocol. In 14 patients the corresponding 12- and 24-month OCT follow-up was available and evaluated. The OCT analysis was performed at 1 mm longitudinal intervals. For the 5-mm proximal and distal edges as well as at the 2-mm margins of the scaffold the edge vascular restenosis was assessed in a frame-by-frame fashion. The following OCT parameters were evaluated: lumen and scaffold area, strut malapposition and neointimal thickness.
Results: Between 12 and 24 months after BVS implantation a significant increase in the mean neointimal thickness of 89μm was recorded. Despite that, the minimum and mean lumen was not diminished, which could likely be explained by the concomitant enlargement of the mean and minimal scaffold area. No late malapposition or device failures were reported during the observation period. Conclusions: The vascular response to the BVS implanted in STEMI patients evaluated with OCT between 12- and 24-months confirmed safety and efficacy of the device.
Variable Minimum lumen area (mm2) Mean lumen area (mm2) Mean scaffold area (mm2) Minimum scaffold area (mm2) Malapposition distance (mm) Malapposition distance (mm) Mean neointima thickness (μm)
Optical coherence tomography analysis (scaffold level) 12 M FU n = 14 24 M FU n = 14 4.85 ± 1.91 4.26 ± 1.52 6.72 ± 1.58 6.5 ± 1.57 8.82 ± 1.53 9.49 ± 1.89 7.00 ± 1.58 6.41 ± 2.45 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 203 (181-251) 292 (248 - 325)
p-value 0.0552 0.5016 0.0166 0.2744
0.0006