Vol 25, No 4 (2018)
Original articles — Interventional cardiology
Published online: 2018-03-02
Optical coherence tomography-guided versus angiography-guided implantation of everolimus-eluting bioresorbable vascular scaffolds: Comparison of coverage, apposition and clinical outcome. The ALSTER-OCT ABSORB registry
Abstract
Background: Suboptimal implantation of everolimus-eluting bioresorbable vascular scaffolds (EE-BVS) leading to strut malapposition and lack of neointima coverage has been hypothesized to be linked to late BVS-thrombosis. Optical coherence tomography (OCT) allows assessing subtle differences in BVS-healing. We aimed to link 6-months OCT-data on EE-BVS coverage and malapposition to implantation technique and clinical outcome. Methods: Twenty-nine consecutive EE-BVS-patients were included. EE-BVS-implantation was guided by angiography in the first 17 patients (group 1). Vessel sizing prior to implantation and implantation result was assessed by OCT in the 12 following patients (group 2). EE-BVS-implantation was performed in both groups with adequate lesion preparation, sizing and systematic high-pressure post-dilatation. All patients received 6-months invasive control including OCT-analysis and clinical follow-up for 2 years. Results: The rate of uncovered struts was group 1: 10.8 ± 10.0%; group 2: 10.6 ± 8.2%, p = 0.934. Target lesion failure due to BVS-thrombosis occurred in 2/17 patients at 9 and 18 months (11.8%, group 1), and no patients in group 2 (p = 0.218). Conclusions: Optical coherence tomography analysis at 6-months following EE-BVS-implantation finds almost 90% of struts to be covered. No difference between OCT vs. angiography-guided EE-BVS-implantation was observed. OCT at 6-months was not able to predict late BVS-thrombosis of EE-BVS.
Keywords: optical coherence tomographybioabsorbable vascular scaffoldsvascular healing
References
- Serruys PW, Chevalier B, Dudek D, et al. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015; 385(9962): 43–54.
- Ellis SG, Kereiakes DJ, Metzger DC, et al. ABSORB III Investigators. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med. 2015; 373(20): 1905–1915.
- Ellis SG: Everolimus-eluting bioresorbable vascular scaffolds in patients with coronary artery disease: ABSORB III trial 2-year results. Presented at: ACC 2017. Washington, DC, March 18, 2017.
- Stone GW, Gao R, Kimura T, et al. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016; 387(10025): 1277–1289.
- Kraak RP, Wykrzykowska JJ, Wykrzykowska JJ, et al. AIDA Investigators. Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. N Engl J Med. 2017; 376(24): 2319–2328.
- Tamburino C, Latib A, van Geuns RJ, et al. Contemporary practice and technical aspects in coronary intervention with bioresorbable scaffolds: a European perspective. EuroIntervention. 2015; 11(1): 45–52.
- Colombo A, Azzalini L. Optimal implantation is the way to prevent scaffold thrombosis: a hypothesis to be tested. EuroIntervention. 2017; 13(2): e142–e144.
- Sotomi Y, Suwannasom P, Serruys PW, et al. Possible mechanical causes of scaffold thrombosis: insights from case reports with intracoronary imaging. EuroIntervention. 2017; 12(14): 1747–1756.
- Serruys PW, Chevalier B, Sotomi Y, et al. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet. 2016; 388(10059): 2479–2491.
- Allahwala UK, Cockburn JA, Shaw E, et al. Clinical utility of optical coherence tomography (OCT) in the optimisation of Absorb bioresorbable vascular scaffold deployment during percutaneous coronary intervention. EuroIntervention. 2015; 10(10): 1154–1159.
- Prati F, Di Vito L, Biondi-Zoccai G, et al. Angiography alone versus angiography plus optical coherence tomography to guide decision-making during percutaneous coronary intervention: the Centro per la Lotta contro l'Infarto-Optimisation of Percutaneous Coronary Intervention (CLI-OPCI) study. EuroIntervention. 2012; 8(7): 823–829.
- Guagliumi G, Musumeci G, Sirbu V, et al. ODESSA Trial Investigators. Optical coherence tomography assessment of in vivo vascular response after implantation of overlapping bare-metal and drug-eluting stents. JACC Cardiovasc Interv. 2010; 3(5): 531–539.
- Heeger C-H, Fenski M, Hildebrand L, et al. Optical coherence tomography analysis of neointimal tissue in drug-eluting stents with biodegradable and durable polymer coatings: the ALSTER-OCT registry. AsiaIntervention. 2017; 3: 41–48.
- Heeger CH, Busjahn A, Hildebrand L, et al. Delayed coverage of drug-eluting stents after interventional revascularisation of chronic total occlusions assessed by optical coherence tomography: the ALSTER-OCT-CTO registry. EuroIntervention. 2016; 11(9): 1004–1012.
- Malle C, Tada T, Steigerwald K, et al. Tissue characterization after drug-eluting stent implantation using optical coherence tomography. Arterioscler Thromb Vasc Biol. 2013; 33(6): 1376–1383.
- Kochman J, Tomaniak M, Pietrasik A, et al. Bioresorbable everolimus-eluting vascular scaffold in patients with ST-segment elevation myocardial infarction: Optical coherence tomography evaluation and clinical outcomes. Cardiol J. 2015; 22(3): 315–322.
- Sakakura K, Ako J, Wada H, et al. ACC/AHA classification of coronary lesions reflects medical resource use in current percutaneous coronary interventions. Catheter Cardiovasc Interv. 2012; 80(3): 370–376.
- Windecker S, Kolh P, Alfonso F, et al. 2014 ESC/EACTS guidelines on myocardial revascularization. EuroIntervention. 2015; 10(9): 1024–1094.
- Serruys PW, Onuma Y, Ormiston JA, et al. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes. Circulation. 2010; 122(22): 2301–2312.
- Tearney GJ, Regar E, Akasaka T, et al. International Working Group for Intravascular Optical Coherence Tomography (IWG-IVOCT). Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. J Am Coll Cardiol. 2012; 59(12): 1058–1072.
- Prati F, Guagliumi G, Mintz GS, et al. Expert's OCT Review Document. Expert review document part 2: methodology, terminology and clinical applications of optical coherence tomography for the assessment of interventional procedures. Eur Heart J. 2012; 33(20): 2513–2520.
- Ormiston JA, Serruys PW, Onuma Y, et al. First serial assessment at 6 months and 2 years of the second generation of absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study. Circ Cardiovasc Interv. 2012; 5(5): 620–632.
- Serruys PW, Onuma Y, Dudek D, et al. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol. 2011; 58(15): 1578–1588.
- Pilgrim T, Heg D, Roffi M, et al. Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE): a randomised, single-blind, non-inferiority trial. Lancet. 2014; 384(9960): 2111–2122.
- Waltenberger J, Brachmann J, van der Heyden J, et al. BIOFLOW-III Investigators. Real-world experience with a novel biodegradable polymer sirolimus-eluting stent: twelve-month results of the BIOFLOW-III registry. EuroIntervention. 2016; 11(10): 1106–1110.
- Kimura T, Morimoto T, Natsuaki M, et al. RESET Investigators. Comparison of everolimus-eluting and sirolimus-eluting coronary stents: 1-year outcomes from the Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting stent Trial (RESET). Circulation. 2012; 126(10): 1225–1236.
- Räber L, Zaugg S, Windecker S, et al. Intricacies in the analysis and interpretation of optical coherence tomography findings. EuroIntervention. 2014; 9(12): 1374–1377.
- Kim BK, Ha J, Mintz GS, et al. Randomised comparison of strut coverage between Nobori biolimus-eluting and sirolimus-eluting stents: an optical coherence tomography analysis. EuroIntervention. 2014; 9(12): 1389–1397.
- Meincke F, Spangenberg T, Heeger CH, et al. Very Late Scaffold Thrombosis Due to Insufficient Strut Apposition. JACC Cardiovasc Interv. 2015; 8(13): 1768–1769.
- Felix CM, Vlachojannis GJ, IJsselmuiden AJJ, et al. Potentially increased incidence of scaffold thrombosis in patients treated with Absorb BVS who terminated DAPT before 18 months. EuroIntervention. 2017; 13(2): e177–e184.
- Gao R: Gao R, on behalf of the ABSORB-China Investigators. Randomized comparison of everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents in patients with coronary artery disease. Presented at: EuroPCR 2017.
- on behalf of the ABSORB-Japan Investigators. ABSORB-Japan: 3-year clinical and angiographic results of a randomized trial evaluating the Absorb bioresorbable vascular scaffold vs metallic DES in de novo native coronary artery lesions. Presented at: EuroPCR 2017.
