Vol 25, No 4 (2018)
Original articles — Interventional cardiology
Published online: 2018-05-16
Implantation of bioresorbable scaffolds under guidance of optical coherence tomography: Feasibility and pilot clinical results of a systematic protocol
Abstract
Background: Herein is hypothesised that a comprehensive optical coherence tomography (OCT)-guided implantation protocol for bioresorbable scaffolds (BRS) can improve expansion and apposition, thus resulting in better clinical outcomes, particularly in reducing thrombotic events.
Methods: Patients considered suitable for BRS therapy in de novo coronary lesions underwent OCT. The predominant type of plaque was classified as lipidic, fibrous or calcific. Accordingly they underwent tailored plaque preparation. After proper sizing, BRS was deployed and final OCT was acquired. Post-dilation was performed only in cases of suboptimal deployment. Procedural and 12 month clinical follow-up is reported.
Results: Twenty nine patients (41 lesions) who were considered clinically and angiographically suitable for BRS were enrolled, including challenging clinical scenarios such as ST-segment elevation myocardial infarction or CTOs. The OCT-guided protocol was feasible in 90.2% of the lesions: 14 (37.8%) lipidic, 11 (29.7%) fibrous, and 12 (32.4%) calcific. Three (8%) lesions classified as calcific were changed to treatment with metallic stent. BRS were implanted in 34 (91.9%) lesions, thereof 30 (88.2%) with optimal deployment in OCT. One (3.6%) periprocedural MI occurred, resulting in 3.6% target vessel failure and 0% scaffold thrombosis of any kind after a 12 month follow-up.
Conclusions: OCT-guided BRS implantation is feasible in 90.2% of de novo lesions and results in optimal expansion and apposition, correlating with 3.6% incidence of target vessel failure and 0% scaffold thrombosis at 12 m follow-up, probably due to better selection of lesions amenable for BRS treatment and to a possibility of tailoring intervention to the type of plaque. These encouraging pilot results require confirmation in larger clinical studies.
Keywords: tomographyoptical coherencebioresorbable scaffoldpercutaneous coronary intervention
References
- Wykrzykowska JJ, Onuma Y, Serruys PW. Vascular restoration therapy: the fourth revolution in interventional cardiology and the ultimate "rosy" prophecy. EuroIntervention. 2009; 5 Suppl F: F7–F8.
- Kereiakes DJ, Onuma Y, Serruys PW, et al. Bioresorbable Vascular Scaffolds for Coronary Revascularization. Circulation. 2016; 134(2): 168–182.
- Ormiston JA, Serruys PW, Regar E, et al. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008; 371(9616): 899–907.
- Serruys PW, Ormiston JA, Onuma Y, et al. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009; 373(9667): 897–910.
- Onuma Y, Serruys PW, Ormiston JA, et al. Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2010; 6(4): 447–453.
- Dudek D, Onuma Y, Ormiston JA, et al. Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2012; 7(9): 1060–1061.
- 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.
- 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.
- Serruys PW, Ormiston J, van Geuns RJ, et al. A polylactide bioresorbable scaffold eluting everolimus for treatment of coronary stenosis: 5-year follow-up. J Am Coll Cardiol. 2016; 67(7): 766–776.
- Capodanno D, Gori T, Nef H, et al. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention. 2015; 10(10): 1144–1153.
- Puricel S, Cuculi F, Weissner M, et al. Bioresorbable coronary scaffold thrombosis: multicenter comprehensive analysis of clinical presentation, mechanisms, and predictors. J Am Coll Cardiol. 2016; 67(8): 921–931.
- 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.
- Wykrzykowska JJ, Kraak RP, Hofma SH, et al. AIDA Investigators. Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. N Engl J Med. 2017; 376(24): 2319–2328.
- Räber L, Brugaletta S, Yamaji K, et al. Very late scaffold thrombosis: intracoronary imaging and histopathological and Spectroscopic findings. J Am Coll Cardiol. 2015; 66(17): 1901–1914.
- Muramatsu T, Onuma Y, García-García HM, et al. Incidence and short-term clinical outcomes of small side branch occlusion after implantation of an everolimus-eluting bioresorbable vascular scaffold: an interim report of 435 patients in the ABSORB-EXTEND single-arm trial in comparison with an everolimus-eluting metallic stent in the SPIRIT first and II trials. JACC Cardiovasc Interv. 2013; 6(3): 247–257.
- Mangiameli A, Ohno Y, Attizzani GF, et al. Neoatherosclerosis as the cause of late failure of a bioresorbable vascular scaffold. JACC Cardiovasc Interv. 2015; 8(4): 633–634.
- Bastante T, Rivero F, Benedicto A, et al. Recurrent neoatherosclerosis after bioresorbable vascular scaffold treatment of in-stent restenosis. JACC Cardiovasc Interv. 2015; 8(9): 1264–1265.
- Gutiérrez-Chico JL, Regar E, Nüesch E, et al. Delayed coverage in malapposed and side-branch struts with respect to well-apposed struts in drug-eluting stents: in vivo assessment with optical coherence tomography. Circulation. 2011; 124(5): 612–623.
- Gutiérrez-Chico JL, Wykrzykowska J, Nüesch E, et al. Vascular tissue reaction to acute malapposition in human coronary arteries: sequential assessment with optical coherence tomography. Circ Cardiovasc Interv. 2012; 5(1): 20–9, S1.
- Foin N, Gutiérrez-Chico JL, Nakatani S, et al. Incomplete stent apposition causes high shear flow disturbances and delay in neointimal coverage as a function of strut to wall detachment distance: implications for the management of incomplete stent apposition. Circ Cardiovasc Interv. 2014; 7(2): 180–189.
- Ormiston JA, De Vroey F, Serruys PW, et al. Bioresorbable polymeric vascular scaffolds: a cautionary tale. Circ Cardiovasc Interv. 2011; 4(5): 535–538.
- Onuma Y, Serruys P, Muramatsu T, et al. Incidence and imaging outcomes of acute scaffold disruption and late structural discontinuity after implantation of the absorb everolimus-eluting fully bioresorbable vascular scaffold. JACC: Cardiovascular Interventions. 2014; 7(12): 1400–1411.
- Prati F, Kodama T, Romagnoli E, et al. Suboptimal stent deployment is associated with subacute stent thrombosis: optical coherence tomography insights from a multicenter matched study. From the CLI Foundation investigators: the CLI-THRO study. Am Heart J. 2015; 169(2): 249–256.
- Rivero F, Benedicto A, Bastante T, et al. Subacute thrombosis of a bioresorbable vascular scaffold implanted for recurrent in-stent restenosis. EuroIntervention. 2015; 11(7): 780.
- Ruiz-Salmerón RJ, Pereira S, de Araujo D. Bioresorbable vascular scaffold collapse causes subacute thrombosis. J Invasive Cardiol. 2014; 26(7): E98–E99.
- Karanasos A, Van Mieghem N, van Ditzhuijzen N, et al. Angiographic and optical coherence tomography insights into bioresorbable scaffold thrombosis: single-center experience. Circ Cardiovasc Interv. 2015; 8(5).
- Ormiston JA, Webber B, Ubod B, et al. Absorb everolimus-eluting bioresorbable scaffolds in coronary bifurcations: a bench study of deployment, side branch dilatation and post-dilatation strategies. EuroIntervention. 2015; 10(10): 1169–1177.
- Ormiston JA, Webber B, Ubod B, et al. An independent bench comparison of two bioresorbable drug-eluting coronary scaffolds (Absorb and DESolve) with a durable metallic drug-eluting stent (ML8/Xpedition). EuroIntervention. 2015; 11(1): 60–67.
- Foin N, Lee R, Mattesini A, et al. Bioabsorbable vascular scaffold overexpansion: insights from in vitro post-expansion experiments. EuroIntervention. 2016; 11(12): 1389–1399.
- Farooq V, Gomez-Lara J, Brugaletta S, et al. Proximal and distal maximal luminal diameters as a guide to appropriate deployment of the ABSORB everolimus-eluting bioresorbable vascular scaffold: a sub-study of the ABSORB Cohort B and the on-going ABSORB EXTEND Single Arm Study. Catheter Cardiovasc Interv. 2012; 79(6): 880–888.
- Windecker S, Kolh P, Alfonso P, et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). . Eur Heart J. 2014; 35(37): 2541–2619.
- Gutiérrez-Chico JL, Radu MD, Diletti R, et al. Spatial distribution and temporal evolution of scattering centers by optical coherence tomography in the poly(L-lactide) backbone of a bioresorbable vascular scaffold. Circ J. 2012; 76(2): 342–350.
- Sheehy A, Gutiérrez-Chico JL, Diletti R, et al. In vivo characterisation of bioresorbable vascular scaffold strut interfaces using optical coherence tomography with Gaussian line spread function analysis. EuroIntervention. 2012; 7(10): 1227–1235.
- Oberhauser JP, Hossainy S, Rapoza RJ. Design principles and performance of bioresorbable polymeric vascular scaffolds. EuroIntervention. 2009; 5 Suppl F: F15–F22.
- Schmidt W, Behrens P, Brandt-Wunderlich C, et al. In vitro performance investigation of bioresorbable scaffolds - Standard tests for vascular stents and beyond. Cardiovasc Revasc Med. 2016; 17(6): 375–383.
- Fajadet J, Haude M, Joner M, et al. Magmaris preliminary recommendation upon commercial launch: a consensus from the expert panel on 14 April 2016. EuroIntervention. 2016; 12(7): 828–833.
- Gibson CM, de Lemos JA, Murphy SA, et al. TIMI Study Group. Combination therapy with abciximab reduces angiographically evident thrombus in acute myocardial infarction: a TIMI 14 substudy. Circulation. 2001; 103(21): 2550–2554.
- Prati F, Cera M, Ramazzotti V, et al. Safety and feasibility of a new non-occlusive technique for facilitated intracoronary optical coherence tomography (OCT) acquisition in various clinical and anatomical scenarios. EuroIntervention. 2007; 3(3): 365–370.
- Collet C, Suwannasom P, Almeida M, et al. Coronary bioresorbable vascular scaffold radiopaque marker embolization. Eur Heart J. 2017; 38(21): 1690.
- Gutiérrez-Chico JL, Alegría-Barrero E, Teijeiro-Mestre R, et al. Optical coherence tomography: from research to practice. Eur Heart J Cardiovasc Imaging. 2012; 13(5): 370–384.
- Cutlip DE, Windecker S, Mehran R, et al. Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007; 115(17): 2344–2351.
- Cortés C, Jaguszewski M, Amat-Santos IJ, et al. Bas-relief in three dimensional optical coherence tomography: a novel sign after subintimal scaffolding in a chronic total occlusion. Eur Heart J. 2017; 38(31): 2445.
- Fabris E, Caiazzo G, Kilic ID, et al. Is high pressure postdilation safe in bioresorbable vascular scaffolds? Optical coherence tomography observations after noncompliant balloons inflated at more than 24 atmospheres. Catheter Cardiovasc Interv. 2016; 87(5): 839–846.
- Kawamoto H, Jabbour RJ, Tanaka A, et al. Contained coronary rupture following bioresorbable scaffold implantation in a small vessel. Int J Cardiol. 2016; 209: 24–25.
