Abstract
Introduction: Coronary bifurcation lesions (CBL) are one fifth of all coronary lesions and they do not have an optimal strategy for stenting yet. Bioresorbable scaffolds (BRS) are novel inventions proposed to be the optimal solution. The aim of this systematic review was to assess the role of BRS in treating CBL by comparing it to dedicated bifurcation stents (DBS).
Methods: A systematic review was conducted following the PRISMA guidelines, searching databases such as ScienceDirect, EMBASE, MEDLINE, NIH, TRIP, PUBMED, and ClinicalTrials. gov. The risk of bias was assessed by MINORS and modified Cowley’s criteria. Q statistic was used for heterogeneity testing and a meta-analysis was conducted using the “meta” package in the R software application.
Results: Fourteen studies were included with an average follow-up period of twelve months. Almost 80% of the participants were male (p-value= 0.148) and around two-thirds were smokers. Meta-analysis was performed for myocardial infarction (MI), target lesion revascularisation (TLR), major adverse cardiac events (MACE), and stent thrombosis (ST). These showed statistically nonsignificant differences, with a slight trend favouring BRS except with stent thrombosis.
Conclusion: There is a lack of randomised trials on the topic, which may be an area for further research. But the results showed favourable yet statistically insignificant outcomes for BRS except for ST, an issue that can be addressed with technological advancement.
Keywords: Bioresorbable scaffolds, coronary bifurcation lesions, dedicated bifurcation stents, BRS, CBL, DBS.
Graphical Abstract
[1]
Lee DH, de la Torre Hernandez JM. The newest generation of drug-eluting stents and beyond. Eur Cardiol 2018; 13(1): 54-9.
[http://dx.doi.org/10.15420/ecr.2018:8:2] [PMID: 30310472]
[http://dx.doi.org/10.15420/ecr.2018:8:2] [PMID: 30310472]
[2]
Picard F, Pighi M, de Hemptinne Q, et al. Comparison of the biodegradable polymer everolimus-eluting stent with contemporary drug-eluting stents: A systematic review and meta-analysis. Int J Cardiol 2019; 278: 51-6.
[http://dx.doi.org/10.1016/j.ijcard.2018.11.113] [PMID: 30503189]
[http://dx.doi.org/10.1016/j.ijcard.2018.11.113] [PMID: 30503189]
[3]
Lipinski MJ, Escarcega RO, Baker NC, et al. Scaffold thrombosis after percutaneous coronary intervention with absorb bioresorbable vascular scaffold: A systematic review and meta-analysis. JACC Cardiovasc Interv 2016; 9(1): 12-24.
[http://dx.doi.org/10.1016/j.jcin.2015.09.024] [PMID: 26762906]
[http://dx.doi.org/10.1016/j.jcin.2015.09.024] [PMID: 26762906]
[4]
Kang SH, Chae IH, Park JJ, et al. Stent thrombosis with drug-eluting stents and bioresorbable scaffolds: Evidence from a network meta-analysis of 147 trials. JACC Cardiovasc Interv 2016; 9(12): 1203-12.
[http://dx.doi.org/10.1016/j.jcin.2016.03.038] [PMID: 27262860]
[http://dx.doi.org/10.1016/j.jcin.2016.03.038] [PMID: 27262860]
[5]
Wykrzykowska JJ, Kraak RP, Hofma SH, et al. Bioresorbable scaffolds versus metallic stents in routine pci. N Engl J Med 2017; 376(24): 2319-28.
[http://dx.doi.org/10.1056/NEJMoa1614954] [PMID: 28402237]
[http://dx.doi.org/10.1056/NEJMoa1614954] [PMID: 28402237]
[6]
Byrne RA, Alfonso F, Schneider S, et al. Prospective, randomized trial of bioresorbable scaffolds vs. everolimus-eluting stents in patients undergoing coronary stenting for myocardial infarction: the Intracoronary Scaffold Assessment a Randomized evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) trial. Eur Heart J 2019; 40(2): 167-76.
[http://dx.doi.org/10.1093/eurheartj/ehy710] [PMID: 30520980]
[http://dx.doi.org/10.1093/eurheartj/ehy710] [PMID: 30520980]
[7]
Sawaya FJ, Lefèvre T, Chevalier B, et al. Contemporary approach to coronary bifurcation lesion treatment. JACC Cardiovasc Interv 2016; 9(18): 1861-78.
[http://dx.doi.org/10.1016/j.jcin.2016.06.056] [PMID: 27659563]
[http://dx.doi.org/10.1016/j.jcin.2016.06.056] [PMID: 27659563]
[8]
Lassen JF, Holm NR, Banning A, et al. Percutaneous coronary intervention for coronary bifurcation disease: 11th consensus document from the European Bifurcation Club. EuroIntervention 2016; 12(1): 38-46.
[http://dx.doi.org/10.4244/EIJV12I1A7] [PMID: 27173860]
[http://dx.doi.org/10.4244/EIJV12I1A7] [PMID: 27173860]
[9]
Collet C, Asano T, Miyazaki Y, et al. Late thrombotic events after bioresorbable scaffold implantation: A systematic review and meta-analysis of randomized clinical trials. Eur Heart J 2017; 38(33): 2559-66.
[http://dx.doi.org/10.1093/eurheartj/ehx155] [PMID: 28430908]
[http://dx.doi.org/10.1093/eurheartj/ehx155] [PMID: 28430908]
[10]
Yuki K, Gregg WS, Yoshinobu O, Patrick WS. State of the art: The inception, advent and future of fully bioresorbable scaffolds. EuroIntervention 2017; 13(6): 734-50.
[11]
Sakamoto A, Jinnouchi H, Torii S, Virmani R, Finn AV. Understanding the impact of stent and scaffold material and strut design on coronary artery thrombosis from the basic and clinical points of view. Bioengineering 2018; 5(3): 71.
[http://dx.doi.org/10.3390/bioengineering5030071] [PMID: 30181463]
[http://dx.doi.org/10.3390/bioengineering5030071] [PMID: 30181463]
[12]
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): 247-57.
[http://dx.doi.org/10.1016/j.jcin.2012.10.013] [PMID: 23517836]
[http://dx.doi.org/10.1016/j.jcin.2012.10.013] [PMID: 23517836]
[14]
Methley AM, Campbell S, Chew-Graham C, McNally R, Cheraghi-Sohi S. PICO, PICOS and SPIDER: A comparison study of specificity and sensitivity in three search tools for qualitative systematic reviews. BMC Health Serv Res 2014; 14(1): 579.
[http://dx.doi.org/10.1186/s12913-014-0579-0] [PMID: 25413154]
[http://dx.doi.org/10.1186/s12913-014-0579-0] [PMID: 25413154]
[15]
Slim K, Nini E, Forestier D, Kwiatkowski F, Panis Y, Chipponi J. Methodological index for non-randomized studies (minors): Development and validation of a new instrument. ANZ J Surg 2003; 73(9): 712-6.
[16]
Cowley DE. Prostheses for primary total hip replacement. A critical appraisal of the literature. Int J Technol Assess Health Care 1995; 11(4): 770-8.
[http://dx.doi.org/10.1017/S026646230000920X] [PMID: 8567209]
[http://dx.doi.org/10.1017/S026646230000920X] [PMID: 8567209]
[17]
Warton DI, Hui FKC. The arcsine is asinine: The analysis of proportions in ecology. Ecology 2011; 92(1): 3-10.
[http://dx.doi.org/10.1890/10-0340.1] [PMID: 21560670]
[http://dx.doi.org/10.1890/10-0340.1] [PMID: 21560670]
[18]
Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997; 315(7109): 629-34.
[http://dx.doi.org/10.1136/bmj.315.7109.629] [PMID: 9310563]
[http://dx.doi.org/10.1136/bmj.315.7109.629] [PMID: 9310563]
[19]
Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics 1994; 50(4): 1088-101.
[http://dx.doi.org/10.2307/2533446] [PMID: 7786990]
[http://dx.doi.org/10.2307/2533446] [PMID: 7786990]
[20]
Gori T, Wiebe J, Capodanno D, et al. Early and midterm outcomes of bioresorbable vascular scaffolds for ostial coronary lesions: Insights from the GHOST-EU registry. EuroIntervention 2016; 12(5): e550-6.
[http://dx.doi.org/10.4244/EIJY15M09_10] [PMID: 26348681]
[http://dx.doi.org/10.4244/EIJY15M09_10] [PMID: 26348681]
[21]
Rampat R, Mayo T, Hildick-Smith D, Cockburn J. A randomized trial comparing two stent sizing strategies in coronary bifurcation treatment with bioresorbable vascular scaffolds - The Absorb Bifurcation Coronary (ABC) trial. Cardiovasc Revasc Med 2019; 20(1): 43-9.
[http://dx.doi.org/10.1016/j.carrev.2018.08.007] [PMID: 30170828]
[http://dx.doi.org/10.1016/j.carrev.2018.08.007] [PMID: 30170828]
[22]
Gordon T, Castelli WP, Hjortland MC, Kannel WB, Dawber TR. Predicting coronary heart disease in middle-aged and older persons. The Framington study. JAMA 1977; 238(6): 497-9.
[http://dx.doi.org/10.1001/jama.1977.03280060041018] [PMID: 577575]
[http://dx.doi.org/10.1001/jama.1977.03280060041018] [PMID: 577575]
[23]
Buysschaert I, Dubois CL, Dens J, et al. Three-year clinical results of the Axxess Biolimus a9 eluting bifurcation stent system: The diverge study. EuroIntervention 2013; 9(5): 573-81.
[24]
Hochman JS, Tamis JE, Thompson TD, et al. Sex, clinical presentation, and outcome in patients with acute coronary syndromes. N Engl J Med 1999; 341(4): 226-32.
[http://dx.doi.org/10.1056/NEJM199907223410402] [PMID: 10413734]
[http://dx.doi.org/10.1056/NEJM199907223410402] [PMID: 10413734]
[25]
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.
[http://dx.doi.org/10.1016/S0140-6736(14)61455-0] [PMID: 25230593]
[http://dx.doi.org/10.1016/S0140-6736(14)61455-0] [PMID: 25230593]
[26]
Abizaid A, Ribamar JCJ, Bartorelli AL, Whitbourn R, Chevalier B, Patel T, et al. The absorb extend study: Preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled. EuroIntervention 2015; 10(12): 1396-401.
[27]
Barrett-Connor E, Suarez L, Khaw KT, Criqui MH, Wingard DL. Ischemic heart disease risk factors after age 50. J Chronic Dis 1984; 37(12): 903-8.
[28]
Serruys PW, Onuma Y. Bioresorbable scaffolds: From basic concept to clinical applications. (1st ed.), Boca Raton: CRC Press 2017.
[29]
Braun D, Baquet M, Massberg S, Mehilli J, Hausleiter J. Collapse of a bioresorbable novolimus-eluting coronary scaffold. JACC Cardiovasc Interv 2016; 9(1): e13-4.
[http://dx.doi.org/10.1016/j.jcin.2015.10.019] [PMID: 26685077]
[http://dx.doi.org/10.1016/j.jcin.2015.10.019] [PMID: 26685077]
[30]
Ruiz-Salmerón RJ, Pereira S, de Araujo D. Bioresorbable vascular scaffold collapse causes subacute thrombosis. J Invasive Cardiol 2014; 26(7): E98-9.
[PMID: 24993999]
[PMID: 24993999]
[31]
Capodanno D, Joner M, Zimarino M. What about the risk of thrombosis with bioresorbable scaffolds? EuroIntervention 2015; 11 (Suppl. V): V181-4.
[http://dx.doi.org/10.4244/EIJV11SVA43] [PMID: 25983162]
[http://dx.doi.org/10.4244/EIJV11SVA43] [PMID: 25983162]
[32]
Xu B, Li JJ, Yang YJ, et al. Age-based clinical and angiographic outcomes after sirolimus-eluting stent implantation in patients with coronary artery disease. Chin Med J (Engl) 2007; 120(6): 447-51.
[http://dx.doi.org/10.1097/00029330-200703020-00002] [PMID: 17439734]
[http://dx.doi.org/10.1097/00029330-200703020-00002] [PMID: 17439734]
[33]
Regitz-Zagrosek V, Lehmkuhl E, Weickert MO. Gender differences in the metabolic syndrome and their role for cardiovascular disease. Clin Res Cardiol 2006; 95(3): 136-47.
[34]
Kawamoto H, Latib A, Ruparelia N, et al. Clinical outcomes following bioresorbable scaffold implantation for bifurcation lesions: Overall outcomes and comparison between provisional and planned double stenting strategy. Catheter Cardiovasc Interv 2015; 86(4): 644-52.
[http://dx.doi.org/10.1002/ccd.26045] [PMID: 26013748]
[http://dx.doi.org/10.1002/ccd.26045] [PMID: 26013748]
[35]
Naganuma T, Colombo A, Lesiak M, et al. Bioresorbable vascular scaffold use for coronary bifurcation lesions: A substudy from GHOST EU registry. Catheter Cardiovasc Interv 2017; 89(1): 47-56.
[http://dx.doi.org/10.1002/ccd.26634] [PMID: 27414021]
[http://dx.doi.org/10.1002/ccd.26634] [PMID: 27414021]
[36]
Ojeda Soledad, Pan Manuel, Suárez de Lezo Javier, et al. Patency of coronary side branches covered by an everolimus-eluting bioresorbable vascular scaffold: Clinical outcomes and computed tomography scan follow-up. EuroIntervention 2016; 11: e1283-90.
[http://dx.doi.org/10.4244/EIJV11I11A250]
[http://dx.doi.org/10.4244/EIJV11I11A250]
[37]
Paradies V, Vlachojannis GJ, Royaards KJ, Wassing J, van der Ent M, Smits PC. Angiographic and midterm outcomes of bioresorbable vascular scaffold for coronary bifurcation lesions. Am J Cardiol 2018; 122(12): 2035-42.
[http://dx.doi.org/10.1016/j.amjcard.2018.09.003] [PMID: 30360886]
[http://dx.doi.org/10.1016/j.amjcard.2018.09.003] [PMID: 30360886]
[38]
Suárez de Lezo J, Martín P, Pan M, et al. Bioresorbable vascular scaffold for the treatment of coronary bifurcation lesions: Immediate results and 1-year follow-up. Rev Esp Cardiol (Engl Ed) 2016; 69(6): 554-62.
[http://dx.doi.org/10.1016/j.rec.2015.12.004] [PMID: 26949014]
[http://dx.doi.org/10.1016/j.rec.2015.12.004] [PMID: 26949014]
[39]
Tanaka A, Latib A, Kawamoto H, et al. Clinical outcomes following bifurcation double-stenting with bioresorbable scaffolds. Catheter Cardiovasc Interv 2016; 88(6): 854-62.
[http://dx.doi.org/10.1002/ccd.26579] [PMID: 27184769]
[http://dx.doi.org/10.1002/ccd.26579] [PMID: 27184769]
[40]
Capranzano P, Gargiulo G, Capodanno D, et al. Treatment of coronary bifurcation lesions with bioresorbable vascular scaffolds. Minerva Cardioangiol 2014; 62(3): 229-34.
[PMID: 24831758]
[PMID: 24831758]
[41]
De Paolis M, Felix C, van Ditzhuijzen N, et al. Everolimus-eluting bioresorbable vascular scaffolds implanted in coronary bifurcation lesions: Impact of polymeric wide struts on side-branch impairment. Int J Cardiol 2016; 221: 656-64.
[http://dx.doi.org/10.1016/j.ijcard.2016.06.153] [PMID: 27423087]
[http://dx.doi.org/10.1016/j.ijcard.2016.06.153] [PMID: 27423087]
[42]
Bil J, Gil RJ, Vassilev D, Rzezak J, Kulawik T, Pawlowski T. Dedicated bifurcation paclitaxel-eluting stent BiOSS Expert® in the treatment of distal left main stem stenosis. J Interv Cardiol 2014; 27(3): 242-51.
[http://dx.doi.org/10.1111/joic.12119] [PMID: 24708143]
[http://dx.doi.org/10.1111/joic.12119] [PMID: 24708143]
[43]
Gil RJ, Bil J, Grundeken MJ, et al. Long-term effectiveness and safety of the sirolimus-eluting BiOSS LIM® dedicated bifurcation stent in the treatment of distal left main stenosis: an international registry. EuroIntervention 2016; 12(10): 1246-54.
[http://dx.doi.org/10.4244/EIJY15M10_05] [PMID: 26465375]
[http://dx.doi.org/10.4244/EIJY15M10_05] [PMID: 26465375]
[44]
Gil RJ, Bil J, Vassiliev D, Iñigo Garcia LA. First-in-man study of dedicated bifurcation sirolimus-eluting stent: 12-month results of BiOSS LIM® Registry. J Interv Cardiol 2015; 28(1): 51-60.
[http://dx.doi.org/10.1111/joic.12180] [PMID: 25689548]
[http://dx.doi.org/10.1111/joic.12180] [PMID: 25689548]
[45]
Grundeken MJ, Kraak RP, Baan J Jr, et al. First report on long-term clinical results after treatment of coronary bifurcation lesions with the Tryton dedicated bifurcation stent. Catheter Cardiovasc Interv 2014; 84(5): 759-65.
[http://dx.doi.org/10.1002/ccd.25350] [PMID: 25485348]
[http://dx.doi.org/10.1002/ccd.25350] [PMID: 25485348]
[46]
Triantafyllis AS, Bennett J, Pagourelias E, et al. Long-term outcomes after percutaneous revascularization of complex coronary bifurcation lesions using a dedicated self-expanding biolimus-eluting stent system. Cardiol J 2018; 25(4): 470-8.
[http://dx.doi.org/10.5603/CJ.a2017.0141] [PMID: 29240962]
[http://dx.doi.org/10.5603/CJ.a2017.0141] [PMID: 29240962]
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