Thrombosis and myocardial infarction: the role of bioresorbable scaffolds

Abstract

Coronary atherosclerosis is a leading cause of death as a result of coronary thrombosis and acute myocardial infarction. Drug-eluting stents (DES) have dramatically improved the treatment of coronary artery stenosis. However, stent thrombosis (ST) and in-stent-restenosis (ISR) have remained a vexing limitation of the DES. After DES implantation, despite taking dual antiplatelet (DAPT) therapy, very late ST results in myocardial infarction and death. This occurs regardless of the type of polymer or antiproliferative agent used in the contemporary DES. Such adverse events occur at a rate of approximately 2% to 3% per year after the first year, which have been attributed to strut fractures, loss of vessel compliance, and neoatherosclerosis. Bioresorbable scaffolds (BRS) have been introduced to overcome the above shortfalls and to a “leave nothing behind” approach. While BRS are novel and interesting, the initial experience with BRS was hampered by the increased rate of thrombosis compared with DES. Accordingly, in this review, we summarized underlying mechanisms leading to BRS failure and provided insights into optimizing BRS deployment with intravascular imaging. In addition, we outlined the perspectives of new generations of BRS with thinner struts and new designs as well as alternative materials to improve outcomes.

Keywords

Bioresorbable scaffolds / coronary artery disease / intravascular imaging / scaffold thrombosis

References

[1] Davies MJ.Thrombosis and acute coronary-artery lesions in sudden cardiac ischemic death.N Engl J Med1984;310:1137-40

[2] Stary HC,Dinsmore RE.A definition of advanced types of atherosclerotic lesions and a histological classification of atherosclerosis. A report from the committee on vascular lesions of the council on arteriosclerosis.Circulation1995;92:1355-74

[3] Mahmoud AN,Elgendy IY.Safety and efficacy of second-generation drug-eluting stents compared with bare-metal stents: an updated meta-analysis and regression of 9 randomized clinical trials.Clin Cardiol2018;4:151-58. PMCID:PMC6489746

[4] Valgimigli M,Byrne RA.2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: the task force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS).Eur Heart J2018;39:213-60

[5] Madhavan MV,Redfors B.Stent-related adverse events > 1 year after percutaneous coronary intervention.J Am Coll Cardiol2020;75:590-604

[6] Otsuka F,Yahagi K.Neoatherosclerosis: overview of histopathologic findings and implications for intravascular imaging assessment.Eur Heart J2015;36:2147-59.

[7] Shlofmitz E,M .Restenosis of drug-eluting stents: a new classification system based on disease mechanism to guide treatment and state-of-the-art review.Cir Cardiovasc Interv2019;12:e007023.

[8] Onuma Y.Bioresorbable scaffold: the advent of a new era in percutaneous coronary and peripheral revascularization?.Circulation2011;123:779-97.

[9] OnumaY ,Perkins LE.Intracoronary optical coherence tomography and histology at 1 month and 2, 3, and 4 years after implantation of everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model: an attempt to decipher the human optical coherence tomography images in the ABSORB trial.Circulation2010;122:2288-300.

[10] Vahl TP,Gongora CA.Four-year polymer biocompatibility and vascular healing profile of a novel ultrahigh molecular weight amorphous PLLA bioresorbable vascular scaffold: an OCT study in healthy porcine coronary arteries.EuroIntervention2016;12:1510-18

[11] Ali ZA,Kimura T.Three-year outcomes with the absorb bioresorbable scaffold: individual-patient-data meta-analysis from the ABSORB randomized trials.Circulation2018;137:464-79.

[12] Cassese S,Jüni P.Midterm clinical outcomes with everolimus-eluting bioresorbable scaffolds versus everolimus-eluting metallic stents for percutaneous coronary interventions: a meta-analysis of randomized trials.EuroIntervention2018;13:1565-73.

[13] Kereiakes DJ,Metzger C.ABSORB III Investigators. 3-Year clinical outcomes with everolimus-eluting bioresorbable coronary scaffolds: the ABSORB III trial.J Am Coll Cardiol2017;70:2852-62

[14] Fujii K,Mintz GS.Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation: an intravascular ultrasound study.J Am Coll Cardiol2005;45:995-98.

[15] Okabe T,Buch AN.Intravascular ultrasound parameters associated with stent thrombosis after drug-eluting stent deployment.Am J Cardiol2007;100:615-20

[16] Cuculi F,Jamshidi P.Optical Coherence tomography findings in bioresorbable vascular scaffolds thrombosis.Circ Cardiovasc Interv2015;8:1-9

[17] Capodanno D,Nef H.Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European Multicentre GHOST-EU registry.EuroIntervention2014;10:1144-53

[18] Finn AV,Nakazawa GK.Pathological correlates of late drug-eluting stent throm- bosis: strut coverage as a marker of endothelialization.Circulation2007;115:2435-41.

[19] Awata M,Uematsu M.Serial angioscopic evidence of incomplete neointimal coverage after sirolimus-eluting stent implantation: comparison with bare-metal stents.Circulation2007;116:910-16.

[20] Nebeker JR,Bennett CL.Hypersensitivity cases associated with drug-eluting coronary stents.J Am Coll Cardiol2006;47:175-81.

[21] Otsuka F,Perkins LE.Long-term safety of an everolimus-eluting bioresorbable vascular scaffold and the cobalt-chromium XIENCE V stent in a porcine coronary artery model.Circ Cardiovasc Interv2014;7:330-42

[22] Tellez A,Buszman PP.Peri-strut low-intensity areas in optical coherence tomography correlate with peri-strut inflammation and neointimal proliferation: an in-vivo cor- relation study in the familial hypercholesterolemic coronary swine model of in-stent restenosis.Coron Artery Dis2014;25:595-601

[23] Otsuka F,Ladich E,Virmani R.Pathologic etiologies of late and very late stent thrombosis following first-generation drug-eluting stent placement.Thrombosis2012:608-16 PMCID:PMC3512327

[24] Kerkmeijer LSM,Tijssen RYG.Long-term clinical outcomes of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting stents: final 5-year results of the AIDA randomized clinical trial.EuroIntervention2022;17:1340-7

[25] Serruys PW,Sotomi Y.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.Lancet2016;388:2479-91.

[26] Puricel S,Gendre G.Comparison of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds: 2-year out- comes of the EVERBIO II trial.Int J Cardiol2017;243:121-25

[27] Gao R,Han Y.ABSORB China Investigators. Bioresorbable vascular scaffolds versus metallic stents in patients with coronary artery disease: ABSORB China trial.J Am Coll Cardiol2015;66:21:2298-309

[28] Onuma Y,Shiomi H.Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent: insights from the randomised ABSORB Japan trial.EuroIntervention2016;12:1090-101.

[29] Mahmoud AN,Elgendy AY.Long-term efficacy and safety of everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomized trials.Circ Cardiovasc Interv2017;10:e005286

[30] Stone GW,Onuma Y.Effect of technique on outcomes following bioresorbable vascular scaffold implantation: analysis from the ABSORB trials.J Am Coll Cardiol2017 70:2863-74.

[31] Räber L,Yamaji K.Very late scaffold thrombosis: intracoronary imaging and histopathological and spectroscopic findings.J Am Coll Cardiol2015;66:1901-14

[32] Witzenbichler B,Weisz G.Relationship between intravascular ultrasound guidance and clinical outcomes after drug-eluting stents: the ADAPT-DES study.Circulation2014;129:463-70

[33] Wang L,Witzenbichler B.Differences in underlying culprit lesion morphology between men and women: an IVUS analysis from the ADAPT-DES study.Cardiovasc Imaging2015;S:1936-44

[34] Hong SJ,Ahn CM.Effect of intravascular ultrasound-guided drug-eluting stent implantation: 5-year follow-up of the IVUS-XPL randomized trial.J Am Coll Cardiol Interv2020;13:13:62-71

[35] Gao XF,Kong XQ.3-year outcomes of the ULTIMATE trial comparing intravascular ultrasound versus angiography-guided drug-eluting stent implantation.J Am Coll Cardiol Interv2021 8:14:247-57

[36] Takarada S,Liu Y.Advantage of next-generation frequency-domain optical coherence tomography compared with conventional time- domain system in the assessment of coronary lesion.Catheter Cardiovasc Interv2010;75:202-6

[37] Prati F,Mintz GS.Expert’s OCT Review Document. Expert review document on methodology, terminology, and clinical applications of optical coherence tomography: physical principles, methodology of image acquisition, and clinical application for assessment of coronary arteries and atherosclerosis.Eur Heart J2010;31:401-15

[38] Prati F,Biondi-Zoccai G.Angiography alone versus angiography plus optical coherence tomography to guide decision-making during percutaneous coro- nary intervention: the Centro per la Lotta contro l’Infarto-Optimization of Percutaneous Coronary Intervention (CLI-OPCI) study.EuroIntervention2012;8:823-9

[39] Brown A,Braganza DM.Expansion and malapposition characteristics after bioresorbable vascular stent implantation.Catheter Cardiovasc Interv2014;84:37-45

[40] Elgendy IY,Elgendy AY.Intravascular ultrasound-guidance is associated with lower cardiovascular mortality and myocardial infarction for drug-eluting stent implantation- insights from an updated meta-analysis of randomized trials.Circ J2019;83:1410-13

[41] Leesar MA,Hagood KL.A new method to optimize stent deployment by high-definition intravascular ultrasound.J Invasive Cardiol2021;33:E532-E539

[42] Ali ZA,Generous P.Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III).Lancet2016;388:2618-28.

[43] Costantini CR,De Macedo RM.Absorb bioresorbable vascular scaffold outcomes following implantation with routine intravascular imaging guidance.Catheter Cardiovasc Interv2021;97:48-55

[44] Sakamoto A,Torii S,Finn AV.Understanding the impact of stent and scaffold material and strut design on coronary artery throm- bosis from the basic and clinical points of view.Bio-engineering2019;10:175-89.

[45] Gijsen F,Barlis P.Expert recom- mendations on the assessment of wall shear stress in human coronary arteries: existing methodologies, technical considerations, and clinical applications.Eur Heart J2019;40:3421-33.

[46] Bangalore S,Patel N,Stone GW.Newer-generation ultrathin strut drug-eluting stents versus older second-generation thicker strut drug- eluting stents for coronary artery disease.Circulation2018;138:2216-26

[47] Verheye S,Montorsi P.BIOSOLVE-IV-registry: safety and performance of the Magmaris scaffold: 12-month outcomes of the first cohort of 1,075 patients.Catheter Cardiovasc Interv2021;98:E1-E8 PMCID:PMC8359313

[48] Guti ́errez-Chico JL,Girasis C.Quantitative multi-modality imaging analysis of a fully bioresorbable stent: a head-to-head comparison between QCA, IVUS and OCT.Int J Cardiovasc Imaging2012;28:469-78.

[49] Bangalore S,Rizik DG.The state of the absorb bioresorbable scaffold: consensus from an expert panel.J Am Coll Cardiolo Interv2017;10:2349-59.

[50] Ellis SG,Serruys PW.Clinical, angiographic, and procedural correlates of very late absorb scaffold thrombosis: multi-study registry results.J Am Coll Cardiolo Interv2018;11:638-44.