Absorb bioresorbable vascular scaffold outcomes following implantation with routine intravascular imaging guidance.
bioabsorbable implants
coronary thrombosis
intravascular imaging methods
percutaneous coronary revascularization
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
01 01 2021
01 01 2021
Historique:
received:
14
05
2019
accepted:
22
12
2019
pubmed:
9
1
2020
medline:
25
9
2021
entrez:
9
1
2020
Statut:
ppublish
Résumé
We sought to describe the outcomes of BVS use from a single-center experience in which scaffold implantation was guided by intravascular imaging (ultrasound and/or optical coherence tomography) to identify and treat mechanical factors potentially related to BVS failure. The Absorb bioresorbable vascular scaffold (BVS) has been associated with an unexpectedly high incidence of thrombosis. Between 11/2014 and 10/2016, 100 patients were treated with BVS. Intravascular imaging assessment before and after BVS implantation was performed in all cases. Mean age was 58.1 years; 88% were male, 31% had diabetes, and 28% presented with acute coronary syndromes. A total of 171 lesions in 141 vessels were treated with 190 BVS (mean 1.9 scaffolds/patient). Further intervention following intravascular imaging to optimize BVS implantation was required in 31% of patients. Procedure success was 100%. All patients completed a 1-year follow-up. The 1-year rate of target lesion failure was 4%, and there were no cases (0%) of scaffold thrombosis, myocardial infarction, or death. In this real-world experience, the use of intravascular imaging to guide BVS implantation was associated with a high 1-year event-free survival rate, with no scaffold thrombosis.
Sections du résumé
OBJECTIVES
We sought to describe the outcomes of BVS use from a single-center experience in which scaffold implantation was guided by intravascular imaging (ultrasound and/or optical coherence tomography) to identify and treat mechanical factors potentially related to BVS failure.
BACKGROUND
The Absorb bioresorbable vascular scaffold (BVS) has been associated with an unexpectedly high incidence of thrombosis.
METHODS
Between 11/2014 and 10/2016, 100 patients were treated with BVS. Intravascular imaging assessment before and after BVS implantation was performed in all cases.
RESULTS
Mean age was 58.1 years; 88% were male, 31% had diabetes, and 28% presented with acute coronary syndromes. A total of 171 lesions in 141 vessels were treated with 190 BVS (mean 1.9 scaffolds/patient). Further intervention following intravascular imaging to optimize BVS implantation was required in 31% of patients. Procedure success was 100%. All patients completed a 1-year follow-up. The 1-year rate of target lesion failure was 4%, and there were no cases (0%) of scaffold thrombosis, myocardial infarction, or death.
CONCLUSIONS
In this real-world experience, the use of intravascular imaging to guide BVS implantation was associated with a high 1-year event-free survival rate, with no scaffold thrombosis.
Substances chimiques
Everolimus
9HW64Q8G6G
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
48-55Informations de copyright
© 2020 Wiley Periodicals, Inc.
Références
Gruentzig A, Myler R, Stertzer H. Coronary percutaneous transluminal angioplasty: preliminary results. Circulation. 1978;586:II-56.
Ellis SG, Koglin J, Greenberg JD, et al. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease. JAMA. 2005;294:1215.
Gómez-Hospital JA, Fernández-Avilés F, Alfonso F, et al. Randomized comparison of Sirolimus-eluting stent versus standard stent for percutaneous coronary revascularization in diabetic patients. Circulation. 2005;112:2175-2183.
Lansky AJ, Mastali K, Kereiakes DJ, et al. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010;362:1663-1674.
Buszman P, Meier B, Wijns W, et al. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial. Lancet. 2011;378:1940-1948.
Bourantas CV, Papafaklis MI, Kotsia A, et al. Effect of the endothelial shear stress patterns on neointimal proliferation following drug-eluting bioresorbable vascular scaffold implantation: an optical coherence tomography study. JACC Cardiovasc Interv. 2014;7:315-324.
Bourantas CV, Farooq V, Zhang Y, et al. Circumferential distribution of the neointima at six-month and two-year follow-up after a bioresorbable vascular scaffold implantation: a substudy of the ABSORB cohort B clinical trial. EuroIntervention. 2015;10:1299-1306.
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;58:1578-1588.
Diletti R, Farooq V, Girasis C, et al. Clinical and intravascular imaging outcomes at 1 and 2 years after implantation of absorb everolimus eluting bioresorbable vascular scaffolds in small vessels. Late lumen enlargement: does bioresorption matter with small vessel size? Insight from the ABSO. Heart. 2013;99:98-105.
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. Lancet. 2015;385:43-54.
Ellis SG, Zhang Z, Stone GW, et al. Everolimus-eluting bioresorbable scaffolds for coronary artery disease. N Engl J Med. 2015;373:1905-1915.
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;10:1144-1153.
Kraak RP, Hassell MECJ, Grundeken MJ, et al. Initial experience and clinical evaluation of the absorb bioresorbable vascular scaffold (BVS) in real-world practice: the AMC single Centre real world PCI registry. EuroIntervention. 2015;10:1160-1168.
Stone GW, Abizaid A, Onuma Y, et al. Effect of technique on outcomes following Bioresorbable vascular scaffold implantation: Analysis from the ABSORB Trials. J Am Coll Cardiol. 2017;70:2863-2874.
Rinaldi MJ, Weisz G, Neumann F-J, et al. Relationship between intravascular ultrasound guidance and clinical outcomes after drug-eluting stents. Circulation. 2013;129:463-470.
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;8:823-829.
Maehara A, Ben-Yehuda O, Ali Z, et al. Comparison of stent expansion guided by optical coherence tomography versus intravascular ultrasound: The ILUMIEN II study (Observational Study of Optical Coherence Tomography [OCT] in patients undergoing fractional flow reserve [FFR] and percutaneous cor). JACC Cardiovasc Interv. 2015;8:1704-1714.
Steinvil A, Zhang YJ, Lee SY, et al. Intravascular ultrasound-guided drug-eluting stent implantation: an updated meta-analysis of randomized control trials and observational studies. Int J Cardiol. 2016;216:133-139.
Vandormael MG, Cowley MJ, Topol EJ, et al. Coronary morphologic and clinical determinants of procedural outcome with angioplasty for multivessel coronary disease. Implications for patient selection. Multivessel angioplasty prognosis study group. Circulation. 2011;82:1193-1202.
Sianos G, Morel M-A, Kappetein AP, et al. The SYNTAX score: an angiographic tool grading the complexity of coronary artery disease. EuroIntervention. 2005;1:219-227.
Hugenholtz PG, Gerbrands JJ, Wijns W, et al. Assessment of short-, medium-, and long-term variations in arterial dimensions from computer-assisted quantitation of coronary cineangiograms. Circulation. 2011;71:280-288.
Zhang J, Gao X, Kan J, et al. Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial. J Am Coll Cardiol. 2018;72:3126-3137.
Mintz G. American College of Cardiology Clinical Expert Consensus Document on standards for acquisition, measurement and reporting of intravascular ultrasound studies (IVUS). A report of the American College of Cardiology Task Force on clinical expert consensus do. Eur J Echocardiogr. 2002;2:299-313.
Nair A, Margolis MP, Kuban BD, Vince DG. Automated coronary plaque characterisation with intravascular ultrasound backscatter: ex vivo validation. EuroIntervention. 2007;3:113-120.
Cook S, Wenaweser P, Togni M, et al. Incomplete stent apposition and very late stent thrombosis after drug-eluting stent implantation. Circulation. 2007;115:2426-2434.
De Jaegere P, Mudra H, Figulla H, et al. Intravascular ultrasound-guided optimized stent deployment: immediate and 6 months clinical and angiographic results from the multicenter ultrasound stenting in coronaries study (MUSIC study). Eur Heart J. 1998;19:1214-1223.
Tearney GJ, Regar E, Akasaka T, et al. 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;59:1058-1072.
Chamié D, Stefano GT, Mehanna E, et al. Incidence, predictors, morphological characteristics, and clinical outcomes of stent edge dissections detected by optical coherence tomography. JACC Cardiovasc Interv. 2013;6:800-813.
Garcia-Garcia HM, McFadden EP, Farb A, et al. Standardized end point definitions for coronary intervention trials: the academic research consortium-2 consensus document. Circulation. 2018;137:2635-2650.
Thygesen K, Alpert JS, Jaffe AS, et al. Fourth universal definition of myocardial infarction (2018). Eur Heart J. 2019;40:237-269.
Mukherjee D, Chambers CE, Mauri L, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention. J Am Coll Cardiol. 2011;58:e44-e122.
Abizaid A, Costa JR, Bartorelli AL, et al. The ABSORB EXTEND study: preliminary report of the twelvemonth clinical outcomes in the first 512 patients enrolled. EuroIntervention. 2015;10:1396-1401.
Cassese S, Kastrati A. Bioresorbable vascular scaffold technology benefits from healthy skepticism. J Am Coll Cardiol. 2016;67:932-935.
Kufner S, Kastrati A, Byrne RA, et al. Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials. Lancet. 2015;387:537-544.
Sotomi Y, Suwannasom P, Serruys PW, et al. Possible mechanical causes of scaffold thrombosis: insights from case reports with intracoronary imaging. EuroIntervention. 2017;12:1747-1756.
Yamaji K, Räber L, Windecker S. What determines long-term outcomes using fully bioresorbable scaffolds - the device, the operator or the lesion? EuroIntervention. 2017;12:1684-1687.
Schmermund A, Gori T, Puricel S, et al. Bioresorbable coronary scaffold thrombosis. J Am Coll Cardiol. 2016;67:921-931.
Nissen SE. Pathobiology, not angiography, should guide management in acute coronary syndrome/non-ST-segment elevation myocardial infarction: the non-interventionist's perspective. J. Am. Coll. Cardiol. 2003;41:103S-112S.
Regar E, Lemos PA, Saia F, et al. Incidence of thrombotic stent occlusion during the first three months after sirolimus-eluting stent implantation in 500 consecutive patients. Am J Cardiol. 2004;93:1271-1275.
Goar FGS, Pinto FJ, Alderman EL, Fitzgerald PJ, Stadius ML, Popp RL. Intravascular ultrasound imaging of angiographically normal coronary arteries: an in vivo comparison with quantitative angiography. J Am Coll Cardiol. 1991;18:952-958.
Choi SY, Witzenbichler B, Maehara A, et al. Intravascular ultrasound findings of early stent thrombosis after primary percutaneous intervention in acute myocardial infarction: a harmonizing outcomes with revascularization and stents in acute myocardial infarction (HORIZONS-AMI) substudy. Circ Cardiovasc Interv. 2011;4:239-247.
Tsujioka H, Ino Y, Akasaka T, et al. Advantage of next-generation frequency-domain optical coherence tomography compared with conventional time-domain system in the assessment of coronary lesion. Catheter Cardiovasc Interv. 2009;75:202-206.
Fujino Y, Bezerra HG, Attizzani GF, et al. Frequency-domain optical coherence tomography assessment of unprotected left main coronary artery disease - a comparison with intravascular ultrasound. Catheter Cardiovasc Interv. 2013;82:E173-E183.
Parise H, Maehara A, Stone GW, Leon MB, Mintz GS. Meta-analysis of randomized studies comparing intravascular ultrasound versus angiographic guidance of percutaneous coronary intervention in predrug-eluting stent era. Am J Cardiol. 2011;107:374-382.
Elgendy IY, Mahmoud AN, Elgendy AY, et al. Outcomes with intravascular ultrasound-guided stent implantation. Circ Cardiovasc Interv. 2016;9:e003700.
de la Torre Hernandez JM, Roura Ferrer G, Sanchez Recalde A, et al. Clinical impact of intravascular ultrasound guidance in drug-eluting stent implantation for unprotected left Main coronary disease. JACC Cardiovasc Interv. 2014;7:244-254.
Allahwala UK, Cockburn JA, Shaw E, Figtree GA, Hansen PS, Bhindi R. Clinical utility of optical coherence tomography (OCT) in the optimisation of absorb bioresorbable vascular scaffold deployment during percutaneous coronary intervention. EuroIntervention. 2015;10:1154-1159.
Montorfano M, Montalto C, Chieffo A, et al. Clinical outcomes of a real-world cohort following bioresorbable vascular scaffold implantation utilising an optimised implantation strategy. EuroIntervention. 2017;12:1730-1737.
Colombo A, Ruparelia N. Who is Thrombogenic: the scaffold or the doctor? Back to the future! JACC: Cardiovascular Interventions. 2016;9:25-27.