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Bioresorbable Vascular Scaffolds Versus Drug-Eluting Stents for Diffuse Long Coronary Narrowings

      Clinical benefits of bioresorbable vascular scaffold (BVS) implantation for long coronary lesions were not sufficiently evaluated. The efficacy and safety of BVS and metallic everolimus-eluting stent (EES) were compared for the treatment of long coronary narrowings. A total of 341 patients with diffuse long lesions (requiring device length ≥28 mm) were randomized to receive either BVS (n = 171) or EES (n = 170) implantation. The primary endpoint was major adverse cardiovascular events which included death from cardiac cause, myocardial infarction, device thrombosis, or ischemia-driven target-lesion revascularization at 12 months. The trial was terminated early because the manufacturer stopped supplying BVS. The mean lesion length was 32.2 ± 13.1 mm in the BVS group and 35.3 ± 13.0 mm in the EES group. The 12-month follow-up was completed in 332 patients (97.4%). At 12 months, the primary endpoint events occurred in 2 patients (1.2%) in the BVS group and in 4 patients (2.4%) in the EES group (hazard ratio = 0.49, 95% confidence interval = 0.09 to 2.67, p = 0.398). Definite or probable device thrombosis occurred in 1 patient (0.6%) in the BVS group and 1 patient (0.6%) in the EES group (hazard ratio = 1.00, 95% confidence interval = 0.06 to 15.94, p = 0.998). In conclusion, in patients with long native coronary artery disease, significant differences between BVS and EES were not observed regarding the primary composite endpoint of death from cardiac cause, myocardial infarction, device thrombosis, or target-lesion revascularization at 12 months. However, due to the early termination of this trial and a low number of events, the results cannot be considered clinically relevant (clinicalTrials.gov Identifier: NCT02796157).
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      References

        • Honda Y
        • Muramatsu T
        • Ito Y
        • Sakai T
        • Hirano K
        • Yamawaki M
        • Araki M
        • Kobayashi N
        • Takimura H
        • Sakamoto Y
        • Mouri S
        • Tsutumi M
        • Takama T
        • Takafuji H
        • Tokuda T
        • Makino K
        Impact of ultra-long second-generation drug-eluting stent implantation.
        Catheter Cardiovasc Interv. 2016; 87: E44-E53
        • Lee SW
        • Lee JY
        • Ahn JM
        • Park DW
        • Han S
        • Park YK
        • Lee WS
        • Jang JY
        • Kwon CH
        • Park GM
        • Cho YR
        • Kim WJ
        • Kang SJ
        • Kim YH
        • Lee CW
        • Kim JJ
        • Park SW
        • Park SJ
        Comparison of dual versus triple antiplatelet therapy after drug-eluting stent according to stent length (from the pooled analysis of DECLARE trials).
        Am J Cardiol. 2013; 112: 1738-1744
        • Stefanini GG
        • Serruys PW
        • Silber S
        • Khattab AA
        • van Geuns RJ
        • Richardt G
        • Buszman PE
        • Kelbæk H
        • van Boven AJ
        • Hofma SH
        • Linke A
        • Klauss V
        • Wijns W
        • Macaya C
        • Garot P
        • Di Mario C
        • Manoharan G
        • Kornowski R
        • Ischinger T
        • Bartorelli AL
        • Gobbens P
        • Windecker S
        The impact of patient and lesion complexity on clinical and angiographic outcomes after revascularization with zotarolimus- and everolimus-eluting stents: a substudy of the RESOLUTE All Comers Trial (a randomized comparison of a zotarolimus-eluting stent with an everolimus-eluting stent for percutaneous coronary intervention).
        J Am Coll Cardiol. 2011; 57: 2221-2232
        • Onuma Y
        • Serruys PW
        • Perkins LE
        • Okamura T
        • Gonzalo N
        • García-García HM
        • Regar E
        • Kamberi M
        • Powers JC
        • Rapoza R
        • van Beusekom H
        • van der Giessen W
        • Virmani R
        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.
        Circulation. 2010; 122: 2288-2300
        • Ahn JM
        • Park DW
        • Hong SJ
        • Ahn YK
        • Hahn JY
        • Kim WJ
        • Hong SJ
        • Nam CW
        • Kang DY
        • Lee SY
        • Chun WJ
        • Heo JH
        • Cho DK
        • Kim JW
        • Her SH
        • Kim SW
        • Yoo SY
        • Hong MK
        • Tahk SJ
        • Kim KS
        • Kim MH
        • Jang Y
        • Park SJ
        Bioresorbable vascular scaffold Korean expert panel report.
        Korean Circ J. 2017; 47: 795-810
        • Serruys PW
        • Chevalier B
        • Sotomi Y
        • Cequier A
        • Carrié D
        • Piek JJ
        • Van Boven AJ
        • Dominici M
        • Dudek D
        • McClean D
        • Helqvist S
        • Haude M
        • Reith S
        • de Sousa Almeida M
        • Campo G
        • Iñiguez A
        • Sabaté M
        • Windecker S
        • Onuma 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.
        Lancet. 2016; 388: 2479-2491
        • Wykrzykowska JJ
        • Kraak RP
        • Hofma SH
        • van der Schaaf RJ
        • Arkenbout EK
        • IJsselmuiden AJ
        • Elias J
        • van Dongen IM
        • Tijssen RYG
        • Koch KT
        • Baan Jr, J
        • Vis MM
        • de Winter RJ
        • Piek JJ
        • Tijssen JGP
        • Henriques JPS
        • AIDA Investigators
        Bioresorbable scaffolds versus metallic stents in routine PCI.
        N Engl J Med. 2017; 376: 2319-2328
        • Serruys PW
        • Chevalier B
        • Dudek D
        • Cequier A
        • Carrié D
        • Iniguez A
        • Dominici M
        • van der Schaaf RJ
        • Haude M
        • Wasungu L
        • Veldhof S
        • Peng L
        • Staehr P
        • Grundeken MJ
        • Ishibashi Y
        • Garcia-Garcia HM
        • Onuma Y
        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: 43-54
        • Serruys PW
        • Morice MC
        • Kappetein AP
        • Colombo A
        • Holmes DR
        • Mack MJ
        • Stahle E
        • Feldman TE
        • van den Brand M
        • Bass EJ
        • Van Dyck N
        • Leadley K
        • Dawkins KD
        • Mohr FW
        • SYNTAX Investigators
        Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease.
        N Engl J Med. 2009; 360: 961-972
        • Cutlip DE
        • Windecker S
        • Mehran R
        • Boam A
        • Cohen DJ
        • van Es GA
        • Steg PG
        • Morel MA
        • Mauri L
        • Vranckx P
        • McFadden E
        • Lansky A
        • Hamon M
        • Krucoff MW
        • Serruys PW
        • Academic Research Consortium
        Clinical end points in coronary stent trials: a case for standardized definitions.
        Circulation. 2007; 115: 2344-2351
        • Thygesen K
        • Alpert JS
        • Jaffe AS
        • Simoons ML
        • Chaitman BR
        • White HD
        • Katus HA
        • Lindahl B
        • Morrow DA
        • Clemmensen PM
        • Johanson P
        • Hod H
        • Underwood R
        • Bax JJ
        • Bonow RO
        • Pinto F
        • Gibbons RJ
        • Fox KA
        • Atar D
        • Newby LK
        • Galvani M
        • Hamm CW
        • Uretsky BF
        • Steg PG
        • Wijns W
        • Bassand JP
        • Menasché P
        • Ravkilde J
        • Ohman EM
        • Antman EM
        • Wallentin LC
        • Armstrong PW
        • Simoons ML
        • Januzzi JL
        • Nieminen MS
        • Gheorghiade M
        • Filippatos G
        • Luepker RV
        • Fortmann SP
        • Rosamond WD
        • Levy D
        • Wood D
        • Smith SC
        • Hu D
        • Lopez-Sendon JL
        • Robertson RM
        • Weaver D
        • Tendera M
        • Bove AA
        • Parkhomenko AN
        • Vasilieva EJ
        • Mendis S
        • Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction
        Third universal definition of myocardial infarction.
        Circulation. 2012; 126: 2020-2035
        • Hong SJ
        • Kim BK
        • Shin DH
        • Nam CM
        • Kim JS
        • Ko YG
        • Choi D
        • Kang TS
        • Kang WC
        • Her AY
        • Kim YH
        • Hur SH
        • Hong BK
        • Kwon H
        • Jang Y
        • Hong MK
        • IVUS-XPL investigators
        Effect of intravascular ultrasound-guided vs angiography-guided everolimus-eluting stent implantation: the IVUS-XPL randomized clinical trial.
        JAMA. 2015; 314: 2155-2163
        • Kim BK
        • Shin DH
        • Hong MK
        • Park HS
        • Rha SW
        • Mintz GS
        • Kim JS
        • Kim JS
        • Lee SJ
        • Kim HY
        • Hong BK
        • Kang WC
        • Choi JH
        • Jang Y
        • CTO-IVUS study investigators
        Clinical impact of intravascular ultrasound-guided chronic total occlusion intervention with zotarolimus-eluting versus biolimus-eluting stent implantation: a randomized study.
        Circ Cardiovasc Interv. 2015; 8e002592
        • Tanaka A
        • Latib A
        • Kawamoto H
        • Jabbour RJ
        • Sato K
        • Miyazaki T
        • Naganuma T
        • Mangieri A
        • Pagnesi M
        • Montalto C
        • Chieffo A
        • Carlino M
        • Montorfano M
        • Colombo A
        Clinical outcomes of a real-world cohort following bioresorbable vascular scaffold implantation utilising an optimised implantation strategy.
        EuroIntervention. 2017; 12: 1730-1737
        • Karanasos A
        • Van Mieghem N
        • van Ditzhuijzen N
        • Felix C
        • Daemen J
        • Autar A
        • Onuma Y
        • Kurata M
        • Diletti R
        • Valgimigli M
        • Kauer F
        • van Beusekom H
        • de Jaegere P
        • Zijlstra F
        • van Geuns RJ
        • Regar E
        Angiographic and optical coherence tomography insights into bioresorbable scaffold thrombosis: single-center experience.
        Circ Cardiovasc Interv. 2015; 8e002369
        • Puricel S
        • Cuculi F
        • Weissner M
        • Schmermund A
        • Jamshidi P
        • Nyffenegger T
        • Binder H
        • Eggebrecht H
        • Münzel T
        • Cook S
        • Gori T
        Bioresorbable coronary scaffold thrombosis: multicenter comprehensive analysis of clinical presentation, mechanisms, and predictors.
        J Am Coll Cardiol. 2016; 67: 921-931
        • Zou Y
        • Hu C
        • Ye W
        • Fan L
        • Xu L
        • Zhang A
        Long-term clinical efficacy and safety of adding cilostazol to dual antiplatelet therapy after drug-eluting stent implantation in coronary arteries: A meta-analysis of randomized controlled trials.
        Thromb Res. 2015; 136: 870-877
        • Lee SW
        • Park SW
        • Kim YH
        • Yun SC
        • Park DW
        • Lee CW
        • Kang SJ
        • Park SJ
        • Lee JH
        • Choi SW
        • Seong IW
        • Lee NH
        • Cho YH
        • Shin WY
        • Lee SJ
        • Lee SW
        • Hyon MS
        • Bang DW
        • Choi YJ
        • Kim HS
        • Lee BK
        • Lee K
        • Park HK
        • Park CB
        • Lee SG
        • Kim MK
        • Park KH
        • Park WJ
        • DECLARE-LONG II Study Investigators
        A randomized, double-blind, multicenter comparison study of triple antiplatelet therapy with dual antiplatelet therapy to reduce restenosis after drug-eluting stent implantation in long coronary lesions: results from the DECLARE-LONG II (Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients with Long Coronary Lesions) trial.
        J Am Coll Cardiol. 2011; 57: 1264-1270
        • Lee CH
        • Lee JY
        • Park GM
        • Lee SW
        • Kim HS
        • Choi YJ
        • Nam CW
        • Cho JH
        • Shin WY
        • Seo JB
        • Choi SW
        • Lee JH
        • Min PK
        • Her SH
        • Lee PH
        • Ahn JM
        • Park DW
        • Kang SJ
        • Kim YH
        • Lee CW
        • Park SW
        • Park SJ
        Comparison of 1-year outcomes of triple (Aspirin + Clopidogrel + Cilostazol) versus dual antiplatelet therapy (Aspirin + Clopidogrel + Placebo) after implantation of second-generation drug-eluting stents into one or more coronary arteries: from the DECREASE-PCI trial.
        Am J Cardiol. 2018; 121: 423-429
        • Lee SW
        • Park SW
        • Hong MK
        • Kim YH
        • Lee BK
        • Song JM
        • Han KH
        • Lee CW
        • Kang DH
        • Song JK
        • Kim JJ
        • Park SJ
        Triple versus dual antiplatelet therapy after coronary stenting: impact on stent thrombosis.
        J Am Coll Cardiol. 2005; 46: 1833-1837