The impact of the use of bioresorbable vascular scaffolds and drug-coated balloons in coronary bifurcation lesions
Tóm tắt
Despite the improvement in techniques and tools, coronary lesions involving a bifurcation are still challenging and the outcome with drug-eluting stents is not always optimal. The role of bioresorbable vascular scaffolds (BVS) and drug-coated balloons (DCB) in this setting has not been adequately investigated yet. From the databases of 6 italian centers with high proficiencies in newer technologies, we retrospectively collected all consecutive cases of coronary bifurcations managed or attempted with the implantation of at least one BVS in the main vessel and the use of one DCB in the side branch (SB). Primary study endpoint was the occurrence of major adverse cardiovascular events (MACE) at the longest available follow-up. Fourty patients fulfilled the enrollment criterion, 22.5% had diabetes and 50% an acute coronary syndrome. Average syntax score was 15.04 ± 7.18, all lesions were de novo, and 27 patients (67.5%) had a type 1,1,1 Medina lesion. Twenty-three lesions (57.5%) involved the proximal left anterior-descending artery/first diagonal branch. Only 32.5% of patients underwent an intravascular imaging-guided angioplasty. Average lesion length was 21.4 mm in the main vessel and 11.49 mm in the SB. MV was always predilated and BVS received a postdilation in 100% of the cases. In 42.5% of the cases, the DCB was used during final kissing balloon inflation, and in no cases, a stent/BVS was required in the SB. Procedural success was achieved in 100% of the cases. After an average follow-up of 15.5 (± 11.5) months, we observed no MACE with only one case of target vessel revasularization (2.5%). Management of coronary bifurcation lesions with the use of newer technologies including BVS and DCB seems feasible and effective at mid-term and long-term clinical follow-up.
Tài liệu tham khảo
Banning AP, Lassen JF, Burzotta F et al (2019) Percutaneous coronary intervention for obstructive bifurcation lesions: the 14th consensus document from the European Bifurcation Club. EuroIntervention 15:90–98. https://doi.org/10.4244/EIJ-D-19-00144
Belkacemi A, Agostoni P, Voskuil M, Stella PR (2011) Coronary bifurcation lesions treated with the drug-eluting balloon: a preliminary insight from the DEBIUT study. EuroIntervention 7 Suppl K:K66–9. https://doi.org/10.4244/EIJV7SKA12
Chevalier B, Onuma Y, van Boven A et al (2016) Randomised comparison of a bioresorbable everolimus-eluting scaffold with a metallic everolimus-eluting stent for ischaemic heart disease caused by de novo native coronary artery lesions: the 2-year clinical outcomes of the ABSORB II trial. EuroIntervention 12:1102–1107. https://doi.org/10.4244/EIJY16M08_01
Colombo A, Moses JW, Morice MC et al (2004) Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions. Circulation 109:1244–1249. https://doi.org/10.1161/01.CIR.0000118474.71662.E3
Cortese B, Silva Orrego P, Agostoni P et al (2015) Effect of drug-coated balloons in native coronary artery disease left with a dissection. JACC: Cardiovascular Interventions 8:2003–2009. https://doi.org/10.1016/j.jcin.2015.08.029
Diletti R, Serruys PW, Farooq V et al (2012) ABSORB II randomized controlled trial: a clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: rationale and study design. Am Heart J 164:654–663
Elwany M, Latini RA, Di Palma G et al (2017) First experience of drug-coated balloons for treatment of bioresorbable vascular scaffold restenosis. Cardiovasc Revasc Med. https://doi.org/10.1016/j.carrev.2017.03.020
Kraak RP, Tijssen RYG, van Dongen IM et al (2019) Bioresorbable vascular scaffold versus Xience metallic stents: outcomes in the AIDA trial stratified by SYNTAX score. EuroIntervention. https://doi.org/10.4244/EIJ-D-18-00884
Latini RA, Buccheri D, Cortese B (2017) First reported use of drug-coated balloon for bioresorbable in-scaffold restenosis. Cathet Cardiovasc Interventions 89:676–678. https://doi.org/10.1002/ccd.26803
Loh JP, Waksman R (2012) Paclitaxel drug-coated balloons: a review of current status and emerging applications in native coronary artery de novo lesions. JACC: Cardiovasc Interv 5:1001–1012. https://doi.org/10.1016/j.jcin.2012.08.005
Longo G, Granata F, Capodanno D et al (2015) Anatomical features and management of bioresorbable vascular scaffolds failure: a case series from the GHOST registry. Catheterization and Cardiovascular Interventions 85:1150–1161. https://doi.org/10.1002/ccd.25819
Medina A, Suárez de Lezo J, Pan M (2006) A new classification of coronary bifurcation lesions. Rev Esp Cardiol 59:183
Onuma Y, Serruys PW (2011) Bioresorbable scaffold. Circulation 123:779–797. https://doi.org/10.1161/CIRCULATIONAHA.110.971606
Otsuka F, Pacheco E, Perkins LEL et al (2014) 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 Interv 7:330–342. https://doi.org/10.1161/CIRCINTERVENTIONS.113.000990
Sanchez OD, Yahagi K, Byrne RA et al (2015) Pathological aspects of bioresorbable stent implantation. EuroIntervention 11 Suppl V:V159–65. https://doi.org/10.4244/EIJV11SVA39
Serruys PW, Chevalier B, Dudek D et al (2015) 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 385:43–54. https://doi.org/10.1016/S0140-6736(14)61455-0
Serruys PW, Onuma Y, Garcia-Garcia HM et al (2014) Dynamics of vessel wall changes following the implantation of the absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months. EuroIntervention 9:1271–1284. https://doi.org/10.4244/EIJV9I11A217
Steinvil A, Rogers T, Torguson R, Waksman R (2016) Overview of the 2016 U.S. Food and Drug Administration Circulatory System Devices Advisory Panel Meeting on the Absorb Bioresorbable Vascular Scaffold System. JACC: Cardiovascular Interventions 9:1757–1764. https://doi.org/10.1016/j.jcin.2016.06.027
Stone GW, Kimura T, Gao R et al (2019) Time-varying outcomes with the absorb bioresorbable vascular scaffold during 5-year follow-up: a systematic meta-analysis and individual patient data pooled study. JAMA Cardiol. https://doi.org/10.1001/jamacardio.2019.4101
Wykrzykowska JJ, Kraak RP, Hofma SH, et al (2017) Bioresorbable scaffolds versus metallic stents in routine PCI. http://dxdoiorg/101056/NEJMoa1614954 NEJMoa1614954. doi: https://doi.org/10.1056/NEJMoa1614954