Everolimus-Eluting Bioresorbable Vascular Scaffold in Real World Practice - A Single Center Experience

Overview

Journal Acta Cardiol Sin

Date 2017 Jun 1

PMID 28559655

Citations 3

Authors

Huai-Wen Liang

Hsien-Li Kao

Yen-Hung Lin

Juey-Jen Hwang

Mao-Shin Lin

Fu-Tien Chiang

Chii-Ming Lee

Chih-Fan Yeh

Tzung-Dau Wang

Cho-Kai Wu

Lian-Yu Lin

Chia-Ti Tsai

Ying-Hsien Chen

Affiliations

Soon will be listed here.

Abstract

Background: Drug-eluting stents are widely used in coronary artery intervention. However, vessel caging and very late thrombotic events are of persistent and substantial concern. Bioresorbable vascular scaffolds (BVS) were developed to deliver vascular reparative therapy, by eliminating permanent mechanical restraint. However, data regarding its clinical performance is lacking.

Methods: After the BVS implantation procedure received national approval in May 2014, patients receiving BVS implantation until November 2014 in National Taiwan University Hospital (NTUH) were enrolled. Clinical variables, angiographic data, procedural details, and follow-up information were collected and compared with those receiving BVS at NTUH as part of the global ABSORB EXTEND trial.

Results: A total of 35 patients (38 target vessels) with 48 BVS implanted after approval were enrolled, as the "real-world practice" group. Data of the 34 patients (34 target vessels) with 37 BVS implanted in the ABSORB EXTEND trial were also obtained. Differences in lesion complexity (0% type B2/C lesion in ABSORB EXTEND, versus 23.7% in real-world, p = 0.007) and lesion length (20.9 ± 6.1 mm in ABSORB EXTEND, versus 29.5 ± 15.9 mm in real-world, p = 0.008) were noted. The ischemia-driven target vessel revascularization after an average of 732 days follow-up was 11.8% in the ABSORB EXTEND trial. However, there was no ischemia-driven target lesion revascularization (TLR), no scaffold thrombosis, no myocardial infarction (MI), and no patients passed during the follow-up period. In real-world patients, there is 5.3% of MI, 2.6% ischemia-driven TLR, and 2.6% of non-fatal probable scaffold thrombosis.

Conclusions: The use of BVS in real-world practice is feasible, with clinical outcomes comparable to those in the ABSORB EXTEND trial.

Citing Articles

Percutaneous Coronary Intervention for Tortuous Left Anterior Descending Artery with Bioresorbable Vascular Scaffold via the Transradial Approach.

Lee W, Fang H, Wu C Acta Cardiol Sin. 2018; 34(6):530-532.

PMID: 30449995 PMC: 6236573. DOI: 10.6515/ACS.201811_34(6).20180818B.

Anti-Inflammatory Effect of Gallic Acid-Eluting Stent in a Porcine Coronary Restenosis Model.

Lim K, Park J, Jeong M, Bae I, Park D, Shim J Acta Cardiol Sin. 2018; 34(3):224-232.

PMID: 29844643 PMC: 5968338. DOI: 10.6515/ACS.201805_34(3).20171204A.

Thirty-Day and One-Year Clinical Outcomes of Bioresorbable Vascular Scaffold Implantation: A Single-Center Experience.

Lee W, Wu C, Chen C, Yang C, Hsueh S, Yip H Acta Cardiol Sin. 2017; 33(6):614-623.

PMID: 29167614 PMC: 5694925. DOI: 10.6515/ACS20170714A.

References

Kastrati A, Mehilli J, Pache J, Kaiser C, Valgimigli M, Kelbaek H . Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med. 2007; 356(10):1030-9. DOI: 10.1056/NEJMoa067484. View

Thygesen K, Alpert J, White H, Jaffe A, Katus H, Apple F . Third universal definition of myocardial infarction. J Am Coll Cardiol. 2012; 60(16):1581-98. DOI: 10.1016/j.jacc.2012.08.001. View

Di Mario C, Werner G, Sianos G, Galassi A, Buttner J, Dudek D . European perspective in the recanalisation of Chronic Total Occlusions (CTO): consensus document from the EuroCTO Club. EuroIntervention. 2009; 3(1):30-43. View

Wohrle J, Naber C, Schmitz T, Schwencke C, Frey N, Butter C . Beyond the early stages: insights from the ASSURE registry on bioresorbable vascular scaffolds. EuroIntervention. 2014; 11(2):149-56. DOI: 10.4244/EIJY14M12_10. View

Dudek D, Onuma Y, Ormiston J, Thuesen L, Miquel-Hebert K, Serruys P . Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2011; 7(9):1060-1. DOI: 10.4244/EIJV7I9A168. View

Lai C, Lee W, Sung S, Hsu P, Chen Y, Chan W . Comparison of Bare-Metal Stent and Drug-Eluting Stent for the Treatment of Patients Undergoing Percutaneous Coronary Intervention for Unprotected Left Main Coronary Artery Disease - Long-Term Result from a Single Center Experience. Acta Cardiol Sin. 2016; 31(5):381-9. PMC: 4804801. DOI: 10.6515/acs20140630g. View

Abizaid A, Costa Jr J, Bartorelli A, Whitbourn R, van Geuns R, Chevalier B . The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled. EuroIntervention. 2014; 10(12):1396-401. DOI: 10.4244/EIJV10I12A243. View

Karanasos A, van Mieghem N, van Ditzhuijzen N, Felix C, Daemen J, Autar A . Angiographic and optical coherence tomography insights into bioresorbable scaffold thrombosis: single-center experience. Circ Cardiovasc Interv. 2015; 8(5). PMC: 4482452. DOI: 10.1161/CIRCINTERVENTIONS.114.002369. View

Fischman D, Leon M, Baim D, Schatz R, Savage M, Penn I . A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994; 331(8):496-501. DOI: 10.1056/NEJM199408253310802. View

10.

Serruys P, Ormiston J, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia H . A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009; 373(9667):897-910. DOI: 10.1016/S0140-6736(09)60325-1. View

11.

Kraak R, Hassell M, Grundeken M, Koch K, Henriques J, Piek J . 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. 2014; 10(10):1160-8. DOI: 10.4244/EIJY14M08_08. View

12.

Brugaletta S, Heo J, Garcia-Garcia H, Farooq V, van Geuns R, De Bruyne B . Endothelial-dependent vasomotion in a coronary segment treated by ABSORB everolimus-eluting bioresorbable vascular scaffold system is related to plaque composition at the time of bioresorption of the polymer: indirect finding of vascular reparative.... Eur Heart J. 2012; 33(11):1325-33. DOI: 10.1093/eurheartj/ehr466. View

13.

Serruys P, Chevalier B, Dudek D, Cequier A, Carrie D, Iniguez A . 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.... Lancet. 2014; 385(9962):43-54. DOI: 10.1016/S0140-6736(14)61455-0. View

14.

Ishibashi Y, Onuma Y, Muramatsu T, Nakatani S, Iqbal J, Garcia-Garcia H . Lessons learned from acute and late scaffold failures in the ABSORB EXTEND trial. EuroIntervention. 2014; 10(4):449-57. DOI: 10.4244/EIJV10I4A78. View

15.

Moses J, Leon M, Popma J, Fitzgerald P, Holmes D, OShaughnessy C . Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003; 349(14):1315-23. DOI: 10.1056/NEJMoa035071. View

16.

Serruys P, Onuma Y, Dudek D, Smits P, Koolen J, Chevalier B . 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(15):1578-88. DOI: 10.1016/j.jacc.2011.05.050. View

17.

Onuma Y, Serruys P, Ormiston J, Regar E, Webster M, Thuesen L . Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2010; 6(4):447-53. DOI: 10.4244/EIJ30V6I4A76. View

18.

ELLIS S, Vandormael M, Cowley M, Disciascio G, Deligonul U, Topol E . Coronary morphologic and clinical determinants of procedural outcome with angioplasty for multivessel coronary disease. Implications for patient selection. Multivessel Angioplasty Prognosis Study Group. Circulation. 1990; 82(4):1193-202. DOI: 10.1161/01.cir.82.4.1193. View

19.

Serruys P, Onuma Y, Garcia-Garcia H, Muramatsu T, van Geuns R, De Bruyne B . 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. 2013; 9(11):1271-84. DOI: 10.4244/EIJV9I11A217. View

20.

Lane J, Perkins L, Sheehy A, Pacheco E, Frie M, Lambert B . Lumen gain and restoration of pulsatility after implantation of a bioresorbable vascular scaffold in porcine coronary arteries. JACC Cardiovasc Interv. 2014; 7(6):688-95. DOI: 10.1016/j.jcin.2013.11.024. View