A comparative assessment by optical coherence tomography of the performance of the first and second generation of the everolimus-eluting bioresorbable vascular scaffolds

被引:45
作者
Gomez-Lara, Josep [1 ]
Brugaletta, Salvatore [1 ]
Diletti, Roberto [1 ]
Garg, Scot [1 ]
Onuma, Yoshinobu [1 ]
Gogas, Bill D. [1 ]
van Geuns, Robert Jan [1 ]
Dorange, Cecile [4 ]
Veldhof, Susan [4 ]
Rapoza, Richard [4 ]
Whitbourn, Robert [3 ]
Windecker, Stephan [2 ]
Garcia-Garcia, Hector M. [1 ]
Regar, Evelyn [1 ]
Serruys, Patrick W. [1 ]
机构
[1] Erasmus MC, Thoraxctr, Dept Internal Cardiol, NL-3015 CE Rotterdam, Netherlands
[2] Swiss Cardiovasc Ctr, Bern, Switzerland
[3] St Vincents Hosp, Melbourne, Vic, Australia
[4] Abbott Vasc, Diegem, Belgium
关键词
Bioresorbable vascular scaffold; Shrinkage; Optical coherence tomography; Bioresorption;
D O I
10.1093/eurheartj/ehq458
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Aims The first generation of the everolimus-eluting bioresorbable vascular scaffold (BVS 1.0) showed an angiographic late loss higher than the metallic everolimus-eluting stent Xience V due to scaffold shrinkage. The new generation (BVS 1.1) presents a different design and manufacturing process than the BVS 1.0. This study sought to evaluate the differences in late shrinkage, neointimal response, and bioresorption process between these two scaffold generations using optical coherence tomography (OCT). Methods and results A total of 12 lesions treated with the BVS 1.0 and 12 selected lesions treated with the revised BVS 1.1 were imaged at baseline and 6-month follow-up with OCT. Late shrinkage and neointimal area (NIA) were derived from OCT area measurements. Neointimal thickness was measured in each strut. Strut appearance has been classified as previously described. Baseline clinical, angiographic, and OCT characteristics were mainly similar in the two groups. At 6 months, absolute and relative shrinkages were significantly larger for the BVS 1.0 than for the BVS 1.1 (0.98 vs. 0.07 mm(2) and 13.0 vs. 1.0%, respectively; P = 0.01). Neointimal area was significantly higher in the BVS 1.0 than in the BVS 1.1 (in-scaffold area obstruction of 23.6 vs. 12.3%; P < 0.01). Neointimal thickness was also larger in the BVS 1.0 than in the BVS 1.1 (166.0 vs. 76.4 mu m; P < 0.01). Consequently, OCT, intravascular ultrasound, and angiographic luminal losses were higher with the BVS 1.0 than with the BVS 1.1. At 6 months, strut appearance was preserved in only 2.9% of the BVS 1.0 struts, but remained unchanged with the BVS 1.1 indicating different state of strut microstucture and/or their reflectivity. Conclusion The BVS 1.1 has less late shrinkage and less neointimal growth at 6-month follow-up compared with the BVS 1.0. A difference in polymer degradation leading to changes in microstructure and reflectivity is the most plausible explanation for this finding.
引用
收藏
页码:294 / 304
页数:11
相关论文
共 28 条
[1]  
Ormiston J.A., Serruys P.W., Regar E., Dudek D., Thuesen L., Webster M.W., Onuma Y., Garcia-Garcia H.M., McGreevy R., Veldhof S., A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): A prospective open-label trial, The Lancet, 371, 9616, pp. 899-907, (2008)
[2]  
Painter J.A., Mintz G.S., Wong S.C., Popma J.J., Pichard A.D., Kent K.M., Satler L.F., Leon M.B., Serial intravascular ultrasound studies fail to show evidence of chronic Palmaz-Schatz stent recoil, Am J Cardiol, 75, pp. 398-400, (1995)
[3]  
Okamura T., Garg S., Gutierrez-Chico J.L., Shin E.S., Onuma Y., Garcia-Garcia H.M., Rapoza R., Sudhir K., Regar E., Serruys P.W., In vivo evalution of stent strut distribution patterns in the bioabsorbable everolimus-eluting device: An OCT ad hoc analysis of the revision 1.0 and revision 1.1 stent design in the ABSORB clinical trial, EuroIntervention, 5, pp. 932-938, (2010)
[4]  
Serruys P.W., Ormiston J.A., Onuma Y., Regar E., Gonzalo N., Garcia-Garcia H.M., Nieman K., Bruining N., Dorange C., Miquel-Hebert K., Veldhof S., Webster M., Thuesen L., Dudek D., A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods, Lancet, 373, pp. 897-910, (2009)
[5]  
Kawase Y., Hoshino K., Yoneyama R., McGregor J., Hajjar R.J., Jang I.-K., Hayase M., In vivo volumetric analysis of coronary stent using optical coherence tomography with a novel balloon occlusion-flushing catheter: A comparison with intravascular ultrasound, Ultrasound in Medicine and Biology, 31, 10, pp. 1343-1349, (2005)
[6]  
Suzuki Y., Ikeno F., Koizumi T., Tio F., Yeung A.C., Yock P.G., Fitzgerald P.J., Fearon W.F., In vivo comparison between optical coherence tomography and intravascular ultrasound for detecting small degrees of in-stent neointima after stent implantation, JACC: Cardiovascular Interventions, 1, 2, pp. 168-173, (2008)
[7]  
Onuma Y., Serruys P.W., Ormiston J.A., Regar E., Webster M., Thuesen L., Dudek D., Veldhof S., Rapoza R., Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: The ABSORB trial, EuroInterv, 6, pp. 447-453, (2010)
[8]  
Reiber J.H.C., Serruys P.W., Kooijman C.J., Assessment of short-, medium-, and long-term variations in arterial dimensions from computer-assisted quantitation of coronary cineangiograms, Circulation, 71, 2, pp. 280-288, (1985)
[9]  
Takarada S., Imanishi T., Liu Y., Ikejima H., Tsujioka H., Kuroi A., Ishibashi K., Komukai K., Tanimoto T., Ino Y., Kitabata H., Kubo T., Nakamura N., Hirata K., Tanaka A., Mizukoshi M., Akasaka T., Advantage of next-generation frequency-domain optical coherence tomography compared with conventional time-domain system in the assessment of coronary lesion, Catheter Cardiovasc Interv, 75, pp. 202-206, (2009)
[10]  
Tanimoto S., Serruys P.W., Thuesen L., Dudek D., De Bruyne B., Chevalier B., Ormiston J.A., Comparison of in vivo acute stent recoil between the bioabsorbable everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: Insights from the ABSORB and SPIRIT trials, Catheterization and Cardiovascular Interventions, 70, 4, pp. 515-523, (2007)