Three- and 6-month optical coherence tomographic surveillance following percutaneous coronary intervention with the Angiolite (R) drug-eluting stent: The ANCHOR study
Por:
Puri, R, Otaegui, I, Sabate, M, Serra-Penaranda, A, Puigfel, M, de Prado, AP, Nombela-Franco, L, Hernandez, JMD, Nadal, RO, Iniguez-Romo, A, Jimenez, G, Fernandez-Vazquez, F, Cuellas-Ramon, C, Gonzalo, N, Diaz, VAJ, Duocastella, L, Molina, M, Amoros, M, Perez, I, Perez, AB, Beaumont, EP, Nicholls, SJ, del Blanco, BG, Rodes-Cabau, J
Publicada:
15 feb 2018
Resumen:
BackgroundPre-clinical results of a novel open-cell, thin strut, durable polymer, laser cut cobalt chromium sirolimus-eluting stent (Angiolite) were promising. Using quantitative optical coherence tomographic (OCT) analyses, we explored the healing characteristics of the Angiolite DES system at 3- and 6-months post implantation.
MethodsA total of 103 patients with de novo coronary lesions underwent percutaneous coronary intervention with the Angiolite DES and were randomized 1:3 into two cohorts for angiographic and OCT follow-up, with 28 and 70 patients returning for 3- or 6-month post-PCI surveillance, respectively. The primary endpoints were the 6-month rates of OCT-derived neointimal proliferation, strut coverage and incomplete strut apposition (ISA), whilst the secondary endpoints were 3-month OCT-derived measures of strut coverage and ISA, as well as 6-month quantitative coronary angiographic-derived measures [late lumen loss (LLL), binary restenosis].
ResultsThe Angiolite stent was successfully implanted in all patients, without periprocedural complications. At 3- and 6-months follow-up, OCT strut coverage was evident in 86.3% and 83.3% of struts, mean neointimal thickness was 73.746.5 m and 73.9 +/- 54.3 m, mean neo-intimal area obstruction of 5.8% +/- 10.3% and 4.4%+/- 11.3%, and ISA rates were 1.3%+/- 7.3% and 1.1%+/- 6.2%, respectively. In-stent LLL at 6 months was 0.07 +/- 0.37 mm, with a binary in-stent angiographic restenosis rate of 0% without any stent thrombosis, myocardial infarction or cardiovascular death, with 1 patient undergoing ischemia-driven target-lesion revascularization.
ConclusionsAt 6 months, the Angiolite DES was safe with high rates of strut coverage, modest degrees of neointimal hyperplasia and very low rates of strut malapposition. These data coupled with the absence of in-stent binary restenosis and a very low 6-month in-stent LLL point towards an efficacious DES. Future studies are required to evaluate its efficacy in broader lesion subsets with longer follow-up.
Filiaciones:
Puri, R:
Laval Univ, Quebec Heart & Lung Inst, Dept Cardiol, Quebec City, PQ, Canada
Cleveland Clin, Coordinating Ctr Clin Res C5R, Cleveland, OH 44106 USA
Univ Adelaide, Dept Med, Adelaide, SA, Australia
Otaegui, I:
Hosp Univ Vall dHebron, Barcelona, Spain
Sabate, M:
Hosp Clin Barcelona, Barcelona, Spain
Serra-Penaranda, A:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Puigfel, M:
Hosp Univ Girona Dr Josep Trueta, Girona, Spain
de Prado, AP:
Hosp Univ Leon, Leon, Spain
Nombela-Franco, L:
Hosp Clin San Carlos, Madrid, Spain
Hernandez, JMD:
Hosp Univ Marques de Valdecilla, Santander, Spain
Nadal, RO:
Hosp Univ Miguel Servet, Zaragoza, Spain
Iniguez-Romo, A:
Hosp Alvaro Cunqueiro, Vigo, Spain
Jimenez, G:
Hosp Clin Barcelona, Barcelona, Spain
Fernandez-Vazquez, F:
Hosp Univ Leon, Leon, Spain
Cuellas-Ramon, C:
Hosp Univ Leon, Leon, Spain
Gonzalo, N:
Hosp Clin San Carlos, Madrid, Spain
Diaz, VAJ:
Hosp Alvaro Cunqueiro, Vigo, Spain
Duocastella, L:
iVascular, Barcelona, Spain
Molina, M:
iVascular, Barcelona, Spain
Amoros, M:
iVascular, Barcelona, Spain
Perez, I:
iVascular, Barcelona, Spain
Perez, AB:
Laval Univ, Quebec Heart & Lung Inst, Dept Cardiol, Quebec City, PQ, Canada
Beaumont, EP:
Laval Univ, Quebec Heart & Lung Inst, Dept Cardiol, Quebec City, PQ, Canada
Nicholls, SJ:
Univ Adelaide, SAHMRI, Adelaide, SA, Australia
del Blanco, BG:
Hosp Univ Vall dHebron, Barcelona, Spain
Rodes-Cabau, J:
Laval Univ, Quebec Heart & Lung Inst, Dept Cardiol, Quebec City, PQ, Canada
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