TY - JOUR
T1 - Plaque sealing and passivation with a mechanical self-expanding low outward force nitinol vShield device for the treatment of IVUS and OCT-derived thin cap fibroatheromas (TCFAs) in native coronary arteries: report of the pilot study vShield Evaluated at Cardiac hospital in Rotterdam for Investigation and Treatment of TCFA (SECRITT)
AU - Wykrzykowska, Joanna J.
AU - Diletti, Roberto
AU - Gutierrez-Chico, Juan Luis
AU - van Geuns, Robert Jan
AU - van der Giessen, Wim J.
AU - Ramcharitar, Steven
AU - Duckers, H. Eric
AU - Schultz, Carl
AU - de Feyter, Pim
AU - van der Ent, Martin
AU - Regar, Evelyn
AU - de Jaegere, Peter
AU - Garcia-Garcia, Hector M.
AU - Pawar, Rawindra
AU - Gonzalo, Nieves
AU - Ligthart, Jurgen
AU - de Schepper, Jean
AU - van den Berg, Nico
AU - Milewski, Krzysztof
AU - Granada, Juan F.
AU - Serruys, Patrick W.
PY - 2012
Y1 - 2012
N2 - Aims: The aim of the pilot SECRITT trial was to evaluate the safety and feasibility of sealing the high risk IVUS and optical coherence tomography-derived thin cap fibroatheroma (TCFA), with a dedicated nitinol self-expanding vShield device. Methods and results: After screening with angiography, fractional flow reserve (FFR), intravascular ultrasound virtual histology (IVUS-VH) and optical coherence tomography (OCT), 23 patients met enrolment criteria (presence of non-obstructive VH-derived TCFA lesion with thin cap on OCT) and were randomised to vShield (n=13) versus medical therapy (n=10). In the shielded group, baseline percent diameter stenosis was 33.1+/-13.5%, FFR was 0.93+/-0.06. At six-month follow-up in shielded patients percent diameter stenosis further decreased to 18.7+/-16.9% and FFR remained the same 0.93+/-0.05. Average late loss was 0.24+/-0.13 mm Average baseline fibrous cap thickness was 48+/-12 mu m. After shield placement at six-month follow-up neo-cap formation was observed with average cap thickness of 201+/-168 mu M. There were no dissections after shield placement and no plaque ruptures. In addition, mean stent area of 8.76+/-2.16 mm(2) increased to 9.45+/-2.30 mm(2), that is by 9% at six-month follow-up. The number of malapposed struts decreased from 10.7% to 7.6% and the number of uncovered struts at six months was 8.1%. There were no device-related major adverse cardiovascular events (MACE) events at six-month follow-up. Conclusions: High risk plaque passivation and sealing with a vShield self-expanding nitinol device appears feasible and safe. A long-term larger randomised study with streamlined screening criteria is needed to evaluate the efficacy of this approach over medical therapy
AB - Aims: The aim of the pilot SECRITT trial was to evaluate the safety and feasibility of sealing the high risk IVUS and optical coherence tomography-derived thin cap fibroatheroma (TCFA), with a dedicated nitinol self-expanding vShield device. Methods and results: After screening with angiography, fractional flow reserve (FFR), intravascular ultrasound virtual histology (IVUS-VH) and optical coherence tomography (OCT), 23 patients met enrolment criteria (presence of non-obstructive VH-derived TCFA lesion with thin cap on OCT) and were randomised to vShield (n=13) versus medical therapy (n=10). In the shielded group, baseline percent diameter stenosis was 33.1+/-13.5%, FFR was 0.93+/-0.06. At six-month follow-up in shielded patients percent diameter stenosis further decreased to 18.7+/-16.9% and FFR remained the same 0.93+/-0.05. Average late loss was 0.24+/-0.13 mm Average baseline fibrous cap thickness was 48+/-12 mu m. After shield placement at six-month follow-up neo-cap formation was observed with average cap thickness of 201+/-168 mu M. There were no dissections after shield placement and no plaque ruptures. In addition, mean stent area of 8.76+/-2.16 mm(2) increased to 9.45+/-2.30 mm(2), that is by 9% at six-month follow-up. The number of malapposed struts decreased from 10.7% to 7.6% and the number of uncovered struts at six months was 8.1%. There were no device-related major adverse cardiovascular events (MACE) events at six-month follow-up. Conclusions: High risk plaque passivation and sealing with a vShield self-expanding nitinol device appears feasible and safe. A long-term larger randomised study with streamlined screening criteria is needed to evaluate the efficacy of this approach over medical therapy
U2 - https://doi.org/10.4244/EIJV8I8A144
DO - https://doi.org/10.4244/EIJV8I8A144
M3 - Article
C2 - 22669133
SN - 1774-024X
VL - 8
SP - 945
EP - 954
JO - Eurointervention
JF - Eurointervention
IS - 8
ER -