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).
OBJECTIVE
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.


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 33.2±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 µm. After shield placement at six-month follow-up neo-cap formation was observed with average cap thickness of 201±168 µm. There were no dissections after shield placement and no plaque ruptures. In addition, mean stent area of 8.76±2.16 mm2 increased to 9.45±2.30 mm2, 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.
Department of Interventional Cardiology, Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
Joanna J
JJ
Wykrzykowska
Roberto
R
Diletti
Juan Luis
JL
Gutierrez-Chico
Robert Jan
RJ
van Geuns
Wim J
WJ
van der Giessen
Steven
S
Ramcharitar
H Eric
HE
Duckers
Carl
C
Schultz
Pim
P
de Feyter
Martin
M
van der Ent
Evelyn
E
Regar
Peter
P
de Jaegere
Hector M
HM
Garcia-Garcia
Rawindra
R
Pawar
Nieves
N
Gonzalo
Jurgen
J
Ligthart
Jean
J
de Schepper
Nico
N
van den Berg
Krzysztof
K
Milewski
Juan F
JF
Granada
Patrick W
PW
Serruys
D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys / Q000627:therapeutic use*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D053805:Fractional Flow Reserve, Myocardial; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation*; D010865:Pilot Projects; D058226:Plaque, Atherosclerotic / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D015607:Stents; D041623:Tomography, Optical Coherence; D018084:Ultrasonography, Interventional
D000497:Alloys; C013616:nitinol