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).

Abstract

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 33.2±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.

• Authors: Joanna J Wykrzykowska, Roberto Diletti, Juan Luis Gutierrez-Chico, Robert Jan van Geuns, Wim J van der Giessen, Steven Ramcharitar, H Eric Duckers, Carl Schultz, Pim de Feyter, Martin van der Ent, Evelyn Regar, Peter de Jaegere, Hector M Garcia-Garcia, Rawindra Pawar, Nieves Gonzalo, Jurgen Ligthart, Jean de Schepper, Nico van den Berg, Krzysztof Milewski, Juan F Granada, Patrick W Serruys
• Journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology (EuroIntervention) Vol. 8 Issue 8 Pg. 945-54 (Dec 20 2012) ISSN: 1969-6213 [Electronic] France
• PMID: 22669133 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Alloys
• nitinol

Topics

• Aged
• Aged, 80 and over
• Alloys (therapeutic use)
• Coronary Angiography
• Coronary Artery Disease (diagnostic imaging, pathology, therapy)
• Coronary Stenosis (diagnostic imaging, pathology, therapy)
• Feasibility Studies
• Female
• Fractional Flow Reserve, Myocardial
• Humans
• Longitudinal Studies
• Male
• Middle Aged
• Percutaneous Coronary Intervention (instrumentation)
• Pilot Projects
• Plaque, Atherosclerotic (diagnostic imaging, pathology, therapy)
• Stents
• Tomography, Optical Coherence
• Ultrasonography, Interventional