Optical Coherence Tomography Analysis of the Stenting of Saphenous Vein Graft (SOS) Xience V Study: Use of the Everolimus-Eluting Stent in Saphenous Vein Graft Lesions

Volume 24 - Issue 8 - August 2012
Posted on: 7/27/12
0 Comments
4299 reads

Author(s):

Aristotelis C. Papayannis, MD^1,2, Tesfaldet T. Michael, MD, MPH^1,2, Dinara Yangirova, MD², Abdul-rahman Abdel-karim, MD^1,2, Julia Kohlhaas, MD², Arif Mahmood, MD^1,2, Tayo Addo, MD², Donald Haagen, MD¹, Lorenza Makke, MD¹, Michele Roesle, MD¹, Bavana Rangan, MD¹, Subhash Banerjee, MD^1,2, Emmanouil S. Brilakis, MD, PhD^1,2

Abstract: Objectives. The Stenting of Saphenous Grafts-Xience V (SOS-Xience V) trial prospectively examined the frequency of angiographic in-stent restenosis in saphenous vein graft (SVG) lesions 12 months after implantation of a Xience V everolimus-eluting stent (EES; Abbott Vascular). Optical coherence tomography (OCT) during follow-up angiography was added to the protocol after OCT was approved for clinical use in the United States. Methods. Forty patients with 40 SVG lesions were enrolled in the study, of whom 27 underwent 12-month coronary angiography and 12 (only 1 of whom had in-stent restenosis) also had follow-up OCT evaluation. OCT strut-level analysis was performed to determine the percentage of strut coverage, malapposition, strut protrusion, neointimal thickness, and the existence of thrombus. Results. Mean patient age was 67 ± 7 years, and 95% were men. A total of 2584 struts were evaluated by OCT. The percentages for uncovered, malapposed, and protruding struts were 4%, 9%, and 15%, respectively. The mean strut neointimal thickness was 0.094 ± 0.094 mm. Of the 12 stents analyzed, 4 (33%) showed full neointimal coverage, 2 (17%) had all the struts embedded, 7 (58%) had at least 1 malapposed strut, and 10 (83%) had at least 1 protruding strut. The mean difference between the stent area and the lumen area was 0.36 ± 1.6 mm^². No thrombus was detected in the stented areas. Conclusions. Use of EES in SVGs is associated with high rates of stent strut coverage and high malapposition rates at 12 months post implantation.

J INVASIVE CARDIOL 2012;24(8):390-394

Key words: saphenous vein grafts, drug-eluting stents, percutaneous coronary intervention, coronary artery bypass graft surgery, optical coherence tomography

_______________________________________________

Although two^1-3 of the three published randomized-controlled trials of drug-eluting stents (DES) in saphenous vein grafts (SVGs) showed improved outcomes with DES implantation, concerns remain about the safety of DES in this setting, given the higher all-cause mortality observed with DES in the Reduction of Restenosis In Saphenous vein grafts with Cypher sirolimus-eluting stent (RRISC) trial.⁴ With a resolution of 15-20 µm, optical coherence tomography (OCT) may allow assessment of the risk of stent thrombosis by accurate evaluation of stent strut coverage and malapposition.⁵

The Stenting Of Saphenous Vein Grafts Xience V (SOS-Xience V) study (NCT00911976) was the first prospective study of a second-generation DES in de novo SVG lesions and showed 22% 12-month binary angiographic restenosis in patients receiving the Xience V everolimus-eluting stent (EES; Abbott Vascular) in SVG lesions.⁶ After approval of OCT imaging in the US, the SOS Xience V protocol was modified to incorporate OCT follow-up evaluation to determine the frequency of stent strut coverage and malapposition and evaluate neointimal thickness.