Author + information
- Yuichi Ozaki1,
- Hector M. Garcia-Garcia1,
- Alexandre Hideo Kajita1,
- Kayode O. Kuku1,
- Michael Haude2,
- Hüseyin Ince3,
- Alexandre Abizaid4,
- Ralph Tölg5,
- Pedro Alves Lemos6,
- Clemens von Birgelen7,
- Evald Høj Christiansen8,
- William Wijns9,
- Javier Escaned10,
- Jouke Dijkstra11 and
- Ron Waksman1
- 1MedStar Washington Hospital Center, Washington, DC
- 2Lukaskrankenhaus GmbH, Neuss, Germany
- 3Vivantes Klinikum im Friedrichschain and Am Urban, Berlin, Germany
- 4Instituto de Cardiologia Dante Pazzanese, Sao Paulo, Brazil
- 5Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany
- 6University of Sao Paulo, São Paulo, Brazil
- 7Thoraxcentrum Twente, Enschede, Netherlands
- 8Aarhus University Hospital, Aarhus, Denmark
- 9Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium
- 10Hospital Clinico San Carlos, Madrid, Spain
- 11Leiden University, Leiden, Netherlands
Second-generation drug-eluting absorbable metal scaffold (Magmaris) is an alternative novel device for treating coronary lesions. However, the relationship between in-scaffold geometry after implantation of Magmaris and late lumen loss (LLL) is unknown. The aim of this study is, therefore, to investigate the effect of implantation technique, using optical coherence tomography (OCT), on Magmaris and LLL.
The present study population comprises of a total 67 patients with 67 lesions who were enrolled in the prospective, multicenter BIOSOLVE-II trial between October 2013 and May 2015. We assessed apposition, dissection, intraluminal mass, side branch relationship, and expansion of Magmaris after implantation evaluating frame by frame using OCT. % device expansion was defined as a ratio of mean device area to mean reference lumen area at post procedure and expansion group was defined as either patients who have in-scaffold MLA > 90% of the average reference lumen area or ≥ 100% of lumen area of the reference segment with the lowest lumen area. In addition, lumen volume loss was also assessed by OCT. Using quantitative coronary angiography (QCA), LLL at 6 months was also assessed.
By OCT, a total of 8726 frames were assessed. The total number of incomplete scaffold strut apposition (r = 0.25, p = 0.04) and the sum of maximum distance from strut to lumen surface (r = 0.23, p = 0.06) correlated with in-scaffold LLL (QCA). The other OCT findings including presence of dissection, malapposition, intraluminal mass and presence of a side branch after implantation of Magmaris had no statistically significant correlations with in-scaffold LLL (QCA) at 6 months follow-up. However, in-scaffold lumen volume loss evaluated by OCT was significantly greater in patients with expansion group compared to those without (p = 0.03). Furthermore, % device expansion at post procedure tended to be inversely correlated with in-scaffold lumen volume loss (r = 0.23, p = 0.06).
We found that high expansion indexes are associated with high late luminal loss assessed by OCT. Excessive scaffold expansion (i.e. “the bigger, the better”) might not be needed to reduce in-scaffold late luminal loss assessed by OCT in Magmaris implantation. These findings should be considered hypothesis generation and need to be confirmed in future studies.