Skip to main content
Erschienen in: Heart and Vessels 6/2021

22.01.2021 | Original Article

Efficacy of optical frequency domain imaging in detecting peripheral artery disease: the result of a multi-center, open-label, single-arm study

verfasst von: Hiroyuki Kawamori, Akihide Konishi, Toshiro Shinke, Hirokuni Akahori, Masaharu Ishihara, Hiroaki Tsujita, Hiromasa Otake, Takayoshi Toba, Shinsuke Nakano, Kosuke Tanimura, Yoshiro Tsukiyama, Isao Nanba, Yasumasa Kakei, Takahiro Yasuda, Takashi Omori, Takashi Kubo, Amane Kozuki, Junya Shite, Ken-ichi Hirata

Erschienen in: Heart and Vessels | Ausgabe 6/2021

Einloggen, um Zugang zu erhalten

Abstract

Optical frequency domain imaging (OFDI) is a high-resolution intracoronary imaging modality with fast automated longitudinal pullback. We aimed to evaluate the ability of performing OFDI from the superficial femoral artery (SFA) to the below-knee (BK) artery. This clinical trial was a multi-center, single-arm, open-label study. The primary endpoint was to obtain a clear image of the intra-vascular lumen from the SFA to the BK artery, specifically  > 270° visualization of the blood vessel lumen with  > 16/21 cross sections. The proportion of the clear image (≥ 85%) was regarded as confirmatory of the ability of OFDI to visualize the vessel lumen. Overall, 20 patients were enrolled. The proportion of the primary endpoint was 90% (18/20), and the pre-specified criterion was successfully attained. The proportion of the clear image assessed by the operator was 100% (20/20), and an additional statistical analysis for the proportion of the visualization,  > 270°, of the blood vessel lumen revealed a significantly higher cut-off value than that for the pre-specified criterion, 85% (p = 0.0315). There were three adverse events not related to OFDI. OFDI achieved acceptable visualization of the vessel lumen without any adverse event related to it. After regulatory approval based on the present study, OFDI will be available as a new option of endovascular imaging for peripheral artery diseases in daily practice
Trial registration: This study was registered in the Japanese Registry of Clinical Trials (jRCT 2052190025, https://​jrct.​niph.​go.​jp/​latest-detail/​jRCT2052190025).
Literatur
1.
Zurück zum Zitat Rigatelli G, Cardaioli P, Giordan M (2007) Endovascular treatment of femoro-popliteal obstructive disease. Minerva Cardioangiol 55:125–132PubMed Rigatelli G, Cardaioli P, Giordan M (2007) Endovascular treatment of femoro-popliteal obstructive disease. Minerva Cardioangiol 55:125–132PubMed
2.
Zurück zum Zitat Zdanowski Z, Albrechtsson U, Lundin A, Jonung T, Ribbe E, Thorne J, Norgren L (1999) Percutaneous transluminal angioplasty with or without stenting for femoropopliteal occlusions? A randomized controlled study. Int Angiol 18:251–255PubMed Zdanowski Z, Albrechtsson U, Lundin A, Jonung T, Ribbe E, Thorne J, Norgren L (1999) Percutaneous transluminal angioplasty with or without stenting for femoropopliteal occlusions? A randomized controlled study. Int Angiol 18:251–255PubMed
3.
Zurück zum Zitat Vroegindeweij D, Vos LD, Tielbeek AV, Buthvd Bosch JHC (1997) Balloon angioplasty combined with primary stenting versus balloon angioplasty alone in femoropopliteal obstructions: a comparative randomized study. Cardiovasc Intervent Radiol 20:420–425CrossRef Vroegindeweij D, Vos LD, Tielbeek AV, Buthvd Bosch JHC (1997) Balloon angioplasty combined with primary stenting versus balloon angioplasty alone in femoropopliteal obstructions: a comparative randomized study. Cardiovasc Intervent Radiol 20:420–425CrossRef
4.
Zurück zum Zitat Becquemin JP, Favre JP, Marzelle J, Nemoz C, Corsin C, Leizorovicz A (2003) Systematic versus selective stent placement after superficial femoral artery balloon angioplasty: a multicenter prospective randomized study. J Vasc Surg 37:487–494CrossRef Becquemin JP, Favre JP, Marzelle J, Nemoz C, Corsin C, Leizorovicz A (2003) Systematic versus selective stent placement after superficial femoral artery balloon angioplasty: a multicenter prospective randomized study. J Vasc Surg 37:487–494CrossRef
5.
Zurück zum Zitat Kawasaki D, Tsujino T, Fujii K, Masutani M, Ohyanagi M, Masuyama T (2008) Novel use of ultrasound guidance for recanalization of iliac, femoral, and popliteal arteries. Catheter Cardiovasc Interv 71:727–733CrossRef Kawasaki D, Tsujino T, Fujii K, Masutani M, Ohyanagi M, Masuyama T (2008) Novel use of ultrasound guidance for recanalization of iliac, femoral, and popliteal arteries. Catheter Cardiovasc Interv 71:727–733CrossRef
6.
Zurück zum Zitat Fujihara M, Kozuki A, Tsubakimoto Y, Takahara M, Shintani Y, Fukunaga M, Iwasaki Y, Nakama T, Yokoi Y (2019) Lumen gain after endovascular therapy in calcified superficial femoral artery occlusive disease assessed by intravascular ultrasound (CODE study). J Endovasc Ther 26:322–330CrossRef Fujihara M, Kozuki A, Tsubakimoto Y, Takahara M, Shintani Y, Fukunaga M, Iwasaki Y, Nakama T, Yokoi Y (2019) Lumen gain after endovascular therapy in calcified superficial femoral artery occlusive disease assessed by intravascular ultrasound (CODE study). J Endovasc Ther 26:322–330CrossRef
7.
Zurück zum Zitat Shammas NW, Radaideh Q, Shammas WJ, Daher GE, Rachwan RJ, Radaideh Y (2019) The role of precise imaging with intravascular ultrasound in coronary and peripheral interventions. Vasc Health Risk Manag 15:283–290CrossRef Shammas NW, Radaideh Q, Shammas WJ, Daher GE, Rachwan RJ, Radaideh Y (2019) The role of precise imaging with intravascular ultrasound in coronary and peripheral interventions. Vasc Health Risk Manag 15:283–290CrossRef
8.
Zurück zum Zitat Otsuka K, Shimada K, Ishikawa H, Nakamura H, Katayama H, Takeda H, Fujimoto K, Kasayuki N, Yoshiyama M (2020) Usefulness of pre- and post-stent optical frequency domain imaging findings in the prediction of periprocedural cardiac troponin elevation in patients with coronary artery disease. Heart Vessels 35:451–462CrossRef Otsuka K, Shimada K, Ishikawa H, Nakamura H, Katayama H, Takeda H, Fujimoto K, Kasayuki N, Yoshiyama M (2020) Usefulness of pre- and post-stent optical frequency domain imaging findings in the prediction of periprocedural cardiac troponin elevation in patients with coronary artery disease. Heart Vessels 35:451–462CrossRef
9.
Zurück zum Zitat Amano H, Noike R, Yabe T, Watanabe I, Okubo R, Koizumi M, Toda M, Ikeda T (2020) Frailty and coronary plaque characteristics on optical coherence tomography. Heart Vessels 35:750–761CrossRef Amano H, Noike R, Yabe T, Watanabe I, Okubo R, Koizumi M, Toda M, Ikeda T (2020) Frailty and coronary plaque characteristics on optical coherence tomography. Heart Vessels 35:750–761CrossRef
10.
Zurück zum Zitat Okamura T, Gonzalo N, Gutierrez-Chico JL, Serruys PW, Bruining N, de Winter S, Dijkstra J, Commossaris KH, van Geuns RJ, van Soest G, Ligthart J, Regar E (2010) Reproducibility of coronary Fourier domain optical coherence tomography: quantitative analysis of in vivo stented coronary arteries using three different software packages. EuroIntervention 6:371–379CrossRef Okamura T, Gonzalo N, Gutierrez-Chico JL, Serruys PW, Bruining N, de Winter S, Dijkstra J, Commossaris KH, van Geuns RJ, van Soest G, Ligthart J, Regar E (2010) Reproducibility of coronary Fourier domain optical coherence tomography: quantitative analysis of in vivo stented coronary arteries using three different software packages. EuroIntervention 6:371–379CrossRef
11.
Zurück zum Zitat Miki K, Fujii K, Fukunaga M, Nishimura M, Horimatsu T, Saita T, Sumiyoshi A, Tamaru H, Imanaka T, Shibuya M, Naito Y, Masuyama T, Ishihara M (2016) Strut coverage after paclitaxel-eluting stent implantation in the superficial femoral artery. JACC Cardiovasc Imaging 9:753–755CrossRef Miki K, Fujii K, Fukunaga M, Nishimura M, Horimatsu T, Saita T, Sumiyoshi A, Tamaru H, Imanaka T, Shibuya M, Naito Y, Masuyama T, Ishihara M (2016) Strut coverage after paclitaxel-eluting stent implantation in the superficial femoral artery. JACC Cardiovasc Imaging 9:753–755CrossRef
12.
Zurück zum Zitat Ali ZA, Maehara A, Genereux P, Shlofmitz RA, Fabbiocchi F, Nazif TM, Guagliumi G, Meraj PM, Alfonso F, Samady H, Akasaka T, Carlson EB, Leesar MA, Matsumura M, Ozan MO, Mintz GS, Ben-Yehuda O, Stone GW, Investigators IIOP (2016) Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial. Lancet 388:2618–2628CrossRef Ali ZA, Maehara A, Genereux P, Shlofmitz RA, Fabbiocchi F, Nazif TM, Guagliumi G, Meraj PM, Alfonso F, Samady H, Akasaka T, Carlson EB, Leesar MA, Matsumura M, Ozan MO, Mintz GS, Ben-Yehuda O, Stone GW, Investigators IIOP (2016) Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial. Lancet 388:2618–2628CrossRef
13.
Zurück zum Zitat Kubo T, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Otake H, Kozuma K, Ioji T, Kaneda H, Serikawa T, Kataoka T, Okada H, Akasaka T (2017) Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results. Eur Heart J 38:3139–3147CrossRef Kubo T, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Otake H, Kozuma K, Ioji T, Kaneda H, Serikawa T, Kataoka T, Okada H, Akasaka T (2017) Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results. Eur Heart J 38:3139–3147CrossRef
14.
Zurück zum Zitat Otake H, Kubo T, Takahashi H, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Kozuma K, Ioji T, Kaneda H, Akasaka T (2018) Optical frequency domain imaging versus intravascular ultrasound in percutaneous coronary intervention (OPINION Trial): results from the OPINION Imaging Study. JACC Cardiovasc Imaging 11:111–123CrossRef Otake H, Kubo T, Takahashi H, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Kozuma K, Ioji T, Kaneda H, Akasaka T (2018) Optical frequency domain imaging versus intravascular ultrasound in percutaneous coronary intervention (OPINION Trial): results from the OPINION Imaging Study. JACC Cardiovasc Imaging 11:111–123CrossRef
15.
Zurück zum Zitat Kozuki A, Shinke T, Otake H, Kijima Y, Masano T, Nagoshi R, Imamura K, Fujiwara R, Shibata H, Takeshige R, Tsukiyama Y, Yanaka K, Nakano S, Fukuyama Y, Kawashima S, Hirata K, Shite J (2016) Optical coherence tomography study of chronic-phase vessel healing after implantation of bare metal and paclitaxel-eluting self-expanding nitinol stents in the superficial femoral artery. J Cardiol 67:424–429CrossRef Kozuki A, Shinke T, Otake H, Kijima Y, Masano T, Nagoshi R, Imamura K, Fujiwara R, Shibata H, Takeshige R, Tsukiyama Y, Yanaka K, Nakano S, Fukuyama Y, Kawashima S, Hirata K, Shite J (2016) Optical coherence tomography study of chronic-phase vessel healing after implantation of bare metal and paclitaxel-eluting self-expanding nitinol stents in the superficial femoral artery. J Cardiol 67:424–429CrossRef
16.
Zurück zum Zitat Miki K, Fujii K, Shibuya M, Fukunaga M, Imanaka T, Tamaru H, Nishimura M, Horimatsu T, Honda Y, Fitzgerald PJ, Masuyama T, Ishihara M (2016) Comparing the vascular response in implantation of self-expanding, bare metal nitinol stents or paclitaxel-eluting nitinol stents in superficial femoral artery lesions: a serial optical frequency domain imaging study. EuroIntervention 12:1551–1558CrossRef Miki K, Fujii K, Shibuya M, Fukunaga M, Imanaka T, Tamaru H, Nishimura M, Horimatsu T, Honda Y, Fitzgerald PJ, Masuyama T, Ishihara M (2016) Comparing the vascular response in implantation of self-expanding, bare metal nitinol stents or paclitaxel-eluting nitinol stents in superficial femoral artery lesions: a serial optical frequency domain imaging study. EuroIntervention 12:1551–1558CrossRef
17.
Zurück zum Zitat Miki K, Fujii K, Shibuya M, Fukunaga M, Imanaka T, Kawai K, Tamaru H, Sumiyoshi A, Nishimura M, Horimatsu T, Saita T, Yoshihara N, Kimura T, Honda Y, Fitzgerald PJ, Masuyama T, Ishihara M (2017) Impact of stent diameter on vascular response after self-expanding paclitaxel-eluting stent implantation in the superficial femoral artery. J Cardiol 70:346–352CrossRef Miki K, Fujii K, Shibuya M, Fukunaga M, Imanaka T, Kawai K, Tamaru H, Sumiyoshi A, Nishimura M, Horimatsu T, Saita T, Yoshihara N, Kimura T, Honda Y, Fitzgerald PJ, Masuyama T, Ishihara M (2017) Impact of stent diameter on vascular response after self-expanding paclitaxel-eluting stent implantation in the superficial femoral artery. J Cardiol 70:346–352CrossRef
18.
Zurück zum Zitat Kawamori H, Konishi A, Otake H, Toba T, Nakano S, Tanimura K, Tsukiyama Y, Namba I, Omori T, Shinke T, Hirata K (2020) Efficacy of optical frequency-domain imaging in detecting peripheral artery disease: a single-center open-label, single-arm study protocol. Cardiovasc Interv Ther 35:385–391CrossRef Kawamori H, Konishi A, Otake H, Toba T, Nakano S, Tanimura K, Tsukiyama Y, Namba I, Omori T, Shinke T, Hirata K (2020) Efficacy of optical frequency-domain imaging in detecting peripheral artery disease: a single-center open-label, single-arm study protocol. Cardiovasc Interv Ther 35:385–391CrossRef
19.
Zurück zum Zitat Gonzalo N, Serruys PW, Okamura T, Shen ZJ, Onuma Y, Garcia-Garcia HM, Sarno G, Schultz C, van Geuns RJ, Ligthart J, Regar E (2009) Optical coherence tomography assessment of the acute effects of stent implantation on the vessel wall: a systematic quantitative approach. Heart 95:1913–1919CrossRef Gonzalo N, Serruys PW, Okamura T, Shen ZJ, Onuma Y, Garcia-Garcia HM, Sarno G, Schultz C, van Geuns RJ, Ligthart J, Regar E (2009) Optical coherence tomography assessment of the acute effects of stent implantation on the vessel wall: a systematic quantitative approach. Heart 95:1913–1919CrossRef
21.
Zurück zum Zitat Meissner OA, Rieber J, Babaryka G, Oswald M, Reim S, Siebert U, Redel T, Reiser M, Mueller-Lisse U (2006) Intravascular optical coherence tomography: comparison with histopathology in atherosclerotic peripheral artery specimens. J Vasc Interv Radiol 17:343–349CrossRef Meissner OA, Rieber J, Babaryka G, Oswald M, Reim S, Siebert U, Redel T, Reiser M, Mueller-Lisse U (2006) Intravascular optical coherence tomography: comparison with histopathology in atherosclerotic peripheral artery specimens. J Vasc Interv Radiol 17:343–349CrossRef
22.
Zurück zum Zitat Eberhardt KM, Treitl M, Boesenecker K, Maxien D, Reiser M, Rieger J (2013) Prospective evaluation of optical coherence tomography in lower limb arteries compared with intravascular ultrasound. J Vasc Interv Radiol 24:1499–1508CrossRef Eberhardt KM, Treitl M, Boesenecker K, Maxien D, Reiser M, Rieger J (2013) Prospective evaluation of optical coherence tomography in lower limb arteries compared with intravascular ultrasound. J Vasc Interv Radiol 24:1499–1508CrossRef
23.
Zurück zum Zitat Marmagkiolis K, Lendel V, Cawich I, Leesar M, Feldman MD, Cilingiroglu M (2014) Optical coherence tomography to guide below-the-knee endovascular interventions. Int J Cardiol 176:1336–1338CrossRef Marmagkiolis K, Lendel V, Cawich I, Leesar M, Feldman MD, Cilingiroglu M (2014) Optical coherence tomography to guide below-the-knee endovascular interventions. Int J Cardiol 176:1336–1338CrossRef
Metadaten
Titel
Efficacy of optical frequency domain imaging in detecting peripheral artery disease: the result of a multi-center, open-label, single-arm study
verfasst von
Hiroyuki Kawamori
Akihide Konishi
Toshiro Shinke
Hirokuni Akahori
Masaharu Ishihara
Hiroaki Tsujita
Hiromasa Otake
Takayoshi Toba
Shinsuke Nakano
Kosuke Tanimura
Yoshiro Tsukiyama
Isao Nanba
Yasumasa Kakei
Takahiro Yasuda
Takashi Omori
Takashi Kubo
Amane Kozuki
Junya Shite
Ken-ichi Hirata
Publikationsdatum
22.01.2021
Verlag
Springer Japan
Erschienen in
Heart and Vessels / Ausgabe 6/2021
Print ISSN: 0910-8327
Elektronische ISSN: 1615-2573
DOI
https://doi.org/10.1007/s00380-020-01758-y

Weitere Artikel der Ausgabe 6/2021

Heart and Vessels 6/2021 Zur Ausgabe

Update Kardiologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.