Skip to main content
Erschienen in: Cardiovascular Intervention and Therapeutics 4/2013

01.10.2013 | Original Article

Angiographic findings of everolimus-eluting as compared to sirolimus-eluting stents: angiographic sub-study from the Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial (RESET)

verfasst von: Ken Kozuma, Takeshi Kimura, Kazushige Kadota, Satoru Suwa, Kazuo Kimura, Masashi Iwabuchi, Kazuya Kawai, Akiyoshi Miyazawa, Masaki Kawamura, Koichi Nakao, Ryuta Asano, Takashi Yamamoto, Nobuaki Suzuki, Jiro Aoki, Hiroyuki Kyono, Gaku Nakazawa, Kengo Tanabe, Yoshihiro Morino, Keiichi Igarashi

Erschienen in: Cardiovascular Intervention and Therapeutics | Ausgabe 4/2013

Einloggen, um Zugang zu erhalten

Abstract

Several recent randomized trials comparing everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) reported similar clinical outcomes. This study was aimed to clarify the differences in the angiographic findings of EES as compared to SES. Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial is a prospective multicenter randomized open-label trial comparing EES with SES in Japan. From February to July 2010, 3197 patients were randomly assigned to receive either EES or SES. Of these, angiographic sub-study enrolled 571 patients (EES 285 patients, SES 286 patients). Angiograms were assessed qualitatively and quantitatively at procedure and at 8–12 months in the independent core angiographic laboratory. Late loss of the proximal edges tended to be greater in the EES group than that in the SES group (0.12 ± 0.49 vs. 0.04 ± 0.43 mm, P = 0.05), although late loss in the other segments was similar between the 2 groups. Edge restenosis was mainly observed in EES group, whereas body restenosis was demonstrated in half of SES group. Stent fracture was observed only in the SES group (1.5 %), and peri-stent contrast staining (PSS) tended to be more frequently observed in the SES group than in the EES group (3.6 and 1.5 %, P = 0.18). Restenotic response in the proximal edge was more prominent in the EES group as compared to the SES group. Abnormal angiographic findings such as stent fracture and PSS tended to be more frequent in the SES group
Anhänge
Nur mit Berechtigung zugänglich
Literatur
1.
Zurück zum Zitat Kotani J, Ikari Y, Kyo E, Nakamura M, Yokoi H, Furuno K, et al. Five-year outcomes of Cypher coronary stent: report from J-PMS Study. Cardiovasc Interv Ther. 2012;27:63–71.PubMedCrossRef Kotani J, Ikari Y, Kyo E, Nakamura M, Yokoi H, Furuno K, et al. Five-year outcomes of Cypher coronary stent: report from J-PMS Study. Cardiovasc Interv Ther. 2012;27:63–71.PubMedCrossRef
2.
Zurück zum Zitat Kimura T, Morimoto T, Nakagawa Y, Kadota K, Nozaki Y, Tada T, et al. Antiplatelet therapy and long-term clinical outcome after sirolimus-eluting stent implantation: 5-year outcome of the j-Cypher registry. Cardiovasc Interv Ther. 2012;27:181–8.PubMedCrossRef Kimura T, Morimoto T, Nakagawa Y, Kadota K, Nozaki Y, Tada T, et al. Antiplatelet therapy and long-term clinical outcome after sirolimus-eluting stent implantation: 5-year outcome of the j-Cypher registry. Cardiovasc Interv Ther. 2012;27:181–8.PubMedCrossRef
3.
Zurück zum Zitat Stone GW, Rizvi A, Sudhir K, Newman W, Applegate RJ, Cannon LA, et al. Randomized comparison of everolimus- and paclitaxel-eluting stents. 2-year follow-up from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) IV trial. J Am Coll Cardiol. 2011;58:19–25.PubMedCrossRef Stone GW, Rizvi A, Sudhir K, Newman W, Applegate RJ, Cannon LA, et al. Randomized comparison of everolimus- and paclitaxel-eluting stents. 2-year follow-up from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) IV trial. J Am Coll Cardiol. 2011;58:19–25.PubMedCrossRef
4.
Zurück zum Zitat Smits PC, Kedhi E, Royaards KJ, Joesoef KS, Wassing J, Rademaker-Havinga TA, et al. 2-year follow-up of a randomized controlled trial of everolimus- and paclitaxel-eluting stents for coronary revascularization in daily practice. COMPARE (Comparison of the everolimus eluting XIENCE-V stent with the paclitaxel eluting TAXUS LIBERTE stent in all-comers: a randomized open label trial). J Am Coll Cardiol. 2011;58:11–8.PubMedCrossRef Smits PC, Kedhi E, Royaards KJ, Joesoef KS, Wassing J, Rademaker-Havinga TA, et al. 2-year follow-up of a randomized controlled trial of everolimus- and paclitaxel-eluting stents for coronary revascularization in daily practice. COMPARE (Comparison of the everolimus eluting XIENCE-V stent with the paclitaxel eluting TAXUS LIBERTE stent in all-comers: a randomized open label trial). J Am Coll Cardiol. 2011;58:11–8.PubMedCrossRef
5.
Zurück zum Zitat Kim WJ, Lee SW, Park SW, Kim YH, Yun SC, Lee JY, et al. Randomized comparison of everolimus-eluting stent versus sirolimus-eluting stent implantation for de novo coronary artery disease in patients with diabetes mellitus (ESSENCE-DIABETES): results from the ESSENCE-DIABETES trial. Circulation. 2011;124:886–92.PubMedCrossRef Kim WJ, Lee SW, Park SW, Kim YH, Yun SC, Lee JY, et al. Randomized comparison of everolimus-eluting stent versus sirolimus-eluting stent implantation for de novo coronary artery disease in patients with diabetes mellitus (ESSENCE-DIABETES): results from the ESSENCE-DIABETES trial. Circulation. 2011;124:886–92.PubMedCrossRef
6.
Zurück zum Zitat Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, et al. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA J Am Med Assoc. 2008;299:1903–13.CrossRef Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, et al. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA J Am Med Assoc. 2008;299:1903–13.CrossRef
7.
Zurück zum Zitat Serruys P, Ruygrok P, Neuzner J, Piek J, Seth A, Schofer J, et al. A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent: the SPIRIT II trial. EuroInterv. 2006;2:286–94. Serruys P, Ruygrok P, Neuzner J, Piek J, Seth A, Schofer J, et al. A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent: the SPIRIT II trial. EuroInterv. 2006;2:286–94.
8.
Zurück zum Zitat Sabate M, Costa MA, Kozuma K, Kay IP, van der Giessen WJ, Coen VL, et al. Geographic miss: a cause of treatment failure in radio-oncology applied to intracoronary radiation therapy. Circulation. 2000;101:2467–71.PubMedCrossRef Sabate M, Costa MA, Kozuma K, Kay IP, van der Giessen WJ, Coen VL, et al. Geographic miss: a cause of treatment failure in radio-oncology applied to intracoronary radiation therapy. Circulation. 2000;101:2467–71.PubMedCrossRef
9.
Zurück zum Zitat Waksman R, White RL, Chan RC, Bass BG, Geirlach L, Mintz GS, et al. Intracoronary gamma-radiation therapy after angioplasty inhibits recurrence in patients with in-stent restenosis. Circulation. 2000;101:2165–71.PubMedCrossRef Waksman R, White RL, Chan RC, Bass BG, Geirlach L, Mintz GS, et al. Intracoronary gamma-radiation therapy after angioplasty inhibits recurrence in patients with in-stent restenosis. Circulation. 2000;101:2165–71.PubMedCrossRef
10.
Zurück zum Zitat Costa MA, Angiolillo DJ, Tannenbaum M, Driesman M, Chu A, Patterson J, et al. Impact of stent deployment procedural factors on long-term effectiveness and safety of sirolimus-eluting stents (final results of the multicenter prospective STLLR trial). Am J Cardiol. 2008;101:1704–11.PubMedCrossRef Costa MA, Angiolillo DJ, Tannenbaum M, Driesman M, Chu A, Patterson J, et al. Impact of stent deployment procedural factors on long-term effectiveness and safety of sirolimus-eluting stents (final results of the multicenter prospective STLLR trial). Am J Cardiol. 2008;101:1704–11.PubMedCrossRef
11.
Zurück zum Zitat Liu J, Maehara A, Mintz GS, Weissman NJ, Yu A, Wang H, et al. An integrated TAXUS IV, V, and VI intravascular ultrasound analysis of the predictors of edge restenosis after bare metal or paclitaxel-eluting stents. Am J Cardiol. 2009;103:501–6.PubMedCrossRef Liu J, Maehara A, Mintz GS, Weissman NJ, Yu A, Wang H, et al. An integrated TAXUS IV, V, and VI intravascular ultrasound analysis of the predictors of edge restenosis after bare metal or paclitaxel-eluting stents. Am J Cardiol. 2009;103:501–6.PubMedCrossRef
12.
Zurück zum Zitat Canan T, Lee MS. Drug-eluting stent fracture: incidence, contributing factors, and clinical implications. Catheter Cardiovasc Interv. 2010;75:237–45.PubMedCrossRef Canan T, Lee MS. Drug-eluting stent fracture: incidence, contributing factors, and clinical implications. Catheter Cardiovasc Interv. 2010;75:237–45.PubMedCrossRef
13.
Zurück zum Zitat Imai M, Kadota K, Goto T, Fujii S, Yamamoto H, Fuku Y, et al. Incidence, risk factors, and clinical sequelae of angiographic peri-stent contrast staining after sirolimus-eluting stent implantation. Circulation. 2011;123:2382–91.PubMedCrossRef Imai M, Kadota K, Goto T, Fujii S, Yamamoto H, Fuku Y, et al. Incidence, risk factors, and clinical sequelae of angiographic peri-stent contrast staining after sirolimus-eluting stent implantation. Circulation. 2011;123:2382–91.PubMedCrossRef
14.
Zurück zum Zitat Kimura T, Morimoto T, Natsuaki M, Shiomi H, Igarashi K, Kadota K, et al. Comparison of everolimus-eluting and sirolimus-eluting coronary stents: 1-year outcomes from the Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting stent Trial (RESET). Circulation. 2012. Kimura T, Morimoto T, Natsuaki M, Shiomi H, Igarashi K, Kadota K, et al. Comparison of everolimus-eluting and sirolimus-eluting coronary stents: 1-year outcomes from the Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting stent Trial (RESET). Circulation. 2012.
15.
Zurück zum Zitat Popma JJ, Tiroch K, Almonacid A, Cohen S, Kandzari DE, Leon MB. A qualitative and quantitative angiographic analysis of stent fracture late following sirolimus-eluting stent implantation. Am J Cardiol. 2009;103:923–9.PubMedCrossRef Popma JJ, Tiroch K, Almonacid A, Cohen S, Kandzari DE, Leon MB. A qualitative and quantitative angiographic analysis of stent fracture late following sirolimus-eluting stent implantation. Am J Cardiol. 2009;103:923–9.PubMedCrossRef
16.
Zurück zum Zitat Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346:1773–80.PubMedCrossRef Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346:1773–80.PubMedCrossRef
17.
Zurück zum Zitat Sianos G, Morel MA, Kappetein AP, Morice MC, Colombo A, Dawkins K, et al. The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease. EuroInterv. 2005;1:219–27. Sianos G, Morel MA, Kappetein AP, Morice MC, Colombo A, Dawkins K, et al. The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease. EuroInterv. 2005;1:219–27.
18.
Zurück zum Zitat Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O’Shaughnessy C, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003;349:1315–23.PubMedCrossRef Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O’Shaughnessy C, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003;349:1315–23.PubMedCrossRef
19.
Zurück zum Zitat Ikari Y, Kotani J, Kozuma K, Kyo E, Nakamura M, Yokoi H. Assessment of sirolimus-eluting coronary stent implantation with aspirin plus low dose ticlopidine administration: one year results from CYPHER Stent Japan Post-Marketing Surveillance Registry (J-PMS). Circ J. 2009;73:1038–44.PubMedCrossRef Ikari Y, Kotani J, Kozuma K, Kyo E, Nakamura M, Yokoi H. Assessment of sirolimus-eluting coronary stent implantation with aspirin plus low dose ticlopidine administration: one year results from CYPHER Stent Japan Post-Marketing Surveillance Registry (J-PMS). Circ J. 2009;73:1038–44.PubMedCrossRef
20.
Zurück zum Zitat Burzotta F, Trani C, Todaro D, Mariani L, Talarico GP, Tommasino A, et al. Prospective randomized comparison of sirolimus- or everolimus-eluting stent to treat bifurcated lesions by provisional approach. JACC Cardiovasc Interv. 2011;4:327–35.PubMedCrossRef Burzotta F, Trani C, Todaro D, Mariani L, Talarico GP, Tommasino A, et al. Prospective randomized comparison of sirolimus- or everolimus-eluting stent to treat bifurcated lesions by provisional approach. JACC Cardiovasc Interv. 2011;4:327–35.PubMedCrossRef
21.
Zurück zum Zitat Park DW, Kim YH, Song HG, Ahn JM, Kim WJ, Lee JY, et al. Comparison of everolimus- and sirolimus-eluting stents in patients with long coronary artery lesions: a randomized LONG-DES-III (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III) Trial. JACC Cardiovasc Interv. 2011;4:1096–103.PubMedCrossRef Park DW, Kim YH, Song HG, Ahn JM, Kim WJ, Lee JY, et al. Comparison of everolimus- and sirolimus-eluting stents in patients with long coronary artery lesions: a randomized LONG-DES-III (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III) Trial. JACC Cardiovasc Interv. 2011;4:1096–103.PubMedCrossRef
22.
Zurück zum Zitat Sakakibara T, Ishii H, Toriyama T, Aoyama T, Takahashi H, Kamoi D, et al. Sirolimus-eluting stent vs. everolimus-eluting stent for coronary intervention in patients on chronic hemodialysis. Circ J. 2012;76:351–5.PubMedCrossRef Sakakibara T, Ishii H, Toriyama T, Aoyama T, Takahashi H, Kamoi D, et al. Sirolimus-eluting stent vs. everolimus-eluting stent for coronary intervention in patients on chronic hemodialysis. Circ J. 2012;76:351–5.PubMedCrossRef
23.
Zurück zum Zitat Jensen LO, Thayssen P, Hansen HS, Christiansen EH, Tilsted HH, Krusell LR, et al. Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV). Circulation. 2012;125:1246–55.PubMedCrossRef Jensen LO, Thayssen P, Hansen HS, Christiansen EH, Tilsted HH, Krusell LR, et al. Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV). Circulation. 2012;125:1246–55.PubMedCrossRef
24.
Zurück zum Zitat Sakurai R, Ako J, Morino Y, Sonoda S, Kaneda H, Terashima M, et al. Predictors of edge stenosis following sirolimus-eluting stent deployment (a quantitative intravascular ultrasound analysis from the SIRIUS trial). Am J Cardiol. 2005;96:1251–3.PubMedCrossRef Sakurai R, Ako J, Morino Y, Sonoda S, Kaneda H, Terashima M, et al. Predictors of edge stenosis following sirolimus-eluting stent deployment (a quantitative intravascular ultrasound analysis from the SIRIUS trial). Am J Cardiol. 2005;96:1251–3.PubMedCrossRef
25.
Zurück zum Zitat Kang SJ, Ahn JM, Kim WJ, Lee JY, Park DW, Lee SW, et al. Intravascular ultrasound assessment of drug-eluting stent coverage of the coronary ostium and effect on outcomes. Am J Cardiol. 2013. Kang SJ, Ahn JM, Kim WJ, Lee JY, Park DW, Lee SW, et al. Intravascular ultrasound assessment of drug-eluting stent coverage of the coronary ostium and effect on outcomes. Am J Cardiol. 2013.
26.
Zurück zum Zitat Kozuma K, Costa MA, Sabate M, Kay IP, Marijnissen JP, Coen VL, et al. Three-dimensional intravascular ultrasound assessment of noninjured edges of beta-irradiated coronary segments. Circulation. 2000;102:1484–9.PubMedCrossRef Kozuma K, Costa MA, Sabate M, Kay IP, Marijnissen JP, Coen VL, et al. Three-dimensional intravascular ultrasound assessment of noninjured edges of beta-irradiated coronary segments. Circulation. 2000;102:1484–9.PubMedCrossRef
27.
Zurück zum Zitat Kuramitsu S, Iwabuchi M, Haraguchi T, Domei T, Nagae A, Hyodo M, et al. Incidence and clinical impact of stent fracture after everolimus-eluting stent implantation. Circ Cardiovasc Interv. 2012;5:663–71.PubMedCrossRef Kuramitsu S, Iwabuchi M, Haraguchi T, Domei T, Nagae A, Hyodo M, et al. Incidence and clinical impact of stent fracture after everolimus-eluting stent implantation. Circ Cardiovasc Interv. 2012;5:663–71.PubMedCrossRef
28.
Zurück zum Zitat Nakazawa G, Finn AV, Vorpahl M, Ladich E, Kutys R, Balazs I, et al. Incidence and predictors of drug-eluting stent fracture in human coronary artery a pathologic analysis. J Am Coll Cardiol. 2009;54:1924–31.PubMedCrossRef Nakazawa G, Finn AV, Vorpahl M, Ladich E, Kutys R, Balazs I, et al. Incidence and predictors of drug-eluting stent fracture in human coronary artery a pathologic analysis. J Am Coll Cardiol. 2009;54:1924–31.PubMedCrossRef
29.
Zurück zum Zitat Kon H, Sakai H, Otsubo M, Takano H, Okamoto K, Sato T, et al. Contrast staining outside the sirolimus-eluting stent leading to coronary aneurysm formation: a case of very late stent thrombosis associated with hypersensitivity reaction. Circ Cardiovasc Interv. 2011;4:e1–3.PubMedCrossRef Kon H, Sakai H, Otsubo M, Takano H, Okamoto K, Sato T, et al. Contrast staining outside the sirolimus-eluting stent leading to coronary aneurysm formation: a case of very late stent thrombosis associated with hypersensitivity reaction. Circ Cardiovasc Interv. 2011;4:e1–3.PubMedCrossRef
30.
Zurück zum Zitat Cook S, Ladich E, Nakazawa G, Eshtehardi P, Neidhart M, Vogel R, et al. Correlation of intravascular ultrasound findings with histopathological analysis of thrombus aspirates in patients with very late drug-eluting stent thrombosis. Circulation. 2009;120:391–9.PubMedCrossRef Cook S, Ladich E, Nakazawa G, Eshtehardi P, Neidhart M, Vogel R, et al. Correlation of intravascular ultrasound findings with histopathological analysis of thrombus aspirates in patients with very late drug-eluting stent thrombosis. Circulation. 2009;120:391–9.PubMedCrossRef
31.
Zurück zum Zitat Nakazawa G, Finn AV, Vorpahl M, Ladich ER, Kolodgie FD, Virmani R. Coronary responses and differential mechanisms of late stent thrombosis attributed to first-generation sirolimus- and paclitaxel-eluting stents. J Am Coll Cardiol. 2011;57:390–8.PubMedCrossRef Nakazawa G, Finn AV, Vorpahl M, Ladich ER, Kolodgie FD, Virmani R. Coronary responses and differential mechanisms of late stent thrombosis attributed to first-generation sirolimus- and paclitaxel-eluting stents. J Am Coll Cardiol. 2011;57:390–8.PubMedCrossRef
32.
Zurück zum Zitat Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, et al. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004;109:701–5.PubMedCrossRef Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, et al. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004;109:701–5.PubMedCrossRef
Metadaten
Titel
Angiographic findings of everolimus-eluting as compared to sirolimus-eluting stents: angiographic sub-study from the Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial (RESET)
verfasst von
Ken Kozuma
Takeshi Kimura
Kazushige Kadota
Satoru Suwa
Kazuo Kimura
Masashi Iwabuchi
Kazuya Kawai
Akiyoshi Miyazawa
Masaki Kawamura
Koichi Nakao
Ryuta Asano
Takashi Yamamoto
Nobuaki Suzuki
Jiro Aoki
Hiroyuki Kyono
Gaku Nakazawa
Kengo Tanabe
Yoshihiro Morino
Keiichi Igarashi
Publikationsdatum
01.10.2013
Verlag
Springer Japan
Erschienen in
Cardiovascular Intervention and Therapeutics / Ausgabe 4/2013
Print ISSN: 1868-4300
Elektronische ISSN: 1868-4297
DOI
https://doi.org/10.1007/s12928-013-0179-7

Weitere Artikel der Ausgabe 4/2013

Cardiovascular Intervention and Therapeutics 4/2013 Zur Ausgabe

Update Kardiologie

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