Acute Gain in Minimal Lumen Area Following Implantation of Everolimus-Eluting ABSORB Biodegradable Vascular Scaffolds or Xience Metallic Stents

Intravascular Ultrasound Assessment From the ABSORB II Trial

Yohei Sotomi, Yuki Ishibashi, Pannipa Suwannasom, Shimpei Nakatani, Yun Kyeong Cho, Maik J. Grundeken, Yaping Zeng, Hiroki Tateishi, Pieter C. Smits, Paul Barragan, Ran Kornowski, Anthony H. Gershlick, Stephan Windecker, Robert Jan van Geuns, Antonio L. Bartorelli, Robbert J. de Winter, Jan Tijssen, Patrick W. Serruys, Yoshinobu Onuma

Research output: Contribution to journalArticle

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Abstract

Objectives The study compared, by intravascular ultrasound (IVUS), acute gain (AG) at the site of the pre-procedural minimal lumen area (MLA) achieved by either the Absorb (Abbott Vascular, Santa Clara, California) scaffold or the Xience stent and identified the factors contributing to the acute performance of these devices. Background It is warranted that the acute performance of Absorb matches that of metallic stents; however, concern exists about acute expansion and lumen gain with the use of Absorb. Methods Of a total of 501 patients (546 lesions) in the ABSORB II (ABSORB II Randomized Controlled Trial) randomized trial, 445 patients with 480 lesions were investigated by IVUS pre- and post-procedure. Comparison of MLA pre- and post-procedure was performed at the MLA site by matching pre- and post-procedural IVUS pullbacks. Results Lower AG on IVUS (lowest tertile) occurred more frequently in the Absorb arm than in the Xience arm (3.46 mm2 vs. 4.27 mm2, respectively; p < 0.001; risk ratio: 3.04; 95% confidence interval: 1.94 to 4.76). The plaque morphology at the MLA cross-section was not independently associated with IVUS acute gain. The main difference in AG in MLD by angiography was observed at the time of device implantation (Xience vs. Absorb, Δ+1.50 mm vs. Δ+1.23 mm, respectively), whereas the gain from post-dilation was similar between the 2 arms (Δ+0.16 mm vs. Δ+0.16 mm) when patients underwent post-dilation, although expected balloon diameter was smaller in the Absorb arm than in the Xience arm (p = 0.003) during post-dilation. Conclusions At the site of the pre-procedural MLA, the increase of the lumen post-procedure was smaller in the Absorb-arm than in the Xience arm. To achieve equivalent AG to Xience, the implantation of Absorb may require more aggressive strategies at implantation, pre- and post-dilation than the technique used in the ABSORB II trial. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281)

Original languageEnglish
Pages (from-to)1216-1227
Number of pages12
JournalJACC: Cardiovascular Interventions
Volume9
Issue number12
DOIs
Publication statusPublished - Jun 27 2016

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Stents
Blood Vessels
Dilatation
Randomized Controlled Trials
Post and Core Technique
Equipment and Supplies
Everolimus
Angiography
Odds Ratio
Confidence Intervals

Keywords

  • bioresorbable vascular scaffold
  • drug-eluting stent(s)
  • intravascular ultrasound

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Acute Gain in Minimal Lumen Area Following Implantation of Everolimus-Eluting ABSORB Biodegradable Vascular Scaffolds or Xience Metallic Stents : Intravascular Ultrasound Assessment From the ABSORB II Trial. / Sotomi, Yohei; Ishibashi, Yuki; Suwannasom, Pannipa; Nakatani, Shimpei; Cho, Yun Kyeong; Grundeken, Maik J.; Zeng, Yaping; Tateishi, Hiroki; Smits, Pieter C.; Barragan, Paul; Kornowski, Ran; Gershlick, Anthony H.; Windecker, Stephan; van Geuns, Robert Jan; Bartorelli, Antonio L.; de Winter, Robbert J.; Tijssen, Jan; Serruys, Patrick W.; Onuma, Yoshinobu.

In: JACC: Cardiovascular Interventions, Vol. 9, No. 12, 27.06.2016, p. 1216-1227.

Research output: Contribution to journalArticle

Sotomi, Y, Ishibashi, Y, Suwannasom, P, Nakatani, S, Cho, YK, Grundeken, MJ, Zeng, Y, Tateishi, H, Smits, PC, Barragan, P, Kornowski, R, Gershlick, AH, Windecker, S, van Geuns, RJ, Bartorelli, AL, de Winter, RJ, Tijssen, J, Serruys, PW & Onuma, Y 2016, 'Acute Gain in Minimal Lumen Area Following Implantation of Everolimus-Eluting ABSORB Biodegradable Vascular Scaffolds or Xience Metallic Stents: Intravascular Ultrasound Assessment From the ABSORB II Trial', JACC: Cardiovascular Interventions, vol. 9, no. 12, pp. 1216-1227. https://doi.org/10.1016/j.jcin.2016.03.022
Sotomi, Yohei ; Ishibashi, Yuki ; Suwannasom, Pannipa ; Nakatani, Shimpei ; Cho, Yun Kyeong ; Grundeken, Maik J. ; Zeng, Yaping ; Tateishi, Hiroki ; Smits, Pieter C. ; Barragan, Paul ; Kornowski, Ran ; Gershlick, Anthony H. ; Windecker, Stephan ; van Geuns, Robert Jan ; Bartorelli, Antonio L. ; de Winter, Robbert J. ; Tijssen, Jan ; Serruys, Patrick W. ; Onuma, Yoshinobu. / Acute Gain in Minimal Lumen Area Following Implantation of Everolimus-Eluting ABSORB Biodegradable Vascular Scaffolds or Xience Metallic Stents : Intravascular Ultrasound Assessment From the ABSORB II Trial. In: JACC: Cardiovascular Interventions. 2016 ; Vol. 9, No. 12. pp. 1216-1227.
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abstract = "Objectives The study compared, by intravascular ultrasound (IVUS), acute gain (AG) at the site of the pre-procedural minimal lumen area (MLA) achieved by either the Absorb (Abbott Vascular, Santa Clara, California) scaffold or the Xience stent and identified the factors contributing to the acute performance of these devices. Background It is warranted that the acute performance of Absorb matches that of metallic stents; however, concern exists about acute expansion and lumen gain with the use of Absorb. Methods Of a total of 501 patients (546 lesions) in the ABSORB II (ABSORB II Randomized Controlled Trial) randomized trial, 445 patients with 480 lesions were investigated by IVUS pre- and post-procedure. Comparison of MLA pre- and post-procedure was performed at the MLA site by matching pre- and post-procedural IVUS pullbacks. Results Lower AG on IVUS (lowest tertile) occurred more frequently in the Absorb arm than in the Xience arm (3.46 mm2 vs. 4.27 mm2, respectively; p < 0.001; risk ratio: 3.04; 95{\%} confidence interval: 1.94 to 4.76). The plaque morphology at the MLA cross-section was not independently associated with IVUS acute gain. The main difference in AG in MLD by angiography was observed at the time of device implantation (Xience vs. Absorb, Δ+1.50 mm vs. Δ+1.23 mm, respectively), whereas the gain from post-dilation was similar between the 2 arms (Δ+0.16 mm vs. Δ+0.16 mm) when patients underwent post-dilation, although expected balloon diameter was smaller in the Absorb arm than in the Xience arm (p = 0.003) during post-dilation. Conclusions At the site of the pre-procedural MLA, the increase of the lumen post-procedure was smaller in the Absorb-arm than in the Xience arm. To achieve equivalent AG to Xience, the implantation of Absorb may require more aggressive strategies at implantation, pre- and post-dilation than the technique used in the ABSORB II trial. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281)",
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author = "Yohei Sotomi and Yuki Ishibashi and Pannipa Suwannasom and Shimpei Nakatani and Cho, {Yun Kyeong} and Grundeken, {Maik J.} and Yaping Zeng and Hiroki Tateishi and Smits, {Pieter C.} and Paul Barragan and Ran Kornowski and Gershlick, {Anthony H.} and Stephan Windecker and {van Geuns}, {Robert Jan} and Bartorelli, {Antonio L.} and {de Winter}, {Robbert J.} and Jan Tijssen and Serruys, {Patrick W.} and Yoshinobu Onuma",
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TY - JOUR

T1 - Acute Gain in Minimal Lumen Area Following Implantation of Everolimus-Eluting ABSORB Biodegradable Vascular Scaffolds or Xience Metallic Stents

T2 - Intravascular Ultrasound Assessment From the ABSORB II Trial

AU - Sotomi, Yohei

AU - Ishibashi, Yuki

AU - Suwannasom, Pannipa

AU - Nakatani, Shimpei

AU - Cho, Yun Kyeong

AU - Grundeken, Maik J.

AU - Zeng, Yaping

AU - Tateishi, Hiroki

AU - Smits, Pieter C.

AU - Barragan, Paul

AU - Kornowski, Ran

AU - Gershlick, Anthony H.

AU - Windecker, Stephan

AU - van Geuns, Robert Jan

AU - Bartorelli, Antonio L.

AU - de Winter, Robbert J.

AU - Tijssen, Jan

AU - Serruys, Patrick W.

AU - Onuma, Yoshinobu

PY - 2016/6/27

Y1 - 2016/6/27

N2 - Objectives The study compared, by intravascular ultrasound (IVUS), acute gain (AG) at the site of the pre-procedural minimal lumen area (MLA) achieved by either the Absorb (Abbott Vascular, Santa Clara, California) scaffold or the Xience stent and identified the factors contributing to the acute performance of these devices. Background It is warranted that the acute performance of Absorb matches that of metallic stents; however, concern exists about acute expansion and lumen gain with the use of Absorb. Methods Of a total of 501 patients (546 lesions) in the ABSORB II (ABSORB II Randomized Controlled Trial) randomized trial, 445 patients with 480 lesions were investigated by IVUS pre- and post-procedure. Comparison of MLA pre- and post-procedure was performed at the MLA site by matching pre- and post-procedural IVUS pullbacks. Results Lower AG on IVUS (lowest tertile) occurred more frequently in the Absorb arm than in the Xience arm (3.46 mm2 vs. 4.27 mm2, respectively; p < 0.001; risk ratio: 3.04; 95% confidence interval: 1.94 to 4.76). The plaque morphology at the MLA cross-section was not independently associated with IVUS acute gain. The main difference in AG in MLD by angiography was observed at the time of device implantation (Xience vs. Absorb, Δ+1.50 mm vs. Δ+1.23 mm, respectively), whereas the gain from post-dilation was similar between the 2 arms (Δ+0.16 mm vs. Δ+0.16 mm) when patients underwent post-dilation, although expected balloon diameter was smaller in the Absorb arm than in the Xience arm (p = 0.003) during post-dilation. Conclusions At the site of the pre-procedural MLA, the increase of the lumen post-procedure was smaller in the Absorb-arm than in the Xience arm. To achieve equivalent AG to Xience, the implantation of Absorb may require more aggressive strategies at implantation, pre- and post-dilation than the technique used in the ABSORB II trial. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281)

AB - Objectives The study compared, by intravascular ultrasound (IVUS), acute gain (AG) at the site of the pre-procedural minimal lumen area (MLA) achieved by either the Absorb (Abbott Vascular, Santa Clara, California) scaffold or the Xience stent and identified the factors contributing to the acute performance of these devices. Background It is warranted that the acute performance of Absorb matches that of metallic stents; however, concern exists about acute expansion and lumen gain with the use of Absorb. Methods Of a total of 501 patients (546 lesions) in the ABSORB II (ABSORB II Randomized Controlled Trial) randomized trial, 445 patients with 480 lesions were investigated by IVUS pre- and post-procedure. Comparison of MLA pre- and post-procedure was performed at the MLA site by matching pre- and post-procedural IVUS pullbacks. Results Lower AG on IVUS (lowest tertile) occurred more frequently in the Absorb arm than in the Xience arm (3.46 mm2 vs. 4.27 mm2, respectively; p < 0.001; risk ratio: 3.04; 95% confidence interval: 1.94 to 4.76). The plaque morphology at the MLA cross-section was not independently associated with IVUS acute gain. The main difference in AG in MLD by angiography was observed at the time of device implantation (Xience vs. Absorb, Δ+1.50 mm vs. Δ+1.23 mm, respectively), whereas the gain from post-dilation was similar between the 2 arms (Δ+0.16 mm vs. Δ+0.16 mm) when patients underwent post-dilation, although expected balloon diameter was smaller in the Absorb arm than in the Xience arm (p = 0.003) during post-dilation. Conclusions At the site of the pre-procedural MLA, the increase of the lumen post-procedure was smaller in the Absorb-arm than in the Xience arm. To achieve equivalent AG to Xience, the implantation of Absorb may require more aggressive strategies at implantation, pre- and post-dilation than the technique used in the ABSORB II trial. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281)

KW - bioresorbable vascular scaffold

KW - drug-eluting stent(s)

KW - intravascular ultrasound

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