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 language | English |
|---|---|
| Pages (from-to) | 1216-1227 |
| Number of pages | 12 |
| Journal | JACC: Cardiovascular Interventions |
| Volume | 9 |
| Issue number | 12 |
| DOIs | |
| Publication status | Published - Jun 27 2016 |
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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 journal › Article
}
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
UR - http://www.scopus.com/inward/record.url?scp=84994044884&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84994044884&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2016.03.022
DO - 10.1016/j.jcin.2016.03.022
M3 - Article
AN - SCOPUS:84994044884
VL - 9
SP - 1216
EP - 1227
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
SN - 1936-8798
IS - 12
ER -