Arterial Remodeling After Bioresorbable Scaffolds and Metallic Stents

Patrick W. Serruys, Yuki Katagiri, Yohei Sotomi, Yaping Zeng, Bernard Chevalier, René J. van der Schaaf, Andreas Baumbach, Pieter Smits, Nicolas M. van Mieghem, Antonio Bartorelli, Paul Barragan, Anthony Gershlick, Ran Kornowski, Carlos Macaya, John Ormiston, Jonathan Hill, Irene M. Lang, Mohaned Egred, Jean Fajadet, Maciej LesiakStephan Windecker, Robert A. Byrne, Lorenz Räber, Robert Jan van Geuns, Gary S. Mintz, Yoshinobu Onuma

Research output: Contribution to journalArticle

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Abstract

Background Although previous observational studies have documented late luminal enlargement and expansive remodeling following implantation of a bioresorbable vascular scaffold (BVS), no comparison with metallic stents has been conducted in a randomized fashion. Objectives This study sought to compare vessel remodeling patterns after either Absorb BVS or Xience metallic drug-eluting stent (DES) implantation (Abbott Vascular, Santa Clara, California) and determine the independent predictors of remodeling. Methods In the ABSORB II randomized trial, 383 lesions (n = 359) were investigated by intravenous ultrasound both post-procedure and at 3-year follow-up. According to vessel and lumen area changes over 3 years, we categorized 9 patterns of vessel remodeling that were beyond the reproducibility of lumen and vessel area measurements. Results The relative change in mean vessel area was significantly greater with the BVS compared to the DES (6.7 ± 12.6% vs. 2.9 ± 11.5%; p = 0.003); the relative change in mean lumen area was significantly different between the 2 arms (1.4 ± 19.1% vs. −1.9 ± 10.5%, respectively; p = 0.031). Multivariate analysis indicated that use of the BVS, female sex, balloon-artery ratio >1.25, expansion index ≥0.8, previous percutaneous coronary intervention, and higher level of low-density lipoprotein cholesterol were independent predictors of expansive remodeling. Furthermore, in the BVS arm, necrotic core pre-procedure was an independent determinant of expansive remodeling. Conclusions Expansive vessel wall remodeling was more frequent and intense with the BVS than the metallic DES and could be determined by patient baseline characteristics and periprocedural factors. The clinical effect of the observed lumen and vessel remodeling must be investigated in further large clinical studies to optimize the clinical outcome of patients and lesions treated by bioresorbable scaffolds. (ABSORB II Randomized Controlled Trial; NCT01425281)

Original languageEnglish
Pages (from-to)60-74
Number of pages15
JournalJournal of the American College of Cardiology
Volume70
Issue number1
DOIs
Publication statusPublished - Jul 4 2017

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Stents
Blood Vessels
Drug-Eluting Stents
Percutaneous Coronary Intervention
LDL Cholesterol
Observational Studies
Multivariate Analysis
Randomized Controlled Trials
Arteries

Keywords

  • coronary artery disease
  • expansion index
  • intravascular ultrasound
  • lumen area
  • plaque area
  • vessel area

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Serruys, P. W., Katagiri, Y., Sotomi, Y., Zeng, Y., Chevalier, B., van der Schaaf, R. J., ... Onuma, Y. (2017). Arterial Remodeling After Bioresorbable Scaffolds and Metallic Stents. Journal of the American College of Cardiology, 70(1), 60-74. https://doi.org/10.1016/j.jacc.2017.05.028

Arterial Remodeling After Bioresorbable Scaffolds and Metallic Stents. / Serruys, Patrick W.; Katagiri, Yuki; Sotomi, Yohei; Zeng, Yaping; Chevalier, Bernard; van der Schaaf, René J.; Baumbach, Andreas; Smits, Pieter; van Mieghem, Nicolas M.; Bartorelli, Antonio; Barragan, Paul; Gershlick, Anthony; Kornowski, Ran; Macaya, Carlos; Ormiston, John; Hill, Jonathan; Lang, Irene M.; Egred, Mohaned; Fajadet, Jean; Lesiak, Maciej; Windecker, Stephan; Byrne, Robert A.; Räber, Lorenz; van Geuns, Robert Jan; Mintz, Gary S.; Onuma, Yoshinobu.

In: Journal of the American College of Cardiology, Vol. 70, No. 1, 04.07.2017, p. 60-74.

Research output: Contribution to journalArticle

Serruys, PW, Katagiri, Y, Sotomi, Y, Zeng, Y, Chevalier, B, van der Schaaf, RJ, Baumbach, A, Smits, P, van Mieghem, NM, Bartorelli, A, Barragan, P, Gershlick, A, Kornowski, R, Macaya, C, Ormiston, J, Hill, J, Lang, IM, Egred, M, Fajadet, J, Lesiak, M, Windecker, S, Byrne, RA, Räber, L, van Geuns, RJ, Mintz, GS & Onuma, Y 2017, 'Arterial Remodeling After Bioresorbable Scaffolds and Metallic Stents', Journal of the American College of Cardiology, vol. 70, no. 1, pp. 60-74. https://doi.org/10.1016/j.jacc.2017.05.028
Serruys PW, Katagiri Y, Sotomi Y, Zeng Y, Chevalier B, van der Schaaf RJ et al. Arterial Remodeling After Bioresorbable Scaffolds and Metallic Stents. Journal of the American College of Cardiology. 2017 Jul 4;70(1):60-74. https://doi.org/10.1016/j.jacc.2017.05.028
Serruys, Patrick W. ; Katagiri, Yuki ; Sotomi, Yohei ; Zeng, Yaping ; Chevalier, Bernard ; van der Schaaf, René J. ; Baumbach, Andreas ; Smits, Pieter ; van Mieghem, Nicolas M. ; Bartorelli, Antonio ; Barragan, Paul ; Gershlick, Anthony ; Kornowski, Ran ; Macaya, Carlos ; Ormiston, John ; Hill, Jonathan ; Lang, Irene M. ; Egred, Mohaned ; Fajadet, Jean ; Lesiak, Maciej ; Windecker, Stephan ; Byrne, Robert A. ; Räber, Lorenz ; van Geuns, Robert Jan ; Mintz, Gary S. ; Onuma, Yoshinobu. / Arterial Remodeling After Bioresorbable Scaffolds and Metallic Stents. In: Journal of the American College of Cardiology. 2017 ; Vol. 70, No. 1. pp. 60-74.
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abstract = "Background Although previous observational studies have documented late luminal enlargement and expansive remodeling following implantation of a bioresorbable vascular scaffold (BVS), no comparison with metallic stents has been conducted in a randomized fashion. Objectives This study sought to compare vessel remodeling patterns after either Absorb BVS or Xience metallic drug-eluting stent (DES) implantation (Abbott Vascular, Santa Clara, California) and determine the independent predictors of remodeling. Methods In the ABSORB II randomized trial, 383 lesions (n = 359) were investigated by intravenous ultrasound both post-procedure and at 3-year follow-up. According to vessel and lumen area changes over 3 years, we categorized 9 patterns of vessel remodeling that were beyond the reproducibility of lumen and vessel area measurements. Results The relative change in mean vessel area was significantly greater with the BVS compared to the DES (6.7 ± 12.6{\%} vs. 2.9 ± 11.5{\%}; p = 0.003); the relative change in mean lumen area was significantly different between the 2 arms (1.4 ± 19.1{\%} vs. −1.9 ± 10.5{\%}, respectively; p = 0.031). Multivariate analysis indicated that use of the BVS, female sex, balloon-artery ratio >1.25, expansion index ≥0.8, previous percutaneous coronary intervention, and higher level of low-density lipoprotein cholesterol were independent predictors of expansive remodeling. Furthermore, in the BVS arm, necrotic core pre-procedure was an independent determinant of expansive remodeling. Conclusions Expansive vessel wall remodeling was more frequent and intense with the BVS than the metallic DES and could be determined by patient baseline characteristics and periprocedural factors. The clinical effect of the observed lumen and vessel remodeling must be investigated in further large clinical studies to optimize the clinical outcome of patients and lesions treated by bioresorbable scaffolds. (ABSORB II Randomized Controlled Trial; NCT01425281)",
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AU - Serruys, Patrick W.

AU - Katagiri, Yuki

AU - Sotomi, Yohei

AU - Zeng, Yaping

AU - Chevalier, Bernard

AU - van der Schaaf, René J.

AU - Baumbach, Andreas

AU - Smits, Pieter

AU - van Mieghem, Nicolas M.

AU - Bartorelli, Antonio

AU - Barragan, Paul

AU - Gershlick, Anthony

AU - Kornowski, Ran

AU - Macaya, Carlos

AU - Ormiston, John

AU - Hill, Jonathan

AU - Lang, Irene M.

AU - Egred, Mohaned

AU - Fajadet, Jean

AU - Lesiak, Maciej

AU - Windecker, Stephan

AU - Byrne, Robert A.

AU - Räber, Lorenz

AU - van Geuns, Robert Jan

AU - Mintz, Gary S.

AU - Onuma, Yoshinobu

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N2 - Background Although previous observational studies have documented late luminal enlargement and expansive remodeling following implantation of a bioresorbable vascular scaffold (BVS), no comparison with metallic stents has been conducted in a randomized fashion. Objectives This study sought to compare vessel remodeling patterns after either Absorb BVS or Xience metallic drug-eluting stent (DES) implantation (Abbott Vascular, Santa Clara, California) and determine the independent predictors of remodeling. Methods In the ABSORB II randomized trial, 383 lesions (n = 359) were investigated by intravenous ultrasound both post-procedure and at 3-year follow-up. According to vessel and lumen area changes over 3 years, we categorized 9 patterns of vessel remodeling that were beyond the reproducibility of lumen and vessel area measurements. Results The relative change in mean vessel area was significantly greater with the BVS compared to the DES (6.7 ± 12.6% vs. 2.9 ± 11.5%; p = 0.003); the relative change in mean lumen area was significantly different between the 2 arms (1.4 ± 19.1% vs. −1.9 ± 10.5%, respectively; p = 0.031). Multivariate analysis indicated that use of the BVS, female sex, balloon-artery ratio >1.25, expansion index ≥0.8, previous percutaneous coronary intervention, and higher level of low-density lipoprotein cholesterol were independent predictors of expansive remodeling. Furthermore, in the BVS arm, necrotic core pre-procedure was an independent determinant of expansive remodeling. Conclusions Expansive vessel wall remodeling was more frequent and intense with the BVS than the metallic DES and could be determined by patient baseline characteristics and periprocedural factors. The clinical effect of the observed lumen and vessel remodeling must be investigated in further large clinical studies to optimize the clinical outcome of patients and lesions treated by bioresorbable scaffolds. (ABSORB II Randomized Controlled Trial; NCT01425281)

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KW - coronary artery disease

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KW - lumen area

KW - plaque area

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