Incidence and short-term clinical outcomes of small side branch occlusion after implantation of an everolimus-eluting bioresorbable vascular scaffold: An interim report of 435 patients in the ABSORB-EXTEND single-arm trial in comparison with an everolimus-eluting metallic stent in the SPIRIT first and II trials

Takashi Muramatsu, Yoshinobu Onuma, Hector M. García-García, Vasim Farooq, Christos V. Bourantas, Marie Angèle Morel, Xiaolin Li, Susan Veldhof, Antonio Bartorelli, Robert Whitbourn, Alexandre Abizaid, Patrick W. Serruys

Research output: Contribution to journalArticle

89 Citations (Scopus)

Abstract

Objectives The aim of this study was to investigate the incidence and clinical sequelae of small side branch occlusion (SBO) after Absorb (Abbott Vascular Santa Clara, California) bioresorbable vascular scaffold (BVS) implantation. Background The thicker strut of metallic stents potentially contributes to a higher incidence of SBO. Methods We performed a post-hoc angiographic assessment of 1,209 side branches in 435 patients enrolled in the ABSORB-EXTEND single-arm trial (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions), in comparison with 682 side branches in 237 patients treated with the everolimus-eluting metallic stent (EES) in the SPIRIT (A Clinical Evaluation of an Investigational Device. The Abbott XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) first and II trials. Any visible side branches originating within the device implantation site or the 5-mm proximal and distal margins were included in the angiographic assessment. The SBO was defined as a reduction in Thrombolysis In Myocardial Infarction flow grade 0 or 1. Results Post-procedural SBO was observed in 73 side branches (6.0%) in BVS group and 28 side branches (4.1%) in EES group (p = 0.09). Patients with post-procedural SBO were significantly associated with an increased incidence of in-hospital myocardial infarction (6.5% in SBO group vs. 0.5% in non-SBO group, p <0.01). Multivariable analysis revealed that BVS was an independent predictor of post-procedural SBO (odds ratio: 2.09; 95% confidence interval: 1.18 to 3.68). By stratified analysis, BVS demonstrated a higher incidence of post-procedural SBO compared with EES only in small side branches with a reference vessel diameter ≤ 0.5 mm (10.5% vs. 3.9%, p = 0.03 between the groups, p for interaction = 0.08). Conclusions Bioresorbable vascular scaffold was associated with a higher incidence of post-procedural SBO compared with EES. This effect was more pronounced with small side branches with a reference vessel diameter ≤ 0.5 mm. (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions: NCT01023789).

Original languageEnglish
Pages (from-to)247-257
Number of pages11
JournalJACC: Cardiovascular Interventions
Volume6
Issue number3
DOIs
Publication statusPublished - Mar 2013

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Stents
Blood Vessels
Incidence
Coronary Vessels
Myocardial Infarction
Equipment and Supplies
Everolimus
Therapeutics
Odds Ratio
Confidence Intervals

Keywords

  • Bioresorbable vascular scaffold
  • Complications
  • Drug-eluting stent(s)
  • Myocardial infarction
  • Side branch occlusion

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

Incidence and short-term clinical outcomes of small side branch occlusion after implantation of an everolimus-eluting bioresorbable vascular scaffold : An interim report of 435 patients in the ABSORB-EXTEND single-arm trial in comparison with an everolimus-eluting metallic stent in the SPIRIT first and II trials. / Muramatsu, Takashi; Onuma, Yoshinobu; García-García, Hector M.; Farooq, Vasim; Bourantas, Christos V.; Morel, Marie Angèle; Li, Xiaolin; Veldhof, Susan; Bartorelli, Antonio; Whitbourn, Robert; Abizaid, Alexandre; Serruys, Patrick W.

In: JACC: Cardiovascular Interventions, Vol. 6, No. 3, 03.2013, p. 247-257.

Research output: Contribution to journalArticle

Muramatsu, Takashi ; Onuma, Yoshinobu ; García-García, Hector M. ; Farooq, Vasim ; Bourantas, Christos V. ; Morel, Marie Angèle ; Li, Xiaolin ; Veldhof, Susan ; Bartorelli, Antonio ; Whitbourn, Robert ; Abizaid, Alexandre ; Serruys, Patrick W. / Incidence and short-term clinical outcomes of small side branch occlusion after implantation of an everolimus-eluting bioresorbable vascular scaffold : An interim report of 435 patients in the ABSORB-EXTEND single-arm trial in comparison with an everolimus-eluting metallic stent in the SPIRIT first and II trials. In: JACC: Cardiovascular Interventions. 2013 ; Vol. 6, No. 3. pp. 247-257.
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abstract = "Objectives The aim of this study was to investigate the incidence and clinical sequelae of small side branch occlusion (SBO) after Absorb (Abbott Vascular Santa Clara, California) bioresorbable vascular scaffold (BVS) implantation. Background The thicker strut of metallic stents potentially contributes to a higher incidence of SBO. Methods We performed a post-hoc angiographic assessment of 1,209 side branches in 435 patients enrolled in the ABSORB-EXTEND single-arm trial (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions), in comparison with 682 side branches in 237 patients treated with the everolimus-eluting metallic stent (EES) in the SPIRIT (A Clinical Evaluation of an Investigational Device. The Abbott XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) first and II trials. Any visible side branches originating within the device implantation site or the 5-mm proximal and distal margins were included in the angiographic assessment. The SBO was defined as a reduction in Thrombolysis In Myocardial Infarction flow grade 0 or 1. Results Post-procedural SBO was observed in 73 side branches (6.0{\%}) in BVS group and 28 side branches (4.1{\%}) in EES group (p = 0.09). Patients with post-procedural SBO were significantly associated with an increased incidence of in-hospital myocardial infarction (6.5{\%} in SBO group vs. 0.5{\%} in non-SBO group, p <0.01). Multivariable analysis revealed that BVS was an independent predictor of post-procedural SBO (odds ratio: 2.09; 95{\%} confidence interval: 1.18 to 3.68). By stratified analysis, BVS demonstrated a higher incidence of post-procedural SBO compared with EES only in small side branches with a reference vessel diameter ≤ 0.5 mm (10.5{\%} vs. 3.9{\%}, p = 0.03 between the groups, p for interaction = 0.08). Conclusions Bioresorbable vascular scaffold was associated with a higher incidence of post-procedural SBO compared with EES. This effect was more pronounced with small side branches with a reference vessel diameter ≤ 0.5 mm. (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions: NCT01023789).",
keywords = "Bioresorbable vascular scaffold, Complications, Drug-eluting stent(s), Myocardial infarction, Side branch occlusion",
author = "Takashi Muramatsu and Yoshinobu Onuma and Garc{\'i}a-Garc{\'i}a, {Hector M.} and Vasim Farooq and Bourantas, {Christos V.} and Morel, {Marie Ang{\`e}le} and Xiaolin Li and Susan Veldhof and Antonio Bartorelli and Robert Whitbourn and Alexandre Abizaid and Serruys, {Patrick W.}",
year = "2013",
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TY - JOUR

T1 - Incidence and short-term clinical outcomes of small side branch occlusion after implantation of an everolimus-eluting bioresorbable vascular scaffold

T2 - An interim report of 435 patients in the ABSORB-EXTEND single-arm trial in comparison with an everolimus-eluting metallic stent in the SPIRIT first and II trials

AU - Muramatsu, Takashi

AU - Onuma, Yoshinobu

AU - García-García, Hector M.

AU - Farooq, Vasim

AU - Bourantas, Christos V.

AU - Morel, Marie Angèle

AU - Li, Xiaolin

AU - Veldhof, Susan

AU - Bartorelli, Antonio

AU - Whitbourn, Robert

AU - Abizaid, Alexandre

AU - Serruys, Patrick W.

PY - 2013/3

Y1 - 2013/3

N2 - Objectives The aim of this study was to investigate the incidence and clinical sequelae of small side branch occlusion (SBO) after Absorb (Abbott Vascular Santa Clara, California) bioresorbable vascular scaffold (BVS) implantation. Background The thicker strut of metallic stents potentially contributes to a higher incidence of SBO. Methods We performed a post-hoc angiographic assessment of 1,209 side branches in 435 patients enrolled in the ABSORB-EXTEND single-arm trial (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions), in comparison with 682 side branches in 237 patients treated with the everolimus-eluting metallic stent (EES) in the SPIRIT (A Clinical Evaluation of an Investigational Device. The Abbott XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) first and II trials. Any visible side branches originating within the device implantation site or the 5-mm proximal and distal margins were included in the angiographic assessment. The SBO was defined as a reduction in Thrombolysis In Myocardial Infarction flow grade 0 or 1. Results Post-procedural SBO was observed in 73 side branches (6.0%) in BVS group and 28 side branches (4.1%) in EES group (p = 0.09). Patients with post-procedural SBO were significantly associated with an increased incidence of in-hospital myocardial infarction (6.5% in SBO group vs. 0.5% in non-SBO group, p <0.01). Multivariable analysis revealed that BVS was an independent predictor of post-procedural SBO (odds ratio: 2.09; 95% confidence interval: 1.18 to 3.68). By stratified analysis, BVS demonstrated a higher incidence of post-procedural SBO compared with EES only in small side branches with a reference vessel diameter ≤ 0.5 mm (10.5% vs. 3.9%, p = 0.03 between the groups, p for interaction = 0.08). Conclusions Bioresorbable vascular scaffold was associated with a higher incidence of post-procedural SBO compared with EES. This effect was more pronounced with small side branches with a reference vessel diameter ≤ 0.5 mm. (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions: NCT01023789).

AB - Objectives The aim of this study was to investigate the incidence and clinical sequelae of small side branch occlusion (SBO) after Absorb (Abbott Vascular Santa Clara, California) bioresorbable vascular scaffold (BVS) implantation. Background The thicker strut of metallic stents potentially contributes to a higher incidence of SBO. Methods We performed a post-hoc angiographic assessment of 1,209 side branches in 435 patients enrolled in the ABSORB-EXTEND single-arm trial (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions), in comparison with 682 side branches in 237 patients treated with the everolimus-eluting metallic stent (EES) in the SPIRIT (A Clinical Evaluation of an Investigational Device. The Abbott XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) first and II trials. Any visible side branches originating within the device implantation site or the 5-mm proximal and distal margins were included in the angiographic assessment. The SBO was defined as a reduction in Thrombolysis In Myocardial Infarction flow grade 0 or 1. Results Post-procedural SBO was observed in 73 side branches (6.0%) in BVS group and 28 side branches (4.1%) in EES group (p = 0.09). Patients with post-procedural SBO were significantly associated with an increased incidence of in-hospital myocardial infarction (6.5% in SBO group vs. 0.5% in non-SBO group, p <0.01). Multivariable analysis revealed that BVS was an independent predictor of post-procedural SBO (odds ratio: 2.09; 95% confidence interval: 1.18 to 3.68). By stratified analysis, BVS demonstrated a higher incidence of post-procedural SBO compared with EES only in small side branches with a reference vessel diameter ≤ 0.5 mm (10.5% vs. 3.9%, p = 0.03 between the groups, p for interaction = 0.08). Conclusions Bioresorbable vascular scaffold was associated with a higher incidence of post-procedural SBO compared with EES. This effect was more pronounced with small side branches with a reference vessel diameter ≤ 0.5 mm. (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions: NCT01023789).

KW - Bioresorbable vascular scaffold

KW - Complications

KW - Drug-eluting stent(s)

KW - Myocardial infarction

KW - Side branch occlusion

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