1-Year Outcomes of Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Stents A Propensity-Matched Comparison of the GHOST-EU and XIENCE v USA Registries

Corrado Tamburino, Piera Capranzano, Tommaso Gori, Azeem Latib, MacIej Lesiak, Holger Nef, Giuseppe Caramanno, Christopher Naber, Julinda Mehilli, Carlo Di Mario, Manel Sabaté, Thomas Münzel, Antonio Colombo, Aleksander Araszkiewicz, Jens Wiebe, Salvatore Geraci, Christoph Jensen, Alessio Mattesini, Salvatore Brugaletta, Davide Capodanno

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

Objectives The purpose of this study was to compare the 1-year outcomes of the ABSORB everolimus-eluting bioresorbable scaffold (BRS) (Abbott Vascular, Santa Clara, California) and the XIENCE everolimus-eluting stent (EES) (Abbott Vascular) in patients undergoing percutaneous coronary intervention. Background Randomized studies of the ABSORB BRS have been performed in selected patient and lesion scenarios. The available registries of the ABSORB BRS reflect real-world practice more closely compared with randomized studies, but most of them are limited by the small sample size and the lack of comparative outcomes versus second-generation drug-eluting stents. Methods A total of 1,189 consecutive patients treated with ABSORB BRS from the GHOST-EU (Gauging coronary Healing with bioresorbable Scaffolding plaTforms in EUrope) registry and 5,034 patients treated with XIENCE EES from the XIENCE V USA registry were analyzed. Clinical outcomes were compared with the use of propensity-score matching techniques and reported as Kaplan-Meier estimates and absolute risk difference (D) with 95% confidence intervals (CIs). The primary endpoint was a device-oriented composite endpoint, including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 1-year follow-up. Results After propensity score matching was performed for the entire population (N = 6,223), there were 905 matched pairs of patients. In the matched cohort (N = 1,810), there was no significant difference between ABSORB BRS and XIENCE EES in the risk of device-oriented composite endpoint at 1 year (5.8% vs. 7.6%, D = -1.8 [95% CI: -4.1 to 0.5]; p = 0.12). Cardiac death was less likely to occur in the ABSORB BRS group (0.7% vs. 1.9%, D = -1.2 [95% CI: -2.2 to 0.2]; p = 0.03), and a trend toward a reduction in myocardial infarction was noted with ABSORB BRS compared with XIENCE EES (2.4% vs. 4.0%, D = -1.6 [95% CI: -3.2 to 0.0]; p = 0.07). Conversely, no differences in ischemia-driven target lesion revascularization (4.6% vs. 3.5%, D = 1.1 [95% CI: -0.7 to 2.9]; p = 0.22) and definite or probable device thrombosis (1.8% vs. 1.1%, D = 0.7 [95% CI: -0.4 to 1.8]; p = 0.23) were detected between ABSORB BRS and XIENCE EES. Conclusions In a contemporary large cohort of patients undergoing percutaneous coronary intervention with ABSORB BRS, the combined rate of ischemic events at 1 year was low and nonsignificantly different compared with matched patients treated with XIENCE EES.

Original languageEnglish
Pages (from-to)440-449
Number of pages10
JournalJACC: Cardiovascular Interventions
Volume9
Issue number5
DOIs
Publication statusPublished - Mar 14 2016

Fingerprint

Stents
Registries
Confidence Intervals
Propensity Score
Percutaneous Coronary Intervention
Equipment and Supplies
Blood Vessels
Myocardial Infarction
Drug-Eluting Stents
Kaplan-Meier Estimate
Everolimus
Sample Size
Myocardial Ischemia
Thrombosis
Ischemia
Population

Keywords

  • bioresorbable scaffolds
  • drug-eluting stent(s)
  • propensity score

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

1-Year Outcomes of Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Stents A Propensity-Matched Comparison of the GHOST-EU and XIENCE v USA Registries. / Tamburino, Corrado; Capranzano, Piera; Gori, Tommaso; Latib, Azeem; Lesiak, MacIej; Nef, Holger; Caramanno, Giuseppe; Naber, Christopher; Mehilli, Julinda; Di Mario, Carlo; Sabaté, Manel; Münzel, Thomas; Colombo, Antonio; Araszkiewicz, Aleksander; Wiebe, Jens; Geraci, Salvatore; Jensen, Christoph; Mattesini, Alessio; Brugaletta, Salvatore; Capodanno, Davide.

In: JACC: Cardiovascular Interventions, Vol. 9, No. 5, 14.03.2016, p. 440-449.

Research output: Contribution to journalArticle

Tamburino, C, Capranzano, P, Gori, T, Latib, A, Lesiak, M, Nef, H, Caramanno, G, Naber, C, Mehilli, J, Di Mario, C, Sabaté, M, Münzel, T, Colombo, A, Araszkiewicz, A, Wiebe, J, Geraci, S, Jensen, C, Mattesini, A, Brugaletta, S & Capodanno, D 2016, '1-Year Outcomes of Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Stents A Propensity-Matched Comparison of the GHOST-EU and XIENCE v USA Registries', JACC: Cardiovascular Interventions, vol. 9, no. 5, pp. 440-449. https://doi.org/10.1016/j.jcin.2015.10.042
Tamburino, Corrado ; Capranzano, Piera ; Gori, Tommaso ; Latib, Azeem ; Lesiak, MacIej ; Nef, Holger ; Caramanno, Giuseppe ; Naber, Christopher ; Mehilli, Julinda ; Di Mario, Carlo ; Sabaté, Manel ; Münzel, Thomas ; Colombo, Antonio ; Araszkiewicz, Aleksander ; Wiebe, Jens ; Geraci, Salvatore ; Jensen, Christoph ; Mattesini, Alessio ; Brugaletta, Salvatore ; Capodanno, Davide. / 1-Year Outcomes of Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Stents A Propensity-Matched Comparison of the GHOST-EU and XIENCE v USA Registries. In: JACC: Cardiovascular Interventions. 2016 ; Vol. 9, No. 5. pp. 440-449.
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abstract = "Objectives The purpose of this study was to compare the 1-year outcomes of the ABSORB everolimus-eluting bioresorbable scaffold (BRS) (Abbott Vascular, Santa Clara, California) and the XIENCE everolimus-eluting stent (EES) (Abbott Vascular) in patients undergoing percutaneous coronary intervention. Background Randomized studies of the ABSORB BRS have been performed in selected patient and lesion scenarios. The available registries of the ABSORB BRS reflect real-world practice more closely compared with randomized studies, but most of them are limited by the small sample size and the lack of comparative outcomes versus second-generation drug-eluting stents. Methods A total of 1,189 consecutive patients treated with ABSORB BRS from the GHOST-EU (Gauging coronary Healing with bioresorbable Scaffolding plaTforms in EUrope) registry and 5,034 patients treated with XIENCE EES from the XIENCE V USA registry were analyzed. Clinical outcomes were compared with the use of propensity-score matching techniques and reported as Kaplan-Meier estimates and absolute risk difference (D) with 95{\%} confidence intervals (CIs). The primary endpoint was a device-oriented composite endpoint, including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 1-year follow-up. Results After propensity score matching was performed for the entire population (N = 6,223), there were 905 matched pairs of patients. In the matched cohort (N = 1,810), there was no significant difference between ABSORB BRS and XIENCE EES in the risk of device-oriented composite endpoint at 1 year (5.8{\%} vs. 7.6{\%}, D = -1.8 [95{\%} CI: -4.1 to 0.5]; p = 0.12). Cardiac death was less likely to occur in the ABSORB BRS group (0.7{\%} vs. 1.9{\%}, D = -1.2 [95{\%} CI: -2.2 to 0.2]; p = 0.03), and a trend toward a reduction in myocardial infarction was noted with ABSORB BRS compared with XIENCE EES (2.4{\%} vs. 4.0{\%}, D = -1.6 [95{\%} CI: -3.2 to 0.0]; p = 0.07). Conversely, no differences in ischemia-driven target lesion revascularization (4.6{\%} vs. 3.5{\%}, D = 1.1 [95{\%} CI: -0.7 to 2.9]; p = 0.22) and definite or probable device thrombosis (1.8{\%} vs. 1.1{\%}, D = 0.7 [95{\%} CI: -0.4 to 1.8]; p = 0.23) were detected between ABSORB BRS and XIENCE EES. Conclusions In a contemporary large cohort of patients undergoing percutaneous coronary intervention with ABSORB BRS, the combined rate of ischemic events at 1 year was low and nonsignificantly different compared with matched patients treated with XIENCE EES.",
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TY - JOUR

T1 - 1-Year Outcomes of Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Stents A Propensity-Matched Comparison of the GHOST-EU and XIENCE v USA Registries

AU - Tamburino, Corrado

AU - Capranzano, Piera

AU - Gori, Tommaso

AU - Latib, Azeem

AU - Lesiak, MacIej

AU - Nef, Holger

AU - Caramanno, Giuseppe

AU - Naber, Christopher

AU - Mehilli, Julinda

AU - Di Mario, Carlo

AU - Sabaté, Manel

AU - Münzel, Thomas

AU - Colombo, Antonio

AU - Araszkiewicz, Aleksander

AU - Wiebe, Jens

AU - Geraci, Salvatore

AU - Jensen, Christoph

AU - Mattesini, Alessio

AU - Brugaletta, Salvatore

AU - Capodanno, Davide

PY - 2016/3/14

Y1 - 2016/3/14

N2 - Objectives The purpose of this study was to compare the 1-year outcomes of the ABSORB everolimus-eluting bioresorbable scaffold (BRS) (Abbott Vascular, Santa Clara, California) and the XIENCE everolimus-eluting stent (EES) (Abbott Vascular) in patients undergoing percutaneous coronary intervention. Background Randomized studies of the ABSORB BRS have been performed in selected patient and lesion scenarios. The available registries of the ABSORB BRS reflect real-world practice more closely compared with randomized studies, but most of them are limited by the small sample size and the lack of comparative outcomes versus second-generation drug-eluting stents. Methods A total of 1,189 consecutive patients treated with ABSORB BRS from the GHOST-EU (Gauging coronary Healing with bioresorbable Scaffolding plaTforms in EUrope) registry and 5,034 patients treated with XIENCE EES from the XIENCE V USA registry were analyzed. Clinical outcomes were compared with the use of propensity-score matching techniques and reported as Kaplan-Meier estimates and absolute risk difference (D) with 95% confidence intervals (CIs). The primary endpoint was a device-oriented composite endpoint, including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 1-year follow-up. Results After propensity score matching was performed for the entire population (N = 6,223), there were 905 matched pairs of patients. In the matched cohort (N = 1,810), there was no significant difference between ABSORB BRS and XIENCE EES in the risk of device-oriented composite endpoint at 1 year (5.8% vs. 7.6%, D = -1.8 [95% CI: -4.1 to 0.5]; p = 0.12). Cardiac death was less likely to occur in the ABSORB BRS group (0.7% vs. 1.9%, D = -1.2 [95% CI: -2.2 to 0.2]; p = 0.03), and a trend toward a reduction in myocardial infarction was noted with ABSORB BRS compared with XIENCE EES (2.4% vs. 4.0%, D = -1.6 [95% CI: -3.2 to 0.0]; p = 0.07). Conversely, no differences in ischemia-driven target lesion revascularization (4.6% vs. 3.5%, D = 1.1 [95% CI: -0.7 to 2.9]; p = 0.22) and definite or probable device thrombosis (1.8% vs. 1.1%, D = 0.7 [95% CI: -0.4 to 1.8]; p = 0.23) were detected between ABSORB BRS and XIENCE EES. Conclusions In a contemporary large cohort of patients undergoing percutaneous coronary intervention with ABSORB BRS, the combined rate of ischemic events at 1 year was low and nonsignificantly different compared with matched patients treated with XIENCE EES.

AB - Objectives The purpose of this study was to compare the 1-year outcomes of the ABSORB everolimus-eluting bioresorbable scaffold (BRS) (Abbott Vascular, Santa Clara, California) and the XIENCE everolimus-eluting stent (EES) (Abbott Vascular) in patients undergoing percutaneous coronary intervention. Background Randomized studies of the ABSORB BRS have been performed in selected patient and lesion scenarios. The available registries of the ABSORB BRS reflect real-world practice more closely compared with randomized studies, but most of them are limited by the small sample size and the lack of comparative outcomes versus second-generation drug-eluting stents. Methods A total of 1,189 consecutive patients treated with ABSORB BRS from the GHOST-EU (Gauging coronary Healing with bioresorbable Scaffolding plaTforms in EUrope) registry and 5,034 patients treated with XIENCE EES from the XIENCE V USA registry were analyzed. Clinical outcomes were compared with the use of propensity-score matching techniques and reported as Kaplan-Meier estimates and absolute risk difference (D) with 95% confidence intervals (CIs). The primary endpoint was a device-oriented composite endpoint, including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 1-year follow-up. Results After propensity score matching was performed for the entire population (N = 6,223), there were 905 matched pairs of patients. In the matched cohort (N = 1,810), there was no significant difference between ABSORB BRS and XIENCE EES in the risk of device-oriented composite endpoint at 1 year (5.8% vs. 7.6%, D = -1.8 [95% CI: -4.1 to 0.5]; p = 0.12). Cardiac death was less likely to occur in the ABSORB BRS group (0.7% vs. 1.9%, D = -1.2 [95% CI: -2.2 to 0.2]; p = 0.03), and a trend toward a reduction in myocardial infarction was noted with ABSORB BRS compared with XIENCE EES (2.4% vs. 4.0%, D = -1.6 [95% CI: -3.2 to 0.0]; p = 0.07). Conversely, no differences in ischemia-driven target lesion revascularization (4.6% vs. 3.5%, D = 1.1 [95% CI: -0.7 to 2.9]; p = 0.22) and definite or probable device thrombosis (1.8% vs. 1.1%, D = 0.7 [95% CI: -0.4 to 1.8]; p = 0.23) were detected between ABSORB BRS and XIENCE EES. Conclusions In a contemporary large cohort of patients undergoing percutaneous coronary intervention with ABSORB BRS, the combined rate of ischemic events at 1 year was low and nonsignificantly different compared with matched patients treated with XIENCE EES.

KW - bioresorbable scaffolds

KW - drug-eluting stent(s)

KW - propensity score

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