One-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents

A propensity score comparison of patients enrolled in the ABSORB EXTEND and SPIRIT trials

José De Ribamar Costa, Alexandre Abizaid, Antonio L. Bartorelli, Robert Whitbourn, Nigel Jepson, Marco Perin, Clemens Steinwender, Marrianne Stuteville, Divine Ediebah, Krishnankutty Sudhir, Patrick W. Serruys

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Aims: We sought to compare the outcomes of low/moderate complexity patients treated with the Absorb BVS from the ABSORB EXTEND trial with patients treated with the XIENCE everolimus-eluting stent (EES), using propensity score (PS) matching of pooled data from the SPIRIT trials (SPIRIT II, SPIRIT III, SPIRIT IV) and the XIENCE V USA trial. Methods and results: ABSORB EXTEND was a prospective, single-Arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and with a reference vessel diameter of 2.0-3.8 mm (as assessed by online QCA). The propensity score was obtained by fitting a logistic regression model with the cohort indicator as the binary outcome and other variables as the predictor variables. At one-year clinical follow-up, there was no statistical difference between groups with regard to MACE (5.0% vs. 4.8%, p=0.83), target lesion failure (5.0% vs. 4.7%, p=0.74), ischaemia-driven target vessel revascularisation (2.3% vs. 3.0%, p=0.38) and device thrombosis (1.0% vs. 0.3%, p=0.11). Myocardial infarction was higher with Absorb (3.3% vs. 1.5%, p=0.02), at the expense of periprocedural CK-MB elevation. Independent predictors of MACE among patients receiving Absorb BVS were treatment of multivessel disease, insulin-dependent diabetes and performance of post-dilation. Conclusions: At one-year follow-up, propensity score-matched analysis demonstrated that the clinical safety and effectiveness of Absorb are comparable to those of XIENCE EES among non-complex patients treated with PCI.

Original languageEnglish
Pages (from-to)1255-1262
Number of pages8
JournalEuroIntervention
Volume12
Issue number10
DOIs
Publication statusPublished - Nov 1 2016

Fingerprint

Propensity Score
Stents
Blood Vessels
Logistic Models
Dilatation
Thrombosis
Ischemia
Myocardial Infarction
Everolimus
Insulin
Safety
Equipment and Supplies
Therapeutics

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

One-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents : A propensity score comparison of patients enrolled in the ABSORB EXTEND and SPIRIT trials. / De Ribamar Costa, José; Abizaid, Alexandre; Bartorelli, Antonio L.; Whitbourn, Robert; Jepson, Nigel; Perin, Marco; Steinwender, Clemens; Stuteville, Marrianne; Ediebah, Divine; Sudhir, Krishnankutty; Serruys, Patrick W.

In: EuroIntervention, Vol. 12, No. 10, 01.11.2016, p. 1255-1262.

Research output: Contribution to journalArticle

De Ribamar Costa, José ; Abizaid, Alexandre ; Bartorelli, Antonio L. ; Whitbourn, Robert ; Jepson, Nigel ; Perin, Marco ; Steinwender, Clemens ; Stuteville, Marrianne ; Ediebah, Divine ; Sudhir, Krishnankutty ; Serruys, Patrick W. / One-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents : A propensity score comparison of patients enrolled in the ABSORB EXTEND and SPIRIT trials. In: EuroIntervention. 2016 ; Vol. 12, No. 10. pp. 1255-1262.
@article{ec376ca22f9f48f4b7ba9c356d7af5b0,
title = "One-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: A propensity score comparison of patients enrolled in the ABSORB EXTEND and SPIRIT trials",
abstract = "Aims: We sought to compare the outcomes of low/moderate complexity patients treated with the Absorb BVS from the ABSORB EXTEND trial with patients treated with the XIENCE everolimus-eluting stent (EES), using propensity score (PS) matching of pooled data from the SPIRIT trials (SPIRIT II, SPIRIT III, SPIRIT IV) and the XIENCE V USA trial. Methods and results: ABSORB EXTEND was a prospective, single-Arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and with a reference vessel diameter of 2.0-3.8 mm (as assessed by online QCA). The propensity score was obtained by fitting a logistic regression model with the cohort indicator as the binary outcome and other variables as the predictor variables. At one-year clinical follow-up, there was no statistical difference between groups with regard to MACE (5.0{\%} vs. 4.8{\%}, p=0.83), target lesion failure (5.0{\%} vs. 4.7{\%}, p=0.74), ischaemia-driven target vessel revascularisation (2.3{\%} vs. 3.0{\%}, p=0.38) and device thrombosis (1.0{\%} vs. 0.3{\%}, p=0.11). Myocardial infarction was higher with Absorb (3.3{\%} vs. 1.5{\%}, p=0.02), at the expense of periprocedural CK-MB elevation. Independent predictors of MACE among patients receiving Absorb BVS were treatment of multivessel disease, insulin-dependent diabetes and performance of post-dilation. Conclusions: At one-year follow-up, propensity score-matched analysis demonstrated that the clinical safety and effectiveness of Absorb are comparable to those of XIENCE EES among non-complex patients treated with PCI.",
author = "{De Ribamar Costa}, Jos{\'e} and Alexandre Abizaid and Bartorelli, {Antonio L.} and Robert Whitbourn and Nigel Jepson and Marco Perin and Clemens Steinwender and Marrianne Stuteville and Divine Ediebah and Krishnankutty Sudhir and Serruys, {Patrick W.}",
year = "2016",
month = "11",
day = "1",
doi = "10.4244/EIJV12I10A206",
language = "English",
volume = "12",
pages = "1255--1262",
journal = "EuroIntervention",
issn = "1774-024X",
publisher = "EuroPCR",
number = "10",

}

TY - JOUR

T1 - One-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents

T2 - A propensity score comparison of patients enrolled in the ABSORB EXTEND and SPIRIT trials

AU - De Ribamar Costa, José

AU - Abizaid, Alexandre

AU - Bartorelli, Antonio L.

AU - Whitbourn, Robert

AU - Jepson, Nigel

AU - Perin, Marco

AU - Steinwender, Clemens

AU - Stuteville, Marrianne

AU - Ediebah, Divine

AU - Sudhir, Krishnankutty

AU - Serruys, Patrick W.

PY - 2016/11/1

Y1 - 2016/11/1

N2 - Aims: We sought to compare the outcomes of low/moderate complexity patients treated with the Absorb BVS from the ABSORB EXTEND trial with patients treated with the XIENCE everolimus-eluting stent (EES), using propensity score (PS) matching of pooled data from the SPIRIT trials (SPIRIT II, SPIRIT III, SPIRIT IV) and the XIENCE V USA trial. Methods and results: ABSORB EXTEND was a prospective, single-Arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and with a reference vessel diameter of 2.0-3.8 mm (as assessed by online QCA). The propensity score was obtained by fitting a logistic regression model with the cohort indicator as the binary outcome and other variables as the predictor variables. At one-year clinical follow-up, there was no statistical difference between groups with regard to MACE (5.0% vs. 4.8%, p=0.83), target lesion failure (5.0% vs. 4.7%, p=0.74), ischaemia-driven target vessel revascularisation (2.3% vs. 3.0%, p=0.38) and device thrombosis (1.0% vs. 0.3%, p=0.11). Myocardial infarction was higher with Absorb (3.3% vs. 1.5%, p=0.02), at the expense of periprocedural CK-MB elevation. Independent predictors of MACE among patients receiving Absorb BVS were treatment of multivessel disease, insulin-dependent diabetes and performance of post-dilation. Conclusions: At one-year follow-up, propensity score-matched analysis demonstrated that the clinical safety and effectiveness of Absorb are comparable to those of XIENCE EES among non-complex patients treated with PCI.

AB - Aims: We sought to compare the outcomes of low/moderate complexity patients treated with the Absorb BVS from the ABSORB EXTEND trial with patients treated with the XIENCE everolimus-eluting stent (EES), using propensity score (PS) matching of pooled data from the SPIRIT trials (SPIRIT II, SPIRIT III, SPIRIT IV) and the XIENCE V USA trial. Methods and results: ABSORB EXTEND was a prospective, single-Arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and with a reference vessel diameter of 2.0-3.8 mm (as assessed by online QCA). The propensity score was obtained by fitting a logistic regression model with the cohort indicator as the binary outcome and other variables as the predictor variables. At one-year clinical follow-up, there was no statistical difference between groups with regard to MACE (5.0% vs. 4.8%, p=0.83), target lesion failure (5.0% vs. 4.7%, p=0.74), ischaemia-driven target vessel revascularisation (2.3% vs. 3.0%, p=0.38) and device thrombosis (1.0% vs. 0.3%, p=0.11). Myocardial infarction was higher with Absorb (3.3% vs. 1.5%, p=0.02), at the expense of periprocedural CK-MB elevation. Independent predictors of MACE among patients receiving Absorb BVS were treatment of multivessel disease, insulin-dependent diabetes and performance of post-dilation. Conclusions: At one-year follow-up, propensity score-matched analysis demonstrated that the clinical safety and effectiveness of Absorb are comparable to those of XIENCE EES among non-complex patients treated with PCI.

UR - http://www.scopus.com/inward/record.url?scp=85002444319&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85002444319&partnerID=8YFLogxK

U2 - 10.4244/EIJV12I10A206

DO - 10.4244/EIJV12I10A206

M3 - Article

VL - 12

SP - 1255

EP - 1262

JO - EuroIntervention

JF - EuroIntervention

SN - 1774-024X

IS - 10

ER -