Blinded outcomes and angina assessment of coronary bioresorbable scaffolds

30-day and 1-year results from the ABSORB IV randomised trial

ABSORB IV Investigators

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Background: Previous studies showed more adverse events with coronary bioresorbable vascular scaffolds (BVS) than with metallic drug-eluting stents (DES), although in one randomised trial angina was reduced with BVS. However, these early studies were unmasked, lesions smaller than intended for the scaffold were frequently enrolled, implantation technique was suboptimal, and patients with myocardial infarction, in whom BVS might be well suited, were excluded. Methods: In the active-controlled, blinded, multicentre, randomised ABSORB IV trial, patients with stable coronary artery disease or acute coronary syndromes aged 18 years or older were recruited from 147 hospitals in five countries (the USA, Germany, Australia, Singapore, and Canada). Enrolled patients were randomly assigned (1:1) to receive polymeric everolimus-eluting BVS (Absorb; Abbott Vascular, Santa Clara, CA, USA) with optimised implantation technique or cobalt-chromium everolimus-eluting stents (EES; Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetic status, whether patients would have been eligible for enrolment in the previous ABSORB III trial, and site. Patients and clinical assessors were masked to randomisation. The primary endpoint was target lesion failure (cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation) at 30 days, tested for non-inferiority with a 2·9% margin for the risk difference. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02173379, and is closed to accrual. Findings: Between Aug 15, 2014, and March 31, 2017, we screened 18 722 patients for eligibility, 2604 of whom were enrolled. 1296 patients were assigned to BVS, and 1308 patients were assigned to EES. Follow-up data at 30 days and 1 year, respectively, were available for 1288 and 1254 patients with BVS and for 1303 and 1272 patients with EES. Biomarker-positive acute coronary syndromes were present in 622 (24%) of 2602 patients, and, by angiographic core laboratory analysis, 78 (3%) of 2893 of lesions were in very small vessels. Target lesion failure at 30 days occurred in 64 (5·0%) patients assigned to BVS and 48 (3·7%) patients assigned to EES (difference 1·3%, upper 97·5% confidence limit 2·89; one-sided p non-inferiority =0·0244). Target lesion failure at 1 year occurred in 98 (7·8%) patients assigned to BVS and 82 (6·4%) patients assigned to EES (difference 1·4%, upper 97·5% confidence limit 3·4; one-sided p non-inferiority =0·0006). Angina, adjudicated by a central events committee at 1 year, occurred in 270 (20·3%) patients assigned to BVS and 274 (20·5%) patients assigned to EES (difference −0·3%, 95% CI −3·4% to 2·9%; one-sided p non-inferiority =0·0008; two-sided p superiority =0·8603). Device thrombosis within 1 year occurred in nine (0·7%) patients assigned to BVS and four (0·3%) patients assigned to EES (p=0·1586). Interpretation: Polymeric BVS implanted with optimised technique in an expanded patient population resulted in non-inferior 30-day and 1-year rates of target lesion failure and angina compared with metallic DES. Funding: Abbott Vascular.

Original languageEnglish (US)
Pages (from-to)1530-1540
Number of pages11
JournalThe Lancet
Volume392
Issue number10157
DOIs
StatePublished - Oct 27 2018
Externally publishedYes

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Outcome Assessment (Health Care)
Blood Vessels
Drug-Eluting Stents
Acute Coronary Syndrome
Random Allocation
Myocardial Infarction
Intention to Treat Analysis
Singapore
Chromium
Cobalt
Canada
Stents
Myocardial Ischemia
Germany
Coronary Artery Disease
Thrombosis
Biomarkers

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

@article{ba28454c83bd43248c12059f9e5c5da2,
title = "Blinded outcomes and angina assessment of coronary bioresorbable scaffolds: 30-day and 1-year results from the ABSORB IV randomised trial",
abstract = "Background: Previous studies showed more adverse events with coronary bioresorbable vascular scaffolds (BVS) than with metallic drug-eluting stents (DES), although in one randomised trial angina was reduced with BVS. However, these early studies were unmasked, lesions smaller than intended for the scaffold were frequently enrolled, implantation technique was suboptimal, and patients with myocardial infarction, in whom BVS might be well suited, were excluded. Methods: In the active-controlled, blinded, multicentre, randomised ABSORB IV trial, patients with stable coronary artery disease or acute coronary syndromes aged 18 years or older were recruited from 147 hospitals in five countries (the USA, Germany, Australia, Singapore, and Canada). Enrolled patients were randomly assigned (1:1) to receive polymeric everolimus-eluting BVS (Absorb; Abbott Vascular, Santa Clara, CA, USA) with optimised implantation technique or cobalt-chromium everolimus-eluting stents (EES; Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetic status, whether patients would have been eligible for enrolment in the previous ABSORB III trial, and site. Patients and clinical assessors were masked to randomisation. The primary endpoint was target lesion failure (cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation) at 30 days, tested for non-inferiority with a 2·9{\%} margin for the risk difference. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02173379, and is closed to accrual. Findings: Between Aug 15, 2014, and March 31, 2017, we screened 18 722 patients for eligibility, 2604 of whom were enrolled. 1296 patients were assigned to BVS, and 1308 patients were assigned to EES. Follow-up data at 30 days and 1 year, respectively, were available for 1288 and 1254 patients with BVS and for 1303 and 1272 patients with EES. Biomarker-positive acute coronary syndromes were present in 622 (24{\%}) of 2602 patients, and, by angiographic core laboratory analysis, 78 (3{\%}) of 2893 of lesions were in very small vessels. Target lesion failure at 30 days occurred in 64 (5·0{\%}) patients assigned to BVS and 48 (3·7{\%}) patients assigned to EES (difference 1·3{\%}, upper 97·5{\%} confidence limit 2·89; one-sided p non-inferiority =0·0244). Target lesion failure at 1 year occurred in 98 (7·8{\%}) patients assigned to BVS and 82 (6·4{\%}) patients assigned to EES (difference 1·4{\%}, upper 97·5{\%} confidence limit 3·4; one-sided p non-inferiority =0·0006). Angina, adjudicated by a central events committee at 1 year, occurred in 270 (20·3{\%}) patients assigned to BVS and 274 (20·5{\%}) patients assigned to EES (difference −0·3{\%}, 95{\%} CI −3·4{\%} to 2·9{\%}; one-sided p non-inferiority =0·0008; two-sided p superiority =0·8603). Device thrombosis within 1 year occurred in nine (0·7{\%}) patients assigned to BVS and four (0·3{\%}) patients assigned to EES (p=0·1586). Interpretation: Polymeric BVS implanted with optimised technique in an expanded patient population resulted in non-inferior 30-day and 1-year rates of target lesion failure and angina compared with metallic DES. Funding: Abbott Vascular.",
author = "{ABSORB IV Investigators} and Stone, {Gregg W.} and Ellis, {Stephen G.} and Tommaso Gori and Metzger, {D. Christopher} and Bernardo Stein and Matthew Erickson and Jan Torzewski and Jerome Williams and William Lawson and Broderick, {Thomas M.} and Ameer Kabour and Guy Piegari and Jeffrey Cavendish and Barry Bertolet and Choi, {James W.} and Marx, {Steven O.} and Philippe Genereux and Kereiakes, {Dean J.}",
year = "2018",
month = "10",
day = "27",
doi = "10.1016/S0140-6736(18)32283-9",
language = "English (US)",
volume = "392",
pages = "1530--1540",
journal = "The Lancet",
issn = "0140-6736",
publisher = "Elsevier Limited",
number = "10157",

}

Blinded outcomes and angina assessment of coronary bioresorbable scaffolds : 30-day and 1-year results from the ABSORB IV randomised trial. / ABSORB IV Investigators.

In: The Lancet, Vol. 392, No. 10157, 27.10.2018, p. 1530-1540.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Blinded outcomes and angina assessment of coronary bioresorbable scaffolds

T2 - 30-day and 1-year results from the ABSORB IV randomised trial

AU - ABSORB IV Investigators

AU - Stone, Gregg W.

AU - Ellis, Stephen G.

AU - Gori, Tommaso

AU - Metzger, D. Christopher

AU - Stein, Bernardo

AU - Erickson, Matthew

AU - Torzewski, Jan

AU - Williams, Jerome

AU - Lawson, William

AU - Broderick, Thomas M.

AU - Kabour, Ameer

AU - Piegari, Guy

AU - Cavendish, Jeffrey

AU - Bertolet, Barry

AU - Choi, James W.

AU - Marx, Steven O.

AU - Genereux, Philippe

AU - Kereiakes, Dean J.

PY - 2018/10/27

Y1 - 2018/10/27

N2 - Background: Previous studies showed more adverse events with coronary bioresorbable vascular scaffolds (BVS) than with metallic drug-eluting stents (DES), although in one randomised trial angina was reduced with BVS. However, these early studies were unmasked, lesions smaller than intended for the scaffold were frequently enrolled, implantation technique was suboptimal, and patients with myocardial infarction, in whom BVS might be well suited, were excluded. Methods: In the active-controlled, blinded, multicentre, randomised ABSORB IV trial, patients with stable coronary artery disease or acute coronary syndromes aged 18 years or older were recruited from 147 hospitals in five countries (the USA, Germany, Australia, Singapore, and Canada). Enrolled patients were randomly assigned (1:1) to receive polymeric everolimus-eluting BVS (Absorb; Abbott Vascular, Santa Clara, CA, USA) with optimised implantation technique or cobalt-chromium everolimus-eluting stents (EES; Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetic status, whether patients would have been eligible for enrolment in the previous ABSORB III trial, and site. Patients and clinical assessors were masked to randomisation. The primary endpoint was target lesion failure (cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation) at 30 days, tested for non-inferiority with a 2·9% margin for the risk difference. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02173379, and is closed to accrual. Findings: Between Aug 15, 2014, and March 31, 2017, we screened 18 722 patients for eligibility, 2604 of whom were enrolled. 1296 patients were assigned to BVS, and 1308 patients were assigned to EES. Follow-up data at 30 days and 1 year, respectively, were available for 1288 and 1254 patients with BVS and for 1303 and 1272 patients with EES. Biomarker-positive acute coronary syndromes were present in 622 (24%) of 2602 patients, and, by angiographic core laboratory analysis, 78 (3%) of 2893 of lesions were in very small vessels. Target lesion failure at 30 days occurred in 64 (5·0%) patients assigned to BVS and 48 (3·7%) patients assigned to EES (difference 1·3%, upper 97·5% confidence limit 2·89; one-sided p non-inferiority =0·0244). Target lesion failure at 1 year occurred in 98 (7·8%) patients assigned to BVS and 82 (6·4%) patients assigned to EES (difference 1·4%, upper 97·5% confidence limit 3·4; one-sided p non-inferiority =0·0006). Angina, adjudicated by a central events committee at 1 year, occurred in 270 (20·3%) patients assigned to BVS and 274 (20·5%) patients assigned to EES (difference −0·3%, 95% CI −3·4% to 2·9%; one-sided p non-inferiority =0·0008; two-sided p superiority =0·8603). Device thrombosis within 1 year occurred in nine (0·7%) patients assigned to BVS and four (0·3%) patients assigned to EES (p=0·1586). Interpretation: Polymeric BVS implanted with optimised technique in an expanded patient population resulted in non-inferior 30-day and 1-year rates of target lesion failure and angina compared with metallic DES. Funding: Abbott Vascular.

AB - Background: Previous studies showed more adverse events with coronary bioresorbable vascular scaffolds (BVS) than with metallic drug-eluting stents (DES), although in one randomised trial angina was reduced with BVS. However, these early studies were unmasked, lesions smaller than intended for the scaffold were frequently enrolled, implantation technique was suboptimal, and patients with myocardial infarction, in whom BVS might be well suited, were excluded. Methods: In the active-controlled, blinded, multicentre, randomised ABSORB IV trial, patients with stable coronary artery disease or acute coronary syndromes aged 18 years or older were recruited from 147 hospitals in five countries (the USA, Germany, Australia, Singapore, and Canada). Enrolled patients were randomly assigned (1:1) to receive polymeric everolimus-eluting BVS (Absorb; Abbott Vascular, Santa Clara, CA, USA) with optimised implantation technique or cobalt-chromium everolimus-eluting stents (EES; Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetic status, whether patients would have been eligible for enrolment in the previous ABSORB III trial, and site. Patients and clinical assessors were masked to randomisation. The primary endpoint was target lesion failure (cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation) at 30 days, tested for non-inferiority with a 2·9% margin for the risk difference. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02173379, and is closed to accrual. Findings: Between Aug 15, 2014, and March 31, 2017, we screened 18 722 patients for eligibility, 2604 of whom were enrolled. 1296 patients were assigned to BVS, and 1308 patients were assigned to EES. Follow-up data at 30 days and 1 year, respectively, were available for 1288 and 1254 patients with BVS and for 1303 and 1272 patients with EES. Biomarker-positive acute coronary syndromes were present in 622 (24%) of 2602 patients, and, by angiographic core laboratory analysis, 78 (3%) of 2893 of lesions were in very small vessels. Target lesion failure at 30 days occurred in 64 (5·0%) patients assigned to BVS and 48 (3·7%) patients assigned to EES (difference 1·3%, upper 97·5% confidence limit 2·89; one-sided p non-inferiority =0·0244). Target lesion failure at 1 year occurred in 98 (7·8%) patients assigned to BVS and 82 (6·4%) patients assigned to EES (difference 1·4%, upper 97·5% confidence limit 3·4; one-sided p non-inferiority =0·0006). Angina, adjudicated by a central events committee at 1 year, occurred in 270 (20·3%) patients assigned to BVS and 274 (20·5%) patients assigned to EES (difference −0·3%, 95% CI −3·4% to 2·9%; one-sided p non-inferiority =0·0008; two-sided p superiority =0·8603). Device thrombosis within 1 year occurred in nine (0·7%) patients assigned to BVS and four (0·3%) patients assigned to EES (p=0·1586). Interpretation: Polymeric BVS implanted with optimised technique in an expanded patient population resulted in non-inferior 30-day and 1-year rates of target lesion failure and angina compared with metallic DES. Funding: Abbott Vascular.

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U2 - 10.1016/S0140-6736(18)32283-9

DO - 10.1016/S0140-6736(18)32283-9

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EP - 1540

JO - The Lancet

JF - The Lancet

SN - 0140-6736

IS - 10157

ER -