1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: A pooled analysis of the ABSORB and the SPIRIT trials

Takashi Muramatsu, Yoshinobu Onuma, Robert Jan Van Geuns, Bernard Chevalier, Tejas M. Patel, Ashok Seth, Roberto Diletti, Hector M. García-García, Cécile C. Dorange, Susan Veldhof, Wai Fung Cheong, Yukio Ozaki, Robert Whitbourn, Antonio Bartorelli, Gregg W. Stone, Alexandre Abizaid, Patrick W. Serruys

Research output: Contribution to journalArticle

46 Citations (Scopus)

Abstract

Objectives The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treated with the Absorb bioresorbable vascular scaffold (BVS). Background Clinical outcomes of diabetic patients after BVS implantation have been unreported. Methods This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450 patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients were compared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimus-eluting metal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System]) were used for the comparison by applying propensity score matching. The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1-year follow-up. Results The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patients treated with the BVS (3.7% vs. 5.1%, p = 0.64). Diabetic patients treated with the BVS had a similar incidence of the DoCE compared with diabetic patients treated with EES in the matched study group (3.9% for the BVS vs. 6.4% for EES, p = 0.38). There were no differences in the incidence of definite or probable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0% for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group). Conclusions In the present analyses, diabetic patients treated with the BVS showed similar rates of DoCEs compared with nondiabetic patients treated with the BVS and diabetic patients treated with EES at 1-year follow-up.

Original languageEnglish
Pages (from-to)482-493
Number of pages12
JournalJACC: Cardiovascular Interventions
Volume7
Issue number5
DOIs
Publication statusPublished - 01-01-2014

Fingerprint

Blood Vessels
Stents
Metals
Everolimus
Clinical Trials
Equipment and Supplies
Incidence
Research Design
Propensity Score
Thrombosis
Myocardial Infarction

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Muramatsu, Takashi ; Onuma, Yoshinobu ; Van Geuns, Robert Jan ; Chevalier, Bernard ; Patel, Tejas M. ; Seth, Ashok ; Diletti, Roberto ; García-García, Hector M. ; Dorange, Cécile C. ; Veldhof, Susan ; Cheong, Wai Fung ; Ozaki, Yukio ; Whitbourn, Robert ; Bartorelli, Antonio ; Stone, Gregg W. ; Abizaid, Alexandre ; Serruys, Patrick W. / 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds : A pooled analysis of the ABSORB and the SPIRIT trials. In: JACC: Cardiovascular Interventions. 2014 ; Vol. 7, No. 5. pp. 482-493.
@article{9660158836054075be78de3bd423ce12,
title = "1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: A pooled analysis of the ABSORB and the SPIRIT trials",
abstract = "Objectives The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treated with the Absorb bioresorbable vascular scaffold (BVS). Background Clinical outcomes of diabetic patients after BVS implantation have been unreported. Methods This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450 patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients were compared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimus-eluting metal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System]) were used for the comparison by applying propensity score matching. The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1-year follow-up. Results The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patients treated with the BVS (3.7{\%} vs. 5.1{\%}, p = 0.64). Diabetic patients treated with the BVS had a similar incidence of the DoCE compared with diabetic patients treated with EES in the matched study group (3.9{\%} for the BVS vs. 6.4{\%} for EES, p = 0.38). There were no differences in the incidence of definite or probable scaffold/stent thrombosis (0.7{\%} for both diabetic and nondiabetic patients with the BVS; 1.0{\%} for diabetic patients with the BVS vs. 1.7{\%} for diabetic patients with EES in the matched study group). Conclusions In the present analyses, diabetic patients treated with the BVS showed similar rates of DoCEs compared with nondiabetic patients treated with the BVS and diabetic patients treated with EES at 1-year follow-up.",
author = "Takashi Muramatsu and Yoshinobu Onuma and {Van Geuns}, {Robert Jan} and Bernard Chevalier and Patel, {Tejas M.} and Ashok Seth and Roberto Diletti and Garc{\'i}a-Garc{\'i}a, {Hector M.} and Dorange, {C{\'e}cile C.} and Susan Veldhof and Cheong, {Wai Fung} and Yukio Ozaki and Robert Whitbourn and Antonio Bartorelli and Stone, {Gregg W.} and Alexandre Abizaid and Serruys, {Patrick W.}",
year = "2014",
month = "1",
day = "1",
doi = "10.1016/j.jcin.2014.01.155",
language = "English",
volume = "7",
pages = "482--493",
journal = "JACC: Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "5",

}

Muramatsu, T, Onuma, Y, Van Geuns, RJ, Chevalier, B, Patel, TM, Seth, A, Diletti, R, García-García, HM, Dorange, CC, Veldhof, S, Cheong, WF, Ozaki, Y, Whitbourn, R, Bartorelli, A, Stone, GW, Abizaid, A & Serruys, PW 2014, '1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: A pooled analysis of the ABSORB and the SPIRIT trials', JACC: Cardiovascular Interventions, vol. 7, no. 5, pp. 482-493. https://doi.org/10.1016/j.jcin.2014.01.155

1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds : A pooled analysis of the ABSORB and the SPIRIT trials. / Muramatsu, Takashi; Onuma, Yoshinobu; Van Geuns, Robert Jan; Chevalier, Bernard; Patel, Tejas M.; Seth, Ashok; Diletti, Roberto; García-García, Hector M.; Dorange, Cécile C.; Veldhof, Susan; Cheong, Wai Fung; Ozaki, Yukio; Whitbourn, Robert; Bartorelli, Antonio; Stone, Gregg W.; Abizaid, Alexandre; Serruys, Patrick W.

In: JACC: Cardiovascular Interventions, Vol. 7, No. 5, 01.01.2014, p. 482-493.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds

T2 - A pooled analysis of the ABSORB and the SPIRIT trials

AU - Muramatsu, Takashi

AU - Onuma, Yoshinobu

AU - Van Geuns, Robert Jan

AU - Chevalier, Bernard

AU - Patel, Tejas M.

AU - Seth, Ashok

AU - Diletti, Roberto

AU - García-García, Hector M.

AU - Dorange, Cécile C.

AU - Veldhof, Susan

AU - Cheong, Wai Fung

AU - Ozaki, Yukio

AU - Whitbourn, Robert

AU - Bartorelli, Antonio

AU - Stone, Gregg W.

AU - Abizaid, Alexandre

AU - Serruys, Patrick W.

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Objectives The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treated with the Absorb bioresorbable vascular scaffold (BVS). Background Clinical outcomes of diabetic patients after BVS implantation have been unreported. Methods This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450 patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients were compared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimus-eluting metal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System]) were used for the comparison by applying propensity score matching. The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1-year follow-up. Results The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patients treated with the BVS (3.7% vs. 5.1%, p = 0.64). Diabetic patients treated with the BVS had a similar incidence of the DoCE compared with diabetic patients treated with EES in the matched study group (3.9% for the BVS vs. 6.4% for EES, p = 0.38). There were no differences in the incidence of definite or probable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0% for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group). Conclusions In the present analyses, diabetic patients treated with the BVS showed similar rates of DoCEs compared with nondiabetic patients treated with the BVS and diabetic patients treated with EES at 1-year follow-up.

AB - Objectives The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treated with the Absorb bioresorbable vascular scaffold (BVS). Background Clinical outcomes of diabetic patients after BVS implantation have been unreported. Methods This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450 patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients were compared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimus-eluting metal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System]) were used for the comparison by applying propensity score matching. The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1-year follow-up. Results The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patients treated with the BVS (3.7% vs. 5.1%, p = 0.64). Diabetic patients treated with the BVS had a similar incidence of the DoCE compared with diabetic patients treated with EES in the matched study group (3.9% for the BVS vs. 6.4% for EES, p = 0.38). There were no differences in the incidence of definite or probable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0% for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group). Conclusions In the present analyses, diabetic patients treated with the BVS showed similar rates of DoCEs compared with nondiabetic patients treated with the BVS and diabetic patients treated with EES at 1-year follow-up.

UR - http://www.scopus.com/inward/record.url?scp=84901269957&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84901269957&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2014.01.155

DO - 10.1016/j.jcin.2014.01.155

M3 - Article

C2 - 24746650

AN - SCOPUS:84901269957

VL - 7

SP - 482

EP - 493

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

SN - 1936-8798

IS - 5

ER -