A 10-month angiographic and 4-year clinical outcome of everolimus-eluting versus sirolimus-eluting coronary stents in patients with diabetes mellitus (the diabedES IV randomized angiography trial)

Michael Maeng, Arvydas Baranauskas, Evald Høj Christiansen, Anne Kaltoft, Niels Ramsing Holm, Lars Romer Krusell, Jan Ravkilde, Hans-Henrik Tilsted, Per Thayssen, Lisette Okkels Jensen

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

OBJECTIVE: We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes.

BACKGROUND: There are limited data on long-term outcome after EES vs SES implantation in diabetic patients.

METHODS: We randomized 213 patients with diabetes and coronary artery disease to EES (n = 108) or SES (n = 105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up.

RESULTS: At 10-month angiographic follow-up, in-stent late lumen loss was 0.20 ± 0.53 mm and 0.11 ± 0.49 mm (P = 0.28), and angiographic restenosis rate was 3.8% and 5.2% (P = 0.72) in the EES and SES groups, respectively. At 4-year clinical follow-up, MACE had occurred in 22 (20.4%) patients in the EES group and 25 (23.8%) patients in SES group (HR 0.84, 95% CI 0.47-1.49; P = 0.55), with TLR performed in 6 (5.6%) and 10 (9.5%) patients in the two groups (HR 0.57, 95% CI 0.21-1-58; P = 0.28).

CONCLUSION: EES and SES had comparable 10-month angiographic and 4-year clinical outcomes in patients with diabetes mellitus and coronary artery disease. © 2015 Wiley Periodicals, Inc.

OriginalsprogEngelsk
TidsskriftCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Vol/bind86
Udgave nummer7
Sider (fra-til)1161-7
ISSN1522-1946
DOI
StatusUdgivet - 1. dec. 2015

Fingeraftryk

Stents
Diabetes Mellitus
Coronary Artery Disease
Everolimus

Citer dette

@article{416bd5ed0a6c426aa2077f9d4856cb0f,
title = "A 10-month angiographic and 4-year clinical outcome of everolimus-eluting versus sirolimus-eluting coronary stents in patients with diabetes mellitus (the diabedES IV randomized angiography trial)",
abstract = "OBJECTIVE: We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes.BACKGROUND: There are limited data on long-term outcome after EES vs SES implantation in diabetic patients.METHODS: We randomized 213 patients with diabetes and coronary artery disease to EES (n = 108) or SES (n = 105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up.RESULTS: At 10-month angiographic follow-up, in-stent late lumen loss was 0.20 ± 0.53 mm and 0.11 ± 0.49 mm (P = 0.28), and angiographic restenosis rate was 3.8{\%} and 5.2{\%} (P = 0.72) in the EES and SES groups, respectively. At 4-year clinical follow-up, MACE had occurred in 22 (20.4{\%}) patients in the EES group and 25 (23.8{\%}) patients in SES group (HR 0.84, 95{\%} CI 0.47-1.49; P = 0.55), with TLR performed in 6 (5.6{\%}) and 10 (9.5{\%}) patients in the two groups (HR 0.57, 95{\%} CI 0.21-1-58; P = 0.28).CONCLUSION: EES and SES had comparable 10-month angiographic and 4-year clinical outcomes in patients with diabetes mellitus and coronary artery disease. {\circledC} 2015 Wiley Periodicals, Inc.",
author = "Michael Maeng and Arvydas Baranauskas and Christiansen, {Evald H{\o}j} and Anne Kaltoft and Holm, {Niels Ramsing} and Krusell, {Lars Romer} and Jan Ravkilde and Hans-Henrik Tilsted and Per Thayssen and Jensen, {Lisette Okkels}",
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A 10-month angiographic and 4-year clinical outcome of everolimus-eluting versus sirolimus-eluting coronary stents in patients with diabetes mellitus (the diabedES IV randomized angiography trial). / Maeng, Michael; Baranauskas, Arvydas; Christiansen, Evald Høj; Kaltoft, Anne; Holm, Niels Ramsing; Krusell, Lars Romer; Ravkilde, Jan; Tilsted, Hans-Henrik; Thayssen, Per; Jensen, Lisette Okkels.

I: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, Bind 86, Nr. 7, 01.12.2015, s. 1161-7.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - A 10-month angiographic and 4-year clinical outcome of everolimus-eluting versus sirolimus-eluting coronary stents in patients with diabetes mellitus (the diabedES IV randomized angiography trial)

AU - Maeng, Michael

AU - Baranauskas, Arvydas

AU - Christiansen, Evald Høj

AU - Kaltoft, Anne

AU - Holm, Niels Ramsing

AU - Krusell, Lars Romer

AU - Ravkilde, Jan

AU - Tilsted, Hans-Henrik

AU - Thayssen, Per

AU - Jensen, Lisette Okkels

N1 - © 2015 Wiley Periodicals, Inc.

PY - 2015/12/1

Y1 - 2015/12/1

N2 - OBJECTIVE: We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes.BACKGROUND: There are limited data on long-term outcome after EES vs SES implantation in diabetic patients.METHODS: We randomized 213 patients with diabetes and coronary artery disease to EES (n = 108) or SES (n = 105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up.RESULTS: At 10-month angiographic follow-up, in-stent late lumen loss was 0.20 ± 0.53 mm and 0.11 ± 0.49 mm (P = 0.28), and angiographic restenosis rate was 3.8% and 5.2% (P = 0.72) in the EES and SES groups, respectively. At 4-year clinical follow-up, MACE had occurred in 22 (20.4%) patients in the EES group and 25 (23.8%) patients in SES group (HR 0.84, 95% CI 0.47-1.49; P = 0.55), with TLR performed in 6 (5.6%) and 10 (9.5%) patients in the two groups (HR 0.57, 95% CI 0.21-1-58; P = 0.28).CONCLUSION: EES and SES had comparable 10-month angiographic and 4-year clinical outcomes in patients with diabetes mellitus and coronary artery disease. © 2015 Wiley Periodicals, Inc.

AB - OBJECTIVE: We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes.BACKGROUND: There are limited data on long-term outcome after EES vs SES implantation in diabetic patients.METHODS: We randomized 213 patients with diabetes and coronary artery disease to EES (n = 108) or SES (n = 105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up.RESULTS: At 10-month angiographic follow-up, in-stent late lumen loss was 0.20 ± 0.53 mm and 0.11 ± 0.49 mm (P = 0.28), and angiographic restenosis rate was 3.8% and 5.2% (P = 0.72) in the EES and SES groups, respectively. At 4-year clinical follow-up, MACE had occurred in 22 (20.4%) patients in the EES group and 25 (23.8%) patients in SES group (HR 0.84, 95% CI 0.47-1.49; P = 0.55), with TLR performed in 6 (5.6%) and 10 (9.5%) patients in the two groups (HR 0.57, 95% CI 0.21-1-58; P = 0.28).CONCLUSION: EES and SES had comparable 10-month angiographic and 4-year clinical outcomes in patients with diabetes mellitus and coronary artery disease. © 2015 Wiley Periodicals, Inc.

U2 - 10.1002/ccd.25875

DO - 10.1002/ccd.25875

M3 - Journal article

VL - 86

SP - 1161

EP - 1167

JO - Catheterization and Cardiovascular Interventions

JF - Catheterization and Cardiovascular Interventions

SN - 1522-1946

IS - 7

ER -