A meta-analysis of specifically designed randomized trials of sirolimus-eluting versus paclitaxel-eluting stents in diabetic patients with coronary artery disease

Sebastian Kufner, Antoinette De Waha, Fabrizio Tomai, Seong Wook Park, Seung Whan Lee, Do-Sun Lim, Moo Hyun Kim, Anders M. Galloe, Michael Maeng, Carlo Briguori, Alban Dibra, Albert Schömig, Adnan Kastrati

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Background: There is an ongoing debate on the optimal drug-eluting stent (DES) in diabetic patients with coronary artery disease. We addressed this issue by making a synthesis of the available evidence on the relative long-term efficacy and safety of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) in these patients. Methods: Individual patient data were analyzed from 6 randomized trials specifically designed to compare SES with PES in diabetic patients. In total, 1183 patients were followed up for a median of 3.9 years (25th, 75th percentiles 3.4-4.5 years). The primary efficacy end point was target lesion revascularization (TLR). The composite of death and myocardial infarction (MI) was the primary safety end point. Stent thrombosis was a secondary end point. Overall hazard ratios (HRs) with 95% CIs were calculated as summary estimates. Results: No significant heterogeneity was seen across the 6 randomized trials for all analyzed events. Sirolimus-eluting stent was associated with a significant reduction in the risk of TLR (HR 0.65 [0.47-0.91], P =.01). No significant differences were observed regarding the risk of death or MI (HR 1.04 [0.74-1.45], P =.83) and stent thrombosis (HR 1.00 [0.31-3.30], P =.67). Mortality was also not affected by the type of DES (HR 0.95 [0.65-1.39], P =.79). Conclusions: In diabetic patients with coronary artery disease, SES leads to a sustained reduction in the risk of TLR compared with PES. Both these DES types are, however, comparable with respect to the risk of stent thrombosis, MI, or death over long-term follow-up.

Original languageEnglish
Pages (from-to)740-747
Number of pages8
JournalAmerican Heart Journal
Volume162
Issue number4
DOIs
Publication statusPublished - 2011 Oct 1

Fingerprint

Sirolimus
Paclitaxel
Stents
Meta-Analysis
Coronary Artery Disease
Drug-Eluting Stents
Thrombosis
Myocardial Infarction
Risk Reduction Behavior
Safety
Mortality

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

A meta-analysis of specifically designed randomized trials of sirolimus-eluting versus paclitaxel-eluting stents in diabetic patients with coronary artery disease. / Kufner, Sebastian; De Waha, Antoinette; Tomai, Fabrizio; Park, Seong Wook; Lee, Seung Whan; Lim, Do-Sun; Kim, Moo Hyun; Galloe, Anders M.; Maeng, Michael; Briguori, Carlo; Dibra, Alban; Schömig, Albert; Kastrati, Adnan.

In: American Heart Journal, Vol. 162, No. 4, 01.10.2011, p. 740-747.

Research output: Contribution to journalArticle

Kufner, S, De Waha, A, Tomai, F, Park, SW, Lee, SW, Lim, D-S, Kim, MH, Galloe, AM, Maeng, M, Briguori, C, Dibra, A, Schömig, A & Kastrati, A 2011, 'A meta-analysis of specifically designed randomized trials of sirolimus-eluting versus paclitaxel-eluting stents in diabetic patients with coronary artery disease', American Heart Journal, vol. 162, no. 4, pp. 740-747. https://doi.org/10.1016/j.ahj.2011.07.003
Kufner, Sebastian ; De Waha, Antoinette ; Tomai, Fabrizio ; Park, Seong Wook ; Lee, Seung Whan ; Lim, Do-Sun ; Kim, Moo Hyun ; Galloe, Anders M. ; Maeng, Michael ; Briguori, Carlo ; Dibra, Alban ; Schömig, Albert ; Kastrati, Adnan. / A meta-analysis of specifically designed randomized trials of sirolimus-eluting versus paclitaxel-eluting stents in diabetic patients with coronary artery disease. In: American Heart Journal. 2011 ; Vol. 162, No. 4. pp. 740-747.
@article{0ce52d77aeb54604ade0db2cac86a119,
title = "A meta-analysis of specifically designed randomized trials of sirolimus-eluting versus paclitaxel-eluting stents in diabetic patients with coronary artery disease",
abstract = "Background: There is an ongoing debate on the optimal drug-eluting stent (DES) in diabetic patients with coronary artery disease. We addressed this issue by making a synthesis of the available evidence on the relative long-term efficacy and safety of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) in these patients. Methods: Individual patient data were analyzed from 6 randomized trials specifically designed to compare SES with PES in diabetic patients. In total, 1183 patients were followed up for a median of 3.9 years (25th, 75th percentiles 3.4-4.5 years). The primary efficacy end point was target lesion revascularization (TLR). The composite of death and myocardial infarction (MI) was the primary safety end point. Stent thrombosis was a secondary end point. Overall hazard ratios (HRs) with 95{\%} CIs were calculated as summary estimates. Results: No significant heterogeneity was seen across the 6 randomized trials for all analyzed events. Sirolimus-eluting stent was associated with a significant reduction in the risk of TLR (HR 0.65 [0.47-0.91], P =.01). No significant differences were observed regarding the risk of death or MI (HR 1.04 [0.74-1.45], P =.83) and stent thrombosis (HR 1.00 [0.31-3.30], P =.67). Mortality was also not affected by the type of DES (HR 0.95 [0.65-1.39], P =.79). Conclusions: In diabetic patients with coronary artery disease, SES leads to a sustained reduction in the risk of TLR compared with PES. Both these DES types are, however, comparable with respect to the risk of stent thrombosis, MI, or death over long-term follow-up.",
author = "Sebastian Kufner and {De Waha}, Antoinette and Fabrizio Tomai and Park, {Seong Wook} and Lee, {Seung Whan} and Do-Sun Lim and Kim, {Moo Hyun} and Galloe, {Anders M.} and Michael Maeng and Carlo Briguori and Alban Dibra and Albert Sch{\"o}mig and Adnan Kastrati",
year = "2011",
month = "10",
day = "1",
doi = "10.1016/j.ahj.2011.07.003",
language = "English",
volume = "162",
pages = "740--747",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby Inc.",
number = "4",

}

TY - JOUR

T1 - A meta-analysis of specifically designed randomized trials of sirolimus-eluting versus paclitaxel-eluting stents in diabetic patients with coronary artery disease

AU - Kufner, Sebastian

AU - De Waha, Antoinette

AU - Tomai, Fabrizio

AU - Park, Seong Wook

AU - Lee, Seung Whan

AU - Lim, Do-Sun

AU - Kim, Moo Hyun

AU - Galloe, Anders M.

AU - Maeng, Michael

AU - Briguori, Carlo

AU - Dibra, Alban

AU - Schömig, Albert

AU - Kastrati, Adnan

PY - 2011/10/1

Y1 - 2011/10/1

N2 - Background: There is an ongoing debate on the optimal drug-eluting stent (DES) in diabetic patients with coronary artery disease. We addressed this issue by making a synthesis of the available evidence on the relative long-term efficacy and safety of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) in these patients. Methods: Individual patient data were analyzed from 6 randomized trials specifically designed to compare SES with PES in diabetic patients. In total, 1183 patients were followed up for a median of 3.9 years (25th, 75th percentiles 3.4-4.5 years). The primary efficacy end point was target lesion revascularization (TLR). The composite of death and myocardial infarction (MI) was the primary safety end point. Stent thrombosis was a secondary end point. Overall hazard ratios (HRs) with 95% CIs were calculated as summary estimates. Results: No significant heterogeneity was seen across the 6 randomized trials for all analyzed events. Sirolimus-eluting stent was associated with a significant reduction in the risk of TLR (HR 0.65 [0.47-0.91], P =.01). No significant differences were observed regarding the risk of death or MI (HR 1.04 [0.74-1.45], P =.83) and stent thrombosis (HR 1.00 [0.31-3.30], P =.67). Mortality was also not affected by the type of DES (HR 0.95 [0.65-1.39], P =.79). Conclusions: In diabetic patients with coronary artery disease, SES leads to a sustained reduction in the risk of TLR compared with PES. Both these DES types are, however, comparable with respect to the risk of stent thrombosis, MI, or death over long-term follow-up.

AB - Background: There is an ongoing debate on the optimal drug-eluting stent (DES) in diabetic patients with coronary artery disease. We addressed this issue by making a synthesis of the available evidence on the relative long-term efficacy and safety of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) in these patients. Methods: Individual patient data were analyzed from 6 randomized trials specifically designed to compare SES with PES in diabetic patients. In total, 1183 patients were followed up for a median of 3.9 years (25th, 75th percentiles 3.4-4.5 years). The primary efficacy end point was target lesion revascularization (TLR). The composite of death and myocardial infarction (MI) was the primary safety end point. Stent thrombosis was a secondary end point. Overall hazard ratios (HRs) with 95% CIs were calculated as summary estimates. Results: No significant heterogeneity was seen across the 6 randomized trials for all analyzed events. Sirolimus-eluting stent was associated with a significant reduction in the risk of TLR (HR 0.65 [0.47-0.91], P =.01). No significant differences were observed regarding the risk of death or MI (HR 1.04 [0.74-1.45], P =.83) and stent thrombosis (HR 1.00 [0.31-3.30], P =.67). Mortality was also not affected by the type of DES (HR 0.95 [0.65-1.39], P =.79). Conclusions: In diabetic patients with coronary artery disease, SES leads to a sustained reduction in the risk of TLR compared with PES. Both these DES types are, however, comparable with respect to the risk of stent thrombosis, MI, or death over long-term follow-up.

UR - http://www.scopus.com/inward/record.url?scp=80053630382&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=80053630382&partnerID=8YFLogxK

U2 - 10.1016/j.ahj.2011.07.003

DO - 10.1016/j.ahj.2011.07.003

M3 - Article

VL - 162

SP - 740

EP - 747

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

IS - 4

ER -