Novel approaches for preventing or limiting events in diabetic patients (naples-diabetes) trial: A randomized comparison of 3 drug-eluting stents in diabetic patients

Carlo Briguori, Flavio Airoldi, Gabriella Visconti, Amelia Focaccio, Gianluca Caiazzo, Bruno Golia, Giuseppe Biondi-Zoccai, Bruno Ricciardelli, Gerolama Condorelli

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Abstract

Background-To expand the paucity of data on the efficacy of various drug-eluting stents in diabetic patients. Methods and Results-Type 2 diabetic patients treated in our institution from October 2005 to January 2007 presenting with of de novo lesions in native coronary arteries were randomly assigned to sirolimus-eluting stents (Cypher group; n=76); paclitaxel-eluting stents (Taxus group; n=75); and everolimus-eluting stents (Endeavor group; n=75). Poor metabolic control (HbA1c >7% and low-density lipoprotein cholesterol >100 mg/dL) and microvascular complications (retinopathy and/or nephropathy) were assessed. The primary end point was the 3-year composite of major adverse cardiac events (MACE), including death of any cause, myocardial infarction, and clinically driven target vessel revascularization. MACE-free survival was 86.8% in the Cypher group, 82.5% in the Taxus group, and 64.4% in the Endeavor group (P=0.006 by log-rank test). The post hoc comparisons showed no significant difference between Cypher versus Taxus groups (adjusted P=1.0) but a higher MACE rate in the Endeavor group versus both the Cypher group (adjusted P=0.012) and the Taxus group (adjusted P=0.075). Independent predictors of 3-year MACE at Cox analysis were treatment by Endeavor versus Cypher stent (2.35 [95% confidence interval, 1.07 to 5.41]; P=0.030), multivessel disease (hazard ratio, 1.78 [95% confidence interval, 1.06 to 2.66]; P=0.031), diabetic retinopathy (hazard ratio, 1.60; [95% confidence interval, 1.03 to 2.76]; P=0.038), and poor metabolic control (hazard ratio, 1.60; [95% confidence interval, 1.02 to 2.52]; P=0.048). Conclusions-The present pilot study suggests that in diabetic patients, the Endeavor stent is associated with a higher 3-year MACE rate when compared with Cypher and Taxus stents.

Original languageEnglish
Pages (from-to)121-129
Number of pages9
JournalCirculation: Cardiovascular Interventions
Volume4
Issue number2
DOIs
Publication statusPublished - Apr 2011

Fingerprint

Drug-Eluting Stents
Taxus
Stents
Confidence Intervals
Safety Management
Diabetic Retinopathy
Sirolimus
Paclitaxel
LDL Cholesterol
Disease-Free Survival
Cause of Death
Coronary Vessels
Myocardial Infarction

Keywords

  • Diabetes mellitus
  • Drug-eluting stent
  • Outcome

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

Novel approaches for preventing or limiting events in diabetic patients (naples-diabetes) trial : A randomized comparison of 3 drug-eluting stents in diabetic patients. / Briguori, Carlo; Airoldi, Flavio; Visconti, Gabriella; Focaccio, Amelia; Caiazzo, Gianluca; Golia, Bruno; Biondi-Zoccai, Giuseppe; Ricciardelli, Bruno; Condorelli, Gerolama.

In: Circulation: Cardiovascular Interventions, Vol. 4, No. 2, 04.2011, p. 121-129.

Research output: Contribution to journalArticle

Briguori, Carlo ; Airoldi, Flavio ; Visconti, Gabriella ; Focaccio, Amelia ; Caiazzo, Gianluca ; Golia, Bruno ; Biondi-Zoccai, Giuseppe ; Ricciardelli, Bruno ; Condorelli, Gerolama. / Novel approaches for preventing or limiting events in diabetic patients (naples-diabetes) trial : A randomized comparison of 3 drug-eluting stents in diabetic patients. In: Circulation: Cardiovascular Interventions. 2011 ; Vol. 4, No. 2. pp. 121-129.
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AU - Visconti, Gabriella

AU - Focaccio, Amelia

AU - Caiazzo, Gianluca

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AU - Biondi-Zoccai, Giuseppe

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N2 - Background-To expand the paucity of data on the efficacy of various drug-eluting stents in diabetic patients. Methods and Results-Type 2 diabetic patients treated in our institution from October 2005 to January 2007 presenting with of de novo lesions in native coronary arteries were randomly assigned to sirolimus-eluting stents (Cypher group; n=76); paclitaxel-eluting stents (Taxus group; n=75); and everolimus-eluting stents (Endeavor group; n=75). Poor metabolic control (HbA1c >7% and low-density lipoprotein cholesterol >100 mg/dL) and microvascular complications (retinopathy and/or nephropathy) were assessed. The primary end point was the 3-year composite of major adverse cardiac events (MACE), including death of any cause, myocardial infarction, and clinically driven target vessel revascularization. MACE-free survival was 86.8% in the Cypher group, 82.5% in the Taxus group, and 64.4% in the Endeavor group (P=0.006 by log-rank test). The post hoc comparisons showed no significant difference between Cypher versus Taxus groups (adjusted P=1.0) but a higher MACE rate in the Endeavor group versus both the Cypher group (adjusted P=0.012) and the Taxus group (adjusted P=0.075). Independent predictors of 3-year MACE at Cox analysis were treatment by Endeavor versus Cypher stent (2.35 [95% confidence interval, 1.07 to 5.41]; P=0.030), multivessel disease (hazard ratio, 1.78 [95% confidence interval, 1.06 to 2.66]; P=0.031), diabetic retinopathy (hazard ratio, 1.60; [95% confidence interval, 1.03 to 2.76]; P=0.038), and poor metabolic control (hazard ratio, 1.60; [95% confidence interval, 1.02 to 2.52]; P=0.048). Conclusions-The present pilot study suggests that in diabetic patients, the Endeavor stent is associated with a higher 3-year MACE rate when compared with Cypher and Taxus stents.

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