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Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes.
- Source :
-
The New England journal of medicine [N Engl J Med] 2015 Oct 29; Vol. 373 (18), pp. 1709-19. Date of Electronic Publication: 2015 Oct 14. - Publication Year :
- 2015
-
Abstract
- Background: The choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention (PCI) has been debated. Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin (now called sirolimus) or its analogues (everolimus or zotarolimus) have produced contradictory results, ranging from equivalence between stent types to superiority of everolimus-eluting stents.<br />Methods: We randomly assigned 1830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. We used a noninferiority trial design with a noninferiority margin of 4 percentage points for the upper boundary of the 95% confidence interval of the risk difference. The primary end point was target-vessel failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization at the 1-year follow-up.<br />Results: At 1 year, paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point (rate of target-vessel failure, 5.6% vs. 2.9%; risk difference, 2.7 percentage points [95% confidence interval, 0.8 to 4.5]; relative risk, 1.89 [95% confidence interval, 1.20 to 2.99]; P=0.38 for noninferiority). There was a significantly higher 1-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure (P=0.005), spontaneous myocardial infarction (3.2% vs. 1.2%, P=0.004), stent thrombosis (2.1% vs. 0.4%, P=0.002), target-vessel revascularization (3.4% vs. 1.2%, P=0.002), and target-lesion revascularization (3.4% vs. 1.2%, P=0.002).<br />Conclusions: In patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year. (Funded by Boston Scientific; TUXEDO-India Clinical Trials Registry-India number, CTRI/2011/06/001830).
- Subjects :
- Aged
Coronary Angiography
Coronary Artery Disease complications
Coronary Artery Disease mortality
Everolimus
Female
Humans
Intention to Treat Analysis
Logistic Models
Male
Middle Aged
Retreatment statistics & numerical data
Sirolimus administration & dosage
Treatment Outcome
Coronary Artery Disease therapy
Diabetes Complications therapy
Drug-Eluting Stents
Paclitaxel administration & dosage
Percutaneous Coronary Intervention
Sirolimus analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 1533-4406
- Volume :
- 373
- Issue :
- 18
- Database :
- MEDLINE
- Journal :
- The New England journal of medicine
- Publication Type :
- Academic Journal
- Accession number :
- 26466202
- Full Text :
- https://doi.org/10.1056/NEJMoa1510188