Clinical outcomes following implantation of the ION™ paclitaxel-eluting platinum chromium coronary stent in routine clinical practice: Results of the ION U.S. post-approval study

Autor: Louis Cannon, Paul Underwood, Timothy Grady, Paul R. Myers, Anthony White, Carey Kimmelstiel, R J Hill, Keith D. Dawkins
Rok vydání: 2016
Předmět:
Chromium
Male
medicine.medical_specialty
Time Factors
Paclitaxel
medicine.medical_treatment
Coronary Artery Disease
030204 cardiovascular system & hematology
Prosthesis Design
Coronary artery disease
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Internal medicine
Coronary stent
medicine
Clinical endpoint
Product Surveillance
Postmarketing
Humans
Radiology
Nuclear Medicine and imaging
Routine clinical practice
030212 general & internal medicine
Prospective Studies
Registries
Angioplasty
Balloon
Coronary
Aged
Platinum
business.industry
Stent
Cardiovascular Agents
Drug-Eluting Stents
General Medicine
Middle Aged
medicine.disease
Confidence interval
United States
Treatment Outcome
chemistry
Drug-eluting stent
Female
Cardiology and Cardiovascular Medicine
business
Zdroj: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac AngiographyInterventionsREFERENCES. 94(3)
ISSN: 1522-726X
Popis: BACKGROUND The ION Study assessed clinical outcomes for the thin-strut, ION™ (TAXUS Element) Paclitaxel-Eluting Platinum Chromium Coronary Stent System (Boston Scientific, Marlborough, MA) in unselected patients. METHODS This prospective, open-label registry enrolled the first 1,120 consenting patients treated with the ION stent without clinical or angiographic inclusion criteria at 40 clinical sites. Follow-up was at discharge, 30 days, 180 days, 1 and 2 years. The primary endpoint, the 1-year rate of cardiac death or MI (CD/MI) in PERSEUS-like patients (i.e., patients similar to those enrolled in PERSEUS, the pivotal approval trial), was tested in patients pooled from the ION study (N = 316), the European TAXUS Element post-approval registry (TE-PROVE; N = 306 PERSEUS-like patients), and the PERSEUS WH/SV populations (N = 1,166); and then compared with a prespecified performance goal. Additional outcomes were examined in the overall ION patient population. RESULTS A total of 1,111 (out of 1,120) enrolled patients received a study stent. Most patients were male (70%) and mean age was 64 years. At 1 year, the primary endpoint of CD/MI occurred in 2.1% (6/292) of PERSEUS-like patients in ION, and 2.3% (40/1,729) of patients in the combined analysis. The upper one-sided 95% confidence interval for the combined analysis was 2.9%, which was significantly less than the performance goal of 7.6% (P
Databáze: OpenAIRE
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