Back to Search
Start Over
Five-year clinical outcomes of everolimus-eluting stents from the post marketing study of CoCr-EES (XIENCE V/PROMUS) in Japan.
- Source :
-
Cardiovascular intervention and therapeutics [Cardiovasc Interv Ther] 2019 Jan; Vol. 34 (1), pp. 40-46. Date of Electronic Publication: 2018 Feb 26. - Publication Year :
- 2019
-
Abstract
- The Cobalt Chromium Everolimus-Eluting Stent (CoCr-EES) Post Marketing Surveillance (PMS) Japan study is a prospective multicenter registry designed to evaluate the safety and efficacy of XIENCE V/PROMUS everolimus-eluting stents in routine clinical practice at 47 centers representative of the clinical environment in Japan. We enrolled 2010 consecutive patients (2649 lesions) who underwent percutaneous coronary intervention using CoCr-EES. Clinical outcomes were evaluated through 5 years. Mean age was 68.8 years, 41.9% had diabetes, 4.9% received hemodialysis. Five-year clinical follow up was available for 1704 (84.8%) patients. Major adverse cardiovascular events (MACE) occurred in 10.7% of patients, including cardiac death (3.8%), myocardial infarction (1.8%), and clinically driven target lesion revascularization (TLR) (6.0%). Beyond 1 year, annual incidence of clinically driven TLR was 0.5-0.8%. Definite or probable stent thrombosis occurred in 9 (0.5%) patients at 5 years. After 1 year, definite stent thrombosis occurred in only 1 patient. Significant predictors for MACE were dialysis (ODDs ratio 4.58, 95% CI 2.75-7.64), prior cardiac intervention (ODDs ratio 2.47, 95% CI 1.75-3.49), total stent length (ODDs ratio 1.01, 95% CI 1.01-1.02), and number of diseased vessels (ODDs ratio 1.66, 95% CI 1.08-2.55). Five-year clinical outcomes from the CoCr-EES PMS Japan study demonstrated a low incidence of clinical events in the daily practice up to 5 years.Clinical Trial Registration Information: https://clinicaltrials.gov/ct2/show/NCT01086228 .
- Subjects :
- Aged
Chromium administration & dosage
Chromium adverse effects
Cobalt administration & dosage
Cobalt adverse effects
Everolimus adverse effects
Female
Follow-Up Studies
Humans
Japan
Male
Middle Aged
Percutaneous Coronary Intervention adverse effects
Percutaneous Coronary Intervention methods
Product Surveillance, Postmarketing
Prospective Studies
Prosthesis Design
Registries
Survival Analysis
Treatment Outcome
Coronary Artery Disease surgery
Drug-Eluting Stents adverse effects
Everolimus administration & dosage
Percutaneous Coronary Intervention instrumentation
Subjects
Details
- Language :
- English
- ISSN :
- 1868-4297
- Volume :
- 34
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Cardiovascular intervention and therapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 29484580
- Full Text :
- https://doi.org/10.1007/s12928-018-0515-z