Journal article
First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent: Angiographic, IVUS, OCT, and Clinical Outcomes From the RevElution Study.
- Worthley SG Cardiovascular Research Centre, Royal Adelaide Hospital and Cardiac Unit, St Andrews Hospital, Adelaide, Australia. Electronic address: stephen.worthley@genesiscare.com.au.
- Abizaid A Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, Cardiovascular Research Center, and Hospital Israelita Albert Einstein, São Paulo, Brazil.
- Kirtane AJ Department of Medicine, Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York.
- Simon DI Department of Medicine-Cardiovascular Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio.
- Windecker S Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland.
- Brar S Clinical Research Department, Medtronic, Santa Rosa, California.
- Meredith IT Monash Health and Monash University, Melbourne, Australia.
- Shetty S Department of Cardiology, Fiona Stanley Hospital, Murdoch, Australia, and University of Western Australia, Perth, Australia.
- Sinhal A Heart and Vascular Institute, Flinders Medical Centre, Bedford Park, Australia.
- Almonacid AP Cardiovascular Imaging Core Lab, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
- Chamié D Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, Cardiovascular Research Center, and Hospital Israelita Albert Einstein, São Paulo, Brazil.
- Maehara A Department of Medicine, Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York.
- Stone GW Department of Medicine, Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York.
- 2017-01-21
Published in:
- JACC. Cardiovascular interventions. - 2017
drug-eluting stent(s)
drug-filled stent(s)
percutaneous coronary intervention
polymer-free stent
Australia
Chromium Alloys
Coronary Angiography
Coronary Artery Disease
Coronary Restenosis
Coronary Thrombosis
Coronary Vessels
Drug Therapy, Combination
Drug-Eluting Stents
Female
Humans
Latin America
Male
Middle Aged
Myocardial Infarction
Percutaneous Coronary Intervention
Platelet Aggregation Inhibitors
Predictive Value of Tests
Prosthesis Design
Risk Factors
Singapore
Sirolimus
Tantalum
Time Factors
Tomography, Optical Coherence
Treatment Outcome
Ultrasonography, Interventional
English
OBJECTIVES
This study sought to assess the safety and effectiveness of the drug-filled stent (DFS) (Medtronic, Santa Rosa, California) in the treatment of patients with coronary artery disease.
BACKGROUND
Polymer-free drug-eluting stents have the potential to improve clinical outcomes and facilitate shorter durations of dual antiplatelet therapy. The polymer-free DFS is made from a trilayered continuous wire with an outer cobalt chromium layer, a middle tantalum layer, and an inner lumen coated with sirolimus. Small laser-drilled holes on the abluminal stent surface control drug elution.
METHODS
The RevElution trial enrolled 100 patients with de novo coronary lesions 2.25 to 3.50 mm in diameter and length ≤27 mm in 2 cohorts of 50 patients for angiographic, intravascular ultrasound, and clinical assessment at 9 or 24 months, with optical coherence tomography performed in a subset of 30 patients at each time period. The primary endpoint was angiographic in-stent late lumen loss at 9 months compared with Resolute zotarolimus-eluting stent (Medtronic) historical control data.
RESULTS
Fifty patients with 56 lesions were treated with DFS in the 9-month cohort. In-stent late lumen loss was 0.26 ± 0.28 mm for DFS and 0.36 ± 0.52 mm for Resolute (pnoninferiority <0.001). The binary angiographic restenosis rate was 0%. Median stent strut coverage by optical coherence tomography was 91.4%, 95.6%, and 99.1% at 1, 3, and 9 months, respectively. One non-Q-wave myocardial infarction occurred, with a 9-month target lesion failure rate of 2.1%. No stent thrombosis occurred.
CONCLUSIONS
At 9 months, the polymer-free DFS was safe and effective with high rates of early strut coverage and noninferior late lumen loss compared to Resolute. (Medtronic RevElution Trial [RevElution]; NCT02480348).
This study sought to assess the safety and effectiveness of the drug-filled stent (DFS) (Medtronic, Santa Rosa, California) in the treatment of patients with coronary artery disease.
BACKGROUND
Polymer-free drug-eluting stents have the potential to improve clinical outcomes and facilitate shorter durations of dual antiplatelet therapy. The polymer-free DFS is made from a trilayered continuous wire with an outer cobalt chromium layer, a middle tantalum layer, and an inner lumen coated with sirolimus. Small laser-drilled holes on the abluminal stent surface control drug elution.
METHODS
The RevElution trial enrolled 100 patients with de novo coronary lesions 2.25 to 3.50 mm in diameter and length ≤27 mm in 2 cohorts of 50 patients for angiographic, intravascular ultrasound, and clinical assessment at 9 or 24 months, with optical coherence tomography performed in a subset of 30 patients at each time period. The primary endpoint was angiographic in-stent late lumen loss at 9 months compared with Resolute zotarolimus-eluting stent (Medtronic) historical control data.
RESULTS
Fifty patients with 56 lesions were treated with DFS in the 9-month cohort. In-stent late lumen loss was 0.26 ± 0.28 mm for DFS and 0.36 ± 0.52 mm for Resolute (pnoninferiority <0.001). The binary angiographic restenosis rate was 0%. Median stent strut coverage by optical coherence tomography was 91.4%, 95.6%, and 99.1% at 1, 3, and 9 months, respectively. One non-Q-wave myocardial infarction occurred, with a 9-month target lesion failure rate of 2.1%. No stent thrombosis occurred.
CONCLUSIONS
At 9 months, the polymer-free DFS was safe and effective with high rates of early strut coverage and noninferior late lumen loss compared to Resolute. (Medtronic RevElution Trial [RevElution]; NCT02480348).
- Language
-
- English
- Open access status
- hybrid
- Identifiers
-
- DOI 10.1016/j.jcin.2016.10.020
- PMID 28104208
- Persistent URL
- https://sonar.ch/global/documents/170083
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