Five-year clinical outcomes of the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer.
Medicine (Baltimore)
; 100(19): e25765, 2021 May 14.
Article
in En
| MEDLINE
| ID: mdl-34106607
ABSTRACT
ABSTRACT This study evaluated the 5-year clinical outcomes of the Genoss DES, the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer.We previously conducted the first-in-patient prospective, multicenter, randomized trial with a 11 ratio of patients using the Genoss DES and Promus Element stents; the angiographic and clinical outcomes of the Genoss DES stent were comparable to those of the Promus Element stent. The primary endpoint was major adverse cardiac events (MACE), which was a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR) at 5âyears.We enrolled 38 patients in the Genoss DES group and 39 in the Promus Element group. Thirty-eight patients (100%) from the Genoss DES group and 38 (97.4%) from the Promus Element group were followed up at 5âyears. The rates of MACE (5.3% vs 12.8%, Pâ=â.431), death (5.3% vs 10.3%, Pâ=â.675), TLR (2.6% vs 2.6%, Pâ=â1.000), and target vessel revascularization (TVR) (7.9% vs 2.6%, Pâ=â.358) at 5âyears did not differ significantly between the groups. No TLR or target vessel revascularization was reported from years 1 to 5 after the index procedure, and no MI or stent thrombosis occurred in either group during 5âyears.The biodegradable polymer Genoss DES and durable polymer Promus Element stents showed comparable low rates of MACE at the 5-year clinical follow-up.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Coronary Artery Disease
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Cardiovascular Agents
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Sirolimus
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Drug-Eluting Stents
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Percutaneous Coronary Intervention
Type of study:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limits:
Adult
/
Aged
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Aged80
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Female
/
Humans
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Male
/
Middle aged
Country/Region as subject:
Asia
Language:
En
Journal:
Medicine (Baltimore)
Year:
2021
Document type:
Article