A Long-Term Single-Center Registry of 6893 Patients Undergoing Elective Percutaneous Coronary Intervention With the Xience Everolimus-Eluting Stent.
Aged
Coronary Artery Disease
/ surgery
Coronary Restenosis
/ diagnosis
Drug-Eluting Stents
Everolimus
/ therapeutic use
Female
Humans
Immunosuppressive Agents
/ therapeutic use
Italy
/ epidemiology
Long Term Adverse Effects
/ diagnosis
Male
Middle Aged
Outcome and Process Assessment, Health Care
Percutaneous Coronary Intervention
/ adverse effects
Registries
/ statistics & numerical data
Reoperation
/ methods
Risk Factors
Time Factors
clinical outcomes
drug-eluting stent
everolimus-eluting stent
stent thrombosis
Journal
The Journal of invasive cardiology
ISSN: 1557-2501
Titre abrégé: J Invasive Cardiol
Pays: United States
ID NLM: 8917477
Informations de publication
Date de publication:
May 2019
May 2019
Historique:
pubmed:
16
1
2019
medline:
18
12
2019
entrez:
16
1
2019
Statut:
ppublish
Résumé
The safety and effectiveness of the everolimus-eluting stent (EES) have been previously demonstrated. To assess very long-term performance and outcomes of the EES in a real-world population. This single-center registry prospectively enrolled 6893 patients (mean age, 66 ± 9.7 years; 81.4% men) undergoing elective coronary intervention with the EES over a decade. Clinical follow-up (FU) was performed at 1 year and then yearly thereafter. Multiple risk factors were present in 34%. Stable angina was the main stenting indication (78.1%), followed by unstable angina (5.3%) and positive stress test (16.6%) for 1-vessel (44%) or 2/3-vessel disease (56%). Multiple stents (stent/patient ratio: 2.1 ± 0.8) in >1 vessel were implanted in 36.9% (mean stent length, 43 ± 31.3 mm). At 1 year, 80% of patients were on dual-antiplatelet therapy, while only 3% were on therapy at 2 years. A low 1-year major adverse cardiac event (MACE) rate of 5.0% was observed; stent thrombosis (ST) occurred in 19 patients (0.3%), with a prevalence of early (n = 9) over late (n = 4) and very late events (n = 6; 0.08%). Clinically driven target- lesion revascularization/target-vessel revascularization (TLR/TVR) occurred in 3.3% at 1-year follow-up. Long-term FU (3 years) completed in 6210 patients (90.0%) showed a MACE rate of 5.9%, while very long-term FU (>5 years and up to 10 years), available in 3550 out of 4635 exposed patients (76.6%), showed a MACE rate of 8.6%. Independent MACE predictors were stented segment length (odds ratio [OR], 2.1; 95% confidence interval [CI] 1.57-2.82), small vessel stenting (OR, 1.34; 95% CI, 1.08-1.68), and multivessel disease (2-vessel disease: OR, 1.59; 95% CI, 1.21-2.08; 3-vessel disease: OR, 2.26; 95% CI, 1.72-2.97). This large, prospective registry confirms the very long-term safety and efficacy of the EES in unselected real-world and complex coronary lesions.
Sections du résumé
BACKGROUND
BACKGROUND
The safety and effectiveness of the everolimus-eluting stent (EES) have been previously demonstrated.
AIMS
OBJECTIVE
To assess very long-term performance and outcomes of the EES in a real-world population.
METHODS
METHODS
This single-center registry prospectively enrolled 6893 patients (mean age, 66 ± 9.7 years; 81.4% men) undergoing elective coronary intervention with the EES over a decade. Clinical follow-up (FU) was performed at 1 year and then yearly thereafter.
RESULTS
RESULTS
Multiple risk factors were present in 34%. Stable angina was the main stenting indication (78.1%), followed by unstable angina (5.3%) and positive stress test (16.6%) for 1-vessel (44%) or 2/3-vessel disease (56%). Multiple stents (stent/patient ratio: 2.1 ± 0.8) in >1 vessel were implanted in 36.9% (mean stent length, 43 ± 31.3 mm). At 1 year, 80% of patients were on dual-antiplatelet therapy, while only 3% were on therapy at 2 years. A low 1-year major adverse cardiac event (MACE) rate of 5.0% was observed; stent thrombosis (ST) occurred in 19 patients (0.3%), with a prevalence of early (n = 9) over late (n = 4) and very late events (n = 6; 0.08%). Clinically driven target- lesion revascularization/target-vessel revascularization (TLR/TVR) occurred in 3.3% at 1-year follow-up. Long-term FU (3 years) completed in 6210 patients (90.0%) showed a MACE rate of 5.9%, while very long-term FU (>5 years and up to 10 years), available in 3550 out of 4635 exposed patients (76.6%), showed a MACE rate of 8.6%. Independent MACE predictors were stented segment length (odds ratio [OR], 2.1; 95% confidence interval [CI] 1.57-2.82), small vessel stenting (OR, 1.34; 95% CI, 1.08-1.68), and multivessel disease (2-vessel disease: OR, 1.59; 95% CI, 1.21-2.08; 3-vessel disease: OR, 2.26; 95% CI, 1.72-2.97).
CONCLUSIONS
CONCLUSIONS
This large, prospective registry confirms the very long-term safety and efficacy of the EES in unselected real-world and complex coronary lesions.
Substances chimiques
Immunosuppressive Agents
0
Everolimus
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Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM