Abstract
BACKGROUND: Elderly patients represent one-third of all admissions for non-ST-elevation acute coronary syndrome (NSTEACS) in the coronary care units. Despite their high-risk characteristics and worse outcomes, compared with younger patients, the elderly receive less aggressive treatments, also due to less clear evidence regarding the most effective treatment strategy. PURPOSE: The Italian Elderly ACS study includes patients older than 74 years of age with NSTEACS in a multicenter randomized clinical trial, comparing an early aggressive and an initially conservative approach. Patients not enrolled due to specific exclusion criteria or any other reason will be enrolled in a Registry. CENTERS: Centers with on-site interventional cathlab and centers without on-site cathlab refering patients to a cathlab within a consolidated percutaneous coronary intervention network. PATIENTS: Patients admitted within 48 h of the most recent ischemic symptoms are eligible if they show transient ischemic ECG changes and/or CKMB/Tn elevation. Patients with secondary ischemia, ongoing ischemia, or heart failure, despite optimal therapy or recent coronary intervention, serum creatinine more than 2.5 mg/dl, high bleeding risk, and severe concomitant disease, are excluded from the study. DESIGN: Central randomization to a systematic early aggressive approach (coronary angiography within 48 h of admission and, when indicated, coronary revascularization) or an initially conservative approach (optimal medical therapy with coronary angiography in selected cases with refractory ischemia). Follow-up will include patient visits and ECG at 30 days, 6 months, and 1 year, post randomization. PRIMARY END POINT: The composite of all-cause mortality, myocardial (re)infarction, disabling stroke, and rehospitalization for cardiovascular diseases or severe bleeding within 6 months. SAMPLE SIZE: Expected primary end point rates of 30% in the conservative arm vs. 20% in the invasive arm. According to these estimates, with two-tailed α of 0.05, power will be 80, 85, or 90% with 252, 289, and 338 patients per group, respectively. The goal is to enroll 700 patients from 50 centers.
| Original language | English |
|---|---|
| Pages (from-to) | 217-226 |
| Number of pages | 10 |
| Journal | Journal of Cardiovascular Medicine |
| Volume | 9 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Mar 2008 |
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Keywords
- Acute coronary syndrome
- Elderly
- Randomized clinical trial
- Registry
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
Cite this
Early aggressive vs. initially conservative treatment in elderly patients with non-ST-elevation acute coronary syndrome : The Italian Elderly ACS study. / Savonitto, Stefano; De Servi, Stefano; Petronio, Anna Sonia; Bolognese, Leonardo; Cavallini, Claudio; Greco, Cesare; Indolfi, Ciro; Visconti, Luigi Oltrona; Piscione, Federico; Ambrosio, Giuseppe; Galvani, Marcello; Marzocchi, Antonio; Santilli, Ignazio; Steffenino, Giuseppe; Maseri, Attilio.
In: Journal of Cardiovascular Medicine, Vol. 9, No. 3, 03.2008, p. 217-226.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Early aggressive vs. initially conservative treatment in elderly patients with non-ST-elevation acute coronary syndrome
T2 - The Italian Elderly ACS study
AU - Savonitto, Stefano
AU - De Servi, Stefano
AU - Petronio, Anna Sonia
AU - Bolognese, Leonardo
AU - Cavallini, Claudio
AU - Greco, Cesare
AU - Indolfi, Ciro
AU - Visconti, Luigi Oltrona
AU - Piscione, Federico
AU - Ambrosio, Giuseppe
AU - Galvani, Marcello
AU - Marzocchi, Antonio
AU - Santilli, Ignazio
AU - Steffenino, Giuseppe
AU - Maseri, Attilio
PY - 2008/3
Y1 - 2008/3
N2 - BACKGROUND: Elderly patients represent one-third of all admissions for non-ST-elevation acute coronary syndrome (NSTEACS) in the coronary care units. Despite their high-risk characteristics and worse outcomes, compared with younger patients, the elderly receive less aggressive treatments, also due to less clear evidence regarding the most effective treatment strategy. PURPOSE: The Italian Elderly ACS study includes patients older than 74 years of age with NSTEACS in a multicenter randomized clinical trial, comparing an early aggressive and an initially conservative approach. Patients not enrolled due to specific exclusion criteria or any other reason will be enrolled in a Registry. CENTERS: Centers with on-site interventional cathlab and centers without on-site cathlab refering patients to a cathlab within a consolidated percutaneous coronary intervention network. PATIENTS: Patients admitted within 48 h of the most recent ischemic symptoms are eligible if they show transient ischemic ECG changes and/or CKMB/Tn elevation. Patients with secondary ischemia, ongoing ischemia, or heart failure, despite optimal therapy or recent coronary intervention, serum creatinine more than 2.5 mg/dl, high bleeding risk, and severe concomitant disease, are excluded from the study. DESIGN: Central randomization to a systematic early aggressive approach (coronary angiography within 48 h of admission and, when indicated, coronary revascularization) or an initially conservative approach (optimal medical therapy with coronary angiography in selected cases with refractory ischemia). Follow-up will include patient visits and ECG at 30 days, 6 months, and 1 year, post randomization. PRIMARY END POINT: The composite of all-cause mortality, myocardial (re)infarction, disabling stroke, and rehospitalization for cardiovascular diseases or severe bleeding within 6 months. SAMPLE SIZE: Expected primary end point rates of 30% in the conservative arm vs. 20% in the invasive arm. According to these estimates, with two-tailed α of 0.05, power will be 80, 85, or 90% with 252, 289, and 338 patients per group, respectively. The goal is to enroll 700 patients from 50 centers.
AB - BACKGROUND: Elderly patients represent one-third of all admissions for non-ST-elevation acute coronary syndrome (NSTEACS) in the coronary care units. Despite their high-risk characteristics and worse outcomes, compared with younger patients, the elderly receive less aggressive treatments, also due to less clear evidence regarding the most effective treatment strategy. PURPOSE: The Italian Elderly ACS study includes patients older than 74 years of age with NSTEACS in a multicenter randomized clinical trial, comparing an early aggressive and an initially conservative approach. Patients not enrolled due to specific exclusion criteria or any other reason will be enrolled in a Registry. CENTERS: Centers with on-site interventional cathlab and centers without on-site cathlab refering patients to a cathlab within a consolidated percutaneous coronary intervention network. PATIENTS: Patients admitted within 48 h of the most recent ischemic symptoms are eligible if they show transient ischemic ECG changes and/or CKMB/Tn elevation. Patients with secondary ischemia, ongoing ischemia, or heart failure, despite optimal therapy or recent coronary intervention, serum creatinine more than 2.5 mg/dl, high bleeding risk, and severe concomitant disease, are excluded from the study. DESIGN: Central randomization to a systematic early aggressive approach (coronary angiography within 48 h of admission and, when indicated, coronary revascularization) or an initially conservative approach (optimal medical therapy with coronary angiography in selected cases with refractory ischemia). Follow-up will include patient visits and ECG at 30 days, 6 months, and 1 year, post randomization. PRIMARY END POINT: The composite of all-cause mortality, myocardial (re)infarction, disabling stroke, and rehospitalization for cardiovascular diseases or severe bleeding within 6 months. SAMPLE SIZE: Expected primary end point rates of 30% in the conservative arm vs. 20% in the invasive arm. According to these estimates, with two-tailed α of 0.05, power will be 80, 85, or 90% with 252, 289, and 338 patients per group, respectively. The goal is to enroll 700 patients from 50 centers.
KW - Acute coronary syndrome
KW - Elderly
KW - Randomized clinical trial
KW - Registry
UR - http://www.scopus.com/inward/record.url?scp=40049112553&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=40049112553&partnerID=8YFLogxK
U2 - 10.2459/JCM.0b013e3282f7c8df
DO - 10.2459/JCM.0b013e3282f7c8df
M3 - Article
C2 - 18301136
AN - SCOPUS:40049112553
VL - 9
SP - 217
EP - 226
JO - Journal of Cardiovascular Medicine
JF - Journal of Cardiovascular Medicine
SN - 1558-2027
IS - 3
ER -