Abstract
Background Whether cyclosporine A (CsA) has beneficial effects in reperfused myocardial infarction (MI) is debated. Objectives This study investigated whether CsA improved ST-segment resolution in a randomized, multicenter phase II study. Methods The authors randomly assigned 410 patients from 31 cardiac care units, age 63 ± 12 years, with large ST-segment elevation MI within 6 h of symptom onset, Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 to 1 in the infarct-related artery, and committed to primary percutaneous coronary intervention, to 2.5 mg/kg intravenous CsA (n = 207) or control (n = 203) groups. The primary endpoint was incidence of ≥70% ST-segment resolution 60 min after TIMI flow grade 3. Secondary endpoints included high-sensitivity cardiac troponin T (hs-cTnT) on day 4, left ventricular (LV) remodeling, and clinical events at 6-month follow-up. Results Time from symptom onset to first antegrade flow was 180 ± 67 min; a median of 5 electrocardiography leads showed ST-segment deviation (quartile [Q]1 to Q3: 4 to 6); 49.8% of MIs were anterior. ST-segment resolution ≥70% was found in 52.0% of CsA patients and 49.0% of controls (p = 0.55). Median hs-cTnT on day 4 was 2,160 (Q1 to Q3: 1,087 to 3,274) ng/l in CsA and 2,068 (1,117 to 3,690) ng/l in controls (p = 0.85). The 2 groups did not differ in LV ejection fraction on day 4 and at 6 months. Infarct site did not influence CsA efficacy. There were no acute allergic reactions or nonsignificant excesses of 6-month mortality (5.7% CsA vs. 3.2% controls, p = 0.17) or cardiogenic shock (2.4% CsA vs. 1.5% controls, p = 0.33). Conclusions In the CYCLE (CYCLosporinE A in Reperfused Acute Myocardial Infarction) trial, a single intravenous CsA bolus just before primary percutaneous coronary intervention had no effect on ST-segment resolution or hs-cTnT, and did not improve clinical outcomes or LV remodeling up to 6 months. (CYCLosporinE A in Reperfused Acute Myocardial Infarction [CYCLE]; NCT01650662; EudraCT number 2011-002876-18)
| Original language | English |
|---|---|
| Pages (from-to) | 365-374 |
| Number of pages | 10 |
| Journal | Journal of the American College of Cardiology |
| Volume | 67 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - Feb 2 2016 |
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Keywords
- acute myocardial infarction
- echocardiography
- left ventricular function
- troponins
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
Cite this
Cyclosporine A in Reperfused Myocardial Infarction the Multicenter, Controlled, Open-Label CYCLE Trial. / Ottani, Filippo; Latini, Roberto; Staszewsky, Lidia; La Vecchia, Luigi; Locuratolo, Nicola; Sicuro, Marco; Masson, Serge; Barlera, Simona; Milani, Valentina; Lombardi, Mario; Costalunga, Alessandra; Mollichelli, Nadia; Santarelli, Andrea; De Cesare, Nicoletta; Sganzerla, Paolo; Boi, Alberto; Maggioni, Aldo Pietro; Limbruno, Ugo.
In: Journal of the American College of Cardiology, Vol. 67, No. 4, 02.02.2016, p. 365-374.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Cyclosporine A in Reperfused Myocardial Infarction the Multicenter, Controlled, Open-Label CYCLE Trial
AU - Ottani, Filippo
AU - Latini, Roberto
AU - Staszewsky, Lidia
AU - La Vecchia, Luigi
AU - Locuratolo, Nicola
AU - Sicuro, Marco
AU - Masson, Serge
AU - Barlera, Simona
AU - Milani, Valentina
AU - Lombardi, Mario
AU - Costalunga, Alessandra
AU - Mollichelli, Nadia
AU - Santarelli, Andrea
AU - De Cesare, Nicoletta
AU - Sganzerla, Paolo
AU - Boi, Alberto
AU - Maggioni, Aldo Pietro
AU - Limbruno, Ugo
PY - 2016/2/2
Y1 - 2016/2/2
N2 - Background Whether cyclosporine A (CsA) has beneficial effects in reperfused myocardial infarction (MI) is debated. Objectives This study investigated whether CsA improved ST-segment resolution in a randomized, multicenter phase II study. Methods The authors randomly assigned 410 patients from 31 cardiac care units, age 63 ± 12 years, with large ST-segment elevation MI within 6 h of symptom onset, Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 to 1 in the infarct-related artery, and committed to primary percutaneous coronary intervention, to 2.5 mg/kg intravenous CsA (n = 207) or control (n = 203) groups. The primary endpoint was incidence of ≥70% ST-segment resolution 60 min after TIMI flow grade 3. Secondary endpoints included high-sensitivity cardiac troponin T (hs-cTnT) on day 4, left ventricular (LV) remodeling, and clinical events at 6-month follow-up. Results Time from symptom onset to first antegrade flow was 180 ± 67 min; a median of 5 electrocardiography leads showed ST-segment deviation (quartile [Q]1 to Q3: 4 to 6); 49.8% of MIs were anterior. ST-segment resolution ≥70% was found in 52.0% of CsA patients and 49.0% of controls (p = 0.55). Median hs-cTnT on day 4 was 2,160 (Q1 to Q3: 1,087 to 3,274) ng/l in CsA and 2,068 (1,117 to 3,690) ng/l in controls (p = 0.85). The 2 groups did not differ in LV ejection fraction on day 4 and at 6 months. Infarct site did not influence CsA efficacy. There were no acute allergic reactions or nonsignificant excesses of 6-month mortality (5.7% CsA vs. 3.2% controls, p = 0.17) or cardiogenic shock (2.4% CsA vs. 1.5% controls, p = 0.33). Conclusions In the CYCLE (CYCLosporinE A in Reperfused Acute Myocardial Infarction) trial, a single intravenous CsA bolus just before primary percutaneous coronary intervention had no effect on ST-segment resolution or hs-cTnT, and did not improve clinical outcomes or LV remodeling up to 6 months. (CYCLosporinE A in Reperfused Acute Myocardial Infarction [CYCLE]; NCT01650662; EudraCT number 2011-002876-18)
AB - Background Whether cyclosporine A (CsA) has beneficial effects in reperfused myocardial infarction (MI) is debated. Objectives This study investigated whether CsA improved ST-segment resolution in a randomized, multicenter phase II study. Methods The authors randomly assigned 410 patients from 31 cardiac care units, age 63 ± 12 years, with large ST-segment elevation MI within 6 h of symptom onset, Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 to 1 in the infarct-related artery, and committed to primary percutaneous coronary intervention, to 2.5 mg/kg intravenous CsA (n = 207) or control (n = 203) groups. The primary endpoint was incidence of ≥70% ST-segment resolution 60 min after TIMI flow grade 3. Secondary endpoints included high-sensitivity cardiac troponin T (hs-cTnT) on day 4, left ventricular (LV) remodeling, and clinical events at 6-month follow-up. Results Time from symptom onset to first antegrade flow was 180 ± 67 min; a median of 5 electrocardiography leads showed ST-segment deviation (quartile [Q]1 to Q3: 4 to 6); 49.8% of MIs were anterior. ST-segment resolution ≥70% was found in 52.0% of CsA patients and 49.0% of controls (p = 0.55). Median hs-cTnT on day 4 was 2,160 (Q1 to Q3: 1,087 to 3,274) ng/l in CsA and 2,068 (1,117 to 3,690) ng/l in controls (p = 0.85). The 2 groups did not differ in LV ejection fraction on day 4 and at 6 months. Infarct site did not influence CsA efficacy. There were no acute allergic reactions or nonsignificant excesses of 6-month mortality (5.7% CsA vs. 3.2% controls, p = 0.17) or cardiogenic shock (2.4% CsA vs. 1.5% controls, p = 0.33). Conclusions In the CYCLE (CYCLosporinE A in Reperfused Acute Myocardial Infarction) trial, a single intravenous CsA bolus just before primary percutaneous coronary intervention had no effect on ST-segment resolution or hs-cTnT, and did not improve clinical outcomes or LV remodeling up to 6 months. (CYCLosporinE A in Reperfused Acute Myocardial Infarction [CYCLE]; NCT01650662; EudraCT number 2011-002876-18)
KW - acute myocardial infarction
KW - echocardiography
KW - left ventricular function
KW - troponins
UR - http://www.scopus.com/inward/record.url?scp=84959369033&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84959369033&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2015.10.081
DO - 10.1016/j.jacc.2015.10.081
M3 - Article
C2 - 26821623
AN - SCOPUS:84959369033
VL - 67
SP - 365
EP - 374
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
SN - 0735-1097
IS - 4
ER -