Cyclosporine A in Reperfused Myocardial Infarction: The Multicenter, Controlled, Open-Label CYCLE Trial
| Autor: | Filippo, Ottani, Roberto, Latini, Lidia, Staszewsky, Luigi, La Vecchia, Nicola, Locuratolo, Marco, Sicuro, Serge, Masson, Simona, Barlera, Valentina, Milani, Mario, Lombardi, Alessandra, Costalunga, Nadia, Mollichelli, Andrea, Santarelli, Nicoletta, De Cesare, Paolo, Sganzerla, Alberto, Boi, Aldo Pietro, Maggioni, Ugo, Limbruno |
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| Rok vydání: | 2015 |
| Předmět: |
Male
Dose-Response Relationship Drug Ventricular Remodeling Myocardial Infarction Myocardial Reperfusion Middle Aged Coronary Angiography Ventricular Function Left Electrocardiography Treatment Outcome Echocardiography Injections Intravenous Cyclosporine Humans Female Prospective Studies Immunosuppressive Agents Follow-Up Studies |
| Zdroj: | Journal of the American College of Cardiology. 67(4) |
| ISSN: | 1558-3597 |
| Popis: | Whether cyclosporine A (CsA) has beneficial effects in reperfused myocardial infarction (MI) is debated.This study investigated whether CsA improved ST-segment resolution in a randomized, multicenter phase II study.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.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).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). |
| Databáze: | OpenAIRE |
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