A single intravenous cyclosporine A bolus before primary percutaneous coronary intervention did not improve ST-segment resolution compared to control (52.0% vs 49.0%; p=0.55).
RCT (n=410)
Yes
Does a single intravenous cyclosporine A bolus improve ST-segment resolution in patients with large ST-segment elevation MI undergoing primary percutaneous coronary intervention?
Absolute Event Rate: 52% vs 49%
p-value: p=0.55
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 Q1 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).
“IV administration of cyclosporine A immediately before primary coronary angioplasty within 6 hours from the onset of symptoms in patients with STEMI did not improve markers of myocardial injury, ventricular remodeling or clinical outcomes, indicating that this strategy did not prevent or reduce reperfusion-related injury. Additional research is needed to identify more effective adjunctive strategies to attenuate ischemia/reperfusion injury in patients with STEMI undergoing primary PCI.”
Ottani et al. (Mon,) conducted a rct in ST-segment elevation myocardial infarction (n=410). Cyclosporine A vs. control was evaluated on incidence of ≥70% ST-segment resolution 60 min after TIMI flow grade 3 (p=0.55). A single intravenous cyclosporine A bolus before primary percutaneous coronary intervention did not improve ST-segment resolution compared to control (52.0% vs 49.0%; p=0.55).
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