Cyclosporine A in Reperfused Myocardial Infarction: The Multicenter, Controlled, Open-Label CYCLE Trial.

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).

Outcomes following primary percutaneous coronary intervention for unprotected left main-related ST-segment elevation myocardial infarction.

INTRODUCTION: Unprotected left main (ULM) related ST-segment elevation myocardial infarction (STEMI) is a severe event, often leading to circulatory failure and/or sudden cardiac death. Although high-risk ULM thrombosis populations treated by primary percutaneous coronary intervention (PPCI) have been previously described, very little is known regarding the outcomes following PPCI for ULM-related STEMI in a hospital without on-site surgical back-up. METHODS: A retrospective cohort analysis was performed on all consecutive patients who underwent PPCI for ULM-related STEMI in a single center. The primary end-point was to assess in-hospital mortality in the overall population and according to the presence/absence of cardiogenic shock at admission. RESULTS: Between October 2006 and December 2012, 1094 patients underwent PPCI for STEMI. PPCI for ULM-related STEMI was performed in 34 (3.1%) patients. Among these, 22 (64.7%) were in cardiogenic shock at admission. Baseline mean ejection fraction was lower (P = 0.008), whereas the prevalence of patients with pre-procedural cardiac arrest and Killip Class III-IV was significantly higher in the cardiogenic shock (P = 0.05 and P < 0.001, respectively) compared with non-cardiogenic shock group. Furthermore, patients with cardiogenic shock had a higher prevalence of pre-procedural thrombolysis in myocardial infarction flow 0-1 (P = 0.05) and associated other vessel chronic total occlusion (P = 0.05) compared with non-cardiogenic shock group. Procedural success rate was lower in the cardiogenic shock compared with non-cardiogenic shock group (77.3 vs. 100%, P = 0.09), whereas in-hospital mortality rate was significantly higher in the cardiogenic shock compared with non-cardiogenic shock group (36.4 vs. 0%, P = 0.02). No deaths were reported among survivors of the acute phase at mid-term follow-up, whereas target lesion revascularization rate was 7.6%. CONCLUSIONS: PPCI for ULM-related STEMI in a hospital without on-site surgical back-up was technically feasible in most of the cases. Although the procedural success and in-hospital mortality rates were influenced by cardiogenic shock at admission, an excellent mid-term outcome among patients who survived the hospitalization was reported independently by the severity of clinical presentation.

[Primary percutaneous coronary intervention and therapeutic hypothermia in comatose survivors after out-of-hospital cardiac arrest complicating acute myocardial infarction: a single-center experience]. / Angioplastica primaria ed ipotermia terapeutica in pazienti comatosi con infarto miocardico acuto sopravvissuti ad arresto cardiaco extraospedaliero: esperienza di un singolo centro.

BACKGROUND: Therapeutic hypothermia (TH) is associated with improved neurologic outcomes in comatose survivors of out-of-hospital cardiac arrest (OHCA). There are currently limited data on the outcomes of patients presenting with resuscitated OHCA in the setting of acute myocardial infarction. The aim of this study was to assess the outcomes of comatose survivors of OHCA complicating acute myocardial infarction treated with primary percutaneous coronary intervention (PCI) and TH. METHODS: A retrospective cohort analysis was performed on all consecutive patients referred for primary PCI and TH between August 2008 and December 2013 in a single center. The primary endpoint was survival to hospital discharge with sufficient neurologic recovery (defined as Cerebral Performance Category score <2). RESULTS: Among 886 consecutive patients referred for primary PCI, 24 were comatose survivors of OHCA complicating acute myocardial infarction. All these patients underwent primary PCI followed by TH. Median patient age was 59 (IQR 35-87) years and 11 (45.8%) patients had anterior ST-elevation myocardial infarction. Median OHCA-to-balloon time was 120 min (IQR 75-340) while median OHCA-to-TH initiation time was 250 min (IQR 180-310). Survival with sufficient neurologic recovery to enable discharge home was reached in 16 (66.7%) patients. Time between initiation of cardiopulmonary resuscitation (CPR) to return of spontaneous circulation (ROSC) <20 min was associated with a lower occurrence of death and poor neurologic outcome compared to CPR-to-ROSC time ≥20 min (15.4 vs 54.5%, p=0.05). The occurrence of major bleeding was 8.3%, while no stent thrombosis was reported. CONCLUSIONS: TH in conjunction with primary PCI is feasible and associated with acceptable outcome in the majority of comatose survivors of OHCA complicating acute myocardial infarction, especially if CPR-to-ROSC time was <20 min. Randomized studies are needed to better assess the superiority of TH and primary PCI vs primary PCI alone in this complex subset of OHCA patients.

Treatment of refractory heart failure with a percutaneous circulatory support device.

End-stage heart failure refractory to medical therapy is a clinical challenge. Heart transplantation is considered the best strategy, but it remains burdened with substantial limitations due to the scanty availability of facilities with a transplant programme, donor shortage, and unpredictable waiting lists. Alternatively, assist devices may allow an improvement of the haemodynamic conditions, modifying the history of end-stage heart failure and introducing new management strategies. The goal of a minimally invasive short-term circulatory support device in the treatment of end-stage heart failure patients awaiting heart transplant is to restore the haemodynamic conditions and to improve end-organ dysfunction, with a low incidence of major adverse cardiac events. This report describes the first implantation in Italy of a new percutaneous circulatory support device, the Cancion cardiac recovery system, in a patient with severe end-stage heart failure listed for transplantation.