G-CSF treatment for STEMI: final 3-year follow-up of the randomised placebo-controlled STEM-AMI trial.

OBJECTIVE: To assess whether granulocyte colony-stimulating factor (G-CSF) treatment induces a sustained benefit on adverse remodelling in patients with large anterior ST-elevation myocardial infarction (STEMI) and left ventricular (LV) dysfunction after successful reperfusion. METHODS: The STEM-AMI Trial was a prospective, placebo-controlled, multicentre study. Sixty consecutive patients with a first anterior STEMI, who underwent primary percutaneous coronary intervention 2-12 h after symptom onset, with LV ejection fraction (LVEF) ≤45% measured by echocardiography within 12 h after successful revascularisation (TIMI flow score ≥2), were randomised 1:1 to G-CSF (5 µg/Kg body weight b.i.d.) or placebo. Clinical events and Major Adverse Cardiac and Cerebrovascular Event (MACCE) were monitored, and LVEF, LV end-diastolic (LVEDV) and end-systolic (LVESV) volumes, and infarct size were evaluated by MRI at the final 3-year follow-up. RESULTS: Fifty-four patients completed the study, of whom 35 with MRI. No significant differences were found in mortality and MACCE between G-CSF and placebo-treated groups. The 3-year infarct size was not different between groups, whereas LVEDV was significantly lower in G-CSF (n=20) than in placebo (n=15) patients (170.1±8.1 vs 197.2±8.9 mL, respectively; p=0.033 at analysis of covariance). A significant inverse correlation was detected in G-CSF patients between the number of circulating CD34 cells at 30 days after reperfusion and the 3-year absolute and indexed LVEDV (ρ=-0.71, 95% CI -0.90 to -0.30, and ρ=-0.62, -0.86 to -0.14, respectively), or their change over time (r=-0.59, -0.85 to -0.11, and r=-0.55, -0.83 to -0.06, respectively). CONCLUSIONS: G-CSF therapy may be beneficial in attenuating ventricular remodelling subsequent to a large anterior STEMI in the long term. No differences have been detected in clinical outcome.

Modalities of treatment and 30-day outcomes of unselected patients older than 75 years with acute ST-elevation myocardial infarction: data from the BLITZ study.

BACKGROUND: The optimal treatment strategy for elderly patients presenting with ST-elevation myocardial infarction is still controversial and few investigations have studied this high-risk population in a community setting. METHODS: We analyzed data from the BLITZ survey on patients with any acute myocardial infarction admitted to the Italian Coronary Care Unit (CCU) network, in order to assess current treatment strategies among unselected patients older than 75 years presenting with ST-elevation myocardial infarction. We also evaluated the 30-day rates of major adverse cardiovascular events (death/re-myocardial infarction/stroke) relative to different treatment strategies. RESULTS: The registry included 1959 patients, of whom 529 (27%) were over 75 years old. According to the ECG on admission, 296 of these patients (56%) were classified as having ST-elevation myocardial infarction: 26 (8.8%) underwent primary percutaneous coronary intervention, 101 (34.1%) were treated with systemic thrombolysis, and the remaining 169 (57.1%) did not receive any early reperfusion therapy. At 30-day follow-up, the cumulative rate of major adverse cardiovascular events was not significantly different among the three treatment modality groups (31.4, 27.7, and 23.1% among no reperfusion, thrombolysis and primary percutaneous coronary intervention groups, respectively; P = 0.59). On multivariable analysis, age [odds ratio (OR) x 5-year increment 1.5; 95% confidence interval (CI) 1.2-2.0; P = 0.007], Killip class II-IV at admission (OR 3.7; 95% CI 2.1-6.3; P < 0.0001), and coronary multivessel disease (OR 2.4; 95% CI 1.1-5.3; P = 0.03) were the only independent predictors of major adverse cardiovascular events. CONCLUSION: In a nationwide clinical practice, the vast majority of patients older than 75 years presenting with ST-elevation myocardial infarction does not receive any early reperfusion treatment and presents a significant incidence of major clinical events at 30 days.

Comparative effects of candesartan and enalapril on left ventricular hypertrophy in patients with essential hypertension: the candesartan assessment in the treatment of cardiac hypertrophy (CATCH) study.

BACKGROUND: A limited number of studies have evaluated the effect of angiotensin II receptor antagonists (AIIAs) on left ventricular hypertrophy (LVH) in comparison with other antihypertensive drugs, and no large study has compared AIIAs with angiotensin-converting enzyme inhibitors (ACEIs). METHODS AND RESULTS: The CATCH (Candesartan Assessment in the Treatment of Cardiac Hypertrophy) study was a multicenter prospective randomized double-blind trial comparing the effects of candesartan cilexetil (8-16 mg once daily) and enalapril (10-20 mg once daily) with possible addition of hydrochlorothiazide (12.5-25 mg once daily) on echocardiographic left ventricular mass index (LVMI), in 239 hypertensives with LVH (LVMI 120 g/m2 in men and 100 g/m2 in women). Two-dimensionally guided M-mode echocardiograms were carried out at screening (recruiting scan), randomization (baseline scan) and after 24 and 48 weeks of treatment. Baseline and treatment echocardiograms were read at two central labs without knowledge of the scan time sequence. In intention-to-treat (ITT) analyses (196 patients), systolic and diastolic blood pressures (SBP, DBP) were significantly and equally reduced by the two treatments. Candesartan and enalapril reduced LVMI to the same extent, i.e. by 15.0 and 13.1 g/m2 (-10.9 and -8.4%; P<0.001 for both). The proportion of patients achieving normalization of LVMI was non-significantly higher with candesartan (36.3 versus 28.6%). Similar results were obtained in per-protocol (PP) analyses. Cough incidence was lower with candesartan ( P<0.03). CONCLUSIONS: CATCH is the first large study comparing the effects of an AIIA and an ACEI on LVMI. Candesartan cilexetil was found to be equally effective as enalapril in reducing SBP, DBP and LVMI in hypertensives with LVH, according to both ITT and PP analyses.