Thiazide-type diuretics are superior in preventing 1 or more major forms of CVD and are less expensive. They should be preferred for first-step antihypertensive therapy.
Context
Clinical trial results suggest that intracoronary delivery of autologous bone marrow mononuclear cells (BMCs) may improve left ventricular (LV) function when administered within the first week following myocardial infarction (MI). However, since a substantial number of patients may not present for early cell delivery, we investigated the efficacy of autologous BMC delivery 2–3 weeks post-MI.
Objective
To determine if intracoronary delivery of autologous BMCs improves global and regional LV function when delivered 2–3 weeks following first MI.
Design, Setting, and Patients
LateTIME is a randomized, double-blind, placebo-controlled trial of the National Heart, Lung, and Blood Institute - sponsored Cardiovascular Cell Therapy Research Network (CCTRN) of 87 patients with significant LV dysfunction (LVEF ≤ 45%) following successful primary percutaneous coronary intervention (PCI).
Interventions
Intracoronary infusion of 150 × 106 autologous BMCs (total nucleated cells) or placebo (2:1 BMC:placebo) was performed within 12 hours of bone marrow aspiration after local automated cell processing.
Main Outcome Measures
The primary endpoints were changes in global (LVEF) and regional (wall motion) LV function in the infarct and border zone from baseline to 6 months as measured by cardiac MRI at a core lab blinded to treatment assignment Secondary endpoints included changes in LV volumes and infarct size.
Results
87 patients were randomized between July 2008 and February 2011: mean age = 57 ± 11 yrs, 83% male. Harvesting, processing, and intracoronary delivery of BMCs in this setting was feasible and safe. The change from baseline to six months in the BMC group, when compared to the placebo group, for LVEF (48.7 to 49.2% vs. 45.3 to 48.8%; Difference = −3.0, 95% CI −7.0 to 0.9), wall motion in the infarct zone (6.2 to 6.5 vs. 4.9 to 5.9 mm; Difference = −0.7, 95% CI −2.8 to 1.3), and wall motion in the border zone (16.0 to 16.6 mm vs. 16.1 to 19.3 mm; Difference = −2.6; 95% CI −6.0 to 0.8) were not statistically significant. There was no significant change in LV volumes and infarct volumes decreased by a similar amount in both groups at 6 months compared to baseline.
Conclusions
Among patients with MI and LV dysfunction following reperfusion with PCI, intracoronary infusion of autologous BMCs compared to intracoronary placebo infusion, 2–3 weeks after PCI did not improve global or regional function at 6 months.
Background
Variability of blood pressure (BP) across outpatient visits is frequently dismissed as random fluctuation around a patient’s underlying BP. Objective: Examine the association between visit-to-visit variability (VVV) of systolic and diastolic BP (SBP and DBP) on cardiovascular disease and mortality outcomes.
Design
Prospective cohort study
Setting
Post-hoc analysis of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).
Participants
25,814 ALLHAT participants.
Measurements
VVV of SBP was defined as the standard deviation (SD) across BP measurements obtained at 7 visits conducted from 6 to 28 months following ALLHAT enrollment. Participants free of cardiovascular disease events during the first 28 months of follow-up were followed from the month 28 study visit through the end of active ALLHAT follow-up. Outcomes included fatal coronary heart disease or non-fatal myocardial infarction, all-cause mortality, stroke and heart failure.
Results
There were 1194 cases of fatal CHD or non-fatal MI, 1948 deaths, 606 cases of stroke and 921 cases of heart failure during follow-up. After multivariable adjustment including mean SBP, the hazard ratio comparing participants in the highest versus lowest quintile of SD of SBP (≥14.4 mmHg versus <6.5 mmHg) was 1.30 (1.06–1.59) for fatal coronary heart disease or non-fatal myocardial infarction, 1.58 (1.32–1.90) for all-cause mortality, 1.46 (1.06–2.01) for stroke, and 1.25 (0.97–1.61) for heart failure. Higher VVV of DBP was also associated with cardiovascular disease events and mortality.
Limitations
Long-term outcomes were not available.
Conclusions
Higher VVV of SBP is associated with increased cardiovascular disease and mortality risk. Future studies should examine whether reducing VVV of BP lowers this risk.
Primary funding source
National Institutes of Health
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