Cardio Trial Files: An AI-ECG Alert Intervention, Paclitaxel-Coated vs. Uncoated Balloon in In-Stent Restenosis, and Exercise for CVD Risk
AI-enabled electrocardiography alert intervention and all-cause mortality
Lin CS et al. Nature Medicine (April 2024)
Bottom Line: This was a randomized controlled trial involving 39 physicians and 15,965 hospitalized patients to evaluate the effectiveness of an AI-enabled electrocardiogram (ECG) in identifying high-risk patients. The intervention group received an AI report and warning messages, while the control group did not. The primary outcome was a reduction in all-cause mortality within 90 days. The trial found that implementation of the AI-ECG alert was associated with a reduction in all-cause mortality within 90 days: 3.6% patients in the intervention group, compared to 4.3% in the control group (4.3%) (hazard ratio = 0.83, 95% confidence interval = 0.70–0.99). A secondary analysis showed a significant reduction in cardiac death in the high-risk ECG group of patients in the intervention group.
Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis (AGENT IDE)
Yeh RW et al. JAMA (March 2024)
Bottom Line: This is a multicenter single-blinded randomized clinical trial that enrolled 600 patients with in-stent restenosis at 40 centers in the United States. Participants were randomized to receive either a paclitaxel-coated balloon or an uncoated balloon. The primary outcome of 1-year target lesion failure was significantly lower in the paclitaxel-coated balloon group compared to the uncoated balloon group (hazard ratio [HR], 0.59 [95% CI, 0.42-0.84]; 2-sided P = .003). This study provides evidence that paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis. The study had a follow-up duration of 1 year. Safety assessments showed a lower rate of target lesion revascularization and target vessel-related myocardial infarction in the paclitaxel-coated balloon group. The study concludes that among patients undergoing coronary angioplasty for in-stent restenosis, a paclitaxel-coated balloon was superior to an uncoated balloon with respect to target lesion failure.
Aerobic, resistance, or combined exercise training and cardiovascular risk profile in overweight or obese adults (CardioRACE)
Lee D et al. European Heart Journal (January 2024)
Bottom Line: This randomized controlled trial enrolled 406 adults aged 35-70 years with overweight or obesity and elevated blood pressure. Participants were randomly assigned to one of four arms: resistance, aerobic, combined resistance plus aerobic exercise, or no-exercise control. The primary outcome was the change in standardized composite Z-score of four CVD risk factors from baseline to 1 year. Results showed that aerobic and combination groups had decreased composite Z-scores, indicating improved CVD risk profile, while the resistance group did not show any change. Both aerobic and combination groups had greater reductions in the composite Z-score compared to the resistance group, and there was no difference between the aerobic and combination groups. Percent body fat decreased in all exercise groups, but other CVD risk factors (blood pressure, LDL cholesterol, and fasting glucose) did not change. In conclusion, aerobic exercise alone or combined resistance plus aerobic exercise improved CVD risk profile in adults with overweight or obesity, while resistance exercise alone did not.
Cardio Trial Files Issue #CRD-2024-10
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