Symptomatic relief from angina pectoris is the main reason for patients with stable coronary heart disease to undergo percutaneous coronary intervention (PCI), but the evidence comes from unblinded studies. Moreover, in the2017 ORBITA trial², PCI did not improve exercise tolerance and chest pain compared to a placebo procedure in patients receiving concomitant anti-anginal medications. However, optimal anti-anginal medication can be difficult to achieve in clinical practice and PCI would still be the preferred option for many patients.

ORBITA-2 trial¹, presented at AHA congress and simultaneously published in the New England Journal of Medicine, is providing improved evidence to the efficacy of PCI in patients with angina pectoris with no or little antianginal medication. ORBITA-2 enrolled 301 patients eligible for PCI, who met specific inclusion criteria, and were randomly assigned to either a PCI or a placebo procedure, in a double-blind fashion. At enrollment, patients stopped treatment with antianginal medications unless prescribed for a different indication. Importantly, patients allocated to the placebo group had a sham procedure, all further care was provided without knowledge of the trial-group assignment. During the trial, participants regularly used a specialized smartphone application to communicate their daily experience of chest pain. The information gathered from these reports, along with the need for chest pain medication, was used to calculate the angina symptom score, serving as primary endpoint in the study.

At the 12-week follow-up, the mean angina symptom score was 2.9 in the PCI group and 5.6 in the placebo group (odds ratio, 2.21; 95% confidence interval, 1.41 to 3.47; p<0.001).  The benefit was mostly driven by a reduction in the number of daily angina episodes (0.3 vs 0.7; OR 3.44; 95% CI 2.0-5.9), with no significant difference seen between groups in the number of patients who received antianginal medications (0.2 vs 0.3 units; OR 1.21; 95% CI 0.70-2.10).

The daily data showed that the effect of PCI was immediate and sustained.
Furthermore, exercise time increased by 60 seconds more among patients in the PCI group vs. the placebo group and the EuroQOL questionnaires showed improvements in quality of life. 
The results of this study showed the antianginal benefit of PCI for stable CAD and helps consider the use of PCI as an upfront procedure. Going forward, patients and HCPs might have the choice of two options for chest pain relief, both with their own associated benefits, risks and costs. 

Listen to our post-AHA podcast, where we'll explore key insights from a recent study investigating lipid-lowering therapy and LDL-C control for primary prevention of people living with type 2 diabetes  across 90 health systems in the United States. Click below to listen to the podcast

The study⁴  included 4,012 individuals experiencing subclinical atrial fibrillation (SCAF) episodes lasting six minutes to 24 hours, as detected by implanted pacemakers or other cardiac monitors, and who also exhibited additional risk factors for stroke. Participants were randomly assigned in a double-blind, double-dummy manner to receive either Apixaban at 5mg twice daily (or 2.5mg twice daily if dose reduction criteria were met) or aspirin at 81mg once daily, over an average duration of four years. The mean CHA2DS2-VASc score for stroke risk in atrial fibrillation was 3.9±1.1, and the median duration of their longest SCAF episode was 1.47 (0.2-4.95) hours. Apixaban demonstrated a statistically significant 37% reduction in stroke risk (hazard ratio, 0.63; 95% CI, 0.45 to 0.88; P=0.007, ARR 0.46 %), decreasing from an annual rate of 1.24%, with a concurrent 49% reduction in disabling or fatal strokes (Modified Rankin Score of 3-6). However, patients receiving apixaban experienced a higher rate of major bleeding (hazard ratio, 1.80; 95% CI, 1.26 to 2.57; P=0.001, ARR 0.77 %).), with a corresponding risk of 1.7% per year.

The ARTERSiA trial provides valuable information for clinicians managing patients with subclinical AF. Going forward, it will be important to strike a balance between the increased bleeding risks and the risk for disabling strokes when deciding to prescribe anticoagulants. However, additional studies and meta-analyses are still needed to offer more insights regarding treatment benefits in specific subgroups and refine treatment approaches, taking into consideration the patient bleeding risk.

The CARDIA-SSBP trial⁵

Following 1 week of usual diet, 213 patients from 50 to 75 years old were enrolled in this prospective cross-over trial, with both high- and low-sodium diet each for a week. Low-sodium diet corresponds to 500mg of sodium daily, and high-sodium diet was an addition of 2 200mg sodium daily to usual diet. For the low-sodium diet group, all meals were prepared and provided to participants at no cost along with instructions not to eat anything outside the study meals. On day 7 of each diet, ambulatory 24-hour blood pressure monitoring was performed. 

Patients included were either with normotension (25%), controlled hypertension (20%), uncontrolled hypertension (31%) or untreated hypertension (25%). The average age of participants who completed both diets was 61 years, with 65% being females and 64% Black.
Starting from a baseline of 125 mm Hg, the high-sodium diet resulted in an increase in systolic blood pressure to 126 mm Hg, whereas the low-sodium diet led to a decrease, bringing systolic blood pressure down to 119 mm Hg. By the end of the initial week of dietary intervention, the average systolic blood pressure difference between individuals adhering to a high-sodium diet compared to those on a low-sodium diet was 8 mm Hg (95% CI 4-11 mm Hg; P < 0.001).  The low-sodium diet exhibited a blood pressure reduction in around 75% of participants, with approximately half experiencing a decrease of more than 5 mm Hg in mean arterial pressure with the low-sodium diet. The decline in BP was independent of hypertension status and anti-hypertensive medication use, consistent across subgroups, and did not result in excess adverse events.

These findings emphasize the critical role of reducing dietary sodium intake in managing blood pressure, even for individuals who are already on hypertension medications, but can be questioned by the long-term feasibility of such a strict dietary approach.

1.    Christopher A et al. A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina. N Engl J Med. 2023 Nov 11.
2.    Al-Lamee R et al. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomized controlled trial. Lancet. 2018 Jan 06. 391:10115(31-40)
3.    Decicco E et al. Lipid-lowering therapy and LDL-C control for primary prevention in persons with diabetes across 90 health systems in the United States. American Journal of Preventive Cardiology, 2023 Nov 12. Available online: 100604
4.    Healey JS et al. Apixaban for Stroke Prevention in Subclinical Atrial Fibrillation. N Engl J Med. 2023 Nov 12.
5.    Gupta DK et al. Effect of Dietary Sodium on Blood Pressure: A Crossover Trial. JAMA. Published online November 11, 2023