Controversy Surrounding Angioplasty in Stable Angina

Controversy Surrounding Angioplasty in Stable Angi

Research Highlights:

The ORBITA-2 study found that stents improved chest pain, exercise capacity, and quality of life compared with a placebo procedure among patients with stable chest pain and taking little or no chest pain medication.
The effect of the stent was immediate and sustained during 12 weeks of follow-up.
The research is a follow-up to the 2017 ORBITA study, the first placebo-controlled trial of stenting, which showed that stenting did not improve exercise tolerance or chest pain more than a placebo procedure in patients with stable chest pain and single vessel disease. who were taking medications according to guidelines with an average of three pain relievers on the chest.
The ORBITA-2 trial explored the effect of stenting compared with placebo without background medication for chest pain in a larger sample of patients, with stable chest pain and both single-vessel and multivessel disease.

Background

Percutaneous coronary intervention ( PCI) is frequently performed to reduce the symptoms of stable angina. It is still unknown whether PCI relieves angina more than a placebo procedure in patients not receiving antianginal medication.

Methods

We conducted a double-blind, randomized, placebo-controlled trial of PCI in patients with stable angina . Patients discontinued all antianginal medications and underwent a 2-week symptom assessment phase before randomization. Patients were then randomly assigned in a 1:1 ratio to undergo PCI or a placebo procedure and were followed for 12 weeks.

The primary endpoint was the angina symptom score, which was calculated daily based on the number of angina episodes that occurred on a given day, the number of antianginal medications prescribed that day, and clinical events, including the occurrence of unblinding due to up to unacceptable angina or acute coronary syndrome or death. Scores range from 0 to 79, with higher scores indicating worse health status with respect to angina.

Results

A total of 301 patients were randomized: 151 to the PCI group and 150 to the placebo group. The mean age (±SD) was 64±9 years and 79% were men. Ischemia was present in one cardiac territory in 242 patients (80%), in two territories in 52 patients (17%), and in three territories in 7 patients (2%).

In target vessels , the median fractional flow reserve was 0.63 (interquartile range, 0.49 to 0.75) and the median instantaneous wave-free index was 0.78 (interquartile range, 0.49 to 0.75). 55 to 0.87).

At 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).

One patient in the placebo group had unacceptable angina, which led to unblinding. Acute coronary syndromes occurred in 4 patients in the PCI group and in 6 patients in the placebo group.

Conclusions

Among patients with stable angina who were receiving little or no antianginal medication and had objective evidence of ischemia, PCI resulted in a lower angina symptom score than a placebo procedure, indicating better health status relative to angina.

(Funded by the National Institute for Health and Care Research, Imperial Biomedical Research Center and others; ORBITA-2 ClinicalTrials.gov number, NCT03742050. opens in new tab.)

Controversy Surrounding Angioplasty in Stable Angina

Results of a placebo-controlled trial investigating the efficacy of percutaneous coronary intervention for stable angina.