Clinical Question
Does percutaneous coronary intervention (PCI) reduce the symptoms of stable angina compared with a placebo procedure in patients who are not taking antianginal medications?
Bottom Line
In patients with stable angina who are not taking antianginal medications, PCI is effective. The study results suggest that for patients who are able to tolerate a maximal antianginal medical regimen, there is little or no benefit to PCI, but for those unable to adhere to medication, PCI provides an important benefit. (Level of Evidence = 1b)
Synopsis
The original ORBITA trial compared PCI with placebo in patients who were taking guideline-directed antianginal medications and found that there was no additional benefit with PCI for symptoms or treadmill exercise time. However, the authors acknowledge that achieving guideline-directed maximal medical therapy in the real world can be challenging. In this study, the authors identified patients with stable angina, severe stenosis of at least one vessel, and evidence of ischemia. They asked patients to stop taking any antianginal medications; antihypertensive medications with antianginal effects were replaced with alternate agents. Dual antiplatelet agents and statins were still prescribed. During a 2-week run-in period, the patients reported episodes of angina, and if they had at least one episode (n = 301) they were randomized to receive PCI or a placebo procedure involving sedation but no PCI. For the next 12 weeks, the patients reported anginal symptoms daily. At baseline, the patients' mean age was 64 years, 79% were male, 28% had diabetes mellitus, 80% had single-vessel disease, and most had moderate to severe angina (Canadian Cardiovascular Society class II or III). The median number of stents implanted was two in the PCI group. At 12 weeks, the mean daily number of angina episodes (0.3 vs. 0.7; odds ratio = 3.4; 95% CI, 2.0 to 5.9) and the angina symptoms score (2.9 vs. 5.6; P < .001) favored the PCI group. Masking was assessed to be effective.
Study design: Randomized controlled trial (double-blinded)
Funding source: Government
Allocation: Concealed
Setting: Outpatient (specialty)
Reference: Rajkumar CA, Foley MJ, Ahmed-Jushuf F, et al.; ORBITA-2 Investigators. A placebo-controlled trial of percutaneous coronary intervention for stable angina. N Engl J Med. 2023;389(25):2319-2330.
Editor's Note: Dr. Ebell is deputy editor for evidence-based medicine for AFP and cofounder and editor-in-chief of Essential Evidence Plus, published by Wiley-Blackwell.
