ORBITA-2: Objective Randomized Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina

The ORBITA-2 (Objective Randomized Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina) trial data demonstrate that, in patients with stable angina and ischemia producing coronary stenoses who are taking no or minimal antianginal medications, percutaneous coronary intervention (PCI) provides symptomatic and exercise benefits compared with sham treatment. That is, PCI reduces angina.

The ORBITA-2 trial compared PCI with a placebo intervention for angina relief in patients with chronic stable angina.1 A total of 301 patients (21% women) screened at 14 sites in the United Kingdom were randomized 1:1 to undergo PCI (n = 151) or placebo (n = 150). Patients who underwent PCI had complete revascularization. Patients who received placebo underwent a sham procedure without interventions. Patients who underwent PCI had lower mean angina scores than did those who received placebo (2.9 vs. 5.6; odds ratio, 2.21; p < 0.001), mean daily angina frequency (0.3 vs. 0.7 episodes), and use of antianginal therapy (0.2 vs. 0.3 units). Secondary endpoints were also improved in the PCI group, including mean treadmill testing time (700.9 vs. 641.4 sec).

The findings of this study demonstrated that, for patients with stable angina and hemodynamically significant coronary lesions, PCI results in symptomatic improvement. This trial differed from the ORBITA (Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina) trial, in which PCI did not improve exercise time in patients receiving optimal medical therapy.2 Limitations of this study included short duration of follow-up, low representation of women, and low angina severity in both groups (Canadian Cardiovascular Society [CCS] class <2).

References

  1. 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;389:2319-30.
  2. Al-Lamee R, Thompson D, Dehbi HM, et al.; ORBITA Investigators. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet 2018;391:31-40.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Chronic Angina

Keywords: Angina, Stable, Percutaneous Coronary Intervention, AHA Annual Scientific Sessions, AHA23


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