Stable CAD and Angina: PCI without medical therapy as first treatment (ORBITA-2)

Key Points

In patients not taking antianginal meds, PCI alleviated some—but not all—symptoms

Background:

Percutaneous coronary intervention (PCI) is commonly used to alleviate stable angina symptoms.

Uncertainty exists regarding whether PCI is more effective than a placebo procedure in patients not using antianginal medication.

Methods:

A double-blind, randomized, placebo-controlled PCI trial was conducted in stable angina patients.

Patients underwent a 2-week symptom assessment phase after stopping antianginal medications.

Randomized 1:1, patients received either PCI or a placebo, with a 12-week follow-up.

The primary endpoint was the angina symptom score, calculated based on daily angina episodes, antianginal medications, and clinical events.

Results:

301 patients were randomized (151 PCI, 150 placebo), with a mean age of 64 and 79% men.

Ischemia was present in 80% of one cardiac territory, 17% in two, and 2% in three territories.

At 12 weeks, the mean angina symptom score was significantly lower in the PCI group (2.9) than in the placebo group (5.6).

The odds ratio for improved scores with PCI was 2.21 (95% CI, 1.41 to 3.47; P<0.001).

One patient in the placebo group had unacceptable angina leading to unblinding.

Acute coronary syndromes occurred in 4 patients in the PCI group and 6 in the placebo group.

Conclusions:

In stable angina patients not using antianginal medication and with objective evidence of ischemia, PCI resulted in a lower angina symptom score compared to a placebo procedure.

Indicates an improved health status concerning angina following PCI.

Link to article:

DOI: 10.1056/NEJMoa2310610