TCT 2017 | ORBITA: The Placebo Effect of Angioplasty

Courtesy of the SBHCI.

Chronic stable angina and severe coronary lesion patients who undergo angioplasty in a single vessel show no better outcomes than individuals who undergo a placebo sham procedure when it comes to exercise capacity and symptoms, according to this study presented at TCT and published simultaneously in the Lancet.

The curious results of this work astonished a whole panel devoted to coronary revascularization; however, it should be noted that all patients in the study had good left ventricular function and single-vessel coronary artery disease. This is, undoubtedly, the first placebo-controlled trial of angioplasty.

Read also: “TCT 2017 | PREVAIL: Final Outcomes of the Watchman Device”.

In the opinion of the authors of this work, ORBITA outcomes might downgrade the recommendation for angioplasty in stable patients in cardiology guidelines.

The ORBITA study included 200 patients with angina or equivalent symptoms and at least one angiographically significant single-vessel lesion. Patients were enrolled in a 6-week medical optimization program, and all patients underwent a procedure including an angiography and an assessment of fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) before randomization to angioplasty or placebo.

Read also: “TCT 2017 | The TRI-REPAIR and the FORMA Trials: New Devices for the “Forgotten Valve”.

At 6 weeks post-angioplasty or after the placebo procedure, patients treated with angioplasty had a statistically significant improvement in exercise time while those treated with the placebo procedure also had an improvement, which was non-significant in relation to baseline values. The difference between groups was not significant.

In any case, 200 patients are not enough to change what has been our recommendation for years, but this work will surely have everyone talking.

Courtesy of SBHCI.

Original title: Percutaneous Coronary Intervention in Stable Angina (ORBITA): A Double-Blind, Randomized Trial.

Presenter: Al-Lamee R.

ORBITA

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