Rediscovering the Orbit of Percutaneous Coronary Intervention After ORBITA
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The publication of the ORBITA trial (Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina) generated an immense amount of discussion, debate, and controversy.1 The editorialists posed in their title whether the ORBITA trial is the “Last nail in the coffin for PCI [percutaneous coronary intervention] in stable angina?”2 The ensuing press coverage has been extensive, although mostly 1-sided, and largely following the negative tone set by the editorial. The exchange on social media has been at times vitriolic, both pro and con. The number of tweets of the article (1716 as of February 25, 2018) now exceeds the number of patients enrolled by >7-fold. Thus, ORBITA has disrupted the orbit of PCI.
On a historical note, the first patient to undergo PCI was an ORBITA-like patient with successful treatment of an isolated proximal left anterior descending artery lesion, rendering the patient symptom-free for >20 years. It took 40 years to conduct ORBITA, a well-designed and -executed trial reporting that PCI for stable angina was not superior to a sham procedure in terms of exercise time, the trial’s primary end point. The main strength of the trial was the sham design, a major step forward in coronary intervention, building on the use of sham designs in recent trials of renal denervation.3 The assessment of the primary end point at 6 weeks, precluding information on long-term outcomes, the inclusion of ~25% of patients with mild symptoms prerandomization, the large between-group difference in ostial and proximal lesions likely because of the small sample size, and the removal of patients after randomization, were all significant limitations of the trial (Table). An important unintended consequence of ORBITA has been a misunderstanding that the results might also …