Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial

Abstract

SummaryBackground Symptomatic relief is the primary goal of percutaneous coronary intervention (PCI) in stable angina and is commonly observed clinically. However, there is no evidence from blinded, placebocontrolled randomised trials to show its efficacy.

A systematic review and critical analysis of cost-effectiveness studies for coronary artery disease treatment

“…There is no evidence from the papers included in this review that PCI is cost-effective when compared with other competing treatment options. Therefore the current cost-effectiveness evidence does not support the increased use of PCI that has been seen in Australia and internationally, and there is increasingly reduced evidence of clinical effectiveness 32 .…”

‘Faith Healing’ and ‘Subtraction Anxiety’ in Unblinded Trials of Procedures

“…Use of placebo control in PCI is achievable, as demonstrated in ORBITA. 5 Importantly, ethical concerns, which limited follow-up to 6 weeks in this trial, are less and less pressing with the accumulating evidence of prognostic neutrality of PCI. With longer follow-up, a broader range of end points could be assessed and the uncertain role of PCI in stable coronary disease may finally be defined.…”

“…For instance, 1 grant body reviewer rejected funding for ORBITA (Objective Randomized Blinded Investigaton with optimal medical Therapy or Angioplasty in stable angina), 5 the first truly blinded randomized controlled trial of PCI, because another trial had used an impartial end point committee: …”

“…In ORBITA, most patients continued to have angina after PCI. 5 In contrast, enthusiastic unblinded investigators, who personally eradicated the lesion by PCI, witnessed the immediate hemodynamic resolution and subsequent normalization of ischemia tests, achieved not the borderline angina relief of ORBITA, but elimination of chest pain with 100% effectiveness. 8 We should use power of faith healing unashamedly in clinical practice but should not allow it to color scientific research.…”

Myocardial perfusion imaging prior to coronary revascularization: From risk stratification to procedure guidance

“…9 The recently presented Objective Randomised Blinded Investigation with optimal medical Therapy of Angioplasty in stable angina (ORBITA) trial cast some doubt on the effectiveness of PCI on symptom burden in stable CAD when assessed in a blinded, randomized placebo-controlled fashion. 10 There is abundance of literature on the prognostic value of MPI in patients with stable CAD which allows for its use in risk stratification. [11][12][13] While the COURAGE trial did not demonstrate a benefit of coronary revascularization on hard cardiovascular events in patients with stable CAD, 5 a seminal retrospective study suggested that MPI may be useful to guide coronary revascularization.…”