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

  title={Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial},
  author={Rasha Al‐Lamee and Douglas Thompson and Hakim-Moulay Dehbi and Sayan Sen and Kare H Tang and John R. Davies and Thomas R. Keeble and Michael Mielewczik and Raffi R Kaprielian and Iqbal S. Malik and Sukhjinder Singh Nijjer and Ricardo Petraco and Christopher M. Cook and Yousif Ahmad and James Howard and Christopher S. Baker and Andrew S. P. Sharp and Robert Gerber and Suneel Talwar and Ravi G. Assomull and Jamil Mayet and Roland Wensel and David J Collier and Matthew J. Shun-shin and Simon A. M. Thom and Justin E. Davies and Darrel P. Francis and Amarjit S Sethi and Punit S. Ramrakha and Rodney A. Foale and Ramzi Y. Khamis and Nearchos Hadjiloizou and Masood Khan and Jaspal S Kooner and Michael F Bellamy and Ghada W. Mikhail and Piers Clifford and P O'Kane and Terry Levy and Rosie A Swallow},
  journal={The Lancet},

Figures and Tables from this paper

PCI does not improve outcomes for patients with stable angina
It is remarkable that, 40 years after Andreas Gruntzig’s first PCI, the first double-blind, placebo-controlled trial of PCI in stable angina: the Objective Randomised Blinded Investigation with optimal medical Therapy of Angioplasty in stableAngina (ORBITA) trial is only now published.
Orbita – Much Ado about Nothing?
  • A. Zaman
  • Medicine
    The journal of the Royal College of Physicians of Edinburgh
  • 2018
The outcome measures were angina, quality of life, functional capacity using cardiopulmonary exercise testing and myocardial ischaemic burden with dobutamine stress echocardiography, which indicated that patients with stable angina or equivalent symptoms and at least one angiographically severe lesion were vulnerable to PCI.
Percutaneous coronary intervention for the management of stable ischemic heart disease.
Findings from this first placebo-controlled trial of PCI in patients with single vessel SIHD suggest that PCI need not necessarily be the first line or default strategy for symptomatic improvement.
Interventional Cardiology : Coronary Percutaneous Coronary Intervention for Clinical Syndromes Stable Angina
The ORBITA trial was the first sham-controlled trial of PCI where 200 medically optimized patients with single vessel disease were randomized to PCI or placebo procedure and failed to show a benefit of PCI at 6 weeks in the primary endpoint of exercise treadmill time or secondary endpoints of patient-centered outcomes.
Has too much cardiology been sent into the appropriateness ORBITA?
The ORBITA trial questioned what has now become routine clinical practice, namely PCI for patients with stable angina and suggested that patients who undergo PCI accept a small, but not insignificant, risk of harm for no benefit.
ORBITA Trial: Redefining the Role of Intervention in the Treatment of Stable Coronary Disease?
Contrary to the concepts derived from previous non-randomized studies, the authors concluded that in patients with medically treated angina and severe coronary stenosis, PCI did not increase exercise time by more than the effect of a placebo procedure.
Rethinking revascularization in patients with stable angina
The ORBITA trial found no significant improvement in exercise time, functional status, angina relief and quality of life in the PCI group compared with placebo, and the evidence is not sufficient to alter revascularization guidelines.
The ORBITA trial and the future of percutaneous coronary intervention for stable angina.
The role of PCI in the treatment of stable CAD is now being further questioned following the publication of the Objective Randomized Blinded Investigation with optimal medical Therapy of Angioplasty in stable angina (ORBITA) trial.
ORBITA: What Goes Around, Comes Around… Or Does It?
The recently published ORBITA trial compared OMT + PCI with OMT - 'placebo' PCI in patients with angina and single-vessel coronary artery disease, and found no significant difference in treadmill exercise time between the two groups after six weeks.
Meta-analysis of long-term outcomes of percutaneous coronary intervention versus medical therapy in stable coronary artery disease
It is suggested that in patients with stable CAD, PCI was not associated with a reduction in cardiovascular outcomes, angina relief or survival benefit compared with MT at 5 years mean follow-up duration, which is contrary to the current standard of care.


Meta-analysis: Effects of Percutaneous Coronary Intervention Versus Medical Therapy on Angina Relief
Percutaneous coronary intervention was associated with greater freedom from angina compared with medical therapy, but this benefit was largely attenuated in contemporary studies.
Optimal medical therapy with or without PCI for stable coronary disease.
As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy.
Effect of PCI on quality of life in patients with stable coronary disease.
Among patients with stable angina, both thosetreated with PCI and those treated with optimal medical therapy alone had marked improvements in health status during follow-up, and similar incremental benefits from PCI were seen in some but not all RAND-36 domains.
Percutaneous coronary intervention outcomes in patients with stable obstructive coronary artery disease and myocardial ischemia: a collaborative meta-analysis of contemporary randomized clinical trials.
In patients with stable CAD and objectively documented myocardial ischemia, PCI with MT was not associated with a reduction in death, nonfatal MI, unplanned revascularization, or angina compared with MT alone.
How cardiologists present the benefits of percutaneous coronary interventions to patients with stable angina: a qualitative analysis.
If future quantitative studies support the findings of this hypothesis-generating analysis, modifications to cardiologists' approach to describing the risks and benefits of the procedure may improve patient understanding.
Fractional flow reserve-guided PCI for stable coronary artery disease.
In patients with stable coronary artery disease, FFR-guided PCI, as compared with medical therapy alone, improved the outcome and was significantly lower in the PCI group than in the medical-therapy group.
Antianginal and Antiischemic Effects of Ivabradine, an If Inhibitor, in Stable Angina: A Randomized, Double-Blind, Multicentered, Placebo-Controlled Trial
The results suggest that ivabradine, representing a novel class of antianginal drugs, is effective and safe during 3 months of use; longer-term safety requires additional assessment.
Management of Percutaneous Coronary Intervention Complications
The current data related to common periprocedural complications related to PCI is reviewed and customized informed consent should be provided to all patients and should include the potential risks from radiation injury.
Fractional flow reserve versus angiography for guiding percutaneous coronary intervention.
Routine measurement of FFR in patients with multivessel coronary artery disease who are undergoing PCI with drug-eluting stents significantly reduces the rate of the composite end point of death, nonfatal myocardial infarction, and repeat revascularization at 1 year.