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PCI = sham PCI for exercise tolerance in patients with stable angina plus severe CAD (ORBITA)
Clinical Question
Do patients with stable angina and severe coronary artery stenosis treated with percutaneous interventions (PCIs) have greater improvement in exercise tolerance than those treated with sham PCI?
Bottom line
In patients with stable angina and severe coronary artery disease, PCI plus optimal medical treatment does not improve exercise tolerance or angina more than sham PCI plus optimal medical treatment. 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Government
Setting: Outpatient (specialty)
Synopsis
We have reported multiple studies for approximately 20 years that have shown that mortality and cardiac events are comparable for patients with stable angina who are treated medically, with PCI, or with bypass. These authors wanted to see if the exercise tolerance of patients with stable angina and severe coronary stenosis (at least 70% stenosis in one or more vessels) improved more with PCI compared with aggressive guideline-guided medical treatment. All patients completed a 6-week medical optimization period followed by a pre-randomization baseline assessment. The researchers then randomized patients to receive PCI (n = 105) or placebo intervention (catheterization without intervention). Including a sham intervention makes this study unique. All patients received dual antiplatelet therapy until the final assessment at 6 weeks after intervention. Four of the placebo-treated patients had a procedural complication that resulted in PCI, but were analyzed in the placebo group. After 6 weeks, each group had a few seconds of increased exercise time but the difference in improvement was not significant. Additionally, there was no differences in physical limitation, angina frequency, or angina stability. Finally, the authors found no differences in quality of life.
Reviewer
Henry C. Barry, MD, MS
Professor
Michigan State University
East Lansing, MI
Comments
The follow up period is too short to be convincing.
It would be more useful to see the results at one and two years later after the study.
PCI=shampci
At 6 weeks cardiac recovery is starting. Maybe a 6 month post rx exercise assessment might be more informative. If the assessment was based on exercise time only... the study should not even have been quoted.
PCI=shampci
At 6 weeks cardiac recovery is starting. Maybe a 6 month post rx exercise assessment might be more informative. If the assessment was based on exercise time only... the study should not even have been quoted.
I wish they would check mortality as well
Lots of unconvincing criticisms of the study being voiced here. Mortality wasn't studied because it's *been* studied. PCI doesn't prevent deaths more than medical treatment does. Yes, it takes time to build exercise tolerance. But relief of angina by opening the stenosed coronary artery doesn't take weeks, it takes minutes. This is a well done provocative study!
WHAT? A 6/52 study on medical intervention ????
Good poem
again goes back to preventative medicine, and how much better off we might be if there was incentive for good health...........
So why do we do PCI? Are we doing them on too many patients, rather than having tools to select only those patients who will truly benefit? A procedure which pays for the cardiologists VMW but doesn't help the patient is unethical to promote.