Al-Lamee R, Thompson D, Dehbi H-M, et al. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. The Lancet. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32714-9/abstract
Background - 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, placebo-controlled randomised trials to show its efficacy.
Methods - ORBITA is a blinded, multicentre randomised trial of PCI versus a placebo procedure for angina relief that was done at five study sites in the UK. We enrolled patients with severe (≥70%) single-vessel stenoses. After enrolment, patients received 6 weeks of medication optimisation. Patients then had pre-randomisation assessments with cardiopulmonary exercise testing, symptom questionnaires, and dobutamine stress echocardiography. Patients were randomised 1:1 to undergo PCI or a placebo procedure by use of an automated online randomisation tool. After 6 weeks of follow-up, the assessments done before randomisation were repeated at the final assessment. The primary endpoint was difference in exercise time increment between groups. All analyses were based on the intention-to-treat principle and the study population contained all participants who underwent randomisation. This study is registered with ClinicalTrials.gov, number NCT02062593.
Findings - ORBITA enrolled 230 patients with ischaemic symptoms. After the medication optimisation phase and between Jan 6, 2014, and Aug 11, 2017, 200 patients underwent randomisation, with 105 patients assigned PCI and 95 assigned the placebo procedure. Lesions had mean area stenosis of 84·4% (SD 10·2), fractional flow reserve of 0·69 (0·16), and instantaneous wave-free ratio of 0·76 (0·22). There was no significant difference in the primary endpoint of exercise time increment between groups (PCI minus placebo 16·6 s, 95% CI −8·9 to 42·0, p=0·200). There were no deaths. Serious adverse events included four pressure-wire related complications in the placebo group, which required PCI, and five major bleeding events, including two in the PCI group and three in the placebo group.
Interpretation -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. The efficacy of invasive procedures can be assessed with a placebo control, as is standard for pharmacotherapy.
‘Unbelievable’: Heart Stents Fail to Ease Chest Pain
‘Unbelievable’: Heart Stents Fail to Ease Chest Pain
Researchers have reported a procedure used to relieve chest pain in ~half million of heart patients each year is useless for many of them.http://www.thelancet.com/…/PIIS0140-6736(17)32714-9/abstract
Their study focused on the insertion of stents, tiny wire cages, to open blocked arteries. The devices are lifesaving when used to open arteries in patients in the throes of a heart attack.
But they are most often used in patients who have a blocked artery and chest pain that occurs, for example, walking up a hill or going up stairs. Sometimes patients get stents when they have no pain at all, just blockages.
The new study stunned leading cardiologists by countering decades [~40 years!!!] of clinical experience. The findings raise questions about whether stents should be used so often — or at all — to treat chest pain.
The investigators randomized 200 patients with severe single-vessel stenosis to Percutaneous Coronary Intervention [PCI] or sham PCI. In the first phase of the study all patients received intensive OMT for 6 weeks. Patients were then randomized to either PCI or a sham procedure and followed for another 6 weeks.
There was no significant difference in the primary endpoint, which was exercise tolerance the change in exercise time between the two groups at 6 weeks.
As the authors write:
“The necessity for placebo-controlled trials has been rediscovered several times in cardiology, typically to considerable surprise. Often a therapy is thought to be so beneficial that a placebo-controlled trial is deemed unnecessary and perhaps unethical. However, 40 years after the first PCI, ORBITA’s findings show that placebo-controlled randomised trials remain necessary.”
Background - 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, placebo-controlled randomised trials to show its efficacy.
Methods - ORBITA is a blinded, multicentre randomised trial of PCI versus a placebo procedure for angina relief that was done at five study sites in the UK. We enrolled patients with severe (≥70%) single-vessel stenoses. After enrolment, patients received 6 weeks of medication optimisation. Patients then had pre-randomisation assessments with cardiopulmonary exercise testing, symptom questionnaires, and dobutamine stress echocardiography. Patients were randomised 1:1 to undergo PCI or a placebo procedure by use of an automated online randomisation tool. After 6 weeks of follow-up, the assessments done before randomisation were repeated at the final assessment. The primary endpoint was difference in exercise time increment between groups. All analyses were based on the intention-to-treat principle and the study population contained all participants who underwent randomisation. This study is registered with ClinicalTrials.gov, number NCT02062593.
Findings - ORBITA enrolled 230 patients with ischaemic symptoms. After the medication optimisation phase and between Jan 6, 2014, and Aug 11, 2017, 200 patients underwent randomisation, with 105 patients assigned PCI and 95 assigned the placebo procedure. Lesions had mean area stenosis of 84·4% (SD 10·2), fractional flow reserve of 0·69 (0·16), and instantaneous wave-free ratio of 0·76 (0·22). There was no significant difference in the primary endpoint of exercise time increment between groups (PCI minus placebo 16·6 s, 95% CI −8·9 to 42·0, p=0·200). There were no deaths. Serious adverse events included four pressure-wire related complications in the placebo group, which required PCI, and five major bleeding events, including two in the PCI group and three in the placebo group.
Interpretation -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. The efficacy of invasive procedures can be assessed with a placebo control, as is standard for pharmacotherapy.
‘Unbelievable’: Heart Stents Fail to Ease Chest Pain
‘Unbelievable’: Heart Stents Fail to Ease Chest Pain
Researchers have reported a procedure used to relieve chest pain in ~half million of heart patients each year is useless for many of them.http://www.thelancet.com/…/PIIS0140-6736(17)32714-9/abstract
Their study focused on the insertion of stents, tiny wire cages, to open blocked arteries. The devices are lifesaving when used to open arteries in patients in the throes of a heart attack.
But they are most often used in patients who have a blocked artery and chest pain that occurs, for example, walking up a hill or going up stairs. Sometimes patients get stents when they have no pain at all, just blockages.
The new study stunned leading cardiologists by countering decades [~40 years!!!] of clinical experience. The findings raise questions about whether stents should be used so often — or at all — to treat chest pain.
The investigators randomized 200 patients with severe single-vessel stenosis to Percutaneous Coronary Intervention [PCI] or sham PCI. In the first phase of the study all patients received intensive OMT for 6 weeks. Patients were then randomized to either PCI or a sham procedure and followed for another 6 weeks.
There was no significant difference in the primary endpoint, which was exercise tolerance the change in exercise time between the two groups at 6 weeks.
As the authors write:
“The necessity for placebo-controlled trials has been rediscovered several times in cardiology, typically to considerable surprise. Often a therapy is thought to be so beneficial that a placebo-controlled trial is deemed unnecessary and perhaps unethical. However, 40 years after the first PCI, ORBITA’s findings show that placebo-controlled randomised trials remain necessary.”
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