A lancet study shows that the metal mesh device to open clogged arteries is not as effective
A new study in The lancet, which included 230 heart patients in the United Kingdom, shocked the international cardiology community on Thursday as it reported that for patients with medically treated angina and severe coronary stenosis, an intervention did not have a more lasting effect than the effect of a placebo procedure.
The findings from the study contradicted the widespread assumption that using stents — a metal mesh tube to prop open clogged arteries — would allow patients to walk longer on a treadmill by hastening blood flow to the muscles that make the heart pump.
Angina is chest pain or discomfort caused when your heart muscle doesn’t get enough oxygen-rich blood. It may feel like pressure or squeezing in your chest. The discomfort also can occur in your shoulders, arms, neck, jaw, or back. Angina pain may even feel like indigestion.
Symptomatic relief is the primary goal of percutaneous coronary intervention (PCI) or stents in stable angina and is commonly observed clinically. However, there is no evidence from blinded, placebo-controlled randomised trials to show its efficacy.
Of the 230 participants with stable angina, 195 were randomly assigned procedures. Of those, 105 were given stents and 95, the control group, were given placebo procedures, where a catheter was inserted and then removed without placing a stent. The study had a double blind, which meant neither the participants nor the doctors who subsequently followed them for six weeks knew who had what procedure.
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. They 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 per cent (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 per cent 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.