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PRAMI: Preventive PCI in noninfarct arteries reduced risk for CV events
AMSTERDAM — The use of preventive PCI in noninfarct coronary arteries when compared with infarct-artery-only PCI led to a reduced risk for adverse CV events in patients with STEMI and multivessel disease, according to the PRAMI trial results presented here.
“At the time of treating a heart attack, it is common to find other arteries that have narrowed, which are not the cause of the heart attack, but still catch your attention. This is where the dilemma arises,” David S. Wald, MD, trial investigator from the Wolfson Institute of Preventive Medicine, Barts, and the London School of Medicine and Dentistry, Queen Mary University of London, said in a press conference. “Some doctors take the view that these other arteries can be treated there and then with a so-called ‘preventive PCI’ on the basis that this treatment may prevent future heart attack. Others take the view that undertaking an extended procedure at that time is too risky and that there is no evidence it would be beneficial.”
Wald and fellow investigators sought to determine the best approach in these patients by enrolling 465 patients who had acute STEMI and were undergoing infarct-artery PCI into the PRAMI trial. Patients were randomly assigned to preventive PCI (n=234), which involved stenting of partially obstructed vessels that are not cause of an MI to prevent a future MI, or no preventive PCI (n=231).
They defined the primary outcome as a composite of death from cardiac causes, nonfatal MI or refractory angina, and used an intention-to-treat analysis.
David S. Wald
At follow-up (mean, 23 months), the primary outcome occurred in 21 patients in the preventive PCI group compared with 53 patients who received only infract-artery PCI, which equated to significantly more events in the latter group (23 events per 100 patients vs. 9 events per 100 patients; P<.001). Researchers reported the following HRs for the three components of the primary outcome: death from cardiac causes, HR=0.34 (95% CI, 0.11-1.08); nonfatal MI, HR=0.32 (95% CI, 0.13-0.75); and refractory angina, HR=0.35 (95% CI, 0.18-0.69). These results were not significantly affected by the five prespecified covariates — age, sex, presence or absence of diabetes, infarct location and the number of coronary arteries with stenosis.
The PRAMI trial was stopped early by the data and safety monitoring board after determining that the results were conclusive.
As a result of the findings, Wald concluded in his presentation that “partially obstructed vessels that are not [the] cause of heart attack should be treated there and then to prevent future MI,” he said. – by Brian Ellis
For more information:
Wald DS. Hot Line II: Late breaking trials on intervention and devices. Presented at: the European Society of Cardiology Congress; Aug. 31-Sept. 4, 2013; Amsterdam.
Wald DS. N Engl J Med. 2013;doi:10.1056/nejmoa1305520.
Disclosure: Wald reports being a director of and having equity interest in Polypill. The study was funded by Barts and the London Charity.
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The results of the PRAMI trial are interesting and helpful for interventional cardiologists. There has been a long debate about what to do with non-acute lesions in the setting of acute MI. The PRAMI trial shows that, in a relatively dramatic way, the incidence of subsequent events is high in patients who don’t have those lesions treated. This significantly helps our understanding of which lesions should be treated.
There are additional questions that can be raised and probably are a source of potential study in the future. One is whether this strategy can be safely done at the time of the primary lesion being treated; another is whether the lesions should be treated with fractional flow reserve or some other guidance for the significance of the lesion; and, finally, the more interesting question is whether the same results would apply with NSTEMI. There is still much work to be done, but this was a very important trial in terms of helping interventionalists know what to do with additional lesions in the setting of STEMI.
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