Randomized trial of preventive angioplasty in myocardial infarction

- Published on September 1, 2013 by Wald et al.

OBJECTIVE:
- the aim of this study, also called the PRAMI trial, was to determine whether
performing preventive PCI as part of the procedure to treat the infarct artery
would reduce the combined incidence of death from cardiac causes, nonfatal
myocardial infarction, or refractory angina
- PCI for STEMI restores blood flow to the culprit, infarcted artery but the
value of PCI in noninfarct coronary arteries with major stenosis (preventive
PCI) is unkown
- Some physicians believe that stenosis in noninfarct arteries may cause
serious adverse cardiac events that could be avoided by performing
preventive PCI during the initial procedure whereas other physicians believe
more in medical treatment
- Uncertainty has led to variation in practice


METHODS:
- From April 2008 to January 2013, 465 patients at five coronary care centers
in the United Kingdom were enrolled in the study
- The trial enrolled patients of any age with acute STEMI (3 patients with LBB),
and multivessel coronary disease detected at the time of emergency PCI.
- Patients were considered for eligibility after undergoing PCI in the infarct
artery while they were in the catherization laboratory
- They were deemed to be eligible if the infarct artery had been treated
successfully and there was a stenosis of 50% or more in one or more
coronary arteries other than the infarct artery
- Exclusion criteria: cardiogenic shock, previous CABG, a stenosis of 50% or
more in the left main stem or ostia of both the left anterior descending and
circumflex arteries (indications ofr CABG), or chronic total occlusion
- After PCI of the infarct artery, eligible patients were randomly assigned to
undergo preventive PCI in noninfarct arteries with more than 50% stenosis
(preventive PCI) or no further PCI procedures
- Finally, 234 patients were randomly assigned to the preventive-PCI group
and 231 to the group receiving no preventive PCI
- The characteristics of the patients at baseline were similar in the two groups,
as were the use of bare-metal and drug-eluting stents and medical therapies
at hospital discharge; mean follow-up was 23 months
- Primary outcome: composite of death from cardiac causes, non-fatal
myocardial infarction, or refractory angina (each component also assessed
individually)
- Secondary outcomes: death from noncardiac causes and the need for repeat
revascularization procedures (PCI or CABG)

RESULTS:
- By January 2013, the results were considered conclusive and the safety
monitoring committee recommended that the trial be stopped early
- During a mean follow-up of 23 months, the primary outcome occurred in 21
patients assigned to preventive PCI and in 53 patients assigned to no
preventive PCI, for event rates of 9 per 100 and 23 per 100 respectively, and
absolute risk reduction 14 percentage points in the preventive-PCI group
(hazard ratio in the preventive-PCI group, 0.35, P 0.001
- Hazard ratios for the three components of the primary outcome were 0.34
for death from cardiac causes, 0.32 for non-fatal myocardial infarction, and
0.35 for refractory angina
- For the secondary outcomes, death from noncardiac causes was no different
between the two groups and there was a significant difference in repeat
revascularization (16 vs 46, HR=0.3)

CONCLUSION:
- In patients with STEMI and multivessel coronary artery disease undergoing
infarct-artery PCI, preventive PCI in noninfarct coronary arteries with major
stenosis significantly reduced the risk of adverse cardiovascular events as
compared with PCI limited to the infarct artery
- Questions not answered by this study:
- 1) Are the benefits of preventive PCI applicable to patients with non-STEMI?
- 2) Do the benefits extend to coronary-artery stenosis of less than 50%?
- 3) The finding do not address the question of immediate vs delayed
preventive PCI which would need to be clarified in a separate trial