DR.PRAVEEN NAGULA

Single blind randomized study
David S Wald et al,
NEJM 2013;369:1115-23


In acute ST segment elevation myocardial infarction(STEMI),the
use of percutaneous coronary intervention(PCI) to treat the artery
responsible for the infarct(infarct or culprit artery) improves
prognosis.

THE PREVENTIVE PCI





From 2008 through 2013
465 patients at five coronary care centers in UK.
Consecutive patients of any age with acute STEMI and
multivessel coronary disease detected at the time of emergency
PCI.
Trial was limited to patients with STEMI.


Patients were considered for eligibility after undergoing PCI in
the infarct artery, in catheterization laboratory.

Deemed to be eligible if the infarct artery had been treated
successfully and there was stenosis of ≥50% in one or more
coronary arteries other than the infarct artery and treatable by
PCI.

The treating cardiologist had to consider that both infarct
artery- only PCI and preventive PCI would be acceptable
treatment options.

Patients in
 Cardiogenic shock
 Unable to provide consent
 Previous CABG
 Left main ,ostial LAD,LCX stenosis of ≥ 50%(CABG
indications)
 Non infarct stenosis being a chronic total occlusion (PCI is C/I).

Primary outcome:
 Composite of death from cardiac causes,non fatal myocardial
infarction,or refractory angina.
 Each component was assessed individually.
Secondary outcomes:
 Death from noncardiac causes
 Repeat revascularization procedures (PCI or CABG).

Independent cardiologist and cardiac surgeon who were not
notified about study group assignments examined specified
primary and secondary outcomes.


For a power of at least 80% to detect a reduction in risk of 30% in
the preventive PCI group,as compared with other,at a level of 5%
significance, assuming a 20% annual rate of the primary outcome
in the latter group – 600 patients to be enrolled.


Survival outcomes by log rank statistic.
Stopping criteria included a clear answer to the trial question from
the emerging literature or from the results of the trial,(P<0.001).

All were included in analysis on an intention to treat basis.


Recruitment stopped early after noting a significant between
group difference (P<0.001) in the incidence of the primary
outcome favoring the preventive PCI.

465 patients were enrolled.

234 –preventive PCI,231 to non preventive PCI.
Mean follow up was 23 months.




67% patients were followed for atleast 1yr.
46% pts -2 yrs.
10 pts in preventive PCI ,8 in the other group lost to follow up.

Preventive PCI
no Preventive PCI
Primary outcome
21 pts
53 pts
Event rates
9/100
23/100
Absolute risk reduction
14%
STEMI
2
9
NSTEMI
5
11
Stent thrombosis
2
3
Ischemia testing
1/6
1/3
asymptomatic
8
44
symptomatic
31
37


Risk reduction in the preventive PCI group was evident within
the 6 months after the procedure and was maintained thereafter.

The rate of death from non cardiac causes did not differ
significantly between the two study groups.(hazard
ratio,1.10;95%CI,0.38 to 3.18;P=0.86)

The results were not materially affected by the five
prespecified covariates – age sex, of diabetes,infarct
location,and the number of coronary arteries with stenosis.


Procedure time,fluoroscopy dose,and contrast volume were
increased in the preventive PCI group.

Rates of complications(procedure related stroke,bleeding
requiring transfusion,surgery,CIN requiring dialysis)were
similar in both groups.

Median length of stay in the hospital was 2 days with 95%
patients being discharged within 1 week.

In one study
 69 patients were randomly assigned (3:1ratio) to preventive
PCI in patients with acute STEMI undergoing PCI in the
infarct artery.

At 1 year, in the preventive PCI group,there were
nonsignificant reductions in the rates of repeat
revascularization (17% and 35%)and cardiac death or
myocardial infarction (4%and 6%) respectively.
Di Mario et al ,HELP AMI study.
Int J Cardiovasc Intervent 2004;6:128-33

In the other trial,
 214 patients were randomly assigned to one of three groups;
 No preventive PCI(84 pts),immediate preventive
PCI(65pts),and staged preventive PCI performed during a
second procedure about 40 days later(65 pts)
 At 2.5 yrs the rate of repeat revascularization was less frequent
in the immediate and staged preventive PCI groups combined,as
compared with the group receiving no preventive PCI(11% and
33% respectively).
 Nonsignificant decrease in the rate of cardiac death (5 and 12 %
respectively).
Politi et al , Heart 2010;96:662-7.

Studies
MVA
IRA
MORTALITY/
events
P value
Others
Kong et al
632
1350
0.8vs2.3%
P-0.018
OR-0.27
Khattab et al
28
45
24 vs28%
P-0.73
Qarawani et al
95
25
16.7vs52%
P-0.0001
Renal dysf(8.4%
vs 4%)
Chen et al
239
1145
equal
P-0.78
Varani et al
243
156
2.3%vs 6.3%
P-.023

Politi L et al, HEART 2010;96:662-7. Kong JA et al ,Coronary Artery Dis 2006;17:71-5.

Khattab A et al , Clin Rese Cardiol 2008;97:32-8. Qarawani D et al ,Int J Cardiol 2008;123:288-92.

Chen LY et al ,Am J Cardiol 2005;95:349-54. Varani et al ,Catheter Cardiovasc Interven 2008;72:927-33.

Study
Pvalue
reinfarction
2.8%
13.8%
0.001
25%
15%
0.007
Mortality in pts with
Card.shock
27.8%
36.5%
0.01
overall
Cavender et al
MultiPCI
revascularization
Roberto et al
IRA
7.9%
5.1%
0.01
Corpus et al, Am Heart J 2004;148:493-500 Roe et al, Am J Cardiol 2001;88:170-3,A6.
Cavender MA et al, Am J Caridol 2009;104:507-13. Hannan EL et al, JACC Cardiovasc Interven 2010;3:22-31
Toma et al ,APEX-AMI trial, Eur Heart J 2010;31;1701-7.

Lack of statistical power
Reliance on repeat revascularization

Current guidelines recommend only infarct artery only PCI in
patients with multivessel disease,owing to a lack of evidence
with respect to preventive PCI

1.Immedicate versus staged PCI.
2.Are the benefits of preventive PCI applicable to NSTEMI.
3.Do the benefits extend to the stenoses less than 50%.
4.Level of stenoses at which the risks of PCI outweigh
benefits.
5.Would FFR offer an advantage over angiographic visual
assessment in guiding preventive PCI


In patients undergoing emergency infarct artery PCI for
acute STEMI, preventive PCI of stenoses in noninfarct
arteries reduced the risk of subsequent adverse
cardiovascular events,as compared with PCI limited to the
infarct artery.