The study used the NCDR CathPCI registry to examine
a.The proportion of patients who met the inclusion criteria for ischemia (versus 4 other groups that did not meet the Ischemia-trial criteria).
b.The association between each group with all-cause mortality
(3/14)
Methods:
Patients in the CathPCI registry were categorized into:
1 ACS + Arrest + Cardiogenic Shock (n=538K)
2 Not Ischemia High Risk (n=71K)
3 Not Ischemia (low risk) (n=67K)
4 ***ISCHEMIA-like (n=125k) +stress OR abnormal FFR***
5 Not classified (n=123k)
(4/14)
Results:
Ischemia-like cohort:
Mean age = 67 years
Female patients = 26%
Mostly non-Hispanic Whites
DM = 41%
Highest #RadialFirst utilization = 53%
(5/14) Mortality Rate
Ischemia-like (n=125k) had the lowest mortality: 0.11%
Ischemia-Like: 135 patients out of 124,302 = 0.00108
-
Not Ischemia High-Risk: 481 out of 71,852= 0.00669
Not-Ischemia Low-Risk: 114 out of 67,159 = 0.00169
Not classified: 289 out of 123,899 = 0.00233
(6/14)
Of ALL patients who underwent PCI from 2017 to 2019 | only 13% resemble the ischemia trial population.
(125,302/927,011=13%)
(7/14)
The calculation of this proportion (%) above in (6/14) is what the trialists question.
See 8, 9 and 10 below.
(8/14)
Trialists' Take #1:
Those who have low risk features should not be included in the denominator because they do not benefit from PCI | given data from courage and BARI 2D
(9/14)
Trialists' Take 2:
Those who are not classified (because they do not have stress test reported in NCDR) may included in the ischemia-like cohort if the data was available ~ 50%.
(10/14)
Fair questioning by the trialists, but these are assumptions that cannot be proven and reflected by data.
** I also did not include the discussion on ischemia-CKD study inclusion (slicing the denominator and numerator further).
(11/14)
The trialists' conclusion in the editorial was fair and balanced:
No one knows exactly what the % of Ischemia-population is in practice.
that said...
(12/14)
The principal investigator(s) of JACC Interv Study @jaygirimd are not expected to introduce assumptions when reporting NCDR data from clinical practice.
They tried to estimate the % of patients who most resemble ischemia based on available data..
(13/14)
My take:
1. In the United States, most PCI is performed for ACS (not ischemia like patients)
2. Ischemia criteria when applied to clinical practice is clearly not a majority.
3. The mortality rate with PCI in Ischemia like population is exceedingly small!
Fair?
(14/14)
Good study; good question; good editorial!
Truth is grounded in ethics.
We should distinguish between emotional truths and logical truths!