trials

Question 1

COURAGE

Answer 1

NEJM 2007

• OMT + PCI vs OMT-alone was a/w no difference in death and MI after 4.6 years
• in 2300 pts w/ stable CAD.
• No anatomic subset of CAD stenosis severity (70-90% narrowing, and > 90% narrowing of LAD) was found to benefit from PCI vs OMT.

Question 2

BARI-2D

Answer 2

NEJM 2009

• CABG+OMT vs OMT alone reduced rate of CV events after 5 years
• in 2368 pts w/ CAD and T2DM who are CABG candidates.
• No difference in PCI cohorts.

Question 3

FREEDOM

Answer 3

NEJM 2012

• CABG vs PCI reduced rates of death and MI after 3.8 years
• among 1900 diabetic pts w/multivessel CAD, but was a/w modest increase in stroke.

Question 4

ISCHEMIA

Answer 4

NEJM 2020

• invasive Tx (PCI/CABG) was not better than OMT (optimal medical therapy) to prevent CV events
• in 5200 pts w/ SIHD (stable ischemic heart disease).
• At 4 years, there was no different in primary endpoint (composite of CV death, MI, resuscitated cardiac arrest, hospitalization for unstable angina or HF), 13.3% vs 15.5% in invasive vs conservative groups.

Question 5

ISCHEMIA-CKD

Answer 5

NEJM 2020
-there was no difference between invasive strategy (CABG, PCI) vs conservative (medical tx first, then angiography if med tx failed) in terms of death or non-fatal MI, among pts w Stable CAD and advanced CKD

Question 6

DEFER

Answer 6

EHJ 2015

• RCT using FFR in 325 pts w intermediate stenosis planned to undergo PCI: to “defer group” (OMT) if FFR ≥ 0.75, or to “perform group” (PCI) if FFR < 0.75. Other group was “reference group” who underwent planned PCI.
• After 15 years, death rate was not different between 3 groups (33% vs 31.1% vs 36.1%).
• Rate of MI was significantly lower in defer group (2.2%) vs perform (10.0%).

Question 7

FAME

Answer 7

Lancet 2015

• pts w multivessel stenosis, RCT, conventional PCI (guided by angiogram) vs FFR-guided PCI (PCI performed if FFR < 0.8). FFR-guided PCI was a/w lower 2-year death or MI.
• From year 2 to 5 risks were similar.
• After year 5, outcomes were similar, bur FFR-guided PCI had lower number of stented arteries and less resource use.
• FAME did not include comparison group that received GDMT w/o revascularization.

Question 8

FAME-2

Answer 8

NEJM 2018

• RCT, FFR-guided PCI + OMT vs OMT alone, was a/w lower primary end point of death, MI, urgent revascularizations (13.9% vs 27%) after 5 years
• among 888 pts w angiographically significant stenosis and stable CAD, in whom at least one stenosis was HD significant (FFR < 0.8).
• Difference was mostly driven by urgent revascularization (6.3% vs 21.1%).
• There were no differences in terms of death or MI.

Question 9

EXCEL

Answer 9

NEJM 2019
-this was a fiasco.
-Among 1900 pts w/ left main disease of low/intermediate anatomical complexity, there was no difference between PCI and CABG in composite outcome (death, stroke, or MI) at 5 years.
• An initial 3-year outcomes was published in NEJM 2016. There was no difference between PCI and CABG in LM disease, for composite endpoint of death, stroke, or MI. This study was included in 2018 EACTS-ESC guidelines for PCI.
• In Dec 2019, news from BBC report showed errors in methodology/reporting of trial. Cases of MI were higher in the PCI group because researchers used third universal definition of MI. Also early members of the trial said trialist manipulated data in a way that results favored PCI. Study was funded by Abbott.

Question 10

STICH

Answer 10

NEJM 2011

• addition of CABG to OMT (optimal medical therapy) does NOT sig reduce all-cause mortality after 5 years, but DOES reduce CV-related deaths/hospitalizations
• among 1212 pts w/ ischemic CMP with LVEF < 35%.
• There was sig reduction on all-cause mortality after 10 years with CABG.