prep jansen lecture Flashcards
1. Trial design of voyager
2. 2 substrata
3. Major finding, %ages, NNT, ARR
4. Stratification with plavix
5. do need to adjust 2.5 for renal function
6. Advantage of Xarelto 2.5
7. what was the study follow up.
Asa + Xarelto vs. Asa alone
Surgical vs. endo revasc
plavix use.
- LDR (low dose riva reduced MALE - limb ischemia, major amp and mace at 3 years ARR 2.6% 17.3 vs. 191. HR 0.85 p =-0.008, NNT 39 however increased TIMI major bleeding but not fatal or intracranial bleeding.
- Benefits shown independent of plavix use.
- no
- dual pathway inhibition.
7, q6mo out to a median of 28 months and a total of 3 years.
Paper that addressed your concern re voyager
Not a paper. TCT connect 2020 leat braker. Drug coated substudy. Connie Hess presented.
What was the primary endpoint again of the Voyager study
ALI, amjor amp vasc cause, MI, stroke, cv death
How many patients in voyager
6564 patients
Describe your patient?
74 presenting 2 years after complex coronary intervention. Had 2 stents to the LAD and one to the RCA with imaging guidance.
Only on ASA 81
PMHx DM with and A1c tx with empaglifozin 10 and metformin
HLD cresotr 20
CKD III
Also with a carotid of 50-69% amndbilateral decreased avis with a decreased DP on the left.
Your patients labs
A1c 7.2,
LDL 82
Xarelto mechanism
Xa inhibtor which blocks the conversion of prothrombin to thrombin
also inhibits PAR 1 preventing plt agg.
Asa also address plt aggregation
Compass set up
How many patients
Mean follow up
What happended to Xarelto 5 mg bid
Inclusion
efficacy outcome
saftey
results
3 arms
- Xarelto 2.5 mg bid + asa 100 mg once daily
asa 100 mg daily
Xarelto 5 mg bid alone
30 K
2 years,
This was not superior to asa alone so no longer studies.
CAD/PAD or both
CV death, stroke or MI
major bleeding ISTH criteria and fatal bleeding, sx bleeding into critical organ and bleeding leading to hosp (all bleeding leading to hosp or acute careas major)
Results 4.1 % v.s 5.4% ASA 0.76 ; 95% CI 0.66- P M0.001 24% RRR
COMPASS RRR
percentages
ARR
NNT
24%
- 1 vs. 5.4 for mace (CV death,mi storke)
- 3%
76
Compass inclusion
CAD or PAD or both based on inclusion criteria
Patients with coronary artery disease who were younger than 65 years of age were also required to have documentation of atherosclerosis involving at least two vascular beds or to have at least two additional risk factors (current smoking, diabetes mellitus, an estimated glomerular filtration rate [GFR] <60 ml per minute, heart failure, or nonlacunar ischemic stroke ≥1 month earlier)
Huge thing about compass
Mortality reduction!!! HR 0.82 4.1 to 3.4%