美國心腎週
本週是美國心腎週，AHA 在芝加哥，ASN在奧蘭多。跟各位分享必看五大重點研究：
1. EMPA-KIDNEY: empagliflozin vs pbo in CKD
2. TRANSFORM-HF: torsemide vs furosemide in hosp. HF
3. RESPECT EPA: EPA 1.8g/d + statin vs statin alone in stable CAD
4. ISCHEMIA-EXTENDed: interim mortality analysis of ISCHEMIA & ISCHEMIA-CKD at longer f/u
5. BEST-CLI: EVT vs bypass in patients with critical limb ischemia.
EMPA-KIDNEY
EMPA-KIDNEY (N=6609)
Event-driven (n=1070) RCT of empagliflozin vs placebo in CKD.
Study stopped early in 3/2022 after 1st interim analysis met prespecified stopping criteria based on PEP and CV death or ESKD.
Primary results to be presented at ASN meeting in Orlando on Nov 4
看倌重點：
key Qs regarding EMPA-KIDNEY:
1.Will it answer question whether or not albuminuria is a prerequisite for renal benefits of SGLT2i (CREDENCE, DAPA-CKD provided efficacy in pts with albuminuria). EMPA-KIDNEY收案時並非100％有蛋白尿
2.Will it show a mortality benefit as was observed in CREDENCE & DAPA-CKD? 如果減少死亡那才是全壘打
TRANSFORM-HF
TRANSFORM-HF:
Pragmatic trial of Torsemide vs furosemide in hosp. HF.
Event-driven trial (n=721), 85% power to detect 20% RRR in all-cause mortality (PEP)
Prediction: a null effect on PEP but it will inform optimal design for future trials in this kind of situation and condition.
迷之音：
lasix 從沒減少過死亡率？
torsemide 會嗎？ 顯示較少
RESPECT-EPA
RESPECT-EPA Trial
Open-label active control randomized trial evaluating purified EPA (1.8g/d) + statin vs statin alone in 3900 Japanese patients with stable CAD. PEP: CV death, MI, stroke, hosp. for UA/CR, or CR.
Key question
1. 解答是否EPA才有心臟保護
Will it serve as a tiebreaker given positive results in REDUCE-IT (EPA 4g/d) but not STRENGTH (EPA+DHA 4g/d), OMEMI (EPA+DHI 1.8g/d)?
2.對照組不是用礦物油
No mineral oil placebo used. If results are positive, will it resolve controversy surrounding mineral oil placebo in REDUCE-IT?
3. 觀察組（體內EPA濃度已高者）的預後有差嗎？
4. 東方人/日本人 1.8g EPA 就很夠用了？
ISCHEMIA-EXTENDed
ISCHEMIA-EXTENDed
Prospective observational study with primary outcome of all-cause death, CV death & non-CV death at 10y. Mortality NOT be centrally adjudicated.
Interim analysis results will be presented as a latebreaker.
In ISCHEMIA, HR were 0.87 (0.66-1.15) for CV death (late divergence in favor of INV strategy), 1.05 (0.83-1.32) for ACM, & 1.45 (1.0-2.1) for non-CV death.
Will CV death signal emerge in favor of INV strategy?
Will non-CV death continue to show harm with INV strategy?
How to interpret discordant effects on CV vs non-CV death?
Why report an interim analysis given projected median f/u of 10y?
How many interim mortality analyses planned?
BEST-CLI
Large (N=2100) pragmatic RCT comparing endovascular therapy to open surgical bypass in patients with critical limb ischemia.不負責預測：
EVT 從來沒有贏過 open by-pass grafting.
