前情提要
其實一年半以前,我有發過類似的文章,有興趣的朋可以參閱,『丹麥足球隊員 Christian Eriksen 球場上被CPR救回一命,我們可以學到什麼?』。
美國心腎很快過去了,兩個大會明年都將在賓州費城舉行(AHA23 11/11-13 ,ASN23 11/02-05),跟各位分享五大重點研究結果:
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.
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 (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:
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)
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
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?
之前曾經談過的議題『日行萬步,促進心血管健康』,只要適當的步行可以減少死亡率,這些都是正確的訊息,過去的研究也很多。但是這一類的研究,多半是用『問卷』,或是『量表』,由受試者或是民眾藉由『回顧』『回憶』去填答,在依照填答結果分群分類,看看運動量、活動量、運動強度等等跟日後的健康狀況甚至死亡率有無關係。
這些過去的(運動狀況)的研究,就跟(飲食習慣、飲酒、抽煙、檳榔、睡眠)的研究一樣,常常落人口舌的批評,說,這樣的研究,最重要的是有嚴重的 Recall bias (回憶偏差),必須由研究對象回憶以往的經驗,因此常常會面臨到記憶不全所造成的重大影響。所以,在看待這類型研究的結果時,必須非常的謹慎解讀。
ESC 睽違兩年終於實體會議再次展開,總共有14000人報名實體會議,4000人報名線上會議。開始之前,我做了五個研究的結果『猜測』,只有兩個正確,這次會議的結果,充分體現了『當代實證醫學』的奧義。以下分別跟各位整理重要研究的結果,如果對某的研究有興趣深入了解,直接按下標題,就可以連到相關網頁或是全文資料。
研究顯示,感染 COVID-19 後急性心肌梗塞和缺血性腦中風的發病率增加與血栓形成風險增加有關。COVID-19疫苗可以有效減少感染(至少在Omicron變異株出現以前)、預防進展為重症。然而,尚不清楚疫苗是否也能減少前述的心腦血管併發症。