@kaulcsmc.bsky.social
Cardiologist, evidence appraiser, data detective, rock music fan
No 'additive' cardioprotective effect of GLP-1RA on background use of SGLT2i in HARMONY, AMPLITUDE-O and most recently SOUL.
Cardioprotective effects of GLP-1RA are 'independent' of SGLT2i
ahajournals.org/doi/epdf/10.11…
10.1016/j.jacc.2023.05.048
Cardioprotective effects of GLP-1RA are 'independent' of SGLT2i
ahajournals.org/doi/epdf/10.11…
10.1016/j.jacc.2023.05.048
April 2, 2025 at 10:26 PM
No 'additive' cardioprotective effect of GLP-1RA on background use of SGLT2i in HARMONY, AMPLITUDE-O and most recently SOUL.
Cardioprotective effects of GLP-1RA are 'independent' of SGLT2i
ahajournals.org/doi/epdf/10.11…
10.1016/j.jacc.2023.05.048
Cardioprotective effects of GLP-1RA are 'independent' of SGLT2i
ahajournals.org/doi/epdf/10.11…
10.1016/j.jacc.2023.05.048
Warrior trial PEP result shown below.
Is this a NULL trial or a NEGATIVE trial?
Trial powered for HR 0.80 which was excluded by 95% CI
How many null or negative PRAGMATIC trials before we seriously consider/scrutinize the utility of such trials?
Is this a NULL trial or a NEGATIVE trial?
Trial powered for HR 0.80 which was excluded by 95% CI
How many null or negative PRAGMATIC trials before we seriously consider/scrutinize the utility of such trials?
March 29, 2025 at 3:02 PM
Warrior trial PEP result shown below.
Is this a NULL trial or a NEGATIVE trial?
Trial powered for HR 0.80 which was excluded by 95% CI
How many null or negative PRAGMATIC trials before we seriously consider/scrutinize the utility of such trials?
Is this a NULL trial or a NEGATIVE trial?
Trial powered for HR 0.80 which was excluded by 95% CI
How many null or negative PRAGMATIC trials before we seriously consider/scrutinize the utility of such trials?
Reposted
Very proud of this work with @kaulcsmc.bsky.social just published in Progress in Cardiovascular Diseases
Are ORBITA trials practice-changing?
We discuss whether the enthousiasm of some after ORBITA-2 is really justified.
www.sciencedirect.com/science/arti...
#medsky
#cardiosky
Are ORBITA trials practice-changing?
We discuss whether the enthousiasm of some after ORBITA-2 is really justified.
www.sciencedirect.com/science/arti...
#medsky
#cardiosky
Are ORBITA trials practice-changing?
www.sciencedirect.com
March 16, 2025 at 8:10 PM
Very proud of this work with @kaulcsmc.bsky.social just published in Progress in Cardiovascular Diseases
Are ORBITA trials practice-changing?
We discuss whether the enthousiasm of some after ORBITA-2 is really justified.
www.sciencedirect.com/science/arti...
#medsky
#cardiosky
Are ORBITA trials practice-changing?
We discuss whether the enthousiasm of some after ORBITA-2 is really justified.
www.sciencedirect.com/science/arti...
#medsky
#cardiosky
Are the Device Approval Standards Lax? JACC Cardiovasc Interv. 2025 Feb 10;18(3):380-384. doi: 10.1016/j.jcin.2024.08.037. PMID: 39939040.
Device Approval in the United States: The FDA Is on Target. JACC Cardiovasc Interv. 2025 Feb 10;18(3):385-387. doi: 10.1016/j.jcin.2024.10.044. PMID: 39939041.
Device Approval in the United States: The FDA Is on Target. JACC Cardiovasc Interv. 2025 Feb 10;18(3):385-387. doi: 10.1016/j.jcin.2024.10.044. PMID: 39939041.
February 16, 2025 at 10:07 PM
Are the Device Approval Standards Lax? JACC Cardiovasc Interv. 2025 Feb 10;18(3):380-384. doi: 10.1016/j.jcin.2024.08.037. PMID: 39939040.
Device Approval in the United States: The FDA Is on Target. JACC Cardiovasc Interv. 2025 Feb 10;18(3):385-387. doi: 10.1016/j.jcin.2024.10.044. PMID: 39939041.
Device Approval in the United States: The FDA Is on Target. JACC Cardiovasc Interv. 2025 Feb 10;18(3):385-387. doi: 10.1016/j.jcin.2024.10.044. PMID: 39939041.
Reposted
Editorial on the renal results of FINEARTS HF in @jaccjournals.bsky.social from @kaulcsmc.bsky.social and moi
Free link:
authors.elsevier.com/a/1kQ%7Ec2d9...
#NephSky #CardioSky #Finerenone
Free link:
authors.elsevier.com/a/1kQ%7Ec2d9...
#NephSky #CardioSky #Finerenone
January 13, 2025 at 4:10 PM
Editorial on the renal results of FINEARTS HF in @jaccjournals.bsky.social from @kaulcsmc.bsky.social and moi
Free link:
authors.elsevier.com/a/1kQ%7Ec2d9...
#NephSky #CardioSky #Finerenone
Free link:
authors.elsevier.com/a/1kQ%7Ec2d9...
#NephSky #CardioSky #Finerenone
Imagine if I excluded centers in a multicenter trial of SAVR vs TAVR where TAVR outperformed SAVR, I could show that SAVR was superior to TAVR in high-risk patients with AS (PARTNER-1A).
December 19, 2024 at 7:48 PM
Imagine if I excluded centers in a multicenter trial of SAVR vs TAVR where TAVR outperformed SAVR, I could show that SAVR was superior to TAVR in high-risk patients with AS (PARTNER-1A).
Should Heart Failure Trials routinely report on all-cause hospitalizations?
Should clinicians, guidelines & payers favor interventions that favorably impact cause-specific & all-cause outcomes?
jamanetwork.com/journals/jaman…
jamanetwork.com/journals/jaman
Should clinicians, guidelines & payers favor interventions that favorably impact cause-specific & all-cause outcomes?
jamanetwork.com/journals/jaman…
jamanetwork.com/journals/jaman
https://jamanetwork.com/journals/jaman…
November 27, 2024 at 5:19 PM
Should Heart Failure Trials routinely report on all-cause hospitalizations?
Should clinicians, guidelines & payers favor interventions that favorably impact cause-specific & all-cause outcomes?
jamanetwork.com/journals/jaman…
jamanetwork.com/journals/jaman
Should clinicians, guidelines & payers favor interventions that favorably impact cause-specific & all-cause outcomes?
jamanetwork.com/journals/jaman…
jamanetwork.com/journals/jaman
1/
Is LDL-C lowering by CETP inhibitor cardioprotective?
Brief history
ACCELERATE (Evacetrapib), N=12092, F/U: 28m
Mean LDL 81; LDL⬇️37%, Lp(a)⬇️22%
PEP (MACE-5): 12.9% vs 12.8% HR 1.01, 0.91-1.11
Trial stopped early due to futility
x.com/mdavidsonmd/...
Is LDL-C lowering by CETP inhibitor cardioprotective?
Brief history
ACCELERATE (Evacetrapib), N=12092, F/U: 28m
Mean LDL 81; LDL⬇️37%, Lp(a)⬇️22%
PEP (MACE-5): 12.9% vs 12.8% HR 1.01, 0.91-1.11
Trial stopped early due to futility
x.com/mdavidsonmd/...
x.com
x.com
November 20, 2024 at 5:42 AM
1/
Is LDL-C lowering by CETP inhibitor cardioprotective?
Brief history
ACCELERATE (Evacetrapib), N=12092, F/U: 28m
Mean LDL 81; LDL⬇️37%, Lp(a)⬇️22%
PEP (MACE-5): 12.9% vs 12.8% HR 1.01, 0.91-1.11
Trial stopped early due to futility
x.com/mdavidsonmd/...
Is LDL-C lowering by CETP inhibitor cardioprotective?
Brief history
ACCELERATE (Evacetrapib), N=12092, F/U: 28m
Mean LDL 81; LDL⬇️37%, Lp(a)⬇️22%
PEP (MACE-5): 12.9% vs 12.8% HR 1.01, 0.91-1.11
Trial stopped early due to futility
x.com/mdavidsonmd/...
1/
OPTION
LAAC device vs DOAC post a fib ablation
N=1600, f/u 3y
PEP (death, stroke or SE)
NI margin 5% RD, 1.5 RR
Result: 41 vs 44, 5.3% vs 5.8% (c/w 10% assumed), RD: -0.5%, UL 1.8%; HR 0.91, 0.59-1.39
NI met for RD and RR margin
www.nejm.org/doi/full/10....
Left Atrial Appendage Closure after Ablation for Atrial Fibrillation | NEJM
Oral anticoagulation is recommended after ablation for atrial fibrillation among patients at high risk for stroke. Left atrial appendage closure is a mechanical alternative to anticoagulation, but ...
www.nejm.org
November 16, 2024 at 8:08 PM
1/
OPTION
LAAC device vs DOAC post a fib ablation
N=1600, f/u 3y
PEP (death, stroke or SE)
NI margin 5% RD, 1.5 RR
Result: 41 vs 44, 5.3% vs 5.8% (c/w 10% assumed), RD: -0.5%, UL 1.8%; HR 0.91, 0.59-1.39
NI met for RD and RR margin
www.nejm.org/doi/full/10....
1/
SUMMIT
Torzepatide in HFpEF in patients with BMI>30 (N=731)
F/U 2y
PEP:
1. CV death or worsening HF
2. Change in KCCQ-CSS
Key results:
PEP, HR 0.62, 0.41-0.95, p=0.03
kCCQ improved along with 6MWD, weight loss, SBP, & CRP.
Slight ⬆️ in HR
GI AEs ⬆️
www.nejm.org/doi/full/10....
SUMMIT
Torzepatide in HFpEF in patients with BMI>30 (N=731)
F/U 2y
PEP:
1. CV death or worsening HF
2. Change in KCCQ-CSS
Key results:
PEP, HR 0.62, 0.41-0.95, p=0.03
kCCQ improved along with 6MWD, weight loss, SBP, & CRP.
Slight ⬆️ in HR
GI AEs ⬆️
www.nejm.org/doi/full/10....
Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity | NEJM
Obesity increases the risk of heart failure with preserved ejection fraction. Tirzepatide, a long-acting agonist of glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor...
www.nejm.org
November 16, 2024 at 3:31 PM
1/
SUMMIT
Torzepatide in HFpEF in patients with BMI>30 (N=731)
F/U 2y
PEP:
1. CV death or worsening HF
2. Change in KCCQ-CSS
Key results:
PEP, HR 0.62, 0.41-0.95, p=0.03
kCCQ improved along with 6MWD, weight loss, SBP, & CRP.
Slight ⬆️ in HR
GI AEs ⬆️
www.nejm.org/doi/full/10....
SUMMIT
Torzepatide in HFpEF in patients with BMI>30 (N=731)
F/U 2y
PEP:
1. CV death or worsening HF
2. Change in KCCQ-CSS
Key results:
PEP, HR 0.62, 0.41-0.95, p=0.03
kCCQ improved along with 6MWD, weight loss, SBP, & CRP.
Slight ⬆️ in HR
GI AEs ⬆️
www.nejm.org/doi/full/10....
1/
BPROAD (N=12821)
F/U 4.2y
SBP delta: 16.7 (118.3 vs 135 median)
A1C at 48m = 7.6%
PEP (CV death, MI, stroke or HF):
393 vs 492, 0.79, 0.69-0.90
ARD = 1.55% (6.13% vs 7.68%)
PEP driven by stroke: 284 vs 356, HR 0.79, 0.67-0.92
Stroke dominated PEP
No diff. in serious AE
BPROAD (N=12821)
F/U 4.2y
SBP delta: 16.7 (118.3 vs 135 median)
A1C at 48m = 7.6%
PEP (CV death, MI, stroke or HF):
393 vs 492, 0.79, 0.69-0.90
ARD = 1.55% (6.13% vs 7.68%)
PEP driven by stroke: 284 vs 356, HR 0.79, 0.67-0.92
Stroke dominated PEP
No diff. in serious AE
November 16, 2024 at 3:07 PM
1/
BPROAD (N=12821)
F/U 4.2y
SBP delta: 16.7 (118.3 vs 135 median)
A1C at 48m = 7.6%
PEP (CV death, MI, stroke or HF):
393 vs 492, 0.79, 0.69-0.90
ARD = 1.55% (6.13% vs 7.68%)
PEP driven by stroke: 284 vs 356, HR 0.79, 0.67-0.92
Stroke dominated PEP
No diff. in serious AE
BPROAD (N=12821)
F/U 4.2y
SBP delta: 16.7 (118.3 vs 135 median)
A1C at 48m = 7.6%
PEP (CV death, MI, stroke or HF):
393 vs 492, 0.79, 0.69-0.90
ARD = 1.55% (6.13% vs 7.68%)
PEP driven by stroke: 284 vs 356, HR 0.79, 0.67-0.92
Stroke dominated PEP
No diff. in serious AE
1/
Key trials at AHA 2024
BPROAD
Intensive BP lowering (SBP<120) vs standard treatment (SBP <140) in diabetes.
PEP: 4-MACE (CV death, MI, stroke or HHF)
ACCORD failed to validate the hypothesis that SBP target of <120 was the optimal target in diabetes.
Key trials at AHA 2024
BPROAD
Intensive BP lowering (SBP<120) vs standard treatment (SBP <140) in diabetes.
PEP: 4-MACE (CV death, MI, stroke or HHF)
ACCORD failed to validate the hypothesis that SBP target of <120 was the optimal target in diabetes.
November 15, 2024 at 6:01 PM
1/
Key trials at AHA 2024
BPROAD
Intensive BP lowering (SBP<120) vs standard treatment (SBP <140) in diabetes.
PEP: 4-MACE (CV death, MI, stroke or HHF)
ACCORD failed to validate the hypothesis that SBP target of <120 was the optimal target in diabetes.
Key trials at AHA 2024
BPROAD
Intensive BP lowering (SBP<120) vs standard treatment (SBP <140) in diabetes.
PEP: 4-MACE (CV death, MI, stroke or HHF)
ACCORD failed to validate the hypothesis that SBP target of <120 was the optimal target in diabetes.
Albuminuria is a strong ‘prognostic’ biomarker for kidney and CV risk across a wide spectrum of CKM syndrome.
Is it a reliable ‘predictor’ biomarker (lowering it reduces risk) for:
1. Kidney & CV (including HF) risk in CKD?
2. Kidney and HF risk in HF?
www.ahajournals.org/doi/10.1161/...
Is it a reliable ‘predictor’ biomarker (lowering it reduces risk) for:
1. Kidney & CV (including HF) risk in CKD?
2. Kidney and HF risk in HF?
www.ahajournals.org/doi/10.1161/...
Albuminuria: An Underappreciated Risk Factor for Cardiovascular Disease | Journal of the American Heart Association
www.ahajournals.org
November 13, 2024 at 6:56 PM
Albuminuria is a strong ‘prognostic’ biomarker for kidney and CV risk across a wide spectrum of CKM syndrome.
Is it a reliable ‘predictor’ biomarker (lowering it reduces risk) for:
1. Kidney & CV (including HF) risk in CKD?
2. Kidney and HF risk in HF?
www.ahajournals.org/doi/10.1161/...
Is it a reliable ‘predictor’ biomarker (lowering it reduces risk) for:
1. Kidney & CV (including HF) risk in CKD?
2. Kidney and HF risk in HF?
www.ahajournals.org/doi/10.1161/...