Sanjay Kaul
@kaulcsmc
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cardiologist, evidence appraiser, data detective, nonconformist
Los Angeles, CA
Joined March 2009
NEJM rarely publishes meta-analysis (NEJM Evidence does), but this is a good one! @NEJM
https://t.co/FhTnIcy7YV
nejm.org
The benefit of beta-blockers after myocardial infarction in patients with a preserved left ventricular ejection fraction (LVEF) is unclear. We conducted a meta-analysis at the individual-patient le...
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Why should one accept 1M dual therapy to be up to twice as worse as 12M dual therapy for ischemic outcomes?
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Was NI met in OPTIMA-AF? NI margin: 5% RD or RR 1.5 Expected vs observed control rate: 10% vs 5% RD: NI met RR: NI not met Because observed rate is <50% of expected rate, NI should be established for RR margin Safety advantage driven by nonmaj bleed @DFCapodanno @CMichaelGibson
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2/ 2020’s: DES bad, DEB good (leave no metal behind) Late 2020’s: will DEB deliver on the promise?
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1/ Shifting paradgims in PCI 1990’s: PTCA bad, stents good (⬇️restenosis) 2000’s: BMS bad, DES good (DES⬇️restenosis) Mid 2000’s: DES not so good (⬆️stent thrombosis) 2010-2020’s: Newer-generation DES safer 2010-2020’s: Bioabsorbable SS promise to be safer until they arent
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As usual, Davide is on target! 👇🏻
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For screening, low false negative rate is generally more important to avoid delayed diagnosis and treatment. A false negative rate of 59% is too high, IMO!
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Apple Watches' HTN Notification Feature was recently approved by FDA to be substantially equivalent to legally marketed predicate devices. https://t.co/WQjZiBEY0U Sensitivity was 41% & specificity was 92%. https://t.co/Ri4IYWbwNr For it to be useful, what attribute is desirable?
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https://t.co/R5kOOf8xcn  Key finding: Each 1% reduction in A1C is associated with 27% lower MACE risk? Does SURPASS CVOT support this conclusion? 0.8% lower A1C with tirzepatide = HR 0.92 Can meta-regression analyses mislead? 👇🏻 https://t.co/yB0FjFInm6
dom-pubs.pericles-prod.literatumonline.com
Aims To evaluate relationships of cardiovascular and kidney outcomes with glycemic or bodyweight reductions in randomised placebo-controlled trials of glucagon-like peptide-1 receptor agonists...
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Reappraisal of Evidentiary Support for Transcatheter Aortic Valve Implantation for Low-Risk Aortic Stenosis: Insights From Midterm Results of the PARTNER 3 and Evolut LR Trials | JACC https://t.co/66Ip4hbbyt 👇 https://t.co/saUxGFlDQY
jacc.org
Should TAVI procedures continue to be reimbursed as “reasonable and necessary” even when clinical practice has moved beyond evidence or guidelines?
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4/ 9. Bleeding advantage driven by BARC 2 bleeding, not 3 or 5 bleeding (of greater prognostic value). Bottom line, the inference of NI is not robust. It would be premature to discontinue aspirin early post-PCI based on these results.
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3/ 6. NI met (barely) using RD margin in ITT & as treated (AT) but not the more robust per protocol (PP) analysis. 7. NI not met for RR margin for ITT, AT or PP analysis. 8. NI inference is fragile (p=0.02) as 1-2 excess events in P2Y12i mono-Rx arm would overturn NI.
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2/ 3. Choice of PEP: combined ischemic/bleeding NACE rather than ischemic MACE alone. 4. NI margin fixed as risk difference (RD) of 1.25%. 5. Observed active control rate (2.2%) lower than expected (3.5%). This amplifies the risk ratio (RR) margin from 1.36 to 1.57
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1/ Rumors of aspirin’s demise are greatly exaggerated. Concerns with TARGET-FIRST trial: 1. Sample size estimation assumes 1% superiority of P2Y12i monotherapy (2.5% vs 3.5%) rather than conventional equivalence. 2. 80% power low for NI assessment. https://t.co/sRkh5f0Fp9
nejm.org
An appropriate duration of dual antiplatelet therapy after percutaneous coronary intervention for acute myocardial infarction that has been treated with guideline-recommended complete revasculariza...
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Evidentiary landscape for P2Y12i mono-Rx vs DAPT post-ACS is as clear as mud! Even though non-inferiority was not met technically, P2Y12i mono-Rx was associated with Rx effect ranging from 2% benefit to 68% harm. Balancing benefit-risk post-PCI is hard. https://t.co/kRhtjoYUpE
nejm.org
Whether potent P2Y12 inhibitor monotherapy without aspirin initiated shortly after successful percutaneous coronary intervention (PCI) is effective and safe for patients with acute coronary syndrom...
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Is rescuing null trials with a meta-analysis, regardless of study-level or IPD, a proper use of meta-analysis? Totality of evidence is often a euphemism for we failed to win, but we get a second chance!
tctmd.com
DAPA ACT HF – TIMI 68 missed its primary endpoint, but experts say the totality of the evidence backs early use of the drugs.
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2/ Expected risk ratio margin was 1.33 [(15+5)/15]. HR for PEP at 1y: 1.4, 0.7-2.9; at 3y: 1.3, 0.8-2.2. Despite higher number of events accrued at 3y, TAVI failed to meet noninferiority! All endpoints ‘leaned’ in favor of SAVR. Is conclusion of …comparable outcomes… justified?
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https://t.co/CrUHTi6pi9 NOTION-2 results at 3y continue to show that TAVI is NOT non-inferior to SAVR. Study was designed as a noninferiority trial with a risk difference margin of 5% over expected SAVR rate of 15%. Actual SAVR rate was 7.1%.
ahajournals.org
Background: Transcatheter aortic valve replacement (TAVR) is increasingly performed in younger, low surgical risk patients. This NOTION-2 study reports mid-term outcomes in low-risk patients aged...
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What is your overall impression of the 2025 ESC/EACTS Guidelines for VHD?
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Should TAVI procedures continue to be reimbursed as “reasonable and necessary” even when clinical practice has moved beyond evidence or guidelines?
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