Sanjay Kaul
@kaulcsmc
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cardiologist, evidence appraiser, data detective, nonconformist
Los Angeles, CA
Joined March 2009
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 👇.
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.
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.
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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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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Given that the midterm benefit-to-risk balance of TAVI devices, especially the SAPIEN 3, differs significantly from the short-term balance, Is it time to downgrade TAVI to a less-definitive Class 2 recommendation for low-risk patients?.
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For a deep dive into HF therapies approved over the past decade. 👇🏻. @JACCJournals.
jacc.org
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3/.Coupled with the fragile results from SUMMIT (tirzepatide vs pbo) in HFpEF + obesity, what should we make of the overall CV effects of GLP-1RA/GIP agonist, tirzepatide?.
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2/.If superiority of active comparator (dulaglutide) vs placebo is not established, is noninferiority design justified?. How to interpret all-cause mortality results?. Why did greater efficacy on A1C ⬇️, weight loss & eGFR not translate into CV outcome benefit?.
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1/.SURPASS CVOT.Trial had 90% power to detect 15% RRR in MACE c/w dulaglutide. PEP: HR 0.92, 0.83-1.01 (HR 0.85 barely contained within 95.3% CI).MACE, Dulaglutide vs pbo (REWIND).Overall (N=9901): HR 0.88, 0.79-0.99. ASCVD (N=3014): HR 0.87, 0.74-1.02.
Wow, the game has changed! #SURPASSCVOT meets its primary & secondary endpoints in first *head-to-head* CV outcomes trial!. Tirzepatide (dual GLP1/GIP agonist) vs Dulaglutide (GLP-1RA). including 16% lower risk of all cause mortality!.
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1/.2-year follow-up results of TRILUMINATE trial of T-TEER for severe TR were published in Circulation. Are the results informative and credible?
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Close Call with 56% voting for European guidelines being more faithful to the evidence. Our perspective is more aligned with the European guideline which give a weak recommendation for abbreviated DAPT to mitigate bleeding. 👇🏻. @JACCJournals @brophyj.
jacc.org
ACS Guidelines for shortening DAPT to mitigate bleeding risk. 2023 ESC/EACTs: Class 2b LoE B for aspirin or P2Y12 monotherapy after 1m. 2025 ACC/AHA: Class 1 LoE A for ticagrelor monotherapy after 1m. Which guidelines are more faithful to the evidence?.
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61% voted to downgrade or retire beta-blocker recommendation and 39% to wait for additional evidence from ongoing trials.👇.For deeper dive into current evidentiary support (or lack thereof).👇.@JACCJournals @drjohnm @AndrewFoy82.
jacc.org
On the basis of current evidence, what is the appropriate action regarding routine early use of beta blocker post-MI which is endorsed as Class 1 LoE A recommendation by 2025 ACS guideline?.
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