Interventional cardiologist, trialist, innovator, educator, husband, father, loyal friend
New York and the world
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1/2 Our updated meta-analysis of intravascular imaging guidance publ in JACC. Since our last synthesis in Lancet 2024, there have been 6 new RCTs with 8,670 additional pts. Total is now 28 RCTs with 24,634 patients with mean FU 22 mos. Should be enough for a definitive answer!
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Our work from ILUMIEV IV in diabetic pts w/ and w/o complex lesions publ in JACC Interv, a particularly hazardous combination w/poor outcomes after PCI. OCT guidance → ↓ stent thrombosis in all groups w/trend for ↓serious MACE w/o ΔTVF. Free download: authors.elsevier.com/a/1nn9E…
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Gregg W. Stone MD retweeted
Results were consistent in HFrEF and HFpEF & IpcPH and CpcPH. PADN also → concordant improvements in KCCQ, NT-pro-BNP, 6MWD and left and right heart structure/function. PADN in group 2 PH is further being studied in the sham-controlled PULSE-LHD RCT in CpcPH (NCT07214376).
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Gregg W. Stone MD retweeted
The primary EP of clinical worsening (death, transplant, HF hosp, outpt HF or 6MWD↓) was reduced by 51% with PADN (51.5% vs 25.7%, HR 0.49, 95%CI 0.30-0.82, p=0.006). Clinical events w/o the 6MWD component were also ↓52% by PADN (20.8% vs 40.3%, HR 0.48 (0.27–0.86), P=0.01).
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Presented today and published in NEJM, our PADN-HF-PH trial in which 264 pts with left-heart failure (HFrEF or HFpEF) and pulmonary hypertension (mPAP >20 mmHg and PCWP >15 mmHg) were randomized at 25 centers to pulmonary artery denervation (PADN) + GDMT vs GDMT alone.
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The primary EP of clinical worsening (death, transplant, HF hosp, outpt HF or 6MWD↓) was reduced by 51% with PADN (51.5% vs 25.7%, HR 0.49, 95%CI 0.30-0.82, p=0.006). Clinical events w/o the 6MWD component were also ↓52% by PADN (20.8% vs 40.3%, HR 0.48 (0.27–0.86), P=0.01).
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In BRIGHT-4 (n=6016 randomized), bivalirudin + a 2-4h infusion ↓ mortality & major bleeding during primary PCI in STEMI c/w UFH (Lancet). At ESC/JACC today, in a prespecified substudy, the survival and bleeding benefits extended to low as well as high bleeding-risk pts.
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In their editorial Valgimigli et al note the class IA 2025 ACC/AHA GL for bival to ↓ death and bleeding in primary PCI and conclude “The present analysis supports the broader use of bivalirudin which should represent the mainstay anticoagulant in primary PCI rather than UFH.”
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Our publ in JACC CV Imaging from ILUMIEN IV: Pre-PCI OCT stratifies 2-year TVF based on plaque morphology. Highest risk (mainly due to TVR) were calcific > lipidic > fibrotic lsns, related to stent under-expansion. Despite median calc arc 271°, only 26% had advanced lesion prep.
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Our publ in CIrc HF from RELIEVE-HF. Although group outcomes with V-wave atrial shunt implant were markedly positive in HFrEF and negative in HFrEF, individual pt modeling predicts 67.2% and 21.4% HFrEF and HFpEF pts might benefit. Download free: ahajournals.org/eprint/SH3RQ…
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Our AHJ publ, lessons from the feasibility phase of the PCORI-funded RECHARGE trial of PCI v CABG in women, Black & Hispanic pts with a novel pt-centered endpoint of survival & QOL. They said it couldn’t be done – it can! - with dedicated focus on enrolling under-represented pts.
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Our publ in NEJM (DAPT-MVD): Among 8250 pts not at high bleeding risk w/MVD & ACS, extending ASA+clopidogrel from 12 to 24 mo decreased MACE from 6.8% to 5.8% (P=0.03) w/o incr bleeding c/w ASA alone. While shortening DAPT is appropriate in many pts, in some long DAPT is better!
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CHIP-BCIS3 investigators said “…periprocedural myocardial injury, which we know from the primary trial results is associated with CV death...” This is not accurate. Small troponin elevations have not been associated w/CVD, and to my knowledge, this was not shown in the trial.
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Complete revasc (CR) in pts with non-shock STEMI and multivessel ds. reduces MACE. But is the best timing for non-culprit lsn PCI immediate (during primary PCI) or staged? Our new meta-analysis publ in Circ CV Interv suggests immediate CR may increase mortality, same as in shock.
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Please join us Fri March 27 @2:30 - 6PM before ACC for a special (and free!) symposium "The Next Era of Cardiometabolic Care" reviewing the latest science directing new pathways to individualized care. Incredible faculty incl Fuster, Libby, Bhatt, Hedin, Figree, Erlinge and more.
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They wanted a 50% NI margin. Ignore the fact that this is wide. They observed DEB 5.3% vs. DES 4.4%. So upper bound of margin = 2.2% increase. Their risk diff=0.91, 95% CI (-0.55, 2.38). 2.38 is >2.2 - the trial missed non-inferiority. This was a NEGATIVE trial.
Why wouldn’t it be a superiority test? Nothing less costly or less invasive about DCB? Any “advantage” is theoretical.
Stuff like this is why it’s so bad that docs like @VPrasadMDMPH can’t work at FDA.
Regulatory failure that pts were experimented on in a badly designed trial
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