Gregg W. Stone MD
@GreggWStone
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Interventional cardiologist, trialist, innovator, educator, husband, father, loyal friend
New York and the world
Joined December 2016
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Our perspective on the vulnerable plaque and vulnerable patient just published in Nature Reviews Cardiology. Please DM me a request with your email address and I would be pleased to send you a journal-approved copy.
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Published today in EHJ: Meta-analysis of all left main DES vs. CABG RCTs. 5 trials, 4612 pts, mean 5.6 year follow-up (including all long-term data from EXCEL, NOBLE and SYNTAX). Similar all-cause rates of death with PCI and CABG - RR 1.03, 95% CI 0.81–1.32; P = 0.78.
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#EXCEL
investigators detailed response to the false narrative that has been promulgated. Please read and move beyond sensationalism, back to science and patient care. Note: We will not further debate this in the press or on Twitter.
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MitraClip approved by FDA today for Rx of severe secondary MR in pts with heart failure who remain symptomatic despite GDMT. Great day for suffering pts in whom this therapy offers potential for improved survival, reduced hospitalizations and enhanced quality-of-life.
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MASTER DAPT trial. Important because this is the first trial in a high bleeding risk population adequately sized to convincingly demonstrate non-inferiority for ischemia. The new standard of care.
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ISCHEMIA cost $100M of taxpayer money. Some are complaining that’s outrageous. Is it? There are 140,000,000 US taxpayers. ISCHEMIA took 7 years. That’s 10 cents per taxpayer per year. Worth it? I think so!! We should fund more major trials like this addressing essential issues.
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At the Mount Sinai Hospital system, we’ve been running ~2000 COVID-19 in-pts per day, with ~500 in ICUs. Finally starting to see a downturn in these numbers. More than 2800 patients have been discharged. Amazing effort by everyone on the front line as well as hospital leadership.
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Both PARTNER 3 and EVOLUT low risk trials show reduced composite death/stroke/rehosp in low risk AS pts. Much faster recovery and early QOL. Some diffs between the trials in PPM, PV leaks, valve hemodynamics, but results both overwhelmingly positive. A new era has begun.
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FDA has approved the pivotal randomized trial of Impella in 668 pts with anterior STEMI designed to demonstrate that LV unloading starting pre-PCI will safely reduce Infarct size. Hugely important study.
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IVUS used in only 5.6% of nearly 2 million Medicare PCI pts - but strongly associated with reduced death, MI and reintervention (JACC CV Int publ today). Similar results to 10 RCTs. So why isn't IVUS (or OCT) used more frequently? Poll to follow.
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Amazing case in JACC Int of a 58 yo asymptomatic man who developed a STEMI from plaque rupture 2 hrs after a routine CT with 0 calcium. It's the plaque morphology and inflammation, not the calcium that predicts risk! Calcium is a marker useful in some but (obviously) not all pts.
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The EXCEL, NOBLE, SYNTAX and PRECOMBAT investigators have agreed to pool the data from their trials for an independently led individual patient data pooled analysis. Hopefully the data analysis will be completed and reported later this year.
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Excited to announce that today we completed enrollment of ILUMIEN IV, with 2490 pts randomized to OCT vs angio guided stenting. Fantastic work by PIs
@ziadalinyc
and Ulf Landmesser, the steering committee, core lab led by
@MaeharaAkiko
and all the sites.
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Less than 48 hours to
#ISCHEMIA
! Amazing 10-year journey. Whatever the results show great thanks to study leads Judy Hochman and David Maron for extraordinary effort and professionalism, and NIH for funding this effort.
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1/4 Just publ in the Lancet our updated network meta-analysis of imaging-guided (OCT or IVUS) vs. angio-guided PCI across the spectrum of CAD. With 22 RCTs and 15,964 pts this is the 1st study to demonstrate that imaging reduces all-cause death (by 25%), as well as all MI (17%).
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Our state of the art review on hybrid coronary revascularization (LIMA-LAD + DES elsewhere) now published in JACC. The best of both worlds for complex left main and multivessel ds?
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COAPT team is working closely with John Francois Obadia and Alec Vahanian to pool the COAPT and MITRA-FR databases to help identify which patients with secondary MR will and will not benefit from MitraClip. All echos will be read at same core lab. Excellent collaboration.
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Gotta love randomized Twitter trials. RCT showing that Twitter dissemination of study results leads to 43% increase in citations. Even a positive dose-response curve was demonstrated.
#cardiotwitter
@CMichaelGibson
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Important new study in JACC Int in 13,452 pts undergoing PCI. CKMB >=10X ULN was an independent predictor of mortality whereas troponin elevations, even >=70X were not. Only large periprocedural MIs matter, and best assessed by CKMB.
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As regards
#COAPT
, I don’t understand the critics. It would seem that with a breakthrough of such magnitude and beyond any question of statistical significance that can so positively affect hundreds of thousands of suffering pts, the natural human emotion would be to celebrate.
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Most say provisional stenting is best for bifurcation lsns. Today largest analysis of bif techniques (21 RCTs, 5711 pts) published. DK-crush associated with best outcomes, principally d/t lower TLR w/trends for lower CD & MI. Has the tide turned – at least for true bifurcations?
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Three major late breaking trials at TCT tomorrow: FAME-3 (PCI with FFR guidance vs. CABG); FAVOR III China (large-scale RCT of QFR (angio-FFR)-guided vs angio-guided PCI); and SUGAR (RCT of DES in diabetes). Will impact practice. Be there or tune in!
#TCT2021
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Cholera has produced 7 pandemics since 1817, killing >40M people. This poem written during the 4th cholera pandemic (1863–1875) provides hope that something positive can be gained from sheltering.
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In new study from SCOT-HEART publ in Circ, low attenuation plaque by CTA was the strongest predictor of future MI - more so than plaque calcium or extent. Same as in PROSPECT and other studies. Must change our focus: Ischemia predicts symptoms, vulnerable plaque predicts ACS.
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ULTIMATE late breaking science at
#TCT2020
. 1448 all-comers DES pts rand to IVUS vs angio guidance. 40% decr TVF at 3 yrs (abs 4% diff), w/directional decr all components. Stent thrombosis decr 88% (1% absol decr). So many pos RCTs – no excuse for not using IVUS/OCT!
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Just published in JACC, our article examining different ways, methods & issues w/the reporting of primary & secondary outcomes in RCTs. Includes discussion of p-value abuse and interpretation, multiplicity, control of type I error & more. Our perspectives, w/concrete suggestions.
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PROSPECT II published in Lancet. We can identify vulnerable plaques and pts before events with NIRS-IVUS! Link to free download for 50 days. Next: Definitive therapy trials.
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Important slide from COAPT. 3+/4+ MR was selected by ASE -recommended multi-parametric integrated approach. But they don’t tell you how to do it. This is the algorithm we developed for COAPT. Use this selection method to duplicate the COAPT results.
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Love it. This is what I tell the fellows (graph): Initially you'll think you know everything, then year after year you'll realize there's more and more you DON'T know - but your knowledge is actually increasing. It's essential to have this awareness and honestly self-appraise.
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Pt with Medina 1,1,0 distal LM bifurcation. PCI with provisional 1-stent technique - 3.5 mm DES followed by 4.5 mm POT - resulted in high-grade stenosis at origin of LCX. TIMI 3 flow, no symptoms or ECG changes. iFR of LCX performed=0.94. Next steps? Poll to follow.
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Make sure you listen to this!
constrictive pericarditis (preoperative) with sound
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Normally I don’t put much stock in astrology, but this is likely to be spot on.
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Most comprehensive meta-analysis (19,806 pts) with longest FU to date in EHJ shows coronary revasc in stable CAD reduces cardiac death (by 21%, P<0.001) and spontaneous MI (by 26%, P<0.001). Effect incr w/longer FU and similar in w/PCI vs CABG and w/w/o post-ACS or CTO. See poll.
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Just had the pleasure to be part of a great AHA session and speak on "Revascularization Reduces (Re)Infarction: True or False?" My conclusion was "YES! But we can do better". A few slides here.
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Our publ in JACC today - an individual data pooled analysis of 25,032 pts from 19 stent RCTs shows an ongoing ~2%/year risk of stent-related events with all stent types with no plateau evident. Must reduce both long-term stent- & non-stent-related outcomes to improve prognosis.
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Best example of Twitter publication bias. 18 hours ago I posted 2 simultaneous tweets on positive and negative
#ESCongress
trials. Pos studies tweet has 30,678 views, 214 likes, 76 retweets. Neg studies tweet has 16,696 views, 111 likes, 49 retweets.
@CMichaelGibson
@mmamas1973
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New poster format
@TCT2019
this yr being implemented to enhance communication and observer recall of the primary message. ~60% of the poster area is a central figure/table with the take-home message. Presentation starts there. Margins contain remainder for discussion. Thoughts?
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Nice article by Jacqueline Saw in current issue of EuroIntervention on whether and how to treat spontaneous coronary artery dissection.
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I'm pleased to announce that PROTECT IV, our large-scale randomized trial of Impella CP circulatory support vs. control in 1252 pts with low LVEF and extensive CAD undergoing complex PCI has randomized its 626th patient - half-way complete! - a major milestone.
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1/2 ESC take-home messages (partial)
Positive trials:
EMPEROR-Preserved: Empagliflozin decr HFH in HFpEF
MASTER-DAPT2: 1-mo DAPT in HBR pts decr bld, noninf ischemia
IAMI: Influenza vaccine in-hosp after MI decr death
ACST-2: Carotid stenting, surgery similar in asymptomatic pts
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Excellent point from the REVIVED editorial: pts with the most severe CAD were likely referred to CABG as a GDMT arm wouldn't have been ethical. A PCI vs CABG strategy would have overcome this limitation but would have required more pts and longer FU.
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This is pretty cool. First read it from top to bottom, then make sure you read it from bottom to top. Life is perspective. Happy 4th of July everyone!
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Major announcement! Now everyone can join us online if you can't travel to Orlando for the late breaking trials and clinical science, live cases, innovation, abstracts and other scientific symposia.
The digital component of
#TCT2021
will now be FREE! After careful consideration & achieving a critical level of support from industry partners, complimentary registration includes all content via livestream during the meeting & on-demand access for 1 year.
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Three RCTs of PFO closure in cryptogenic stroke published in the same issue of NEJM should remove any doubt about the utility of this procedure. HRs are impressive. NNT ~20 to prevent 1 stroke in 5-10 yrs. Remaining challenge is to identify pts who will benefit the most.
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COMPLETE: 4041 pts with STEMI +MVD rand to culprit lsn PCI only vs. delayed 2nd PCI for complete revasc. CV death or MI at median 3 yrs reduced by 26%, p=0.004. No diff in CV death. MI reduced by 32%. Also reduced UAP and unplanned revasc. No safety issues. Practice changing.
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Gave Cardiology Grand Rounds at University of Texas Heart Institute today. Met with 16 cardiology fellows before and told them all about the Parachute Trial. None had heard of it yet. None were on Twitter. All were amazed.
@CMichaelGibson
@ajaykirtane
@rwyeh
@bnallamo
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7/8
#ISCHEMIA
: An important implication of the trial is that if you want to try a non-cath-based conservative approach you need to exclude left main ds, which was present in ~10% of pts by screening CTA! These pts should undergo angiography for probable PCI or CABG.
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First 3-vessel OCT imaging study publ in JACC w/long-term FU showing OCT can identify vulnerable plaques with strong discrimination. Our editorial on whether inv imaging (OCT, NIRS-IVUS, RF-IVUS) can detect VP: "Case Closed"! There are now at least 10 good studies!
@ziadalinyc
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Nice state-of-the-art review on coronary artery aneurysms in today’s JACC Intrv, emphasizing their high-risk prognosis, increased complication rates with PCI and CABG, and lack of robust data to inform treatment decisions.
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Thrombosis is a major contributor to poor outcomes in COVID. We’re randomizing 3600 hosp’d but not intubated COVID-19 pts to diff anticoagulation regimens. Investigator-sponsored study, Valentin Fuster PI. If interested email Gregg.Stone
@mountsinai
.org and Michael.Farkouh
@uhn
.ca.
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Our publ in JACC Int on DAPT d/c after PCI. Largest and most detailed study to date (ADAPT-DES, n=8582 all-comers). Unplanned premature d/c (~1/6 pts,
#1
cause surgery/trauma) was strongly associated with cardiac death, MI and ST, esp if d/c w/i 90d, and esp if both ASA & P2Y12i.
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Results of FAME 3 are not nearly as clear cut (to me) as the headlines—all depends on the primary endpoint that was chosen. From all the data, for every 1000 pts Rx with CABG rather than PCI there will be [Fig]. Pts need to understand (and docs need to appreciate) both profiles.
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Lithotripsy of heavily calcified aortic valve with 7.0 mm x
60 mm Shockwave balloon (with Sentinel cerebral protection) reduced the AV gradient and improved leaflet mobility prior to TAVR without complication. Fascinating care report by Sharma et al in EHJ. Thoughts?
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This is an important historical event. PROTECT IV is the most rigorous trial to date of MCS in high-risk low LVEF pts with complex CAD. 1252-2500 pts (adaptive), 3-yr FU. Hypothesis is improved early and late outcomes. Major viability, RHC and renal substudies, and more.
1st patient in the world randomized in PROTECT 4 RCT at St John’s in Detroit City! 87 y/o, EF 33%, 3VD, Cr 2.7. Congrats to the steering committees, investigators, and ABIOMED for committing to a rigorous RCT. Lets all enroll and advance the evidence for this group of patients!
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IVUS substudy from NOBLE published online in EuroInt. IVUS used in 72% of PCI cases. IVUS use and stent MLA were strongly associated with 5-year freedom from left main TLR. Must use IVUS to get best results of LM PCI. All studies show this.l
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1/8
#ISCHEMIA
: 5179 pts w/stable CAD, mostly mild symptoms w/mod/sev ischemia. No overall diffs w/early invasive vs conservative Rx in CV death, MI or other hard endpoints. Peri-procedural MI was increased but non-procedural MIs were decreased with the invasive approach.
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1/ Individual pt data pooled analysis of the 4 left main DES vs CABG trials (n=4394) led by TIMI (Sabatine/Braunwald) in Lancet. No sig diffs in 5-yr or 10-yr all-cause death. By Bayesian analysis, any possible diffs are likely small (cardiac death <0.1%/yr, all death <0.2%/yr).
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To ensure everyone's safety, TCT 2020 will be a virtual event, Oct 14-18, a unique digital experience with live cases, training, extensive interaction and more. The abstract and late breaking trial deadlines will also be extended. We're excited and hope you join us!
We’re bringing
#TCTConnect
to you! A unique and compelling virtual experience featuring live case-based transmissions, late-breakers, virtual training & opportunities to learn and engage with the brightest minds in the field. More details coming soon.
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If you ever doubted that there would be a role for remote control robotics....
Remote procedure by a London-based surgeon on a Californian banana! 🍌👨⚕️
#IoT
#5G
#MedicalTechnology
#future
#AI
#ML
#VR
#AR
#innovation
#SmartCity
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Important study showing the prognostic superiority of 24 hr ambulatory BP compared with office BP measures. Masked HTN (present on 24h test only) even more strongly associated w/death. Suggests to me we should routinely incorporate ambulatory BP assessment in practice.
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Published today in JACC: After primary PCI in cardiogenic shock the extent of incomplete revasc was an independent predictor of mortality. Complete revasc was infrequent (17%). Suggests the negative primary trial results may have been due to inadequate PCI. Hypothesis generating.
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Merry Christmas everyone. Our gift was today's EHJ which contains our manuscript describing the methodology, pitfalls and practical applications of the WIN ratio (developed by Stuart Pocock), an increasingly adopted method to determine the primary outcome in RCTs. Enjoy!
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In the SYNTAX trial, anatomic complete revasc (CR) was more common after CABG than PCI. Compared with CABG+CR, PCI+CR had lower 10-year mortality. Conversely mortality was higher after PCI with incomplete revasc. Must honestly appraise likelihood of CR after PCI when choosing.
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START registry: ISCHEMIA may apply to ~4% of stable CAD, and non-ISCHEMIA pts were at much higher risk for events (thus potentially more likely to benefit from revasc). Editorial by Bill Boden (Table 1) shows how restrictive ISCHEMIA was-excluded most pts with substantial angina.
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Report in JACC HF: <25% of JACC and CIRC editorial boards are on Twitter; those who are mostly have <500 followers and don’t regularly tweet. But there is public interest - each journal has >10,000 followers. Twitter needs academicians to be more involved - a real opportunity!
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The highlight of ACC 2019 will be the two pivotal randomized trials of TAVR versus SAVR in low risk patients, representing the majority of AS. If non-inferior at 1 year and economically dominant, a tsunami practice change may occur. Durability the last (but important) question.
Congratulations to Suzanne Baron, MD MSc and the amazing health economics research group at
@MidAmericaHeart
who conducted this ground-breaking study!
#TAVR
is truly a revolutionary procedure.
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New insights to REVIVED after an interview with Diveka Perera. Indication for inclusion was site LVEF <35%. By core lab mean LVEF was 31.8%, and few pts had active disease, i.e. little angina and only mild HF in most. A stable, quiescent population. Not the typical CHIP PCI pt.
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Small RCT in JACC: epi resulted in incr tachycardia, lactic acidosis & refr shock vs norepi in CS. Good editorial. With SOAP II trial in NEJM showing decr mortality with norepi vs dopa in CS, norepi is emerging as default pressor (but should individualize based on hemodynamics).
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RCT of high vs low dose chloroquine for COVID-19 stopped early after 81 pts for excess death in the HD group. Plus greater QTc prolongation. Unfortunately no placebo control group. Important lesson – we can’t deviate from science in this pandemic – we can do more harm than good.
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Our ACC late breaking trial presented today on the impact of complete revasc (CR) from the ISCHEMIA trial. Anatomic and functional CR were achieved in 44% & 59% of pts. By IPW, 4-yr outcomes were improved with an INV compared with CON approach w/anatomic CR but not functional CR.
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1/2 Our JACC article on the limitations of revascularization as an endpoint in clinical trials. Unlike D/MI/CVA, revasc doesn’t just “happen” – it must be ordered and performed, introducing indication bias.
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6/8
#ISCHEMIA
limitations: Doesn’t apply to ACS, LVEF <35%, left main or very symptomatic pts (excluded). CV outcomes and angina relief are greater w/revasc in such pts. Completeness of revasc data not yet available (ACC 2020). Nonetheless, results are clear & inform practice.
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COAPT results have now been incorporated in the 2020 Focused Update of the 2017 ACC Expert Consensus Decision Pathway for Treatment of Mitral Regurgitation. Last remaining hurdle (in the US) is CMS reimbursement, which will hopefully occur in the next few months.
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COLCOT results: 4745 recent MI pts rand to colchicine vs placebo. Primary endpoint of CV death, MI, stroke,arrest or urgent hosp for revasc reduced by 28%, with all components in the right direction! Mean FU 23 mo. No major adverse events. Wow!
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ORBTA-1 showed how difficult it is to design a rigorous trial to test something inherently true. The trial design can mask the effect. Overcoming the limitations of ORBITA-1 allowed the truth to emerge in ORBITA-2. Congrats to Rasha & team - no one else could have done this.
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Individual patient data pooled analysis of 15 primary PCI trials with 10,979 pts in JACC. DES superior (safer and more efficacious) than BMS in every measure. Second gen DES have lowest thrombosis rates. Time to remove BMS from the shelves.
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From EXCEL in JACC: LM pts undergoing staged PCI tended to have better outcomes than if all done at a single procedure, despite greater anatomic SYNTAX scores. Don’t do too much at one sitting, consider staging.
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Our study from EXCEL in JACCInt today. Repeat revasc was ~5% more after PCI than CABG at 3 years. Repeat revasc after both PCI & CABG was associated with all-cause death, but mainly after CABG procedures. And associated risk of death was << after stroke and < after MI.
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Bivalirudin vs. heparin during PCI in STEMI? The 2 best regimens (biv + high-dose post-PCI infusion) vs heparin alone (w/o routine GPI) have not been compared in a powered RCT. That changes Sunday at AHA - I'll be presenting BRIGHT-4, a 6016-pt RCT in STEMI w/radial access.
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1/3 Our perspective in JACC from a surgeon and IC: It’s time to reconsider new endpoints in revasc trials. MACE has major limitations and doesn’t characterize the totality of benefits & risks of PCI & CABG. 1) Death, MI, stroke, revasc are not equal. 2) MI defn is controversial.
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4/8
#ISCHEMIA
: Substantial reduction in angina and improved QOL in pts w/any baseline angina with invasive approach. NNT to make 1 pt angina-free =~3-5! Benefits were sustained through 3+ yrs (unlike COURAGE in non-DES era). Minimal differences in asymptomatic pts.
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The publication process can be quite arbitrary, depending on the mood and views of two or three reviewers. Never stop believing in yourself.
This is the rejection letter for the work that just won the Nobel Prize. Don’t stop believing!
I should save all of mine and maybe one day some stranger will think it’s an amazing relic and tweet it...
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Large study (non-rand) today suggesting pre-loading oral P2Y12 inhibitors in STEMI is not effective. They all work too slow to be active during primary PCI (most adverse events are periprocedural), even if crushed. IV cangrelor overcomes this, but lacking definitive RCT data.
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Maybe breakfast truly is the most important meal of the day
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Our JACC state of the art manuscript just published reviewing the currently approved and investigational devices for heart failure. This is the next major cardiovascular condition for which novel interventional therapies can provide substantial benefits for patient outcomes.
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Direct stenting in STEMI often touted to reduce distal embolization & improve clinical outcomes - w/o much evidence. Study from combined individual data of 18,306 pts in TAPAS, TASTE, and TOTAL shows no benefit (or harm) of direct stenting. Not randomized, but best data to date.
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Honored to be elected MSCAI. This is a great organization that truly has the interests of interventional cardiologists and patients at heart.
Congratulations to the very honorable
#MSCAI
class of 2020!
#SCAI2020
@SCAI
Dr. John S Douglas
Dr. Donald Hagler
Dr. Thomas K. Jones
Dr. Augustin Prichard
Dr: Steven R Ramee
Dr. Damon K Sharma
Dr.
@GreggWStone
Dr. Paul Terstein
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If you like tennis and Jack Nicholson movies you'll probably find this funny.
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6/ Lancet conclusions: There was no statistically sig diff in 5-yr all-cause death b/t PCI & CABG. There were trade-offs in MI, stroke and revasc risks. A heart team approach to communicate expected outcome differences might be useful to assist patients in reaching a Rx decision.
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If I had true angina and single vessel disease, I would take a 30 min PCI over daily use of 2-3 anginal drugs in a heartbeat.
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DAPA HF: 4744 pts w/HFrEF w/or w/o diabetes rand to SGLT2i dapaglifozin vs placebo. Med 18 mo FU. CV death, HF hosp or urgent HF visit reduced by 26%, p<0.0001. Sign decrease in CV death as well as HF events. All death decr. Benefits identical in pts w/& w/o DM. New Rx for HFrEF!
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Our publ in today's JACC CV Int on non-fatal peri-procedural compls after LM revasc in EXCEL. Rate 11.9% after PCI and 45.4% after CABG. Highly predictive of 30d and late death after both procedures. Reducing procedural complications can improve outcomes after both PCI and CABG.
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Interesting study online in JACC from 5 major FFR studies (n=5129) - in pts with ACS lesions deferred with FFR >0.80 have higher MACE than in stable CAD. Most likely (IMO) due to vulnerable plaques despite being non-flow limiting. No difference in outcomes for treated lesions.
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Final poll results: 45% PCI, 30% no Rx, 25% want more info. Equipoise! Here's what happened (Gupta & Chhikara, EHJ). They left it, pt remained stable, routine FU at 6 mo showed resolution of the angio lesion. We need a large study to determine if this is the right approach.
Pt with Medina 1,1,0 distal LM bifurcation. PCI with provisional 1-stent technique - 3.5 mm DES followed by 4.5 mm POT - resulted in high-grade stenosis at origin of LCX. TIMI 3 flow, no symptoms or ECG changes. iFR of LCX performed=0.94. Next steps? FU and attribution tomorrow.
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COACT published. 552 non-shock pts with out of hospital arrest without ST elevation randomized to immediate v delayed angio. No 90-day differences in the survival or secondary endpoints. Importantly, only 3.4% had acute thrombotic occlusions and only 13.6% unstable lesions.
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Mehmet Oz first came up with the idea of percutaneously approximating the mitral leaflets. We were honored to be able to demonstrate the profound benefit of the MitraClip in heart failure pts with secondary MR in
#COAPT
. Inspiring to do the snow with him.
#TuneIn
NOW to the
@DrOz
Show, where
#NYP
/
@ColumbiaMed
's
@GreggWStone
is discussing the groundbreaking
#COAPT
trial and what these new findings mean for
#heartfailure
patients.
#NYPHeart
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Everyone should know that all slides from
#TCT2018
are available as PDF files for free from . Gold and higher subscribers can download the PowerPoint slides and linked audio files as well. Tremendous resource.
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RECOVER IV will randomize 560 STEMI pts with cardiogenic shock to Impella vs control, with FDA approved Exception From Informed Consent. We need sites who acknowledge equipoise to enroll all consecutive pts. If interested please DM me.
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New Yorkers are taking the appropriate precautions
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