News and Views from ACC 2015

News and Views from ACC 2015

The American College of Cardiology (ACC) meeting was in San Diego from March 14 to March 16, 2015. Our journalists and contributors blogged live from the conference floor, providing top-line results of the major studies and tidbits from the conference sessions.

Scroll through the blog below to see how the meeting unfolded. Full coverage of the meeting found on our ACC conference page.
  • For the whole OSLER story, check out Deborah Brauser's story on theheart.org. Deborah is new to theheart.org but she's covering this stuff like a seasoned pro. Story is here:
  • Yes! great information on PCSK9 inhibitor sub q injection EVOLOCUMAB : “The curves diverged early and continued to separate over time", said Dr. Marc Sabatine. The therapy was safe and well tolerated but neurocognitive events : confusion, delirium and forgetfulness included in this ‘grab bag’ of adverse events occurred in .9% on therapy vs. 0.3% on standard therapy. We look forward to the FOURIER trial in which formal neurocognitive testing will be performed -to be reported in 2017. FOURIER will include primary and much desired HARD endpoints of CV death, MI, hospitalization for Unstable Angina, stroke and revascularization.
  • Eric Peterson to Dr. Michael Gibson: “Congratulations for joining the ranks of those who have studied drugs that work well in animals but not so well in humans”; commenting on the EMBRACE trial. The compound BENDAVIA was studied and it’s effect on Re-perfusion injury on patients treated with standard therapy including primary PCI for STEMI. The study was not powered to detect an impact on reperfusion arrhythmias.
  • Enjoyed hearing Dr. Sabatine's presentation on the OSLER trials at this morning's Late-Breaker Trials session -- especially after interviewing him yesterday about this!

  • Study Interrupted! REG1 novel anticoagulation system in patients undergoing PCI demonstrated a similar incidence of ischemia compared to Bivalirudin but with 1 fatal allergic reaction and 9 other anaphylactic reactions, the study was terminated. Allergic reactions were “An unacceptable and infrequent” occurrence, said Dr. Roxana Mehran. When asked if this system will remain a target for future study, she replied, “This was my first exposure to this compound. It’s extremely effective and it definitely is a target”.
    by Melissa Walton-Shirley MD FACC edited by Tricia Ward, Medscape 3/15/2015 3:57:27 PM
  • Dr. David Newby on CCTA patients with suspected angina: (Prior to the study), "We were doing an awfully lot of unnecessary angiograms. We had a lot of skeptics across Scotland. For me, it's that clarification of the diagnosis. We stopped a lot of statins and anti-anginals. These are treatments that would have been given for life. We need to do the economic evaluation which is a work in progress. There are two issues: Early outcomes that are driven by revascularization and long term outcomes...to see if statins perhaps over a 5-year period of time will make a difference".
  • Now in the press conference for the late-breaking clinical trials, with Dr. Sabatine chatting about the OSLER study. I'm covering the SCOT-HEART study, which is a trial of coronary CT angiography. As Dr. Walton-Shirley stated, the researchers are reporting they improved the certainty of diagnosing angina due to coronary artery disease but also reduced unnecessary interventions, such as coronary angiograms.
  • To prove the below note, here's a pic of Mike O'Riordan in the press conference right now (He's the one at the laptop)

  • Refers to top-floor lounge at the Grand Hyatt, but very close to our mantra.


  • At the press conference, Dr. Sabatine was just asked by our own Dr. Melissa Walton-Shirley re: PCSK9 inhibitors, "If you were a statin, would you be troubled now?" He noted that he doesn't view these as competitors to statins. "I see statins as the foundation. These are just additional tools."
  • There was an important poster contribution today on dofetilide use in women. Researchers from Duke University 129 male and female patients with AF admitted for dofetilide. The patients were well matched and had similar creatinine clearance. Importantly they also had similar baseline QTc intervals.

    But women were more likely to require a dose reduction. (34% v 19%) or have the drug stopped (18% v 8%). Taken together, in this small series, more than half the time, women required dose adjustment or discontinuation. The authors suggested further studies to determine the optimum dosing of dofetilide in women.

    This is very relevant study to routine clinical practice. I see this phenomenon often.

    My take-home messages are three-fold:

    1) Generally, women have less repolarization reserve than men. That warrants pause. 2) Women may metabolize drugs differently than men. 3) Studies that show benefit in studies that included mostly men, may not generalize to women. ‘

    Here is the hyperlink to the poster: http://www.abstractsonline.com/pp8/#!/3658/presentation/31811
  • I am also looking at this oral presentation on surgical LAA appendage closure. A group of researchers from Mayo Clinic did a propensity score matched analysis of patients who had (or did not have) LAA closure at the time of heart surgery.

    They found that surgical closure increased the risk of post-op AF and did not reduce the risk of stroke or MORTALITY in a 5 year follow-up. This study had a lot of patients, long follow-up and the two cohorts were well matched. It was not a randomized trial, confounding is possible, but these results provide context to the recent news about LAA closure.

    Namely, if surgical closure in high-risk group of patients does not reduce the risk of stroke or death, how in the world we expect a percutaneous device to do the same? It speaks to the concept that stroke, like AF and CAD, is a systemic disease—and focal therapies will prove ineffective.

    Let me know your thoughts. I am trying to speak with the author of this study as I type this.

    JMM
  • Now in the Joint Symposium of the Chinese Society of Cardiology and the American College of Cardiology for a presentation on the CSPPT trial on folic acid in the prevention of stroke among adults with hypertension in China by Dr. Huo Yong. The results were simultaneously published in JAMA.
  • Dr. Huo Yong, current president of the Chinese Society of Cardiology during his folic acid presentation

  • Lots of long-term data from PARTNER cohort A and B today, with researcher showing similar results. In the late-breaking clinical trials session, Dr. Michael Mack showed similar mortality and stroke outcomes between TAVR and SAVR at 5 years. Dr. Michael Reardon (no relation, ha!) presented two-year data on the CoreValve, suggesting that TAVR provided sustained and durable results in the long-term when compared with SAVR. Right now, we're seeing data from PARTNER-2 with the new Edwards device, although this is just safety and efficacy out to 30 days. Lots of new information for physicians to digest!
  • I hope to have a couple stories up later today highlighting these new findings. In the meantime, I'm noticing it's pretty sunny outside in San Diego today. That could be distracting!
  • Sunny San Diego, Why Must You Tease Me So!

  • The CSPPT study, which included almost 21,000 adults in China, showed that 10 mg enalapril plus 0.8 mg folic acid reduced the risk of first stroke in those with no prior history of MI vs enalapril alone (its primary outcome). No significant between-group differences in frequency of treatment-related adverse events. Presenter Dr. Huo Yong: "We believe these findings are universal and not only for China populations but also for populations throughout the world, including the United States."
  • Drs Seth Bilazarian and Marc Sabatine preparing for their interviews on PEGASUS and PCSK9 inhibitors

  • Culprit Lesion PCI only vs complete mutlivessel PCI vs staged PCI

    My take home:
    1.  Doing the culprit alone is reasonable in STEMI treated with PPCI
    2.  There is clinical equipoise in our community and specialty about whether complete revascularization is appropriate (the audience was surveyed and half said they would and half said they would not treat a 90% mid RCA lesion after LAD PPCI)
    3. Doing culprit lesion and returning for staged PCI is preferred to culprit only PPCI according to NY State PCI registry
    4.  Choosing wisely and guidelines should be very cautious about using restrictive or prohibiting language for therapies that are not strongly supported by evidence
    5.  Doing complete revasscularizaion is justifiable in shock or in patients with ongoing ischemia after treatment with PPCI.
  • The MitraClip may shine a little brighter, at least in its perceived prowess: Its CMS-mandated postmarket study, presented at a late-breaker today by Dr Paul Sorajja (Minneapolis Heart Institute) found more pronounced mitral valve functional improvement than had been observed in the pre-approval randomized trials. Why? Could be any of a number of factors, he told me, but one possibility: freed of having to comply with study eligibility criteria in the real word experience, operators may have taken on patients with more severe MV impairment in the first place. The worse the valve function initially, often, the greater the improvement with intervention. My story is coming soon.
  • Dr. Seth Bilazarian asks Dr. Marc Sabatine about PEGASUS

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  • "Patients have preferences on their mode of death, if we are brave enough to ask." @drjohnm #ACC15 @SCAINews
  • .@ShelleyWood2 @SCAINews would love to see live case of @drjohnm in exam room doing pre ICD counseling #ACC15
  • #ACC15 @drjohnm "we must consider psychosocial factors as risks" in ICD implant discussions. Shared decision making a must here.
  • Dr John's talk at ACC15 is resonating with the twittersphere. A few selections posted:
  • The NOTION trial looked at the “lowest risk to date” cohort of severe aortic stenosis 70ish year old patients expected to live more than one year post procedure. Patients with severe CAD were excluded. When compared to standard open heart surgery TAVR was safe and effective but not superior to SAVR regarding the composite rate of death from any cause, stroke or MI after 1 year. The gradients were lower with TAVR protheses but there was a highly statistically significant rate of AI in the TAVR group, likely reflecting the low rate of CT guidance utilized to assist implantation. Long term durability and morbidity data are required in lower risk patients.
  • In the “Ulnar Artery Intervention Non-inferiority to radial approach" talk today, Dr. Rajendra Gokhroo” dispelled the myth that ulnar access is inferior to transradial approach. Chalking up the prior poor results to inexperience, he looked at ulnar cannulation performed only by operators who had performed at least 50 ulnar cannulations. CABG and shock patients were excluded . 2400 patients were randomized to ulnar or the radial approach. The primary endpoint was a composite of MACE, major cardiovascular events, hematoma and cross over. The primary endpoint was comparable in both groups with radial cases have a surprisingly but not statistically significant increase in vasospasm. Dr. Gokhroo concluded that “if you have expertise in ulnar cannulation, 75% of femoral artery cannulations can be avoided” and “If both arteries are palpable, I’ll go for ulnar. We are doing all palpable ulnar arteries first at our center”. Very very Interesting.
  • Antonio Columbo - update on bifurcation tips and tricks
    1. If side branch disease is more than 5 mm beyond the ostium don't treat it as bifurcation - put in 2 stents
    2. For sidebranch rewiring avoid hydrophillic wire for recrossing
    3. DK-crush is preferred to culotte because yoou dont have to give up the parent wire
    4. Almost always do post dilation and finish with IVUS with goal of > 7 mm2 final CSA
    5. When crossing to 2 stent strategy from provisional approach use TAP: T and protrusion
    6. In planned 2 stent technique use DK Crush or culotte
    7. Ostial diagonal lesions are particularly challenging - use medical therapy until the patient matures the LAD lesion. The hazard of ostial diagonal lesion treatment alone is significant for LAD compromise. Less is more.
  • Dr. Jung-Min Ahn from South Korea presented the 5-year follow up results from the Pre-COMBAT study. These were Unprotected left main patients comparing PCI to standard surgery. At 1 year, PCI was non-inferior. After two years, ischemic TVR rates were higher in the PCI group at 9% vs. 4.2%. 5-year follow up data demonstrated that only 70% of PCI patients were still on standard anti- platelet therapy. Though the rate of MACCE as well as the rate of death, MI or stroke was not significantly different between patients assigned to PCI with a CYPHER stent compared to those who underwent CABG, there was an increased incidence of ischemia driven TVR of 17% in those with Left Main and 3v vessel disease who underwent a PCI vs. 4% in those who underwent CABG. An audience question: Would newer stent platforms have preformed better? My question: Especially in CYPHER patients if more than 70% had remained on standard anti-platelet therapy, would that have significantly impacted outcomes?
  • Commenting on the GARY Registry, the LARGE high-risk all-comer population of German cohorts of 15,964 TAVR patients Dr. Thomas Walther presented outcomes of a severe vital complication rate plus cross-over rates remaining at 4%, stable sternotomy requirements of 1.2% and decreasing complication rates over the years. At the conclusion of his presentation, he was asked, “Do you plan to go on recording every single procedure?” He replied, “We can’t go on forever capturing every single procedure. It costs some money”. He later added, “We need some more time for valve durability studies”, so I guess that really is a “yes”.
  • Tips for crossing uncrosable lesions by Emmanouil Brilakis
    1.  Make sure wire is in distal main vessel before starting 
    2.  Modify the lesion with 1.25 mm balloon - inflate it until the balloon ruptures =  "grenadoplasty" - this can modify the lesion and permit crossing
    3.  Use a Tornus catheter or Corsair or Fine Cross or Turnpike or Threader to cross
    4.  Use the wire cutting technique (basically inflating with a buddy wire)
    5.  Improve guide support: better guide, e.g. AL1, and upsize to 8 F.  Consider support with Guideliner, Guideliner Navigator  or Guidezilla.  Can also use sidebranch anchor or a distal anchor inflated balloon that will allow the guide to support delivery
    6.  modify the lesion with laser or atherectomy (orbital or rotatonal)
    7.  Use shorter stents or balloons
  • The DAPT data was described today by a commenter as “An amazing study not likely to be duplicated”. This study randomized 11K ACS and non-ACS patients post PCI remaining on thienopyridine therapy for 12 months to now 18 months. While ACS patients had greater risks for ischemic events, the treatment benefit of continuing thienopyridine therapy was beneficial for both and bleeding risks were similar. When Dr. Robert Yeh, the presenter of the DAPT data was asked ‘what is the future?’, he replied, “We have an NIH grant to develop clinical tools to identify a population of patients in whom it’s exceedingly necessary to continue therapy. He also pointed out that the majority who developed adverse events were due to repeat revascularization, oddly enough, not bleeding. There was a numerical imbalance as well with cancer rates that was explained by a cancer diagnosis at the time of randomization.
  • Dr. Susheel Kodali and Dr. Thomas Walther on CoreValve vs. PARTNER

  • Late-Breaking Clinical Trial Session IV features:
    AATAC: Ablation vs. Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted device
    CSTN: Effectiveness of Surgical Ablation of Atrial Fibrillation during Mitral Valve Surgery: A Randomized Clinical Trial from the Cardiothoracic Surgical Trials Network
    LEGACY-AF: Long-Term Effect of Goal Directed Weight Management on an Atrial Fibrillation Cohort: A 5-Year Follow-Up Study
    Everolimus-Eluting Stents versus Bypass Surgery for Multivessel Coronary Artery Disease
    ERRICA: Effect of Remote Ischemic Preconditioning on Clinical Outcomes in Patients Undergoing Coronary Artery Bypass Graft Surgery: A Multi-Center Randomized Controlled Clinical Trial
  • Late-Breaking Clinical Trial Session V features:
    TOTAL: A Randomized Trial Of Routine Aspiration Thrombectomy With Percutaneous Coronary Intervention (PCI) Versus PCI Alone In Patients With St-elevation Myocardial Infarction Undergoing Primary PCI
    MATRIX: Transradial Versus Transfemoral Access In Patients With Acute Coronary Syndromes Undergoing Invasive Management
    MATRIX: Bivalirudin Infusion Compared To Unfractionated Heparin In Patients With Acute Coronary Syndromes Undergoing Invasive Management
    DANAMI:The Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction: PRImary PCI in MULTIvessel Disease
    After Eighty Study: Invasive vs Conservative strategy in NSTEMI patients over 80 years old.
  • Dr Melissa Walton-Shirley loves the idea of evolocumab, but . . . What Should the FDA Do With the PCSK9 Inhibitor Evolocumab?
  • Dr John Mandrola on his wife, Dr Staci Mandrola's ACC presentation 15 Things All Cardiologists Should Know About Palliative Care
  • LEGACY trial of AF and weight loss (BMI > 27) and weight fluctuation
    Published in JACC
    Patients also prescribed 200 minutes of exercise per week
    Patietns did best with weight loss clinic and weight fluctating (yo-yo ing) is also signigicant contributor
  • LEGACY Conclusion slide

  • K-M curve based on degree of weight loss

  • BEST trial of teh ABbot Xience DES vs CABG in multivessel CAD, showed that MACE was higher with PCI 17% vs. 12% CABG at 5 yrs, mostly driven by revascuaization with no signifiant digffenece in death (but trends against PCI.

    >CABG still "best" for MVD esp daibetes
  • Additional commentary from Dr. Rajeev Pathak from the LEGACY trial, "Sustained weight loss is associated with a 'dose-dependent' reduction in AFib and maintenance of sinus rhythm". Interesting that we feel compelled to couch the impact of life style changes on outcomes with pharmaceutical vernacular in order to make practitioners better relate to the results. Gets the point across though!
  • Just heard a wonderful quote about the LEGACY trial: "Next time I see my fat AF patients I'm putting them on a weight-loss program."
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