Melissa Walton-Shirley, MD

Disclosures

March 17, 2017

Day 1 at the American College of Cardiology (ACC) 2017 Scientific Sessions started at 5:30 am with a cup of coffee and a sleepy walk toward the shower. We had been warned that the good seats at the opening session would be taken by 7:30 am. Thankfully, the brisk walk in 28°F weather in downtown Washington, DC was pleasant enough, thanks to the company of Patrice, one of our crackerjack heartwire from Medscape journalists. That forecast about the potential lack of seats did indeed come true and was driven mostly by the much-anticipated FOURIER trial presentation. I've never seen "seat monitors" before at a late breaker. They made absolutely certain that only panelists were sitting in reserved seats. The hoopla was a bit over the top, in my opinion. In the medical meeting world, "hoopla" is usually a surrogate marker for an anticipated major economic impact somewhere in the mix of molecules and procedures to be discussed. Despite all the commotion, the morning was interesting and the information helpful. When I return to my practice in Gallatin, TN, here are a few things I can tell my patients about this morning's presentations:

FOURIER[1]
  • The 2% reduction in cardiovascular death, MI, or stroke benefit with evolocumab (Repatha, Amgen) for LDL lowering is so far less than exciting, but it looks like the longer the patients were on it, the better the data looked.

  • I do think you will be interested in signing up for a drug that produced fewer heart attacks and fewer strokes, provided you fit the mold for these trial participants (prior stroke, heart attack, or peripheral vascular disease with resistant LDL elevation, already taking a statin).

  • I think you will probably stick with the injections (once or twice monthly) because nearly all study patients stayed on the drug.

  • If you are just statin intolerant, perhaps due to muscle aching or you have a history of liver issues, I really can't project how much this medication will help you. These trial participants were on statin therapy, and this drug was an add-on to help them get their bad cholesterol to ultralow levels.

  • The medication is safe at least for up to 2 years of use based on this trial and up to 4 years in other trials. There were no reported significant allergic reactions or side effects other than minor injection-site irritation in a minority of patients. I have no fear about giving it to you other than the possibility that your insurance company may take out a hit on me.

  • Your insurance company will drive me crazy with denials, faxes, phone calls, forms, and rejections if you decide to take it.

  • Your chances of getting it approved in my practice experience thus far is about 20%, and I fought for every single patient.

  • I kind of understand the insurance companies not wanting to pay $14,000 per year for your drug, but I also think the cost analysis in the next year or so will be favorable. Our chances for approval will be better then. You need to eat the Mediterranean diet and exercise. Multiple trials have shown benefit in lifestyle modification.

  • I will explain my musing at what could have probably been the mortality reduction if lifestyle change had been added as another arm of the trial alongside placebo. I will boast that it probably would have been at the least noninferior if not superior and absolutely would be cheaper.

  • Make no mistake here; the company that developed this molecule is the winner. The insurance companies thus far are the losers, and many patients are left somewhere in the middle.

  • I'll feel a lot better about the long-term efficacy when those data are available; meanwhile it won't hurt you to try this drug. If you do, your cholesterol levels will definitely yield.

SURTAVI[2]
  • I know you are 80 and your aortic-valve leaflets are thick and rusted. Blood can't escape your heart to supply the rest of your body because of this logjam. If you like the idea of not being so short of air due to fluid filling your lungs, perhaps fainting less, and looking forward to less chest pain, I can offer you traditional surgery at a very low mortality of less than 2% or you can have a valve implant without opening your chest.

  • The death rate is about the same with either the traditional surgical or the percutaneous (through the leg or subclavian) approach.

  • If you get a first-generation CoreValve (Medtronic) your chances of needing a pacemaker are higher by 26% compared with the downside of opening your chest and prolonging your hospital stay and recovery.

  • Not opening your chest will lead to less atrial fibrillation than a traditional valve-replacement approach. Afib is a hassle of a heart rhythm to deal with.

  • You asked me what I would do if I were you? At age 56, I'd get a bioprosthetic valve and buy shirts with a higher neckline. At age 80, I'd get a TAVR but I'd ask for a Sapien (Edwards Lifesciences), at least until they get a handle on the pacer-implant thing.

  • Don't get me wrong, if I needed a pacer, I'd be the first to sign up, but I don't want it (or any drug, device, or procedure) if I don't really need it. If my lungs are filling with fluid from a tight aortic valve at age 80, I'm going to die sooner than later, so I'd go for it.

  • My dad has had a TAVR and has a Mitraclip, so I don't make these recommendations lightly.

SPIRE

No need to really discuss SPIRE at any office visit.[3,4] It might be the kind of thing I'd talk about if the person lying next to me at poolside happened to be a physician or researcher, say, 20 years from now if I live long enough to retire. It was a great failed trial, chock full of information on how not to develop a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor for cholesterol lowering. It worked for a while, but 3% mouse parts caused patients to build antibodies, and it stopped working. Just another reason to not like mice, but also another reason to respect researchers like Dr Paul Ridker.

So that's my wrap on ACC 2017's morning sessions. It was a lot to think about. I'm still thinking…

Editor's Note: An earlier version of this commentary incorrectly stated that there was a 2% reduction in mortality with evolocumab. No mortality benefit was reported.

 

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