2017 National Lipid Association ePoster

A Practical Office-Based Cholesterol Management System: A Ten-Year User Experience - From Closing the Treatment Gap to “Turning Off the Faucet Instead of Just Mopping the Floor”.

2017 NLA EPOSTER

These are the five main slides.


These are the six embedded slides.


Answers to the questions others have asked.

About our cholesterol treatment guidelines.  Cholesterol treatment guidelines are moving targets. The NCEP ATP III was launched in 2001 and a year later, it was already out-of-date when Heart Protection Study showed additional benefits in lowering LDL-c to less than 70 mg/dL. 

Statin Trials and Clinical Outcomes

I was practicing traditional non-invasive cardiology in a busy private practice from 1979 to 2001. Many hundreds of patients had CABGS and later, many hundreds had angioplasty/stenting. Many established CHD patients were caught in a revolving door of recurring events leading up to chronic heart failure and/or premature death despite the number of interventions. The future of cardiovascular disease management can’t be more of the same interventions. I want to take a more proactive rather than a reactive approach after the fact. That was how my journey to prevention began. 

My practice used NCEP ATP III as the minimum standard of care - we can’t do less but we can do more and in most cases we did. We expanded the intermediate risk group from 10% to 20%, to 6% to 20%.  We tried to tease out patients within this group who were, in fact, high risk, not intermediate risk. Risk status was upgraded selectively using coronary calcium scoring, hs-CRP, strong family history of premature CHD, chronic heavy smoking, uncontrolled hypertension, etc.

About our early use of ezetimibe. I started using ezetimibe as soon as it became available in 2003. I used it in combination with statin and on average, achieve an additional 20% LDL-c reduction. That beats doubling statin dose with a 6% additional LDL-c lowering. Also beats triple statin titration.

POSCH Surgical Trial-2

POSCH Trial reduced LDL-c by 38% after ileal bypass surgery. The slide above showed that POSCH patients had CHD event reductions in line with statins. The lack of superiority of statins over ileal bypass did not support direct pleiotropic effects of statins. 

The need to address residual risk in high risk patients, the evidence supporting that lower LDL-c is better and that very low LDL-c has no harmful effects, that plaque stabilization and regression are achievable within a relative short period of time, the strong desire to further improve patient outcomes lead me to use statin+ezetimibe combination therapy a decade before IMPROVE-IT and I am glad I did. This use of combination therapy facilitated the closing of the treatment gap by 2006 and “turning off the faucet instead of just mopping the floor” approach. The addition of ezetimibe to statin therapy made possible reaching low LDL-c levels far lower than was possible even with maximum statin dose alone. 

By 2006 when we published our first performance data, 31% of our high risk patients were on statin+ezetimibe combination. 85% reached LDL-c <100 mg/dl and 32% had LDL-c <70 mg/dL and 5.6% had LDL-c <50 mg/dL. 

When Lipitor became available in generic, some patients on simvastatin were switched. When Crestor became generic, even more patients previously on simvastatin and atorvastatin were switched to rosuvastatin. 

By 2017, 89% of high risk patients reached LDL-c <100 mg/dL; 51% reached LDL-c <70 mg/dL and 16% reached LDL-c < 50 mg/dL. 28% were on statin-ezetimibe combination therapy. Rosuvastatin and atorvastatin were the most frequently used statins, followed by simvastatin and Livalo (pitavastatin). Very few on pravastatin. One on lovastatin and none on fluvastatin. 

About 2013 ACC/AHA cholesterol treatment guidelines. Cholesterol treatment guidelines are moving targets and while they tend to move forward, the 2013 ACC/AHA guidelines moved two steps backward. These ACC/AHA guidelines, if they were in place during the COURAGE Trial, the conclusions would have been just the opposite and we will still be in the dark ages of  accelerating and unnecessary stent placement. The 2013 ACC/AHA guidelines recommended fixed statin dosing, forsake the longstanding treatment principle of proportionality of intensity of treatment to the level of risk, did not recommend treating residual risk, the use of statin+ezetimibe combination therapy and the use of PSCK9 inhibitors in selected high risk patient population.

COURAGE Trial conclusions
Titration not Fixed Statin Dosing

COURAGE trial enrolled patients with severe obstructive CHD, majority had severe multi-vessel disease. The mean baseline LDL-c showed that many of these patients were suboptimally treated with LDL-c of 100 mg/dL and higher. With statin titration and combination therapy, by year 5, mean LDL-c was 71 mg/dL and 72 mg/dL in the two groups. In a large multi-center study with 2,287 patients, reaching a mean LDL-c in that range was a remarkable feat and it was a pivotal moment for both interventional therapy and optimal medical therapy. The previously accelerating deployment of more and more stents not only decelerated and stopped but reversed while optimal lipid therapy took a more central role.

In 2017, the American Academy of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) abandoned the 2013 ACC/AHA Guidelines. Their own guidelines recommend LDL-c goals of <55 mg/dL, <70 mg/dL, <100 mg/dL and <130 mg/dL for individuals at extreme, very high, high/moderate, and low risk for cardiovascular events respectively, citing evidence that lowering LDL-c levels, regardless of the starting point, is beneficial.

About maintaining high compliance with statin therapy.

Patient Mentoring1

Right from the beginning - once you determined that the patient is at high risk and before you write a prescription for a statin, start patient mentoring. The best person to educate your patient is the one he/she trusts the most - you. Answer all your patient’s questions clearly and fully. Our website has a collection of slides that I use regularly for practically every questions my patients ask me. Here is an example with patient Jim.  

About clinical inertia and outpatient medical errors.

"Clinical inertia is defined as lack of treatment intensification in a patient not at evidence-based goals for care. Clinical inertia related to the management of lipid disorders, hypertension and diabetes may contribute up to 80% of heart attacks and strokes. Clinical inertia is a leading cause of potentially preventable adverse events, disability, death, and excess medical care cost. It fits the the definition of medical errors given by the Institute of Medicine.”

Potential Reduction in CVD

When I first saw the above findings of Simon, et al in 2009, I was surprised at its magnitude (stroke deaths not even included) and that nothing was being done to solve it. 

The Million Hearts Initiative Grand Round

That is changing. In 2012, the Million Hearts Initiative was launched. In 2017, a new solution is being tested - the Million Hearts CV Risk Reduction Model. What next?

Another potential solution is acknowledging that clinical inertia in high risk patients as outpatient medical errors and create incentives to make preventive cardiology-lipid clinic practices (as affiliated heart attack and stroke prevention centers) more widely available. Atherosclerosis causing plaque rupture is like the goose that lays the golden eggs for the cardiovascular industry. Effective generic drugs are widely available that stop the goose from laying eggs are underutilized. Let us be honest and admit that a large cardiovascular industry has grown and prospered catering to now largely preventable events and this presents a significant obstacle that can be and must be overcome. 

About starting a preventive cardiology-clinical lipidology practice. That depends in your particular situation. If you are self-employed and you get personal and professional satisfaction knowing that by preventing heart attack, stroke, hospitalization, stent and heart bypass, you made your patient’s life better in many way, then you should strongly consider pursuing it. If you are a member of an independent ACO that will reward you financially based on a percentage of the cost savings from "closing the treatment gap and turning off the faucet instead of just mopping the floor”, you should also strongly consider it.

If your are working for an employer that assigns a $RVU value to you solely based on the direct and indirect revenues attributable to you, then “closing the treatment gap and turning off the faucet instead of just mopping the floor” while good for your patients, is not good for your employer’s business under the current payment model.

About our PaKS approach and ACCEPT system. These are what made our performance possible. PaKS stands for the three essential requirements: Passion, Knowledge, System. Passion means that you must really want to save and improve the lives of your patients. Devastating but preventable illnesses can have serious economic impact on the lives of your patients and their families - good health can lift people from poverty while poor health can sink them into poverty. Knowledge means a good working knowledge of basic lipidology. Being a member of the NLA is a must. System means a numerically goal-oriented clinical management system. The system is called ACCEPT - A Cholesterol Clinic in Every Medical Practice. It will take many dedicated and trained medical practitioners to prevent heart attack and stroke in over 60 million high risk Americans during their lifetime.

If there is enough interest, a half-day small group workshop can be make available in the future. 

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