Chris’ Corner: Why Don’t We Follow the Guidelines?
For me, a seminal moment in the field of quality and outcomes was Gregg Fonarow's publication in 2001 in Circulation from the National Registry of Myocardial Infarction 3 (NRMI) database of nearly 1,500 hospitals across the U.S., where he reported that only 31.7 percent of MI patients were discharged on lipid-lowering therapy. This number stood out as a frightening statement on how haphazard medical treatment can be: we have effective therapies, but we don’t use them.
Gregg has devoted much of his career to developing the whole field of quality, which involves collecting data in registries on what current practice is (i.e., how many patients are treated with aspirin, beta-blockers, statins, etc.) and trying to improve care. He had actually started this work a decade before when, at his own hospital, he developed the Cardiac Hospital Atherosclerosis Management Program (CHAMP) program that monitored practice performance in 1992-93 and led to the implementation of critical pathways and discharge order sheets to improve compliance with guideline recommendations in 1994-95. The results were striking: statin uses increased from just 6 to 86 percent; aspirin use jumped from 68 to 92 percent; beta-blocker use improved from 12 to 64percent.
This single-hospital effort became the basis for the national Get With the Guidelines (GWTG) program. Hundreds of hospitals participated in the same effort of monitoring how guideline therapies were being used and then trying to implement locally some quality improvement efforts. Over time the hospitals were successful with improvements to nearly 90 percent use of these basic treatments. Monitoring of these metrics by the government (with public reporting of the rates on www.hospitalcompare.hhs.gov) was another factor that helped hospitals improve on the use of aspirin, beta-blockers, early reperfusion, and a few other metrics.
The better use of guideline-recommended therapies, notably statins, has been cited as one of the main reasons to explain the falling mortality from cardiovascular disease in the U.S. and around the world. As such, this process is a huge success story for modern medicine.
One downside: this effort seems limited to a small number of very basic treatments. Of course we should treat our patients with aspirin, beta-blockers and statins. But shouldn't we also monitor the use of additional therapies? For example, P2Y12 inhibitors (clopidogrel, prasugrel and ticagrelor) have led to big improvements in outcomes—shouldn't they be included?
A new case in point for how we still don't follow the guidelines was just published (Conflict of Interest Alert: I am a co-author) in JACC, and was presented by Andrew Rassi, MD, at the American Heart Association's (AHA) Quality of Care and Outcomes Research meeting this past April, and again at a special session at the AHA Scientific Sessions this month. This analysis of the GWTG data looked at the use of aldosterone antagonists in post-MI patients from 219 hospitals between 2006 and 2009, where 11,255 were eligible for aldosterone antagonist therapy (i.e., had reduced ejection fraction [<40 percent] and evidence of heart failure or diabetes, and no renal dysfunction or other contraindications). Guess what percentage was treated with aldosterone inhibitors? Only 9 percent! Isn't that just amazing?! We had to double-check three times to make sure it was really that bad. Over time there was this improvement: in 2009 the use increased to 13.4 percent, more than double the from 6 percent rate at baseline. However, it should be seven times that high!
The ACC/AHA STEMI guidelines included these agents as Class I, Level of Evidence A recommendation back in 2004, based on results from the EPHESUS trial that showed a mortality benefit with the addition of eplerenone seen at two years, but also after just 30 days. Yet, even five years after the publication of these guidelines, we were only up to 13 percent use. How could this be? Well, consider that this is not one of the metrics that is publicly reported. Thus, nothing public that would make hospitals scramble to get a good report card. There have also been reports of hyperkalemia in clinical use—a real safety component of therapy and ACE inhibitors—that we have overcome.
Interestingly, this is a class of drugs with very little promotion by the pharmaceutical industry. The makers of eplerenone tried to market it initially, but (the few) doctors who prescribed an agent in this class would often use the generic agent spironolactone. With low sales for eplerenone, marketing efforts by the company were limited. Thus, this agent is a case of what happens when we doctors are left to our own devices.
Clopidogrel, on the other hand, had extensive marketing of all types, and compliance with guidelines is much better. It has been assumed that the "influence" of pharma on prescribing is bad, but I wonder if raising awareness of new effective therapies could actually be good.
Well, my hope is that this latest example, which has similarities to the original work on statins post-MI, will spur awareness and make us all take another look at the use of this class of agents for our patients with post-MI LV dysfunction, or those with HF of any type where they are effective as well. Hopefully we can make forward progress and "get with the guidelines."
Christopher P. Cannon, MD, FACC, is a professor of medicine at Harvard Medical School in Boston, Massachusetts. He is also the editor-in-chief of CardioSource Science and Quality.
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