In regards to your February 11, 2010 article in The Wall Street Journal “A Simple Health-Care Fix Fizzles Out” by Keith Winstein, I would like to add a few comments and perhaps an explanation why, in my opinion, studies such as the COURAGE trial have had little or no effect on the way Coronary Artery Disease (CAD) is treated: COURAGE is only one of a number of publications that have provided proof of equal or better outcomes with alternate treatments than stenting (Percutaneous Coronary Interventions or PCI).
Some of these include:
- Optimal Medical Therapy[i]
- The Syntax Trial[ii]
- The BARI-2D trial[iii]
- The Occluded Artery Trial (OAT)[iv]
- Survival of Diabetics[v]
As you discussed in your article, neither the COURAGE trial, nor these other studies have had any effect on reducing the number of stent procedures, or for that matter, in reducing health care costs in the US. I would like to add the following explanations:
- Angiography, the injection of dye into the coronary arteries to visualize blockages, is the gold-standard to diagnose coronary artery blockages, and is performed by the same practitioners who place stents;
- Almost invariably, stents are placed during diagnostic angiography. This means that different options are often not discussed before an irreversible intervention is done, even though the majority of procedures are performed in stable patients who should thus be able to participate in that decision;
- The long-term consequences of stenting, such as occlusion, thrombosis, deterioration of heart function, as well as a host of other complications are usually minimized when presented to a patient;
- Alternatives which have been shown to actually improve mortality, such as medical therapy and risk factor reduction[vi] or, for more serious disease, coronary artery bypass surgery, are often not presented as excellent or even superior options to patients with coronary artery disease[vii]
- Angiography referrals come from another “non-invasive” cardiologist, most often a partner of those who will perform the procedure. Thus, a physician who refers a patient for coronary angiography benefits financially if stent placement becomes part of the procedure;
- The financial benefits increase with the number of stents placed, whether or not additional blockages are causing any symptoms;
- With the stent industry generating $15B/year in revenues, there is an enormous incentive to ignore other options and to continue pushing this procedure over any other. This is supported by for-profit research[viii], with the major contributors to recent literature invariably on the pay role of the sponsoring company. It is no accident that the American College of Cardiologist’s PAC recently sponsored an invasive cardiologist to run for office in Congress[ix]
There is no doubt that the use of PCI, like CABG, is an important weapon in the arsenal of treatments for CAD. However, aside from the cost to society, it is unethical for a physician to offer anything but optimal treatment for a disease that claimed over 600,000 deaths in 2007[x], or to expect a personal benefit from a referral to another physician. In the fight against Coronary Artery Disease optimal medical therapy and behavior modification are often neglected in favor of PCI that no matter how successful (even if used appropriately) does not improve long term survival. The disease process of atherosclerosis that causes obstructions in arteries can only be controlled by other measures. Sadly, there is little incentive to those most involved in the treatment of CAD to modify their behavior,
Joan F. Tryzelaar, M.D. South Portland, Maine
Cc: Keith J. Winstein
[i] Optimal Medical Therapy With or Without Percutaneous Coronary Intervention in Older Patients With Stable Coronary Disease A Pre-Specified Subset Analysis of the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation) Trial; Koon K. Teo et al. JACC; 54:1303-1308: OMT is as effective in stable CAD patients age >65 years as in patients age <65 years, and PCI, when added to OMT, does not reduce clinical events or improve angina relief during long-term follow-up. … it nonetheless appears difficult to justify PCI as an initial treatment strategy in the majority of older patients with stable CAD…
[ii] The Syntax Trial: Percutaneous Coronary Intervention versus Coronary-Artery Bypass Grafting for Severe Coronary Artery Disease, Serruys P et al. N Engl J Med2009; 360:961-972. Currently available data emphasize the fact that CABG remains an excellent and often superior long-term form of revascularization in some selected groups of patients with two-vessel diseases and most groups of patients with three-vessels CAD.
[iii] The BARI-2D trial: The Impact of Different Treatment Strategies on Cardiac Death and MI Rates in Patients with Type 2 Diabetes and Stable Coronary Disease, N Engl J Med2009; 360:2503- 2515. Patients with Type2 Diabetes and stable ischemic CAD, similar to those enrolled in the PCI stratum, an initial strategy of Intense Medical Therapy should be considered, and does not require immediate PCI to prevent cardiac death or MI, when angina symptoms are controlled In patients with more extensive coronary disease, similar to those enrolled in the CABG stratum, a strategy of prompt CABG, IMT and IS therapy should be considered the preferred strategy to reduce the incidence of spontaneous MI.
[iv] The Occluded Artery Trial (OAT): Coronary Intervention for Persistent Occlusion after Myocardial Infarction, Judith S. Hochman et al. N Engl J Med2006; 355: 2395- 2407: PCI did not reduce the occurrence of death, re-infarction, or heart failure, and there was a trend toward excess re-infarction during 4 years of follow-up in stable patients with occlusion of the infarct-related artery 3 to 28 days after myocardial infarction.
[v] Survival of patients with diabetes and multivessel coronary artery disease after surgical or percutaneous coronary revascularization: results of a large regional prospective study. Niles NW et al. of the Northern New England Cardiovascular Disease Study Group, J Am Coll Cardiol 2001;37:1008–1015. … Published the results of survival of patients with diabetes and MVD after surgical or percutaneous coronary revascularization. Their results showed that in 2766 risk matched diabetics PCI increased five-year mortality by 1.5–3.9 times.
[vi] COURAGE Under Fire: On the Management of Stable Coronary Disease, George A. Diamond, and Sanjay Kaul, J. Am. Coll. Cardiol. 2007;50;1604-1609 … While the actual numbers are open to debate, the simple fact is that many patients with stable angina (and an additional number of asymptomatic patients) are undergoing PCI without having received sufficient medical therapy.
[vii] CABG has the reputation of being a dangerous, painful and expensive alternative to PCI and has long stopped being offered as the best long term solution for a devastating disease, often even when available evidence supports CABG as the optimal choice;
[viii] “For Profit Research” with investigators receiving consulting fees from the sponsor (not much progress since 2001):
- Medical Journal Editors Demand Accountability from Study Authors, Sponsors, AJHP, 11/1/2001:
“…clinical studies are increasingly conducted with the goal of marketing products …”
- New “principles” on authorship and COI, Heartwire, October 2, 2009:
…”mounting scrutiny and protests over how clinical trials are conducted and reported…” A Sample of research trials with investigators and research financed by Product manufacturers:
|Executive & COMPARE||Abbott Vascular|
|ENDEAVOR II||Medtronic Vascular|
[ix] ACC backs cardiologist for Congress, tests political clout at pivotal time for US healthcare February 14, 2010, Steve Stiles, The Heart.org.
[x] Heart Disease:
- CAD: leading cause of death in the United States in both men and women.
Number of non-institutionalized adults over 18 with diagnosed heart disease: 25.1 million Number of deaths: 631,636 (Summary Health Statistics for U.S. Adults: National Health Interview Survey, 2007)