Tens of thousands of patients with serious but stable heart disease soon may see themselves treated more with prescription drugs and less with rushed surgeries, especially bypass procedures or operations that seek to open clogged blood vessels with wire cages called stents.
A possible shift away from stents — which have come under question for some time now — may be accelerated by the just-announced findings of a $100 million, multi-year study of more than 5,000 heart patients at 320 sites and in 37 countries. The research, the New York Times reported, sought to provide rigorous and more incontrovertible evidence on procedures that now are a bulwark of heart care:
“[The study dubbed] Ischemia is the largest trial to address the effect of opening blocked arteries in non-emergency situations and the first to include today’s powerful drug regimens, which doctors refer to as medical therapy. All the patients had moderate to severe blockages in coronary arteries. Most had some history of chest pain, although one in three had no chest pain in the month before enrollment in the study. One in five experienced chest pain at least once a week. All participants were regularly counseled to adhere to medical therapy. Depending on the patient’s condition, the therapy variously included high doses of statins and other cholesterol-lowering drugs, blood pressure medications, aspirin and, for those with heart damage, a drug to slow the heart rate. Those who got stents also took powerful anti-clotting drugs for six months to a year. Patients were randomly assigned to have medical therapy alone or an intervention and medical therapy. Of those in the intervention group, three-quarters received stents; the others received bypass surgery. The number of deaths among those who had stents or bypass was 145, compared to 144 among the patients who received medication alone. The number of patients who had heart attacks was 276 in the stent and bypass group, compared with 314 in the medication group, an insignificant difference.”
As the Washington Post reported of this study and the hotly contested issue of drugs vs. surgery:
“Ischemia found no difference in a constellation of major heart-disease outcomes, including cardiac death, heart attacks, heart-related hospitalizations and resuscitation after cardiac arrest. There was no benefit to an invasive strategy in people without chest pain. Overall, the keenly anticipated … study results suggest that invasive procedures, stents and bypass surgery, should be used more sparingly in patients with stable heart disease and the decision to use them should be less rushed, experts said.”
Don’t, however, expect heart specialists (aka interventional cardiologists) to let go quickly or easily of what has become a huge part of the treatment of their patients, the Washington Post noted:
“Coronary heart disease affects 17.6 million Americans; companies that make stents are multibillion-dollar enterprises; the procedures are a major income stream to interventional cardiologists and hospitals; and many people who have stents credit their good health to the procedure … [Still,] about 500,000 heart stent procedures are performed each year in the United States, and the researchers estimate that about a fifth of those are for people with stable heart disease. Of those, about a quarter — or an estimated 23,000 procedures — are for people without any chest pain. If just those procedures are avoided, researchers estimated, it could save about $570 million each year. But the researchers think that is a conservative estimate, and that as doctors and patients discuss options, even more procedures might be delayed or skipped depending on each patient’s circumstances, preferences and activity level.”
To be sure, researchers — who presented their findings at a major medical conference over the weekend — said that stent and bypass procedures make sense in specific circumstances, including if patients are suffering heart attacks. Specialists now also may need to counsel patients with more care and detail about options, discussing, for example, how patients with severe chest pain (angina) may get more immediate relief from surgery than medications and lifestyle changes, including exercise. That may not matter to a mostly sedentary senior. But younger and active patients might opt more readily for a pain-relieving operation, rather than taking drugs that might take longer and still resolve less the throbbing in their chests they experience when exerting themselves.
Results of the federally funded heart study will be published soon, but the researchers have been under fire for some time already over their methodologies, as the Washington Post reported:
“There was a slight shift in the two groups’ experience of a composite of five disease-related events over the course of the trial: In the first year, people who received an invasive strategy were at slightly higher risk of heart attacks than those on medicine alone. By the end of the trial at four years, they were at a slightly lower risk of heart attacks. The researchers found that this did not lead to a significant difference between the overall rates of clinical events between the two groups, but [experts said] … this decreased risk [may be] an important and significant result. The Ischemia investigators hope to follow the patients for another five years.”
Earlier studies of stents vs. drugs failed to sway practices, partly because doctors criticized them for failing to control for risk factors, the New York Times reported. The Washington Post quoted heart surgeons who found the Ischemia study results unsurprising. That’s because they said colleagues already had evolved treatment as they gained more experience with stenting and bypasses. Those procedures are not done without clear reasons they will be beneficial, the surgeons argued, adding that techniques also have advanced. Stents, in particular, now can be implanted without opening the chest and in minimally invasive fashion, snaking a long tube or catheter through a vein in the groin and then up to the heart area.
Stenting, by the way, costs an average of $25,000 per patient, while bypass surgery costs an average of $45,000 in the United States, the New York Times reported.
In my practice, I see the harms that patients suffer while seeking medical services, notably the injuries inflicted on them in therapies or procedures performed too readily and almost as a routine. All medical procedures come with risks. Surgery — no matter how a given operation has become standard practice — should be considered and carried out with great care.
Patients always should be given their fundamental right to informed consent. This means they are told clearly and fully all the important facts they need to make an intelligent decision about what treatments to have, where to get them, and from whom. This also requires that doctors and specialists stay up to date in their field, and as excellent practitioners do, that they pursue and apply in relentless fashion what the best, current, and rigorous evidence says benefits their patients most.
The Ischemia study may suggest that heart specialists may have gotten fixed on a treatment path, even as facts built up to urge them to reconsider — as they need to. John Spertus, a cardiologist at St. Luke’s Mid America Heart Institute and one of the study leaders, told the Washington Post:
“[Doctors] have very strong emotional beliefs, and they’ve been practicing in a way that sends these patients straight to the cath lab for [stents or bypass procedures for] generations, and that’s not going to change overnight. I think it’s incredibly important [to do so] in this era where we’re trying to improve the value of health care, improve patients’ outcomes at a lower cost.'”
For patients, it’s caveat emptor. We’ve got a lot of work to do to ensure that heart care produces optimum outcomes, and that it does so, with rigorous, evidence-based treatment.