Once hailed as a breakthrough in the care of angina, stents are in the crosshairs of skeptics. Two cardiologists sort through the controversy.
Earlier this year, the Clinical Outcomes
Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial showed that patients with stable angina treated with medication alone did just as well long-term as those who got stents (N Engl J Med. 2007;356:1572-1574). And even when stent use is less debatable, treatment course still is not always clear: A number of other studies have found that drug-eluting stents (DES)—long-touted as an improvement over the bare-metal version—put patients at risk for late stent thrombosis.
Your patients with heart disease are counting on you to help them decide whether to undergo percutaneous coronary intervention (PCI) and, if they do get stents, to help them with post-placement medication management and ongoing monitoring. To find out how primary-care practitioners (PCPs) can put the new data in perspective, Nelly Edmondson Gupta spoke with Steven Nissen, MD, chairman of the department of cardiovascular medicine at Cleveland Clinic, and George W. Vetrovec, MD, professor of medicine and chairman of the division of cardiology at the Pauley Heart Center at Virginia Commonwealth University Medical Center in Richmond. Here’s what they said.
Q: What kind of patient triggers the stent/medical-therapy-only debate?Dr. Nissen: Patients with stable angina, no coronary syndromes, and fewer than 7-10 angina episodes per week.
Dr. Vetrovec: Those who experience exertional chest pain that goes away with rest. In these patients, the questions then become: Are you better off putting in a stent, or is it okay to treat with just medication? Which method will treat chest pain more effectively, and does one treatment have a survival and outcome advantage over the other?
Q: Which patients are considered good candidates for stenting? Which are not?
Dr. Nissen: Patients who cannot tolerate their angina and whose quality of life is significantly impaired by it are good candidates for stenting. Good candidates for medical therapy, on the other hand, are patients with relatively mild angina who are willing to give medication a try to see if it will control their symptoms.
Dr. Vetrovec: Good stent candidates are patients whose angina is stable but whose symptoms are not easily controlled with medication. These patients also have to have satisfactory anatomy to put in a stent. That means relatively focal disease and reasonable-sized arteries. If there are multiple blockages, patients may do better with bypass surgery. And stents cannot be placed in extremely tiny arteries.
Q: Is the stent/medical-therapy dispute really a turf battle between interventional and noninterventional cardiologists?
Dr. Nissen: No, I think it’s about where the science takes us. When you have a study that compares two treatments, the discussion is about what the evidence shows. As far as I’m concerned, turf has nothing to do with it.
Dr. Vetrovec: I think it’s a philosophical issue. People who put in stents believe in them; people who use medication alone believe in that.
Q: What should PCPs take away from the COURAGE trial?
Dr. Nissen: That if they and their patients with heart disease want to try medical therapy for mild-to-moderate angina, clinicians can do so without putting those patients at particularly increased risk.
Dr. Vetrovec: That in angina patients who do not have severe disease and whose symptoms are easily controlled, medication alone is satisfactory. Remember, though, that this is a very specific group of patients; physicians must be sure a patient is not at high risk of MI. Also, if symptoms are incompletely controlled with medication, patients should be referred to a cardiologist for evaluation. The bottom line is, medications aren’t bad, but in many circumstances, intervention with a stent improves quality of life.
Q: What issues/limitations should PCPs look for in the COURAGE trial results?
Dr. Nissen: The investigators had a significant crossover rate; a substantial number of patients who started down the road of medical therapy had to shift gears and undergo PCI with a stent.
Q: In light of recent events, what should PCPs tell patients who ask about the safety and efficacy of DES?
Dr. Nissen: They should say there is concern about the risk of late stent thrombosis with DES and that patients with DES have to be very careful about staying on their antiplatelet therapy—usually aspirin and clopidogrel (Plavix)—for 12 months or face the risk of serious complications.
Dr. Vetrovec: The safety of DES is still being evaluated. In patients who fulfill the criteria of the original U.S. studies—low-risk patients with defined disease—it looks like there’s a 0.5 percentage point increase in stent thrombosis over time. In most cases, this does not seem to translate into an increased risk of death or MI, although in patients with multiple stents or very complex anatomy, this is still unclear. Additionally, once patients get a DES, they need to tell their PCP if they are going to have noncardiac surgery so they can be counseled on how to stop medication to minimize excessive bleeds and other risks.
Q: What should PCPs tell patients to expect from stenting? What should they tell them not to expect?
Dr. Nissen: Most people who get stents will become angina-free, but they will not necessarily live any longer, nor will they be protected from having an MI. PCPs should also tell patients that while angina relief may not be quite as good with medical therapy as it is with a stent, stents are not a slam dunk for better symptom relief. At one year follow-up, differences between the two groups were quite small.
Dr. Vetrovec: Patients with stable angina should expect an improvement in terms of symptoms and should be able to take fewer medications. Patients with unstable angina or acute MI can expect better outcomes overall.
Q: Do the new data on stents require PCPs to make any changes in how they evaluate and treat heart disease patients?
Dr. Nissen: I think PCPs should be very careful in determining which patients to refer to cardiologists. Referral should take place when patients have an unacceptable level of angina, and that’s in the eye of the beholder. The patient should be the one who determines what is and isn’t an acceptable level of angina.
Dr. Vetrovec: I don’t think so. When PCPs see a new patient with angina, they need to confirm the diagnosis and gauge the severity of CAD with a stress test. A patient who has excellent exercise performance and good heart function can be considered for medical therapy. If high-risk features become apparent on a stress test, the patient should be evaluated for more interventional treatment by a cardiologist. The benefit of stents is that they improve symptoms. If you can control a patient’s symptoms with medication alone, you don’t necessarily need a stent. However, if medication controls the patient’s symptoms but has side effects, he may still be better off with a stent.Another issue has to do with using multiple medications. Patients in the COURAGE trial were taking a lot of drugs, some of which they needed whether they got stents or not. Many patients have an aversion to taking 8-10 medications each day; one thing a stent does is reduce the number of medications a patient must take.
Q: Once a patient has been referred to a cardiologist, what level of follow-up is the PCP responsible for?
Dr. Nissen: There are no specific recommendations for routine patient follow-up after stent placement over and above what the clinician has been doing in the way of routine health maintenance.
Dr. Vetrovec: A study done some years ago showed that patients who see a PCP and a cardiologist do best after MI because there’s greater emphasis on taking medications regularly and on making lifestyle changes—so it’s a double whammy in terms of reminding people to take care of themselves. PCPs and cardiologists need to have a good working relationship. Some PCPs hope patients will be followed by the cardiologist forever; others want to see the patients regularly themselves and refer them back to cardiologists only if there are specific problems. Whichever way it is handled, though, somebody must ensure the right things are done for the patient.
Q: What signs indicate to a PCP that a patient needs to see his cardiologist again?
Dr. Nissen: If the patient has recurrent chest pain or is just not doing well.
Dr. Vetrovec: Symptoms of new or recurrent trouble, such as increased swelling in or around the groin site, chest pain, or shortness of breath.