Statin Use Can Stop When Illness Is Terminal, Study Reports

Patients whose life expectancy is less than a year can safely stop using statins, a new study reports. (Image: ©iStock.com/Gannet77)

Patients whose life expectancy is less than a year can safely stop using statins, a new study reports. (Image: ©iStock.com/Gannet77)

Discontinuing statin use in patients with late-stage cancer or other terminal illnesses isn’t harmful and may help improve patients’ quality of life, according to new research.

Data presented today at the American Society for Clinical Oncology’s annual meeting in Chicago show that ending statin use in patients with advanced diseases appears to offer several benefits. The study’s lead author, Jean Kutner, MD, MSPH, of the University of Colorado Cancer Center in Aurora, called research on when to stop preventive medications “a new line of investigation.”

Statins are among the most prescribed medications for their ability to lower cholesterol and reduce the risk of heart attack and stroke. About 40% of the drugs are prescribed to prevent a first heart attack or stroke and often patients take them for the rest of their lives.

Kutner and her colleagues with the Palliative Care Research Cooperative Group, which includes more than 20 US member institutions, enrolled 381 patients whose estimated life expectancy was 7 months. About half had cancer and all had taken a statin for at least 3 months. Two-thirds of the patients had taken a statin for more than 5 years.

Half of the patients were randomized to continue the drug, and the other half to stop taking it. Patients were monitored for up to a year to track cardiovascular events, changes in quality of life, and survival.

Death rates within 60 days were similar in both groups, about 20%. Rates of cardiovascular events were approximately 6% in each group. Median survival was 190 days among patients who continued taking a statin compared with 229 days among those who stopped the drug. Patients who quit statins had significant improvements in quality of life, especially in feelings of well-being and support. Stopping the drug also saves money.

Whether or when to stop preventive medications is an important issue in end-of-life care, the investigators noted. Some patients may start anticancer drugs or opioids for pain, increasing the risk of adverse events as their medications accumulate.

Kutner advised that patients with a life expectancy of less than 1 year who take a statin but haven’t recently had a heart attack or stroke talk with their physician about stopping the drug.

“One thing we found during the study was clinicians saying, ‘Hey, I never thought about stopping people’s statins,’ ” Kutner said in a statement. “Here’s a setting in which these drugs may not be doing most patients any good any more, and bringing up the subject of stopping unneeded medications offers the opportunity for shared decision making.”

Medications to prevent osteoporosis, blood clots, high blood pressure, and diabetes are candidates for future studies, Kutner added.

 

 

 

 

Renal Denervation Appears Less Effective in Reducing Blood Pressure Than Previously Thought

The efficacy of renal denervation to reduce blood pressure in patients with resistant hypertension remains in question. Image: iStock.com/ginosphotos

The efficacy of renal denervation to reduce blood pressure in patients with resistant hypertension remains in question. Image: iStock.com/ginosphotos

Washington, DC—A minimally invasive procedure thought to provide dramatic improvements in blood pressure for patients with resistant hypertension may not work or offers only modest improvement.

The procedure, renal denervation, involves the use of  a steerable catheter with an electrode tip to deliver pulses of radiofrequency energy along each renal artery to deactivate renal sympathetic  nerves, which can reduce blood pressure. Earlier and small studies of renal denervation found the procedure appeared to reduce systolic blood pressure by more than 30 mm Hg. The procedure is used in more than 80 countries, but it has not been approved in the United States.

Studies presented over the weekend at late-breaking clinical trials showcased at the Scientific Sessions of the American College of Cardiology should give proponents of the procedure pause.

On Saturday, researchers presented results from the SYMPLICITY HTN-3 trial. In this trial, 535 patients with resistant hypertension (systolic blood pressure of 140 mm Hg or higher despite taking 3 or more antihypertensive medications) were randomly assigned in a ratio of about 2 to 1 to receive renal angiography plus denervation or a sham procedure of renal angiography only. At 6 months, office-based systolic blood pressure dropped 14.13 mm Hg in the denervation group and 11.74 mm Hg in the sham group, a nonstatistical difference. For 24-hour ambulatory blood pressure, systolic pressure dropped 6.75 mm Hg in the denervation group and 4.79 mm Hg in the sham group, also a nonstatistical difference.

Findings presented on Sunday offered less pessimistic but still modest results for denervation proponents. For this study, researchers looked at 6-month results from the first 1000 patients enrolled in the Global SYMPLICITY Registry. The registry will ultimately enroll 5000 patients from 200 sites worldwide to assess the safety and efficacy of the procedure at 6 months. The investigators found that office systolic blood pressure readings dropped 11.9 mm Hg for all patients and 19.8 mm Hg for those with systolic pressures of 160 mm Hg or higher. For the ambulatory setting, systolic pressure dropped 7.9 mm Hg for patients with initial systolic blood pressure of 140 mm Hg or higher and 9.2 mm Hg for those with systolic pressures of 160 mm Hg or higher.

As for what these results mean for the procedure , renal denervation is “not dead,” said George Bakris, MD, a coauthor of SYMPLICTY HTN-3 trial and director of the Hypertensive Disease Center at the University of Chicago Medical Center. “These studies answered some question and raised others.”

Medtronic Inc, which sponsored both studies and whose SYMPLICITY renal denervation system was used in the study, said in a news release that it planned to continue providing the system in countries already with regulatory approval and will continue to seek approval in the United States.

To Reduce Hospital Readmissions, Perhaps Focus on the Whole Patient and Not a Specific Condition

Stenting blocked coronary arteries at hospitals without the ability to perform emergency cardiac surgery appears save and effective. (Image: andipantz )

Research suggests that the way to reduce hospital readmissions is to treat the patient as a whole and not concentrate on reducing the risk of a recurrence of the condition that led to hospitalization in the first place. (Image: andipantz/iStock.com )

US Hospitals, which can face financial penalties for readmitting large numbers of patients within 30 days of discharging them, want to lower their 30-day readmission rates. And patients certainly don’t want such return visits, either. Research appearing today in BMJ suggests that hospitals can lower 30-day readmission rates by developing strategies that focus on the whole patient rather than concentrating on such a specific time period or diagnoses that have historically been associated with a higher percentage of readmissions.

The researchers reached this conclusion based on findings of a retrospective cohort study of Medicare beneficiaries who were readmitted in 2007 through 2009 within 30 days after hospital admission for heart failure, acute heart attack, or pneumonia. There were 320 003 readmissions within 30 days of 1.29 million admissions for heart failure among 4041 hospitals, 102 536 readmissions after 517 827 admissions for acute heart attack among 2378 hospitals, and 208 438 readmissions after 1.14 million admissions for pneumonia among 4283 hospitals.

About 21% of patients admitted for heart failure initially treated at high-performing hospitals were readmitted within 30 days compared with nearly 25% at average-performing hospitals and nearly 29% at low-performing hospitals. Among patients initially admitted for acute heart attack, about 16%, 20%, and 25% were readmitted at high-, average-, and low-performing hospitals, respectively. About 15%, 18%, and 22% of patients admitted for pneumonia were readmitted to high-, average-, and low-performing hospitals, respectively. High-performing hospitals were defined as those with a high probability of having a 30-day readmission rate lower than the national rate during the 3-year study period; low-performing hospitals were highly likely to have a rate that exceeded the national rate.

The researchers said high-performing hospitals appeared to achieve lower overall rates of readmission not by reducing readmissions for specific diagnoses or time periods such as 30 days after discharge, but rather through using general strategies and interventions that apply broadly across potential readmission diagnoses and not just those that led to the initial admissions and time periods within and beyond 30 days after discharge.

“This study suggests that the path to excellence in readmission is a result of an approach that focuses on the patient as a whole rather than on what caused them to be admitted,” said Harlan Krumholz, MD, senior author and director of Yale School of Medicine’s Center for Outcomes Research in New Haven, Connecticut, in a release. “And this study adds emphasis to the idea that patients are susceptible to a wide range of conditions after a hospitalization: they are a highly vulnerable population and we need to focus intently on making the immediate postdischarge period safer.”

Author Insights: Patients Resuscitated After Heart Attack May Not Benefit From Cooling During Emergency Transport to Hospital

Francis Kim, MD, an associate professor of medicine at the University of Washington, and colleagues found that cooling patients with cardiac arrest before they reach the hospital doesn’t improve outcomes. Image: University of Washington.

Francis Kim, MD, an associate professor of medicine at the University of Washington, and colleagues found that cooling patients with cardiac arrest before they reach the hospital doesn’t improve outcomes. Image: University of Washington.

Cooling patients who have been hospitalized after a heart attack has emerged as a promising strategy to protect the brain from damage related to the attack. But a study published in JAMA this week finds that cooling patients earlier, while they are being transported to the hospital, does not appear to help and may hurt.

Brain injury contributes to neurological impairment and death among many patients who have been resuscitated from a heart attack. Cooling patients who have been resuscitated from a heart attack at the hospital has been shown in clinical trials to improve survival and neurological function. But it can take hours to cool patients at the hospital and some have proposed that starting cooling in the ambulance may improve outcomes further.

To test this approach, Francis Kim, MD, an associate professor of medicine at the University of Washington, and his colleagues randomized 1359 patients who were resuscitated by paramedics from cardiac arrest either to receive usual care or to be “precooled” using intravenous (IV) administration of chilled saline by paramedics. Nearly 583 patients who had ventricular fibrillation (VF) were included in the study.

Although the cooled saline did reduce patients’ body temperatures and helped reduce the time it took patients to reach the target temperature in the hospital, the researchers found no improvement in survival or neurologic status in those cooled en route to the hospital compared with those who were not. In addition, the cooled patients had an increased risk for pulmonary edema (fluid in the lungs) and were more likely to have a rearrest and to receive diuretics. They did not find a difference between patients with VF and those without.

Dr Kim discussed the results with news@JAMA.

news@JAMA: Why did you decide to do this study?

Dr Kim: We did the study mainly because cooling is usually initiated in the hospital for ventricular fibrillation patients. But a lot of animal studies suggest that cooling needs to start as soon as possible after cardiac arrest. The paramedic usually starts an IV so cooled saline was a very feasible way for emergency medical teams to cool patients.

news@JAMA: What did the results tell you about this cooling strategy?

Dr Kim: The main findings were that the strategy of rapid cooling in the field did not improve survival or neurologic status, both for non-VF patients and VF patients. Furthermore, we saw some harm from the fluid. People who received fluid had an increase in rearrest, and they had evidence for an increased pulmonary edema, which resolved by the second day.

news@JAMA: How do these results compare with results from other studies about prehospitalization hypothermia for cardiac arrest?

Dr Kim: Ours was the largest randomized trial. There was another a few years ago by Bernard et al in Australia that randomized 234 patients with VF to cold fluid or standard care and didn’t see a significant difference in survival or neurologic outcomes. The results came out during the middle of our trial. Our study, in conjunction with the Bernard study, really doesn’t support cold fluid as a means of cooling patients with cardiac arrest in the field.

news@JAMA: Why do you think you did not find an advantage to prehospitalization hypothermia?

Dr Kim: One reason may be that the cooling technique didn’t cool patients fast enough, but it was the easiest tech to use. Cooling at the time of arrest may be even more beneficial. Perhaps the fluid caused early harm, which masked any benefit from the hypothermia. The last possibility is that prehospitalization cooling won’t improve survival or neurologic outcomes.

news@JAMA: How do you explain the harms you saw?

Dr Kim: Fluid volume load during cardiac arrest may decrease coronary artery perfusion and impair heart function. Other cooling technologies that cool the body externally may avoid this problem.

news@JAMA: What do you think is the main take-away message?

Dr Kim: This strategy of cooling with cold fluid doesn’t improve survival and should be abandoned. Further research is needed on whether cooling [during the cardiac arrest] or using other cooling technologies may be beneficial.

Bariatric Surgery Achieves Long-term Diabetes Remission in Some Patients, Study Shows

Roux-en-Y gastric bypass surgery is more likely than other bariatric surgical procedures to reverse diabetes in obese patients who have the condition, according to a new study. (Image: JAMA, ©AMA)

Roux-en-Y gastric bypass surgery is more likely than other bariatric surgical procedures to reverse diabetes in obese patients who have the condition, according to a new study. (Image: JAMA, ©AMA)

Bariatric surgery can reverse type 2 diabetes for more than 5 years in some obese patients who have the condition, according to new research.

The study, published online today in the Annals of Surgery, followed up 217 obese patients with type 2 diabetes for a median of 6 years after they had bariatric surgery. Patients had 1 of 3 bariatric procedures: 162 had Roux-en-Y gastric bypass surgery, in which the size of the stomach is permanently reduced; 32 had gastric banding, which uses an adjustable band to narrow the opening from the esophagus to the stomach; and 23 had sleeve gastrectomy, in which much of the stomach is removed.

Overall, patients lost 55% of their excess weight and half of the patients had a complete or partial remission of their diabetes after the median 6-year follow-up period. Specifically, 24% of patients had a complete remission of their diabetes with a blood sugar level of less than 6% without diabetes medications. The American Diabetes Association (ADA) recommends a blood sugar level no higher than 7%.

An additional 26% of patients had a partial remission of their diabetes, and 34% had improved glycemic control. Cardiovascular risk factors decreased by 25%. Diabetic neuropathy improved in 53% of patients and stabilized in 47%.

The investigators also found that patients who had long-term weight loss, were diagnosed with diabetes less than 5 years before their surgery, and had gastric bypass surgery rather than the other 2 procedures were most likely to have sustained diabetes remission.

However, 19% of patients who achieved full or partial remission had a recurrence of their diabetes. Even so, those patients had improved glycemic control and cardiovascular risk factors compared with their status before surgery. The investigators noted that 75% of patients who had a recurrence still met the ADA goal of blood sugar levels less than 7%.

“Only about half of diabetics in the United States currently have acceptable control of their blood glucose level,” lead investigator Stacy Brethauer, MD, a bariatric surgeon at the Cleveland Clinic Bariatric and Metabolic Institute, said in a statement. “This study confirms that [Roux-en-Y gastric bypass surgery] can offer durable remission of diabetes in some patients and should be considered as an earlier treatment option for patients with uncontrolled diabetes.”

Author Insights: Early Mitral Valve Repair Is Associated With Longer Life and Reduced Risk of Heart Failure

Rakesh M. Suri, MD, DPhil, of the Mayo Clinic in Rochester, Minnesota, and colleagues found that treating mitral valve with degenerative regurgitation with surgery soon after diagnosis was associated with longer life and less risk of heart failure compared with watchful waiting. (Image: Mayo Clinic)

Rakesh M. Suri, MD, DPhil, of the Mayo Clinic in Rochester, Minnesota, and colleagues found that treating mitral valve with degenerative regurgitation with surgery soon after diagnosis was associated with longer life and less risk of heart failure compared with watchful waiting. (Image: Mayo Clinic)

For years, cardiologists have debated about whether early surgical repair or watchful waiting is the better strategy for dealing with degenerative mitral regurgitation, a common heart valve problem that may produce no symptoms other than a heart murmur. Now, new research findings appearing today in JAMA indicate that early mitral valve surgery appears to be associated with greater long-term survival and a lower risk of heart failure than watchful waiting for a distinct event such as symptoms or indications of heart dysfunction before doing such surgery.

Researchers studied 575 patients with flail mitral valve regurgitation who were medically managed initially and 446 who underwent mitral valve surgery within 3 months after detection. These patients were enrolled in the Mitral Regurgitation International Database and received routine cardiac care from 6 tertiary centers in France, Italy, Belgium, and the United States. At 10 years’ follow-up, 86% of patients undergoing the early surgery were alive compared with 69% who were initially managed medically. Of those undergoing early surgery, 7% developed heart failure by year 10 compared with 23% of those who were medically managed.

Lead author Rakesh M. Suri, MD, DPhil, of the Mayo Clinic in Rochester, Minnesota, discusses his team’s findings.

news@JAMA: Who are these patients?

Dr Suri: These are patients you might see on the street who’ve been told they have a heart murmur but they feel well and are asymptomatic. They don’t have the typical triggers that would prompt surgery, such as having symptoms or heart dysfunction.

news@JAMA: Guideline writers have been ambivalent in endorsing this early surgery in patients who are asymptomatic. You support early surgery. Why?

Dr Suri: People have been hesitant because the surgery was not widely available. That has changed in the last decade and now we have surgeons with high levels of expertise who are performing a very safe and durable operation. The caveat I’d raise is that these should be performed within programs that are high-volume mitral valve programs.

news@JAMA: How onerous is the operation for patients?

Dr Suri: That is a rapidly shifting goalpost as these high-volume centers get better at performing the operation. Traditional valve repair operations will keep a patient in the hospital 7 days and get them back to work in 6 to 8 weeks. But for some patients who are candidates for minimally invasive valve repair, the procedure lasts about 4 to 6 hours, and we can get them out of the hospital in 3 days and back to work in 2 or 3 weeks.

news@JAMA: What would you tell patients with this type of mitral regurgitation who are considering their options?

Dr Suri: I’d like to get the message out there that degenerative mitral regurgitation is immensely treatable. With the right team performing the right operation without delay, that up-front investment of time and energy leads to important downstream benefits, including more years of life lived and more healthy years.

Author Insights: Study Finds Single-Chamber Implantable Defibrillators Safer and as Effective as Newer Dual-Chamber Devices

Pamela N. Peterson, MD, MSPH, of the Denver Health Medical Center in Colorado, and colleagues found that use of newer dual-chamber implantable defibrillators for primary prevention of life-threatening heart arrhythmias did not result in clinical outcomes that were any better than those associated with use of single-chamber devices and resulted in higher complication rates. (Image: Denver Health Medical Center)

Pamela N. Peterson, MD, MSPH, of the Denver Health Medical Center in Colorado, and colleagues found that use of newer dual-chamber implantable defibrillators for primary prevention of life-threatening heart arrhythmias did not result in clinical outcomes that were any better than those associated with use of single-chamber devices and resulted in higher complication rates. (Image: Denver Health Medical Center)

Sometimes, more is not better, as researchers report in a new study of implantable defibrillators, devices that use electrical shocks to prevent sudden cardiac arrest in people with potentially life-threatening heart arrhythmias. In research published today in JAMA, investigators found that implantation of newer “dual-chamber” implantable cardioverter-defibrillators (ICDs) is associated with a higher risk of device-related complications when compared with single-chamber ICDs. At the same time, rates of hospitalization or death among patients during the first year after implantation were the same regardless of whether patients received a single- or dual-chamber device.

In theory, compared with single-chamber devices, dual-chamber ICDs produce electrograms that are easier for physicians to interpret, and these devices are better able to identify dangerous arrhythmias, reducing unnecessary electrical shocks. But dual-chamber ICDs are more difficult to implant and may be associated with more infections and displacement of wires, or leads, requiring reoperations.

For the JAMA article, researchers retrospectively studied 32 034 patients who received a single-chamber or dual-chamber device for primary prevention (to prevent sudden cardiac arrest in people who are at high risk for this problem) from 2006 to 2009. Complication rates were 3.51% for single-chamber devices compared with 4.72% for dual-chamber devices. Rates of 1-year mortality, as well as 1-year all-cause hospitalization or hospitalization for heart failure, were similar. The increased complication rate without an apparent increase in benefit led the researchers to ask why almost two-thirds of all ICDs implanted in this population for primary prevention were dual-chamber devices.

Lead author Pamela N. Peterson, MD, MSPH, an associate professor of medicine at the Denver Health Medical Center in Colorado, discusses her team’s findings:

news@JAMA: What prompted you to study single-chamber versus dual-chamber ICD use for primary prevention?

Dr Peterson: We had several reasons. First, the major trials that looked at primary prevention with ICDs predominately tested single-chamber devices, and when dual chambers came out, there was little study of their effects for primary prevention. Second, with the introduction of dual-chamber ICDs, we saw practice pattern changes, with a significant number of patients receiving them. Third, we also saw great geographical variation in the use of single- or dual-chamber ICDs that was not associated with patient characteristics.

news@JAMA: You compared the devices in terms of primary prevention of life-threatening arrhythmias. What are the characteristics of a patient that would suggest implanting an ICD for primary prevention?

Dr Peterson: They can be patients who have a reduced ejection fraction: their heart function is weak. Also, those at high risk for these irregular heart rhythms, who are at risk for sudden cardiac arrest.

news@JAMA: Why have clinicians turned to implanting dual-chamber ICDs for the primary prevention of dangerous arrhythmias?

Dr Peterson: As technology advances, it is hard to believe the advanced technology is not better than the prior technology. One theoretical benefit of the dual chamber is that it is better able to detect and differentiate a lethal from nonlethal arrhythmia, but the data have yet to show that. Also, the culture of practice is a significant player in this geographic variation we observed. It becomes a “this is the way we do it here” culture.

news@JAMA: What issues do patients discuss with clinicians when they are being considered for an ICD?

Dr Peterson: The decision whether to receive a device at all is the most important decision, and there aren’t great data to support one device over the other. Once it’s decided that a patient needs a device, the choice of single chamber or dual chamber often doesn’t involve the patient. It’s often a physician-level decision.