July 30th, 2012
Selections from Richard Lehman’s Literature Review: July 30th
Richard Lehman, BM, BCh, MRCGP
CardioExchange is pleased to reprint selections from Dr. Richard Lehman’s weekly journal review blog at BMJ.com. Selected summaries are relevant to our audience, but we encourage members to engage with the entire blog.
NEJM 26 July 2012 Vol 367
Using CTA to Rule Out MI and Ischemia in the ED (pg. 299): ROMICAT stands for Rule Out Myocardial Infarction/Ischemia Using Computer Assisted Tomography, and this is the second trial so far—hence ROMICAT-II. The primary end-point was time to discharge from hospital and this 1,000 person randomized trial shows that you can cut it from a median of 26.7 hours to 8.6 if you do immediate CT scans on all patients presenting with possible cardiac chest pain. At least that’s what Table 3 says. In the Abstract the figure given is a mean reduction of stay by 7.6 hours. A good illustration of the difference between the median and the mean, and a rare example of a study underselling itself. But questions remain. Part of the rationale of the study was that reliance on ECG biochemical markers in acute chest pain can leave residual diagnostic uncertainty, yet the rate of adverse cardiovascular events within 28 days in the two groups was exactly the same—zero. Moreover, those who had immediate coronary CT had more downstream diagnostic tests, not fewer. The only thing they gained was earlier discharge home; costs were identical, and on the down side, the CT group notched up a sizeable dose of ionizing radiation. Given that we can’t quantify the harm from this, here’s a situation where patients with acute chest pain have a very difficult choice to make as they arrive in the emergency room, wondering if their end has come. “Do you want a high radiation scan or would you be willing to stay here a bit longer to avoid it?” I wonder how many ER doctors would even ask them.
n-3 Fatty Acids for Preventing CV Events in Patients with Dysglycemia (pg. 309): The acronym for the next trial is ORIGIN, and it looked at two things which were thought promising to prevent cardiovascular events in 12,536 subjects with dysglycaemia: n-3 fatty acids and/or basal insulin. In fact, neither of these had any effect on CV events. But maybe this is a good moment to remind you of the three categories of “dysglycaemia” as currently defined. There is type 2 diabetes, defined by a persistent fasting blood glucose of 7.0 mmol/L or more. There is impaired fasting glucose, defined as a fasting glucose level between 6.1 and 7.0; and there is impaired glucose tolerance, defined as a rise in blood glucose to between 7.8 and 11.1 two hours after a glucose load. All of these states confer some additional cardiovascular risk.
Basal Insulin and CV Outcomes in Those with Dysglycemia (pg. 319): So let’s move on to the second and more interesting part of this 2×2 factorial trial which tested the hypothesis that reducing fasting glucose to 5.3 or lower by means of injected basal insulin glargine will lower cardiovascular events in all these patients. The logic of this must be familiar to all of you: 5.3 is the level of fasting glucose that represents the threshold for increased macrovascular risk. So let’s see what happens if we try to lower everyone’s sugar to 5.3 with insulin. I’ve already told you the answer—nothing. And this is important. Firstly because it is one more bit of evidence that pushing down sugar levels below quite a high level (perhaps above 8 mmol/L) is a futile strategy for risk reduction, and secondly because it shows that exogenous insulin itself does not increase cardiovascular risk. It does however increase the risk of severe hypoglycaemic events, from 0.3 to 1.0 per 100 person-years.
Lancet 28 July 2012 Vol 380
Citicoline for Acute Ischemic Stroke (pg. 349): Some ideas seem so good that they just keep on being tested, to repeated destruction. Stem cells for cardiac repair; HDL raising for lowering cardiovascular events; neuroprotective drugs for better stroke outcomes. We would all love them to work, but in trial after trial, they bomb. Here, in a multi-centre European trial, citicoline, which works in animal models of stroke, fails to have any effect in 2298 patients with moderate-to-severe acute ischaemic stroke, though it’s already got a licence in several European countries. In The Marriage of Heaven and Hell (c.1793) William Blake has Isaiah over for dinner and asks him, “does a firm perwasion that a thing is so, make it so?” The prophet replies, “All poets believe that it does, & in ages of imagination this firm perwasion removed mountains.” Alas, what may be a fine rule for poets and prophets is not a very good one for drug licensing bodies and medical practitioners.
BMJ 28 July 2012 Vol 345
Hypertension Misperception and Medication Adherence: Another thing that never seems to change is public misperception of high blood pressure as something that is caused by stress and which gives rise to symptoms. Here is a systematic review of qualitative studies from a total of 16 countries—more of these please!—and everywhere the myth is the same. Lay people of all nations share the delusion that if you take away the stress, down goes the blood pressure and the symptoms disappear, so you can stop taking the tablets. Not that doctors are free of myths about hypertension either, but that is another matter, and deserves a similar level of qualitative enquiry.
Predicting the 10-Year CV Risk in the U.K.: And another risk score I won’t be using much is QRISK2, because it is so rare for me to initiate long-term treatment these days, and I tend to be of the “statins for everyone” persuasion anyway. But if you care deeply about better discrimination of risk, this external validation study shows it’s better than Framingham for the UK population—by 5% in men and more in women.
Arch Intern Med 23 July 2012 Vol 172
CV Risk Among Those with Atherothrombosis Who Live Alone (pg. 1086):
When love, with one another so
Interinanimates two soules,
That abler soule, which thence doth flow,
Defects of lonelinesse controules.
Wee then, who are this new soule, know,
Of what we are compos’d, and made,
For, th’Atomies of which we grow,
Are soules, whom no change can invade.
So John Donne, in one of his greatest poems, The Extasie, describes the fusion of souls achieved by sexual love. Some think the poem was addressed to his 17-year-old wife, Anne; and certainly when she died after giving birth to their twelfth child at the age of 33, he became obsessed with his own death, which he believed might re-interinanimate their souls. When he eventually sickened at the age of 58, he duly prepared his tomb, and had himself depicted lying within it before he rose to preach his last sermon. Loneliness in older persons is a predictor of functional decline and death. In this paper, it is also found to be broadly true of people over the age of 45 who have atherosclerosis and who are living alone.
Six-Minute Walk Test for Predicting CV Events in Patients with Stable CHD (pg. 1096): In the Heart and Soul Study, “Distance walked on the 6 Minute Walk Test predicted cardiovascular events in patients with stable coronary heart disease. The addition of a simple 6MWT to traditional risk factors improved risk prediction and was comparable with treadmill exercise capacity.” Interesting: and I bet if you look in five years’ time, cardiologists will still be doing as many treadmill tests and as few six minute walks as they do now.
Patient Preference in the Decision to Place ICDs (pg. 1104): When questioned, patients with heart failure often rate better quality of life as more important than longer duration of life, but they are seldom offered the choice. Implantable cardioverter-defibrillators improve overall survival figures in patients with systolic heart failure and QRS prolongation, but few patients are aware that they are therefore more likely to experience a slow death from breathlessness than a sudden death from ventricular arrhythmia. This survey of AHA physicians (12% response rate) shows that cardiologists don’t, by and large, discuss this with their patients. They know best: ICDs save lives, and earn fees.
July 30th, 2012
And The Survey Says: You Are Thinking About Retirement
Harlan M. Krumholz, MD, SM
I saw a news item today with an alarming statistic about the number of doctors who plan to retire in the next decade. We all have days where work can be frustrating – but the article indicated that 45% of cardiologists planned to retire in the next decade. I was thinking about what the natural attrition rate might be and how this compared with other eras. What is your experience? Do you have the sense that people are planning to leave the profession earlier than they might have planned a few years ago? The job market for new cardiologists remains tight.
What do you think? Are we headed for an unprecedented exodus from the field?
July 27th, 2012
FDA Approves New Prescription Fish Oil Pill
Larry Husten, PHD
The FDA has approved a new prescription formulation of fish oils for treating very high triglyceride levels.
The drug will be sold under the brand name Vascepa. According to Amarin, the manufacturer, it will be indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (>500 mg/dL).
Vascepa contains ultra-purified ethyl EPA, an omega-3 fatty acid. Vascepa will be the second prescription fish oil formulation, following GlaxoSmithKline’s Lovaza.
The triglyceride-lowering efficacy of Vascepa has been studied in two 12-week, placebo-controlled phase 3 studies: ANCHOR, in patients with triglyceride levels between 200 and 500 mg/dL; and MARINE, in patients with triglyceride levels between 500 and 2000 mg/dL. Last year Amarin announced the commencement of REDUCE-IT (Reduction of Cardiovascular Events with EPA – Intervention Trial), designed to evaluate the efficacy of Vascepa when given in addition to a statin in reducing major cardiovascular events in a high-risk population.
A recent meta-analysis of studies with various preparations of fish oils found no evidence of a reduction in cardiovascular events with fish oil supplements in patients with a history of cardiovascular disease.
Click here to read the press release from Amarin.
Click here to read prescribing information for Vascepa.
July 26th, 2012
ESC Position Paper: Population-Based Strategies to Reduce CV Deaths
Larry Husten, PHD
About half of all cardiovascular deaths could be prevented by implementing population-level changes, according to a position paper from the European Society of Cardiology published in the European Journal of Preventive Cardiology. Torben Jørgensen and colleagues maintain that population-level interventions are much more effective than current strategies that seek to reduce individual risk.
Population-based strategies include taxation, legislation, and environmental changes. The authors call the move away from individual risk and toward a population-based strategy “a paradigm shift in CVD prevention.”
The authors argue that the change is necessary because “societal changes during the last decades have led to the present harmful environment with high calorie intake, low degree of physical activity, continuous smoking, and high alcohol intake.” Further, they note, efforts to promote a healthy lifestyle “routinely face opposition by commercial vested interest from corporations (e.g., food, tobacco, alcohol).”
Addressing a common criticism of population-based strategies, the authors counter the allegation that the “‘nanny state’ hinders the free choice of people” with the observation that “people today are nudged in the wrong direction by corporations’ de facto setting of the default option. Yet corporations do not have responsibility for population health – this is the responsibility of governments.”
“Population interventions make the environment healthier and change happens automatically, whereas with an individual approach you need an active response,” said Professor Simon Capewell, a coauthor of the paper, in an ESC press release.
Here are several of the paper’s major recommendations:
• Healthy dietary habits will be supported by changes in agricultural policies, tax on products with free sugar and saturated fat and subsidies for fruit and vegetables, reduction of salt and trans-fatty acids in processed foods, clear labelling of foods, and limiting advertising for junk food.
• Completely smoke-free environments are the only way to protect non-smokers. Smoking and second-hand smoking can be regulated by taxation, restrictions in sale and use, banning advertising, plain packaging, and warning labels.
• Physical activities should be integrated in daily life by subsidies to public transport and re-allocating of road space to cycle and footpath lanes. Changes in schools, worksites, and built environment can make physical activity a more natural part of daily life.
• Alcohol intake can be reduced by taxation, low availability, regulation of advertising, and low social and legal tolerance of drink driving.
July 25th, 2012
ROMICAT-II Provokes Opposing Views on CT Angiography in the ED
Larry Husten, PHD
For patients with suspected acute coronary syndromes (ACS), CT angiography (CTA) compared to standard treatment can reduce the time in the emergency department (ED), according to results of the ROMICAT-II (Rule Out Myocardial Infarction/Ischemia Using Computer-Assisted Tomography) trial, published in the New England Journal of Medicine. However, CTA resulted in more tests being performed and increased radiation exposure.
One thousand patients with possible ACS but without ECG signs of ischemia or a positive troponin test were randomized to either CTA or standard treatment. The primary endpoint, the mean length of hospital stay, was 30.8 hours in the standard evaluation group and 23.2 hours in the CTA group, a highly significant difference of 7.6 hours (P<0.001). In addition, many more patients in the CTA group were discharged directly from the ED (47% vs. 12%; P<0.001). There were no cases of undetected ACS in either group and very few major adverse cardiovascular events (2 vs. 6; P=0.18). Half of the patients in the CTA group were discharged within 8.6 hours, compared with only 10% of the controls.
ED and hospital costs were similar in the two groups. Radiation exposure was higher in the CTA group (13.9 mSv vs. 4.7 mSv), and more diagnostic tests were performed in the CTA group.
The authors concluded that their “data should allow providers and patients to make informed decisions about the use of this technology as an option for evaluation when symptoms are suggestive of an acute coronary syndrome.”
Schrödinger’s ROMICAT
In contrast to the neutral presentation of the authors in the NEJM paper, strikingly different positions about the utility of CT angiography were taken in an accompanying editorial by Rita Redberg and a press release issued by the National Heart Lung and Blood Institute, which sponsored the study.
In her editorial, Redberg writes:
Although shorter lengths of stay in the hospital are highly desirable, especially from the patient’s point of view, the ROMICAT-II study reveals a deeper flaw in the approach to chest pain in the emergency department. The underlying assumption… is that some diagnostic test must be performed before discharging these low-to-intermediate-risk patients from the emergency department. This assumption is unproven and probably unwarranted. The rationale for any test, as compared with no testing, should be that it will lead to an improved outcome, and here there is no evidence that the tests performed led to improved outcomes.
Redberg points out that the very low (under 1%) rate of subjects who actually had an MI means “that it is impossible to know whether the CCTA groups received any benefit whatsoever.” Further, factoring in radiation doses both from CTA and nuclear stress tests and adverse reactions to contrast dye, “clinicians may legitimately ask whether the tests did more harm than good.”
For patients like those in ROMICAT II, with normal ECG findings and negative troponin tests, “multiple studies show no evidence that any additional testing further reduces that risk.”Although CTA can reduce length of stay in the hospital compared to standard care, “it is even faster to discharge these patients without any additional diagnostic test after determining that their ECG findings and troponin levels are normal.” She concludes:
In short, the question is not which test leads to faster discharge of patients from the emergency department, but whether a test is needed at all.
By contrast, the NHLBI press release focuses exclusively on the benefits of CTA and lacks any significant discussion of its potential limitations, as presented in the NEJM paper and as discussed in detail by Redberg. The press release quotes Susan Shurin, the acting director of the NHLBI:
Identifying the underlying cause of chest pain more quickly with CT scans could allow medical care providers to better allocate limited resources to the patients who are most in need of treatment.
The principal investigator of the study, Udo Hoffmann, says that ROMICAT II can “help health care providers and patients make better informed decisions by knowing the risks and potential benefits of using CT scans to more quickly diagnose acute coronary syndrome,” but he glosses over the risks and then focuses on the benefits:
It can be a relief to patients with chest pain to quickly know they are not having a heart attack and that they can spend the night at home, instead of in a hospital bed.
Finally, the press release gives short shrift to the radiation issue:
Participants in the CT group were exposed to more radiation than those in the standard screening group, though the study authors suggested that future CT scans could be done using less radiation, which could help lower exposure without sacrificing accuracy.
July 24th, 2012
The Academic Squeeze Play
Shengshou Hu, M.D.
CardioExchange welcomes this guest post from Dr. Westby Fisher, an electrophysiologist practicing at NorthShore University HealthSystem in Evanston, Illinois, and a Clinical Associate Professor of Medicine at the University of Chicago’s Pritzker School of Medicine. This piece originally appeared on his blog, Dr. Wes.
If you want to succeed in academic cardiology, get a federal grant for research.
Better yet: get a few well-paid industry grants, too.
These days lower-paid academic cardiologists are finding it tougher to find protected time for research and speaking because grants are harder to come by, and money from their academic center is getting tight. For instance, the National Heart, Lung and Blood Institute (NHLBI) of the NIH no longer accepts the investigator-initiated innovative research grant program (R21), which was an important source of funding for researchers and has cut funding lines for established research funding grants (R01) from a 15% to a 10% acceptance rate. Medical device and pharmaceutical companies are also feeling the financial squeeze from diminished demand for their devices and boutique drugs — not to mention higher fees for the right to sell them in the U.S. Even worse, the federal government has less need for innovation in cardiology now but more need for “demonstration projects” for health care reform.
It’s hard to write passionately about health care reform when your real gig is writing about cardiovascular drugs or devices.
And cardiology is still a procedural field that pays hospital systems pretty well. This presents another tough reality for academic cardiologists: They have to generate revenue somehow. Cash-strapped hospitals across the country are looking at challenged bottom lines. They are turning the heat on their revenue pipelines — all of them. Since cardiology is one of those pipelines, the days of stroking one’s chin while researching sarcomeres has quickly evaporated to clinical productivity clauses.
And for academic cardiologists once content to research and pontificate about treatment strategies, they are learning the cold-hard reality that speaking gigs and guideline writing doesn’t generate revenue for their centers.
But there’s still an out — a way forward for academic cardiologists everywhere, if you will.
In the increasingly competitive and evolving health care markets of America, there is a need for brand name doctor-managers: Folks with marketing marquis value can drive clinical referrals to more clinical centers while serving as intermediaries between hospital administrators struggling to mesh newly hired cardiology groups with their former core cardiologist-employees. How successful these poster children for health care innovation will be in their newly created positions remains to be seen, but the demand is there and the migration’s on. Lucrative pastures await for fairly low-paid academic cardiologists as health care consortiums grapple for ways to differentiate themselves from their competitors.
So like the mice in “Who Moved My Cheese,” academic cardiologists are beginning to make their move, and no ivory-tower academic medical center is safe.
July 24th, 2012
St. Jude Spills the Beans on PFO Closure Trial
Larry Husten, PHD
(Updated at bottom with statement from St. Jude Medical)
Dan Starks, the CEO of St. Jude Medical, stated during a quarterly earnings call last week that results of the RESPECT trial of PFO closure for crytpogenic stroke were “favorable” and that the full trial results will be presented in October at the TCT meeting in Miami. But his statement raises more questions than it answers.
It should be noted that it is impossible to ascertain the actual results of the trial from his remarks. He did not even state whether the trial had met its primary endpoint, and there are always potential dangers when the full data from a large trial are analyzed. Further, when asked to confirm whether RESPECT was indeed scheduled for presentation at TCT, TCT’s Gregg Stone told CardioBrief that “the submission deadline [for late-breaking clinical trials] has not even been reached yet.”
Jonathan Tobis, an expert in PFO closure at UCLA, told CardioBrief that any evaluation of the trial should await the full presentation of the data: “This is anybody’s guess until the data is presented,” he said.
Here is the transcript of the relevant portions of the conference call:
Dan Starks (CEO): Earlier this year, we announced that we completed enrollment in our landmark RESPECT clinical trial, evaluating the benefit of PFO closure in patients who suffer from cryptogenic stroke. As a reminder, the RESPECT trial enrolled 980 patients and generated more than 2,700 patient years of experience. We expect the results of this trial to be presented at a late-breaking clinical trial session during the TCT meeting later this year.
In stark contrast to prior randomized trials of competitive PFO devices for mitigation of risk in cryptogenic stoke patients, we are confident our trial will demonstrate greater benefit and less risk in the device arm of the trial.
Michael Weinstein (JP Morgan analyst): … Dan, you mentioned that the PFO closure for stroke RESPECT trial, can you just update us on the filing of that data and that PMA with the FDA? …
Dan Starks: On the PFO closure, the submission to FDA is being prepared as we speak and there is a lot of data to analyze and prepare and organize. And so, I would be confident that the PMA submission will be in during the fourth quarter and I suspect that we would be unlikely to get that submission in before the end of the third quarter. So timing wise that’s our update.
Within that, though, one can see that we have a number – since our organization is strongly focused on preparing that submission, obviously we’re no longer blinded to the data and that was the basis for the level of confidence we’ve expressed that when the full trial results are reported at the TCT, we are optimistic that these will be favorable results.
Comment: The statement that the “trial will demonstrate greater benefit and less risk” for St. Jude’s PFO closure device is highly unusual. One danger is that the company’s initial evaluation of the results may clash with the eventual evaluation of the academic investigators, peer reviewers, other experts, and, ultimately, FDA reviewers and consultants. Companies are in no position to be objective about their own products or trials. That is why academic investigators, peer reviewers, editors, FDA reviewers and consultants, and other interested experts play important roles in discussing and ultimately judging the value of new therapies. Taking the word of a company is simply not acceptable any more.
Many companies in the past have released highly positive press releases of trials that ultimately have been received in a far harsher light. In some of these cases, there have also been suspicions that the premature release of results could be used to affect a stock price. Indeed, Starks’ statement was first reported by an analyst for Merrill Lynch, who wrote that the statement by Starks was “a major disclosure” and concluded that the statement suggests that the trial “hit its primary endpoint.” Ultimately, he wrote, the PFO closure market represents a $500 million “annual market opportunity.” Maybe. But that’s an awfully long way to go on the basis of few vague words spoken in the heat of a conference call.
Caution is warranted especially because of the sorry history of negative trials in this area. It’s possible of course that the St. Jude device is superior to the failed STARFlex Septal Closure System from the now-defunct NMT Medical, but until it can be convincingly demonstrated otherwise, the burden of proof lies with those who advocate the continued use of these devices. But the Merrill analyst believes that positive results from RESPECT could spark greater usage in Europe (where the device is already available, despite the complete absence of evidence supporting its use) and greater usage in the U.S. of “other STJ closure technologies,” since many U.S. physicians “believe in the mechanism and the technology as a valid tool to prevent strokes.”
But let’s remember the NEJM editorial by S. Claiborne Johnston that accompanied the Closure 1 trial earlier this year. In it he outlined some of the troubling issues raised by the trial. Because of off-label use of closure devices, enrollment in the trial took 5 years and forced a reduction in the sample size. He continued:
During the 9 years it took for the results of this trial to be reported, approximately 80,000 patients have had a patent foramen ovale closed with the use of a device at an average cost of $10,000 per procedure. Even if only half these patients were treated by this method for the purpose of preventing stroke, it would suggest that during that period of time $400 million was spent on a procedure that had no apparent benefit, to say nothing of the potential clinical risks involved. By limiting the use of device closure to within the remaining clinical trials, such an expense could be curtailed and completion of these trials might be accelerated. In this setting, a strategy of withholding reimbursement for unproven device therapy unless such treatment is part of a randomized trial seems justified.
There are more reasons to be skeptical. Although Starks was quick to bring up RESPECT, he was silent about another St. Jude PFO Closure trial, the European-based PC-Trial, which was finished and had completed its followup before the RESPECT trial. To date, the company has yet to release any information about the results of the trial.
The entire case, I think, highlights the importance of restoring the system whereby trial investigators, not companies, present the results of clinical trials. It’s not a perfect system by any means. But it’s a lot better than the alternative offered here by St. Jude’s CEO.
I’ve asked for comments from St. Jude, the RESPECT trial investigators, and other experts. I’ll update this story as necessary.
Click here for a full transcript of the St. Jude conference call.
Update: Shortly after publication of the above story, I received the following statement from St. Jude in response to an earlier request. I will leave it for readers to decide whether this adequately addresses the issues I’ve raised.
St. Jude Medical has previously expressed confidence in our RESPECT program because of fundamental differences in clinical trial design, patient selection, and device design compared to competitive programs. Mr. Starks was reiterating this confidence and optimism that because of these differences, the outcomes of the RESPECT trial would be different than prior randomized trials. We have also publically indicated our intention to file the PFO PMA before the end of this year which, of course, requires the Company to have visibility into the data in order to perform the required analysis. Mr. Starks’ statement that we are now unblinded to the data is intended to be nothing more than a reflection of the fact that we are analyzing the data for the PMA submission. In his comments, there was no specific data or endpoint information disclosed. It would be our intention to issue a press release, including formal statements by the Steering Committee membership, at the same time the RESPECT clinical trial results are presented or published, which, as Mr. Starks indicated, will likely occur during the TCT meeting.
The PC Trial is an investigator-sponsored trial, funded by St. Jude Medical. You would need to contact the trial sponsors for further information about the presentation of results.
July 23rd, 2012
Elevated Risk for Acute MI After Total-Hip or -Knee Replacement Surgery
Larry Husten, PHD
A large study reports a high increased risk for acute MI (AMI) in the first 6 weeks after total-hip replacement (THR) or total-knee replacement (TKR) surgery. Analyzing a nationwide cohort from Denmark that included 95,227 patients who underwent THR or TKR and matched controls, Arief Lalmohamed and colleagues calculated the adjusted hazard ratios (HR) for AMI. Their results are published in the Archives of Internal Medicine.
The risk for AMI was significantly higher in the first two postoperative weeks for both THR and TKR, but the risk was higher only in the THR group for weeks 2 through 6.
Adjusted HR, Weeks 1 to 2:
- THR: 25.5 (95% CI, 17.1-37.9)
- TKR: 30.9 (95% CI, 11.1-85.5)
Adjusted HR, Weeks 2 to 6:
- THR: 5.05 (95% CI, 3.58-7.13)
- TKR: 0.81 (95% CI, 0.37-1.77)
At 6 weeks, the absolute rate of AMI was 0.51% in the THR group and 0.21% in the TKR group. The only significant effect modifier identified by the investigators was age, with the greatest excess risk found in patients age 80 or older. By contrast, no increase in risk was found in patients younger than 60 years.
In an accompanying commentary, Arthur Wallace writes that the study “once again confirms that the perioperative period increases cardiac risk. Physicians must go further than establishing risk factors; physicians must actively work to reduce perioperative risk.” Risk can be reduced with the appropriate use of preoperative beta-blockers, clonidine, statins, and aspirin, he writes. Despite level 1 evidence supporting the use of antiischemic agents, many physicians discontinue their use in the perioperative period, he notes.