July 20th, 2011
Ticagrelor (Brilinta) Gains FDA Approval
Larry Husten, PHD
The FDA has approved ticagrelor (Brilinta, AstraZeneca). In a press release, the FDA said that the drug was approved to reduce cardiovascular death and MI in patients with acute coronary syndromes.
The drug’s label will include a boxed warning about bleeding risks, and — of considerable significance in light of the enormous amount of discussion about the topic — the label will state that aspirin doses greater than 100 mg/day decrease the drug’s efficacy. Said the FDA’s Norman Stockbridge, the director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research:
“In clinical trials, Brilinta was more effective than Plavix in preventing heart attacks and death, but that advantage was seen with aspirin maintenance doses of 75 to 100 milligrams once daily.”
The FDA said that the drug was approved with a Risk Evaluation and Mitigation Strategy, which will require the company to educate physicians about the risk of using higher doses of aspirin.
Click here to download a PDF of the Brilinta label.
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July 18th, 2011
Study Suggests Possibility That CETP Inhibitors May Improve Glycemic Control
Larry Husten, PHD
A new analysis of the ILLUMINATE trial raises the possibility that CETP inhibitors like torcetrapib might have the unexpected beneficial effect of improving glycemic control in addition to their intended effect of raising HDL cholesterol. Development of torcetrapib was halted several years ago following the early termination of the large ILLUMINATE trial due to an excess of deaths and cardiovascular events in patients treated with the drug. Other CETP inhibitors (anacetrapib from Merck and dalcetrapib from Roche) are under active development, however, as many researchers believe that the adverse effects of torcetrapib were due to off-target effects of the drug that may not be found with other drugs in the class.
In a post-hoc analysis published in Circulation, Philip Barter and colleagues studied the 6,661 diabetic patients enrolled in ILLUMINATE. At baseline there were no differences in glycemic parameters. At 3 months, however, compared to patients receiving atorvastatin alone, patients receiving torcetrapib in addition to atorvastatin had:
- plasma glucose levels 0.34 mmol/L lower (P<0.0001)
- insulin levels 11.7 µU/mL lower (P<0.0001)
At 6 months, mean hemoglobin A1c levels were 7.29% in the atorvastatin arm versus 7.06% in the combination therapy arm (P<0.0001). A similar pattern was observed in ILLUMINATE patients who did not have diabetes, but these differences did not achieve statistical significance.
The authors raise “an obvious question” and ask whether the effects they observed are “secondary to CETP inhibition, or did they reflect an off-target effect of the drug unrelated to inhibition of CETP?”
In an accompanying editorial, Stephen Wiviott writes that although the differences are small, the consistency of the findings across multiple subgroups, measures, and time points “suggests that these findings may indeed be real.” He writes that dalcetrapib and anacetrapib “are clean CETP inhibitors” that “do not seem to share the hyperalderosteronism/hypertension off-target effects of torcetrapib.” Large phase III clinical outcomes trials with these drugs “will be of substantial interest to determine . . . whether the glycemic effects of torcetrapib are a class effect of CETP inhibitors, or unique to this agent.”
July 18th, 2011
FDA Releases Briefing Documents for Advisory Panel on the Edwards SAPIEN Transcatheter Aortic Valve Implant
Larry Husten, PHD
The FDA has posted the briefing documents for the much anticipated meeting on Wednesday (July 20) of the Circulatory System Devices Panel for the Edwards SAPIEN transcatheter heart valve (THV) system in patients with severe aortic stenosis who are not eligible for surgical valve replacement, as studied in the PARTNER B trial. Overall, the FDA document suggests that the committee will likely recommend approval of the device. The document raises no major unexpected concerns about the pivotal PARTNER B trial, and states that the “trial met the pre-specified criteria for study success, as defined by the primary safety and effectiveness endpoint of all-cause mortality throughout the duration of the study, demonstrating superiority of the SAPIEN THV as compared to the Control group.”
Much of the discussion will likely focus on the questions surrounding the rate of strokes in PARTNER B (see the FDA text below) and the details of a post-approval study and risk mitigation strategy. Edwards has proposed a post-approval study of an anticoagulation/antiplatelet regimen to help reduce the risk of stroke.
Some of the discussion will revolve around the definition of “inoperable” used in PARTNER B and the use of “standard” therapy in these patients. The FDA points out that there is a wide variety of treatments used for patients with inoperable aortic disease and that “there is no ‘standard’ therapy for this patient cohort as evidenced by the various treatments received.”
Here is the text of the FDA’s discussion question regarding neurological adverse events:
As shown in the tables below, there was a significant increase in the neurological event risk in the SAPIEN arm compared to Control, noting that the majority of Controls had [balloon aortic valvuloplasty], in both the acute periprocedural period and the longer-term follow-up phase of the PARTNER trial. The breakdown of neurological events by type (stroke, transient ischemic attack, intracranial hemorrhage) is also presented. These events may actually have been under-reported, since the identification of stroke in the current study depended on recognition of symptoms by the cardiovascular team, rather than rigorous neurological evaluations. While interpretation of the increased late event rate is complicated because of the higher mortality rate in the Control group, neurological adverse events remain an important safety consideration for this device and impact the overall risk-benefit profile of the SAPIEN THV.
Q3a. Please comment on the clinical significance of the neurological adverse event risk observed in patients treated with the SAPIEN THV.The cause of neurological injury with transcatheter valve implantation is multifactorial. One important consideration is management of coagulation and platelet aggregation. The PARTNER trial did not require patients to be on a protocolized anticoagulation or antiplatelet regimen. In light of this, as well as the increased neurological event risk discussed above, the sponsor has proposed a protocolized anticoagulation/antiplatelet regimen to be used in the proposed post-approval study.
CardioExchange readers may be interested to learn that Rick Lange, our inveterate Interventional Cardiology blogger, will be a voting member of the advisory panel.
July 15th, 2011
Panel: Why Don’t Cardiologists Eat Their OATs?
CardioExchange Editors, Staff
In 2006, the Occluded Artery Trial (OAT) showed no benefit of routine PCI in patients with persistently occluded infarct-related arteries that were identified at least one day after an MI. According to a recent study, led by Judith Hochman, OAT has had minimal impact on clinical practice. We asked Hochman and two other experts why OAT has not affected practice. Here are their answers:
Judith S. Hochman (study author, NYU): OAT did not affect practice for various reasons. First, many physicians and patients don’t want to let go of the intuitive belief that an open artery is better than a closed artery, and many third-party payers continue to reimburse for the late procedure. Second, OAT has often been misunderstood. Some observers don’t appreciate the consistent lack of benefit of PCI for all subgroups of OAT patients with occluded infarct-related arteries: proximal LAD occlusion, across ejection fractions, high-risk patients, presence of viability (directly measured or assessed by an increase in EF), enrollment within the earliest time window (24 to 72 hours post-MI), and for a small subset who received drug-eluting stents. Finally, some have criticized the conclusions of the OAT investigators and guideline writers, citing a meta-analysis that, although it appropriately pooled OAT’s findings with data from smaller trials of PCI for stable patients with total coronary occlusion post-MI, inappropriately combined those data with findings from studies of completely different patients who have an open, stenosed artery with possible severe ischemia and symptoms post-MI. When we examine the ACC NCDR database in the future, I hope to see a large decrease in the use of PCI for patients like those in OAT, as this information is further disseminated.
Eric R. Bates (U. Michigan): This analysis appears to involve PCI for chronic total occlusions, not OAT patients. The OAT hypothesis was essentially this: Revascularization of an infarct artery to an infarct zone without major ischemia improves outcome by changing LV remodeling, electrical stability, or future collateral circulation. To test that hypothesis, the patients would have to be within 28 days of MI and fulfill the OAT inclusion and exclusion criteria. The article and the NCDR CathPCI registry did not identify infarct arteries; record symptoms or exercise test results; detail duration of target-artery occlusion; or describe indications for PCI.
Glenn Levine (Baylor): Unfortunately, it is human nature to embrace studies that affirm our preconceived notions or current practice patterns, and to be more recalcitrant in accepting and incorporating into daily practice study results that contradict them. Assuming the CathPCI Registry analysis truly represents the patients studied in OAT, which it appears to do, it is disappointing that practice patterns have not changed as a result of the study and subsequent published guidelines. The purpose of clinical trials, particularly when there is uncertainty or true equipoise, is to facilitate our charge as physicians to make decisions that are best for the patients we have taken an oath to care for. We should embrace the results of well-conducted trials, such as OAT, that answer important scientific questions, as well as practice guidelines based on those trials, regardless of our preconceived notions or current practice patterns. Performing procedures with no demonstrated benefit — or at least the potential for harm — is not consistent with appropriate patient management.
What are your thoughts about why OAT has not affected clinical practice? Will the new study have an impact?
July 14th, 2011
Rivaroxaban: The Next Non-Warfarin Oral Blood Thinner
John Mandrola, MD, FACC
John Mandrola is a cardiac electrophysiologist and blogger on matters medical and general. Here is a recent post from his blog, Dr John M.
The unrelenting epidemic of inactivity and excessive eating wreaks havoc on more than just the heart and blood vessels. Lugging around extra weight also breaks down the joints and back. For evidence, look no further than the waiting room of any orthopedist: the people waiting for joint replacements look the same as those waiting to see the heart doctor.
Bone doctors and heart doctors must deal with the problem of stasis (pooling) of blood in low-flow parts of the circulation. After joint replacements, blood can clot in the veins of the immobile lower extremities, and in atrial fibrillation (AF) clots may form in the non-contracting left atrium. Using blood-thinning drugs helps to prevent complications in both scenarios. Until 2010, having thin blood meant enduring a sharp needle, or taking warfarin.
The good news for both patients and doctors is that the number of oral blood thinners in the U.S. recently expanded from two (warfarin and dabigatran) to three possibilities.
Last week, the FDA approved once-daily rivaroxaban (Bayer and Johnson & Johnson call it Xarelto) for the prevention of venous blood clots — VTE or venous thromboembolism — in the setting of hip- or knee-replacement surgery.
This highly specific indication gets the 10-mg dose of rivaroxaban on the market.
But what’s far more anticipated is the (likely) approval of the 20-mg once-daily dose of rivaroxaban for the prevention of stroke in patients with nonvalvular AF. The FDA will meet in September to consider approving rivaroxaban for this purpose.
I see little reason to believe that the higher dose of rivaroxaban will not be approved.
The stroke-prevention data on rivaroxaban are quite strong. The ROCKET-AF trial randomized (in blinded fashion) more than 14,000 high-risk AF patients to either a single daily dose (20 mg) of rivaroxaban or warfarin. The results were clear: AF patients who took rivaroxaban had fewer strokes and far fewer serious brain bleeds. (Very nice additional coverage of the Rocket-AF trial can be viewed on these posts at TheHeart.org and
As the second non-warfarin blood thinner approved, rivaroxaban shares many similarities with dabigatran:
- Neither needs INR monitoring;
- Neither has means to measure the degree of blood thinning — Doctors cannot confirm that patients are taking the drug as instructed, only the patient knows;
- Neither requires patients to eat a special diet;
- Both require lower dosages in patients with impaired kidney function;
- Both have a short duration of action, and rapid onset of action — which has important implications for pre-and post-surgical patients;
- Neither has an antidote — but both have less risk for bleeding than warfarin.
And the differences…
- Rivaroxaban is once daily, whereas dabigatran is twice daily — this may have important implications for compliance;
- The metabolism of rivaroxaban may cause potential interactions with other medicines;
- Rivaroxaban thins the blood differently – As a factor Xa inhibitor, it blocks the coagulation cascade one step before the direct-thrombin inhibition of dabigatran.
And here are a few caveats and questions that come to mind:
—The Rocket-AF trial has yet to be published in a peer-reviewed journal. The data were presented in abstract form at last year’s AHA meeting. Look for a major publication soon.
—Will the slightly different manner in which rivaroxaban thins the blood prove significant? So far, the two factor Xa inhibitors, rivaroxaban and apixaban, were found to be ‘noninferior’ to warfarin, whereas the direct thrombin inhibitor, dabigatran, was shown to be ‘superior.’ Is this related to trial designs, or are they real differences?
—Rocket-AF randomized very high-risk AF patients. More than half had a previous history of stroke (or transient stroke), and the average CHADS score — a 6-point measure of stroke risk — was 3.5. As the current debate goes with dabigatran, it’s hard to know whether lower-risk patients doing well on warfarin should switch to rivaroxaban. Clinical judgement will play a large role here; so will patient choice.
—After approval of rivaroxaban, this question will naturally arise: Which is the best blood thinner? Watch for Bayer/Johnson & Johnson to posture the once-daily dosing of rivaroxaban as a major advantage to dabigatran. At the same time, Boehringer-Ingelheim will counter that dabigatran was shown to be superior to warfarin, rather than noninferior. The intricacies of the two trials (RE-LY versus Rocket-AF) will provide infinite ways to compare the two drugs, but without a head-to-head comparison, we simply will not be able to declare a winner.
—It will not be long before the fourth oral blood thinner is approved. Preliminary reports show that apixaban, another factor Xa-inhibitor, appears to be effective in reducing strokes in AF patients. Bristol-Myers Squibb and Pfizer recently announced (in a press release) that the 18,000-patient-strong ARISTOTLE trial showed apixaban to be noninferior to warfarin. An official presentation of the data awaits.
—Dabigatran has practical limitations: (1) Cost. Many patients simply cannot (or will not) pay for a drug that promises statistical benefits in the future. (2) The issue of compliance is both real and unmeasurable. I make judgements (often uneasy ones) every day on whether I think a patient can comply with taking the drug every 12 hours. Can, or did, the patient understand my instructions? (3) Dabigatran causes significant GI side effects — at minimum 10% of the time. The company says these are minor “nuisance” side effects. Maybe so, but I will tell you that sifting through symptoms of AF patients is hard enough, without adding a new pill to the mix. Is the AF patient feeling badly because of AF or because of this new pill?
For now, AF patients at risk for stroke have a choice between dabigatran and warfarin. But there will soon be other choices.
Perhaps in my career, warfarin will be one of those treatments that doctors remember with words like these:
“…remember when we treated people with that ****”
July 14th, 2011
Recurrent Arterial Thrombosis plus GI Bleeding in an Elderly Woman
Faiza Hashmi, MD and James Fang, MD
An 85-year-old woman with a history of hypertension and Crohn’s disease presented with severe pain in the left hand and was admitted to the hospital. Examination revealed a diminished left-radial pulse; arterial Doppler imaging showed a thrombus in the radial artery. The patient underwent surgical thrombectomy. The workup, including a hypercoagulability profile, was negative. Transthoracic and transesophageal echocardiograms did not reveal any intracardiac thrombi or valvular lesions.
After surgery, the patient was started on a heparin drip, with a plan to transition to warfarin for long-term anticoagulation. However, her primary care physician started her on dabigatran (75 mg twice daily) instead of warfarin, for ease of monitoring in an elderly patient.
Ten days after discharge, the patient presented to the ED complaining of dark bowel movements that had started the previous day. Blood was found in her stool. She was admitted to the ICU, and dabigatran was discontinued. She received 2 units of packed red blood cells and 4 units of fresh frozen plasma to reverse the coagulopathy — and underwent colonoscopy with clipping of the bleeding vessel.
Three days later, the patient again complained of left-hand pain and numbness. Her skin was cold, mottled, and bluish in appearance. Repeat arterial Doppler imaging revealed a thrombus in the left radial artery, and the patient was quickly taken to the operating room for another thrombectomy.
Questions:
1. How should anticoagulation proceed, given the patient’s recurrent arterial thrombosis and recent gastrointestinal bleeding?
2. Did the off-label use of dabigatran, rather than use of warfarin, to treat an arterial thrombosis contribute in any way to the patient’s complications?
3. What other causes of the arterial thrombosis should be considered? What additional tests, if any, should be performed?
Response:
1. The standard of care in this situation would still be heparin anticoagulation with transition to warfarin, given that the GI bleeding was due to a specific treatable cause. My concern is that the underlying cause of the arterial thrombosis has yet to be clearly identified. In fact, the arterial thrombosis is recurrent in the same place (namely, the radial artery) and is suggestive of a vascular abnormality rather than an embolic phenomenon and/or pure thrombophilia.
Although malignancy is classically associated with migratory superficial venous thrombosis, it has been found with DVTs and arterial thromboses. In such cases, a high-dose low-molecular-weight heparin may be more effective. Some might add an antiplatelet agent such as aspirin or clopidogrel to warfarin, but this strategy would complicate a GI bleed (if another were to occur), given that the effects of the antiplatelet agents are not easily reversible. The sole use of an antiplatelet agent could be considered, but in most experiences recurrence rates are high.
2. Warfarin would likely have been associated with the same issue of GI bleeding but may have been more effective an anticoagulant in this setting. Extrapolating dabigatran data to the treatment of an arterial thrombosis, particularly in an older patient like this with unclear renal function, is probably not prudent without more published evidence of its efficacy in this clinical context.
3. The recurrent nature of the arterial thrombosis in the same territory suggests a vascular abnormality such as atherosclerosis, thoracic outlet syndrome, or a large-vessel aneurysm. Such a vascular abnormality could also be complicated by a thrombophilia or medium- to large-vessel vasculitis (e.g. Takayasu’s or giant cell arteritis), particularly in light of the Crohn’s disease. I’d consider a magnetic resonance or CT angiography of the thorax to look for abnormal vascular structures. Vasospastic disease is also possible but a difficult diagnosis to make. It would be interesting to know what the “hypercoagulable” workup consisted of. An embolic process is more likely to occur from a localized arterial aneurysm or the aortic arch rather than the heart, in light of the recurrent location of the thrombosis. Heparin-induced thrombocytopenia is unlikely.
July 13th, 2011
Maryland Revokes Medical License of Mark Midei: Doctor Accused of Implanting Unnecessary Stents
Larry Husten, PHD
The Maryland Board of Physicians has revoked the medical license of Mark Midei–the interventional cardiologist accused of implanting hundreds of unnecessary stents at St. Joseph Medical Center in the community of Towson. In its Final Decision and Order the Maryland Board found that Midei was guilty of unprofessional conduct, willfully making a false report, gross overutilization of health care services, violating the standard of quality care, and failure to keep adequate medical records.
The Maryland board issued its final decision today, following a 7-day evidentiary hearing in which Midei was present (and in which he was represented by 9 attorneys), and a subsequent oral appeal on June 22, 2011.
The finding was based on a detailed review of 5 cases. This review, according to the board, was entirely distinct and separate from the investigation of Midei performed by St. Joseph Medical Center.
The board found that Midei “implanted cardiac stents unnecessarily in four of the five patients in question. In every one of the patients, he falsified the extent of blockage of the patients’ coronary arteries by reporting that it was 80% when it was in reality lower– and in most cases much lower.” In 3 cases Midei said the patients had unstable angina when they did not. In addition, in all cases he failed to obtain the Active Coagulation Time (ACT) and “instead simply administered heparin while inserting the catheter,” endangering one patient who had already received an anti-coagulant.
In its lengthy decision, the board “noted some inconsistencies or equivocations in the testimony of Dr. Midei’s primary expert witness, Dr. O’Neill.” The board discredited much of O’Neill’s testimony as it was based on “later-remembered, unrecorded symptoms– symptoms that Dr. O’Neill learned about only orally, from Dr. Midei.” O’Neill, according to the board, was paid $30,000 by Midei for his expert testimony. The state’s expert witness, Matthews Chacko, received $1,400.
The ruling also states that Midei claimed in his defense “that it is appropriate for him to write ‘80%’ to describe a blockage that is in fact less than 50%.” The board said this was “a blatant falsehood that resulted in patients receiving unneeded stents as well as the creation of false records…”
The board rejected Midei’s contention “that the fact that a cardiologist sent a patient to him is in itself evidence of significant symptoms that required his intervention by the placement of stents.”
The board also rejected Midei’s defense that he was not paid based on volume. The board noted that he was hired as an employee by the hospital “at triple his previous salary” and that “he was employed under circumstances in which any employee would feel at least some pressure to produce a high volume of stents.”
July 13th, 2011
Therapeutic Hypothermia Network Provides Benefit to Cardiac Arrest Patients
Larry Husten, PHD
Previous studies have shown that therapeutic hypothermia (TH) improves outcomes in patients who have an out-of-hospital cardiac arrest (OHCA). In a new paper published in Circulation, Michael Mooney and colleagues report on their experience with 140 OHCA patients in Minnesota who received treatment within a regional network of care that transfers OHCA patients to a TH-capable hospital. Prior to arrival at the specialized TH center, patients are cooled with ice bags.
More than half of the patients (56%) survived to hospital discharge. Of these, 92% had a positive neurological outcome. The risk of death increased by 20% for each hour of delay to the start of cooling. Outcomes were similar whether patients were transferred to a TH-capable hospital or were originally treated at a TH-capable hospital. “What our data show is if you have a cardiac arrest 200 miles away or on our doorstep, the quality of the outcomes is identical,” said Mooney in an AHA press release.
The authors report that they were able to successfully achieve concurrent TH with PCI for MI patients without a delay in either procedure. They conclude that TH “can provide an effective rescue therapy for OHCA and should be readily adopted within the context of existing STEMI networks.”
July 12th, 2011
Study Finds High Sodium-Potassium Ratio Strongly Tied to Mortality and CV Disease
Larry Husten, PHD
The separate roles of sodium and potassium in cardiovascular disease have been extensively observed in epidemiologic studies. Now a study published in the Archives of Internal Medicine examines their joint effect.
Quanhe Yang and colleagues analyzed data from 12,267 adults participating in the Third National Health and Nutrition Examination Survey. As expected, they found that higher sodium intake was associated with an increased risk of death from any cause, while higher potassium intake was associated with a lower risk of death. However, potassium — but not sodium — intake was significantly (and inversely) associated with cardiovascular and coronary mortality. A higher sodium-potassium ratio was strongly tied to all outcomes.
Here are the hazard ratios comparing the highest-quartile with the lowest-quartile sodium-potassium ratios:
- all-cause mortality: 1.46 (CI, 1.27-1.67)
- CVD mortality: 1.46 (CI, 1.11-1.92)
- ischemic heart disease mortality: 2.15 (CI, 1.48-3.12)
The authors point out that salt is frequently added to processed foods, thereby increasing the sodium-potassium ratio, while fruits, vegetables, and dairy products tend to have a lower ratio. Therefore, “a low sodium-potassium ratio may be a marker of high intake of plant foods and lower intake of processed foods.” They conclude that “public health recommendations should emphasize simultaneous reduction in sodium intake and increase in potassium intake.”
In an invited commentary, Lynn Silver and Thomas Farley write that the “safest and preferred pathway” to increase dietary potassium is to increase the “consumption of unprocessed, potassium-rich fruits and vegetables,” but they point out that “years of educational campaigns” have had little impact. Although potassium supplements have beneficial effects, they also carry the risk of hyperkalemia. They recommend that “efforts to reduce sodium artificially added to the food supply during processing should continue, because they have positive impacts on absolute sodium intake and the sodium-potassium ratio and thus should reduce mortality.”
July 12th, 2011
Pass (Up) the Guidelines, Please
Richard A. Lange, MD, MBA and L. David Hillis, MD
The Occluded Artery Trial (OAT) demonstrated no benefit of routine PCI in persistently occluded infarct-related arteries identified more than 24 hours after MI. These results were incorporated into the revised guidelines for STEMI, NSTEMI, and PCI (published in 2007 and 2008) as a class III recommendation (i.e., not indicated and inappropriate). The senior investigator for OAT — and coauthor of the revised STEMI guidelines — now reports that the results of OAT have not been incorporated into practice: many patients still undergo late reperfusion (>24 hrs) with PCI of the occluded infarct-related artery despite being asymptomatic and stable.
Why haven’t the guidelines been implemented?
Are many physicians unfamiliar with the guidelines? Possibly. Many busy practitioners find the exhaustive guidelines exhausting to read: excessively long and difficult to navigate.
More likely, physician and patient barriers play a large role in the inappropriate use of angiography and PCI, as we highlighted in a previous editorial. How so?
- In an era in which invasive cardiac procedures are manifestations of high-technology, resource-intensive medical care, many patients expect and insist on aggressive management. The term “conservative management” may project the impression (to physicians and patients alike) of obsolescence, inadequacy, and inferiority rather than of thoughtful reflection and the application of scientifically based, ischemia-guided therapy.
- Physicians are skeptical about the applicability of the results of trials (and guidelines) to their patients. We refer to these as the “DAM” studies (Doesn’t Apply to Me).
- Studies that substantiate preconceived notions are likely to be embraced and their recommendations followed, whereas those that do not are often ignored.
- The abundance of facilities for prompt angiography and revascularization, physicians trained to perform these procedures, and monetary remuneration to the facilities and physicians encourages the use of angiography and revascularization without a clear indication.
In the event of an adverse outcome, the patient and his or her family may be more understanding and forgiving if an aggressive approach was pursued (i.e., if “everything possible was done”), even if such an approach contributes, directly or indirectly, to the adverse outcome.
Do we need more guidelines? Probably not, since we don’t effectively implement the ones we have.
What are your thoughts? How can we more effectively integrate guidelines into clinical practice?
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