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Cardiolo gy News The Leading Independent Newspaper for the Cardiologist

The Leading Independent Newspaper for the Cardiologist V O L . 6, N O . 2

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Newspaper for the Cardiologist V O L . 6, N O . 2 The ENHANCE results

The ENHANCE results were “disappointing, but not surprising” because of the study’s design, according to Dr. Michael Davidson.

Experts Split on Ezetimibe’s Value


Philadelphia Bureau

W hen results from the

controversial study

that assessed ezetim-

ibe’s ability to slow atheroscle- rotic progression when added to a high-dose statin regimen were reported via a press release on Jan. 14, cardiologists split on whether the findings signaled a flawed study or a flawed drug. The results were “disappoint- ing, but not surprising because I had a lot of concern that this was not the right patient popula- tion and not the right methodol- ogy,” Dr. Michael Davidson, pro- fessor of medicine and director of preventive cardiology at the Uni- versity of Chicago, told CARDI-


But other experts tied the study’s negative result to limita- tions of ezetimibe itself. “It appears that this method for lowering LDL cholesterol is not beneficial,” commented Dr. Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic. “I was always worried that LDL lowering with ezetimibe might be less effective than LDL lower- ing with a statin. Statins do many other things that ezetimibe does not do: Statins raise HDL cho- lesterol, lower triglycerides, and reduce inflammation,” he said in an interview.

There are several possible ex- planations why the combination of ezetimibe plus simvastatin failed to slow atherosclerotic pro- gression any better than an iden- tical dosage of simvastatin alone, Dr. Christie M. Ballantyne, pro- fessor of medicine at Baylor Col- lege of Medicine, Houston, and chief of the section of athero- sclerosis and vascular medicine told CARDIOLOGY NEWS. “One ex- planation is that there are differ- ences in the drug effects [be- tween ezetimibe and statins] that go beyond their reduction of LDL. Another is that the trial had technical issues.” See Ezetimibe page 20



  I I N N S S I I D D E E A Shocking Omission

A Shocking


Few physicians talk about ICD shutoff at end of life.



Marrow Victory

Bone marrow cells improved contractile recovery after ST-elevation MI.



contractile recovery after ST-elevation MI. PAGE 7 Contrasting Positions Cardiologists push the FDA to



Cardiologists push the FDA to reconsider its black box warning on contrast agents.





National Health Expenditures As Percentage of Gross Domestic Product

15.8% 15.9% 15.9% 16.0%

13.8% 12.3% 9.1% 7.2%









Note: Based on data from the Centers for Medicare and Medicaid Services. Source: Health Affairs

New Data Drive Guideline Changes For PCI and STEMI

Rapid reperfusion is ultimate STEMI goal.


San Francisco Bureau

T he pace of research in car-

diology is proceeding so

rapidly that important

changes have just been issued to two guidelines initially promul- gated in the not-so-distant past. Announced in December, the “focused updates” involve the treatment of ST-elevation my- ocardial infarction (STEMI) and the technique of percutaneous coronary intervention (PCI). While the updates maintained many of the recommendations in the full guidelines, issued in 2004 for STEMI and 2005 for PCI, they each included significant recom- mendations for practice changes.

The STEMI updates, for ex- ample, reiterate that the overar- ching goal of treatment remains rapid reperfusion. But they state that, with the exception of as- pirin, NSAIDs and cyclooxyge- nase-2 inhibitors should be dis- continued immediately. And β-blockers should not be admin- istered to patients in certain high- risk groups. The PCI updates emphasized the importance of ensuring that patients will be able to comply with dual antiplatelet therapy for a full year after receiving a drug- eluting stent. Bare-metal stents should be substituted when that compliance can’t be ensured. This dual antiplatelet therapy is

See Guideline page 8

Calcium Supplements Up MI Risk in Older Women


Miami Bureau

C alcium supplementation sig- nificantly increased the risk

of a myocardial infarction among healthy, postmenopausal women, compared with placebo, in a sec- ondary analysis of an osteoporo- sis study. Physicians should consider this increased cardiovascular risk against other clinical benefits of calcium supplementation in old- er women until confirmatory studies can be completed, the au- thors suggested. “It is an important finding be-

cause so many women are pre- scribed calcium supplements,” Dr. Rita F. Redberg said in an in- terview. “I would not recom- mend calcium supplementation based on this finding. This raises enough concern. With any sup- plement, you have to show evi- dence of benefit without risk,” said Dr. Redberg, who was not involved in the study. The HDL/LDL cholesterol ra- tios improved among the 732 women who took daily calcium supplementation, compared with the 739 participants who took placebo. This suggests that a dif-

See Supplements page 6


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Anticoagulation for DES a Priority

Guideline from page 1

so important that physicians should take into account the possibility that the patient may later need medical procedures that would require that antiplatelet therapy be discontinued. Bare-metal stents or balloon angioplasty with provisional stent im- plantation should be considered for those patients. The STEMI update was a joint effort of the American College of Cardiology and the American Heart Association and ap- peared in the Jan. 15, 2008 issues of Circu- lation and the Journal of the American Col- lege of Cardiology. The PCI update was a joint effort of the ACC, the AHA, and the Society for Cardiovascular Angiography and Interventions (SCAI) and appeared in Circulation, the Journal of the American College of Cardiology, and Catheteriza- tion and Cardiovascular Interventions. The updates are available online at www.amer- and

The focused update strategy was devel- oped by ACC/AHA Task Force on Prac- tice Guidelines as a way to speed up the often years-long process of developing comprehensive new guidelines on the ba- sis of full literature reviews. Twice a year or more experts are polled, and if there is a consensus that data from late-breaking clinical trials warrant an update, one can be prepared relatively quickly. (See side- bars for update highlights.) According to Dr. Elliott M. Antman, cochair of the STEMI update committee and chair of the 2004 writing committee, new research suggests several important changes in the management of this most critical type of heart attack. Among at least 15 guideline modifications or additions, he highlighted several in an interview. “We indicate that physicians should not routinely administer intravenous β-block- ers acutely to patients with heart failure or

Highlights of STEMI Focused Update

A ccording to the published STEMI guidelines, with additional infor-

mation from Dr. Eric Bates, cardiolo- gist and professor of medicine at the University of Michigan, Ann Arbor:

The overarching goal for treatment of STEMI is that reperfusion therapy should begin within 2 hours, and ide- ally within 1 hour of the event. The use of PCI shouldn’t obscure the importance of fibrinolytic therapy. With the exception of aspirin, all NSAIDs and cyclooxygenase-2 inhibitors should be discontinued immediately at the time of STEMI. If the patient re- quires chronic pain management, the recommendations call for a stepped- care approach beginning with aceta- minophen or aspirin, small doses of narcotics, or nonacetylated salicylates. Early intravenous β-blocker therapy should not be given to STEMI patients who have signs of heart failure, evi- dence of a low-output stage, increased risk of cardiogenic shock, or other rel- ative contraindications to β-blockade. Long-term oral β-blockers should be used for secondary prevention in patients at high risk, once stabilized. The strategy of facilitated PCI

(planned PCI immediately after admin- istration of therapy to improve coro- nary patency) may be considered in subgroups of patients with a large MI or hemodynamic or electrical instabili- ty who are at low risk of bleeding. Rescue PCI is suitable for patients who have received fibrinolytic therapy and who have cardiogenic shock, he- modynamically compromising ventric- ular arrhythmia, or severe congestive heart failure and/or pulmonary edema. Patients undergoing reperfusion with fibrinolytics should receive anti- coagulant therapy for at least 48 hours and preferably for the duration of the initial hospital stay up to 8 days. If an- ticoagulant therapy is given for more than 48 hours, regimens other than unfractionated heparin should be used. Clopidogrel should be added to as- pirin in patients with STEMI whether or not they receive reperfusion thera- py, and the clopidogrel should be con- tinued for at least 14 days. Emergency medical systems should use prehospital 12-lead ECG.

Sources: J. Am. Coll. Cardiol. 2008;51:210- 47 and Dr. Bates



February 2008

shock, or who are at risk for heart failure

or shock,” said Dr. Antman of Harvard

Medical School, Boston. “There is infor- mation about facilitated PCI indicating that a strategy of a full-dose fibrinolytic followed by immediate routine PCI is not

recommended anymore.” On the other hand, “It’s not unreason- able to use a strategy of preparatory phar- macological regimen other than a full- dose fibrinolytic and routine immediate PCI in certain situations where the patient is at risk, PCI cannot be performed with- in 90 minutes, and bleeding risk is low.” Dr. Antman said that he has not heard any significant criticisms of the new STE-

MI guidelines, and that most will not be

difficult to implement. “Physicians un- derstand the importance of responding to evidence,” he said. “These are strategies that are a matter of just organizing sys- tems of care for patients with STEMI. We would hope that physicians would meet as

a team in their local hospitals and local sys- tems and consider how they are going to approach the STEMI patients in the future with this new information in mind.” The recommendation for prehospital 12-lead ECG may be one of the most challenging to implement, since many emergency medical technicians are not trained in interpreting ECGs, and many ambulance systems don’t have prehospital ECG capability, he added. In the PCI update, “We are reaching a point where we really have to look across time and also understand the impact of ad- junctive therapies, and how we combine all of this I think is a real challenge,” said Dr. Sidney C. Smith Jr., cochair of the focused update writing committee, in an interview posted on the ACC’s Cardiosource Web site ( “I still think that the high-risk patients,


patients that are symptomatic, bene-


from revascularization, but we defi-

nitely are getting to a point where I per- sonally will be urging and being certain that my patients not only have revascu- larization when they need it, but that they adhere to the comprehensive medical ther- apies that are so important in terms of re- ducing future events,” continued Dr. Smith of the University of North Caroli-

na, Chapel Hill.

Each of the focused updates includes de-

tailed information about potential conflicts of interest among the members of the writ-

ing committees. Individual members who

appeared to have a conflict recused them- selves from voting on certain sections.

Highlights of the PCI Update

I mportant aspects of the PCI fo- cused update include:

After implantation of a DES, dual antiplatelet therapy comprising clopi- dogrel and aspirin is required for at least 1 year and possibly longer. If the patient is likely to face addi- tional surgery requiring interruption of dual antiplatelet therapy, a bare- metal stent (BMS) or balloon angio- plasty with provisional stent implan- tation should be considered instead of a DES.

Between 24 hours and 28 days af- ter a heart attack, PCI is not recom- mended in patients with one- or two-vessel disease and a totally oc- cluded coronary artery if they are not hemodynamically and electrical- ly stable and have no ongoing or eas- ily provoked chest pain. On the other hand, physicians might consider PCI for those pa- tients or patients who respond favor- ably to initial fibrinolysis treatment if they don’t continue to do well on drug therapy alone. The evidence supports an early in- vasive strategy for PCI in patients with unstable angina or non-STEMI who are at moderate and higher risk. In patients with STEMI, facilitated PCI with regimens other than full- dose fibrinolytic therapy may be considered in high-risk patients if PCI is not immediately available within 90 minutes and if the risk of bleeding is low. In patients with STEMI, a planned reperfusion strategy using full-dose fibrinolytic therapy followed by im- mediate PCI may be harmful. A strategy of coronary angiogra- phy with the intent to perform res- cue PCI is reasonable for patients in whom fibrinolytic therapy has failed. The update includes specific guidelines for ancillary therapy in patients undergoing PCI for STEMI who received prior treatment with unfractionated heparin, enoxaparin, or fondaparinux.

Source: J. Am. Coll. Cardiol. 2008;51:


CMS to Limit Use of Cardiac CT Angiography to Clinical Trials


“The Gray Sheet”

T he Center for Medicare and Medicaid Services wants to scale back coverage of cardiac CT angiography for

diagnosis of coronary artery disease by conditioning pay- ment for the imaging scans on enrollment in clinical stud- ies. It is the latest example of the agency’s commitment to its “coverage-with-evidence-development” policy. CTA is covered by most local Medicare contractors. However, in June CMS said it was considering setting a na- tional policy because of rapid adoption of the procedure. On the basis of its review of available evidence, CMS proposes that CTA for the diagnosis of CAD not be cov- ered for patients at high risk for disease, because they

most often need angiography anyway, and for patients at low risk, in whom the evidence for CTA is unfavorable. But the evidence for patients at intermediate risk suggests enough promise, CMS says, that those patients could be covered in the context of a clinical study if they had chronic stable angina, or unstable angina and low risk of short-term death. To qualify, a study would need to use a 32-slice scanner or higher, and address specified evidence gaps to show whether CTA is as effective as angiography, reduces the need for angiography, or improves health out- comes for patients presenting with acute chest pain. “The current CMS action is consistent with the need to get more evidence on use and benefits of this new tech- nology,” Dr. Rita Redberg of the University of California, San Francisco, who participated in a Medicare Evidence

Development and Coverage Advisory Committee meeting in May 2006, said in an interview. The panel lacked confi- dence in the evidence for noninvasive imaging for diag- nosing CAD, and no large studies since then have looked at outcomes data. Indeed, CT angiography is limited by its “less than opti- mal positive predictive value for identifying patients who have ischemia,” Dr. George Beller said in an interview. “This is because the severity of coronary stenosis tends to be over- estimated by the noninvasive CT technique, compared with quantitative coronary angiography and with functional imaging techniques that detect inducible ischemia,” added Dr. Beller of the University of Virginia, Charlottesville.

This newspaper and “The Gray Sheet” are published by Elsevier.

Pages 8a—8d