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Cardiology News

VO L . 6 , N O. 2 T he Leading Inde p endent Ne wspaper for the Cardiologist F E B R UA RY 2 0 0 8

New Data Drive
Guideline Changes
Rapid reperfusion is ultimate STEMI goal.
A Shocking BY ROBERT FINN The STEMI updates, for ex-
Omission San Francisco Bureau ample, reiterate that the overar-
Few physicians talk about ching goal of treatment remains

ICD shutoff at end of life. he pace of research in car- rapid reperfusion. But they state
diology is proceeding so that, with the exception of as-
PAGE 19 rapidly that important pirin, NSAIDs and cyclooxyge-
The ENHANCE results were “disappointing, but not surprising” changes have just been issued to nase-2 inhibitors should be dis-
because of the study’s design, according to Dr. Michael Davidson. two guidelines initially promul- continued immediately. And
Marrow Victory gated in the not-so-distant past. β-blockers should not be admin-
Bone marrow cells improved Announced in December, the istered to patients in certain high-

Experts Split on contractile recovery after
ST-elevation MI.
“focused updates” involve the
treatment of ST-elevation my-
ocardial infarction (STEMI) and
risk groups.
The PCI updates emphasized
the importance of ensuring that

Ezetimibe’s Value PAGE 7 the technique of percutaneous
coronary intervention (PCI).
While the updates maintained
patients will be able to comply
with dual antiplatelet therapy for
a full year after receiving a drug-
BY MITCHEL L. ZOLER There are several possible ex- many of the recommendations in eluting stent. Bare-metal stents
Philadelphia Bureau planations why the combination the full guidelines, issued in 2004 should be substituted when that
of ezetimibe plus simvastatin for STEMI and 2005 for PCI, they compliance can’t be ensured.

hen results from the failed to slow atherosclerotic pro- each included significant recom- This dual antiplatelet therapy is
controversial study gression any better than an iden- mendations for practice changes. See Guideline page 8
that assessed ezetim- tical dosage of simvastatin alone,
ibe’s ability to slow atheroscle- Dr. Christie M. Ballantyne, pro-
rotic progression when added to
a high-dose statin regimen were
fessor of medicine at Baylor Col-
lege of Medicine, Houston, and Calcium Supplements Up
reported via a press release on chief of the section of athero-
Jan. 14, cardiologists split on sclerosis and vascular medicine Contrasting MI Risk in Older Women
whether the findings signaled a told CARDIOLOGY NEWS. “One ex- Positions
flawed study or a flawed drug. planation is that there are differ- Cardiologists push the FDA BY DAMIAN MCNAMARA cause so many women are pre-
The results were “disappoint- ences in the drug effects [be- Miami Bureau scribed calcium supplements,”
to reconsider its black box
ing, but not surprising because I tween ezetimibe and statins] that Dr. Rita F. Redberg said in an in-
warning on contrast agents.
had a lot of concern that this
was not the right patient popula-
tion and not the right methodol-
go beyond their reduction of
LDL. Another is that the trial
had technical issues.”
PAGE 28 C alcium supplementation sig-
nificantly increased the risk
of a myocardial infarction among
terview. “I would not recom-
mend calcium supplementation
based on this finding. This raises
ogy,” Dr. Michael Davidson, pro- See Ezetimibe page 20 healthy, postmenopausal women, enough concern. With any sup-
fessor of medicine and director of compared with placebo, in a sec- plement, you have to show evi-
preventive cardiology at the Uni- VITAL SIGNS ondary analysis of an osteoporo- dence of benefit without risk,”
versity of Chicago, told CARDI- sis study. said Dr. Redberg, who was not
OLOGY NEWS. Physicians should consider this involved in the study.
National Health Expenditures
But other experts tied the increased cardiovascular risk The HDL/LDL cholesterol ra-
study’s negative result to limita- As Percentage of Gross Domestic Product against other clinical benefits of tios improved among the 732
tions of ezetimibe itself. 15.8% 15.9% 15.9% 16.0% calcium supplementation in old- women who took daily calcium
“It appears that this method for er women until confirmatory supplementation, compared with
lowering LDL cholesterol is not 12.3% studies can be completed, the au- the 739 participants who took
beneficial,” commented Dr. thors suggested. placebo. This suggests that a dif-
Steven Nissen, chairman of the 9.1% “It is an important finding be- See Supplements page 6
department of cardiovascular 7.2%
medicine at the Cleveland Clinic. CARDIOLOGY NEWS Presorted Standard
U.S. Postage
“I was always worried that LDL 5635 Fishers Lane, Suite 6000 PAID

Rockville, MD 20852 Permit No. 384
lowering with ezetimibe might Lebanon Jct. KY
be less effective than LDL lower-
ing with a statin. Statins do many
1970 1980 1990 2000 2003 2004 2005 2006
other things that ezetimibe does
not do: Statins raise HDL cho-
Note: Based on data from the Centers for Medicare and Medicaid
lesterol, lower triglycerides, and Services.
reduce inflammation,” he said in Source: Health Affairs
an interview.
8 News CARDIOLOGY NEWS • Febr uar y 2008

Anticoagulation for DES a Priority shock, or who are at risk for heart failure
or shock,” said Dr. Antman of Harvard Highlights of the
Guideline from page 1 Medical School, Boston. “There is infor-
mation about facilitated PCI indicating PCI Update
so important that physicians should take The focused update strategy was devel- that a strategy of a full-dose fibrinolytic
into account the possibility that the patient
may later need medical procedures that
would require that antiplatelet therapy be
oped by ACC/AHA Task Force on Prac-
tice Guidelines as a way to speed up the
often years-long process of developing
followed by immediate routine PCI is not
recommended anymore.”
On the other hand, “It’s not unreason-
I mportant aspects of the PCI fo-
cused update include:
씰 After implantation of a DES, dual
discontinued. Bare-metal stents or balloon comprehensive new guidelines on the ba- able to use a strategy of preparatory phar- antiplatelet therapy comprising clopi-
angioplasty with provisional stent im- sis of full literature reviews. Twice a year macological regimen other than a full- dogrel and aspirin is required for at
plantation should be considered for those or more experts are polled, and if there is dose fibrinolytic and routine immediate least 1 year and possibly longer.
patients. a consensus that data from late-breaking PCI in certain situations where the patient 씰 If the patient is likely to face addi-
The STEMI update was a joint effort of clinical trials warrant an update, one can is at risk, PCI cannot be performed with- tional surgery requiring interruption
the American College of Cardiology and be prepared relatively quickly. (See side- in 90 minutes, and bleeding risk is low.” of dual antiplatelet therapy, a bare-
the American Heart Association and ap- bars for update highlights.) Dr. Antman said that he has not heard metal stent (BMS) or balloon angio-
peared in the Jan. 15, 2008 issues of Circu- According to Dr. Elliott M. Antman, any significant criticisms of the new STE- plasty with provisional stent implan-
lation and the Journal of the American Col- cochair of the STEMI update committee MI guidelines, and that most will not be tation should be considered instead
lege of Cardiology. The PCI update was a and chair of the 2004 writing committee, difficult to implement. “Physicians un- of a DES.
joint effort of the ACC, the AHA, and the new research suggests several important derstand the importance of responding to 씰 Between 24 hours and 28 days af-
Society for Cardiovascular Angiography changes in the management of this most evidence,” he said. “These are strategies ter a heart attack, PCI is not recom-
and Interventions (SCAI) and appeared in critical type of heart attack. Among at least that are a matter of just organizing sys- mended in patients with one- or
Circulation, the Journal of the American 15 guideline modifications or additions, he tems of care for patients with STEMI. We two-vessel disease and a totally oc-
College of Cardiology, and Catheteriza- highlighted several in an interview. would hope that physicians would meet as cluded coronary artery if they are
tion and Cardiovascular Interventions. The “We indicate that physicians should not a team in their local hospitals and local sys- not hemodynamically and electrical-
updates are available online at www.amer- routinely administer intravenous β-block- tems and consider how they are going to ly stable and have no ongoing or eas- and ers acutely to patients with heart failure or approach the STEMI patients in the future ily provoked chest pain.
with this new information in mind.” 씰 On the other hand, physicians
The recommendation for prehospital might consider PCI for those pa-
Highlights of STEMI Focused Update 12-lead ECG may be one of the most
challenging to implement, since many
tients or patients who respond favor-
ably to initial fibrinolysis treatment

A ccording to the published STEMI
guidelines, with additional infor-
mation from Dr. Eric Bates, cardiolo-
(planned PCI immediately after admin-
istration of therapy to improve coro-
nary patency) may be considered in
emergency medical technicians are not
trained in interpreting ECGs, and many
ambulance systems don’t have prehospital
if they don’t continue to do well on
drug therapy alone.
씰 The evidence supports an early in-
gist and professor of medicine at the subgroups of patients with a large MI ECG capability, he added. vasive strategy for PCI in patients
University of Michigan, Ann Arbor: or hemodynamic or electrical instabili- In the PCI update, “We are reaching a with unstable angina or non-STEMI
씰 The overarching goal for treatment ty who are at low risk of bleeding. point where we really have to look across who are at moderate and higher risk.
of STEMI is that reperfusion therapy 씰 Rescue PCI is suitable for patients time and also understand the impact of ad- 씰 In patients with STEMI, facilitated
should begin within 2 hours, and ide- who have received fibrinolytic therapy junctive therapies, and how we combine all PCI with regimens other than full-
ally within 1 hour of the event. and who have cardiogenic shock, he- of this I think is a real challenge,” said Dr. dose fibrinolytic therapy may be
씰 The use of PCI shouldn’t obscure the modynamically compromising ventric- Sidney C. Smith Jr., cochair of the focused considered in high-risk patients if
importance of fibrinolytic therapy. ular arrhythmia, or severe congestive update writing committee, in an interview PCI is not immediately available
씰 With the exception of aspirin, all heart failure and/or pulmonary edema. posted on the ACC’s Cardiosource Web site within 90 minutes and if the risk of
NSAIDs and cyclooxygenase-2 inhibitors 씰 Patients undergoing reperfusion ( bleeding is low.
should be discontinued immediately at with fibrinolytics should receive anti- “I still think that the high-risk patients, 씰 In patients with STEMI, a planned
the time of STEMI. If the patient re- coagulant therapy for at least 48 hours the patients that are symptomatic, bene- reperfusion strategy using full-dose
quires chronic pain management, the and preferably for the duration of the fit from revascularization, but we defi- fibrinolytic therapy followed by im-
recommendations call for a stepped- initial hospital stay up to 8 days. If an- nitely are getting to a point where I per- mediate PCI may be harmful.
care approach beginning with aceta- ticoagulant therapy is given for more sonally will be urging and being certain 씰 A strategy of coronary angiogra-
minophen or aspirin, small doses of than 48 hours, regimens other than that my patients not only have revascu- phy with the intent to perform res-
narcotics, or nonacetylated salicylates. unfractionated heparin should be used. larization when they need it, but that they cue PCI is reasonable for patients in
씰 Early intravenous β-blocker therapy 씰 Clopidogrel should be added to as- adhere to the comprehensive medical ther- whom fibrinolytic therapy has failed.
should not be given to STEMI patients pirin in patients with STEMI whether apies that are so important in terms of re- 씰 The update includes specific
who have signs of heart failure, evi- or not they receive reperfusion thera- ducing future events,” continued Dr. guidelines for ancillary therapy in
dence of a low-output stage, increased py, and the clopidogrel should be con- Smith of the University of North Caroli- patients undergoing PCI for STEMI
risk of cardiogenic shock, or other rel- tinued for at least 14 days. na, Chapel Hill. who received prior treatment with
ative contraindications to β-blockade. 씰 Emergency medical systems should Each of the focused updates includes de- unfractionated heparin, enoxaparin,
씰 Long-term oral β-blockers should use prehospital 12-lead ECG. tailed information about potential conflicts or fondaparinux.
be used for secondary prevention in of interest among the members of the writ-
patients at high risk, once stabilized. Sources: J. Am. Coll. Cardiol. 2008;51:210- ing committees. Individual members who Source: J. Am. Coll. Cardiol. 2008;51:
씰 The strategy of facilitated PCI 47 and Dr. Bates appeared to have a conflict recused them- 172-209
selves from voting on certain sections. ■

CMS to Limit Use of Cardiac CT Angiography to Clinical Trials
B Y C H L O E TA F T most often need angiography anyway, and for patients at Development and Coverage Advisory Committee meeting
“The Gray Sheet” low risk, in whom the evidence for CTA is unfavorable. in May 2006, said in an interview. The panel lacked confi-
But the evidence for patients at intermediate risk suggests dence in the evidence for noninvasive imaging for diag-

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-
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
nosing CAD, and no large studies since then have looked
at outcomes data.
Indeed, CT angiography is limited by its “less than opti-
ment for the imaging scans on enrollment in clinical stud- short-term death. To qualify, a study would need to use mal positive predictive value for identifying patients who
ies. It is the latest example of the agency’s commitment a 32-slice scanner or higher, and address specified evidence have ischemia,” Dr. George Beller said in an interview. “This
to its “coverage-with-evidence-development” policy. gaps to show whether CTA is as effective as angiography, is because the severity of coronary stenosis tends to be over-
CTA is covered by most local Medicare contractors. reduces the need for angiography, or improves health out- estimated by the noninvasive CT technique, compared with
However, in June CMS said it was considering setting a na- comes for patients presenting with acute chest pain. quantitative coronary angiography and with functional
tional policy because of rapid adoption of the procedure. “The current CMS action is consistent with the need to imaging techniques that detect inducible ischemia,” added
On the basis of its review of available evidence, CMS get more evidence on use and benefits of this new tech- Dr. Beller of the University of Virginia, Charlottesville. ■
proposes that CTA for the diagnosis of CAD not be cov- nology,” Dr. Rita Redberg of the University of California,
ered for patients at high risk for disease, because they San Francisco, who participated in a Medicare Evidence This newspaper and “The Gray Sheet” are published by Elsevier.
Pages 8a—8d佥