From St Luke's Episcopal Hospital, Texas Heart Institute, Baylor
College of Medicine, The University of Texas Health Science Center at Houston.
The following studies
were presented at the 47th Annual Scientific Sessions of the
American College of Cardiology in Atlanta, Ga, March
29–April 1, 1998.
Acute Coronary Syndromes
TIMI 14 (Final Results)
The study: A prospective, multicenter, randomized,
controlled trial of combined therapy with thrombolytic
agents and the platelet glycoprotein IIb/IIIa
antagonist abciximab in patients with AMI. A total of 681
patients were randomized to standard front-loaded tPA (100 mg),
streptokinase (500 000, 750 000, 1 250 000, or 1 500 000 U) plus
abciximab, low-dose tPA (20, 35, 50, or 65 mg) plus abciximab, or
abciximab alone. In the streptokinase groups, lytic therapy was
administered as a 30- to 50-minute infusion. In the tPA groups, lytic
therapy was administered as either a bolus, a bolus plus a 30-minute
infusion, or a bolus plus a 60-minute infusion. The primary end point
of the study was the incidence of TIMI grade 3 flow at 90-minute
angiography.
The results: The incidence of TIMI 3 flow at 90 minutes was
58% in the tPA-alone arm (n=146), 32% in the abciximab-alone arm
(n=31), and 42% (n=36), 39% (n=49), 47% (n=47), and 80% (n=5;
discontinued because of excessive bleeding and excess mortality) in the
respective streptokinase-plus-abciximab groups. In the
tPA-plus-abciximab groups, the incidence of TIMI 3 flow at 90 minutes
was 53% (20-mg bolus; n=36), 38% (35-mg bolus; n=40), 62% (15-mg
bolus, 20-mg infusion over 30 minutes; n=50), 54% (50-mg bolus; n=28),
61% (15-mg bolus, 35-mg infusion over 30 minutes; n=46), 79% (15-mg
bolus, 35-mg infusion over 60 minutes; n=34), and 71% (15-mg bolus,
50-mg infusion over 60 minutes; n=31). A group that combined tPA (15-mg
bolus, 35-mg infusion over 60 minutes) with higher-dose abciximab (and
reduced heparin) had a 90-minute TIMI 3 flow rate of 69% (n=36). The
incidence of major bleeding was 6% with tPA alone; 6% with abciximab
alone; 5%, 8%, 14%, and 67% (discontinued arm) in the respective
streptokinase groups; and 5%, 4%, 0%, 8%, 8%, 5%, and 0% in the
respective tPA groups. The higher-dose abciximab group had a 15%
incidence of major bleeding.
Summary: Abciximab alone achieves TIMI 3 flow rates
comparable to streptokinase alone (in prior studies). The combination
of reduced-dose thrombolytic therapy and abciximab
augments the rate and extent of thrombolysis. With
streptokinase plus abciximab, there appears to be a dose-related
increased risk of major bleeding, and unacceptably high rates of
bleeding and mortality occur with full-dose streptokinase plus
abciximab. The combination of reduced-dose tPA (bolus plus infusion)
with abciximab is a promising alternative to full-dose accelerated
tPA.
PACT
The study: A randomized, placebo-controlled trial of
preprocedure thrombolytic therapy in AMI patients
treated with primary PTCA. AMI patients presenting within 6 hours
of symptoms were randomized to receive either tPA (50-mg bolus; n=302)
or placebo (n=304) and brought immediately to coronary
angiography. If TIMI grade 3 flow was present at initial
angiography, a second bolus of study medication was administered. If
TIMI grade 0, 1, or 2 flow was present, the patient was treated
with PTCA. A predischarge follow-up angiogram was performed in all
patients on day 5 to 7. The primary end point of the study was the
ejection fraction on the predischarge ventriculogram.
The results: On initial angiography, the 50-mg tPA group had
higher rates of TIMI grade 2 (27.7% versus 19.5%) and grade 3 (32.8%
versus 14.8%) flow than did the placebo group. There was no
significant difference between groups in the final post-PTCA incidence
of TIMI grade 3 flow. There was no significant increase in major
bleeding events between groups. Predischarge LVEF, the primary end
point in the trial, was not significantly different between treatment
groups. However, there was a significant difference in the entire
population in mean predischarge LVEF between patients who had TIMI
grade 3 flow on arrival in the catheterization
laboratory (mean LVEF, 62%), those who had grade 3 flow after PTCA
(mean LVEF, 58%), and those who never achieved TIMI grade 3 flow (mean
LVEF, 55%).
Summary: AMI patients treated with a 50-mg bolus of tPA had
significant improvement in vessel patency before PTCA. Early patency in
the entire patient population was associated with an improvement in
ventricular function. There was no adverse effect of
preprocedure thrombolytic therapy on procedural safety
or outcome.
ESSENCE (1-Year Results)
The study: A multicenter, randomized, double-blind,
placebo-controlled, parallel group trial comparing low-molecular-weight
heparin (enoxaparin) with unfractionated heparin in patients with
unstable angina/non–Q-wave MI. A total of 3171 patients in 176 centers
in 8 countries were randomized to enoxaparin 1 mg/kg every 12 hours
plus aspirin versus standard intravenous unfractionated
heparin (titrated to activated partial thromboplastin times)
plus aspirin. Prior reports indicated significant benefit of enoxaparin
at 30 days in reducing the combined incidence of death, MI, or
recurrent angina. The current data represent follow-up of these
patients to 1 year.
The results: The composite incidence of death/MI/recurrent
angina at 1 year was 32.0% in the enoxaparin group and 35.7% in the
heparin group (P=0.022). The composite incidence of death/MI
at 1 year was 11.5% in the enoxaparin group and 13.5% in the heparin
group (P=0.08). By 1 year in the enoxaparin group, there
were significantly fewer repeat diagnostic
catheterizations (55.8% versus 59.4% with
unfractionated heparin) and fewer repeat
revascularizations (35.9% versus 41.2% with
unfractionated heparin). Regarding new end-point events (repeat
catheterization or
revascularization), there were no significant
differences between groups in the time period from day 31 to 1
year.
Summary: In patients with unstable angina/non–Q-wave MI,
the early benefits of enoxaparin over unfractionated heparin are
sustained at 1-year follow-up.
ARGAMI-2
The study: A randomized, controlled trial comparing 2
different doses of the direct thrombin antagonist
argatroban (60-µg bolus plus 2-µg ·
kg-1 · min-1
infusion for 72 hours or 120-µg bolus plus 4-µg ·
kg-1 · min-1
infusion for 72 hours) with heparin in patients with AMI treated with
thrombolytic therapy (streptokinase or tPA). The
primary end point of the trial was 30-day mortality. After an interim
analysis of 609 patients, the lower-dose argatroban arm of the
study was discontinued for lack of efficacy; the trial continued
enrollment, and a total of 1001 patients were considered in the final
analysis.
The results: There was no significant difference in 30-day
mortality between the high-dose argatroban group (5.5%; n=494) and the
heparin group (5.4%; n=507). Other secondary clinical event rates were
also similar between groups. There was a trend toward less frequent
major bleeding events in the argatroban group.
Summary: In patients with AMI treated with
thrombolytic therapy, argatroban was comparable to
heparin in terms of clinical efficacy and exhibited a trend toward
fewer major bleeding events.
Coronary Stenting
EPI-STENT
The study: A multicenter, randomized, parallel group trial
comparing stenting plus abciximab versus stenting alone versus PTCA
plus abciximab in 2399 patients undergoing elective and emergent
coronary intervention; all patients received aspirin. The
procedural heparin dose in the group not receiving abciximab was 100
U/kg titrated to activated clotting times >300 seconds; in the
2 abciximab arms, the heparin dose was 70 U/kg, titrated to
activated clotting times >200 seconds. The primary end point
of the study was the 30-day composite of death/MI/urgent
revascularization.
The results: The 30-day incidence of
death/MI/revascularization was 10.8% in the
stent-only group, 5.3% in the stent-plus-abciximab group, and 6.9% in
the PTCA-plus-abciximab group. The differences between groups were well
established by 24 hours after the procedure. A large component of the
30-day composite end point was the incidence of death or large
non–Q-wave (5x elevation of creatine kinase with positive MB)
infarctions: 7.8% in the stent-only group, 4.7% in the
stent-plus-abciximab group, and 3.0% in the PTCA-plus-abciximab group.
The incidence of major bleeding events tended to be lower in the 2
abciximab arms than in the stent-only study arm (higher-dose heparin).
There was comparable benefit both in patients with stable angina and in
higher-risk patients with acute coronary syndromes.
Summary: Abciximab was effective in reducing the composite
30-day incidence of death/MI/urgent
revascularization in patients undergoing stent
implantation. The use of balloon angioplasty with abciximab had a lower
incidence of composite events at 30 days than stenting alone. Six-month
follow-up data, including angiographic substudies and need for repeat
target-vessel revascularization, will be
forthcoming.
STENT PAMI
The study: A multicenter, randomized, parallel group trial
of primary PTCA versus implantation of a heparin-coated stent in
patients with AMI. A total of 900 patients at 65 clinical centers
worldwide were randomized to PTCA (n=448) or stent (n=452); 67 (15.1%)
of the PTCA patients crossed over to stent. The primary end point of
the trial was the composite incidence of death, recurrent MI, disabling
stroke, or ischemia-driven target-vessel
revascularization at 6 months.
The results: The clinical and angiographic results during
hospital stay and at 30 days were presented. The acute
postprocedural MLD was significantly better in the stent group (mean,
2.55 versus 2.11 mm with PTCA). Angiographic success was high
(97% to 99%) in both groups. The incidence of subsequent clinical
end-point events at 30 days was low: death, 3.5% versus 1.8% (stents
versus PTCA, P=NS); recurrent MI, 0.4% versus 1.1%
(P=NS); disabling cerebrovascular accident, 0.2% versus 0%
(P=NS); and ischemia-driven target-vessel
revascularization, 0.6% versus 2.5%
(P=0.006). The composite end point at 30 days was not
significantly different between groups (4.2% for stent versus 5.4%
for PTCA; P=NS). There was no difference in bleeding
complications between groups. Complete 6-month data will be available
in the fall of 1998.
Summary: Compared with primary PTCA in AMI, the use of a
heparin-coated Palmaz-Schatz stent was associated with a larger
immediate MLD, a comparable procedure success rate, a lower 30-day rate
of ischemia-driven target-vessel
revascularization, and a comparable composite rate
of adverse clinical events at 30 days.
TOSCA
The study: A multicenter, randomized trial of primary
stenting (with a heparin-coated Palmaz-Schatz stent) versus balloon
angioplasty in 410 patients with symptomatic nonacute total
occlusion (TIMI grade 0/1 flow) of native coronary arteries.
Randomization was stratified by duration of occlusion (
The results: The target lesions were complex, with mean
lesion work length of 35 mm and use of multiple stents in the
majority of patients randomized to stent. A total of 10% of the
patients crossed over from the PTCA to the stent arm of the trial
during the initial procedure because of suboptimal results; 4% of the
patients randomized to stent underwent balloon angioplasty instead,
usually because of inability to deliver the stent. The follow-up
incidence of TIMI grade 0 flow was 11% in the PTCA group and 6.8% in
the stent group; the incidence of TIMI grade 1 flow was 2.5% in the
PTCA group and 1.6% in the stent group; the incidence of TIMI grade 2
flow was 6% in the PTCA group and 2.6% in the stent group. The
overall incidence of failure of sustained patency was 19.5% in the
PTCA group and 10.9% in the stent group (P=0.024). The
postprocedural initial MLD was 1.90 mm in the PTCA group and
2.45 mm in the stent group. The final follow-up MLD was 1.23
mm in the PTCA group and 1.48 mm in the stent group. The binary
rate of restenosis (<50% diameter stenosis at
follow-up) was 70% in the PTCA group and 56% in the stent group.
However, the incidence of target-vessel
revascularization was only 13.9% in the PTCA group
and 7.4% in the stent group. The overall incidence of adverse clinical
events did not differ between groups.
Summary: In patients with symptomatic occlusions
of native coronary arteries, stenting resulted in a higher
6-month patency, larger follow-up MLDs, and a decreased need for
target-vessel revascularization. There remains a
high binary angiographic restenosis rate in this anatomically
complex group of patients. Stenting, if feasible, appears to be the
preferable therapy.
Intracoronary Radiation Therapy
BERT Feasibility Study
The study: A trial of adjunctive ß-radiation therapy in
patients undergoing coronary angioplasty for de novo lesions at
4 clinical centers. After successful PTCA, qualifying patients received
1 of 3 doses of radiation (12, 14, or 16 Gy) delivered via a
90Sr/90Y ß-source
advanced hydraulically through a closed-end delivery catheter. The
primary end point of the trial was 6-month quantitative angiography.
Data on the first 64 patients with de novo lesions and complete
angiographic follow-up were presented.
The results: Mean MLD was 0.75 mm before intervention,
2.09 mm immediately after intervention, and 2.07 mm at
6-month follow-up, corresponding to mean percent diameter
stenosis of 75%, 24%, and 26%, respectively. Overall, the
dichotomous rate of restenosis was 14% (20% in the 12-Gy
group and 11% in the 14- and 16-Gy groups). Target-lesion
revascularization was 9%. On quantitative
coronary angiography, it was noted that 38 of 64 patients had
6-month follow-up lumen sizes that were slightly larger than the
immediate postprocedure lumen. No aneurysms or
pseudoaneurysms were observed.
Summary: Adjunctive therapy with locally delivered
ß-irradiation appears to result in improved lesion geometry at
6-month angiographic follow-up. This technique shows very promising
preliminary results, but additional large-scale follow-up data are
warranted.
Coronary Artery Disease
Intracoronary rhVEGF
The study: A dose-ranging trial of rhVEGF in patients with
severe coronary artery disease who are not optimal candidates
for revascularization. A total of 15 patients
received two 10-minute intracoronary infusions of 0.005, 0.017,
0.050, or 0.67 µg · kg-1 ·
min-1. Pharmacodynamic sampling and
hemodynamic monitoring were performed for 24 hours;
nuclear perfusion studies were done at baseline and 30 and 60 days
after treatment. Follow-up 60-day angiograms were done in 7 patients
who demonstrated improved nuclear perfusion studies.
The results: rhVEGF therapy was well tolerated. At maximal
doses, there was a significant reduction (mean, 28%) in
systolic blood pressure that appeared to be related to a local
vasodilator effect. Nuclear perfusion studies showed improved perfusion
in 7 of 15 subjects. From a symptomatic standpoint, 13 of
15 patients had improvement of
Summary: rhVEGF is well tolerated. Maximal doses may cause a
fall in blood pressure. Initial clinical results are encouraging and
indicate improved collaterals, improved perfusion, and improved
symptoms in a significant number of patients. However, these
preliminary results will need larger-scale corroboration.
ACADEMIC
The study: A randomized, placebo-controlled trial of
azithromycin in patients with evidence of coronary artery
disease and positive titers to Chlamydia pneumoniae. A total
of 447 patients with coronary artery disease were screened; 302
with positive C pneumoniae titers (
The results: At 3 months, there were no significant changes
in the individual inflammatory markers or in the composite end point.
There were also no significant changes in antichlamydial IgG levels or
IgA levels at 3 or 6 months. At 6 months, the azithromycin group was
noted to have a significant decrease in C-reactive protein and IL-6;
IL-1 and tumor necrosis factor were unchanged in both groups. Only
limited long-term clinical follow-up data are available; at present
there are no significant differences between groups in clinical
outcomes at 6 months. Azithromycin therapy was well tolerated.
Summary: In patients with coronary artery disease
and positive C pneumoniae titers, azithromycin therapy did
not significantly reduce serum markers of inflammation at 3 months; by
6 months, there were significant decreases in C-reactive protein and
IL-6. Long-term clinical follow-up data will be forthcoming.
Congestive Heart Failure
ATLAS
The study: A multicenter, randomized, placebo-controlled
trial of low-dose versus high-dose ACE-inhibitor therapy in
patients with congestive heart failure. A total of 3164 patients with
class II, III, or IV congestive heart failure at 287 clinical centers
in 19 countries were randomized to either low-dose (2.5 to 5 mg/d) or
high-dose (32.5 to 35 mg/d) lisinopril. To qualify for the
study, patients had to be symptomatic, have an ejection
fraction
The results: By the time of study termination, 17% of
patients were taking a nonstudy ACE inhibitor. Total
mortality (44.9% with low-dose versus 42.5% with high-dose therapy)
was not significantly different between groups. There was a
nonsignificant trend toward lower cardiovascular
mortality in the high-dose lisinopril group (37.2% with
high-dose therapy versus 40.2% with low-dose therapy;
P=0.073). There was a significant decrease in the composite
end point of mortality and recurrent hospitalization with high-dose
lisinopril (79.8% versus 83.9% with low-dose therapy;
P=0.002); this effect was similar across all subgroups of
patients. There was little difference between groups in the incidence
of drug-related adverse effects.
Summary: Compared with low-dose therapy, high-dose
lisinopril therapy did not result in a significant decrease
in mortality but was associated with a significant reduction in the
composite incidence of mortality and recurrent hospitalization.
RESOLVD (Part II)
The study: A multicenter, randomized, placebo-controlled
trial of metoprolol CR in patients with congestive heart failure. Part
I of the study compared candesartan, enalapril, and combination
therapy. Part II took patients who had completed part I and randomized
them to metoprolol CR (200 mg/d; n=215) or placebo (n=211). Treatment
was continued for 24 weeks. The primary end point of the trial was
functional status, as indicated by a 6-minute walk test, NYHA
functional class, and a QOL assessment.
The results: The metoprolol CR group had a significant
reduction in heart rate but no change in blood pressure. At follow-up,
there was no significant difference between groups in 6-minute walk
test results, NYHA class, or QOL scores. Metoprolol patients
demonstrated a decline in angiotensin II and renin levels
and an increase in brain natriuretic peptide and atrial
natriuretic peptide levels. Over time, ejection fraction
did not change in the placebo group but did increase significantly in
the metoprolol group (P=0.001). Ventricular
volume increased in the placebo group but did not change in the
metoprolol group. The overall number of clinical events was very small
in both groups. Metoprolol therapy was very well tolerated.
Summary: Six-month treatment with metoprolol in patients
with congestive heart failure is well tolerated but is not associated
with any significant improvement in 6-minute walk testing, NYHA class,
or QOL scores. There was a significant increase in ejection fraction
and a prevention of ventricular dilatation with metoprolol
therapy.
Arrhythmias
CASH
The study: A multicenter, open-label, randomized trial
comparing ICD therapy with pharmacological treatment in survivors of
sudden cardiac death. The study was initiated in 1987 and was
originally designed to compare ICD with propafenone,
amiodarone, and metoprolol. In July 1990, the protocol was
modified to include the use of transvenously implanted defibrillators.
In March 1992, an interim analysis (mean follow-up of 11 months
at the time) indicated excess mortality in the propafenone arm of the
study (compared with ICD), and the propafenone arm was dropped. The
amio- darone and metoprolol arms of the trial continued, and
follow-up for a minimum of 2 years after randomization was available
for a total of 349 patients. The primary end point of the trial was
total mortality.
The results: At follow-up, total 2-year mortality in the ICD
group was 12.1% versus 19.6% in the combined drug therapy groups
(P=0.047). There was no significant mortality difference
between the 2 types of drug therapy.
Summary: In survivors of sudden cardiac death, ICD therapy
is superior to propafenone in terms of 1-year total mortality. ICD
therapy is also associated with a significantly lower 2-year total
mortality than amiodarone or metoprolol. In this population,
2-year mortality did not appear to differ between amiodarone
and metoprolol.
CIDS
The study: A multicenter, randomized, parallel group trial
comparing ICD therapy (n=328; using any currently available device)
with amiodarone (n=331; 1200 mg/d for 1 week, 400 mg/d for 10
weeks, then 300 mg/d) in cardiac arrest survivors or patients with
sustained, symptomatic ventricular
tachycardia/fibrillation. The trial was initiated in 1990
and continued through December 1997. Patients were followed up for at
least 1 year. The primary end point of the trial was all-cause
mortality; a secondary end point was the incidence of arrhythmic
death.
The results: By the end of 5 years, 22% of the
amiodarone patients had received a subsequent crossover ICD and
30% of the ICD patients had received subsequent crossover
amio- darone. In the ICD group, there was a higher 30-day
mortality rate in patients with thoracotomy devices (3.3%, n=33)
versus transvenous devices (0.36%, n=227). All-cause mortality was
slightly but not significantly lower in the ICD group. (
Summary: In this population of patients with a history of
sudden cardiac death or symptomatic sustained
ventricular tachycardia/fibrillation, ICD
therapy was associated with a modest, nonsignificant reduction in
all-cause mortality.
ARCH
The study: A multicenter, randomized, controlled clinical
trial of amiodarone for the prevention of atrial fibrillation
in patients after open-heart surgery. Patients undergoing CABG surgery,
valve surgery, or combined procedures were randomized to
amiodarone (2 g over 2 days; no loading dose; n=158) or placebo
(n=147). Study drug infusions were begun in the surgical intensive care
unit after surgery at the time of the first hemodynamic
measurements. The primary end point of the study was the postoperative
length of hospital stay.
The results: The amiodarone group had a
significantly lower incidence of atrial fibrillation (35.4% versus
47.2% with placebo); this difference became apparent in the first 3
postoperative days. There was a nonsignificant trend toward shorter
hospital lengths of stay in the amiodarone group (7.5±5.9
versus 8.2±6.2 days with placebo). In the overall population, the
development of atrial fibrillation was associated with a significantly
longer length of stay (9.1±5.3 versus 7.1±6.6 days in patients
without atrial fibrillation). Amio- darone therapy was well
tolerated. The incidence of major morbid events in this population was
very low.
Summary: A low-dose, short course of intravenous
amiodarone reduced the incidence of postoperative atrial
fibrillation but did not significantly reduce postoperative hospital
lengths of stay in this study.
Dexfenfluramine
Randomized Redux Study
The study: A prospective, double-blind, randomized,
placebo-controlled trial of 2 doses of dexfenfluramine (Redux) in
patients with obesity. The trial was stopped when Redux was withdrawn
from the market in response to concerns about valvular
abnormalities. As part of the trial, echocardiograms were obtained in
all patients after a median of
The results: There was a trend toward less valvular
regurgitation in the placebo group (n=330, AR 3.6%, MR
1.2%, composite 4.5%) than in the 2 Redux groups (Redux: n=342, AR
5.0%, MR 1.7%, composite 6.5%; Redux SR [a sustained release
formulation that has not been commercially available]: n=329; AR
5.8%, MR 1.8%, composite 7.3%). However, this difference did not
achieve statistical significance. There was a high incidence (
Summary: In this short-term Redux therapy trial, Redux was
not associated with a significant increase in clinically meaningful
valvular regurgitation. There may be an
increase in physiological or mild MR and some minor
restriction of the posterior mitral leaflet. The incidence of
significant valvular abnormalities in this study was much lower
than in previous early reports.
Selected Abbreviations and Acronyms
Footnotes
Reprint requests to James J. Ferguson, MD, Cardiology Research, MC1–191, Texas Heart Institute, PO Box 20345, Houston, TX 77225.
© 1998 American Heart Association, Inc.
Cardiovascular News
Meeting Highlights
47th Annual Scientific Sessions of the American College of Cardiology
Presenter: Elliott Antman, MD, Brigham and Women's
Hospital and Harvard Medical School, Boston, Mass.
Presenter: Allan Ross, MD, George Washington
University Medical Center, Washington, DC.
Presenter: Marc Cohen, MD, Allegheny University of
the Health Sciences, Hahnemann Division, Philadelphia, Pa.
Presenter: Elieser Kaplinsky, MD, Sheba Medical
Center, Tel-Hashomer, Israel.
Presenter: Eric Topol, MD, Cleveland Clinic,
Cleveland, Ohio.
Presenter: Cindy Grines, MD, William Beaumont
Hospital, Royal Oak, Mich.
Presenter: Christopher Buller, MD, Vancouver
General Hospital, Vancouver, Canada. 
6 weeks versus
>6 weeks/unknown); patients were enrolled in the study after
successful placement of a guidewire across the occlusion. The primary
end point of the trial was failure of sustained patency, defined as
presence of less than TIMI grade 3 flow within 6 months of the
procedure, as confirmed by angiography.
Presenter: Spencer King, MD, Emory
University, Atlanta, Ga.
Presenter: Timothy Henry, MD, Hennepin County
Medical Center, Minneapolis, Minn. 
1 anginal class. On core laboratory
angiographic analysis, there were improved collateral arteries
by visual assessment in 5 of 7 patients and improved collateral density
counts in 7 of 7 patients.
Presenters: Jeffrey L. Anderson, MD, and J.
Brent Muhlstein, Latter Day Saints Hospital, University of Utah,
Salt Lake City, Utah. 1:16) were randomized
to placebo (n=152) or azithromycin (n=150). Treatment was continued for
3 months. The primary end point of the study was the change in a
composite of 4 inflammatory markers (C-reactive protein, IL-1, IL-6,
and tumor necrosis factor) at 3 months. Additional follow-up was
conducted at 6 months.
Presenter: Milton Packer, MD, Columbia University
College of Physicians and Surgeons, New York, NY. 30%, and be on therapy with digitalis, diuretics,
and an ACE inhibitor. After initiation of study drug,
therapy patients were followed up for 3.5 to 5 years. The primary end
point of the study was all-cause mortality.
Presenter: Jean-Lucien Rouleau, MD, Montreal Heart
Institute, Montreal, Quebec, Canada.
Presenter: Karl Kuck, MD, St. George Hospital,
Hamburg, Germany.
Presenter: Stuart Connolly, MD, McMaster
University, Hamilton, Ontario, Canada. 
27% at 4
years with ICD versus 33% with amiodarone;
P=0.07). Both forms of therapy were well tolerated.
Presenter: Thomas Guarnieri, MD, Greater
Baltimore Medical Center, Baltimore, Md.
Presenter: Neil Weissman, MD, Georgetown
University Medical Center, Washington, DC. 77 days of drug therapy.
Echocardiograms were reviewed independently and any valvular
abnormalities noted and categorized. Baseline echos were not routinely
performed. The primary end point of this substudy was the Food and Drug
Administration's definition of significant valvular
regurgitation, ie, the incidence of MR ( moderate) or
AR ( mild). 75%)
of any regurgitation (including
physiological and trivial) in the study population.
Estimated pulmonary artery pressures were not different between
groups. Redux patients were noted to have slightly more frequent
physiological or mild MR and some minor restriction
of the motion of the posterior leaflet of the mitral valve.
AMI
=
acute myocardial infarction
AR
=
atrial regurgitation
ICD
=
implantable cardioverter defibrillator
IL
=
interleukin
LVEF
=
left ventricular ejection fraction
MI
=
myocardial infarction
MLD
=
minimum lumen diameter
MR
=
mitral regurgitation
QOL
=
quality of life
rhVEGF
=
recombinant human vascular endothelial growth
factor
tPA
=
tissue plasminogen activator
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