(Circulation. 1999;99:2486-2491.)
© 1999 American Heart Association, Inc.
Cardiovascular News |
Meeting Highlights
Highlights of the 71st Scientific Sessions of the American Heart Association
From St Luke's Episcopal Hospital, Texas Heart Institute, and the University of Texas Medical School at Houston, Houston, Tex.
The following studies were presented at the 71st Scientific Sessions of the American Heart Association, November 8–11, 1998, in Dallas, Tex.
Heart Failure
The Trial: RALES
Presenter: Bertram Pitt, The University of
Michigan, Ann Arbor, Mich.
The study: A randomized, placebo-controlled trial of
spironolactone (an aldosterone antagonist) in
patients with severe congestive heart failure (CHF). A total of 1663
patients with a left ventricular ejection fraction
35% and NYHA class III or IV CHF who were taking ACE
inhibitors were randomized to spironolactone (25 mg/d) or
placebo. The dose of spironolactone could be increased to 50 mg/d or
decreased to 25 mg QOD at the 8-week follow-up point at the
investigator's discretion. All patients were taking ACE
inhibitors (if tolerated) and a loop diuretic, with
or without digoxin. Sixty percent of patients had an ischemic
origin of their CHF; 89% were taking ACE inhibitors at
baseline. The primary end point was the composite of total mortality
and rehospitalization. The study was originally designed to continue
for 3 years but was terminated early (after 2 years) on the
recommendation of the data safety monitoring board because of
excess benefit in the spironolactone group.
The results: There were a total of 372 deaths in the placebo group (44%) and 283 deaths in the spironolactone group (34%). Rehospitalization was also significantly reduced in the spironolactone group, most prominently in rehospitalizations for exacerbation of CHF, which were reduced 36% in the spironolactone group. The advantages of spironolactone were evident at 3 months of follow-up and persisted through the 2-year time point. The mortality benefit was consistent across a broad range of patient subsets. Age, sex, and ischemic/nonischemic origin of CHF did not influence the benefit of spironolactone. Spironolactone was well tolerated. Gynecomastia in men (8.5% versus 1.5%) and severe hypokalemia (1.3% versus 1.2%) were slightly more frequent with spironolactone than with placebo.
Summary: In this trial, spironolactone significantly reduced mortality and rehospitalization in patients with severe CHF, even with preexisting ACE inhibitor therapy. Whether it may convey benefit in patients with milder heart failure remains unknown.
The Trial: STRETCH
Presenter: Guenter Riegger, University of
Regensborg, Germany.
The study: A randomized trial of candesartan (an oral angiotensin type 1 receptor antagonist) in patients with mild-to-moderate CHF. To qualify, patients had to have NYHA class II (80%) or III (20%) heart failure, an ejection fraction between 30% and 45%, and stable exercise tolerance. After a 4-week placebo run-in period (to wash out effects of ACE inhibitors that were discontinued), 844 patients were randomized to 1 of 3 doses of candesartan (4, 8, or 16 mg/d) or placebo; treatment continued for 3 months. The primary end point of the study was total exercise time on a standardized exercise test.
The results: A total of 807 patients were evaluable. There appeared to be a dose-dependent effect of candesartan in prolonging the exercise time, but it only achieved statistical significance in the 16 mg/d group. The 4 mg/d and 8 mg/d groups also showed benefit in the secondary end point of symptom improvement. There were no differences between groups in heart rate or serum catecholamine levels, but there was a small decrease in aldosterone levels with candesartan. There were no differences among the groups in adverse side effects.
Summary: Higher doses of candesartan appear to significantly improve exercise performance in patients with mild-to-moderate CHF.
Acute MI
The Trial: STENT-PAMI
Presenter: Cindy Grines, Beaumont Hospital, Royal
Oak, Mich.
The study: A randomized trial comparing PTCA and stents for the treatment of acute myocardial infarction (MI). A total of 900 patients presenting within 12 hours of the onset of acute MI were randomized to either primary PTCA or implantation of a heparin-coated stent (Palmaz-Schatz, Cordis). The primary end point of the study was the 6-month composite of death, recurrent MI, disabling stroke, or ischemia-driven target-vessel revascularization.
The results: Acute procedural success was high (>99%) in both groups, although the incidence of postprocedure TIMI grade III flow was somewhat lower in the stent group (89% versus 92% by core laboratory analysis). Stented patients had significantly lower residual stenosis and significantly higher minimum lumen diameters (MLDs). There were 67 PTCA patients (15.1%) who crossed over to a stent because of suboptimal results. At 6-month follow-up angiography, stented patients continued to have significantly larger MLDs, resulting in a significantly lower binary angiographic restenosis rate (20.3% versus 32.5% with PTCA). Primary composite end-point events at 6 months were significantly lower in the stent group (12.4% versus 20.1% with PTCA), as was total target-lesion revascularization (12.8% versus 21.4% with PTCA) and ischemia-driven target-vessel revascularization (7.5% versus 17% with PTCA).
Summary: Coronary stent implantation for acute MI results in an initially better angiographic result although with slightly lower TIMI 3 flow rates. Longer-term follow-up strongly supports the superiority of stenting in reducing restenosis, target-vessel revascularization, ischemia-driven revascularization, and composite events.
The Trial: SPEED/GUSTO-4 Pilot
Presenter: Magnus Ohman, Duke University, Durham,
NC.
The study: A randomized, dose-escalation/evaluation study
evaluating the combination of the platelet glycoprotein
IIb/IIIa antagonist abciximab and reduced doses of the
thrombolytic agent reteplase in patients with acute MI.
A total of 305 qualifying patients were randomized to either abciximab
alone or abciximab plus 5, 7.5, or 10 U of recombinant tissue
plasminogen activator (rtPA), abciximab
plus 5 U and 2.5 U of rtPA (30 minutes apart), or abciximab plus 5 U
and 5 U of rtPA (30 minutes apart). Patients were then brought
for angiography (a mean of 
64 minutes after drug administration)
and underwent angioplasty if necessary. The primary end point
of the study was the incidence of TIMI grade 3 flow at angiography.
The results: At angiography, the frequency of TIMI grade 3 flow in the respective dosing groups was 28%, 53%, 46%, 44%, 48%, and 63%; comparable TIMI 2/3 flow rates were 48%, 72%, 70%, 80%, 70%, and 83%. Respective corrected TIMI frame counts were 100, 40, 45, 44, 36, and 36. Hemorrhagic complications were not significantly increased with combination therapy.
Summary: The combination of low-dose reteplase with standard-dose abciximab does not result in increased hemorrhagic complications and may enhance the efficacy of thrombolytic therapy. A direct, large-scale comparison of combination therapy with standard dose rtPA is currently ongoing.
The Trial: AMISTAD
Presenter: Chris Granger, Duke University Medical
Center, Durham, NC.
The study: A randomized, multicenter trial of adenosine as an adjunct to thrombolytic therapy in patients with acute MI. A total of 236 acute MI patients who received thrombolytic therapy with either tissue plasminogen activator or streptokinase were randomized to receive intravenous adenosine (70 mg · kg-1 · min-1 over 3 hours) or placebo. The primary end point was infarct size, as assessed by SPECT-sestamibi at 6 days.
The results: Myocardial infarct size was significantly reduced in the adenosine group (a 33% relative reduction). There was more prominent benefit (a 67% reduction in infarct size) in patients with anterior infarcts.
Summary: Adenosine in conjunction with thrombolytic therapy appears to reduce myocardial infarct size, particularly with anterior infarcts.
The Trial: INTERCEPT
Presenter: William E. Boden, VA Medical
Center and State University of New York Health Science Center,
Syracuse, NY.
The study: A randomized trial of a long-acting diltiazem formulation in the secondary prevention of recurrent events in patients after MI. A total of 874 patients at 63 participating centers in the United Kingdom, Belgium, The Netherlands, and Denmark who had received thrombolytic therapy for an acute MI were randomized (within 36 to 96 hours of symptom onset) to either diltiazem (300 mg/d) or placebo. All patients received aspirin. Therapy was continued for 6 months or until a clinical event occurred. The primary end point was the composite of death/MI/refractory ischemia.
The results: Composite events in the diltiazem group were 22.6% compared with 29.5% in the placebo group, a 23% relative decrease (hazard ratio, 0.78; 95% CI, –0.6 to 1.0; P=NS). The individual end point of repeat revascularization was significantly reduced in the diltiazem group (7% versus 12%, a 42% relative decrease); there was also a strong trend toward fewer episodes of refractory ischemia with diltiazem (17.2% versus 23.2% with placebo; hazard ratio of 0.76; 95% CI, -0.56 to 1.02; P=NS). There was no increase in symptomatic heart failure noted in the diltiazem group.
Summary: The use of diltiazem after MI in patients initially treated with thrombolytic therapy was associated with a trend toward fewer composite clinical events, although the 23% relative decrease did not achieve statistical significance. The use of diltiazem in these patients may be associated with a decrease in recurrent ischemia and the need for subsequent revascularization.
Interventional Cardiology
The Trial: EPISTENT
Presenters: Eric Topol and A. Michael Lincoff,
Cleveland Clinic, Cleveland, Ohio.
The study: A randomized trial in which 2399 patients eligible for elective stenting were randomized to 1 of 3 groups: stent plus placebo, stent plus abciximab, and PTCA plus abciximab. As previously published and reported, the primary composite end point of death, MI, or urgent revascularization was significantly reduced in the stent-plus-abciximab group at both 30 days and 6 months. Two new presentations focused on long-term (1 year) follow-up and the angiographic substudy within EPISTENT (n=899).
The results: At 1-year follow-up, the use of adjunctive abciximab was associated with a significant reduction in mortality (1.0% in the stent-plus-abciximab group versus 2.4% in the stent-alone group and 2.1% in the PTCA-plus-abciximab group by intention-to-treat [ITT] analysis). Six-month angiographic data demonstrated an initial gain of 1.53 mm in the stent-alone group, 1.60 mm in the stent-plus-abciximab group, and 1.09 mm in the PTCA-plus-abciximab group. Late loss was 0.79 , 0.73 , and 0.46 mm, respectively; net gain (initial gain minus late loss) was 0.73, 0.86, and 0.62 mm, respectively. The respective late loss indexes were 0.60, 0.41, and 0.48. In the subgroup of diabetic patients, the net gain at 6 months was 0.55 mm in the stent-alone group, 0.88 mm in the stent-plus-abciximab group, and 0.43 mm in the PTCA-plus-abciximab group. The net gains in the comparable nondiabetic groups were 0.78, 0.86, and 0.67 mm. Respective MLDs were 1.48, 1.66, and 1.28 mm in the diabetic group and 1.63, 1.66, and 1.51 mm in the nondiabetic group.
Summary: The adjunctive use of abciximab appears to convey a significant mortality benefit in patients undergoing coronary stenting. Angiographically, there appears to be substantial benefit of abciximab in preventing late lumen loss and restenosis in diabetic patients undergoing stenting.
The Trial: WRIST
Presenter: Ron Waksman, Washington Heart Center,
Washington, DC.
The study: A randomized trial of catheter-based low-dose
-radiation therapy for treatment of in-stent restenosis. One
hundred thirty patients with in-stent restenosis in native
coronary arteries (n=100) and vein grafts (n=30) undergoing
percutaneous therapy were randomized to
catheter-delivered fixed-dose -radiation therapy (15 Gy at a
distance of 2 mm from the 192Ir ribbon
source) or placebo. The average lesion length was 29 mm. The
primary end point was the composite of death, MI, and target-lesion
revascularization at 6 months. Diabetes was
present in 38% to 45% of the patients.
The results: Radiation therapy was successfully delivered in
129 of 130 patients. The mean dwell time for the
192Ir source was 22 minutes. At 6 months,
radiation therapy was associated with a significant reduction in
composite events and significant reductions in angiographic
restenosis (16% versus 48% with placebo) and target-lesion
revascularization (26.2% versus 67.7% with
placebo). There appeared to be particular benefit in diabetic patients,
in whom there were dramatic reductions in angiographic
restenosis (13.8% in the radiation group versus 63.1% with
placebo) and target-vessel revascularization
(26.2% versus 67.7% with placebo).
Summary: In this study, low-dose -radiation therapy
appears to be a very effective adjunctive modality for the treatment of
patients with in-stent restenosis.
The Trial: COURT
Presenter: Charles Davidson, Northwestern
University, Chicago, Ill.
The study: A randomized trial comparing 2 types of contrast
media in patients undergoing high-risk PTCA. A total of 853 patients
undergoing high-risk interventions at 13 clinical centers were
randomized to either the nonionic iso-osmolar contrast agent Iodixanol
or the ionic low-osmolar contrast agent Ioxaglate. Half of the patients
had unstable angina, and 33% were undergoing primary interventions
for an acute MI. One third of the patients underwent stent placement,
and 42% of the patients were treated with abciximab. The primary end
point of the study was the composite incidence of in-hospital adverse
events of abrupt closure, MI, recatheterization, or
emergent revascularization.
The results: Composite clinical events were significantly lower in the Iodixanol group (5.2% versus 9.5% with Ioxaglate). Angiographic success was also significantly higher in the Iodixanol group (92.2% versus 85.9%; P=0.004).
Summary: In high-risk patients undergoing coronary intervention, the use of the nonionic iso-osmolar contrast agent Iodixanol is associated with fewer in-hospital adverse clinical events than the ionic low-osmolar contrast agent Ioxaglate.
Coronary Artery Disease
The Trial: VA-HIT
Presenter: Hanna Rubins, VA Medical Center,
Minneapolis, Minn.
The study: A randomized multicenter, placebo-controlled
trial of gemfibrozil in patients with coronary artery disease
(CAD) and low HDL (<40 mg/dL), low LDL (<140 mg/dL), and nonelevated
triglyceride levels (300 mg/dL). A total of 2531
qualifying patients were randomized to gemfibrozil or placebo and
followed up for a mean of 5.1 years. The primary end point of the trial
was the combined incidence of coronary artery–related death
and MI.
The results: Gemfibrozil therapy caused no significant reduction in LDL but did result in a significant 7.5% increase in HDL. The primary end point of the trial was significantly reduced from 21.6% in the placebo group to 17.3% in the gemfibrozil group. The differences between groups became evident as early as 18 months into the trial, and the favorable effect of gemfibrozil was evident across a broad range of subgroups, including diabetics and elderly patients. Total all-cause mortality also tended to be lower in the gemfibrozil group (15.6% versus 17.3% with placebo). The groups did not differ with respect to the incidence of unstable angina or coronary revascularization.
Summary: In this population of patients with CAD and low HDL (with low LDL), there appeared to be clinical benefit of gemfibrozil in raising HDL without lowering LDL.
The Trial: AVERT
Presenter: Bertram Pitt, The University of
Michigan, Ann Arbor, Mich.
The study: A trial of aggressive lipid-lowering therapy versus coronary intervention in patients with stable CAD referred for angioplasty. A total of 341 patients with 1- or 2-vessel CAD and LDL levels >115 mg/dL were randomized to angioplasty (and continuation of prior therapy) or atorvastatin (an HMG Co-A reductase inhibitor) 80 mg/d. The primary end point was the composite of death, MI, stroke, resuscitated cardiac arrest, revascularization, and hospitalization for worsening angina. Because of 2 interim analyses, the significance level for the trial had been adjusted to 0.045. Patients were followed up for 18 months.
The results: Baseline mean LDL cholesterol levels were 140 mg/dL; LDL cholesterol levels fell to 119 mg/dL in the angioplasty group and 77 mg/dL in the atorvastatin group. There was a trend toward fewer composite end points in the atorvastatin group (13%) than in the angioplasty group (21%). This approached but did not achieve statistical significance. The atorvastatin group had a lower incidence of bypass surgery (1.2% versus 5.1% in the angioplasty group) and recurrent hospitalization for worsening angina (6.7% versus 14.1%). The time to first ischemic event was also significantly longer in the atorvastatin group.
Summary: Aggressive lipid lowering is feasible in patients with stable CAD and is associated with outcomes that are at least as good as (if not slightly better than) those achieved with coronary intervention in this population of patients with 1- or 2-vessel CAD.
The Trial: PREVENT
Presenters: Curt Furberg, Wake Forest University,
Winston-Salem, NC, and Bertram Pitt, University of Michigan, Ann Arbor,
Mich.
The study: A randomized, placebo-controlled trial of the
efficacy of amlodipine (a calcium channel antagonist) in
preventing the development of new coronary lesions or the
progression of minor lesions in patients with CAD. A total of 825
patients with 
1 focal stenosis of 30% in a
coronary segment were randomized to placebo or amlodipine (10
mg/d) and followed up for 3 years. Angiography was performed at
baseline and at the end of follow-up. A substudy examined B-mode
carotid artery ultrasounds at baseline and at 6-month intervals. The
primary end point of the trial was the 3-year angiographic
progression.
The results: There were no significant effects of amlodipine therapy on new lesion formation or progression of older lesions. However, the carotid ultrasound substudy showed a significantly greater increase in intima-media thickness in the placebo group than in the amlodipine group. Amlodipine therapy did not significantly reduce all-cause mortality or major events (MI and stroke). The statistical power was limited to detect major events in a low-risk population with an event rate <2% per year. On the other hand, amlodipine did appear to have a clear antiangina effect, as manifested by a significant reduction in ischemic events (hospitalization for angina) and revascularization procedures. This symptomatic benefit occurred despite the lack of effect on lesion progression as shown by angiography.
Summary: Amlodipine does not appear to reduce new coronary lesion formation or to reduce the progression of older coronary lesions. It does appear to reduce the progression of carotid intima-media thickness and to reduce anginal symptoms and thus the need for recurrent hospitalizations for angina and revascularization.
The Trial: ARTS
Presenter: Patrick Serruys, Thoraxcentrum,
Rotterdam, The Netherlands.
The study: A randomized, multicenter trial comparing the efficacy and cost-effectiveness of stenting versus CABG in patients with multivessel CAD. A total of 1200 patients (at 68 clinical centers in 19 countries) were randomized to CABG or stenting (with Cordis Crown or Crossflex stents). The current presentation focused on 30-day safety data. Subsequent ongoing follow-up will document clinical events, quality of life, and cost-effectiveness at 1, 2, 3, and 5 years. The primary outcome of the study (not yet reported) is the composite incidence of death, MI, stroke, or need for revascularization at 1 year.
The results: The average time-to-treatment was 12 days in
the stent group and 30 days in the CABG group. The average number of
lesions treated was 2.7 in both groups. Treatment was successful in
97% of the stent group and 96% of the surgical group; 93% of the
patients in the surgery group received 1 arterial
conduit. Nineteen patients crossed over from the stent group to CABG;
21 crossed over from CABG to stent. At 30 days, the composite incidence
of adverse outcome events (by ITT) was 8.7% in the stent group
and 6.8% in the surgery group (P=NS). Need for repeat
revascularization was significantly higher in the
stent group (3.7% versus 0.8% with CABG). Excluding reintervention,
the composite incidence of death/MI/stroke was 5.0% in the stent group
and 6.0% in the CABG group. More reinterventions were required in the
stent group (3.7%; 10 PTCA, 12 CABG) than in the surgery group (0.8%;
3 PTCA, 2 CABG).
Summary: In terms of early procedural outcomes, stenting provides major event rates comparable to those of surgery, although with a higher need for early repeat revascularization. Subsequent longer-term efficacy, quality of life, and cost-effectiveness data will be available in the future.
The Trial: QUO VADIS
Presenter: Wiek van Gilst, University of
Groningen, The Netherlands.
The study: A randomized, placebo-controlled trial of quinapril (an ACE inhibitor) in the long-term therapy of patients before and after CABG. In the study, 149 patients undergoing elective CABG were randomized (27±1 days before surgery) to quinapril (40 mg) or placebo. Study medication was continued for up to 1 year after surgery. Exercise testing was performed at randomization and at 1 year; a 48-hour Holter study was performed at 1 year. The primary end point of the study was the change in total exercise time. The incidence of clinical ischemic events (re-onset of angina, MI, stroke, or transient ischemic attack) at follow-up and 48-hour Holter results were prespecified secondary end points.
The results: At 1 year, there was a nonsignificant trend toward slightly longer exercise times in the quinapril group, and there was a significant reduction in clinical ischemic events with quinapril (4% versus 18% with placebo; OR, 0.2; 95% CI, 0.04 to 0.96; P=0.03). There were no significant differences between groups in the frequency of ischemic ST-segment changes with exercise; there was a nonsignificant trend toward reduction of ischemic ST-segment changes on Holter monitoring.
Summary: Pre-CABG and post-CABG therapy with quinapril are associated with a significant decrease in new clinical ischemic events but no significant change in exercise capacity or provocable ischemia.
Arrhythmias
The Trial: CTOPP
Presenters: Charles Kerr and Stuart Connolly,
McMaster University, Hamilton, Ontario, Canada.
The study: A randomized trial of physiological pacemakers versus single-chamber VVI pacemaker in 2568 patients requiring ventricular pacing. The primary end point of the trial was the incidence of cardiovascular death or stroke.
The results: Preliminary results indicate that at a mean follow-up of 3.1 years, the incidence of cardiovascular death or stroke was 4.78% per year in the physiological pacing group and 5.43% per year in the VVI pacing group, a nonsignificant difference. The event curves appeared to overlap for the first 2 years of follow-up, and then some divergence of the curves was apparent. There were no significant differences between groups in 6-minute walk test performance or the incidence of CHF. The physiological pacing group was noted to have a somewhat lower incidence of atrial fibrillation (AF) (5.34% per year versus 6.59% per year); again, these differences appeared to emerge after 2 years.
Summary: In the overall CTOPP population, physiological pacing did not appear to result in symptomatic benefit. Further extended follow-up and subgroup analyses will help clarify these results.
The Trial: ASAP
Presenter: Edward Pritchett, Duke University,
Durham, NC.
The study: A randomized, placebo-controlled trial of azimilide (a new class III antiarrhythmic agent) in patients with AF. A total of 367 patients with a documented history of AF (but in sinus rhythm at randomization) were randomized to placebo or azimilide (3 dose groups: 50, 100, or 125 mg BID for 3 days, followed by once daily for 6 months). More than 90% of patients initiated therapy in an outpatient setting. Patients used a transtelephonic ECG transmitter to send in reports on the occurrence of any AF symptoms and at regular 2-week intervals. The primary end point of the trial was time to AF recurrence, outside the initial 3-day loading period.
The results: The median time to AF recurrence was 17 days in the placebo group, 22 days in the 50-mg azimilide group, 41 days in the 100-mg azimilide group, and 130 days in the 125-mg azimilide group. In the 2 highest-dose groups combined, the mean time to recurrence was 60 days. Azimilide was well tolerated. There was only 1 incidence of torsade de pointes in the entire study cohort.
Summary: Azimilide appears to be effective in prolonging the time to recurrence of AF in a broadly inclusive population of patients with AF.
The Trial: EMERALD
Presenter: Robert A. Greenbaum, Edgware General
Hospital, Middlesex, United Kingdom.
The study: A 2-part study of dofetilide in patients with AF or flutter that had persisted for 1 week to 2 years. In the first phase of the trial, patients were randomized to placebo, dofetilide (a class III antiarrhythmic agent) in 1 of 3 doses (125, 250, or 500 µg BID), or sotalol (another class III agent) 80 mg BID. Study drug dose was adjusted for patients with renal dysfunction or excessive QT prolongation on treatment. Patients who did not convert to sinus rhythm within 72 hours received DC cardioversion. All patients in sinus rhythm after 72 hours entered the second phase of the trial to ascertain how long they remained in sinus rhythm.
The results: In the initial treatment phase, pharmacological conversion to sinus rhythm was noted in 6% of patients in the 125-µg BID and 11% of the 250-µg BID dofetilide groups, 5% of the sotalol group, and 29% of the 500-µg BID dofetilide group. Most of the remaining patients were DC cardioverted. After 12 months of follow-up, the probability of AF recurrence was 79% in placebo patients, 34% in the dofetilide 500-µg BID group, and between 48% and 60% in the other groups. There were 3 nonfatal episodes of torsade de pointes (all in the dofetilide 500-µg BID group) and 1 instance of out-of-hospital sudden cardiac death (also in the 500-µg BID dofetilide group).
Summary: Dofetilide in higher doses is capable of converting patients with AF and maintaining them in sinus rhythm, but it is associated with risks of proarrhythmic events.
Peripheral Arterial Disease
The Trial: Cilostazol for PAD
Presenter: David L. Dawson, University of Texas
Health Science Center at San Antonio and Wilford Hall Medical Center,
San Antonio, Tex.
The study: A multicenter, prospective, randomized,
controlled trial of cilostazol (a type 3 phosphodiesterase
inhibitor with potential vasodilatory and antiplatelet
effects), pentoxifylline, and placebo in patients with moderate to
severe claudication. To qualify for the study, patients had to have
confirmed peripheral arterial disease (PAD),
with claudication for 6 months, a pain-free walking distance of
54 m, and a maximal walking distance of <538 m (or 10 minutes on
a treadmill test).
The results: In all 3 groups, there was an increase in pain-free walking distance: a 98% increase with cilostazol, a 68% increase with pentoxifylline, and a 55% increase with placebo. The cilostazol group showed significant improvement over the other 2 groups from 3 months onward. Maximal walking distance was increased 54% in the cilostazol group, 30% in the pentoxifylline group, and 33% in the placebo group. The cilostazol group showed significant improvement over the control group at 4 weeks and highly significant improvement over both groups at 3 months. With regard to the patients' own subjective assessments of the results of therapy, 51% of the cilostazol group, 39% of the pentoxifylline group, and 34% of the placebo group reported that treatment was successful. Both cilostazol and pentoxifylline were well tolerated.
Summary: Cilostazol appears to be effective in improving maximal walking distance and pain-free walking distance in patients with moderate to severe symptoms of intermittent claudication.
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Footnotes
Reprint requests to James J. Ferguson, MD, Cardiology Research, MC 1-191, Texas Heart Institute, 1101 Bates St, Houston, TX 77030.
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