Rassegna della Letteratura

Treatment of Saphenous Vein Bypass Grafts With Ultrasound Thrombolysis: A
Randomized Study (ATLAS)
Mandeep Singh, Uri Rosenschein, Kalon K.L. Ho, Peter B. Berger, Richard Kuntz, and David
R. Holmes, Jr. Circulation 2003; 107: 2331 – 2336
Background Percutaneous coronary interventions (PCIs) in saphenous vein grafts (SVGs) with
thrombus have a high frequency of distal embolization. Acolysis (therapeutic ultrasound) can
break up thrombus in vitro in animal models and humans. Whether this is beneficial during
percutaneous SVG interventions is unknown.
Methods and Results We performed a trial of coronary ultrasound thrombolysis in which
patients with an acute coronary syndrome undergoing PCI in SVGs were randomly assigned to
receive acolysis or abciximab. The primary end point was a successful procedure, defined as
final luminal diameter stenosis 30% or less with Thrombolysis In Myocardial Infarction grade 3
flow and freedom from major adverse cardiac events (composite of death, Q-wave, and non–Q-
wave myocardial infarction [MI], emergency bypass procedure, disabling stroke, and target
lesion revascularization). Of 181 enrolled, 92 received acolysis and 89 abciximab.
Angiographic procedural success was achieved in 63% of acolysis patients and 82% of
abciximab patients (P=0.008). Incidence of major adverse cardiac events at 30 days was 25%
with acolysis and 12% with abciximab (P=0.036), attributable mainly to a greater frequency of
non–Q-wave MI with acolysis (19.6% versus 7.9%, P=0.03). The incidence of Q-wave MI was
also higher with acolysis (5.4% versus 2.2%, P=nonsignificant). The primary end point was
achieved in 53.8% of acolysis patients and 73.1% of abciximab patients (P=0.014).
Conclusions Use of therapeutic ultrasound in vein graft lesions in patients with acute coronary
syndrome had poor angiographic outcome and increased the incidence of acute ischemic
Sirolimus (Rapamycin) Monotherapy Prevents Graft Vascular Disease in Nonhuman
Primate Recipients of Orthotopic Aortic Allografts
Camille Dambrin, Jochen Klupp, Tudor Bîrsan, Jorge Luna, Takeshi Suzuki, Tuan Lam, Peter
Stähr, Bernard Hausen, Uwe Christians, Peter Fitzgerald, Gerald Berry, and Randall Morris.
Circulation 2003; 107: 2369 – 2374
Background Delayed treatment with sirolimus (SRL) halts progression of graft vascular
disease (GVD) in nonhuman primate (NHP) aortic allograft recipients. In this study, we
investigated whether SRL monotherapy prevents the development of GVD.
Methods and Results Pairs of 3-cm infrarenal aortic segments were exchanged between mixed
lymphocyte reaction–mismatched, blood group–compatible NHPs (n=12). Six NHPs were
untreated controls, and 6 were treated orally with SRL starting on the day of transplantation.
Follow-up was 105 days. SRL doses were adjusted individually by assessing SRL blood
concentrations, immune function, and clinical status. The severity of GVD was determined
every 3 weeks by intravascular ultrasound, which quantified intimal area (IA) and intimal
volume (IV) for the middle 1-cm graft segments. The mean±SEM SRL plasma levels were
14.5±9 ng/mL. In grafts from treated NHPs, IA and IV values on days 63, 84, and 105 were
significantly lower than for controls (P<0.05 to P<0.001). On day 105, in the grafts from SRL-
treated NHPs comp ared with grafts from controls, values (mean±SEM) were IA, 2.9±0.9 versus
5.5±0.7 mm2, P<0.001 and IV, 29.6±4.6 versus 55.2±2.8 mm3, P<0.001; IA and IV values for
grafts from SRL-treated NHPs did not increase significantly between days 21 and 105.
Conclusions We show that SRL monotherapy prevented GVD in NHP aortic allograft
recipients, suggesting the value of SRL for controlling GVD in clinical transplantation.
Incomplete Resolution of ST-Segment Elevation Is a Marker of Transient
Microcirculatory Dysfunction After Stenting for Acute Myocardial Infarction
Laurent J. Feldman, Pierre Coste, Alain Furber, Patrick Dupouy, Michel S. Slama, Jean-Pierre
Monassier, Christophe Tron, Antoine Lafont, Marc Faraggi, Dominique Le Guludec, Jean-Luc
Dubois -Randé, and P. Gabriel Steg. Circulation 2003; 107: 2684 – 2689

Background Incomplete ST-segment resolution (STR) after successful primary angioplasty for
acute myocardial infarction (AMI) is associated with a poor prognosis. We used intracoronary
Doppler velocimetry to investigate whether incomplete STR after primary angioplasty is a
marker of severe microcirculatory dysfunction.
Methods and Results Fifty patients with 12-h AMI underwent successful primary angioplasty
and systematic stenting with a Doppler guid ewire. Patients with incomplete (<50%) STR 60
minutes after TIMI 3 flow was restored had flow velocity features suggestive of severe
microcirculatory dysfunction, including a higher incidence of early systolic retrograde flow
(41% versus 9%, P=0.007) and lower coronary flow velocity reserve (CVR, 1.3 versus 1.6,
P<0.001). CVR improved immediately after stenting in patients with 50% STR but not in
patients with <50% STR. There was a significant correlation between STR and poststent CVR.
At 3 months, CVR was similar in patients with <50% and 50% STR. However, left
ventriculography indicated lower global (42% vs 55%, P=0.001) and regional (16% vs 20%,
P=0.03) left ventricular ejection fractions and 201Tl rest-redistribution scintigraphy indicated a
larger infarct size (34% versus 16% 201Tl defect, P=0.007) in patients with <50% STR.
Conclusions After successful primary angioplasty with systematic stenting, <50% STR is a
marker of severe albeit transient microcirculatory dysfunction in patients with AMI and is
associated with more extensive myocardial damage.

Antibiotic Therapy After Acute Myocardial Infarction: A Prospective Randomized Study
Ralf Zahn, Steffen Schneider, Birgit Frilling, Karlheinz Seidl, Ulrich Tebbe, Michael Weber,
Martin Gottwik, Ernst Altmann, Friedrich Seidel, Jürgen Rox, Ulrich Höffler, Karl-Ludwig
Neuhaus, Jochen Senges, and for the Arbeitsgemeinschaft Leitender Kardiologischer
Krankenhausärzte. Circulation 2003; 107: 1253-1259
Background Infection with Chlamydia pneumoniae is suspected to contribute to the
pathogenesis of human atherosclerosis. We investigated whether treatment with the macrolide
antibiotic roxithromycin would reduce mortality or morbidity in patients with an acute
myocardial infarction.
Methods and Results Eight hundred seventy-two patients with an acute myocardial infarction
(AMI) were randomly assigned to receive double-blind treatment with either 300 mg
roxithromycin or placebo daily for 6 weeks. Primary end point was total mortality during 12-
month follow-up. Four hundred thirty-three patients were treated with roxithromycin and 439
with placebo. With the exception of a higher proportion of patients suffering an anterior wall
AMI (48.1% in the roxithromycin group versus 40.2% in the placebo group; P=0.027) and a
lower prevalence of chronic obstructive pulmonary disease in the roxithromycin group (3.5%
versus 6.9%, P=0.028), baseline characteristics, reperfusion therapy, and medical treatment
were well balanced between the two groups. More patients in the roxithromycin group
interrupted their study medication before completion of at least 4 weeks of treatment (78 of 433
[18%] versus 48 of 439 [11%]; P=0.003; odds ratio, 1.8; 95% CI, 1.2 to 2.6). Follow-up at 12
months was achieved in 868 of 872 (99.5%) patients. Total mortality at 12 months was 6.5%
(28 of 431) in the roxithromycin group compared with 6.0% (26 of 437) in the placebo group
(odds ratio, 1.1; 95% CI, 0.6 to 1.9; P=0.739). There were also no differences in the secondary
combined end points at 12 months.
Conclusions Treatment of AMI patients with roxithromycin did not reduce event rates during
12 months of follow-up. Therefore, our findings do not support the routine use of antibiotic
treatment with a macrolide in patients with AMI.

Primary angiopl asty versus intravenous thrombolytic therapy for acute myocardial
infarction: a quantitative review of 23 randomised trials
Ellen C Keeley, Judith A Boura, Cindy L Grines Lancet 2003; 361: 13-20

Background Many trials have been done to compare primary percutaneous transluminal
coronary angioplasty (PTCA) with thrombolytic therapy for acute ST-segment elevation
myocardial infarction (AMI). Our aim was to look at the combined results of these trials and to
ascertain which reperfusion therapy is most effective.
Methods We did a search of published work and identified 23 trials, which together randomly
assigned 7739 thrombolytic-eligible patients with ST-segment elevation AMI to primary PTCA
(n=3872) or thrombolytic therapy (n=3867). Streptokinase was used in eight trials (n=1837),
and fibrin-specific agents in 15 (n=5902). Most patients who received thrombolytic therapy
(76%, n=2939) received a fibrin-specific agent. Stents were used in 12 trials, and platelet
glycoprotein IIb/IIIa inhibitors were used in eight. We identified short-term and long-term
clinical outcomes of death, non-fatal reinfarction, and stroke, and did subgroup analyses to
assess the effect of type of thrombolytic agent used and the strategy of emergent hospital
transfer for primary PTCA. All analyses were done with and without inclusion of the SHOCK
trial data.
Findings Primary PTCA was better than thrombolytic therapy at reducing overall short-term
death (7% [n=270] vs 9% [360]; p=0•0002), death excluding the SHOCK trial data (5% [199]
vs 7% [276]; p=0•0003), non-fatal reinfarction (3% [80] vs 7% [222]; p<0•0001), stroke (1%
[30] vs 2% [64]; p=0•0004), and the combined endpoint of death, non-fatal reinfarction, and
stroke (8% [253] vs 14% [442]; p<0•0001). The results seen with primary PTCA remained
better than those seen with thrombolytic therapy during long-term follow-up, and were
independent of both the type of thrombolytic agent used, and whether or not the patient was
transferred for primary PTCA.
Interpretation Primary PTCA is more effective than thrombolytic therapy for the treatment of
ST-segment elevation AMI.
Effect of short-term treatment with azithromycin on recurrent ischaemic events in
patients with acute coronary syndrome in the Azithromycin in Acute Coronary Syndrome
(AZACS) trial: a randomised controlled trial
Bojan Cercek, Prediman K Shah, Marko Noc, Doron Zahger, Uwe Zeymer, Shlomi Matetzky,
Gerald Maurer, Peter Mahrer, for AZACS Investigators Lancet 2003; 361: 809-13
Background There is serological and epidemiological evidence of an association between
Chlamydia pneumoniae infection and coronary artery disease. Results of previous smaller
studies have indicated a reduction of recurrent ischaemic events in patients with acute coronary
syndrome when given macrolide antibiotics. We aimed to assess whether short -term treatment
with the macrolide antibiotic azithromycin reduces recurrent ischaemic events in patients
admitted for unstable angina or myocardial infarction.
Methods We assessed the effect of azithromycin in a multicentre, double-blind randomised trial
in 1439 patients with unstable angina or acute myocardial infarction. Patients were randomly
allocated to receive 500 mg azithromycin on the first day after randomisation, followed by 250
mg daily for 4 days or placebo. Patients were followed up for 6 months. The primary endpoints
were death, recurrent myocardial infarction, or recurrent ischaemia necessitating
revascularisation. Analysis was done by intention to treat.
Findings Treatment with azithromycin did not result in reduction of either individual endpoints
or any of the primary endpoints. Of the 716 patients in the azithromycin group, 23 (3%) died,
17 (2%) developed myocardial infarction, 65 (9%) had recurrent ischaemia needing
revascularisation, and 100 (14%) had one or more of these endpoints. In the placebo group
(n=723) the corresponding numbers of patients were 24 (4%), 22 (3%), 59 (8%), and 106
(15%), respectively (p=0•664, 95% CI 0•72-1•24). 62 (9%) of patients in the azithromycin
group and 59 (8%) in the placebo group reached the secondary endpoint of ischaemia or
congestive heart failure necessitating admission (difference 0•5%, 95% CI 0•75-1•53;
p=0•707). We recorded few side-effects.
Interpretation Short-term treatment with azithromycin does not reduce development of
recurrent events in patients with acute coronary syndrome.
Coronary stenting versus coronary bypass surgery in patients with multiple vessel disease
and significant proximal LAD stenosis: results from the ERACI II study
A Rodriguez, M Rodríguez Alemparte, J Baldi, J Navia, A Delacasa, D Vogel, R Oliveri, C
Fernández Pereira, V Bernardi, W O’Neill, and I F Palacios. Heart 2003 89: 184-188

Purpose: To compare percutaneous coronary intervention (PCI) using stent implantation versus
coronary artery bypass graft (CABG) in patients with multiple vessel disease with involvement
of the proximal left anterior descending coronary artery (LAD).
Methods: 230 patients with multiple vessel disease and severe stenosis of the proximal LAD
(113 with PCI, 117 with CABG). They were a cohort of patients from the randomised ERACI
(Argentine randomized trial of percutaneous transluminal coronary angioplasty versus coronary
artery bypass surgery in multivessel disease) II study.
Results: Both groups had similar baseline characteristics. There were no significant differences
in 30 day major adverse cardiac events (death, myocardial infarction, stroke, and repeat
procedures) between the strategies (PCI 2.7% v CABG 7.6%, p = 0.18). There were no
significant differences in survival (PCI 96.4% v CABG 95%, p = 0.98) and survival with
freedom from myocardial infarction (PCI 92% v CABG 89%, p = 0.94) at 41.5 (6) months’
follow up. However, freedom from new revascularisation procedures (CABG 96.6% v PCI
73%, p = 0.0002) and frequency of angina (CABG 9.4% v PCI 22%, p = 0.025) were superior
in the CABG group.
Conclusion: Patients with multivessel disease and significant disease of the proximal LAD
randomly assigned in the ERACI II trial to PCI or CABG had similar survival and survival with
freedom from myocardial infarction at long term follow up. Repeat revascularisation
procedures were higher in the PCI group.
Cost effectiveness of extended treatment with low molecular weight heparin (dalteparin)
in unstable coronary artery disease: results from the FRISC II trial
M Janzon, L-Å Levin, and E Swahn. Heart 2003 89: 287-292

Background: In unstable coronary artery disease short term treatment with low molecular
weight heparin in addition to aspirin has been shown to be effective.
Objective: To assess the cost effectiveness of extended treatment with dalteparin in patients
managed with a non-invasive treatment strategy.
Design: Prospective, randomised, multicentre study.
Setting: 58 centres in Sweden, Denmark, and Norway, of which 16 were interventional.
Patients: After at least five days’ treatment with open label dalteparin, 2267 patients were
randomised to continue double blind treatment with either subcutaneous dalteparin twice daily
or placebo for three months. The patients’ use of health service resources was recorded
Main outcome measure: Death/myocardial infarction.
Results: After one month into the double blind period there was a 47% relative reduction in
death or myocardial infarction in the dalteparin group compared with the placebo group (p =
0.002). There was a non-significant mean cost difference, favouring the placebo group, of 849
Swedish crowns (SEK) per patient (equivalent to £58). The incremental cost effectiveness ratio
for giving dalteparin treatment for one month was SEK 30 300 (range -78 000 to 139 000)
(£2060, range -£5300 to £9400) per avoided death or myocardial infarct. At three months, the
decrease in death or myocardial infarction was not significant, precluding cost effectiveness
Conclusions: There is a marginal and non-significant increase in costs for one month of
extended dalteparin treatment compared with placebo. Extended dalteparin treatment lowers the
risk of death or myocardial infarction in patients with unstable coronary artery disease. While in
many countries the resources for early intervention are limited, extended dalteparin treatment
up to one month is a cost effective bridge to invasive intervention.

Drug eluting stents: are human and animal studies comparable?

R Virmani, F D Kolodgie, A Farb, and A Lafont. Heart 2003 89: 133-138

Animal models of stenting probably predict human responses as the stages of healing are
remarkably similar. What is characteristically different is the temporal response to healing,
which is substantially prolonged in humans. The prevention of restenosis in recent clinical trials
of drug eluting stents may represent a near absent or incomplete phase of intimal healing.
Continued long term follow up of patients with drug eluting stents for major adverse cardiac
events and angiographic restenosis is therefore imperative.
Experience with transcatheter closure of secundum atrial septal defects using the
Amplatzer septal occluder: a single centre study in 236 consecutive patients
G Fischer, J Stieh, A Uebing, U Hoffmann, G Morf, and H H Kramer. Heart 2003 89: 199-204

Aim: To evaluate the safety and efficacy of transcatheter closure of secundum atrial septal
defects (ASD) with the Amplatzer septal occluder.
Methods: 236 consecutive patients with a significant ASD (age 6 months to 46 years, median 5
years; body weight 6.5–79 kg, median 18 kg) were considered for transcatheter closure with the
Amplatzer septal occluder; 18 patients with defects that were too large or with a deficient
inferior margin were excluded from attempted transcatheter closure after initial transthoracic (4)
or transoesophageal echocardiography (14).
Results: At cardiac catheterisation, devices were not implanted in 18 patients because the
stretched diameter of the ASD was too large (4), the device was unstable (4), compromised the
mitral valve (1), or obstructed the upper right pulmonary vein (1); eight patients with additional
systemic or pulmonary vein anomalies (5) or a Qp:Qs less than 1.5 (3) were excluded after
angiographic and haemodynamic assessment. Thus ASD closure was done successfully in 200
patients (procedure time 25–210 minutes, median 66 minutes; fluoroscopy time 2.5–60 minutes,
median 12 minutes), among whom 22 had multiple ASDs (14) or a septal aneurysm (8). The
diameter of the devices ranged between 6–34 mm. Severe procedure related complications
(retroperitoneal bleeding, air embolism) occurred in two cases. At follow up (33 days to 4.3
years, median 2.3 years) complete closure was documented in 94%, with a trivial residual shunt
in 12 patients.
Conclusions: The Amplatzer septal occluder is very efficient and offered interventional ASD
closure in 84.7% of our group of consecutive patients, with excellent intermediate results.

Intravascular Ultrasound Analysis of Infarct-Related and Non–Infarct-Related Arteries
in Patients Who Presented With an Acute Myocardial Infarction
Jun-ichi Kotani, Gary S. Mintz, Marco T. Castagna, Ellen Pinnow, Chalak O. Berzingi, Anh B.
Bui, Augusto D. Pichard, Lowell F. Satler, William O. Suddath, Ron Waksman, John R. Laird,
Jr, Kenneth M. Kent, Neil J. Weissman. Circulation 2003 107: 2889 – 2893
Background Previous studies have reported diffuse destabilization of athero sclerotic plaques in
acute myocardial infarction (AMI).
Methods and Results We used intravascular ultrasound (IVUS) to assess 78 coronary arteries
(38 infarct-related arteries [IRAs] with culprit and nonculprit lesions and 40 non-IRAs) from 38
consecutive AMI patients. IVUS analysis included qualitative and quantitative measurements of
reference and lesion external elastic membrane (EEM), lumen, and plaque plus media (P&M)
area. Positive remodeling was defined as lesion/mean reference EEM >1.0. Culprit lesions were
identified by a combination of ECG, wall motion abnormalities (ventriculogram or
echocardiogram), scintigraphic perfusion defects, and coronary angiogram. Culprit lesions
contained more thrombus (23.7% versus 3.4% in nonculprit IRA plaques and 3.1% in non-IRA
plaques; P=0.0011). Culprit lesions were predominantly hypoechoic (63.2% versus 37.9% of
nonculprit IRA plaques and 28.1% of non-IRA plaques; P=0.0022). Culprit lesions were longer
(17.5±10.1, 9.8±4.0, and 10.3±5.7 mm, respectively; P<0.0001), had larger EEM area
(15.0±6.0, 11.5±5.7, and 12.6±5.6 mm2, respectively; P=0.0353) and P&M area (13.0±6.0,
7.5±3.7, 9.3±4.3 mm2, respectively; P<0.0001), smaller lumens (2.0±0.9, 4.1±3.1, and 3.4±2.5
mm2, respectively; P=0.0009), and more positive remodeling (79.4%, 59.0%, and 50.8%,
respectively; P=0.0155). The frequency of plaque rupture/dissection was greater in culprit,
nonculprit IRA, and non-IRA plaques in AMI patients than in a control group of chronic stable
angina patients with multivessel IVUS imaging.
Conclusions Culprit plaques have more markers of instability (thrombus, positive remodeling,
and large plaque mass); however, these markers of instability are not typically found elsewhere.
This suggests that the vascular event in AMI patients is determined by local pre-event lesion
Clopidogrel for Coronary Stenting Response Variability, Drug Resistance, and the Effect
of Pretreatment Platelet Reactivity
Paul A. Gurbel, MD; Kevin P. Bliden, BS; Bonnie L. Hiatt, MD; Christopher M. O’Connor,
MD. Circulation 2003 107: 2908 – 2913

Background Clopidogrel is administered to prevent stent thrombosis; however, the uniformity
of platelet inhibition after treatment and the influence of pretreatment reactivity on drug
response have not been described.
Methods and Results Platelet aggregation (5 and 20 µmol/L ADP), the activation of
glycoprotein IIb/IIIa (PAC-1 antibody), and the expression of P-selectin were measured in
patients undergoing elective coronary stenting (n=96) at baseline and at 2 hours, 24 hours, 5
days, and 30 days after stenting. All patients received aspirin (325 mg). Clopidogrel (300 mg)
was administered in the catheterization laboratory and followed by 75 mg daily. There was
marked interindividual variability in drug response as measured by all markers that showed a
normal distribution. Resistance, defined as baseline aggregation (%) minus posttreatment
aggregation (%) 10% by 5 µmol/L ADP, was present in 31% and 15% of patients at 5 and 30
days, respectively. Patients with the highest pretreatment platelet reactivity remained the most
reactive at 24 hours after treatment (P<0.0001).
Conclusions Interindividual variability in the platelet inhibitory response from clopidogrel
occurs in patients undergoing elective coronary stenting. Patients with high pretreatment
reactivity are least protected. Alternative pharmacological strategies and the association of
adverse ischemic events should be investigated in these patients.
Frame Count Reserve
Martin G. Stoel, MD; Felix Zijlstra, MD, PhD; Cees A. Visser, MD, PhD. Circulation 2003
107: 3034 - 3039

Background The Doppler wire–derived (relative) coronary flow velocity reserve (CVR) that is
used to evaluate functional significance of a coronary stenosis is a method performed only by
interventional cardiologists. An angiographic method would be useful in the diagnostic
catheterization laboratory. For this purpose, we investigated the relation between TIMI frame
count reserve (FCR) and CVR.
Methods and Results In 38 patients, (relative) FCR of left anterior descending (LA D) and left
circumflex coronary artery (LCx) was calculated by using manual, synchronized contrast agent
injections and compared with (relative) CVR. In addition, vessel length was measured with an
intracoronary guidewire and frame count flow velocity was calculated and compared with
average peak velocity. There was a strong correlation between FCR and CVR (r=0.62, P<0.001)
and between relative FCR and relative CVR (r=0.84, P<0.001). The LAD was significantly
longer than the LCx (mean, 14.3±1.6 cm versus 11.4±1.8 cm, P<0.001), and, therefore, TIMI
frame count of LAD was significantly higher than of LCx (mean basal 32.5±15.1 versus
23.6±9.1 and hyperemic 12.1±6.6 versus 8.7±3.2, both P<0.02). However, all flow velocity
measurements and estimations of volume flow were not different for LAD compared with LCx.
There were also no differences between mean FCR and CVR of LAD or LCx, of both vessels
compared with each other and between mean relative FCR and relative CVR.
Conclusion The (relative) frame count reserve can be used to estimate (relative) coronary flow
velocity reserve.
Randomized Comparison of Distal Protection With a Filter-Based Catheter and a Balloon
Occlusion and Aspiration System During Percutaneous Intervention of Diseased
Saphenous Vein Aorto-Coronary Bypass Grafts
Gregg W. Stone, Campbell Rogers, James Hermiller, Robert Feldman, Patrick Hall, Robert
Haber, A. Masud, Patrick Cambier, Ron P. Caputo, Mark Turco, Richard Kovach, Bruce
Brodie, Howard C. Herrmann, Richard E. Kuntz, Jeffrey J. Popma, Steve Ramee, and David A.
Cox. Circulation 2003 108: 548 – 553
Background The high rate of periprocedural complications resulting from atherothrombotic
embolization after percutaneous intervention in diseased saphenous vein grafts is reduced by
distal microcirculatory protection using a balloon occlusion and aspiration system. Whether
filter-based catheters, which offer the inherent advantages of maintained perfusion and ease of
use, are as effective for this purpose has not been established.
Methods and Results A total of 651 patients undergoing percutaneous intervention of 682
saphenous vein graft lesions were prospectively randomized to distal protection with the filter-
based FilterWire EX versus the GuardWire balloon occlusion and aspiration system. Device
success was 95.5% and 97.2% with the FilterWire EX and GuardWire, respectively (P=0.25).
Postprocedural measures of epicardial flow and angiographic complications were similar
between the 2 groups, although bailout IIb/IIIa inhibitors were required slightly less frequently
in the FilterWire EX group (0% versus 1.5%, P=0.03). The primary end point, the composite
incidence of death, myocardial infarction, or target vessel revascularization at 30 days, occurred
in 9.9% of FilterWire EX patients and 11.6% of GuardWire patients (difference [95% CI]=-
1.7% [-6.4%, 3.1%]; P for superiority=0.53, P for noninferiority=0.0008).
Conclusions Distal protection with the FilterWire EX may be safely used as an adjunct to
percutaneous intervention of diseased saphenous vein grafts and, compared with distal
protection with the GuardWire balloon occlusion and aspiration system, results in similar rates
of major adverse cardiac events at 30 days.
Repeat Intracoronary Radiation for Recurrent In-Stent Restenosis in Patients Who Failed
Intracoronary Radiation
Ron Waksman, Robert Lew, Andrew E. Ajani, Augusto D. Pichard, Lowell F. Satler, Kenneth
M. Kent, Rosanna Chan, R. Larry White, William O. Suddath, Ellen Pinnow, Rebecca
Torguson, Christian Dilcher, Roswitha Wolfram, and Joseph Lindsay. Circulation 2003 108:
654 – 656
Background Intracoronary radiation therapy (IRT) is the only proven treatment for in-stent
restenosis (ISR). It is, however, associated with a significant failure rate. The present study
evaluated the outcomes of patients who underwent repeat intracoronary radiation for recurrent
Methods and Results Fifty-one consecutive patients who failed a previous radiation treatment,
presented with angina and angiographic evidence of ISR, and were treated with percutaneous
coronary intervention (PCI) and repeat radiation to the same segment were studied. Twenty-five
patients were treated with gamma radiation in a dose of 15 Gy, and 26 were treated with beta
radiation doses of 18.3 to 23 Gy. The mean cumu lative dose for this cohort was 39.5±11.9 Gy
(range, 29 to 75.6 Gy). The outcomes of those patients were compared with outcomes of 299
patients who also failed initial radiation but were treated with repeat conventional PCI to a
previously irradiated segment without repeat radiation. At 9 months after treatment, the repeat-
IRT group had lower rates of target lesion revascularization (23.5% versus 54.6%; P<0.001)
and major adverse cardiac events, including target vessel revascularization (29.4% versus
61.3%; P<0.001). At 9 months, patients with repeat IRT were free of angiographic and clinical
events related to the radiation therapy.
Conclusions Repeat gamma or beta radiation to treat failed IRT for ISR after conventional PCI
is safe and effective at 9 months and should be considered as a therapeutic option for this
difficult patient subset.

Randomized Study to Assess the Effectiveness of Slow- and Moderate-Release Polymer-
Based Paclitaxel-Eluting Stents for Coronary Artery Lesions

Antonio Colombo, Janusz Drzewiecki, Adrian Banning, Eberhard Grube, Karl Hauptmann,
Sigmund Silber, Dariusz Dudek, Stephen Fort, Francois Schiele, Krysztof Zmudka, Giulio
Guagliumi, and Mary E. Russell Circulation 2003 108: 788 – 794
Background Early clinical studies demonstrated the feasibility of local paclitaxel delivery in
reducing restenosis after treatment of de novo coronary lesions in small patient populations.
Methods and Results We conducted a randomized, double-blind trial of 536 patients at 38
medical centers evaluating slow-release (SR) and moderate-release (MR) formulations of a
polymer-based paclitaxel-eluting stent (TAXUS) for revascularization of single, primary lesions
in native coronary arteries. Cohort I compared TAXUS-SR with control stents, and Cohort II
compared TAXUS-MR with a second control group. The primary end point was 6-month
percent in-stent net volume obstruction measured by intravascular ultrasound. Secondary end
points were 6-month angiographic restenosis and 6- and 12-month incidence of major adverse
cardiac events, a composite of cardiac death, myocardial infarction, and repeat
revascularization. At 6 months, percent net volume obstruction within the stent was
significantly lower for TAXUS stents (7.9% SR and 7.8% MR) than for respective controls
(23.2% and 20.5%; P<0.0001 for both). This corresponded with a reduction in angiographic
restenosis from 17.9% to 2.3% in the SR cohort (P<0.0001) and from 20.2% to 4.7% in the MR
cohort (P=0.0002). The incidence of major adverse cardiac events at 12 mo nths was
significantly lower (P=0.0192) in the TAXUS-SR (10.9%) and TAXUS-MR (9.9%) groups than
in controls (22.0% and 21.4%, respectively), predominantly because of a significant reduction
in repeat revascularization of the target lesion in TAXUS-treated patients.
Conclusions Compared with a bare metal stent, paclitaxel-eluting stents reduced in -stent
neointimal formation and restenosis and improved 12-month clinical outcome of patients with
single de novo coronary lesions.

Lack of Adverse Clopidogrel–Atorvastatin Clinical Interaction From Secondary Analysis
of a Randomized, Placebo-Controlled Clopidogrel Trial

Jacqueline Saw, Steven R. Steinhubl, Peter B. Berger, Dean J. Kereiakes, Victor L. Serebruany,
Danielle Brennan, and Eric J. Topol Circulation 2003 108: 921 – 924
Background Statins primarily metabolized by cytochrome P450 3A4 (CYP3A4) reportedly
reduce clopidogrel’s metabolism to active metabolite, thus attenuating its inhibition of platelet
aggregation ex vivo. However, the clinical impact of this interaction has not been evaluated.
Methods and Results Clopidogrel for the Reduction of Events During Observation (CREDO)
was a double-blind, placebo-controlled, randomized trial comparing pretreatment (300 mg) and
1-year (75 mg/d) clopidogrel therapy (clopidogrel) with no pretreatment and 1-month
clopidogrel therapy (75 mg/d) (control) after a planned percutaneous coronary intervention. All
patients received aspirin. The 1-year primary end point was a composite of death, myocardial
infarction, and stroke. We performed a post hoc analysis to evaluate the clinical efficacy of
concomitant clopidogrel and statin administration, categorizing baseline statin use to those
predominantly CYP3A4-metabolized (atorvastatin, lovastatin, simvastatin, and cerivastatin)
(CYP3A4-MET) or others (pravastatin and fluvastatin) (non-CYP3A4-MET). Of the 2116
patients enrolled, 1001 received a CYP3A4-MET and 158 a non-CYP3A4-MET statin. For the
overall study population, the primary end point was significantly reduced in the clopidogrel
group (8.5% versus 11.5%, RRR 26.9%; P=0.025). This clopidogrel benefit was similar with
statin use, irrespective of treatment with a CYP3A4-MET (7.6% clopidogrel, 11.8% control,
RRR 36.4%, 95% CI 3.9 to 57.9; P=0.03) or non-CYP3A4-MET statin (5.4% clopidogrel,
13.6% control, RRR 60.6%, 95% CI -23.9 to 87.4; P=0.11). Patients given atorvastatin or
pravastatin had similar 1-year event rates. Additionally, concomitant therapy with statins had no
impact on major or minor bleeding rates.
Conclusions Although ex vivo testing has suggested a potential negative interaction when
coadministering a CYP3A4-metabolized statin with clopidogrel, this was not clinically
observed statistically in a post hoc analysis of a placebo-controlled study.
Safety of an Aspirin-Alone Regimen After Intracoronary Stenting With a Heparin-Coated
Stent: Final Results of the HOPE (HEPACOAT and an Antithrombotic Regimen of
Aspirin Alone) Study

Roxana Mehran, Eve D. Aymong, Dale T. Ashby, Tim Fischell, Hall Whitworth, Jr, Robert
Siegel, William Thomas, S. Chiu Wong, Raj Narasimaiah, Alexandra J. Lansky, and Martin B.
Leon Circulation 2003 108: 1078 – 1083

Background Stent thrombosis is an infrequent complication of intracoronary stenting that often
has devastating clinical consequences. This study assesses the additional benefit of heparin
coating with the BX VELOCITY Balloon-Expandable Stent with HEPACOAT, Carmeda end-
point attached heparin (HEPACOAT) in patients with de novo or restenotic native coronary
artery lesions treated with aspirin monotherapy after optimal stenting.
Methods and Results This was a multicenter, prospective, nonrandomized, pilot study. Two
hundred patients (69% men; mean age, 64.1±11.2 years) meeting the eligibility criteria were
treated with the HEPACOAT stent and aspirin alone after stenting. Any other antiplatelet or
anticoagulation therapy was not permitted. Procedural success was achieved in all patients.
There were 3 postprocedural non–Q-wave myocardial infarctions. The primary end point of
stent thrombosis at 30 days occurred in 2 of 200 patients (1%): in one after blunt chest trauma
and in the other in the setting of essential thrombocytosis. Major adverse cardiac events (death,
myocardial infarction, target lesion revascularization, and coronary artery bypass grafting) were
observed at 30 days in 5 of 200 (2.5%) patients.
Conclusions The BX VELOCITY stent with HEPACOAT and aspirin alone after the procedure
was safe in select patients with de novo or restenotic lesions in native coronary arteries. Heparin
coating provides additional protection against stent thrombosis.

Source: http://www.emodinamica.gise.it/35/23-31.pdf


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