(Circulation. 2000;101:2165.)
© 2000 American Heart Association, Inc.
Clinical Investigation and Reports |
Intracoronary 
-Radiation Therapy After Angioplasty Inhibits Recurrence in Patients With In-Stent Restenosis
From the Cardiology Research Foundation, Division of Cardiology (R.W., G.S.M., R.M., A.J.L., M.B.L., L.F.S., L.G., B.B., K.M.K., A.D.P.), and the Washington Cancer Institute (R.L.W., R.C.C., B.G.B.), Washington Hospital Center, Washington DC; The Interventional Cardiology Department Thoraxcenter (P.W.S.), Erasmus University, Rotterdam, the Netherlands; and the Intravascular Ultrasound Core Laboratories (P.F.), Stanford University, Calif.
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Abstract |
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Background—Treatment of in-stent restenosis presents a critical limitation of intracoronary stent implantation. Ionizing radiation has been shown to decrease neointimal formation within stents in animal models and in initial clinical trials. We studied the effects of intracoronary
-radiation therapy versus placebo on the
clinical and angiographic outcomes of patients with in-stent
restenosis.
Methods and Results—One hundred thirty patients with in-stent
restenosis underwent successful coronary intervention
and were then blindly randomized to receive either
intracoronary -radiation with 192Ir (15 Gy) or
placebo. Four independent core laboratories blinded to the treatment
protocol analyzed the angiographic and intravascular ultrasound
end points of restenosis. Procedural success and in-hospital
and 30-day complications were similar among the groups. At 6 months,
patients assigned to radiation therapy required less target lesion
revascularization and target vessel
revascularization (9 [13.8%] and 17 [26.2%],
respectively) compared with patients assigned to placebo (41 [63.1%,
P=0.0001] and 44 [67.7%, P=0.0001],
respectively). Binary angiographic restenosis was lower in the
irradiated group (19% versus 58% for placebo,
P=0.001). Freedom from major cardiac events was lower in
the radiation group (29.2% versus 67.7% for placebo,
P<0.001).
Conclusions—Intracoronary -radiation used as adjunct
therapy for patients with in-stent restenosis significantly
reduces both angiographic and clinical restenosis.
Key Words: restenosis • angioplasty • revascularization • radioisotopes
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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In-stent restenosis after successful intracoronary stent implantation has become a major clinical problem. It occurs in 7% to 37% of patients who undergo stent implantation and is dependent on patient characteristics, lesion morphology, and procedural technique.1 2 3 Serial intravascular ultrasound studies have demonstrated that in-stent restenosis results primarily from neointimal tissue proliferation distributed either focally or diffusely over the entire length of the stent.4 5 The recurrence rate after treatment for in-stent restenosis varies among reported series but remains high (>30%) regardless of treatment modalities, including balloon angioplasty,6 7 8 rotational atherectomy,9 excimer laser ablation,10 and repeat stenting.11 12 The diffuse pattern of in-stent restenosis (>10 mm length) is associated with even higher rates of recurrence and presents a therapeutic challenge.11
Studies with intracoronary ionizing radiation using
-and ß-emitters after intervention delivered by catheter-based
systems have demonstrated a reduction in neointimal
formation in porcine coronary models.13 14 15 16
Clinical feasibility studies in patients have suggested reduced
postangioplasty restenosis after - and ß-radiation
therapy.12 17 18 In the present study, we report the
results from a prospective, randomized, double-blind trial examining
the effectiveness and safety of intracoronary catheter-based
-radiation therapy compared with placebo as an alternative for
patients requiring treatment for in-stent restenosis.
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Methods |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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This clinical trial was sponsored by an Investigational Device Exemption granted by the Food and Drug Administration to the principal investigator (R.W.) and approved by the Institutional Review Board and the Radiation Safety Committee at the Washington Hospital Center. The study was monitored by an external data and safety-monitoring board, which met at 1, 3, 6, and 12 months after the initiation of the study. Informed consent was obtained from all patients before study enrollment.
Selection of Patients
The study population consisted of 130 consecutive patients, 30
to 80 years of age, with previous intracoronary stent
implantation in native coronaries (n=100) or in aortocoronary
venous bypass grafts (n=30). Patients presented with symptoms
of angina and angiographic evidence of in-stent restenosis.
Angiographic entry criteria included diameter stenosis 
50%
within the stent treatment site in vessels that were 3.0 to 5.0 mm
in diameter and had a lesion length <47 mm in patients who
underwent successful (<30% residual stenosis without
complications) angioplasty with the use of (alone or in combination)
balloons, ablative devices, or additional stents. Main exclusion
criteria were patients with recent (<72-hour) acute myocardial
infarction, ejection fraction <20%, prior irradiation treatment to
the chest, evidence of angiographic thrombus, and multiple lesions in
the same vessel.
Study Protocol
Before intervention, an angiogram and an intravascular
ultrasound study (3.2F catheter with motorized pullback at 0.5
mm/s, Cardiovascular Imaging Systems) were performed to
determine lesion length and vessel size. Focal lesions (<10-mm length)
were treated with balloon dilatation, and diffuse lesions (10-mm
length) underwent initial ablation with use of either an excimer laser
or rotational atherectomy, which was then followed by balloon
dilatation. Additional stents were used, as required, to optimize final
angiographic results or to cover unstented portions of the lesion
(including edge dissection). In preparation for radiation treatment,
the patient was sedated, and the activated clotting time was
maintained at >300 seconds with intravenous heparin. Two
leaded shields (2-in thickness) were placed in proximity on either side
of the table to minimize radiation exposure in the room. A closed
end-lumen 5.0F noncentered catheter (Medtronic Vascular Interventional)
was inserted into the vessel and positioned to span the lesion length.
The patient was randomly assigned to receive a nylon ribbon (0.0030-in
diameter) containing different seed trains of either placebo or
192Ir (Best Medical International). The radiation
oncologist hand-loaded the ribbon from a lead container positioned on a
cart next to the table into the closed end-lumen catheter. The
cardiologist documented by angiography accurate positioning of the
source to cover the entire lesion site plus at least a 4-mm overlap of
normal segments on each end. All catheterization
laboratory personnel left the room during the dwell period for active
source radiation or placebo treatment, except for the radiation safety
officer, who measured exposure rates at various locations.
Patients were carefully monitored from the control room adjacent to the
catheterization laboratory. At the end of the
treatment, the radiation oncologist entered to the room and retrieved
the ribbon into the shielded lead container, and the medical personnel
returned once the radiation exposure reached background values. A final
angiogram and an intravascular ultrasound study were performed. If
significant reduction in luminal dimensions was observed, further
balloon dilatation or stent implantation was used to obtain optimal
final results. Patients received routine postangioplasty care,
including treatment with ticlopidine (250 mg orally, twice daily for 1
month.), regardless of whether additional stents were implanted.
Radiation Details and Dosimetry
The prescribed dose was 15 Gy to a distance of 2.0 mm from
the surface of the source for vessels between 3.0 and 4.0 mm or 15
Gy to a distance of 2.4 mm for vessels >4.0 mm in diameter.
Different trains of seeds were used (5, 9, or 13 to cover total lengths
of 19, 36, and 51 mm, respectively). All seeds were equal in
length (3 mm separated with a 1-mm space), with a mean specific
activity of 25.3±3.5 mCi. Monte Carlo calculations detected maximum
dose to the near wall of 
45 Gy, whereas the minimum dose to the far
wall was 7.3 Gy.
End Points and Follow-Up
The primary clinical end point was the cumulative composite
outcome defined as the occurrence of death, myocardial infarction, and
repeat TLR at 6 months. Important secondary angiographic end points at
6 months were restenosis (defined as diameter stenosis
50%), the magnitude of late loss, and the late loss index. All
patients had clinical follow-up evaluations at 1, 3, 6, and 12 months
after the procedure. At 6 months, repeat coronary angiography
and intravascular ultrasound studies were performed.
Angiographic Analysis
Quantitative coronary angiographic analysis was
performed independently by 2 core angiographic laboratories blinded to
the treatment assignment. The Thoraxcenter laboratory used the CASS-II
system (Pie Medical), and the Washington Hospital Center laboratory
used the CMS-GFT system (Medis). Angiographic binary restenosis
at follow-up (angiograms 4 to 8 months after treatment) was defined as
50% diameter narrowing within the stent and in the segment including
the stent plus its edges (within 5 mm). A luminal diameter of
0 mm was imputed in the presence of a total occlusion at baseline
or at follow-up. Acute gain (in millimeters) was defined as the change
in the stent MLD from baseline to the final procedural angiogram. Late
loss (in millimeters) was defined as the change in stent MLD from the
final to the follow-up angiogram, and the arithmetic loss index within
the stent was defined as the ratio of late loss to acute gain.
Intravascular Ultrasound Analysis
Two independent core laboratories, at Stanford University and at
the Washington Hospital Center, blinded to the treatment protocols
independently analyzed the procedural and follow-up studies.
Both procedural and follow-up studies were analyzed at every
1-mm axial length, including the stented segment and a 5-mm length
proximal and distal to the stent edges of the stent. By use of
computerized planimetry, the stent and luminal cross-sectional areas of
each image slice were traced manually, and the cross-sectional area of
intimal hyperplasia (tissue volume) present within the stent on
each image slice was calculated. Intimal plaque volumes were calculated
by Simpson’s rule. The growth of tissue within the stent struts at
follow-up was calculated as the intimal area (or volume) at follow-up
minus the intimal area (or volume) immediately after the procedure.
Statistical Analysis
The target sample size of 130 patients (with previous stent
implantation in 100 native coronaries and 30 saphenous vein grafts with
separate randomization) was determined (80% power and 95% confidence)
to demonstrate a 50% reduction in the composite clinical end point.
Data were recorded prospectively and were forwarded to the
data-coordinating center at the Washington Hospital Center. All
clinical events were independently adjudicated by an external committee
that reviewed source-documented data in a blinded fashion.
Outcomes were analyzed according to the
"intention-to-treat" principle. Results are expressed as mean±SD.
The Student t test was used to compare continuous
variables; the 
2 test or Fisher exact test
was used to compare categorical values. The TLR, TVR, and the composite
clinical end point were analyzed by use of Kaplan-Meier
survival curves, with differences between the 2 treatment groups
compared by the log-rank test. A value of P<0.05 was
considered significant.
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Results |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Between February 1997 and January 1998, 130 patients with in-stent restenosis were enrolled. Baseline clinical and angiographic characteristics of the treatment groups are shown in Tables 1
and 2,
respectively. Overall, 48% had diabetes, 60% had previous treatment
of in-stent restenosis, and 75% had a diffuse pattern of
in-stent restenosis (lesion length >10 mm) with a mean
lesion length of 28.8±12.4 mm.
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Procedural Details and Early Outcome
The distribution of devices and number of seeds used are shown in
Table 2
. Balloon angioplasty alone was used in only 14 (10.7%)
lesions. Atheroablative devices were most frequently used: rotational
atherectomy in 60% of native coronaries and excimer laser in 90% of
vein grafts. Restenting was performed in 46 (35.4%) lesions because of
either tissue prolapse (in 26 lesions) or the necessity to cover edge
dissections (in the remaining 20 lesions). Most lesions were treated
with a 13-seed ribbon with an average of 10.9±2.7 seeds per lesion to
cover an average length of 41.31±11.8 mm. The dwell time was
22.0±5.3 minutes to deliver the prescribed dose and was tolerated well
by most of the patients. However, 4 patients (2 from each group),
including 1 from the placebo group who did not complete the treatment
because of persistent ischemia, required dose fractionation.
Radiation exposure rates during treatment were as follows:
patient’s chest, 5.0±0.2 R/h; catheterization table, 650±120
mR/h; 1 m from the table, 107±35 mR/h; behind the leaded shield,
53±24 mR/h; and at the control room, 0.23±0.06 mR/h (background
levels). All procedures were free of major adverse events, and only 2
patients required vascular access site repair. There were no deaths,
subacute closure, or Q-wave myocardial infarctions in hospital or
after 30 days. Creatine kinase-MB elevations >3 times baseline were
detected in 11% of the irradiated group versus 8% of the placebo
group (P=NS).
Angiographic Results
Follow-up angiography was performed at a mean of 188±59 days in
59 patients (90.7%) from the irradiated group and at a mean of 151±71
days in 59 patients (90.7%) from the placebo group. The quantitative
angiographic results of both core laboratories were similar (Table 3). The cumulative distribution curves
for minimum luminal diameter (MLD) are shown in Figure 1. Compared with placebo, radiation
therapy resulted in a significant reduction in restenosis both
within the stent (67% reduction, P<0.001) and in the
segment including the stent edges (63% reduction, P=0.001).
The radioactive ribbon/lesion length ratio was 0.92; the placebo
ribbon/lesion length ratio was 0.96. In 72% of patients with edge
effect, the source length did not cover the entire treated lesion
length. The greatest treatment benefit was within the stent; a higher
late loss was observed in the segment including the stent edges
(0.36±0.74) versus the segment only including the stent (0.22±0.84,
P=0.04). The predominant angiographic pattern of
restenosis in the irradiated group was at the edges, with a
mean lesion length of 10±3.1 mm, compared with a diffuse pattern
of recurrence in the placebo group, with a mean lesion length
of 21±10.2 mm (P=0.005). There was no evidence of
perforation or aneurysm formation in the irradiated group.
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Intravascular Ultrasound Results
The intravascular ultrasound results analyzed by 2
independent core laboratories confirmed the angiographic results (Table 4). In 25 (53.2%) of the lesions from
the irradiated group, there was an increase in luminal dimensions and a
regression in the neointimal tissue at 6 months. The
neointimal tissue volume measured 59.6±40.3
mm3 after radiation and 57.4±36.3
mm3 at follow-up. An example of tissue regression
is shown in (Figure 2). None of the
patients in the placebo group showed an increase in luminal dimensions
or a regression of tissue volume; the posttreatment tissue volume
increased from 72.8±72.7 to 132.8±137.4
mm3 at follow-up.
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Late Clinical Events
Clinical follow-up at 30 days, 6 months, and 12 months was
obtained in all patients. Event-free survival (freedom from death,
myocardial infarction, and repeat
revascularization) was greater for patients
assigned to radiation compared with placebo (Table 5). Late thrombosis was associated with
non–Q-wave myocardial infarction in 5 of 6 patients from the
irradiated group and in 2 of 2 patients from the control group. At 6
months, freedom from target lesion
revascularization (TLR) and target vessel
revascularization (TVR) was 86% and 74%,
respectively, in the irradiated group versus 37% and 32%,
respectively, in the placebo group (P=0.001). Between 6 and
12 months, there was an increase of 9.3% in TLR and 7.6% in TVR in
the irradiated group only (Table 5, Figure 3).
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A multiple logistic regression analysis indicated that radiation therapy was the only predictor of freedom from angiographic or clinical restenosis (P=0.0001). Subanalysis of patients with native coronaries showed similarly reduced TVR in the irradiated (16%) versus placebo (66%) patients, with a reduction of major cardiac events (32% versus 72%, both P=0.001). In the 30 vein graft patients, there was also a lower incidence of TVR in the irradiated group (6.7%) versus the placebo group (53.3%, P=0.014) and fewer overall major cardiac events in the irradiated group (20%) versus the placebo group (53.3%, P=0.058).
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Intracoronary stenting involves >60% of all coronary interventions performed today. As a result, in-stent restenosis, especially in its diffuse pattern, remains a serious medical problem. The present study demonstrates that intracoronary
-radiation, as adjunct therapy to intervention
for the treatment of in-stent restenosis, is feasible,
effective, and safe without periprocedural adverse events compared with
placebo. The patients in the present study represent the
"real world" of severe in-stent restenosis, the "frequent
fliers" of coronary intervention. The high-risk patient
profiles and the nature of the disease may explain the high event rates
for the overall cohort, with a mortality of 5.2% at 6 months.
Nevertheless, radiation therapy showed a dramatic reduction (>60%) in
clinical restenosis, which was supported by angiographic and
intravascular ultrasound indices. Several feasibility studies using
intracoronary ionizing radiation after angioplasty or stenting
have been reported. Among these, 2 studies used -radiation: a
registry for de novo lesions17 and a small randomized
study for patients with restenosis who were treated with
stenting.12 Both studies reported a reduction in the
angiographic late loss and restenosis frequency associated with
the use of 192Ir. Lower angiographic indices of
restenosis were also reported with ß-emitters, such as
strontium Sr 90/yttrium Y 9018 and phosphorus P 32.
However, none of these studies specifically targeted a patient
population of in-stent restenosis. The present study
demonstrates an important therapeutic application for
intracoronary -radiation, which specifically addresses a
disease state (diffuse in-stent restenosis) that currently
lacks acceptable alternative treatments. The angiographic
analysis demonstrated a striking reduction in late loss for the
irradiated group compared with placebo group, and in >50% of
irradiated patients, the MLD at follow-up was unchanged. These findings
were corroborated by the ultrasound analysis, which showed
convincing evidence of intimal hyperplasia regression after radiation.
Interestingly, the late loss was found to be less at the center of the
lesion compared with the edges, where catheter placement was less
precise, and there was a dose drop-off by as much as 30%. These
findings support the importance of accurate dosimetry and suggest that
better coverage of the lesion by treating longer margins may further
reduce the restenosis rate at the edges. Overall, the dosimetry
strategy for the present study was effective despite the lack of
centering of the radiation catheter and without the use of
intravascular ultrasound imaging to determine minimum and maximum doses
to the tunica media as previously proposed in the Scripps
Coronary Radiation to Inhibit Intimal Proliferation Post
Stenting (SCRIPPS) study.12 The lack of early and late
adverse events supports the notion that the therapeutic and toxic
windows for 192Ir are sufficiently broad to
accommodate a simple fixed dosimetry scheme. The late thrombosis seen
more in the irradiated group was reported in other radiation trials
using ß-emitters19 20 and seems to be a complication of
the radiation therapy that will require further investigation and
treatment strategy, such as prolonged antiplatelet
therapy.20 An important observation is the increase in the revascularization rate between 6 and 12 months in the irradiated group only. Although these changes do not affect the clinical benefit observed in the treated versus placebo groups, they do suggest that radiation may delay in part the biological processes and that a late "catch-up" phenomena or late thrombosis will ultimately minimize the long-term benefit of radiation. In addition, caution should be observed concerning the potential risk of late effects of radiation, which may occur 10 years after treatment, as previously reported with the use of external radiation.21
All clinical interventional practitioners agree that
in-stent restenosis is a compelling dilemma that mandates an
immediate solution. On the basis of the encouraging and convincing
results of the present study, we submit that intracoronary
-radiation using 192Ir is an important and
viable therapeutic option for patients who suffer from
recurrence of in-stent restenosis.
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Acknowledgments |
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This study was supported in part by a nondirected grant from the Pergament Center for Cardiovascular Research. We wish to acknowledge the invaluable assistance of the following individuals during the execution of the clinical trial: Michael Porrazzo, MD, Juliana Simmons, MD, and Pamela Bailey Randolph, MD (Washington Cancer Institute Washington Hospital Center, Washington DC); Manel Sabate, MD (Thoraxcenter, Erasmus University, Rotterdam, the Netherlands); Thosaphol Limpijankit, MD (Stanford University California); and Ann Greenberg (Cardiology Research Foundation, Washington Hospital Center, Washington, DC).
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Footnotes |
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Reprint requests to Dr Ron Waksman, Cardiology Research Institute, Department of Medicine, Washington Hospital Center, 110 Irving St NW, Suite 4B-1, Washington, DC 20010.
The Principal Investigator is consultant to several companies who develop devices for vascular brachytherapy.
Received August 2, 1999; revision received December 6, 1999; accepted December 10, 1999.
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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D. Mukherjee and D. J. Moliterno Brachytherapy for In-Stent Restenosis: A Distant Second Choice to Drug-Eluting Stent Placement JAMA, March 15, 2006; 295(11): 1307 - 1309. [Full Text] [PDF]
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S. C. Smith Jr, T. E. Feldman, J. W. Hirshfeld Jr, A. K. Jacobs, M. J. Kern, S. B. King III, D. A. Morrison, W. W. O'Neill, H. V. Schaff, P. L. Whitlow, et al. ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention--Summary Article: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) J. Am. Coll. Cardiol., January 3, 2006; 47(1): 216 - 235. [Full Text] [PDF]
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S. C. Smith Jr, T. E. Feldman, J. W. Hirshfeld Jr, A. K. Jacobs, M. J. Kern, S. B. King III, D. A. Morrison, W. W. O'Neill, H. V. Schaff, P. L. Whitlow, et al. ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention--Summary Article: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) Circulation, January 3, 2006; 113(1): 156 - 175. [Full Text] [PDF]
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R. M. Wolfram, A. C. Budinsky, B. Pokrajac, R. Potter, and E. Minar Vascular Brachytherapy with 192Ir after Femoropopliteal Stent Implantation in High-Risk Patients: Twelve-month Follow-up Results from the Vienna-5 Trial Radiology, July 1, 2005; 236(1): 343 - 351. [Abstract] [Full Text] [PDF]
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R. M. Wolfram, A. C. Budinsky, B. Pokrajac, R. Potter, and E. Minar Endovascular Brachytherapy: Restenosis in de Novo versus Recurrent Lesions of Femoropopliteal Artery--The Vienna Experience Radiology, July 1, 2005; 236(1): 338 - 342. [Abstract] [Full Text] [PDF]
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F.-J. Neumann, W. Desmet, E. Grube, J. Brachmann, P. Presbitero, P. Rubartelli, A. Mugge, F. Di Pede, D. Fullgraf, W. Aengevaeren, et al. Effectiveness and Safety of Sirolimus-Eluting Stents in the Treatment of Restenosis After Coronary Stent Placement Circulation, April 26, 2005; 111(16): 2107 - 2111. [Abstract] [Full Text] [PDF]
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Authors/Task Force Members, S. Silber, P. Albertsson, F. F. Aviles, P. G. Camici, A. Colombo, C. Hamm, E. Jorgensen, J. Marco, J.-E. Nordrehaug, et al. Guidelines for Percutaneous Coronary Interventions: The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology Eur. Heart J., April 2, 2005; 26(8): 804 - 847. [Full Text] [PDF]
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K. Tanabe, P. W. Serruys, M. Degertekin, E. Grube, G. Guagliumi, W. Urbaszek, J. Bonnier, J.-M. Lablanche, T. Siminiak, J. Nordrehaug, et al. Incomplete Stent Apposition After Implantation of Paclitaxel-Eluting Stents or Bare Metal Stents: Insights From the Randomized TAXUS II Trial Circulation, February 22, 2005; 111(7): 900 - 905. [Abstract] [Full Text] [PDF]
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J M Cotton, K Rance, A Patil, and M R Thomas Intracoronary brachytherapy for the treatment of complex in-stent restenosis Heart, February 1, 2005; 91(2): 231 - 232. [Full Text] [PDF]
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M. Sabate, G. Pimentel, C. Prieto, J. Corral, C. Banuelos, D. J. Angiolillo, F. Alfonso, R. Hernandez-Antolin, J. Escaned, P. Fantidis, et al. Intracoronary brachytherapy after stenting de novo lesions in diabetic patients: Results of a randomized intravascular ultrasound study J. Am. Coll. Cardiol., August 4, 2004; 44(3): 520 - 527. [Abstract] [Full Text] [PDF]
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P. W. Serruys, W. Wijns, G. Sianos, I. de Scheerder, P. A. van den Heuvel, W. Rutsch, H. D. Glogar, C. Macaya, P. H. Materne, S. Veldhof, et al. Direct stenting versus direct stenting followed by centered beta-radiation with intravascular ultrasound-guided dosimetry and long-term anti-platelet treatment: Results of a randomized trial: Beta-radiation Investigation with Direct stenting and Galileo in Europe (BRIDGE) J. Am. Coll. Cardiol., August 4, 2004; 44(3): 528 - 537. [Abstract] [Full Text] [PDF]
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R. Waksman Vascular brachytherapy and coronary stenting for de novo lesions: Love on the rocks J. Am. Coll. Cardiol., August 4, 2004; 44(3): 538 - 540. [Full Text] [PDF]
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K. Krueger, M. Zaehringer, M. Bendel, H. Stuetzer, D. Strohe, M. Nolte, D. Wittig, R.-P. Mueller, and K. Lackner De Novo Femoropopliteal Stenoses: Endovascular Gamma Irradiation Following Angioplasty--Angiographic and Clinical Follow-up in a Prospective Randomized Controlled Trial Radiology, May 1, 2004; 231(2): 546 - 554. [Abstract] [Full Text] [PDF]
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M Jaster, V Fuster, P Rosenthal, M Pauschinger, Q-V Tran, D Janssen, W Hinkelbein, P Schwimmbeck, H-P Schultheiss, and U Rauch Catheter based intracoronary brachytherapy leads to increased platelet activation Heart, February 1, 2004; 90(2): 160 - 164. [Abstract] [Full Text] [PDF]
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R. Waksman, A. E. Ajani, R. L. White, R. Chan, B. Bass, A. D. Pichard, L. F. Satler, K. M. Kent, R. Torguson, R. Deible, et al. Five-Year Follow-Up After Intracoronary Gamma Radiation Therapy for In-Stent Restenosis Circulation, January 27, 2004; 109(3): 340 - 344. [Abstract] [Full Text] [PDF]
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M. Degertekin, P. A. Lemos, C. H. Lee, K. Tanabe, J.E. Sousa, A. Abizaid, E. Regar, G. Sianos, W. J. van der Giessen, P. J. de Feyter, et al. Intravascular ultrasound evaluation after sirolimus eluting stent implantation for de novo and in-stent restenosis lesions Eur. Heart J., January 1, 2004; 25(1): 32 - 38. [Abstract] [Full Text] [PDF]
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J. W. Moses, M. B. Leon, J. J. Popma, P. J. Fitzgerald, D. R. Holmes, C. O'Shaughnessy, R. P. Caputo, D. J. Kereiakes, D. O. Williams, P. S. Teirstein, et al. Sirolimus-Eluting Stents versus Standard Stents in Patients with Stenosis in a Native Coronary Artery N. Engl. J. Med., October 2, 2003; 349(14): 1315 - 1323. [Abstract] [Full Text] [PDF]
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F. Alfonso, J. Zueco, A. Cequier, R. Mantilla, A. Bethencourt, J. R. Lopez-Minguez, J. Angel, J. M. Auge, M. Gomez-Recio, C. Moris, et al. A randomized comparison ofrepeat stenting with balloon angioplasty in patients with in-stent restenosis J. Am. Coll. Cardiol., September 3, 2003; 42(5): 796 - 805. [Abstract] [Full Text] [PDF]
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R. Waksman, R. Lew, A. E. Ajani, A. D. Pichard, L. F. Satler, K. M. Kent, R. Chan, R. L. White, W. O. Suddath, E. Pinnow, et al. Repeat Intracoronary Radiation for Recurrent In-Stent Restenosis in Patients Who Failed Intracoronary Radiation Circulation, August 12, 2003; 108(6): 654 - 656. [Abstract] [Full Text] [PDF]
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P. S. Teirstein and S. King Vascular Radiation in a Drug-Eluting Stent World: It's Not Over Till It's Over Circulation, July 29, 2003; 108(4): 384 - 385. [Full Text] [PDF]
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R. Waksman and J. Weinberger Coronary Brachytherapy in the Drug-Eluting Stent Era: Don't Bury It Alive Circulation, July 29, 2003; 108(4): 386 - 388. [Full Text] [PDF]
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M. Hoher, J. Wohrle, M. Wohlfrom, J. Kamenz, T. Nusser, O. C. Grebe, H. Hanke, M. Kochs, S. N. Reske, V. Hombach, et al. Intracoronary {beta}-Irradiation With a Rhenium-188-Filled Balloon Catheter: A Randomized Trial in Patients With De Novo and Restenotic Lesions Circulation, June 24, 2003; 107(24): 3022 - 3027. [Abstract] [Full Text] [PDF]
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T M Schiele, E Regar, S Silber, E Eeckhout, D Baumgart, W Wijns, A Colombo, W Rutsch, D Meerkin, A Gershlick, et al. Clinical and angiographic acute and follow up results of intracoronary {beta} brachytherapy in saphenous vein bypass grafts: a subgroup analysis of the multicentre European registry of intraluminal coronary {beta} brachytherapy (RENO) Heart, June 1, 2003; 89(6): 640 - 644. [Abstract] [Full Text] [PDF]
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C. O. Costantini, A. J. Lansky, G. S. Mintz, K. Shirai, G. Dangas, R. Mehran, M. Fahy, S. Slack, M. Coral, P. S. Teirstein, et al. Intravascular brachytherapy for native coronary ostial in-stent restenotic lesions J. Am. Coll. Cardiol., May 21, 2003; 41(10): 1725 - 1731. [Abstract] [Full Text] [PDF]
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E. Cheneau, M. C. John, J. Fournadjiev, R. C. Chan, H.-S. Kim, L. Leborgne, R. Pakala, H. Yazdi, A. E. Ajani, R. Virmani, et al. Time Course of Stent Endothelialization After Intravascular Radiation Therapy in Rabbit Iliac Arteries Circulation, April 29, 2003; 107(16): 2153 - 2158. [Abstract] [Full Text] [PDF]
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P. S. Brara, M. Moussavian, M. A. Grise, J. P. Reilly, M. Fernandez, R. A. Schatz, and P. S. Teirstein Pilot Trial of Oral Rapamycin for Recalcitrant Restenosis Circulation, April 8, 2003; 107(13): 1722 - 1724. [Abstract] [Full Text] [PDF]
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R. Waksman, E. Cheneau, A. E. Ajani, R. L. White, E. Pinnow, R. Torguson, R. Deible, L. F. Satler, A. D. Pichard, K. M. Kent, et al. Intracoronary Radiation Therapy Improves the Clinical and Angiographic Outcomes of Diffuse In-Stent Restenotic Lesions: Results of the Washington Radiation for In-Stent Restenosis Trial for Long Lesions (Long WRIST) Studies Circulation, April 8, 2003; 107(13): 1744 - 1749. [Abstract] [Full Text] [PDF]
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A. E. Ajani, R. Waksman, E. Cheneau, D.-H. Cha, S. McGlynn, M. Castagna, R. C. Chan, L. F. Satler, K. M. Kent, A. D. Pichard, et al. The outcome of percutaneous coronary intervention in patients with In-Stentrestenosis who failed intracoronary radiation therapy J. Am. Coll. Cardiol., February 19, 2003; 41(4): 551 - 556. [Abstract] [Full Text] [PDF]
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K. Tanabe, P. W. Serruys, E. Grube, P. C. Smits, G. Selbach, W. J. van der Giessen, M. Staberock, P. de Feyter, R. Muller, E. Regar, et al. TAXUS III Trial: In-Stent Restenosis Treated With Stent-Based Delivery of Paclitaxel Incorporated in a Slow-Release Polymer Formulation Circulation, February 4, 2003; 107(4): 559 - 564. [Abstract] [Full Text] [PDF]
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P.W Radke, A Kaiser, C Frost, and U Sigwart Outcome after treatment of coronary in-stent restenosis: Results from a systematic review using meta-analysis techniques Eur. Heart J., February 1, 2003; 24(3): 266 - 273. [Abstract] [Full Text] [PDF]
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M. Degertekin, E. Regar, K. Tanabe, P. C. Smits, W. J. van der Giessen, S. G. Carlier, P. de Feyter, J. Vos, D. P. Foley, J. M. R. Ligthart, et al. Sirolimus-eluting stent for treatment of complex in-stent restenosis: The first clinical experience J. Am. Coll. Cardiol., January 15, 2003; 41(2): 184 - 189. [Abstract] [Full Text] [PDF]
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J. E. Sousa, M. A. Costa, A. Abizaid, A. G.M.R. Sousa, F. Feres, L. A. Mattos, M. Centemero, G. Maldonado, A. S. Abizaid, I. Pinto, et al. Sirolimus-Eluting Stent for the Treatment of In-Stent Restenosis: A Quantitative Coronary Angiography and Three-Dimensional Intravascular Ultrasound Study Circulation, January 7, 2003; 107(1): 24 - 27. [Abstract] [Full Text] [PDF]
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R. Seabra-Gomes Intracoronary brachytherapy for restenosis: an efficient technique in the struggle for survival? Eur. Heart J., September 1, 2002; 23(17): 1319 - 1321. [Full Text] [PDF]
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P.W. Serruys, G. Sianos, W. van der Giessen, H.J.R.M. Bonnier, P. Urban, W. Wijns, E. Benit, M. Vandormael, R. Dorr, C. Disco, et al. Intracoronary {beta}-radiation to reduce restenosis after balloon angioplasty and stenting. The Beta Radiation In Europe (BRIE) study Eur. Heart J., September 1, 2002; 23(17): 1351 - 1359. [Abstract] [Full Text] [PDF]
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S. Sharma, W. Nyitray, B. Bhambi, R. Waksman, and A. E. Ajani Brachytherapy and Saphenous-Vein Grafts N. Engl. J. Med., August 29, 2002; 347(9): 692 - 693. [Full Text] [PDF]
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J. J. Popma, M. Suntharalingam, A. J. Lansky, R. R. Heuser, B. Speiser, P. S. Teirstein, V. Massullo, T. Bass, R. Henderson, S. Silber, et al. Randomized Trial of 90Sr/90Y {beta}-Radiation Versus Placebo Control for Treatment of In-Stent Restenosis Circulation, August 27, 2002; 106(9): 1090 - 1096. [Abstract] [Full Text] [PDF]
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R. Waksman, A. E. Ajani, E. Pinnow, E. Cheneau, L. Leborgne, R. Dieble, A. B. Bui, L. F. Satler, A. D. Pichard, K. K. Kent, et al. Twelve Versus Six Months of Clopidogrel to Reduce Major Cardiac Events in Patients Undergoing {gamma}-Radiation Therapy for In-Stent Restenosis: Washington Radiation for In-Stent restenosis Trial (WRIST) 12 Versus WRIST PLUS Circulation, August 13, 2002; 106(7): 776 - 778. [Abstract] [Full Text] [PDF]
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D. E. Kandzari and D. B. Mark Intracoronary Brachytherapy: Time to Sell Short? Circulation, August 6, 2002; 106(6): 646 - 648. [Full Text] [PDF]
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D. J. Cohen, R. S. Cosgrove, R. H. Berezin, P. S. Teirstein, M. B. Leon, R. E. Kuntz, and on behalf of the Gamma-1 Investigators Cost-Effectiveness of Gamma Radiation for Treatment of In-Stent Restenosis: Results From the Gamma-1 Trial Circulation, August 6, 2002; 106(6): 691 - 697. [Abstract] [Full Text] [PDF]
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M. Apple, R. Waksman, R. C. Chan, Y. Vodovotz, J. Fournadjiev, and B. G. Bass Radioactive 133-Xenon Gas-Filled Balloon to Prevent Restenosis: Dosimetry, Efficacy, and Safety Considerations Circulation, August 6, 2002; 106(6): 725 - 729. [Abstract] [Full Text] [PDF]
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K. Krueger, P. Landwehr, M. Bendel, M. Nolte, H. Stuetzer, R. Bongartz, M. Zaehringer, G. Winnekendonk, A. Gossmann, R.-P. Mueller, et al. Endovascular Gamma Irradiation of Femoropopliteal de Novo Stenoses Immediately after PTA: Interim Results of Prospective Randomized Controlled Trial Radiology, August 1, 2002; 224(2): 519 - 528. [Abstract] [Full Text] [PDF]
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C. di Mario and K. Toutouzas No room for radiant dreams in the real world Eur. Heart J., July 1, 2002; 23(13): 999 - 1001. [Full Text] [PDF]
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E. Regar, K. Kozuma, G. Sianos, V.L.M.A. Coen, W.J. van der Giessen, D. Foley, P. de Feyter, B. Rensing, P. Smits, J. Vos, et al. Routine intracoronary beta-irradiation. Acute and one year outcome in patients at high risk for recurrence of stenosis Eur. Heart J., July 1, 2002; 23(13): 1038 - 1044. [Abstract] [Full Text] [PDF]
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A. Maehara, N. S. Patel, L. B. Harrison, N. J. Weissman, A. B. Bui, H.-S. Kim, A. E. Ajani, M. T. Castagna, T. L. McMillan, N. Yang, et al. Dose heterogeneity may not affect the neointimal proliferation after gamma radiation for in-stent restenosis: A volumetric intravascular ultrasound dosimetric study J. Am. Coll. Cardiol., June 19, 2002; 39(12): 1937 - 1942. [Abstract] [Full Text] [PDF]
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D. O. Williams Intracoronary Brachytherapy: Past, Present, and Future Circulation, June 11, 2002; 105(23): 2699 - 2700. [Full Text] [PDF]
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M. A. Grise, V. Massullo, S. Jani, J. J. Popma, R. J. Russo, R. A. Schatz, E. M. Guarneri, S. Steuterman, D. A. Cloutier, M. B. Leon, et al. Five-Year Clinical Follow-Up After Intracoronary Radiation: Results of a Randomized Clinical Trial Circulation, June 11, 2002; 105(23): 2737 - 2740. [Abstract] [Full Text] [PDF]
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Y. Morino, T. Limpijankit, Y. Honda, A. J. Lansky, R. Waksman, H. N. Bonneau, P. G. Yock, G. S. Mintz, and P. J. Fitzgerald Late Vascular Response to Repeat Stenting for In-Stent Restenosis With and Without Radiation: An Intravascular Ultrasound Volumetric Analysis Circulation, May 28, 2002; 105(21): 2465 - 2468. [Abstract] [Full Text] [PDF]
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C. Hanefeld, S. Amirie, D. Borchardt, P. Grewe, K.-M. Muller, M. Kissler, and A. Mugge Dosimetric Measurements in Isolated Human Coronary Arteries: Comparison of Commercially Available Iridium192 With Strontium/Yttrium90 Emitters Circulation, May 28, 2002; 105(21): 2493 - 2496. [Abstract] [Full Text] [PDF]
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R. Waksman, A. E. Ajani, R. L. White, R. C. Chan, L. F. Satler, K. M. Kent, A. D. Pichard, E. E. Pinnow, A. B. Bui, S. Ramee, et al. Intravascular Gamma Radiation for In-Stent Restenosis in Saphenous-Vein Bypass Grafts N. Engl. J. Med., April 18, 2002; 346(16): 1194 - 1199. [Abstract] [Full Text] [PDF]
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A. E. Ajani, R. Waksman, D.-H. Cha, L. Gruberg, L. F. Satler, A. D. Pichard, and K. M. Kent The impact of lesion length and reference vessel diameter on angiographic restenosis and target vessel revascularization in treating in-stent restenosis with radiation J. Am. Coll. Cardiol., April 17, 2002; 39(8): 1290 - 1296. [Abstract] [Full Text] [PDF]
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K. Kozuma, M.A. Costa, W.J. van der Giessen, M. Sabate, J.M.R. Ligthart, V.L.M.A. Coen, I.P. Kay, A.J. Wardeh, A.H.M. Knook, P.J de Feyter, et al. Initial observation regarding changes in vessel dimensions after balloon angioplasty and stenting followed by catheter-based {beta}-radiation. Is stenting necessary in the setting of catheter-based radiotherapy? Eur. Heart J., April 2, 2002; 23(8): 641 - 649. [Abstract] [Full Text] [PDF]
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 S. Scott, M. O'Sullivan, S. Hafizi, L. M. Shapiro, and M. R. Bennett Human Vascular Smooth Muscle Cells From Restenosis or In-Stent Stenosis Sites Demonstrate Enhanced Responses to p53: Implications for Brachytherapy and Drug Treatment for Restenosis Circ. Res., March 8, 2002; 90(4): 398 - 404. [Abstract] [Full Text] [PDF]
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J. vom Dahl, U. Dietz, P. K. Haager, S. Silber, L. Niccoli, H. J. Buettner, F. Schiele, M. Thomas, P. Commeau, D. R. Ramsdale, et al. Rotational Atherectomy Does Not Reduce Recurrent In-Stent Restenosis: Results of the Angioplasty Versus Rotational Atherectomy for Treatment of Diffuse In-Stent Restenosis Trial (ARTIST) Circulation, February 5, 2002; 105(5): 583 - 588. [Abstract] [Full Text] [PDF]
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S. Meiners, M. Laule, W. Rother, C. Guenther, I. Prauka, P. Muschick, G. Baumann, P.-M. Kloetzel, and K. Stangl Ubiquitin-Proteasome Pathway as a New Target for the Prevention of Restenosis Circulation, January 29, 2002; 105(4): 483 - 489. [Abstract] [Full Text] [PDF]
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H. C. Lowe, S. N. Oesterle, and L. M. Khachigian Coronary in-stent restenosis: Current status and future strategies J. Am. Coll. Cardiol., January 16, 2002; 39(2): 183 - 193. [Abstract] [Full Text] [PDF]
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A. J. Lansky, G. Dangas, R. Mehran, K. J. Desai, G. S. Mintz, H. Wu, M. Fahy, G. W. Stone, R. Waksman, and M. B. Leon Quantitative angiographic methods for appropriate end-point analysis, edge-effect evaluation, and prediction of recurrent restenosis after coronary brachytherapy with gamma irradiation J. Am. Coll. Cardiol., January 16, 2002; 39(2): 274 - 280. [Abstract] [Full Text] [PDF]
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M. T. Castagna, G. S. Mintz, R. Waksman, J. M. Ahmed, A. Maehara, A. E. Ajani, A. B. Bui, L. F. Satler, W. O. Suddath, K. M. Kent, et al. Comparative Efficacy of {gamma}-Irradiation for Treatment of In-Stent Restenosis in Saphenous Vein Graft Versus Native Coronary Artery In-Stent Restenosis: An Intravascular Ultrasound Study Circulation, December 18, 2001; 104(25): 3020 - 3022. [Abstract] [Full Text] [PDF]
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P. S. Teirstein and R. E. Kuntz New Frontiers in Interventional Cardiology: Intravascular Radiation to Prevent Restenosis Circulation, November 20, 2001; 104(21): 2620 - 2626. [Full Text] [PDF]
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G. S. Mintz, N. J. Weissman, and P. J. Fitzgerald Intravascular Ultrasound Assessment of the Mechanisms and Results of Brachytherapy Circulation, September 11, 2001; 104(11): 1320 - 1325. [Full Text] [PDF]
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S.-W. Park, M.-K. Hong, D. H. Moon, S. J. Oh, C. W. Lee, J.-J. Kim, and S.-J. Park Treatment of diffuse in-stent restenosis with rotational atherectomy followed by radiation therapy with a rhenium-188-mercaptoacetyltriglycine-filled balloon J. Am. Coll. Cardiol., September 1, 2001; 38(3): 631 - 637. [Abstract] [Full Text] [PDF]
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R. M. Wolfram, B. Pokrajac, R. Ahmadi, C. Fellner, M. Gyongyosi, M. Haumer, R. Bucek, R. Potter, and E. Minar Endovascular Brachytherapy for Prophylaxis against Restenosis after Long-Segment Femoropopliteal Placement of Stents: Initial Results Radiology, September 1, 2001; 220(3): 724 - 729. [Abstract] [Full Text] [PDF]
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J. M. Ahmed, G. S. Mintz, R. Waksman, R. Mehran, B. Leiboff, A. D. Pichard, L. F. Satler, K. M. Kent, and N. J. Weissman Serial Intravascular Ultrasound Assessment of the Efficacy of Intracoronary {gamma}-Radiation Therapy for Preventing Recurrence in Very Long, Diffuse, In-Stent Restenosis Lesions Circulation, August 21, 2001; 104(8): 856 - 859. [Abstract] [Full Text] [PDF]
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G. Tepe, L. M. Dinkelborg, U. Brehme, P. Muschick, B. Noll, T. Dietrich, A. Greschniok, A. Baumbach, C. D. Claussen, and S. H. Duda Prophylaxis of Restenosis With 186Re-Labeled Stents in a Rabbit Model Circulation, August 6, 2001; 104(4): 480 - 485. [Abstract] [Full Text] [PDF]
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S. C. Smith Jr, J. T. Dove, A. K. Jacobs, J. Ward Kennedy, D. Kereiakes, M. J. Kern, R. E. Kuntz, J. J. Popma, H. V. Schaff, D. O. Williams, et al. ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines): A report of the American College of Cardiology/ American Heart Association Task Force on practice guidelines (Committee to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty) endorsed by the Society for Cardiac Angiography and Interventions J. Am. Coll. Cardiol., June 15, 2001; 37(8): 2239 - 2239. [Full Text] [PDF]
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M. T. Metzdorff, W. Sapirstein, B. Zuckerman, J. Dillard, M. J. Eisenberg, R. Sheppard, M. B. Leon, P. S. Teirstein, and J. W. Moses Intracoronary Radiotherapy for Restenosis N. Engl. J. Med., June 7, 2001; 344(23): 1796 - 1797. [Full Text] [PDF]
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R. Waksman, A. E. Ajani, R. L. White, E. Pinnow, R. Dieble, A. B. Bui, M. Taaffe, L. Gruberg, G. S. Mintz, L. F. Satler, et al. Prolonged Antiplatelet Therapy to Prevent Late Thrombosis After Intracoronary {{gamma}}-Radiation in Patients With In-Stent Restenosis : Washington Radiation for In-Stent Restenosis Trial Plus 6 Months of Clopidogrel (WRIST PLUS) Circulation, May 15, 2001; 103(19): 2332 - 2335. [Abstract] [Full Text] [PDF]
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G. L. Kaluza, A. E. Raizner, W. Mazur, D. G. Schulz, J. M. Buergler, L. F. Fajardo, F. O. Tio, and N. M. Ali Long-Term Effects of Intracoronary {beta}-Radiation in Balloon- and Stent-Injured Porcine Coronary Arteries Circulation, April 24, 2001; 103(16): 2108 - 2113. [Abstract] [Full Text] [PDF]
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A. Farb, S. Shroff, M. John, W. Sweet, and R. Virmani Late Arterial Responses (6 and 12 Months) After 32P {beta}-Emitting Stent Placement : Sustained Intimal Suppression With Incomplete Healing Circulation, April 10, 2001; 103(14): 1912 - 1919. [Abstract] [Full Text] [PDF]
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R. Seabra-Gomes Radioactive stents to reduce restenosis: time for an epitaph? Eur. Heart J., April 2, 2001; 22(8): 621 - 623. [PDF]
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H.-S. Kim, R. Waksman, Y. Cottin, M. Kollum, B. Bhargava, R. Mehran, R. C. Chan, and G. S. Mintz Edge stenosis and geographical miss following intracoronary gamma radiation therapy for in-stent restenosis J. Am. Coll. Cardiol., March 15, 2001; 37(4): 1026 - 1030. [Abstract] [Full Text] [PDF]
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