(Circulation. 2000;101:1895.)
© 2000 American Heart Association, Inc.
Brief Rapid Communication |
Intracoronary ß-Radiation Therapy Inhibits Recurrence of In-Stent Restenosis
From the Vascular Brachytherapy Institute, Washington Hospital Center, Washington, DC.
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Abstract |
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 Top Abstract IntroductionMethodsResultsDiscussionReferences |
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Background—Intracoronary
-radiation therapy reduces recurrent in-stent restenosis
(ISR). This study, BETA WRIST (Washington Radiation for In-Stent
restenosis Trial) was designed to examine the efficacy and
safety of the ß-emitter 90-yttrium for the prevention of
recurrent ISR.
Methods and Results—A total of 50 consecutive patients with ISR
in native coronaries underwent percutaneous
transluminal coronary angioplasty, laser angioplasty,
rotational atherectomy, and/or stent implantation. Afterward, a
segmented balloon catheter was positioned and automatically loaded with
a 90-yttrium, 0.014-inch source wire that was 29 mm in length to
deliver a dose of 20.6 Gy at 1.0 mm from the balloon surface. In
17 patients, manual stepping of the radiation catheter was necessary
for lesions >25 mm in length. The radiation was delivered
successfully to all patients, with a mean dwell time of 3.0±0.4
minutes. Fractionation of the dose due to ischemia was required
in 11 patients. At 6 months, the binary angiographic restenosis
rate was 22%, the target lesion revascularization
rate was 26%, and the target vessel
revascularization rate was 34%; all rates were
significantly lower than those of the placebo group of -WRIST.
Conclusions—ß-Radiation with a 90-yttrium source used as adjunct therapy for patients with ISR results in a lower-than-expected rate of angiographic and clinical restenosis.
Key Words: stents • restenosis • beta rays • brachytherapy
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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The treatment of in-stent restenosis (ISR), especially when diffuse (>10 mm in length), is challenging, and the recurrence rate is high (30% to 70%), regardless of the technique used.1 2 3 Randomized studies of intracoronary
-ionizing radiation (Ir-192) have demonstrated
a reduction in angiographic late loss, binary restenosis, and
the need for target lesion revascularization and
target vessel revascularization compared with
controls.4 5 Preclinical studies using ß-emitters
demonstrated a reduction of neointima formation in stented
arteries in the porcine model.6 7 Clinical feasibility
studies have suggested that ß-emitters reduce postangioplasty
restenosis.8 9 In the present study, we report
a prospective registry examining the effectiveness and safety of
intracoronary catheter-based radiation treatment of ISR, and we
compare the results with the placebo control from the Washington
Radiation for In-Stent restenosis Trial (WRIST), a randomized
trial of -radiation treatment of ISR. |
Methods |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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This clinical trial involved an Investigational Device Exemption granted by the Food and Drug Administration, and it was approved by the Institutional Review Board and the Radiation Safety Committee at the Washington Hospital Center. Informed consent was obtained from all patients. The study population was 50 patients who had symptoms of angina and native artery ISR. Entry criteria included a diameter stenosis >50%, vessels 2.5 to 4.0 mm in diameter, and lesion length <47 mm, with successful (<30% residual stenosis without complications) primary treatment. Exclusion criteria included recent (<72 hours) acute myocardial infarction (MI), ejection fraction <20%, angiographic thrombus, and multiple lesions in the same vessel.
Radiation Delivery System, Dosimetry, and
Procedure
The ß-radiation system used a 90-yttrium pure ß-emitter with
maximum energy of 2.28 Mev, a half-life of 64 hours, and an initial
activity of 
130 mCi. The source was a flexible, 0.014-inch wire that
was 29 mm in length and was secured between the distal and
proximal tungsten markers for accurate positioning. The source wire was
delivered into a centering balloon-closed end-lumen catheter 30 mm
in length with 4 interconnected-segmented balloons 2.5 to 4.0 mm
in diameter (Schneider-Europe AG). The afterloader (Sauerwein
Isotopen-Technique Germany) automatically advanced the source to the
target and computed the dwell time on the basis of activity,
prescription dose, and balloon size. The prescribed dose was 20.6 Gy to
a distance of 1.0 mm from the surface of the inflated balloon. The
dose rate varied from 16.0 to 5.6 Gy/min. The maximum calculated dose
to the vessel wall was 38 Gy. Focal ISR was treated with balloon
dilatation (n=3). Diffuse lesions were treated either with excimer
laser angioplasty (n=5) or rotational atherectomy (n=27) followed by
balloon dilatation. Additional stents (n=18) were used to optimize
final results or to cover edge dissections.
The centering catheter was selected on the basis of vessel size and was
placed to cover the treatment segment. The catheter was connected to
the afterloader, and the segmented balloons were inflated with 5 cc of
CO2 to avoid the shielding of ß-rays by
contrast. For lesions >25 mm in length (n=17), the balloon
catheter was positioned in 2 steps, with an overlap of 
2 mm at
the stented segment to cover the lesion and the edges. The calculated
dose at the overlapped area did not exceed 70 Gy to the vessel wall.
After the radiation treatment, the source was automatically redelivered
back to the afterloader, and an angiogram and IVUS study documented the
final result. Patients were discharged on a daily dose of clopidogrel
75 mg or ticlopidine 500 mg, given for a month.
Primary and Secondary End Points
The primary end point was the cumulative composite clinical
outcome (major adverse clinical events [MACE]) of death, MI,
and repeat target lesion revascularization at 6
months. Secondary angiographic end points were restenosis, late
loss (in millimeters), and loss index (late loss/acute gain).
Quantitative coronary angiographic analysis was
performed using the cardiovascular measurement system (Medis [The
Netherlands]). Angiographic binary restenosis (at 172±47
days) was defined as <50% diameter stenosis. A minimum lumen
diameter of 0 mm was imputed in the presence of a total occlusion.
Lesions extending <5 mm proximal and distal to the radiated
segment were identified for target lesion
revascularization and any lesions beyond these
margins for target vessel revascularization.
Intravascular ultrasound (IVUS) analysis (motorized transducer pullback) was performed both at baseline and follow-up. Volumes were calculated from planar measurements that were performed at every 1-mm axial length.
Statistical Analysis
An external committee independently adjudicated all events in a
blinded fashion. Results are expressed as mean±1SD. The sample size of
50 patients was selected (80% power and 95% confidence) to
demonstrate a 50% reduction in MACE when compared with the control
group of the native coronary arteries from the WRIST
study.5 Student’s t test was used to compare
continuous variables; 
2 statistics or
Fisher’s exact test was used to compare categorical values.
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Results |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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A total of 50 patients (30 men and 20 women aged 60±10 years) with ISR were enrolled in the study. Clinical characteristics included diabetes (24%), hypertension (73%), hyperlipidemia (86%), current smokers (18%), prior MI (55%), and prior procedures to the treated site (1.46±0.46). Angiographic results are shown in Table 1
. All patients had acute
angiographic success without complications. The average size of the
centering balloon was 3.15±0.45 mm in diameter, and the mean
dwell time was 3.0±0.9 minutes; fractionation of the radiation
treatment due to ischemia was necessary in 11 of the 50
patients. Radiation exposure at the patient chest was 7.0±0.8
miliRam/h and at bedside, 0.07±0.01 mR/h. No procedural or in-hospital
adverse events or complications related to the radiation existed at 30
days.
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At the 6-month follow-up (Table 2), MACE had occurred in 17 of the
50 patients (34%). Angiographic follow-up was performed in 42 patients
(Figure 1). ISR (confined to the borders
of the stent) was present in 9 of 41 patients (22%), but in-lesion
restenosis (extending >5 mm proximal and distal to the
irradiated segment) existed in 14 of 41 patients (34%). MACE and
angiographic restenosis were significantly lower in the treated
group than in the control group (from WRIST); these values were 34%
versus 66% (P>0.01) and 34% versus 72%
(P>0.01), respectively.
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IVUS follow-up was performed in 25 patients. Intimal hyperplasia volume increased by 16±30 mm3, and minimum lumen area decreased by only 1.0±1.4 mm2. These indices are significantly different from the values in the control group (56±55 mm3 and 2.0±1.7 mm2; P>0.01 and P=0.02, respectively).
Late total occlusion (2 to 6 months) after the procedure was detected in 5 patients, 4 of whom presented with clinical events. Two had non-Q-wave MI and 2 had unstable angina.
Multivariant analysis detected ß-radiation as the only predictor for the reduction of angiographic restenosis (odds ratio, 0.17; 95% confidence intervals, 0.059, 0.494; P<0.01) and cardiac events (odds ratio, 0.28; 95% confidence intervals, 0.111, 0.705; P<0.01).
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Prior clinical trials with ß-emitters demonstrated lower indices of late loss and loss index after angioplasty in de novo lesions. The present trial is the first to indicate the feasibility and effectiveness of intracoronary ß-radiation to prevent recurrent ISR. Because this study was based on a registry, the effectiveness of ß-radiation was inferred from a comparison with recurrence rates in control groups from similar studies (Scripps Coronary Radiation to Inhibit Proliferation Post Stenting [SCRIPPS], 55%4 ; WRIST, 62%5 ; GAMMA1, 55%5a; and from the angioplasty [52%] versus rotablation [65%] study for the treatment of diffuse restenosis [ARTIST]). The restenosis rates (in-stent and at the edge) in our study, although slightly higher, were similar to those reported in
-WRIST (Figure 2). The rapid fall of the dose and the
potential shielding of the ß-radiation by the stent10
required a higher prescribed dose in the current trial than in the
trials. However, the centering catheter allowed us to provide a
uniform dose to the vessel wall (35 Gy). This dose was less than
the recorded dose of a non-centered -source (47 Gy), for a
similar dose prescribed to the adventitia. Overlapping the source to
treat longer lesions did not increase complications. A major limitation
of the technique is the high rate of late thrombosis that occurred,
especially when additional stents were placed (4 of 18 patients
[22%] versus 1 of 32 patients [3%] without additional stents,
which is similar to rates reported in other studies using ß- and
-emitters).11
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Limitations
This study was not a randomized, placebo-controlled study, and it
is limited to 6 months of follow-up. Although the inclusion/exclusion
criteria were identical to those of -WRIST, the placebo group had
some increased risk for restenosis, such as longer lesion
length and smaller reference vessel diameter. However,
multivariate analysis detected ß-radiation as
the only predictor for a reduction of angiographic restenosis
and clinical events.
Conclusion
The encouraging results of the current study suggest that
intracoronary ß-radiation using 90-yttrium may be a viable
therapeutic option for patients with ISR. These findings should be
corroborated in randomized clinical trials.
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Acknowledgments |
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This study was supported by the Cardiovascular Research Foundation and, in part, by Scimed, Boston Scientific.
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Footnotes |
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Reprint requests to Dr Ron Waksman, Washington Hospital Center, 110 Irving St, NW, Suite 4B-1, Washington, DC 20010.
The principal investigator, Dr Ron Waksman, serves as a consultant to several device companies, including the sponsors of this study.
Received December 30, 1999; revision received February 22, 2000; accepted February 22, 2000.
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References |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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A. Finkelstein, R. Makkar, T. M. Doherty, V. R. Vegesna, P. Tripathi, M. Liu, J. Bergman, M. Fishbein, J. Hausleiter, K. Takizawa, et al. Increased Expression of Macrophage Colony-Stimulating Factor After Coronary Artery Balloon Injury Is Inhibited by Intracoronary Brachytherapy Circulation, May 21, 2002; 105(20): 2411 - 2415. [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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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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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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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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 D. Elsner How to diagnose and treat coronary artery disease in the uraemic patient: an update Nephrol. Dial. Transplant., June 1, 2001; 16(6): 1103 - 1108. [Full Text] [PDF]
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A. Moustapha, A. R. Assali, S. Sdringola, W. K. Vaughn, R. D. Fish, O. Rosales, G. Schroth, Z. Krajcer, R. W. Smalling, and H. V. Anderson Percutaneous and surgical interventions for in-stent restenosis: long-term outcomes and effect of diabetes mellitus J. Am. Coll. Cardiol., June 1, 2001; 37(7): 1877 - 1882. [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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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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A. E. Raizner, S. N. Oesterle, R. Waksman, P. W. Serruys, A. Colombo, Y.-L. Lim, A. C. Yeung, W. J. van der Giessen, L. Vandertie, J. K. Chiu, et al. Inhibition of Restenosis With {beta}-Emitting Radiotherapy : Report of the Proliferation Reduction With Vascular Energy Trial (PREVENT) Circulation, August 29, 2000; 102(9): 951 - 958. [Abstract] [Full Text] [PDF]
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R. Waksman, B. Bhargava, G. S. Mintz, R. Mehran, A. J. Lansky, L. F. Satler, A. D. Pichard, K. M. Kent, and M. B. Leon Late total occlusion after intracoronary brachytherapy for patients with in-stent restenosis J. Am. Coll. Cardiol., July 1, 2000; 36(1): 65 - 68. [Abstract] [Full Text] [PDF]
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 -Radiation for In-Stent Restenosis Journal Watch Cardiology, June 30, 2000; 2000(630): 4 - 4. [Full Text]
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