Agarwal, Ajay

Duffy, Mary E.

Kamran, Mazullah

Kim, Michael C.

Kini, Annapoorna S.

Mukaddam, Shazia

Sharma, Samin K.

Sherman, Warren

Elsevier - Publisher Connector 

Longer sources of intracoronary brachytherapy for in-stent restenosis reduces restenosis in the real world 

JACC March 19,2003 ABSTRACTS - Angiography & Interventional Cardiology 49A 
stent to artery ratio 1 .l :I .O to 1.2:l .O, and were subjected to gamma-radiation using ‘92ir. 
The prescribed doses were 0 Gy (controls), 15 Gy, or 30 Gy at 2 mm from the center of 
the swrce axis. Animals were sacrificed at 1, 3, and 6 months and arteries were ana- 
lyzed for histomorphometry (n=36) or scanning electron microscopy (n=36). lntimal area 
(IA) was reduced after VBT at 3 months with 15 Gy and 30 Gy es compared to controls 
and at 6 months with 30 Gy (Table). There was no difference in IA at 6 months between 
15 Gy and controls. The surface covered by endothelium was reduced in radiated arter- 
ies at all time points and did not increase from 1 to 6 months. Excess of platelets, mac- 
rophages, and leucocytes were see” in radiated arteries not completely covered by 
endothelial cells. 
1 month 3 months 6 months 
Endothelialized surface 
Control 92 * 4% 95 * 2%, 96 f 2% 
15Gy 37 * 4%’ 32 f 12%’ 40 * 8%’ 
30 Gy 37 * 8%’ 29 * 13%’ 35 * 12%. 
lntimal area. mm2 
Control 0.86 * 0.21 1 .Ol * 0.11 1.28 -t 0.26 
15Gy 0.80 r 0.42 0.66 * 0.07’ 1.35 + 0.37 
30 Gy 0.57 * 0.27 0.66 * 0.04’ 0.75 * 0.09 
* pco.05 versus c0ntrOl 
Conclusions: Re-endothelialization after VBT IS not completed at 6 months after VBT. 
Thus, special cars with prolonged antiplatelet therapy should be considered beyond this 
time point. 
1128-182 Multi-Center Experience With a Novel ir”’ Vascular 
Brachytherapy Device for In-Stent Restenosis: Final 
Results of the Angiorad Radiation Therapy for In- 
Stent Restenosis lntracoronaries II (ARTISTIC II) Trial 
Dean J. Kereiakes. Ron Waksman, Anilkumar Mehra, Carlos E. Morales, Ray Magorien, 
Melissa Mazzoni, Jeffrey J. Popma, The Lindner Center/Ohio Heart Health Center, 
Cincinnati, OH 
Background: Although vascular brachytherapy (VBT) reduces restenosis (RES) and 
major adverse cardiovascular events (MACE) after therapy for in-stent restenosis (ISR), 
both dose (Gy) and VBT catheter profile limit efficacy of currently available devices. 
Methods: A novel 0.0136’ lr’= sourcewire (AngioRadTM, Interventional Therapies, LLC, 
Westport, CT) and a 0.032” proflle delivery catheter/centering balloon (6 Fr guide cathe- 
ter compatible), which provides 18 Gy at 2 mm from the source center, was used to treat 
236 patients (age 62 years; 64% male; 38% diabetes) with ISR at 11 U.S. centers. His- 
torical controls (no VBT) were derived from the following randomized trials: ARTISTIC I 
(“=54) randomized trial and the Washington Radiation for In-stent Restenosis Trial 
(WRIST; n=50). Quantitatw coronary angiography was performed periprocedurally and 
at 6 months; clinical follow-up evaluation was at 30 days and 6 months. 
PRE PROCEDURE 
RVD mm (SD) 
Lesion Length mm (SD) 
lr192 (n=236) Control (n=104) 
2.71 (0.5)‘” 2.55 (0.4) 
14.36 (7.0)” 18.74 (8.4) 
POSTPROCEDURE 
MLD mm (SD) 
% stenosis 
Total MACE’ (30 day) 
1.93 (0.4)” 1.84 (0.4) 
28.9%* 11.5%** 28.7% _+ 11.7% 
2.1% 1.9% 
RVD = reference vessel diameter: MLD = minimum lumen diameter; 
lVR = target vessel revascularization; TSR = target site revascularization 
‘Death, myocardial infarction, emergent CABG or TLR 
*‘73% data complete analysis at submission 
1128-185 Late Stent Melapposition After Brachytherapy: An 
Assessment of the Incidence and Mechanisms Using 
Volumetric Intravascular Ultrasound 
Conclusions: Low profile and delwerability of this novel Ir’g’system facilitate VBT use. 
Effectiveness of the Angiorad TM, System is supported by low 30 day MACE, limited late 
loss and infrequent restenosis. Completed angiographic and clinical follow-up will be pre- 
sented. 
Jerzv Preaowski Lukasz Kallnczuk, Gary S. Mintz, Christian E. Dilcher. Rosanna C. 
Ghan, Jun-ichi Kotani, Vivek Shah, Ron Waksman, Neil J. Weissman, Washington 
Hospital Center, Washington, DC 
1128-183 Prolonged Antiplatelet Therapy After Coronary 
Brachytherapy: When Is It Safe to Stop Clopidogrel? 
Late stent malapposition (LSM) is a potential complication of intracoronary brachyther- 
spy (BT). We evaluated the incidence and mechanism of LSM after gamma-BT (lr-192) 
in 238 patients with in-stent restenosis (ISR) enrolled in the WRIST. Long WRIST. 
WRIST-PLUS, Gamma-l and ARTISTIC trials. Planar and volumetric IVUS analyses was 
performed every lmm within the malapposed segment as well as within 5mm long “con- 
troI” seaments with comr+ete circumferential aooosition: external elastic membrane 
enosis. Patients who did not receive a new stent were treated with cloprdogrel for a mini- 
mum of 6 months. Patients who required a new stent at the time of brachyiherapy 
received clopidorgel for at least 12 months. 
Results: Of 492 patients enrolled, only 22.7% required new stents. Mean follow-up was 
421.9 +148.4 days. Clopidogrel had been discontinued for >6 months in only 
67(13,6%)patie”ts (Table). Three patients sustained subacute thrombosis prior to 30 
days. All three patients had received new stents during their index procedure. There was 
one late thrombosis at 20 months (0.2%) in a patient who did not receive a new stent and 
who completed a six-month ccwrse of clopidogrel. 
Conclusions: A stragedy of avoiding new stem implantation and prolonged adjunctive 
antlplatelet is associated with a very low risk of late thrombosis (0.2%). The zealous use 
of off-protocol clopidogrel makes it difficult to determine the optimal duration of anti-plate- 
let therapy, particularly in patients receiving new stents. Until further data is obtained we 
recommend indefinite clopidogrel therapy after intra-coronary brachytherapy in patients 
receiving new stents. 
Table 1 
Plavix Dicontinued New Stent No New Stent 
>l Month 175 35 
>3 Months 58 29 
>6 Months 42 25 
1128-184 Longer Sources of lntracoronary Brachytherapy for In- 
Stent Restenosis Reduces Restenosis in the Real World 
Annapooma S. Kim, Ajay Agarwal, Shazia Mukaddam, Mary E. Duffy, Michael C. Kim, 
Mazullah Kamran. Warren Sherman, Samin K. Sharma, The Mount Sinai Medical 
Center, New York, NY 
Background: The major concern from randomized intracoronary brachytherapy (ICBT) 
trials was edge restenosis due to use of short source. Target lesion revascularization 
(TLR) with use of longer ICBT swrces has not been studied. 
Methods: We analyzed 150 consecutive patients with in-stent restenosis (170 vessels 
and 182 lesions) who had cutting balloon (CB PTCA) and/or rotational atherectomv fol- 
lowed by beta radiation using the Novoste system (30 mm source in 114 and 4d mm 
swrce in 68 lesions) and followed for mea” 6+3 months. 
Results: Mean age was 64+11 years, male sex 67%, CCS class III-IV 26%, z-1 prior res- 
tenosis 50%, restenosis interval 162+52 days. Periprocedural CK-MB elevation occurred 
in 15.8% patients, average in-hospital stay was 2.1e2.8 days, GP llbillla use 65%. Plavix 
was recommended for l-6 months. At follow-up: TVR 9.3% (14 pts, 11 TLR, and 3 “on- 
TLR), delayed acute closure/subacute thrombosis 0%. death 2.7% (1 in-hospital, 3 at fol- 
low-up). 
Table of Contents 
2 Procedural Characteristics & QCA 
Procedural Characteristics & QCA 
Lesion length (mm) 17.5+8.9 Ref. vessel size (mm) 2.91*0.04 
LADILCWRCAI(%) 44/28/21 MLD-Pre (mm) 0.72+0.31 
Total occlusion 10% MLD-Post (mm) 2.21iO.42 
CB PTCA+Rotablator 65% MLD-Post ICBT (mm) 2.12eO.32 
Rotablator 30% Re-dilatation post ICBT 5% 
Re-stem 3.3% Vessel spasm 4% 
Conclusion: Debulking followed by ICBT provides sustained long-term, acceptable rest- 
enosis in single digits. Compared to randomized trials, these favorable results in the real 
world are perhaps due to better understanding of the restenotic process after ICBT and 
represent the benefit of full lesion coverage by long source, leaving moderate residual 
stenosis and very low need for restenting. 
Antonio P. Madrid, Mark A. Grise, Jeffrey W. Moses, Martin B. Leon, Peter J. Casterella, (EEM), <tent, intra-stent ‘lumen, LSM, effective’ iurne” (intrastent lumen+LSM), and 
Anca Tchelibi, Cristia” Cioar. Huan Giap. Shirish Jani, Steven Baker, Prabhakar plaque (EEM minus effective lumen) area. Dose volume histograms (DVH) were calcu- 
Tripuraneni. Alexandra Lansky, Manuela Negoita, Roxanna Mehran, Paul S. Teirstein, lated for LSM segment, the wall of the vessel with complete apposition opposite the arc 
Scripps Clinic. La Jolla, CA, Lenox Hill, New York, NY of LSM, and the control segments. Results: There were 111152 LSM in the irradiated 
Background: The objective of SCRIPPS Ill study was to evaluate the impact of both 
group (7.2%) vs only 2/86 in the placebo (2.3%. p=O.14). 8 LSM occurred within old 
extended antiplatelet therapy and reduced stenting on late target thrombosis following 
stents and 5 in newly placed stents. 
brachytherapy. 
The length and volume of malapposition were 4.82* 7.44mm and 9.52*10.31mm3. LSM 
Methods: At two centers (Scripps Clinic and Lenax Hill) attempts were made to avoid 
segments underwent vessel enlargement that was greater than the increase in plaque 
new Stent implantation at the time of intracoronary radiation for treatment of in-stem rest- 
while control segments showed no change in EEM or plaque. DVH calculations were 
similar for LSM and control segments. 


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Longer sources of intracoronary brachytherapy for in-stent restenosis reduces restenosis in the real world

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