Comparison of Effectiveness and Safety of Drug-Eluting Stents Versus Vascular
Brachytherapy for Saphenous Vein Graft In-Stent Restenosis
Sundeep Mishra, MD, Roswitha M. Wolfram, MD, Rebecca Torguson, BS,
William W. Chu, MD, PhD, Zhenyi Xue, MS, Natalie Gevorkian, MD,
Sirisha Donekal, MBBS, Rosanna Chan, PhD, Augusto D. Pichard, MD,
Lowell F. Satler, MD, Kenneth M. Kent, MD, PhD, and Ron Waksman, MD*
We investigated the safety and efficacy of drug-eluting stents (DESs) for the treat-
ment of patients who presented with in-stent restenosis (ISR) of saphenous vein grafts
(SVGs) and compared the in-hospital and 6-month clinical outcomes of DESs with
those of intravascular brachytherapy and balloon angioplasty alone. Records of 187
patients who presented with ISR of SVGs were analyzed. Of these, 34 consecutive
patients were treated with DES implantation, 93 were treated with intravascular
brachytherapy (n 60 with -radiation, n 33 with -radiation), and 60 patients
underwent conventional treatment with balloon angioplasty alone. Clinical and an-
giographic characteristics at baseline were comparable between groups. The DES
group had less non–Q-wave myocardial infarction than did the intravascular brachy-
therapy and balloon angioplasty groups (0%, 20%, and 26%, p 0.003 and <0.001,
respectively). At 6 months, death occurred in 0% of the DES group, 2% of the
intravascular brachytherapy group, and 5% of the balloon angioplasty group (p
0.36 and <0.18, respectively). Target lesion revascularization/major adverse cardiac
events were similar in the intravascular brachytherapy and DES groups (12% and
3%, p 0.13) and significantly decreased compared with patients who were treated
with balloon angioplasty alone (55%, p <0.001 for the 2 comparisons). The results of
this retrospective analysis suggest that DES implantation is at least as effective and
safe as intravascular brachytherapy for the treatment of SVG ISR and that these
treatment modalities are superior to balloon angioplasty alone. © 2006 Elsevier Inc.
All rights reserved. (Am J Cardiol 2006;97:1303–1307)
The development of obstructive lesions in saphenous vein
grafts (SVGs) is a well-known, long-term complication af-
ter coronary bypass surgery.
1
Because repeat surgery is
associated with substantial morbidity and mortality, new
techniques for percutaneous treatment of graft disease have
evolved,
2,3
but ultimate treatment success has been limited
by the high incidence of periprocedural complications and
restenosis.
3
With the introduction of intravascular brachy-
therapy using the -emitter iridium-192, a new era began
and restenosis rates and major cardiac events were signifi-
cantly decreased in patients with SVG in-stent restenosis
(ISR) that was treated with intravascular brachytherapy ver-
sus placebo.
4
Although intravascular brachytherapy has re-
mained the only approved technology for the treatment of SVG
ISR, its application requires a specific, not always available
infrastructure and involvement of radiation oncologists and
physicists,
5
and the investigation of potential treatment alter-
natives are warranted. Recently the efficacy of sirolimus- and
paclitaxel-coated drug-eluting stents (DESs) to inhibit resteno-
sis has been analyzed and has shown very promising results in
various clinical trials for de novo lesions.
6–8
However, data
regarding the clinical usefulness of DESs for restenotic le-
sions are limited
9
and not available for SVG ISR. This
observational analysis evaluated the efficacy and clinical
safety of DESs as an alternative, valuable treatment option
to intravascular brachytherapy for SVG ISR.
•••
We analyzed the data of 187 consecutive patients who
presented with symptoms of angina and angiographic evi-
dence of SVG ISR and who underwent percutaneous angio-
plasty for SVG restenosis at the Washington Hospital Cen-
ter (Washington, DC) from May 1997 to September 2004.
For the purpose of analysis, patients were categorized
into 4 groups: DES (n = 34), adjunctive radiation ( n =
60, n = 33), or balloon angioplasty alone (n = 60).
Patients in the -radiation arm and the balloon angioplasty
group were recruited from the -radiation trial Washington
Radiation for In-Stent Restenosis Trial in Saphenous Vein
Grafts (SVG WRIST).
10
The main exclusion criteria for this
registry were myocardial infarction within the previous 72
hours, left ventricular ejection fraction 15%, angiographic
evidence of thrombus, and previous treatment with irradia-
tion of the chest. The -radiation studies involved an inves-
The Washington Hospital Center, Washington, DC. Manuscript re-
ceived June 17, 2005; revised manuscript received and accepted November
15, 2005.
* Corresponding author: Tel: 202-877-2812; fax: 202-877-2715.
E-mail address: ron.waksman@medstar.net (R. Waksman).
0002-9149/06/$ – see front matter © 2006 Elsevier Inc. All rights reserved. www.AJConline.org
doi:10.1016/j.amjcard.2005.11.064