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Acute Efficacy of Cutting Balloon Coronary
Angioplasty in the Treatment of
the Diffuse in-Stent Restenosis

Calvo Cebollero, Isabel; Galache Osuna, José Gabriel;
Sánchez-Rubio Lezcano, Juan; Alonso Francia, Carmen;
Diarte de Miguel, José Antonio;
Salazar González, José Javier; Moreno Esteban, Eva;
Placer Peralta, Luis Javier

Hospital Universitario Miguel Servet, Zaragoza, Spain

SUMMARY
Background: Cutting Balloon (CB) coronary angioplasty has shown to be a reliable, efficient and cheap alternative to treat in-Stent restenosis, with results at least comparable to other techniques.
Aims: Comparative evaluation of acute effectiveness of CB in diffuse in-Stent restenosis vs. focal restenosis.
Material and Methods: 45 patients with 50 in-Stent restenosis lesions, CB treated between February 1999 and March 2001. Technical features of procedure were registered. Basal and post-dilatation quantitative angiographic evaluation were performed, analysing lesion length - considered as a dichotomic variable-severity, basal and post dilatation minimum luminal diameter (MLD), and acute luminal gain (ALG); acute coronary events and vascular complications were registered until discharge from hospital. To compare averages for quantitative variables the t-Student test was used.
Results: Success of the procedure was 94%. No major adverse events were registered nor significant vascular complications. 46 lesions were quantitatively analysable: 21 focal (length < 10 mm), Group F; and 25 diffuse lesions (length > 10mm), Group D. Table 1 below shows the main comparisons and their significance.

Conclusions: Acute efficacy of CB to treat in-Stent restenosis is similar in focal and diffuse lesions, and does not depend on the classification of the lesion. Efficacy and global safety of procedure are very high.

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INTRODUCTION
   The treatment of diffuse in-stent restenosis (DISR) has become one of the greatest challenges to percutaneous coronary interventionism. The conventional balloon usually employed to treat this type of lesion results in new restenosis in more than 60% cases. A length of the restenotic lesion exceeding 10 mm is one of the major predictors for a new restenosis.

   Rotational and directional atheroablation procedures, which are usually completed with balloon angioplasty, are technically difficult and expensive. In addition, the randomized multicenter study ARTIST revealed the superiority of balloon angioplasty over rotational atherectomy followed by balloon dilatation for the treatment of diffuse in-stent restenosis (DISR).

   Intra-stent stenting is an attractive therapeutic option by virtue of its affordability and the increased potential acute gain in the lesion diameter relative to balloon. Both procedures (stenting and balloon) were compared in the randomized multicenter study RIBS; despite the improved initial results of the angiographic procedure, those at 6 months provided no evidence of superiority of stenting over balloon. The restenosis rate for lesions larger than 10 mm in this test was 49% with stenting and 46% with balloon.

   Brachytherapy, which has emerged as an effective treatment in this context, is unavailable at most interventionist centres.

   The cutting balloon (CB) combines the properties of the conventional balloon with those of radial atherectomy of the lesion by using 3-4 microblades 0.010 inches size that are located on the surface of an unexpandable balloon. The mechanism of action of the CB on in-stent restenosis has been evaluated by IVUS; the efficacy of the device has been found to arise not from redilatation of the vessel or stent but from compression and expansion of the plate. The results of small-scale randomized tests suggest that the CB may surpass balloon angioplasty as a treatment for in-stent restenotic lesions including those having a prognosis of new recurrences (e.g. diffuse lesions); also, the technique has additional advantages including simplicity and a low cost.

AIM
   To comparatively evaluate the acute results of the CB procedure as applied to diffuse in-stent restenosis in relation to focal restenosis.

PATIENTS AND METHODS
   An overall 45 patients with 50 in-stent restenosis lesions were treated with CB angioplasty at the "Miguel Servet" University Hospital (Zaragoza, Spain) between February 1999 and March 2001. The procedure was always performed using the femoral way and the Judkins technique, the guiding catheter being of the 6F or 8F type, at the operator's discretion.

The CB used was always 10 mm long and 0.25 mm wider than the stent. Focal lesions (less than 10 mm in size) were inflated with a single balloon at a pressure of 8 atm for 60 s; performing additional dilatations or altering the inflation pressure or time to ensure optimal results was left to the operator's discretion. Long lesions and diffuse in-stent restenoses were treated with multiple sequential inflations lengthwise.

   Dilatation was completed with conventional balloon at a low pressure or stenting when the results of the CB alone were deemed suboptimal.

   The technical details of the procedure were recorded and a basal and post-dilatation quantitative angiographic evaluation was performed by using the software bundled with the Monoplanar Cardiovascular System of the Integris H3000 Philips Medical System.

   We examined the length of the lesion concerned, its severity, the basal and post-dilatation minimum luminal diameter (MLD) and acute luminal gain (ALG). The procedure was deemed successful when the CB reached the lesion, crossed it and dilated it with less than 30% residual stenosis.

   Acute coronary events (death, myocardial infarction and the need for new percutaneous or surgical revascularization) were recorded, and so were clinical and vascular complications from performance of the procedure to discharge from hospital.

   The means for quantitative variables were compared via Student's t values.

RESULTS
   An overall 50 in-stent restenosis lesions were treated with CB. Twenty-three were of the focal (Group F) and 27 of the diffuse type (Group D).

   Forty-three percent of the focal lesions were located in DA, 24% in CX, 19% in CD and 14% in a saphenous vein graft. Sixty-five percent were located in a proximal segment, 24% in a middle segment and 14% were distal.

   Fifty-five percent of the diffuse lesions were located in DA, 20% in CX, 15% in CD and 10% in a saphenous vein graft. Forty-two percent were located in proximal segments, 46% in middle segments and 12% were distal.

   The reference vessel diameter was 3.12 ± 0.38 mm for Group D and 3.23 ± 0.59 mm for Group F.

   The average severity of the stenosis, as the percent diameter reduction, for Group D was 65.90 ± 1.94% and its average length 14.90 ± 3.67 mm. Those for Group F were 65.80 ± 2.20% and 6.7 ± 1.88 mm, respectively.

   The average CB/vessel diameter ratio for the sample as a whole was 1.02 (range 0.7-1.04): 1.00 ± 0.12 for Group F and 1.03 ± 0.09 for Group D. The average number of CB inflations per lesion for Group F was 2.52 ± 1.80 (range 1-7), its mode 2 inflations per lesion and the average inflation pressure 8.00 ± 2.48 atm; those for Group D were 2.6 ± 1.41 (range 1-6, mode 2 inflations per lesion) and 8.44 ± 0.66 atm (range 3-11).

   The procedure was successful in 94% of cases (CB dilatation was effective in 47 of the 50 lesions treated). Forty-six lesions (21 of Group F and 25 of Group D) could be analysed in quantitative terms. The main comparisons and their significance are shown in the Table 1 below.

   No major coronary event or significant vascular complication arose during hospital stay.

DISCUSSION
   Based on our results, atherectomy with cutting balloon is highly effective for the treatment of both focal and diffuse in-stent atherectomy. The results are similar to those reported by Iijima et al. [Am. J. Cardiol., 2000: 86 (suppl 8A); 121i] and testify to the high acute efficacy of this treatment for high-risk restenotic lesions (viz. recurrent restenosis, diffuse lesions and recurrence of symptoms within the first three months of stenting), which exhibited highly significant differences in restenosis rate during the follow-up period (61% with POBA and 30% with CB).

   Worth special note is the high success rate, the low rate of complications and the high expeditiousness and operational simplicity of the technique, all of which make it an effective alternative to the treatment of in-stent restenosis.

CONCLUSIONS
   The acute efficacy of CB for the treatment of in-stent restenosis is quite high and similar for focal and diffuse lesions. The overall efficacy and safety of the procedure is very high. The results of the follow-up at 6 months and 1 year will be reported in a future communication.

 

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2nd Virtual Congress of Cardiology

Dr. Florencio Garófalo
Steering Committee
President
Dr. Raúl Bretal
Scientific Committee
President
Dr. Armando Pacher
Technical Committee - CETIFAC
President
fgaro@fac.org.ar
fgaro@satlink.com
rbretal@fac.org.ar
rbretal@netverk.com.ar
apacher@fac.org.ar
apacher@satlink.com

Copyright© 1999-2001 Argentine Federation of Cardiology
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