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ȣ - 540477 241 |
Safety and Efficacy in Coronary Intervention with a Paclitaxel-coated Balloon Catheter: Short-term results from a single-center study
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가톨릭의과대학교, 순환기내과 |
민진수, 김태훈, 김찬준, 추은호, 서석민, 고윤석, 박훈준, 김범준, 장기육, 정욱성, 승기배 |
Background; Paclitaxel-coated balloon (PCB) was recently introduced as an alternative method for treatment of coronary in-stent restenosis, small coronary arteries, and bifurcation lesions.
Methods; Recently we experienced 69 patients (71 lesions) treated by a PCB from September, 2009 to July, 2010 in Seoul St. Mary’s Hospital. We selected patients with either in-stent restenosis or de-novo coronary lesions, which encompass discrete lesion, vessel size < 2.5mm, and bifurcation lesion. We compared acute lumen gains between these groups.
Results; We used 71 PCBs. Acute lumen gain for all interventions was 1.04±0.61 (p<0.0001). Changes in lumen before and after ballooning were statically significant for both in-stent restenosis and de-novo lesion groups; however, acute lumen gain of in-stent restenosis group was larger than that of de-novo lesion group (1.20±0.62 vs. 0.85±0.54, p=0.02). PCBs in discrete lesion and vessel size < 2.5mm groups resulted significant acute lumen gains, but they were not different with those in long lesion and vessel size ≥ 2.5mm groups respectively (0.74±0.55 vs. 1.02±0.51, p=0.09; 0.91±0.47 vs. 0.82±0.59, p=0.44). We also used a PCB in 3 patients with stenosis of coronary artery bypass graft anastomosis site regaining patent blood flow although its acute lumen gain was insignificant (0.92±0.54, p=0.25). There were 9 procedural complications; 5 dissections, 3 no/slow reflow, and 1 failure. During clinical follow-up period (91.0±73.6 day), there were no major adverse cardiac.
Conclusions; PCBs in both in-stent restenosis and de-novo lesion groups demonstrated effective acute lumen gains with tolerable safety. Treatment using the PCBs may offer an alternative to the implantation of drug-eluting stents.
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Table 1. Change in lumen diameter before and after intervention according to each variable.
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Pre-Tx |
Post-Tx |
Acute
lumen
gain |
p value |
p value
between
groups |
Total (71, 100%) |
0.97±0.54 |
2.01±0.51 |
1.04±0.61 |
<0.0001 |
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In-stent restenosis (38, 53.5%) |
0.90±0.61 |
2.11±0.49 |
1.20±0.62 |
<0.0001 |
0.02 |
De-novo lesion (33, 46.5%) |
1.05±0.43 |
1.90±0.50 |
0.85±0.54 |
<0.0001 |
Discrete lesion (20, 28.2%) |
1.22±0.38 |
1.96±0.49 |
0.74±0.55 |
<0.0001 |
0.09 |
Long lesion (13, 18.3%) |
0.78±0.38 |
1.80±0.53 |
1.02±0.51 |
0.0002 |
Vessel size < 2.5mm (12, 16.9%) |
0.81±0.35 |
1.72±0.50 |
0.91±0.47 |
0.0005 |
0.44 |
Vessel size ≥ 2.5mm (21, 29.6%) |
1.18±0.42 |
2.00±0.49 |
0.82±0.59 |
<0.0001 |
Bifurcation lesion (3, 4.2%) |
1.41±0.21 |
2.16±0.55 |
0.75±0.47 |
0.25 |
- |
Non-bifurcation lesion (30, 42.3%) |
1.01±0.43 |
1.87±0.50 |
0.86±0.56 |
<0.0001 |
CABG anastomosis site (3, 4.2%) |
0.69±0.50 |
1.61±0.04 |
0.92±0.54 |
0.25 |
- |
Native coronary lesion (30, 42.3%) |
1.08±0.42 |
1.93±0.52 |
0.84±0.55 |
<0.0001 |
Tx=Treatment, CABG=Coronary artery bypass graft
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