| Objective: By comparing the early and late coronary angiography results and the frequency of major adverse cardiac events between cutting balloon angiography (CBA) and plain old balloon angioplasty (POBA), to evaluate the efficacy and safety of CBA on coronary in-stent restenosis.Methods: From February 2001 to November 2002, a total of 87 in-hospital patients with in-stent restenosis proven by coronary angiography after primary PCI(58 males,29 females, mean age 68±6 years) were randomizedly divided into two groups: CBA group (48 cases) and POBA group (42 cases) according to the balloon used. The mean minimal lumen diameter (MLD), diameter stenosis (DS), restenosis rates and target lesion revascularization (TLR) in different segment in two groups were compared by the instant and 6-month follow-up quantitative coronary angiography (QCA). The patients in both groups were similar with respect to age, gender, history, the segment of lesion, the length and diameter of lesion. All patients were on an oral medication of 300mg of aspirin q.d and 75mg of clopidogrel q.d three days before the procedure. Left and right coronary angiography in catheterization laboratory. The first access choice of patient with positive Allen's test for right radial artery was right radial artery. If the patient with radial artery spasm or severe tortuous, stenosis and abnormal of radial artery demonstratedby angiography, the access was change to right femoral artery. 6 French radial or femoral artery sheath were inserted after successful Seldinger's puncture. Left and right coronary angiography were performed using 4 French catheter. Guiding catheter size was based on the coronary angiography result while CB size was based on the length and inner diameter of in-stent restenosis lesion (CB to artery ratio=1.1～1.2:1.0). The length of CB was 10mm and mean inflation pressure was 6～8atm (20-40sec). Aiming to improve the angiographic result, the lesion was further dilated until the residual stenosis less than 30%. The time of deflation was not less than 20 seconds before the next manipulation. POBA size was also based on the lesion length and reference artery diameter(balloon to artery ratio=1.0～1.2:1.0). Mean inflation pressure of POBA was 8-16 atm (30-90 seconds). Reinflation using the same or larger balloon was required if the residual stenosis larger than 30%. Four cases required pre-dilation with a small balloon because CB can't through the lesion. Treated vascular segments were analyzed with QCA while the native guiding catheters were used as a reference. Identical projection to the ones utilized for the initial intervention were used during follow-up. Data analysis was performed offline after completion of the follow-up studies, and the observer was blinded. The following parameters were assessed: reference segment diameter, length of lesion, MLD and percent stenosis.Results: Follow-up reangiography was performed in 68 patients (50 males,18 females, mean age 65±5 years). 38 patients in the CBA group and 30 patients in the POBA group.The median follow-up interval were 182±22 days in the CBA group and 172±26 days in the POBA group. Instant coronary angiography result after the procedure: MLD in the CBA group changed from 0.63±0.22mm to 2.72±0.33mm(P<0.05) while that in the POBA group changed from 0.61±0.21mm to 2.68±0.32mm(P<0.05); DS in the CBA group changed from 78.95±6.57% to 18.6±12.4%(P<0.05) while that in the POBA group changed from 79.38±6.06% to 21.4±13.7%(P<0.05). Although there were no difference of these changes between the two groups, the required balloon inflation pressure was significantly lower with CBA(8.36±0.98 atm vs 14.72±4.65 atm, P<0.05). At the 6-month follow-up angiography, QCA results showed a significantly larger MLD in the CBA group than that in the POBA group(2.17±0.70mm vs 1.70±0.63mm, P<0.05)leading to a highly difference for percent diameter stenosis(27.6±17% vs 47.2±20.9, P<0.01).The late loss in the CBA group was 0.57±0.49 while that in the POBA group was 0.99±0.
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