PubMed1994
BACKGROUND AND OBJECTIVES: Previous noncontrolled studies yield conflicting data about the influence of long inflation times on restenosis rate after PTCA. To clear these differences, we designed an open, prospective and randomized study to assess the effect of long versus standard balloon inflations in the incidence of restenosis. METHODS: 153 consecutive patients selected for one-vessel PTCA (62 LAD, 43 LCx, 48 RCA), were randomized to prolonged inflation (13.5 +/- 3.3 min) at 6 atmospheres using an autoperfusion catheter (72 patients) or to standard inflations (3.1 +/- 1.6 min) using conventional catheters (81 patients). Vessel diameter < 2.5 mm, lesions located at distal segments, complete occlusions, tortuous, long, bifurcated or thrombotic lesions were excluded. RESULTS: No significant differences in age, gender, coronary risk factors, ejection fraction, incidence of unstable angina or previous myocardial infarction existed between the two groups. There were no differences either between the dilated vessel, type of lesion (A, B, C) or the segment (proximal, mid) attempted. Successful dilation was obtained in 77/81 (95.0%) cases with standard inflation and in 58/72 (80.5%) with prolonged inflations (p = 0.01), leading to a decrease in the percentage of stenosis from 79.1 +/- 10.6% to 20.2 +/- 15.8% and from 81.4% +/- 9.9% to 21.0 +/- 13.0%, respectively (p = NS). A follow-up coronary arteriogram was obtained in 72/77 patients (93.5%) with standard inflation (mean: 18 +/- 6 weeks) and in 54/58 patients (93.1%) with prolonged inflation (mean: 17 +/- 3 weeks). Restenosis (arterial diameter reduction > 50%) was present in 23/72 (31.9%) of the standard inflation and in 22/54 (40.7%) of the prolonged inflation group (p = 0.4). CONCLUSIONS: These results suggest that longer balloon inflation periods do not reduce the restenosis rate after balloon coronary angioplasty.