Comparison of fixed-wire and over-the-wire balloon dilatation systems for percutaneous transluminal coronary angioplasty

There is controversy concerning the relative safety and efficacy of the 2 currently available percutaneous transluminal coronary angioplasty dilatation systems — fixed-wire (FW) and over-the-wire (OW). A randomized, prospective trial comparing the 2 systems was performed to examine this controversy. Of 1,513 patients undergoing percutaneous transluminal coronary angioplasty at 3 centers between June 1990 and October 1991, 602 (40%) fulfilled the eligibility criteria for the study. There were 643 lesions, of which 327 were randomized to FW and 316 to OW systems. There was no difference in the success rate between FW (92%) and OW (94%) systems. Inability to cross with a wire was infrequent with either system (FW: 1.8%; and OW: 1.6%). Inability to cross with a balloon when the wire crossed the lesion did not occur. An FW system was successful in 6 cases (1.9%) in which the OW system had been unsuccessful, whereas an OW system succeeded in 14 (4.3%) after the FW system had been unsuccessful (p = NS). Time to cross stenoses was 200 ± 21 and 233 ± 22 seconds, procedural time was 21 ± 1.3 and 21 ± 1.0 minutes, fluoroscopy time was 6.7 ± 0.4 and 7.1 ± 0.4 minutes, contrast used was 89.0 ± 4.2 and 84.0 ± 3.5 ml, and number of cine runs was 5.9 ± 3.0 and 6.3 ± 3.4 in the FW and OW systems, respectively. Complications were infrequent with either system (FW: 10.4%; and OW: 9.5%). Acute closure occurred in 1.8 and 2.2% of cases in the FW and OW systems, respectively. Emergency bypass surgery occurred in 1.5 and 0.9% of cases in the FW and OW systems, respectively, and myocardial infarction in 0.3% of both groups. A coronary stent was used to treat dissection in 0.6% of each group, and an autoperfusion balloon or long balloon catheter was used to treat dissection in 0.3 and 1.6% of cases in the FW and OW systems, respectively (p = NS). In conclusion, for these lesions comprising a sizable proportion of those found in everyday clinical practice, there was no difference in success or complication rates, or in measures of the ease of performance of the procedure between the FW and OW balloon catheter systems.