FX MiniRAIL catheter usage for treatment of de novo complex coronary lesions: results from the "OFFAR".
BACKGROUND
Gradual prolonged balloon angioplasty may cause less arterial trauma, higher success rates, and fewer complications than conventional angioplasty (POBA). The OFFAR aimed to determine the safety and effectiveness of the FX MiniRAIL (FX) catheter, used with a slow, stepwise inflation protocol.


RESULTS
From June to December 2003, 181 consecutive patients (age 61.9 +/- 10.6 years) with de novo coronary artery lesions (n = 217) were treated by FX and stent implantation in 11 European centers. Fifty-one patients (28.2%) had diabetes, and 70 (38.7%) had prior MI; 73 patients (40.3%) presented with stable angina and 85 (47.0%) with unstable angina. Fifty-five lesions (25.3%) were in small vessels (<2.5 mm), 40 (18.6%) were highly calcific, and 133 (62%) were long lesions (>18 mm). Stenosis resolution pressure was 7.17 +/- 4.2 atm; inflation time was 116.5 +/- 54.6 seconds. FX technical success (residual stenosis <50% post-FX) was obtained in 191 lesions (88.0%), and FX optimal success (residual stenosis <20% post-FX) in 117 (54.9%). Dissection was observed in 34 lesions (15.9%), 27 (79.3%) of which were type A or B. No coronary ruptures occurred. Nine (5.0%) in-hospital events occurred, all non-Q-wave MI. During 6-month follow-up, major adverse clinical events occurred in 14.4% of cases (n = 26; 3 cardiac deaths, 1 Q-wave MI, 2 non-Q-wave MI, 3 CABG, and 17 re-PTCA).


CONCLUSIONS
The results of the OFFAR suggest that FX utilization for treatment of de novo complex coronary lesions is safe and effective.
Vitrella
Giancarlo
G
San Raffaele Hospital, Milan, Italy.
Sangiorgi
Giuseppe
G
Kornowski
Ran
R
Mosseri
Morris
M
Almagor
Yaron
Y
Ischinger
Thomas
T
Pavlidis
Gregory
G
Rodermann
Jorg
J
Bartorelli
Antonio
A
Wijns
William
W
Grube
Eberhard
E
Colombo
Antonio
A
D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D019917:Blood Vessel Prosthesis Implantation; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015607:Stents