Immediate and Late Clinical and Angiographic Outcomes after GFX Coronary Stenting: Is High-Pressure Balloon Dilatation Always Necessary?

Park, Seong Wook; Hong, Myeong Ki; Lee, Cheol Whan; Kim, Jae Joong; Park, Hoon Ki; Lee, Nae Hee; Cho, Goo Young; Nah, Deuk Young; Kang, Duk Hyun; Song, Jae Kwan; Kim, Min Kyu; Park, Seung Jung

Abstract

BACKGROUND AND OBJECTIVES: The GFX stent is a flexible, balloon-expansible stent made of sinusoidal element of stainless steel. The adjunct high-pressure balloon dilatations after stenting were usually recommended in routine stenting procedure. The aim of this study was 1) to evaluate the immediate and long-term clinical and angiographic outcomes and 2) to investigate the necessity of high-pressure balloon during GFX stenting. MATERIAL AND METHODS: One hundred seventy two consecutive patients underwent single 12 or 18 mm GFX stent implantation in 188 native coronary lesions. Two types of stenting technique were used: 1) stent size of a final stent-to-artery ratio of 1:1 (inflation pressure > 10 atm, usually 12-14 atm: high pressure group) and 2) stent size of 0.5 mm bigger than reference vessel (inflation pressure 10 atm, usually 9 atm: low pressure group). The adjunct high-pressure balloon dilatations were done only in cases of suboptimal results.
RESULTS
The adjunct high-pressure balloon dilatation were required under angiographic guidance in 11 of 83 lesions (13%) in high pressure group and 7 of 105 lesions (7%) in low pressure group (p=0.203). Procedural success rate was 100%. There were no significant differences of in-hospital and long-term clinical events between 2 group. The overall angiographic restenosis rate was 17.7%: 18.4% in high pressure group and 17.1% in low pressure group (p=0.991).
CONCLUSION
GFX stent is a safe and effective device with high procedural success rate and favorable late clinical outcome for treatment of native coronary artery disease. Further randomized trials may be needed to compare stenting techniques in GFX stent implantations.