Immediate Results of AVE GFX(R) Stent

ABSTRACT

Background: The AVE GFX(R) coronary stent, a corrugated ring-type premounted stainless-steel stent, is designed for improved flexibility and trackability with increased vessel support when compared to the current Micro-II stent. We report the immediate results of our experience with the GFX stent. The purpose of this study was to assess the feasibility, safety and efficacy of deployment of the premounted GFX stent in patients with complex coronary anatomy as well as their clinical outcomes within the first month. Method: Between April 1997 and August 1997, fifty-two GFX stents were deployed in the coronary arteries of forrty-nine patients (male 71.4%, mean age 60+/-8 years) with 52 lesions. Thirty-two patients had unstable angina pectoris, five had stable angina, and twelve had acute myocardial infarctions. Results: Results: The frequency of the used stents diameter was 3.0 mm in 23 (44.2%) patients, 3.5 mm in 22 (42.3%) patients, and 4.0 mm in 7 (13.5%) patients. The lengths of used stents were 18 mm (33 cases, 63.6%), 24 mm (17 cases, 32.7%) and 30 mm (2 cases, 3.8%). 2) Single stent implantation was achieved in 47 (92.1%) lesions; multiple stents were deployed in 4 (7.9%) lesions (a case with 2nd GFX stent and 3 lesions overlapped with other kinds of stents). 3) Successful deployment was achieved in 51/52 stents (98.1%) with one case of stent passing failure. Adjuvant high pressure balloon dilatations (over 12 atm) were needed in 14 cases (26.9%) to achieve optimal result. 4) No major adverse cardiac events (MI, repeat PTCA, CABG, death) occurred in this series of 49 consecutive patients within 4 weeks after procedure. Stents were deployed successfully in complex lesions including calcified and angulated (>45degrees) lesions or in lesions with proximal tortuosity; B2 (57.7%), C (28.8%) (procedural success rates and angiographic success rates were both 100%). 5) No subacute stent thrombosis occurred during hospital stay. Peristent dissections were performed in 2 cases distal-to-stent without significant compromise of blood flow. Of the 8 lesions with side branches, 1 side branch was occluded after stent deployment. 6) Mean lumen diameter of target lesion was increased from 0.79+/-0.41 mm to 3.19+/-0.41 mm (P<0.001) after stent implantation. Percent of diameter stenosis was decreased from 75.6+/-12.0% to??.6+/-12.9% (P<0.001) after stent implantation. Mean diameter of reference artery was 3.20+/-0.54 mm. Conclusion: GFX stent implantation can be achieved with high procedural success rate. With several favorable characteristics, good trackability, flexibility, and good vessel support, this new stent was deployed successfully in complex lesions for percutaneous coronary intervention. Follow-up data is needed to assess long term patency of this stent.