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Clinical and Angiographic Experience with Coronary Stenting Using Freedomª Stent
DeScheerder1, Wang, Kerdsinchai
1U.H. Gasthuisberg, Department of Cardiology, 49, Herestraat, 3000, Leuven, Belgium.
Insights
The Freedom coronary stent demonstrated good initial safety and efficacy, with a 16.5% restenosis rate at 6 months in this prospective study. This new fish-scale design shows promise for coronary artery interventions.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomedical Engineering
Background:
- Coronary artery disease necessitates effective revascularization strategies.
- The development of novel stent designs aims to improve clinical outcomes and reduce restenosis rates.
- The Freedom stent, a new fish-scale designed coronary coil stainless steel stent, was evaluated for its safety and efficacy.
Purpose of the Study:
- To assess the immediate safety and efficacy of the Freedom stent.
- To evaluate the 6-month clinical and angiographic follow-up of patients treated with the Freedom stent.
- To determine the procedural success and complication rates associated with Freedom stent implantation.
Main Methods:
- A prospective study was conducted involving 169 patients treated with 233 Freedom stents in 177 vessels.
- Patients underwent stenting for bail-out, suboptimal angioplasty results, or restenosis after percutaneous transluminal coronary angioplasty (PTCA).
- Clinical outcomes and angiographic restenosis were assessed at immediate post-procedure and 6-month follow-up.
Main Results:
- Procedural success was high, achieved in 96% of vessels and patients.
- Low rates of subacute thrombotic occlusion (0.6%) and bleeding complications (3.6%) were observed.
- At 6-month angiography, in-stent restenosis of ≥50% diameter stenosis was found in 16.5% of patients.
Conclusions:
- The Freedom stent exhibits favorable immediate safety and procedural success rates.
- The 6-month clinical and angiographic follow-up indicates a manageable restenosis rate for this novel stent design.
- Further studies are warranted to compare the Freedom stent with existing coronary stents.
Abstract:
The immediate safety and efficacy and the 6 month clinical and angiographic follow-up of a new fish-scale designed coronary coil stainless steel stent (Freedomª) was assessed by a prospective study. During 1995, 169 patients were treated on 177 vessels using 233 Freedom stents. Procedural indication for stenting was a bail-out situation in 79 vessels, a suboptimal angioplasty result in 62 vessels and a third restenosis after PTCA in 36 vessels. Procedural success was achieved in 170 vessels (96%); in 162 patients (96%). Subacute thrombotic occlusion occurred in one patient (0.6%). Acute myocardial infarction occurred in 7 patients (4.1%). Bleeding complications, necessitating blood transfusion occurred in 6 patients (3.6%). There were two non-stent related deaths. Recurrence of stent-related angina pectoris and/or a positive stress test occurred in 10 pts (6.4%). Elective control angiography at 6 months was performed in the first 85 patients. Stent restenosis of ³ 50% diameter stenosis was found in 14 patients (16.5%).