Clinical experience with the S-Flex coronary stent.

Area of Science:

• Cardiology
• Interventional Cardiology
• Biomedical Engineering

Background:

• Coronary stenting is crucial for treating coronary artery disease.
• Restenosis and thrombosis remain significant challenges, limiting stent efficacy.
• The S-Flex stent, a novel 'low injury' device, was developed in South Africa.

Purpose of the Study:

• To conduct a clinical audit of the first 100 patients receiving the S-Flex coronary stent.
• To evaluate the safety and efficacy of the S-Flex stent in a real-world, non-selective patient population.
• To assess the rates of clinical restenosis, major adverse cardiac events (MACE), and target lesion revascularisation (TLR) associated with the S-Flex stent.

Main Methods:

• A retrospective review of 102 patients who received S-Flex stents between September 1999 and March 2001.
• Routine use of S-Flex stents alongside other manufacturers' devices.
• Six-month follow-up (clinical interview or telephone) for all but two patients.
• Primary endpoint: clinical restenosis (angiographic or symptomatic recurrence/TLR).

Main Results:

• 100% device success rate.
• Six-month MACE rate: 7.9%.
• Six-month target lesion revascularisation (TLR) rate: 3.0%.
• Six-month clinical restenosis rate: 7.1%.
• Six-month event-free survival (no MACE or clinical restenosis): 86.1%.

Conclusions:

• The S-Flex coronary stent exhibits a low clinical restenosis rate.
• The stent is effective in a non-selective patient population undergoing coronary stenting.
• These findings support the S-Flex stent as a viable option for managing coronary artery disease.