[Better regulatory framework needed for medical devices]

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Health Technology Assessment

Background:

• Atherosclerotic disease in the lower extremities is a significant health concern.
• Drug-eluting stents and balloons are utilized for treating peripheral arterial disease.
• Patient values and evidence for these devices require thorough evaluation.

Purpose of the Study:

• To summarize a Health Technology Assessment (HTA) report on patient values regarding drug-eluting stents and balloons.
• To evaluate the efficacy and safety of these devices for atherosclerotic disease in lower extremities.
• To assess the certainty of evidence for clinical outcomes.

Main Methods:

• Systematic review of 17 randomized controlled trials, 4 cohort studies, and 13 case series.
• Analysis of approximately 3,000 patients with lower extremity atherosclerotic disease.
• GRADE methodology used to assess the certainty of evidence.

Main Results:

• Low certainty of evidence (GRADE ++) for reduced restenosis risk in critical ischemia, below-knee lesions.
• Modest beneficial effect on ischemic symptoms in a mixed patient population.
• Identified a worrying safety signal: increased risk of amputation in patients with below-knee critical ischemia.

Conclusions:

• Evidence for drug-eluting devices in lower extremity arterial disease is limited by heterogeneity.
• A significant safety concern regarding amputation risk necessitates careful consideration.
• Highlights the need for a structured medical device validation system, similar to pharmaceuticals.