Bioresorbable Vascular Scaffolds for Coronary Revascularization.

Area of Science:

• Cardiovascular medicine
• Biomaterials science

Background:

• Metallic drug-eluting stents (DES) have excellent 1-year outcomes but pose long-term risks like stent thrombosis and myocardial infarction.
• The permanent metallic frame and polymer in DES are implicated in very late adverse events.
• Bioresorbable scaffolds (BRS) aim to provide temporary mechanical support and drug delivery, eventually resorbing to restore vascular function.

Purpose of the Study:

• To evaluate the noninferiority of a first-generation bioresorbable scaffold compared to contemporary metallic drug-eluting stents.
• To assess the potential of bioresorbable scaffolds to improve very late clinical outcomes by enabling vascular recovery.

Main Methods:

• Comparison of a first-generation bioresorbable scaffold against metallic drug-eluting stents.
• Evaluation of overall 1-year patient-oriented and device-oriented outcomes.
• Analysis of scaffold thrombosis and target vessel-related myocardial infarction rates.

Main Results:

• The first-generation bioresorbable scaffold demonstrated noninferiority to metallic DES for 1-year outcomes.
• Higher rates of scaffold thrombosis and target vessel myocardial infarction were observed with bioresorbable scaffolds.
• Potential mitigation strategies include improved patient/lesion selection, procedural techniques, and device development.

Conclusions:

• Bioresorbable scaffolds show promise as an alternative to metallic DES, with comparable short-term outcomes.
• Long-term safety and efficacy require further investigation through large-scale randomized trials.
• Optimization of device design and implantation protocols is crucial for addressing safety concerns like scaffold thrombosis.