Health Problem: Coronary artery disease (CAD) is the most common type of heart disease and the leading cause of death in both men and women in the United States. CAD occurs when the supply of oxygen-rich blood to the heart is limited. Plaque buildup in the coronary arteries, otherwise known as atherosclerosis, develops over many years, hardening and narrowing the artery, thus restricting blood flow. As the disease progresses, the restricted blood flow to the heart can elevate blood pressure, weaken the heart muscle, and lead to angina or heart attack.
Technology Description: Stents are small, expandable wire-mesh tubes that are placed in the opening of narrowed arteries during percutaneous coronary intervention (PCI) to reestablish blood flow. The Absorb Bioresorbable Vascular Scaffold (BVS) is an everolimus-eluting stent with a semi-crystalline poly-L-lactide-based frame that is completely degraded via hydrolysis and bioresorbed within 2 to 3 years postimplantation.
Controversy: Fully resorbable BVS offer a new PCI option for patients with coronary artery disease; however, the long-term safety and efficacy benefits compared with permanent metallic drug-eluting stents (DES) remain unclear. A safety alert issued by the Food and Drug Administration in March 2017 informed healthcare providers about 2-year data from a clinical trial suggesting an increase in major adverse cardiac events among patients receiving BVS compared with patients who received the XIENCE metallic DES.
- How do Bioresorbable Vascular Scaffolds (BVS) compare with other stent types for reducing death, myocardial infarction (MI), repeat revascularizations, and improving symptoms in patients with coronary artery disease (CAD)?
- How do BVS compare with other stent types with respect to safety?
- Have definitive patient selection criteria been
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