Bioresorbable vascular scaffold: promises and the fallen child-as-king?

The main limitation of percutaneous coronary intervention compared to open-heart surgery is the insertion of a foreign body (usually a stent) inside the coronary artery. This is associated with foreign body inflammation that triggers restenosis, neoatherosclerosis and late-occurring stent thrombosis. As such, BVS were considered as a possible solution as early as the late 60s by Dotter with preclinical work,1 and then with the first human study by Higaki and Tamai2 in the late 90s. In these two preliminary experiments, device materials had weak radial strength and came with the risk of scaffold thrombosis (ScT). In addition, long-term preliminary studies of the Higaki-Tamai stent showed pathological remodelling of the artery during the first 3 years. Based on these studies, this early concept was soon abandoned. In 2004 following concerns of late drug-eluting stent (DES) thrombosis and its association with hypersensitivity reaction to permanent polymer, we saw a renewed interest in bioresorbable polymers. First, durable polymers on metallic DES were progressively swapped for lower dose, bioresorbable polymers. Second, a modified version of BVS that combines a novel stent design, a semicrystalline poly L-lactic acid (PLLA) backbone and a coating with everolimus was considered. This seminal work resulted in the first drug-eluting BVS, and subsequently in its first human implantation. The announcement of the first clinical BVS implantation by Ormiston3 generated optimism during the great DES depression of 2006: BVS could potentially eradicate long-term adverse events (restenosis, late stent thrombosis and the newly described neoatherosclerosis ) but could also result in possible coronary restoration with physiological vasomotion. Early studies with intravascular imaging were encouraging: early healing ( capping ) and the foundation of a new …