ABSTRACT

There are several putative clinical advantages of such novel absorbable metal scaffolds (AMS) over permanent stents. The first-generation drug-eluting absorbable metal scaffold (DREAMS-1G) offered incremental improvements including paclitaxel drug elution. The second-generation drug-eluting absorbable metal scaffold (DREAMS-2G) offers sirolimus elution scaffold. A magnesium-based BIOTRONIK scaffold has been designed and incrementally improved over three product innovation steps. This chapter summarizes the main design features and clinical trial results for the AMS, DREAMS-1G, and DREAMS-2G absorbable magnesium scaffolds. Radiopaque tantalum markers have been added at DREAMS-1 G and DREAMS-2 G scaffold ends to permit more precise implantation and postdilatation visibility. The BIOSOLVE-I trial demonstrated that the DREAMS-1G scaffold was associated with target lesion failure rates similar to that of contemporary permanent drug-eluting stents or absorbable everolimus-eluting scaffolds. The chapter shows the variation of fibrous tissue, fibrous fatty tissue, necrotic core tissue, and calcium after implantation of DREAMS-2G in the eleven subjects who underwent serial IVUS analysis.