Efficacy and Safety of Dual Paclitaxel and Sirolimus Nanoparticle-Coated Balloons

CVPath scientists recently evaluated the safety and efficacy of a new dual active pharmaceutical ingredient (API) drug-coated balloon (DCB) using two animal models. Drug-coated balloons are typically used to treat coronary artery disease by delivering antiproliferative drugs to the vessel wall during a percutaneous coronary intervention. In this study, scientists evaluated the SirPlux Duo DCB (Advanced NanoTherapies, Inc), which combines two drugs, paclitaxel (PTX) and sirolimus (SRL), to maximize treatment effect. In addition to the animal model experiment, three sets of experiments were performed in human vascular smooth muscle cells (VSMCs). These cells were treated with nanoparticles encapsulating SRL, PTX, or a combination of both. Then, three days after the incubation period, scientists calculated the percentage of dead cells compared to the total number of cells. The combination of PTX and SRL incorporated into nanoparticles showed positive effects for use in DCBs, and in the rabbit iliac artery model, it demonstrated better inhibition of neointimal proliferation in the acute phase compared with PTX alone. In the porcine model, there was better healing of medial injury in the subacute phase and lower incidence of tissue damage and distal emboli in the downstream myocardium. This highlights the efficacy and safety of a dual API DCB.

More details can be found here, in a paper published by the Journal of the American College of Cardiology.