Discussion
thrombosis, bleeding, anxiety/depression, angioplasty, fracture, impingement, CAD, atherosclerotic CAD, Restenosis, restenosis
THROMBOSIS, BLEEDING, PROLIFERATION, EVENT, CARDIAC DEATH, COMPLICATIONS, RESTENOSIS, RESTENOSIS, CAD
The AGENT Japan study represents the first clinical trial comparing Agent and SeQuent Please DCBs with two different drug formulations in Japanese patients. The principal findings through 1 year include: (1) relatively comparable TLF rates between arms; (2) no significant differences in the rates of individual components of TLF (cardiac death, TV-MI and TLR); (3) rare occurrence of target lesion thrombosis (1.0% Agent vs. 0.0% SeQuent Please); (4) low event rates in patients with ISR with no incidence of device-related target lesion thrombosis through 1 year of follow-up.PCI is the most common treatment for patients with symptomatic CAD. The optimal management of patients presenting with de novo SVD is clinically challenging due to vessel size and difficulties with device delivery. In addition, the issue of ISR following implantation of a BMS or DES remains a clinical challenge, due to late stent thrombosis, dependency on prolonged dual antiplatelet therapy and continued restenosis, leading to a quest for an alternative therapy. DCB technology was developed as an alternative to stent-based treatment for the management of atherosclerotic CAD and ISR. Currently available non-stent therapeutic drug delivery options include angioplasty balloons coated with the antiproliferative drug paclitaxel. DCBs may present an advantage over DES in that they do not introduce an additional stent layer, thereby potentially reducing neointimal proliferation, lumen impingement and mechanical complications (e.g., fracture, malposition, thrombosis) [The Agent DCB is coated with a formulation of paclitaxel and a highly efficient ATBC [Data from the AGENT Japan SV RCT are consistent with those reported previously. In the PICCOLETO II trial [The rate of 1-year TLR in the Agent Japan ISR substudy was 3.3%, which is considerably lower than that reported in the AGENT ISR (27.7%) and ISAR (22.1%; Intracoronary Stenting and Angiographic Results: Drug-Eluting Stent In-Stent Restenosis, 3A study [The QOL response to treatment appeared similar in both Agent and SeQuent Please arms. The initial improvement seen at 6 months plateaued by 1 year; however, pain/discomfort and anxiety/depression scores remained favorable compared to baseline. These are in line with the favorable long-term clinical outcomes demonstrated in both groups. This finding is consistent with that PCI leads to a more rapid recovery and improved short-term health status compared to CABG [DAPT with aspirin and a P2Y12 inhibitor was prescribed for at least 3 months post-procedure, after which these medications were continued at the treating physicians’ discretion. At 1 year, 18% in the Agent and 31% in the SeQuent Please arms were taking DAPT. In the ISR substudy, 48% of patients were taking the DAPT at 1 year. DAPT duration is often influenced by clinical factors observed by the treating physician. This finding seems consistent with a substudy of the BASKET-SMALL 2 trial, which found that the use of DCB had shorter DAPT and less major bleeding compared to DES [