New Ultrasound-Controlled Paclitaxel Releasing Balloon vs. Asymmetric Drug-Eluting Stent in Primary ST-Segment Elevation Myocardial Infarction　― A Prospective Randomized Trial ―

Abstract

the agent is rapidly released locally into the vessel wall. 9 This technology allows a broader area of surface contact and more homogenous drug-tissue transfer compared to stent-based local drug delivery. 10 CAD patients treated with DCB angioplasty may benefit from the absence of a permanent stent and shortened dual antiplatelet therapy. 11-13 DCB application was first recommended by the European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS) guidelines for the treatment of in-stent restenosis (ISR) after prior bare-metal stent (BMS) (Class IIA, Level B) implantation in 2010. 14 Thereafter, DCBs were recommended by the ESC/EACTS guidelines for the treatment of ISR S ince the 1970s, the invention of balloon angioplasty and percutaneous coronary intervention (PCI) have made rapid progress in the treatment of occlusive coronary artery disease (CAD). 1,2 In particular, drug-eluting stents (DES) have become an optimal strategy for the benefit of quickly recovering coronary artery blood flow, inhibiting restenosis. However, endothelial dysfunction, neo-atherosclerosis and thrombosis followed by DES implantation greatly affect the efficacy of clinical prognosis. 3-5 The permanent existence of stent platforms is considered as the main reason. 6-8 Drug-coated balloons (DCBs) are semi-compliant angioplasty balloons covered with an antiproliferative lipophilic agent. When DCB is inflated,

Drug-coated balloons versus drug-eluting stents in patients with acute myocardial infarction undergoing percutaneous coronary intervention: an updated meta-analysis with trial sequential analysis

“…Our meta-analysis included 13 studies of 2644 patients comparing DCB with DES [ 10 , 16 , 18 – 28 ]. All included studies assessed our primary outcome, MACE.…”

“…Many clinical trials have also demonstrated its value in bifurcation lesions, diffuse disease, chronic total occlusions, high blood risk conditions, calcified complex lesions, and even in de novo large vessel disease [ 13 – 15 ]. Although some recent clinical trials have evaluated the feasibility of DCB for the treatment of AMI patients [ 10 , 16 ], these individual studies do not provide very strong evidence of the exact efficacy of DCB for AMI. The effects of DCB in the treatment of AMI are still less well known.…”

Efficacy and safety of drug-coated balloon for de novo lesions of large coronary arteries: Systematic review and meta-analysis of randomized controlled trials

“…Following 165 studies remained to be read the full text for further exclusion. Finally, 10 articles [ [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] ] were included in our meta-analysis, with an overall population of 1468 patients. Among them, 717 (48.8 %) were randomized to a DCB strategy, while 751 (51.2 %) patients to a Stent strategy.7 trials [ 10 , 11 , 14 , [16] , [17] , [18] , [19] ] involving 1010 patients in the control group with DES, 2 trials [ 12 , 13 ] involving 248 patients in the control group with BMS, and one trials [ 15 ] involving 210 patients in the control group with DES or BMS.…”

“…Finally, 10 articles [ [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] ] were included in our meta-analysis, with an overall population of 1468 patients. Among them, 717 (48.8 %) were randomized to a DCB strategy, while 751 (51.2 %) patients to a Stent strategy.7 trials [ 10 , 11 , 14 , [16] , [17] , [18] , [19] ] involving 1010 patients in the control group with DES, 2 trials [ 12 , 13 ] involving 248 patients in the control group with BMS, and one trials [ 15 ] involving 210 patients in the control group with DES or BMS. Four trials [ 11 , 14 , 16 , 18 ] included only patients with STEMI, while five trials [ 10 , 12 , 13 , 15 , 19 ] excluded patients with STEMI, and one trial's [ 17 ] population had unspecified de novo coronary lesions.…”

A New Frontier for Drug-Coated Balloons: Treatment of “De Novo” Stenosis in Large Vessel Coronary Artery Disease

“…Most of the feasibility data of DCB PCI in large vessels come from sub-analysis of larger observational retrospective or prospective studies with few dedicated studies. Data obtained from observational studies [ 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 ] are summarized in Table 1 , whereas randomized studies comparing DCB and stent are presented in Table 2 and Table 3 [ 32 , 33 , 34 , 35 , 36 , 37 , 38 ].…”