Table 1 The summary and baseline of all included studies
Characteristics of All included Studies | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Author, year | Type of Study | Country | Patients (n) (DCB/stent) | Criteria of Small vessel | Procedural success (%) (DCB/stent) | Age (mean) (DCB/stent) | male, n (DCB/stent) | mean follow up (months) | Outcomes reported | DCB type | Stent type | Bailout stenting rate (%) | Medical Conditions, n (DCB/ stent) | ||||||
History of stroke | History of MI | DM | HTN | Hyperlipidaemia | Current smoker | PAD | |||||||||||||
Latib, 2012, Naganuma, 2015 and Latib, 2015 | RCT | italy | 90/92 | 2.41/2.41 | 92/95 | 64.8/66.8 | 72/71 | 6 | MLD/%DS/acute gain/MACE/MI/TLR/TVR/death/Periprocedural MI/binary stenosis/late lumen loss/net gain | IN.PACT Falcon paclitaxel DEB (Medtronic, Inc., Santa Rosa, California) dilation and provisional BMS; | PES (Taxus Libertè, Boston Scientific, Boston, Massachusetts) | 20 | NA | 46/33 | 39/35 | 72/75 | 71/73 | 15/10 | NA |
liistro, 2013 | RCT | italy | 66/59 | 2.77/2.85 | 100/100 | 65/66 | 58/49 | 9 | IDTLR/death/MI/TLR/binary stenosis/RVD/MLD/late loss/restenosis pattern | second-generation Elutax PEB, | Xience V drug-eluting stent | NA | NA | 6/7 | 10/7 | 28/22 | 10/6 | 23/15 | NA |
Nishiyama, 2016 | RCT | japan | 30/30 | 2.88/2.72 | 100/100 | 67.3/70.63 | 20/24 | 8 | MLD/%DS/Late lumen loss/Acute gain | paclitaxel-coated balloon catheter (paclitaxel at a dose of 3 µg/mm2 balloon surface; SeQuent Please; B Braun Melsungen, Germany). | everolimus-eluting stents (EES: Xience Prime/ Xpedition; Abbott Vascular, Santa Clara, CA, USA). | N/A | N/A | N/A | 12/13 | 23/27 | 24/23 | 17/19 | NA |
Shin, 2016 | observational | South Korea. | 44/22 | 2.69/2.92 | 100/100 | 60.6/58.7 | 34/16 | 12.4 Median | major adverse cardiac events including cardiac death, MI, target lesion revascula- rization (TLR), and arterial thrombosis was recorded/MLD/FFR | (SeQuent Please paclitaxel-coated balloon catheter, B. Braun, Melsun- gen, Germany) | DES, ei-ther zotarolimus- or everolimus-eluting stent (Resolute IntegrityVR or Xience primeVR) and BMS (VisionVR) | 0 | NA | 3/0 | 13/5 | 24/8 | 19/8 | 20/5 | NA |
Silverio, 2020 | observational | Sweden | 1154/13,634 | N/A | 98.4/98.2 | 68/69 | 809/9054 | 36 | The primary outcomes were restenosis and definite target lesion thrombosis at 3-year follow-up. The secondary outcomes were the occurrence of all-cause death and myocardial infarction. | N/A | N/A | 0 | NA | 365/3386 | 310/3243 | 791/8779 | 680/6899 | 143/2302 | NA |
Sinaga, 2016 | observational | Singapore | 172/163 | 2.22/2.44 | NA | 132/117 | 61/61.2 | 12 | Composite MACE - Death - MI - TLR - cerebrovascular accident | SeQuent Please pacli-taxel-coated balloon, B-Braun, Melsungen, Germany) | NA | NA | NA | 134/107 | 88/80 | 125/113 | 120/118 | 52/73 | NA |
Tan, 2021 | observational | china | 56/212 | 2.64/2.65 | NA | 64.96/62.39 | 34/139 | 24 | No. with angiographic follow- up / MLD/Diameter stenosis/Late lumen loss/All cause MACE/Cardiovascular death/Non-fatal MI/TVR | (SeQuent® Please; B. Braun Melsungen, Germany) | the zotarolimus-eluting stent (Endeavor Reso- lute, Metronic company) or rapamycin-eluting stent (Fire-bird-2, Microport company) | NA | 5/13 | 56/212 | 18/58 | 21/75 | NA | 29/94 | NA |
Chae 2017 | RCT | Korea | 90/90 | 2.2 –4 mm | 100/100 | 61.2/62.4 | 68/63 | 9 | the in-segment late loss (LL) at 9 months measured by quantitative coronary angiogra- phy (QCA). | paclitaxel-coated balloon | zotarolimus-eluting stent | NA | 4/1 | 3/4 | 28/26 | 25/40 | 15/18 | 27/19 | NA |
Cortese 2010 | RCT | Italy | 28/29 | less than of 2.75 mm | 96.4/100 | 68/67 | 22/22 | 6 | comparing the efficacy of the Dior PCB (Eurocor, Bonn, Germany) with Taxus Libertè DES | paclitaxe coated balloon | Taxus | NA | NA | 5/6 | 13/11 | 21/20 | 17/13 | NA | NA |
Jeger 2018 and Jeger 2020 | RCT | Switzerland and Germany | 382/376 | (< 3 mm in diameter) | 96/98 | 67/68 | 295/262 | 12 | non- inferiority of DCB versus DES regarding MACE after 12 months. | paclitaxel | everolimus | NA | 16/32 | 160/133 | 122/130 | 324/332 | 262/259 | 82/72 | 27/26 |
Tang 2018 and Tian 2019 | RCT | China | 116/114 | > 2.25 mm and < 2.75 mm | 99.1/99.1 | 60.1/60.5 | 77/88 | 9 | DCB was non- inferior to the DES for the primary endpoint of 9- month angiographic in-segment %DS, | drug-eluting ammonium salt- paclitaxel | NA | 5.2/1.8 | 8/14 | 26/28 | 58/71 | 78/86 | 61/55 | 34/36 | NA |
Yu 2022 | RCT | China | 84/79 | 2.25 –4 mm | 97.6/98.7 | 62.6/64 | 62/56 | 12 | lumen loss (LLL) of target lesions at the 9-month angiographic follow-up. | paclitaxel-coated | zotarolimus-eluting | 2/0 | NA | 5/4 | 16/32 | 50/54 | 52/39 | 46/42 | NA |
Zurakowski 2015 | RCT | Poland | 100/102 | 2.25Â mm to 3.5Â mm. | NA | 62.1/64 | 70/68 | 9 | In-stent late lumen loss (LL) in coronary angiography, | paclitaxel-coated balloon | CoroflexTM | NA | NA | 43/35 | 20/25 | 79/90 | 48/60 | 22/17 | 12-Dec |
Tasi 2022 | Observational | Taiwan. | 47/59 | from 2.0 to 2.25Â mm) | NA | 65.1/65.1 | 39/48 | 12 | system. Angiographic, procedural, and clinical outcomes | SeQuent Please Neo | sirolimus-eluting Orsiro | NA | 3 / 2 | 5/7 | 23/32 | 44/49 | 40/42 | 21/21 | 6/10 |
Cortese 2020 | RCT | Italy | 118/114 | 2.23/2.18 | 98.3/98.2 | 64/66 | 83/87 | 12 | MACE/total death /cardiac death/MI/TLR/BARC bleeds type 3 or 5/Vessel thrombosis/RVD/MLD / acute gain /Stenosis, % of lumen diameter/Binary restenosis/late loss/lesion length/net luminal gain | Elutax SV/Emperor | Xience EES | 6.7/NA | NA | 45/34 | 45/40 | 77/76 | 72/63 | 23/19 | NA |
Zheng 2020 | RCT | China | 58/130 | A vessel with a diameter between 2.25 and 2.80Â mm | 98.2/85.4 | 70.5/NA | 44/NA | 12 | MI/TVR/death/procedural success/LLL/MLD | paclitaxel drug-eluting balloon | everolimus-eluting stent | NA | NA | NA | NA | NA | NA | NA | NA |
Tang 2019 | RCT | China | 36/62 | A vessel with a diameter < 2.80 mm | 94.4/94.2 | 65.8/71 | 25/48 | 9 | MI/TLR/death/binary restenosis/procedural success/LLL/NLG/MLD | paclitaxel drug-eluting balloon | paclitaxel-eluting stent | NA | NA | NA | NA | NA | NA | NA | NA |
Zhou 2020 | RCT | China | 50/35 | A vessel with a diameter < 2.80 mm | 94/95.8 | 61.9/67.1 | 37/23 | 12 | MI/TLR/TVR/procedural success/LLL/NLG/MLD | paclitaxel drug-eluting balloon | paclitaxel-eluting stent | NA | NA | NA | NA | NA | NA | NA | NA |
sim 2018 | Observational | China | 78/200 | < 2.25 mm | 97/96 | 58/61 | 70/154 | 12 | target lesion and luminal stenosis | : Paclitaxel-coated balloon (SeQuent Please; B Braun Melsungen AG, Melsungen, Germany) | : Second-generation everolimus-eluting Xience stent (Abbott Vascular, Santa Clara, CA); | NA | NA | NA | 55/108 | 69/136 | 70/153 | 42/59 | NA |
Giannini 2017 | Observational | chinsese | 90/91 | < 2.8 mm | NA | 65/66 | 72/71 | 12 | target lesion and luminal stenosis | : Paclitaxel-coated balloon (SeQuent Please; B Braun Melsungen AG, Melsungen, Germany | Second-generation everolimus-eluting Xience stent (Abbott Vascular, Santa Clara, CA) | NA | NA | 46/53 | 39/37 | 72/74 | 71/71 | NA | NA |