{
  "abstract": "Background In patients with de novo coronary artery disease (CAD), percutaneous coronary intervention (PCI) with drug eluting stent (DES) implantation is the gold standard therapy. New evidence is available with drug coated balloons (DCB) angioplasty. This meta-analysis compared the efficacy and safety of DCB-based PCI versus DES-based PCI for patients with de novo CAD.Methods A systematic search of PubMed, Scopus, Web of Science, and EMBASE databases was performed from 1st January 2006 up until November 1st, 2024. Inclusion criteria were random treatment assignment; PCI with DCB versus DES; patients with de novo coronary artery disease; clinical follow-up available for ≥1 year; and studies published in a peer-reviewed journal.Trial-level incidence rate ratios (IRR) with 95% confidence intervals were pooled by random-effects models with inverse variance weighting. The primary outcome was major adverse cardiac events (MACE). Secondary outcomes included cardiac death, all-cause death, and target lesion revascularization.Results A total of nine clinical trials comprising of 4,284 patients were included ( table 1). The risk of the primary composite endpoint of MACE was comparable with DCB versus DES (IRR 0.95, 95% CI0.61 to 1.48). Secondary endpoints including cardiac death (IRR 1.49, 95% CI 0.96 to 2.33), all-cause death (IRR 1.18, 95% CI 0.80 to 1.74), and target lesion revascularization (IRR 1.17, 95% CI 0.68 to 2.01) were comparable though confidence intervals around treatment effects were wide (figure 1). The results were consistent in a leave-one-out analysis. A sensitivity analysis showed consistent treatment effects in the trials enrolling patients with small vessel disease and those enrolling patients with ACS.Conclusions DCB-based PCI for de novo CAD was associated with similar medium-term clinical outcomes compared with DES. Additional evidence is warranted in view of numerical trends in important secondary endpoints. The findings lend support to angioplasty with DCB in selected patients undergoing intervention for de novo coronary stenosis.Abstract 19 Figure 1Abstract 19 Table 1Main characteristics of the included trials Trial (Year, reference) Patients randomized (DCB vs. DES) Center (n) Region Vessel size Enrollment period Design Primary Endpoint Maximum available follow-up (months) Registration BELLO (2012 (18 ), 2015 (37 )) 90 vs. 92 15 Italy <2.8mm Mar 2010–Mar 2012 Non-Inferiority All-cause death, myocardial infarction, or target vessel revascularization. 36 NCT01086579 BASKET-SMALL 2 (2018 (16 ), 2020 (38 )) 382 vs. 376 14 Germany, Switzerland, Austria ≥2.0 -<3.0mm Apr 2012–Feb 2017 Non-Inferiority Cardiac death, non-fatal myocardial infarction, or target-vessel revascularization. 36 NCT01574534 RESTORE SVD (2018 (17 ), 2020 (39 )) 116 vs. 114 12 China ≥2.25 -2.75mm Aug 2016–Jun 2017 Non-Inferiority Cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularisation. 24 NCT02946307 REVELATION (2019 (19 ), 2021 (40 ), 2024 (41 )) 60 vs. 60 1 Netherlands Any Oct 2014–Nov 2017 Non-Inferiority Death, myocardial infarction, target lesion revascularization, stent thrombosis or major bleeding. 60 NCT02219802 PICCOLETO II (2020 (15 ), 2023 (42 )) 114 vs 118 5 Italy, Spain ≥2.25 - 2.75mm May 2015–May 2018 Non-Inferiority Cardiac death, myocardial infarction, target lesion revascularization. 36 NCT03899818 Hao et al (2021 (21 )) 38 vs 42 1 China 2.5–4.0mm Jan 2018–Dec 2019 Non-Inferiority Cardiac death, target vessel myocardial infarction or target lesion revascularisation. 12 Not available Yu et al (2022 (22 )) 84 vs 79 1 China 2.25mm -4.0mm July 2017–July 2018 Non-Inferiority Late lumen loss (LLL). Secondary endpoint was MACE consisting of Cardiac death, non-fatal myocardial infarction, target lesion revascularization, and target vessel revascularization. 12 Not available Dissolve SVD (2024 (20 )) 129 vs 118 10 China ≥2.25mm-≤2.75 mm Apr 2018–Mar 2019 Non-Inferiority Cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularisation. 12 NCT03376646 REC-CAGEFREE-1 (2024 (23 )) 1133 vs. 1139 43 China Any Feb 2021–May 2022 Non-Inferiority Cardiac death, target vessel myocardial infarction, clinically and physiologically indicated target lesion revascularization. 24 NCT04561739 aRegistration number in www.clinicaltrial.gov database.Abstract 19 Table 2Patient and device characteristics Trial Interventions N DCB type Stent type Mean age mean ± SD Men N, (%) DM N, (%) Prior MI N, (%) ACS N, (%) RVD, mm mean ± SD Bailout Stenting N, (%) BELLO (2012 (18 )) DCB (90) DES (92) IN.PACT Falcon Taxus Liberte (Paclitaxel) 64.8 ± 8.5 66.4 ± 9.0 72 (80) 71 (77.2) 39 (43.3) 35 (38) 46 (51.1) 33 (35.9) 22 (24.4) 20 (21.7) 2.15 ± 0.27 2.26 ± 0.24 18 (20%) BASKET-SMALL 2 (2018 (16)) DCB (382) DES (376) SeQuent Please Taxus Element(paclitaxel) initially then Xience (Everolimus) 67.2 ± 10.3 68.4 ± 10.3 295 (77) 262 (70) 122 (32) 130 (35) 160 (42) 133 (35) 112 (30) 102 (27) NR NR 19 (5.1%) RESTORE SVD China (2018 (17 )) DCB (116) DES (114) Restore Resolute Integrity (Zotarolimus) 60.1 ± 10.5 60.5 ± 10.8 66.4 (77) 77.2 (88) 39.7 (46) 42.1 (48) 22.4 (26) 24.6 (28) 69.0 (80) 71.1 (81) 2.42 ± 0.15 2.42 ± 0.18 6 (5.2%) REVELATION (2019 (19 )) DCB (60) DES (60) Pantera Lux Orsiro (Sirolimus) or Xience(Everolimus) 57.4 ± 9.2 57.3 ± 8.3 52 (87) 52 (87) 8 (13) 4 (7) NR NR 60 (100) 60 (100) NR NR 11 (18%) PICCOLETO II (2020 (15 )) DCB (118) DES (114) Elutax SV/Emperor Xience(Everolimus) 64 (48–80) 66 (50–82) 83 (70.3) 87 (76.9) 45 (38.0) 40 (35.4) 45 (38) 34 (30) 37 (31.4) 32 (21.1) 2.23 ± 0.4 2.18 ± 0.4 8 (6.8%) Hao et al (2021 (21 )) DCB (38) DES (42) Yinyi Biotech Bingo Not reported 59.00 ± 11.00 56.00 ± 11.00 30, (78) 35 (82) 10 (28) 15 (35) NR NR 38 (100%) 42 (100%) 2.5– 4.0mm 2.5–4.0mm 4 (9.5%) Yu et al (2022 (22 )) DCB (84) DES (79) Sequent Please Resolute Integrity (Zotarolimus) or Xience(Everolimus) or Firehawk (rapamycin) 62.6±8.8 64.0±10.5 62 (73.8) 56 (70.9) 16 (19.0) 23 (29.1) NR NR 76 (91.5) 69 (87.3) 2.77 (2.50 to 3.25) 3.01 (2.65 to 3.39) 2 (2.4%) Dissolve SVD (2024 (20 )) DCB (129) DES (118) Dissolve DCB Resolute Integrity (Zotarolimus) 60.2 ± 9.5 60.1 ±9.3 94 (72.9%) 82 (69.5%) 46 (35.7%) 45 (38.1%) 33 (25.6%) 27 (22.9%) 82 (63.6%) 77 (65.3%) 2.20± 0.26 2.21 ± 0.24 5 (3.9%) REC-CAGEFREE I (2024 (23 )) DCB (1133) DES (1139) Swide DCB Firehawk (rapamycin) 61.5 ± 10.3 61.2 ± 10.5 67.9% 70.7% 24.9% 29.7% 7.1% 9.2% 55.6% 55% 2.74 ± 0.51 2.82 ± 0.51 106 (9.4%) DCB: drug coated balloon; DES: drug eluting stent; SD: standard deviation; DM: diabetes mellitus; MI: myocardial infarction; ACS: acute coronary syndrome; RVD: reference vessel diameter",
  "authors": [
    {
      "affiliations": [
        "Cardiovascular Research Institute (CVRI) and Dept. Of Cardiology, Mater Private Network, Dublin, Ireland;, Dublin, Ireland",
        "School of Pharmacy and Biomolecular Sciences, RCSI School of Medicine and Health Sciences, Dublin, Ireland; Dublin, Ireland"
      ],
      "name": "D O’Callaghan"
    },
    {
      "affiliations": [
        "Cardiovascular Research Institute (CVRI) and Dept. Of Cardiology, Mater Private Network, Dublin, Ireland;, Dublin, Ireland",
        "School of Pharmacy and Biomolecular Sciences, RCSI School of Medicine and Health Sciences, Dublin, Ireland; Dublin, Ireland"
      ],
      "name": "H Rai"
    },
    {
      "affiliations": [
        "Cardiovascular Research Institute (CVRI) and Dept. Of Cardiology, Mater Private Network, Dublin, Ireland;, Dublin, Ireland",
        "School of Pharmacy and Biomolecular Sciences, RCSI School of Medicine and Health Sciences, Dublin, Ireland; Dublin, Ireland"
      ],
      "name": "D Giacoppo"
    },
    {
      "affiliations": [
        "Cardiovascular Research Institute (CVRI) and Dept. Of Cardiology, Mater Private Network, Dublin, Ireland;, Dublin, Ireland",
        "School of Pharmacy and Biomolecular Sciences, RCSI School of Medicine and Health Sciences, Dublin, Ireland; Dublin, Ireland"
      ],
      "name": "JJ Coughlan"
    },
    {
      "affiliations": [
        "Cardiovascular Research Institute (CVRI) and Dept. Of Cardiology, Mater Private Network, Dublin, Ireland;, Dublin, Ireland"
      ],
      "name": "R Durand"
    },
    {
      "affiliations": [
        "Department of Cardiology, Maasstad Hospital, Rotterdam, The Netherlands; Rotterdam, Netherlands"
      ],
      "name": "V Paradies"
    },
    {
      "affiliations": [
        "Cardiovascular Research Institute (CVRI) and Dept. Of Cardiology, Mater Private Network, Dublin, Ireland;, Dublin, Ireland",
        "School of Pharmacy and Biomolecular Sciences, RCSI School of Medicine and Health Sciences, Dublin, Ireland; Dublin, Ireland"
      ],
      "name": "R Colleran"
    },
    {
      "affiliations": [
        "Cardiovascular Research Institute (CVRI) and Dept. Of Cardiology, Mater Private Network, Dublin, Ireland;, Dublin, Ireland"
      ],
      "name": "GJ Blake"
    },
    {
      "affiliations": [
        "Cardiology Department, Hospital Universitario de La Princesa, IIS-IP, Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares, Madrid, Spain, Madrid, Spain"
      ],
      "name": "F Alfonso"
    },
    {
      "affiliations": [
        "Cardiovascular Research Institute (CVRI) and Dept. Of Cardiology, Mater Private Network, Dublin, Ireland;, Dublin, Ireland",
        "School of Pharmacy and Biomolecular Sciences, RCSI School of Medicine and Health Sciences, Dublin, Ireland; Dublin, Ireland"
      ],
      "name": "RA Byrne"
    }
  ],
  "title": "19 Drug coated balloons versus drug-eluting stents in patients with de novo coronary artery disease: a systematic review and meta-analysis of randomised controlled trials",
  "uid": "2d0ac309-309a-5d2c-b156-8100152a1846"
}