Michael Megaly1, Abdelrahman Ali2, Bishoy Abraham3, Charl Khalil4, Magdi Zordok5, Marco Shaker2, Mariam Tawadros6, Bassam S Hennawy7, Ayman Elbadawi8, Mohamed Omer9, Marwan Saad10. 1. Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN, USA; Department of Cardiovascular Medicine, Hennepin Healthcare, Minneapolis, MN, USA. Electronic address: michaelmegaly3@gmail.com. 2. Department of Medicine, Mercy Hospital and Medical Center, Chicago, IL, USA. 3. Department of Medicine, Ascension St John Hospital, Detroit, MI, USA. 4. Department of Medicine, University at Buffalo, Buffalo, NY, USA. 5. Department of Medicine, Steward Carney Hospital, Dorchester, MA, USA. 6. Ain Shams University, Faculty of Medicine, Cairo, Egypt. 7. Division of Cardiology, Ain Shams University, Cairo, Egypt. 8. Division of Cardiology, Department of Medicine, University of Texas Medical Branch, Galveston, TX, USA. 9. Division of Cardiology, Department of Medicine, Saint Luke's Hospital, Kansas City, MO, USA. 10. Division of Cardiology, Ain Shams University, Cairo, Egypt; Division of Cardiology, Department of Medicine, University of Arkansas, Little Rock, AR, USA.
Abstract
BACKGROUND: Percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains associated with inferior clinical outcomes and an increased risk of restenosis compared with non-diabetics even in the era of drug-eluting stents (DES). The outcomes with drug-coated balloons (DCBs) in diabetic patients have received limited study. METHODS: We performed a meta-analysis of all studies published between January 2000 and January 2019 reporting the outcomes with DCB vs. DES after PCI of de-novo coronary lesions in diabetic patients. Outcomes included major adverse cardiovascular events (MACE), target lesion revascularization (TLR), binary restenosis by quantitative coronary angiography (QCA), and late lumen loss (LLL). RESULTS: Three studies with 378 patients (440 lesions) were included in the meta-analysis. During 17.3 ± 11.3 months follow-up, DCB were associated with a similar risk of MACE (OR: 0.63, 95% CI [0.36, 1.12], p = 0.11), TLR (OR: 0.51, 95% CI [0.25, 1.06] p = 0.07), binary restenosis (OR: 0.42, 95% CI [0.09, 1.92], p = 0.26), and LLL (mean difference: -0.13 mm, 95% CI [-0.41, 0.14], p = 0.34) compared with DES. CONCLUSION: In diabetic patients with de-novo coronary lesions undergoing PCI, DCBs are associated with similar outcomes compared with first-generation DES, with a signal toward potential benefit in lowering target lesion revascularization. Further randomized studies are needed to compare the newer-generation DCBs and DES in this setting.
BACKGROUND: Percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains associated with inferior clinical outcomes and an increased risk of restenosis compared with non-diabetics even in the era of drug-eluting stents (DES). The outcomes with drug-coated balloons (DCBs) in diabeticpatients have received limited study. METHODS: We performed a meta-analysis of all studies published between January 2000 and January 2019 reporting the outcomes with DCB vs. DES after PCI of de-novo coronary lesions in diabeticpatients. Outcomes included major adverse cardiovascular events (MACE), target lesion revascularization (TLR), binary restenosis by quantitative coronary angiography (QCA), and late lumen loss (LLL). RESULTS: Three studies with 378 patients (440 lesions) were included in the meta-analysis. During 17.3 ± 11.3 months follow-up, DCB were associated with a similar risk of MACE (OR: 0.63, 95% CI [0.36, 1.12], p = 0.11), TLR (OR: 0.51, 95% CI [0.25, 1.06] p = 0.07), binary restenosis (OR: 0.42, 95% CI [0.09, 1.92], p = 0.26), and LLL (mean difference: -0.13 mm, 95% CI [-0.41, 0.14], p = 0.34) compared with DES. CONCLUSION: In diabeticpatients with de-novo coronary lesions undergoing PCI, DCBs are associated with similar outcomes compared with first-generation DES, with a signal toward potential benefit in lowering target lesion revascularization. Further randomized studies are needed to compare the newer-generation DCBs and DES in this setting.