Annals of medicine and surgery (2012) · 2024
Drug-coated balloons for the treatment of in-stent restenosis: an updated systematic review and meta-analysis of randomized controlled trials.
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Guntipalli Manojna, Obi Ogechukwu, Jeswin Teenu Maria, Naidoo Rushern, Ghenai Mohamed Amine, Kansara Nishi, Gardezi Syed Karam, Chathemparambil Mani Sandra, Sheriff Taqiyah, Hidri Sinda, Ehsan Muhammad, Rehman Wajeeh Ur, Munasar Asmaa
Аннотация
BACKGROUND: Drug-coated balloons (DCBs) have emerged as a potential option for treating in-stent restenosis (ISR). We aimed to assess the efficacy and safety of DCB compared to uncoated balloons (UCBs) for patients with ISR.
METHODS: We systematically searched Embase, MEDLINE, and Cochrane Library for randomized controlled trials comparing drug-coated balloons with uncoated balloons for coronary in-stent restenosis (ISR). Dichotomous and continuous outcomes were pooled using Revman 5.4 under a random-effects model. All the outcomes were assessed in a 6-month to 1-year follow-up period.
RESULTS: A total of seven RCTs involving 1407 patients were included in our review. DCBs significantly reduced the rate of target lesion revascularization (TLR) (RR 0.28; 95% CI: 0.16, 0.48), target vessel revascularization (TVR) (RR 0.36; 95% CI: 0.14, 0.90), major adverse cardiovascular events (MACE) (RR 0.39; 95% CI: 0.26, 0.58), and MI (RR 0.56; 95% CI: 0.35, 0.91). However, no significant difference was observed between the two groups regarding all-cause mortality, cardiovascular mortality, and stent thrombosis. DCB significantly improved angiographic outcomes such as binary restenosis (RR 0.23; 95% CI: 0.12, 0.43), late lumen loss (MD -0.44; 95% CI: - 0.55 to -0.33), and percent diameter stenosis (MD -13.91; 95% CI: - 24.15 to -3.67) compared to the UCB group.
CONCLUSION: Our meta-analysis showed that drug-coated balloons have superior efficacy and safety compared to uncoated balloons in coronary in-stent restenosis patients.
METHODS: We systematically searched Embase, MEDLINE, and Cochrane Library for randomized controlled trials comparing drug-coated balloons with uncoated balloons for coronary in-stent restenosis (ISR). Dichotomous and continuous outcomes were pooled using Revman 5.4 under a random-effects model. All the outcomes were assessed in a 6-month to 1-year follow-up period.
RESULTS: A total of seven RCTs involving 1407 patients were included in our review. DCBs significantly reduced the rate of target lesion revascularization (TLR) (RR 0.28; 95% CI: 0.16, 0.48), target vessel revascularization (TVR) (RR 0.36; 95% CI: 0.14, 0.90), major adverse cardiovascular events (MACE) (RR 0.39; 95% CI: 0.26, 0.58), and MI (RR 0.56; 95% CI: 0.35, 0.91). However, no significant difference was observed between the two groups regarding all-cause mortality, cardiovascular mortality, and stent thrombosis. DCB significantly improved angiographic outcomes such as binary restenosis (RR 0.23; 95% CI: 0.12, 0.43), late lumen loss (MD -0.44; 95% CI: - 0.55 to -0.33), and percent diameter stenosis (MD -13.91; 95% CI: - 24.15 to -3.67) compared to the UCB group.
CONCLUSION: Our meta-analysis showed that drug-coated balloons have superior efficacy and safety compared to uncoated balloons in coronary in-stent restenosis patients.