Abstract
Objective To investigate the efficacy of drug-coated balloon (DCB) treatment for de novo coronary artery lesions in randomized controlled trials (RCTs). Background DCB was an effective therapy for patients with in-stent restenosis. However, the efficacy of DCB in patients with de novo coronary artery lesions is still unknown. Methods Eligible studies were searched on PubMed, Web of Science, EMBASE, and Cochrane Library Database. Systematic review and meta-analyses of RCTs were performed comparing DCB with non-DCB devices (such as plain old balloon angioplasty (POBA), bare-metal stents (BMS), or drug-eluting stents (DES)) for the treatment of de novo lesions. Trial sequential meta-analysis (TSA) was performed to assess the false positive and false negative errors. Results A total of 2,137 patients enrolled in 12 RCTs were analyzed. Overall, no significant difference in target lesion revascularization (TLR) was found, but there were numerically lower rates after DCB treatment at 6 to 12 months follow-up (RR: 0.69; 95% CI: 0.47 to 1.01; P = 0.06; TSA-adjusted CI: 0.41 to 1.16). TSA showed that at least 1,000 more randomized patients are needed to conclude the effect on TLR. A subgroup analysis from high bleeding risk patients revealed that DCB treatment was associated with lower rate of TLR (RR: 0.10; 95% CI: 0.01 to 0.78; P = 0.03). The systematic review illustrated that the rate of bailout stenting was lower and decreased gradually. Conclusions DCB treatment was associated with a trend toward lower TLR when compared with controls. For patients at bleeding risk, DCB treatment was superior to BMS in TLR.
Highlights
Stent implantation is the recommended strategy for majority of coronary artery lesions intended for percutaneous coronary intervention (PCI) [1]
Several studies were strictly excluded based on the following criteria: (1) studies assessing the efficacy of drug-coated balloon (DCB) for the treatment of in-stent restenosis (ISR), (2) studies that analyzed the intervention of DCB in patients with peripheral artery disease or treatment of dysfunctional hemodialysis arteriovenous fistulas, (3) observational studies, registries, and conference abstracts not published formally, such as the PICCOLETO II trial reported in the 2019 TCTmd Conference, and (4) randomized controlled trials (RCTs) that compared combination therapy (DCB and bare-metal stents (BMS) or drug-eluting stents (DES) implantation) with other strategies (BMS, DES, or plain old balloon angioplasty (POBA))
The pooled result showed that DCB treatment was superior to non-DCB devices in terms of LLL with a Mean difference (MD) of Records identified through PubMed, Web of Science, EMBASE and Cochrane Library Database (n = 1,370)
Summary
Stent implantation is the recommended strategy for majority of coronary artery lesions intended for percutaneous coronary intervention (PCI) [1]. Long-term follow-up results up to 16 years showed that stent implantation was associated with higher vessel thrombosis and myocardial infarction when compared with plain old balloon angioplasty (POBA) only [2]. Even with the latest generation stent, the rate of major adverse cardiac events was as high as 6.1%, and accompanied with a 2% annual rate thereafter [3]. The persistence of metal material in the vessel wall has been considered one of the causes of adverse events [4]. The exploration of a stentless strategy is persistently on the way
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