Drug-eluting balloons in patients with non-ST elevation acute coronary syndrome

Bešić, Kristina Marić; Strozzi, Maja; Margetić, Eduard; Bulum, Joško; Kolarić, Branko

doi:10.1016/j.jjcc.2014.05.007

Cited by 15 publications

(14 citation statements)

References 30 publications

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“…Following screening for replicates, 405 remained; and after screening abstracts for relevance, a further 371 studies were removed. Finally, full text of the remaining 34 studies were screened, of which 17 randomised controlled trials (17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34) fulfilled the inclusion criteria and were qualitatively and quantitatively analysed.…”

Section: Resultsmentioning

confidence: 99%

Drug-eluting balloons with provisional bail-out or adjunctive stenting in de novo coronary artery lesions—a systematic review and meta-analysis

Patel

Svermova

Burke-Gaffney

et al. 2018

Cardiovasc. Diagn. Ther.

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Background: Efficacy of drug-eluting balloons (DEB) for treatment of de novo coronary lesions remains controversial. The present systematic review and meta-analysis of randomised controlled trials assessed DEB with bare-metal stents (BMS) and also DEB with provisional bail-out stents ('DEB-only' strategy), to other conventional options: plain-old balloon angioplasty (POBA), BMS and drug-eluting stents (DES). Conclusions:The results of this meta-analysis showed that whilst DEB with BMS is superior to BMS alone, the combination is inferior to DES for treatment of de novo coronary lesions. Thus, DEB + BMS should not be applied in de novo lesions unless in patients who have absolute contraindications to DES. DEB alone, however, should be considered for relative contraindications to DES such as small vessel disease and bifurcation lesions.

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Section: Resultsmentioning

confidence: 99%

Drug-eluting balloons with provisional bail-out or adjunctive stenting in de novo coronary artery lesions—a systematic review and meta-analysis

Patel

Svermova

Burke-Gaffney

et al. 2018

Cardiovasc. Diagn. Ther.

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“…Meanwhile, 1 RCT, which adopted regular balloon predilatation, compared the efficacy of BMS and DCB combination versus BMS alone in patients with non-ST elevation acute coronary syndrome also reported significantly lower LLL but the absence of a favorable effect on patient clinical outcomes. [31] Second, we speculated “geographical miss” caused by unfavorable geometric proportions as a potential influencing factor because the reference point for stent or balloon placement was missing. One clinical trial reported that patients treated with DCB predilatation with an additional BMS implantation had a very high proportion of geographical miss, which was identified as an independent significant predictor of restenosis.…”

Section: Discussionmentioning

confidence: 99%

Drug-coated balloon in combination with bare metal stent strategy for de novo coronary artery disease

Liu

Zhu²,

Han³

et al. 2017

Medicine

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Background:Studies examining the efficiency of drug-coated balloon (DCB) + bare metal stent (BMS) compared with stents alone for de novo lesions have reported inconsistent results. The present comprehensive meta-analysis of randomized controlled trials (RCTs) assessed and compared the clinical efficacy and safety of DCB + BMS with those of stents alone for de novo coronary artery disease.Methods:We formally searched electronic databases before September 2016 to identify potential studies. All RCTs were eligible for inclusion if they compared DCB + BMS with a control treatment (drug-eluting stent [DES] alone or BMS alone) in patients with de novo coronary artery disease.Results:Eleven RCTs with a total of 2196 patients met the inclusion criteria were included in our meta-analysis. Subgroup analysis indicated DCB plus BMS was associated with poorer outcomes when compared with DES alone in primary endpoint {(in-segment late lumen loss [LLL]: mean difference [MD], 0.19; 95% confidence interval [CI], 0.06–0.32; P = 0.0042) and (major adverse cardiovascular events [MACEs]: risk ratio [RR], 1.88; 95% CI, 1.44–2.45; P < 0.0001)}. However, DCB + BMS had nonsignificantly lower LLL than BMS alone (in-segment LLL: MD, −0.14; 95% CI, −0.33–0.04; P = 0.24), and was more advantageous in reducing MACE incidence, with borderline significance (MACEs: RR, 0.67; 95% CI, 0.45–0.99; P = 0.05).Conclusions:In summary, the present results do not favor the DCB + BMS strategy as an alternative therapeutic method to DES implantation for de novo coronary artery lesions in percutaneous coronary intervention (PCI). Additional well-designed large RCTs with long-follow-up periods are required to clarify the inconsistent results.

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“…A total of 32 articles were selected for complete review. Finally, 14 RCTs [18,19,20,21,22,23,24,25,26,27,28,29,30,31] involving 2281 patients were included in the current meta-analysis. The study selection process is summarized in Fig 1.…”

Section: Resultsmentioning

confidence: 99%

“…Of the 14 RCTs, 7 compared DEB+BMS and DES [18,24,25,26,27,30,31]; meanwhile, 5 trials compared DEB+BMS and BMS [21,22,23,28,29], and the remaining 2 were 3-arm trials comparing DEB+BMS, BMS, and DES [19,20]. The DEBs used in original trials were SeQuent Please [18,26,27,28,30,31], Dior [19,20], IN.PACT Falcon [22], and other paclitaxel-eluting balloons.…”

Section: Resultsmentioning

confidence: 99%

“…The DEBs used in original trials were SeQuent Please [18,26,27,28,30,31], Dior [19,20], IN.PACT Falcon [22], and other paclitaxel-eluting balloons. One study [21] used two DEB types, including SeQuent Please and Elutax. The devices used in control arms were BMS (7 arms) and DES (9 arms); regarding the type of DES, PES (4 arms), EES (3 arms), zotarolimus-eluting stent (ZES) (1 arm) and sirolimus-eluting stent (SES) (1 arm) were included.…”

Section: Resultsmentioning

confidence: 99%

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Drug-eluting balloon versus bare-mental stent and drug-eluting stent for de novo coronary artery disease: A systematic review and meta-analysis of 14 randomized controlled trials

et al. 2017

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BackgroundDrug-eluting balloon (DEB) has become an alternative option to drug-eluting stent (DES) for the treatment of in-stent restenosis (ISR). However, the effect of drug-eluting balloon with regular bare-mental stent (BMS) in de novo coronary artery disease (CAD) is unclear. This meta-analysis aimed to evaluate the efficacy of DEB with regular BMS compared to BMS or DES in de novo CAD.MethodsRandomized controlled trials (RCTs) assessing the efficacy of DEB+BMS in comparison with BMS or DES were obtained by searching the PubMed, EMBASE, and Cochrane Library databases through January 2016. Primary endpoints were major adverse cardiac events (MACEs) and late lumen loss (LLL). Secondary endpoints included death, myocardial infarction (MI), target lesion revascularization (TLR), stent thrombosis (ST), binary restenosis, and minimum lumen diameter (MLD). Dichotomous and continuous data were presented as odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals (CIs), respectively, and analyzed using a random-effects model.ResultsA total of 14 RCTs involving 2281 patients were included in this meta-analysis. DEB+BMS showed significantly less MACEs (OR: 0.67, 95%CI 0.45 to 0.99, P = 0.04) and reduced LLL (MD: -0.30 mm, 95%CI: -0.48 mm to -0.11 mm, P = 0.001) compared with BMS. Meanwhile, treatment with DEB+BMS had disadvantages over DES in terms of MACEs (OR: 1.94, 95%CI 1.24 to 3.05, P = 0.004), LLL (MD: 0.20 mm, 95%CI: 0.07 mm to 0.33 mm, P = 0.003), TLR (OR: 2.53, 95% CI 1.36 to 4.72, P = 0.003), and MLD (MD: -0.25 mm, 95%CI: -0.42 mm to -0.09 mm, P = 0.003).ConclusionsThis limited evidence demonstrated that treatment with DEB+BMS appears to be effective in de novo CAD. In addition, DEB+ BMS clearly showed superiority to BMS, but is inferior to DES in the treatment of patients with de novo CAD. Hence, DES (especially new generation DES) should be recommended for patients with de novo CAD.

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Drug-eluting balloons in patients with non-ST elevation acute coronary syndrome

Abstract: Patients treated with BMS+DEB combination for non-ST elevation acute coronary syndrome had significantly less LLL in comparison to patients treated with BMS alone but without an impact on patient clinical outcomes.

Cited by 15 publications

References 30 publications

Drug-eluting balloons with provisional bail-out or adjunctive stenting in de novo coronary artery lesions—a systematic review and meta-analysis

Drug-eluting balloons with provisional bail-out or adjunctive stenting in de novo coronary artery lesions—a systematic review and meta-analysis

Drug-coated balloon in combination with bare metal stent strategy for de novo coronary artery disease

Drug-eluting balloon versus bare-mental stent and drug-eluting stent for de novo coronary artery disease: A systematic review and meta-analysis of 14 randomized controlled trials

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