Paclitaxel Eluting Balloon After Bare Metal Stent in St Elevation Myocardial Infarction (The Pebsi Study)

Touchard, Arturo García; Goicolea, Javier; Sabaté, Manel; Alfonso, Fernándo; Ruíz-Salmerón, Rafael; Bethencourt, Armando; Gonzalo, Nieves; Miranda, Faustí; Blanco, Bruno García del; Mazuecos, Jesús Jiménez; Melgares-Moreno, Rafael; Martínez-Romero, Pedro; Hernández-García, José M.; Lezáun, R.; Bullones, Juan A.; Fernández-Portales, Javier; Rumoroso, José Ramón; Ortas, Rosario; Chávarri, Mariano Valdés; Trillo, Ramiro

doi:10.1016/s0735-1097(15)61708-9

Cited by 2 publications

(5 citation statements)

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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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“…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%

“…Study and population characteristics are presented in Table 1 . 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 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. Overall, 3 trials enrolled patients with STEMI [ 20 , 23 , 29 ]; in the remaining 11 trials, patients with stable angina, unstable angina or non-ST segment elevation myocardial infarction were enrolled. Concerning lesion subsets, bifurcations [ 19 , 26 ] and simple de novo lesions [ 18 , 20 , 21 , 22 , 23 , 24 , 25 , 27 , 28 , 29 , 30 , 31 ] were all included in this meta-analysis.…”

Section: Resultsmentioning

confidence: 99%

“…Overall, 3 trials enrolled patients with STEMI [ 20 , 23 , 29 ]; in the remaining 11 trials, patients with stable angina, unstable angina or non-ST segment elevation myocardial infarction were enrolled. Concerning lesion subsets, bifurcations [ 19 , 26 ] and simple de novo lesions [ 18 , 20 , 21 , 22 , 23 , 24 , 25 , 27 , 28 , 29 , 30 , 31 ] were all included in this meta-analysis. Clinical follow-up period ranged from 6 to 60 months; the duration of angiographic follow-up varied between 6 and 9 months.…”

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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Paclitaxel Eluting Balloon After Bare Metal Stent in St Elevation Myocardial Infarction (The Pebsi Study)

Cited by 2 publications

References 0 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-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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