Dataset Information

Comparison of Drug-Eluting Balloon Followed by Bare Metal Stent with Drug-Eluting Stent for Treatment of de Novo Lesions: Randomized, Controlled, Single-Center Clinical Trial.

ABSTRACT: The combined use of a drug-eluting balloon (DEB) and a bare metal stent (BMS) for the treatment of de novo non-small vessel coronary artery diseases (CAD) remains to be evaluated. We investigated the efficacy of a sequential treatment using a DEB together with a BMS implantation in comparison to a zotarolimus-eluting stent (ZES). This study was a prospective, randomized, open-label study. We designed it to demonstrate the non-inferiority of a sequential treatment using a DEB first followed by a BMS (DEB + BMS) compared with the use of a ZES. The primary endpoint was in-segment late loss (LL) at 9 months measured by quantitative coronary angiography (QCA). A total of 180 patients were enrolled in the study. The 9-month follow-up angiography was performed in 72 patients with DEB + BMS and 74 patients with ZES. When comparing the DEB + BMS results with the ZES ones, LL was 0.50 ± 0.46 mm in DEB + BMS patients vs. 0.21 ± 0.44 mm in ZES patients (P < 0.001). The mean difference of the LL was 0.31 mm, which was larger than the prespecified non-inferiority margin of 0.19 mm, and the 2-sided 95% confidence interval was 0.15-0.48. The clinical outcomes were not significantly different. In conclusion, the DEB + BMS strategy is inferior to the ZES one in terms of the LL result at 9 months. The DEB strategy for de novo coronary artery lesions needs to be improved for it to become an alternative treatment option.

SUBMITTER: Chae IH

PROVIDER: S-EPMC5426232 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Comparison of Drug-Eluting Balloon Followed by Bare Metal Stent with Drug-Eluting Stent for Treatment of de Novo Lesions: Randomized, Controlled, Single-Center Clinical Trial.

Chae In Ho IH Yoon Chang Hwan CH Park Jin Joo JJ Oh Il Young IY Suh Jung Won JW Cho Young Seok YS Youn Tae Jin TJ Choi Dong Ju DJ

Journal of Korean medical science 20170601 6

The combined use of a drug-eluting balloon (DEB) and a bare metal stent (BMS) for the treatment of de novo non-small vessel coronary artery diseases (CAD) remains to be evaluated. We investigated the efficacy of a sequential treatment using a DEB together with a BMS implantation in comparison to a zotarolimus-eluting stent (ZES). This study was a prospective, randomized, open-label study. We designed it to demonstrate the non-inferiority of a sequential treatment using a DEB first followed by a ...[more]

PMID: 28480650

Similar Datasets

Project description:Neointimal hyperplasia plays a pivotal role in the pathogenesis of in-stent restenosis in patients undergoing percutaneous coronary interventions. Drug-eluting balloons are a promising tool to prevent restenosis after coronary angioplasty. Moreover, an increased knowledge of the pathophysiology of restenosis my help improve therapeutic strategies.We present the design of an open-label, randomized three-arm clinical trial aimed to assess whether a strategy of bare-metal stent implantation with additional use of drug-eluting balloons, either before (pre-dilation) or after stenting (post-dilation), reduces the primary endpoint of in-stent neointimal hyperplasia area as compared with a strategy of bare-metal stent implantation alone. This primary endpoint will be assessed by optical coherence tomography at follow-up. Secondary endpoints will be the percentage of uncovered struts, and the percentage of struts with incomplete apposition. An ancillary study investigating the relation between systemic levels of endothelial progenitors cells and neointimal hyperplasia, and the interaction between endothelial progenitors cell levels and drug-eluting balloons has been planned. Thirty consecutive patients undergoing percutaneous coronary intervention will be randomized with a 1:1:1 design to bare-metal stent implantation alone (n?=?10); bare-metal stent implantation after pre-dilation with a drug-eluting balloon (n?=?10); or bare-metal stent implantation followed by post-dilation with a drug-eluting balloon (n?=?10). Six-month follow-up coronary angiography with optical coherence tomography imaging of the stented segment will be performed in all patients. Blood samples for the assessment of endothelial progenitors cell levels will be collected on admission and at 6?months.Experimental and early clinical data showed that inhibition of neointimal hyperplasia may be obtained by local administration of antiproliferative drugs loaded on the surface of angioplasty balloons. The INtimal hyPerplasia evAluated by oCT in de novo COROnary lesions treated by drug-eluting balloon and bare-metal stent (IN-PACT CORO) trial was conceived to test the superiority of a strategy of bare-metal stent implantation with additional drug-eluting balloon use (either before or after stenting) versus a strategy of bare-metal stent implantation alone for the reduction of neointimal hyperplasia. We also planned an ancillary study to assess the role of endothelial progenitors cells in the pathophysiology of neointimal hyperplasia.Clinicaltrials.gov NCT01057563.

Project description:BackgroundDrug-coated balloon as a novel therapeutic strategy has been used to treat restenosis in cases of bare metal and drug-eluting stents. However, evidence of its safety and efficacy is scarce in de novo small coronary artery vessel disease. This meta-analysis aimed to compare the safety and efficacy of the drug-coated balloon and the drug-eluting stent.MethodsThe PubMed, EMBASE, Web of Science, and Cochrane library databases were searched for studies published up to October 17, 2018. Studies comparing the drug-coated balloon with the drug-eluting stent strategy in patients with de novo small coronary artery vessel disease (reference diameter, <3 mm) were identified. The clinical outcomes were nonfatal myocardial infarction, cardiac death, all-cause death, target lesion revascularization, and target-vessel revascularization. Data were analyzed using the statistical software RevMan (version 5.3). Fixed effects models were performed to calculate the pooled odds ratios (ORs) and 95% confidence intervals (95% CIs). Sensitivity analyses were used to detect potential sources of heterogeneity, while subgroup analyses were implemented to assess the differential effects.ResultsThree randomized controlled trials and 3 nonrandomized controlled studies were identified. Six studies including a total of 1800 patients compared the differences between the drug-coated balloon and the drug-eluting stent strategies in patients with de novo small coronary artery vessel disease. The results indicated that the drug-coated balloon strategy was associated with a significant reduction in nonfatal myocardial infarction (OR 0.53, 95% CI 0.31-0.90, P = .02) compared with the drug-eluting stent strategy, while insignificant inter-strategy differences were observed in cardiac death (OR 1.56, 95% CI 0.73-3.33, P = .25), all-cause death (OR 0.56, 95% CI 0.25-1.23, P = .15), target lesion revascularization (OR 1.24, 95% CI 0.73-2.1, P = .43), and target-vessel revascularization (OR 0.95, 95% CI 0.59-1.52, P = .84).ConclusionsThis meta-analysis suggests that the drug-coated balloon strategy is noninferior to the drug-eluting stent strategy, delivering a good outcome in nonfatal myocardial infarction, and can be recommended as an optimal treatment strategy in patients with de novo small coronary artery vessel disease. Larger randomized controlled studies with longer follow-up periods are needed to further confirm the benefits of the drug-coated balloon strategy.

Project description:The role of drug-eluting balloons (DEB) is unclear. Increasing evidence has shown a benefit for the treatment of in-stent restenosis. Its effect on de novo coronary lesions is more controversial. Several smaller randomized trials found conflicting results.This is a systematic review and meta-analysis of randomized controlled trials (RCT) evaluating the effect of local Paclitaxel delivery/drug eluting balloons (DEB) (+/- bare metal stent) compared to current standard therapy (stenting) to treat de novo coronary lesions. Data sources for RCT were identified through a literature search from 2005 through 28 December 2012. The main endpoints of interest were target lesion revascularization (TLR), major adverse cardiac events (MACE), binary in-segment restenosis, stent thrombosis (ST), myocardial infarction (MI), late lumen loss (LLL) and mortality. A random effects model was used to calculate the pooled relative risks (RR) with 95% confidence intervals.Eight studies (11 subgroups) and a total of 1,706 patients were included in this analysis. Follow-up duration ranged from 6 to 12 months. Overall, DEB showed similar results to the comparator treatment. The relative risk (RR) for MACE was 0.95 (0.64 to 1.39); P = 0.776, for mortality it was 0.79 (0.30 to 2.11), P = 0.644, for stent thrombosis it was 1.45 (0.42 to 5.01), P = 0.560, for MI it was 1.26 (0.49 to 3.21), P = 0.629, for TLR it was 1.09 (0.71 to 1.68); P = 0.700 and for binary in-stent restenosis it was 0.96 (0.48 to 1.93), P = 0.918. Compared to bare metal stents (BMS), DEB showed a lower LLL (- 0.26 mm (-0.51 to 0.01)) and a trend towards a lower MACE risk (RR 0.66 (0.43 to 1.02)).Overall, drug-eluting balloons (+/- bare metal stent) are not superior to current standard therapies (BMS or drug eluting stent (DES)) in treating de novo coronary lesions. However, the performance of DEB seems to lie in between DES and BMS with a trend towards superiority over BMS alone. Therefore, DEB may be considered in patients with contraindications for DES. The heterogeneity between the included studies is a limitation of this meta-analysis; different drug-eluting balloons have been used.

Dataset Information

Comparison of Drug-Eluting Balloon Followed by Bare Metal Stent with Drug-Eluting Stent for Treatment of de Novo Lesions: Randomized, Controlled, Single-Center Clinical Trial.

Publications

Comparison of Drug-Eluting Balloon Followed by Bare Metal Stent with Drug-Eluting Stent for Treatment of de Novo Lesions: Randomized, Controlled, Single-Center Clinical Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure