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Drug eluting balloons for de novo coronary lesions - a systematic review and meta-analysis.

ABSTRACT: 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.

SUBMITTER: Frohlich GM

PROVIDER: S-EPMC3648374 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature

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Drug eluting balloons for de novo coronary lesions - a systematic review and meta-analysis.

Fröhlich Georg M GM Lansky Alexandra J AJ Ko Dennis T DT Archangelidi Olga O De Palma Rodney R Timmis Adam A Meier Pascal P

BMC medicine 20130508

<h4>Background</h4>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.<h4>Methods</h4>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 sta ...[more]

PMID: 23657123

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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:BackgroundOutcomes of percutaneous coronary intervention for diffuse long lesions remain relatively unfavorable. Prior clinical trials investigated the relative efficacy and safety of different types of drug-eluting stents (DES) in long lesions.ObjectivesThis study sought to compare the relative performance of different types of DES for de novo long (≥25 mm) coronary artery lesions.MethodsUsing a pooled analysis of individual data of 1,450 patients from 3 randomized clinical trials, we compared angiographic and clinical outcomes of 5 different types of DES: 224 patients with cobalt-chromium everolimus-eluting stents (EES), 255 with platinum-chromium EES, 250 with Resolute zotarolimus-eluting stents, 245 with biodegradable polymer biolimus-eluting stents, and 476 with first-generation sirolimus-eluting stents (SES). The primary endpoint was in-segment late lumen loss at 9 months.ResultsThe primary endpoint was not significantly different between 4 second-generation DES and 1 first-generation SES (0.17 ± 0.41 mm in cobalt-chromium EES; 0.11 ± 0.37 in platinum-chromium EES: 0.14 ± 0.38 in Resolute zotarolimus-eluting stents; 0.14 ± 0.38 in biodegradable polymer biolimus-eluting stents; or 0.10 ± 0.37 in SES, respectively, overall P = 0.38). Also, there were no significant between-group differences with respect to death, myocardial infarction, target-vessel revascularization, or stent thrombosis at 12 months. In the multiple treatment propensity-score analysis, the risk of angiographic and clinical outcomes was also similar among several types of DES.ConclusionsIn this patient-level pooled analysis, several second-generation DES showed similar angiographic and clinical outcomes in patients with de novo long coronary lesions. (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III [LONG-DES-III]; NCT01078038; Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV [LONG-DES-IV]; NCT01186094; and Everolimus-eluting [PROMUS-ELEMENT] vs. Biolimus A9-Eluting [NOBORI] Stents for Long-Coronary Lesions [LONG-DES-V]; NCT01186120).

Project description:Background: At present, there are a variety of treatment strategies for percutaneous coronary intervention. The role of drug-coated balloon (DCB) in the treatment of side branch for de novo coronary bifurcated lesions (CBL) is unclear. Objective: To examine the effect of DCB in side branch protection for de novo CBL. Methods: Electronic databases, including Pubmed, Embase, the Web of science, Cochrance library, CNKI, CBM, WanFang Data and VIP were searched for studies that compared DCB with non-drug-coated balloon (NDCB) in side branch protection for de novo CBL from inception through July 7th, 2021. The primary outcome was target lesion revascularization (TLR). Secondary clinical outcomes included myocardial infarction (MI), cardiac death (CD). The angiographic outcomes included side branch late lumen loss (LLL), minimum lumen diameter (MLD), diameter stenosis (DS) and binary restenosis (BR). The target lesion failure (TLF) was also analyzed. Results: A total of 10 studies, including 5 randomized controlled trials and 5 non-randomized observational studies, with 934 patients were included. Meta-analysis results of angiographic outcomes suggested that DCB group had the less LLL, DS and BR and the higher MLD compared with NDCB group at follow-up (P < 0.05). Meta-analysis results of clinical outcomes suggested that the significant difference in the TLR, MI and CD between DCB group and NDCB group has not been found yet (P > 0.05). However, the MACE of DCB group was significantly less than that of NDCB group at 9-month follow-up [OR = 0.21, 95%CI (0.05, 0.84), P = 0.03] and 12-month follow-up [OR = 0.45, 95%CI (0.22, 0.90), P = 0.02]. In addition, there was no significant difference in TLF between DCB group and NDCB group (P > 0.05). Conclusions: DCB had great effect in side branch protection for de novo CBL at short and medium-term follow-up with no reduction in the procedural success rate. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=267426, PROSPERO [Identifier: CRD42021267426].

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Drug eluting balloons for de novo coronary lesions - a systematic review and meta-analysis.

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Drug eluting balloons for de novo coronary lesions - a systematic review and meta-analysis.

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