Drug-eluting balloon versus second generation drug eluting stents in the treatment of in-stent restenosis: a systematic review and meta-analysis

Kevin Liou, Nigel Jepson, Christopher Cao, Roger Luo, Sarvpreet Pala, Sze-Yuan Ooi

Research output: Contribution to journalReview articleResearchpeer-review

Abstract

Background In-stent restenosis (ISR) remains a significant mode of stent failure following PCI. The optimal treatment strategy, however, remains undefined and the role of drug-eluting balloons (DEB) in the management of ISR is also unclear.

Methods A meta-analysis was performed to compare the efficacy of DEB in the treatment of ISR against second generation drug eluting stents (DES).

Results Seven studies comprised of 1,065 patients were included for analysis. The follow-up period ranged from 12-25 months. The use of DEB was associated with an inferior acute gain in minimal luminal diameter (MLD) (0.36, 95% CI: 0.16-0.57 mm), higher late loss in MLD (0.11, 0.02-0.19 mm) and a higher binary restenosis rate at follow-up (risk ratio: 2.24, 1.49-3.37). No significant differences were noted in the overall incidence of the analysed clinical parameters between the two groups. When only the randomised controlled trials (RCT) were considered however, there was a strong trend towards higher target lesion revascularisation (TLR; 9.9% vs. 3.6%; RR: 2.5, p=0.07) and a significantly higher major adverse cardiovascular event (MACE) rate (15.7% vs. 8.8%; RR 1.78; p=0.02) with DEB.

Conclusion While equipoise has been demonstrated in selected clinical outcomes between DEB and second generation DES in the treatment of ISR, the suboptimal angiographic outcome at follow-up and the higher TLR and MACE rates associated with DEB observed in the RCT are concerning. The results of the present analysis should be regarded as preliminary, although the generalised adoption of DEB in the treatment of ISR currently cannot be recommended.

LanguageEnglish
Pages1184-1194
Number of pages11
JournalHeart Lung and Circulation
Volume25
Issue number12
DOIs
Publication statusPublished - Dec 2016

Keywords

  • Drug eluting balloon
  • Drug eluting stent
  • In-stent restenosis
  • Coronary artery disease
  • Percutaneous coronary intervention
  • Outcome assessment

Cite this

Liou, Kevin ; Jepson, Nigel ; Cao, Christopher ; Luo, Roger ; Pala, Sarvpreet ; Ooi, Sze-Yuan. / Drug-eluting balloon versus second generation drug eluting stents in the treatment of in-stent restenosis : a systematic review and meta-analysis. In: Heart Lung and Circulation. 2016 ; Vol. 25, No. 12. pp. 1184-1194.
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title = "Drug-eluting balloon versus second generation drug eluting stents in the treatment of in-stent restenosis: a systematic review and meta-analysis",
abstract = "Background In-stent restenosis (ISR) remains a significant mode of stent failure following PCI. The optimal treatment strategy, however, remains undefined and the role of drug-eluting balloons (DEB) in the management of ISR is also unclear.Methods A meta-analysis was performed to compare the efficacy of DEB in the treatment of ISR against second generation drug eluting stents (DES).Results Seven studies comprised of 1,065 patients were included for analysis. The follow-up period ranged from 12-25 months. The use of DEB was associated with an inferior acute gain in minimal luminal diameter (MLD) (0.36, 95{\%} CI: 0.16-0.57 mm), higher late loss in MLD (0.11, 0.02-0.19 mm) and a higher binary restenosis rate at follow-up (risk ratio: 2.24, 1.49-3.37). No significant differences were noted in the overall incidence of the analysed clinical parameters between the two groups. When only the randomised controlled trials (RCT) were considered however, there was a strong trend towards higher target lesion revascularisation (TLR; 9.9{\%} vs. 3.6{\%}; RR: 2.5, p=0.07) and a significantly higher major adverse cardiovascular event (MACE) rate (15.7{\%} vs. 8.8{\%}; RR 1.78; p=0.02) with DEB.Conclusion While equipoise has been demonstrated in selected clinical outcomes between DEB and second generation DES in the treatment of ISR, the suboptimal angiographic outcome at follow-up and the higher TLR and MACE rates associated with DEB observed in the RCT are concerning. The results of the present analysis should be regarded as preliminary, although the generalised adoption of DEB in the treatment of ISR currently cannot be recommended.",
keywords = "Drug eluting balloon, Drug eluting stent, In-stent restenosis, Coronary artery disease, Percutaneous coronary intervention, Outcome assessment",
author = "Kevin Liou and Nigel Jepson and Christopher Cao and Roger Luo and Sarvpreet Pala and Sze-Yuan Ooi",
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Drug-eluting balloon versus second generation drug eluting stents in the treatment of in-stent restenosis : a systematic review and meta-analysis. / Liou, Kevin; Jepson, Nigel; Cao, Christopher; Luo, Roger; Pala, Sarvpreet; Ooi, Sze-Yuan.

In: Heart Lung and Circulation, Vol. 25, No. 12, 12.2016, p. 1184-1194.

Research output: Contribution to journalReview articleResearchpeer-review

TY - JOUR

T1 - Drug-eluting balloon versus second generation drug eluting stents in the treatment of in-stent restenosis

T2 - Heart Lung and Circulation

AU - Liou, Kevin

AU - Jepson, Nigel

AU - Cao, Christopher

AU - Luo, Roger

AU - Pala, Sarvpreet

AU - Ooi, Sze-Yuan

PY - 2016/12

Y1 - 2016/12

N2 - Background In-stent restenosis (ISR) remains a significant mode of stent failure following PCI. The optimal treatment strategy, however, remains undefined and the role of drug-eluting balloons (DEB) in the management of ISR is also unclear.Methods A meta-analysis was performed to compare the efficacy of DEB in the treatment of ISR against second generation drug eluting stents (DES).Results Seven studies comprised of 1,065 patients were included for analysis. The follow-up period ranged from 12-25 months. The use of DEB was associated with an inferior acute gain in minimal luminal diameter (MLD) (0.36, 95% CI: 0.16-0.57 mm), higher late loss in MLD (0.11, 0.02-0.19 mm) and a higher binary restenosis rate at follow-up (risk ratio: 2.24, 1.49-3.37). No significant differences were noted in the overall incidence of the analysed clinical parameters between the two groups. When only the randomised controlled trials (RCT) were considered however, there was a strong trend towards higher target lesion revascularisation (TLR; 9.9% vs. 3.6%; RR: 2.5, p=0.07) and a significantly higher major adverse cardiovascular event (MACE) rate (15.7% vs. 8.8%; RR 1.78; p=0.02) with DEB.Conclusion While equipoise has been demonstrated in selected clinical outcomes between DEB and second generation DES in the treatment of ISR, the suboptimal angiographic outcome at follow-up and the higher TLR and MACE rates associated with DEB observed in the RCT are concerning. The results of the present analysis should be regarded as preliminary, although the generalised adoption of DEB in the treatment of ISR currently cannot be recommended.

AB - Background In-stent restenosis (ISR) remains a significant mode of stent failure following PCI. The optimal treatment strategy, however, remains undefined and the role of drug-eluting balloons (DEB) in the management of ISR is also unclear.Methods A meta-analysis was performed to compare the efficacy of DEB in the treatment of ISR against second generation drug eluting stents (DES).Results Seven studies comprised of 1,065 patients were included for analysis. The follow-up period ranged from 12-25 months. The use of DEB was associated with an inferior acute gain in minimal luminal diameter (MLD) (0.36, 95% CI: 0.16-0.57 mm), higher late loss in MLD (0.11, 0.02-0.19 mm) and a higher binary restenosis rate at follow-up (risk ratio: 2.24, 1.49-3.37). No significant differences were noted in the overall incidence of the analysed clinical parameters between the two groups. When only the randomised controlled trials (RCT) were considered however, there was a strong trend towards higher target lesion revascularisation (TLR; 9.9% vs. 3.6%; RR: 2.5, p=0.07) and a significantly higher major adverse cardiovascular event (MACE) rate (15.7% vs. 8.8%; RR 1.78; p=0.02) with DEB.Conclusion While equipoise has been demonstrated in selected clinical outcomes between DEB and second generation DES in the treatment of ISR, the suboptimal angiographic outcome at follow-up and the higher TLR and MACE rates associated with DEB observed in the RCT are concerning. The results of the present analysis should be regarded as preliminary, although the generalised adoption of DEB in the treatment of ISR currently cannot be recommended.

KW - Drug eluting balloon

KW - Drug eluting stent

KW - In-stent restenosis

KW - Coronary artery disease

KW - Percutaneous coronary intervention

KW - Outcome assessment

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U2 - 10.1016/j.hlc.2016.04.001

DO - 10.1016/j.hlc.2016.04.001

M3 - Review article

VL - 25

SP - 1184

EP - 1194

JO - Heart Lung and Circulation

JF - Heart Lung and Circulation

SN - 1443-9506

IS - 12

ER -