Drug-Coated Balloons Versus Second-Generation Drug-Eluting Stents for the Management of Recurrent Multimetal-Layered In-Stent Restenosis

Hiroyoshi Kawamoto, Neil Ruparelia, Azeem Latib, Tadashi Miyazaki, Katsumasa Sato, Antonio Mangieri, Rachele Contri, Stefano Stella, Filippo Figini, Alaide Chieffo, Mauro Carlino, Matteo Montorfano, Antonio Colombo

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Abstract

Objectives This study aimed to investigate the clinical outcomes of patients presenting with recurrent drug-eluting stent (DES) in-stent restenosis (ISR) treated with a second-generation DES or with a drug-coated balloon (DCB). Background To date, there are no reports of DCB treatment and limited data with regard to the efficacy of further DES implantation for recurrent ISR. Methods Between January 2008 and December 2013, 171 lesions were assessed for eligibility (82 lesions in the second-generation DES group and 89 lesions in the DCB group). Results Acute gain was greater in the second-generation DES group (second-generation DES, 2.09 ± 0.53 mm vs. DCBs, 1.60 ± 0.62 mm, p <0.001). The rates of major adverse cardiac events were comparable (at 1 year, DES 14.0% vs. DCBs 12.3%; at 2 years, DES 28.8% vs. DCBs 43.5%, p = 0.21). Major adverse cardiac event rates were mainly driven by target lesion revascularization (at 1 year, DES 12.5% vs. DCBs 10.9%; at 2 years, DES 27.7% vs. DCBs 38.3%; p = 0.40). Definite scaffold thrombosis occurred in 2 patients (1 patient in each group). Multivariable analysis revealed ISR recurrence within 1 year (hazard ratio: 2.43, 95% confidence interval: 1.14 to 5.18, p = 0.02) and lesion length (per 10-mm increase) (hazard ratio: 1.15, 95% confidence interval: 1.00 to 1.32, p = 0.049) to be independent predictors of TLR. Conclusions The results after both treatments were equivalent. ISR recurrence within 1 year of the first reintervention and lesion length were independent predictors of future target lesion revascularization. Larger studies are required to confirm the late (>1 year) differences with regard to clinical outcomes.

Original languageEnglish
Pages (from-to)1586-1594
Number of pages9
JournalJACC: Cardiovascular Interventions
Volume8
Issue number12
DOIs
Publication statusPublished - Oct 1 2015

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Drug-Eluting Stents
Stents
Pharmaceutical Preparations

Keywords

  • drug-coated balloon
  • drug-eluting stent
  • in-stent restenosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Drug-Coated Balloons Versus Second-Generation Drug-Eluting Stents for the Management of Recurrent Multimetal-Layered In-Stent Restenosis. / Kawamoto, Hiroyoshi; Ruparelia, Neil; Latib, Azeem; Miyazaki, Tadashi; Sato, Katsumasa; Mangieri, Antonio; Contri, Rachele; Stella, Stefano; Figini, Filippo; Chieffo, Alaide; Carlino, Mauro; Montorfano, Matteo; Colombo, Antonio.

In: JACC: Cardiovascular Interventions, Vol. 8, No. 12, 01.10.2015, p. 1586-1594.

Research output: Contribution to journalArticle

Kawamoto, Hiroyoshi ; Ruparelia, Neil ; Latib, Azeem ; Miyazaki, Tadashi ; Sato, Katsumasa ; Mangieri, Antonio ; Contri, Rachele ; Stella, Stefano ; Figini, Filippo ; Chieffo, Alaide ; Carlino, Mauro ; Montorfano, Matteo ; Colombo, Antonio. / Drug-Coated Balloons Versus Second-Generation Drug-Eluting Stents for the Management of Recurrent Multimetal-Layered In-Stent Restenosis. In: JACC: Cardiovascular Interventions. 2015 ; Vol. 8, No. 12. pp. 1586-1594.
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abstract = "Objectives This study aimed to investigate the clinical outcomes of patients presenting with recurrent drug-eluting stent (DES) in-stent restenosis (ISR) treated with a second-generation DES or with a drug-coated balloon (DCB). Background To date, there are no reports of DCB treatment and limited data with regard to the efficacy of further DES implantation for recurrent ISR. Methods Between January 2008 and December 2013, 171 lesions were assessed for eligibility (82 lesions in the second-generation DES group and 89 lesions in the DCB group). Results Acute gain was greater in the second-generation DES group (second-generation DES, 2.09 ± 0.53 mm vs. DCBs, 1.60 ± 0.62 mm, p <0.001). The rates of major adverse cardiac events were comparable (at 1 year, DES 14.0{\%} vs. DCBs 12.3{\%}; at 2 years, DES 28.8{\%} vs. DCBs 43.5{\%}, p = 0.21). Major adverse cardiac event rates were mainly driven by target lesion revascularization (at 1 year, DES 12.5{\%} vs. DCBs 10.9{\%}; at 2 years, DES 27.7{\%} vs. DCBs 38.3{\%}; p = 0.40). Definite scaffold thrombosis occurred in 2 patients (1 patient in each group). Multivariable analysis revealed ISR recurrence within 1 year (hazard ratio: 2.43, 95{\%} confidence interval: 1.14 to 5.18, p = 0.02) and lesion length (per 10-mm increase) (hazard ratio: 1.15, 95{\%} confidence interval: 1.00 to 1.32, p = 0.049) to be independent predictors of TLR. Conclusions The results after both treatments were equivalent. ISR recurrence within 1 year of the first reintervention and lesion length were independent predictors of future target lesion revascularization. Larger studies are required to confirm the late (>1 year) differences with regard to clinical outcomes.",
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T1 - Drug-Coated Balloons Versus Second-Generation Drug-Eluting Stents for the Management of Recurrent Multimetal-Layered In-Stent Restenosis

AU - Kawamoto, Hiroyoshi

AU - Ruparelia, Neil

AU - Latib, Azeem

AU - Miyazaki, Tadashi

AU - Sato, Katsumasa

AU - Mangieri, Antonio

AU - Contri, Rachele

AU - Stella, Stefano

AU - Figini, Filippo

AU - Chieffo, Alaide

AU - Carlino, Mauro

AU - Montorfano, Matteo

AU - Colombo, Antonio

PY - 2015/10/1

Y1 - 2015/10/1

N2 - Objectives This study aimed to investigate the clinical outcomes of patients presenting with recurrent drug-eluting stent (DES) in-stent restenosis (ISR) treated with a second-generation DES or with a drug-coated balloon (DCB). Background To date, there are no reports of DCB treatment and limited data with regard to the efficacy of further DES implantation for recurrent ISR. Methods Between January 2008 and December 2013, 171 lesions were assessed for eligibility (82 lesions in the second-generation DES group and 89 lesions in the DCB group). Results Acute gain was greater in the second-generation DES group (second-generation DES, 2.09 ± 0.53 mm vs. DCBs, 1.60 ± 0.62 mm, p <0.001). The rates of major adverse cardiac events were comparable (at 1 year, DES 14.0% vs. DCBs 12.3%; at 2 years, DES 28.8% vs. DCBs 43.5%, p = 0.21). Major adverse cardiac event rates were mainly driven by target lesion revascularization (at 1 year, DES 12.5% vs. DCBs 10.9%; at 2 years, DES 27.7% vs. DCBs 38.3%; p = 0.40). Definite scaffold thrombosis occurred in 2 patients (1 patient in each group). Multivariable analysis revealed ISR recurrence within 1 year (hazard ratio: 2.43, 95% confidence interval: 1.14 to 5.18, p = 0.02) and lesion length (per 10-mm increase) (hazard ratio: 1.15, 95% confidence interval: 1.00 to 1.32, p = 0.049) to be independent predictors of TLR. Conclusions The results after both treatments were equivalent. ISR recurrence within 1 year of the first reintervention and lesion length were independent predictors of future target lesion revascularization. Larger studies are required to confirm the late (>1 year) differences with regard to clinical outcomes.

AB - Objectives This study aimed to investigate the clinical outcomes of patients presenting with recurrent drug-eluting stent (DES) in-stent restenosis (ISR) treated with a second-generation DES or with a drug-coated balloon (DCB). Background To date, there are no reports of DCB treatment and limited data with regard to the efficacy of further DES implantation for recurrent ISR. Methods Between January 2008 and December 2013, 171 lesions were assessed for eligibility (82 lesions in the second-generation DES group and 89 lesions in the DCB group). Results Acute gain was greater in the second-generation DES group (second-generation DES, 2.09 ± 0.53 mm vs. DCBs, 1.60 ± 0.62 mm, p <0.001). The rates of major adverse cardiac events were comparable (at 1 year, DES 14.0% vs. DCBs 12.3%; at 2 years, DES 28.8% vs. DCBs 43.5%, p = 0.21). Major adverse cardiac event rates were mainly driven by target lesion revascularization (at 1 year, DES 12.5% vs. DCBs 10.9%; at 2 years, DES 27.7% vs. DCBs 38.3%; p = 0.40). Definite scaffold thrombosis occurred in 2 patients (1 patient in each group). Multivariable analysis revealed ISR recurrence within 1 year (hazard ratio: 2.43, 95% confidence interval: 1.14 to 5.18, p = 0.02) and lesion length (per 10-mm increase) (hazard ratio: 1.15, 95% confidence interval: 1.00 to 1.32, p = 0.049) to be independent predictors of TLR. Conclusions The results after both treatments were equivalent. ISR recurrence within 1 year of the first reintervention and lesion length were independent predictors of future target lesion revascularization. Larger studies are required to confirm the late (>1 year) differences with regard to clinical outcomes.

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