Impact of Optimized Procedure-Related Factors in Drug-Eluting Balloon Angioplasty for Treatment of In-Stent Restenosis

Tae Min Rhee; Joo Myung Lee; Eun Seok Shin; Doyeon Hwang; Jonghanne Park; Ki Hyun Jeon; Hack Lyoung Kim; Han Mo Yang; Jung Kyu Han; Kyung Woo Park; Joo Yong Hahn; Bon Kwon Koo; Sang Hyun Kim; Hyo Soo Kim

doi:10.1016/j.jcin.2018.02.002

Impact of Optimized Procedure-Related Factors in Drug-Eluting Balloon Angioplasty for Treatment of In-Stent Restenosis

Tae Min Rhee
, Joo Myung Lee
, Eun Seok Shin
, Doyeon Hwang
, Jonghanne Park
, Ki Hyun Jeon
, Hack Lyoung Kim
, Han Mo Yang
, Jung Kyu Han
, Kyung Woo Park
, Joo Yong Hahn
, Bon Kwon Koo
, Sang Hyun Kim
, Hyo Soo Kim

Department of Internal Medicine

Seoul National University
Sungkyunkwan University
University of Ulsan
Sejong General Hospital

Research output: Contribution to journal › Article › peer-review

60 Scopus citations

Abstract

Objectives: The aim of this study was to investigate the impact of optimizing procedure-related factors during drug-eluting balloon (DEB) angioplasty on clinical outcomes of drug-eluting stent in-stent restenosis (ISR). Background: Although DEB angioplasty is recommended as a reasonable option for ISR, recurrent target lesion failure (TLF) still occurs in many patients after DEB angioplasty. Methods: Consecutive patients with drug-eluting stent ISR treated with DEB (SeQuent Please) were collected from 4 centers in Korea. The primary outcome was 2-year TLF. Procedure-related modifiable independent predictors for TLF and their best cutoff values were determined. Results: In a total of 256 patients (309 lesions), TLF occurred in 52 patients (20.3%). Modifiable independent predictors of TLF among procedure-related factors were residual diameter stenosis after lesion preparation (residual percentage diameter stenosis [%DS]), DEB-to-stent ratio (BSR), and DEB inflation time (T_inflation), whose best cutoff values were 20%, 0.91, and 60 s, respectively. TLF rates were significantly higher in groups with residual %DS ≥20% (34.7% vs. 12.5%; adjusted hazard ratio: 2.15; 95% confidence interval: 1.86 to 2.48; p < 0.001), BSR ≤0.91 (46.4% vs. 21.9%; adjusted hazard ratio: 2.02; 95% confidence interval: 1.75 to 2.34; p < 0.001), and T_inflation ≤60 s (26.2% vs. 14.0%; adjusted hazard ratio: 1.82; 95% confidence interval: 1.36 to 2.45; p < 0.001). When classifying ISR lesions by combination of procedure-related factors, TLF occurred in 8.3% in the fully optimized procedure group (residual %DS <20%, BSR >0.91, and T_inflation >60 s) and 66.7% in the nonoptimized group (residual %DS ≥20%, BSR ≤0.91, and T_inflation ≤60 s) (p < 0.001). Conclusions: Residual %DS after lesion preparation, BSR, and T_inflation were the only modifiable procedure-related factors in DEB angioplasty. Fully optimized DEB angioplasty with optimal lesion preparation, prolonged inflation, and sufficient dilation may play an important role in reducing TLF after DEB angioplasty.

Original language	English
Pages (from-to)	969-978
Number of pages	10
Journal	JACC: Cardiovascular Interventions
Volume	11
Issue number	10
DOIs	https://doi.org/10.1016/j.jcin.2018.02.002
State	Published - 28 May 2018

Keywords

drug-eluting balloon
in-stent restenosis
paclitaxel-coated balloon
percutaneous coronary intervention
target lesion failure

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10.1016/j.jcin.2018.02.002

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Rhee, T. M., Lee, J. M., Shin, E. S., Hwang, D., Park, J., Jeon, K. H., Kim, H. L., Yang, H. M., Han, J. K., Park, K. W., Hahn, J. Y., Koo, B. K., Kim, S. H., & Kim, H. S. (2018). Impact of Optimized Procedure-Related Factors in Drug-Eluting Balloon Angioplasty for Treatment of In-Stent Restenosis. JACC: Cardiovascular Interventions, 11(10), 969-978. https://doi.org/10.1016/j.jcin.2018.02.002

@article{ef204ec0611a4df5b505c6404dbd8bed,

title = "Impact of Optimized Procedure-Related Factors in Drug-Eluting Balloon Angioplasty for Treatment of In-Stent Restenosis",

abstract = "Objectives: The aim of this study was to investigate the impact of optimizing procedure-related factors during drug-eluting balloon (DEB) angioplasty on clinical outcomes of drug-eluting stent in-stent restenosis (ISR). Background: Although DEB angioplasty is recommended as a reasonable option for ISR, recurrent target lesion failure (TLF) still occurs in many patients after DEB angioplasty. Methods: Consecutive patients with drug-eluting stent ISR treated with DEB (SeQuent Please) were collected from 4 centers in Korea. The primary outcome was 2-year TLF. Procedure-related modifiable independent predictors for TLF and their best cutoff values were determined. Results: In a total of 256 patients (309 lesions), TLF occurred in 52 patients (20.3\%). Modifiable independent predictors of TLF among procedure-related factors were residual diameter stenosis after lesion preparation (residual percentage diameter stenosis [\%DS]), DEB-to-stent ratio (BSR), and DEB inflation time (Tinflation), whose best cutoff values were 20\%, 0.91, and 60 s, respectively. TLF rates were significantly higher in groups with residual \%DS ≥20\% (34.7\% vs. 12.5\%; adjusted hazard ratio: 2.15; 95\% confidence interval: 1.86 to 2.48; p < 0.001), BSR ≤0.91 (46.4\% vs. 21.9\%; adjusted hazard ratio: 2.02; 95\% confidence interval: 1.75 to 2.34; p < 0.001), and Tinflation ≤60 s (26.2\% vs. 14.0\%; adjusted hazard ratio: 1.82; 95\% confidence interval: 1.36 to 2.45; p < 0.001). When classifying ISR lesions by combination of procedure-related factors, TLF occurred in 8.3\% in the fully optimized procedure group (residual \%DS <20\%, BSR >0.91, and Tinflation >60 s) and 66.7\% in the nonoptimized group (residual \%DS ≥20\%, BSR ≤0.91, and Tinflation ≤60 s) (p < 0.001). Conclusions: Residual \%DS after lesion preparation, BSR, and Tinflation were the only modifiable procedure-related factors in DEB angioplasty. Fully optimized DEB angioplasty with optimal lesion preparation, prolonged inflation, and sufficient dilation may play an important role in reducing TLF after DEB angioplasty.",

keywords = "drug-eluting balloon, in-stent restenosis, paclitaxel-coated balloon, percutaneous coronary intervention, target lesion failure",

author = "Rhee, \{Tae Min\} and Lee, \{Joo Myung\} and Shin, \{Eun Seok\} and Doyeon Hwang and Jonghanne Park and Jeon, \{Ki Hyun\} and Kim, \{Hack Lyoung\} and Yang, \{Han Mo\} and Han, \{Jung Kyu\} and Park, \{Kyung Woo\} and Hahn, \{Joo Yong\} and Koo, \{Bon Kwon\} and Kim, \{Sang Hyun\} and Kim, \{Hyo Soo\}",

note = "Publisher Copyright: {\textcopyright} 2018",

year = "2018",

month = may,

day = "28",

doi = "10.1016/j.jcin.2018.02.002",

language = "English",

volume = "11",

pages = "969--978",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "10",

}

TY - JOUR

T1 - Impact of Optimized Procedure-Related Factors in Drug-Eluting Balloon Angioplasty for Treatment of In-Stent Restenosis

AU - Rhee, Tae Min

AU - Lee, Joo Myung

AU - Shin, Eun Seok

AU - Hwang, Doyeon

AU - Park, Jonghanne

AU - Jeon, Ki Hyun

AU - Kim, Hack Lyoung

AU - Yang, Han Mo

AU - Han, Jung Kyu

AU - Park, Kyung Woo

AU - Hahn, Joo Yong

AU - Koo, Bon Kwon

AU - Kim, Sang Hyun

AU - Kim, Hyo Soo

PY - 2018/5/28

Y1 - 2018/5/28

N2 - Objectives: The aim of this study was to investigate the impact of optimizing procedure-related factors during drug-eluting balloon (DEB) angioplasty on clinical outcomes of drug-eluting stent in-stent restenosis (ISR). Background: Although DEB angioplasty is recommended as a reasonable option for ISR, recurrent target lesion failure (TLF) still occurs in many patients after DEB angioplasty. Methods: Consecutive patients with drug-eluting stent ISR treated with DEB (SeQuent Please) were collected from 4 centers in Korea. The primary outcome was 2-year TLF. Procedure-related modifiable independent predictors for TLF and their best cutoff values were determined. Results: In a total of 256 patients (309 lesions), TLF occurred in 52 patients (20.3%). Modifiable independent predictors of TLF among procedure-related factors were residual diameter stenosis after lesion preparation (residual percentage diameter stenosis [%DS]), DEB-to-stent ratio (BSR), and DEB inflation time (Tinflation), whose best cutoff values were 20%, 0.91, and 60 s, respectively. TLF rates were significantly higher in groups with residual %DS ≥20% (34.7% vs. 12.5%; adjusted hazard ratio: 2.15; 95% confidence interval: 1.86 to 2.48; p < 0.001), BSR ≤0.91 (46.4% vs. 21.9%; adjusted hazard ratio: 2.02; 95% confidence interval: 1.75 to 2.34; p < 0.001), and Tinflation ≤60 s (26.2% vs. 14.0%; adjusted hazard ratio: 1.82; 95% confidence interval: 1.36 to 2.45; p < 0.001). When classifying ISR lesions by combination of procedure-related factors, TLF occurred in 8.3% in the fully optimized procedure group (residual %DS <20%, BSR >0.91, and Tinflation >60 s) and 66.7% in the nonoptimized group (residual %DS ≥20%, BSR ≤0.91, and Tinflation ≤60 s) (p < 0.001). Conclusions: Residual %DS after lesion preparation, BSR, and Tinflation were the only modifiable procedure-related factors in DEB angioplasty. Fully optimized DEB angioplasty with optimal lesion preparation, prolonged inflation, and sufficient dilation may play an important role in reducing TLF after DEB angioplasty.

AB - Objectives: The aim of this study was to investigate the impact of optimizing procedure-related factors during drug-eluting balloon (DEB) angioplasty on clinical outcomes of drug-eluting stent in-stent restenosis (ISR). Background: Although DEB angioplasty is recommended as a reasonable option for ISR, recurrent target lesion failure (TLF) still occurs in many patients after DEB angioplasty. Methods: Consecutive patients with drug-eluting stent ISR treated with DEB (SeQuent Please) were collected from 4 centers in Korea. The primary outcome was 2-year TLF. Procedure-related modifiable independent predictors for TLF and their best cutoff values were determined. Results: In a total of 256 patients (309 lesions), TLF occurred in 52 patients (20.3%). Modifiable independent predictors of TLF among procedure-related factors were residual diameter stenosis after lesion preparation (residual percentage diameter stenosis [%DS]), DEB-to-stent ratio (BSR), and DEB inflation time (Tinflation), whose best cutoff values were 20%, 0.91, and 60 s, respectively. TLF rates were significantly higher in groups with residual %DS ≥20% (34.7% vs. 12.5%; adjusted hazard ratio: 2.15; 95% confidence interval: 1.86 to 2.48; p < 0.001), BSR ≤0.91 (46.4% vs. 21.9%; adjusted hazard ratio: 2.02; 95% confidence interval: 1.75 to 2.34; p < 0.001), and Tinflation ≤60 s (26.2% vs. 14.0%; adjusted hazard ratio: 1.82; 95% confidence interval: 1.36 to 2.45; p < 0.001). When classifying ISR lesions by combination of procedure-related factors, TLF occurred in 8.3% in the fully optimized procedure group (residual %DS <20%, BSR >0.91, and Tinflation >60 s) and 66.7% in the nonoptimized group (residual %DS ≥20%, BSR ≤0.91, and Tinflation ≤60 s) (p < 0.001). Conclusions: Residual %DS after lesion preparation, BSR, and Tinflation were the only modifiable procedure-related factors in DEB angioplasty. Fully optimized DEB angioplasty with optimal lesion preparation, prolonged inflation, and sufficient dilation may play an important role in reducing TLF after DEB angioplasty.

KW - drug-eluting balloon

KW - in-stent restenosis

KW - paclitaxel-coated balloon

KW - percutaneous coronary intervention

KW - target lesion failure

UR - https://www.scopus.com/pages/publications/85047212332

U2 - 10.1016/j.jcin.2018.02.002

DO - 10.1016/j.jcin.2018.02.002

M3 - Article

C2 - 29798774

AN - SCOPUS:85047212332

SN - 1936-8798

VL - 11

SP - 969

EP - 978

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 10

ER -

Impact of Optimized Procedure-Related Factors in Drug-Eluting Balloon Angioplasty for Treatment of In-Stent Restenosis

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Keywords

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