Tae-Min Rhee1, Joo Myung Lee2, Eun-Seok Shin3, Doyeon Hwang1, Jonghanne Park1, Ki-Hyun Jeon4, Hack-Lyoung Kim5, Han-Mo Yang1, Jung-Kyu Han1, Kyung Woo Park1, Joo-Yong Hahn2, Bon-Kwon Koo1, Sang-Hyun Kim5, Hyo-Soo Kim6. 1. Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Korea. 2. Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. 3. Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea. 4. Sejong General Hospital, Sejong Heart Institute, Bucheon, Korea. 5. Cardiovascular Center, Seoul National University Boramae Medical Center, Seoul, Korea. 6. Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Korea. Electronic address: usahyosoo@gmail.com.
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.
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.