Hiroyoshi Kawamoto1, Neil Ruparelia2, Azeem Latib1, Tadashi Miyazaki1, Katsumasa Sato1, Antonio Mangieri3, Rachele Contri3, Stefano Stella3, Filippo Figini1, Alaide Chieffo3, Mauro Carlino3, Matteo Montorfano3, Antonio Colombo4. 1. Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy. 2. Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy; Imperial College, London, United Kingdom. 3. Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy. 4. Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy. Electronic address: info@emocolumbus.it.
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.
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.