Off-Label Use of Peripheral Paclitaxel Drug-Coated Balloons in Management of Recurrent Coronary In-Stent Restenosis.
Mahesh V Madhavan, Emad Hakemi, Rishi Neeranjun, Hussein M Rahim, Shayan Nabavi Nouri, Erin Flattery, Megha Prasad, Michael B Collins, Dimitri Karmpaliotis, Ziad A Ali, Sahil A Parikh, Torsten P Vahl, Amisha Patel, Tamim M Nazif, Khady N Fall, Akiko Maehara, Martin B Leon, Ajay J Kirtane, Jeffrey W Moses
Author Information
Mahesh V Madhavan: Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York.
Emad Hakemi: Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates.
Rishi Neeranjun: Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York.
Hussein M Rahim: Valley Health System, Ridgewood, New Jersey.
Shayan Nabavi Nouri: Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York.
Erin Flattery: New York University Langone Medical Center, New York, New York.
Megha Prasad: Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York.
Michael B Collins: Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York.
Dimitri Karmpaliotis: Morristown Medical Center, Morristown, New Jersey.
Ziad A Ali: Cardiovascular Research Foundation, New York, New York.
Sahil A Parikh: Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York.
Torsten P Vahl: Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York.
Amisha Patel: Sorin Medical Group, New York, New York.
Tamim M Nazif: Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York.
Khady N Fall: Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York.
Akiko Maehara: Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York.
Martin B Leon: Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York.
Ajay J Kirtane: Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York.
Jeffrey W Moses: Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York.
Background: While not available for clinical use in the United States, dedicated drug-coated balloons (DCB) are currently under investigation for the management of coronary in-stent restenosis (ISR). Peripheral drug-coated balloons (P-DCB) have been used off-label for coronary ISR. Further data regarding this practice are needed. We aimed to describe outcomes in patients who underwent off-label P-DCB angioplasty for coronary ISR. Methods: We analyzed data on P-DCB angioplasty for coronary ISR at a single high-volume center between April 1, 2015, and December 30, 2017. Demographic and procedural details were collected, with systematic follow-up as clinically indicated. Results: Data from 31 patients treated with P-DCB angioplasty (mean age 68.0 ± 10.7 years) with coronary ISR (17 recurrent and 14 first time) were analyzed. Most patients presented with high-grade angina (81%) or myocardial infarction (13%). Treated ISR lesions were in native coronary arteries (68%), saphenous vein grafts (SVG, 23%), and the left internal mammary artery (10%). Diffuse intrastent ISR was common (69%) with a mean lesion length of 21.7 ± 12.4 mm. No postprocedural myocardial infarction occurred and 1 nonprocedural mortality occurred during index admission. At follow-up (median: 283, interquartile range [IQR]: 354 days), repeat angiography was performed in 19 patients (median: 212, IQR: 188 days), and 11 patients had target lesion recurrent ISR (Kaplan-Meier event-free survival estimate: 44.7%, 95% CI, 26.1%-76.5%). Conclusions: In the absence of availability of dedicated coronary DCB, treatment of coronary ISR using P-DCB angioplasty was feasible, although follow-up demonstrated continued risk for recurrent ISR in this high-risk population.
