Drug-coated balloons (DCBs) deliver antiproliferative agents directly to the coronary vessel wall via a semicompliant balloon coated with drugs (typically paclitaxel, sirolimus, or everolimus) embedded in a carrier matrix that rapidly diffuses into the vessel wall during inflation, without requiring permanent stent implantation. This approach provides localized drug delivery to inhibit neointimal hyperplasia while avoiding additional metallic layers.
For individuals with in-stent restenosis (ISR) who receive percutaneous coronary intervention (PCI) with drug-coated balloons (DCBs), the evidence includes 1 meta-analysis, 1 network meta-analysis, 1 RCT, and 3 non-randomized studies. Relevant outcomes are major adverse cardiac events (MACE) (including cardiac death, myocardial infarction [MI], and target-lesion [TLR]/vessel revascularization [TVR]), stent or target-lesion thrombosis, and treatment-related procedural and long-term complications. A meta-analysis of 4 randomized trials comparing paclitaxel DCB with paclitaxel drug-eluting stents (DES) for coronary ISR and found no statistically significant differences for late lumen loss, recurrent binary restenosis, device success, MI incidence, or death at 6 to 9 months; however, sirolimus and everolimus DES were not included. A network meta-analysis of 18 ISR trials found that, compared with balloon angioplasty without a DCB, limus- and paclitaxel-coated balloons and second-generation DES each reduced MACE and TLR, with no significant difference in MACE between paclitaxel DCB and DES; however, DES was favored over DCBs in rankogram analysis driven by observed relative benefits in the rate of TLR. In the pivotal AGENT IDE RCT of adults with coronary ISR, AGENT DCB reduced 1-year TLF, TLR, TVR, and TVF compared with the uncoated balloon, with similar all-cause and cardiovascular death and numerically fewer definite/probable stent thrombosis events. Prespecified subgroup analyses showed that AGENT maintained a lower 1-year TLF than the uncoated balloon in small-vessel ISR, larger-vessel ISR, and multilayer ISR, with no significant effect in single-layer ISR. Three nonrandomized sources, a small single-arm AGENT Japan ISR substudy (achieved the prespecified TLF performance goal at 6 months and 1 year), the CCS Dragon-Registry of 846 DES-ISR patients (favored thin-strut DES over paclitaxel DCB for TLR and related composites), and a MAUDE analysis of adverse event reports, provide conflicting but lower-certainty data on safety and comparative effectiveness. While DCB has shown effectiveness compared with plain balloon angioplasty, questions remain about its relative effectiveness compared with current-generation DES, and data on the durability of the FDA-approved AGENT device are limited. Ongoing evidence generation from the AGENT IDE study, as well as additional well-conducted research, is required to assess the comparative effectiveness of DCB versus DES, establish the durability of the treatment effect, and elucidate which patients are most likely to benefit from DCB compared with other interventions. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
The use of percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB) in adult individuals for treating coronary in-stent restenosis (ISR) is considered investigational.
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CPT |
0913T |
Percutaneous transcatheter therapeutic drug delivery by intracoronary drug-delivery balloon (eg, drug-coated, drug-eluting), including mechanical dilation by nondrug-delivery balloon angioplasty, endoluminal imaging using intravascular ultrasound (IVUS) or optical coherence tomography (OCT) when performed, imaging supervision, interpretation, and report, single major coronary artery or branch |
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0914T |
Percutaneous transcatheter therapeutic drug delivery by intracoronary drug-delivery balloon (eg, drug-coated, drug-eluting) performed on a separate target lesion from the target lesion treated with balloon angioplasty, coronary stent placement or coronary atherectomy, including mechanical dilation by nondrug-delivery balloon angioplasty, endoluminal imaging using intravascular ultrasound (IVUS) or optical coherence tomography (OCT) when performed, imaging supervision, interpretation, and report, single major coronary artery or branch (List separately in addition to code for percutaneous coronary stent or atherectomy intervention) |
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ICD-10 PCS |
XW0J3HA |
Introduction of Paclitaxel-Coated Balloon Technology, One Balloon into Coronary Artery, One Artery, Percutaneous Approach, New Technology Group 10 |
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XW0J3JA |
Introduction of Paclitaxel-Coated Balloon Technology, Two Balloons into Coronary Artery, One Artery, Percutaneous Approach, New Technology Group 10 |
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XW0J3KA |
Introduction of Paclitaxel-Coated Balloon Technology, Three Balloons into Coronary Artery, One Artery, Percutaneous Approach, New Technology Group 10 |
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XW0J3LA |
Introduction of Paclitaxel-Coated Balloon Technology, Four or More Balloons into Coronary Artery, One Artery, Percutaneous Approach, New Technology Group 10 |
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XW0K3HA |
Introduction of Paclitaxel-Coated Balloon Technology, One Balloon into Coronary Artery, Two Arteries, Percutaneous Approach, New Technology Group 10 |
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XW0K3JA |
Introduction of Paclitaxel-Coated Balloon Technology, Two Balloons into Coronary Artery, Two Arteries, Percutaneous Approach, New Technology Group 10 |
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XW0K3KA |
Introduction of Paclitaxel-Coated Balloon Technology, Three Balloons into Coronary Artery, Two Arteries, Percutaneous Approach, New Technology Group 10 |
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XW0K3LA |
Introduction of Paclitaxel-Coated Balloon Technology, Four or More Balloons into Coronary Artery, Two Arteries, Percutaneous Approach, New Technology Group 10 |
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XW0L3HA |
Introduction of Paclitaxel-Coated Balloon Technology, One Balloon into Coronary Artery, Three Arteries, Percutaneous Approach, New Technology Group 10 |
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XW0L3JA |
Introduction of Paclitaxel-Coated Balloon Technology, Two Balloons into Coronary Artery, Three Arteries, Percutaneous Approach, New Technology Group 10 |
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XW0L3KA |
Introduction of Paclitaxel-Coated Balloon Technology, Three Balloons into Coronary Artery, Three Arteries, Percutaneous Approach, New Technology Group 10 |
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XW0L3LA |
Introduction of Paclitaxel-Coated Balloon Technology, Four or More Balloons into Coronary Artery, Three Arteries, Percutaneous Approach, New Technology Group 10 |
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XW0M3HA |
Introduction of Paclitaxel-Coated Balloon Technology, One Balloon into Coronary Artery, Four or More Arteries, Percutaneous Approach, New Technology Group 10 |
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XW0M3JA |
Introduction of Paclitaxel-Coated Balloon Technology, Two Balloons into Coronary Artery, Four or More Arteries, Percutaneous Approach, New Technology Group 10 |
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XW0M3KA |
Introduction of Paclitaxel-Coated Balloon Technology, Three Balloons into Coronary Artery, Four or More Arteries, Percutaneous Approach, New Technology Group 10 |
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XW0M3LA |
Introduction of Paclitaxel-Coated Balloon Technology, Four or More Balloons into Coronary Artery, Four or More Arteries, Percutaneous Approach, New Technology Group 10 |
| HCPCS | C9610 | Catheter, transluminal drug delivery with or without angioplasty, coronary, non-laser (insertable) |
| ICD-10 CM | T82.855A | Stenosis of coronary artery stent, initial encounter |
| T82.855D | Stenosis of coronary artery stent, subsequent encounter | |
| T82.855S | Stenosis of coronary artery stent, sequela |
Coronary artery disease (CAD) is the leading cause of death worldwide and commonly presents as either chronic coronary syndrome with exertional angina or acute coronary syndromes due to plaque rupture or erosion with thrombotic occlusion.1, Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation has become the standard of care for coronary revascularization because it provides an immediate and stable result, which reduces the risk of major adverse cardiac events (MACE) compared with balloon angioplasty alone.2,3, Earlier generations of bare-metal stents were associated with neointimal hyperplasia and in-stent restenosis (ISR) in approximately 15% to 30% of treated lesions at mid- to long-term follow-up.1, Although second-generation DES substantially lowered ISR and stent thrombosis compared with BMS, a non-negligible risk of ISR and late thrombotic events persists.3, ISR reflects a combination of smooth muscle cell proliferation, inflammatory response to stent-related vessel injury, and later neoatherosclerosis and vessel remodeling, and is more frequent in patients with long stents, diabetes, or complex lesion anatomy.2,1, Patients who develop ISR may experience recurrent angina and ischemia and require repeat revascularization. ISR in multilayer or small-vessel segments can be particularly challenging to manage because additional stent layers may compromise lumen diameter, impair future surgical options, and increase the risk of recurrent restenosis or thrombosis. 2,4,
For patients with coronary in-stent restenosis (ISR), the standard evidence-based approach is repeat stenting using drug-eluting stents (DES), while drug-coated balloons (DCBs) are under active investigation as an alternative therapy. DCBs are angioplasty balloons coated with an antiproliferative drug and an excipient, enabling rapid drug delivery and retention within the vessel wall during balloon inflation. This technique aims to prevent neointimal hyperplasia without requiring a permanent implant.1,2, DCB angioplasty purports several advantages over additional DES implantation, including: preservation of coronary vasomotion, avoidance of multiple stent layers and polymer-related inflammation, the potential for positive vessel remodeling and late luminal enlargement, avoidance of side branch jailing and carina shift in bifurcation lesions, and does not constrain future reinterventions with additional metallic scaffolds.2,3,5,
In February 2024, the AGENT™ Paclitaxel-Coated Balloon Catheter (Boston Scientific) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval (PMA) process (P230035) for use “after appropriate vessel preparation in adult patients undergoing percutaneous coronary intervention (PCI) in coronary arteries 2.0 mm to 4.0 mm in diameter and lesions up to 26 mm in length for the purpose of improving myocardial perfusion when treating in-stent restenosis (ISR).” The device had previously been granted FDA Breakthrough Device designation in January 2021.
Several additional DCBs remain as investigational devices in the United States and have not yet received FDA premarket approval for commercial use:
In October 2024, the FDA granted Medtronic an investigational device exemption (IDE) approval for the Prevail™ paclitaxel-coated drug-coated balloon (DCB) coronary pivotal trial (Prevail Global), designed to evaluate the safety and effectiveness of Prevail for the treatment of coronary ISR and de novo small-vessel coronary disease.
In October 2022 and January 2023, the FDA granted investigational device exemption (IDE) approvals for the SELUTION SLR™ sustained limus-release sirolimus-eluting balloon (MedAlliance, now Cordis) to evaluate sirolimus-coated balloon angioplasty for coronary ISR in October 2022 and for de novo small-vessel coronary lesions in January 2023.
In April 2019, the FDA granted Breakthrough Device designation to the Virtue™ sirolimus-eluting balloon (Orchestra BioMed) for the treatment of coronary ISR. Virtue SAB has subsequently been granted Breakthrough Device designation for the treatment of coronary ISR and coronary small-vessel disease.
In April 2019, the MagicTouch™ sirolimus-coated balloon (Concept Medical) received FDA Breakthrough Device designation for the treatment of coronary artery disease in patients with ISR, and the MagicTouch SCB platform has since obtained IDE approvals for multiple indications, including de novo or small-vessel coronary disease.
No DCBs have been approved by the FDA for the treatment of de novo coronary lesions or small coronary vessel disease.
