Medical Policy

Policy Num:      07.001.182
Policy Name:    Intracoronary Drug Delivery Ballon Procedures
Policy ID:          [07.001.182]  [Ac / B / M- P-]  [7.01.97]

Last Review:       February 17, 2026
Next Review:       February 15, 2027
 

Publication Date: March, 2026

Related Policies:

06.001.028 - Computed Tomography to Detect Coronary Artery Calcification

06.001.026 - Contrast-Enhanced Computed Tomographic Angiography for Coronary Artery Evaluation

06.001.062 - Coronary Computed Tomography Angiography With Selective Noninvasive Fractional Flow Reserve

Intracoronary Drug Delivery Ballon Procedures

summary

Description

Summary of Evidence

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.

Additional Information

Not applicable.

Objective

The objective of this evidence review is to determine if the use of intracoronary drug delivery balloon procedures improves the net health outcome in individuals with coronary in-stent restenosis.

Policy Statements

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.

Policy Guidelines

Coding

See the Codes table for details.

Benefit Application

BlueCard/National Account Issues

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration-approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

In-Stent Restenosis

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,

Treatment

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,

Regulatory Status

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.

Rationale

This evidence review was created in November 2025 with a search of the PubMed database. The most recent literature update was performed through November 3, 2025.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Population References No. 1

Percutaneous Coronary Intervention with a Drug-Coated Balloon for In-Stent Restenosis

Clinical Context and Therapy Purpose

The purpose of percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB) in patients who have intracoronary in-stent restenosis (ISR) is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations

The relevant population(s) of interest are individuals undergoing PCI with intracoronary ISR.

Interventions

The therapy being considered is PCI with a DCB (e.g., the AGENT paclitaxel-coated balloon catheter).

Comparators

The primary evidence-based treatment for intracoronary ISR is repeat implantation of a drug-eluting stent (DES).

The general outcomes of interest are symptoms, functional outcomes, health status measures, and treatment-related morbidity.

To quantify ISR severity and assess the effectiveness of treatments such as DCB or repeat DES, studies typically use a combination of clinical and angiographic outcomes. Common primary clinical endpoints include composite measures such as target-lesion failure (TLF; defined as cardiac death, target-vessel myocardial infarction [MI], or target-lesion revascularization [TLR]), with secondary clinical outcomes including TLR, target-vessel revascularization (TVR), MI, stent or target-lesion thrombosis, and all-cause and cardiac mortality. Angiographic follow-up often evaluates late lumen loss, minimum lumen diameter, and binary restenosis to characterize the response to different devices.

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Consistent with a 'best available evidence approach,' within each category of study design, studies with larger sample sizes and longer durations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Systematic Reviews

Ahmed et al (2025) conducted a meta-analysis of 4 randomized trials (n=734) comparing paclitaxel drug-coated balloons (DCB) with paclitaxel drug-eluting stents (DES) for treatment of coronary ISR.^6, Across trials, device success was high (DCB 99.6% vs. DES 97.9%), restenosis occurred in 20.6% versus 23.7%, myocardial infarction (MI) in 1.9% versus 3.0%, and death in 1.6% versus 3.6%, respectively. Pooled analyses showed no statistically significant differences between DCB and DES for late lumen loss at 6 to 9 months (mean difference [MD], -0.02 mm; 95% CI, -0.25 to 0.22; I²=89%), recurrent binary restenosis (risk ratio [RR], 0.76; 95% CI, 0.19 to 2.99; I²=56%), or device success (RR, 1.01; 95% CI, 0.91 to 1.13; I²=66%). MI (RR, 0.64; 95% CI, 0.24 to 1.69; I²=0%) and death (RR, 0.48; 95% CI, 0.16 to 1.41; I²=0%) at 12 months were infrequent and did not differ significantly between treatment arms. Risk of bias was rated as high in one trial and moderate in another, while the remaining studies were judged to be at low risk. Using GRADE, all outcomes were rated as having very low certainty due to risk of bias, inconsistency, imprecision, and suspected publication bias.

Kiyohara et al (2025) conducted a network meta-analysis of 39 randomized controlled trials (n=10,219), including 18 evaluating ISR, to compare revascularization strategies across a broad spectrum of coronary lesions.^7, Overall, DCB therapy reduced major adverse cardiovascular events (MACE) and repeat revascularization compared with plain balloon angioplasty (POBA), with effect sizes that were generally consistent across subgroups. In the ISR subgroup, both paclitaxel DCBs and second-generation DES were associated with substantial reductions in MACE versus POBA (RR, 0.46; 95% CI, 0.32 to 0.64; and RR, 0.41; 95% CI, 0.25 to 0.69, respectively) and in TLR versus POBA (paclitaxel DCB RR, 0.34; 95% CI, 0.21 to 0.56; DES RR, 0.19; 95% CI, 0.08 to 0.44), without observed differences between groups in MI or cardiovascular death. Rankogram analyses suggested that second-generation DES were most likely to be the top-ranked strategy for reducing MACE and TLR; however, indirect comparisons between paclitaxel DCBs and DES did not demonstrate statistically significant differences, despite point estimates that tended to favor DES, particularly for TLR (RR for paclitaxel DCB vs DES, 1.84; 95% CI, 0.92 to 3.69). Risks of stent thrombosis and major bleeding were similar between DCB and DES strategies.

Randomized Controlled Trials

Yeh et al (2024) reported a multicenter, single-blind RCT (AGENT IDE) of 600 adults with coronary ISR treated at 40 U.S. centers, comparing angioplasty with a paclitaxel-coated balloon (AGENT DCB; n=406) versus an uncoated balloon (n=194) (Table 1).^4, The primary outcome was 1-year TLF defined as a composite of ischemia-driven TLR, target vessel-related myocardial infarction (MI), or cardiac death. At 1 year, TLF occurred in 17.9% of patients in the DCB group and 28.6% in the uncoated balloon group (hazard ratio [HR], 0.59; 95% CI, 0.42 to 0.84; p=.003) (Table 2). Secondary outcomes also favored the DCB arm, with lower rates of TLR (13.0% vs. 24.7%; HR, 0.50; 95% CI, 0.34 to 0.74; p=.001) and target vessel-related MI (5.8% vs. 11.1%; HR, 0.51; 95% CI, 0.28 to 0.92; p=.02). Adverse events were generally similar between groups for all-cause mortality (4.1% vs. 3.7%; p=.85) and cardiac death (2.9% vs 1.6%), with no clear mortality signal associated with the paclitaxel-coated balloon. Definite or probable stent thrombosis occurred in 0% of patients in the DCB arm versus 3.2% in the uncoated balloon arm (p<.001). The trial is ongoing with a 5-year planned follow-up. A major limitation of this evidence is the choice of comparator, while illustrative of the relative effect of paclitaxel, does not compare the treatment to a current standard of care.

Table 1. Summary of Key RCT Characteristics

   RCT: randomized controlled trial. 1 Number randomized; intervention; mode of delivery; dose (frequency/duration). 2 Key eligibility criteria

Table 2. Summary of Key RCT Results

   CI: Confidence interval; CV: Cardiovascular; DCB: Drug-coated balloon; HR: Hazard ratio; MI: Myocardial infarction; TLF: Target lesion failure; TLR: Target-lesion revascularization; TVF: Target-vessel failure; TVR: Target-vessel revascularization; yr: Year. 1. Cardiac death, target-vessel MI, or ischemia-driven TLR 2. TVR + target-vessel MI + cardiac death

The purpose of the study limitations tables (see Tables 3 and 4) is to display notable limitations identified in each study. This information is synthesized as a summary of the body of evidence following each table and provides the conclusions on the sufficiency of evidence supporting the position statement.

Table 3. Study Relevance Limitations

   The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.  a Population key: 1. Intended use population unclear; 2. Study population is unclear; 3. Study population not representative of intended use; 4, Enrolled populations do not reflect relevant diversity; 5. Other. b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest (e.g., proposed as an adjunct but not tested as such); 5: Other. c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively; 5. Other. d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. Incomplete reporting of harms; 4. Not establish and validated measurements; 5. Clinically significant difference not prespecified; 6. Clinically significant difference not supported; 7. Other. e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms; 3. Other.

Table 4. Study Design and Conduct Limitations

   The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias; 5. Other. b Blinding key: 1. Participants or study staff not blinded; 2. Outcome assessors not blinded; 3. Outcome assessed by treating physician; 4. Other. c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication; 4. Other. d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials); 7. Other. e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference; 4. Other. f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated; 5. Other.

Nonrandomized Studies

Nakamura et al (2023) reported AGENT Japan, a randomized trial comparing the AGENT paclitaxel-coated balloon with SeQuent Please paclitaxel-coated balloon for small-vessel de novo lesions, with an embedded single-arm substudy of Japanese patients with ISR treated exclusively with the AGENT DCB.^10, The ISR cohort included 30 patients across 9 sites, all with ISR of previously stented lesions. For ISR patients, the primary endpoint was 6-month TLF (composite of cardiac death, target vessel-related MI, or ischemia-driven TLR). At 6 months, TLF occurred in 3.3% of ISR patients, and the one-sided 97.5% upper confidence bound (UCB) of 9.8% was significantly below the predefined success threshold of 15.1% (p<.0001), meeting the primary non-comparative objective. In-stent binary restenosis at 6 months was 3.4%, with late lumen loss 0.07±0.29 mm and mean percent diameter stenosis 23.3±10.3%. Adverse events in the ISR substudy were infrequent. A subsequent publication by Nakamura et al. (2024) reported a 1-year follow-up of the same AGENT Japan population. In the ISR cohort, the 1-year TLF rate was 6.7%, and target lesion thrombosis remained 0.0%.^11, The authors reported that 1-year TLR occurred in 3.3% of ISR patients, and target vessel failure (composite of ischemia-driven target vessel revascularization, MI related to the target vessel, or cardiac death) was 10.0%. Adverse events remained numerically low in ISR patients at 1 year, and all-cause death or MI occurred in 1 individual (3.3%).

Wanha et al (2024) evaluated 846 consecutive patients with DES-ISR and chronic coronary syndrome treated with either DES (n=381) or paclitaxel DCB (n=465), with a median follow-up of 1006 days as part of the multicenter Chronic Coronary Syndrome Dragon-Registry. ^12, The primary endpoint was TLR, and secondary endpoints included TVR and a device-oriented composite endpoint (DOCE: cardiac death, TLR, or target-vessel MI). In the unmatched cohort, DES use was associated with significantly lower hazards of TLR (HR, 0.50; 95% CI, 0.34 to 0.74; p<.001), TVR (HR, 0.56; 95% CI, 0.39 to 0.86; p<.001), and DOCE (HR, 0.63; 95% CI 0.45 to 0.88; p=.007) compared with DCB, while cardiac death and target-vessel MI did not differ significantly between groups. After propensity score matching (304 DES-DCB pairs), the advantage of DES persisted, with reduced TLR (HR, 0.54; 95% CI 0.33 to 0.88; p=.013), TVR (HR, 0.57; 95% CI, 0.41 to 0.80; p=.009), and DOCE (HR, 0.65; 95% CI, 0.42 to 0.99; p=.046), and no significant between-group differences in cardiac death or target-vessel MI.

Kumar et al (2025) conducted a post-marketing analysis of 155 FDA MAUDE reports on AGENT paclitaxel-coated balloon use in coronary interventions between March 2024 and March 2025.^13, Device malfunctions without injury were the most common report category (56.8%), followed by patient injury (31%) and death (12.26%). Balloon rupture (33.6%) and shaft breakage (10.3%) accounted for most reported device problems, while reported patient injuries included angina (32.8%), acute myocardial infarction (29.9%), and coronary perforation (9%). Approximately 30 reports described off-label use in de novo lesions, with injury rates similar to ISR cases (53.3% vs 57.9%). Because total device utilization is unknown and reporting is voluntary, true incidence rates and confidence intervals for these events cannot be calculated.

Supplemental Information

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in 'Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

Drug-Coated Balloon Academic Research Consortium

The Drug-Coated Balloon (DCB) Academic Research Consortium published a position statement with the following recommendations regarding DCB for ISR:^5,

• DCB treatment is associated with a higher risk of TLR, but comparable risk of all-cause death, MI, or target lesion thrombosis compared to repeat DES.

  • Initial treatment with a DCB may be preferable to a DES when the mechanism of prior stent failure is clearly identified using intravascular imaging, appropriately addressed, and optimal lesion preparation is achieved. Implanting an additional DES layer is reserved for cases in which DCB therapy fails.

• DCB first approach is particularly appealing for patients with:

  • Multiple prior stent layers

  • ISR in small vessels

  • ISR in a bifurcated stent

• Repeat DES may be a more suitable option for:

  • DES ISR in large vessels

  • DES failure due to late neoatherosclerosis

European Society of Cardiology (ESC) / European Association for Cardio-Thoracic Surgery (EACTS)

The European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS) guidelines for the management of chronic coronary syndromes (2024) make the following recommendations related to DCB:^14,

• DES is recommended over DCB for the treatment of in-DES restenosis. (Class I, A)

U.S. Preventive Services Task Force Recommendations

Not applicable.

Medicare National Coverage

There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 5.

Table 5. Summary of Key Trials

   NCT: national clinical trial. a Denotes industry-sponsored or cosponsored trial.

References

1. Radoni V. Evidence on Treating Coronary Artery Disease with Drug-Coated Balloons. Premier J Cardiol. Mar 27 2025; 2:100007.
2. Camaj A, Leone PP, Colombo A, et al. Drug-Coated Balloons for the Treatment of Coronary Artery Disease: A Review. JAMA Cardiol. Feb 01 2025; 10(2): 189-198. PMID 39714903
3. Verde N, Ciliberti G, Pittorino L, et al. Contemporary Use of Drug-Coated Balloons for Coronary Angioplasty: A Comprehensive Review. J Clin Med. Oct 19 2024; 13(20). PMID 39458193
4. Yeh RW, Shlofmitz R, Moses J, et al. Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial. JAMA. Mar 26 2024; 331(12): 1015-1024. PMID 38460161
5. Fezzi S, Serruys PW, Cortese B, et al. Indications for Use of Drug-Coated Balloons in Coronary Intervention: Academic Research Consortium Position Statement. J Am Coll Cardiol. Oct 14 2025; 86(15): 1170-1202. PMID 41062231
6. Ahmed S, Ahmad E, Ahmed M, et al. Paclitaxel-coated balloon catheter versus paclitaxel-eluting stent for the treatment of coronary in-stent restenosis: A GRADE-assessed systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). Apr 11 2025; 104(15): e42113. PMID 40228264
7. Kiyohara Y, Aikawa T, Saito T, et al. Comparison of Limus and Paclitaxel Drug-Coated Balloons, Second-Generation or Newer Drug-Eluting Stents, and Balloon Angioplasty: A Network Meta-Analysis of Randomized Controlled Trials. Circ Cardiovasc Interv. Oct 27 2025: e016005. PMID 41145110
8. Wen J, Dohad S, Shlofmitz R, et al. Paclitaxel-Coated Balloon for the Treatment of Small Vessel In-Stent Restenosis: A Subgroup Analysis of the AGENT IDE Randomized Trial. JACC Cardiovasc Interv. Nov 24 2025; 18(22): 2701-2710. PMID 41297981
9. Kirtane AJ, Shlofmitz R, Moses J, et al. Paclitaxel-Coated Balloon for the Treatment of Multilayer In-Stent Restenosis: AGENT IDE Subgroup Analysis. J Am Coll Cardiol. Aug 19 2025; 86(7): 502-511. PMID 40803784
10. Nakamura M, Isawa T, Nakamura S, et al. Drug-Coated Balloon for the Treatment of Small Vessel Coronary Artery Disease　- A Randomized Non-Inferiority Trial. Circ J. Jan 25 2023; 87(2): 287-295. PMID 36450540
11. Nakamura M, Isawa T, Nakamura S, et al. One-year safety and effectiveness of the Agent paclitaxel-coated balloon for the treatment of small vessel disease and in-stent restenosis. Cardiovasc Interv Ther. Jan 2024; 39(1): 47-56. PMID 37642826
12. Wańha W, D'Ascenzo F, Kuźma Ł, et al. Long-term outcomes following paclitaxel-coated balloons versus thin-strut drug-eluting stents for treatment of in-stent restenosis in chronic coronary syndrome (CCS Dragon-Registry). Kardiol Pol. 2024; 82(7-8): 749-759. PMID 38887780
13. Kumar S, Medranda GA, Rogers T, et al. Real-World Safety and Complications of the Boston Scientific AGENT Drug-Coated Balloon From the FDA MAUDE Database. Catheter Cardiovasc Interv. Oct 2025; 106(4): 2448-2453. PMID 40778487
14. Vrints C, Andreotti F, Koskinas KC, et al. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. Sep 29 2024; 45(36): 3415-3537. PMID 39210710

Codes

Policy History