SynthesisCirculation2019
Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years.
Synthesis in Circulation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective, Randomized, Multi-center, Single-blinded Study for the Treatment of Subjects Presenting With De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries Using Paclitaxel or Bare Percutaneous Transluminal Angioplasty Balloon Catheter
ILLUMENATE Pivotal: ProspectIve, Randomized, SingLe-Blind, U.S. MuLti-Center Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon
ProspectIve, SingLe-Arm, MuLti-Center, Pharmacokinetic Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon
Prospective, Single-Arm, Global Multi-Center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery (SFA) and/or Popliteal Lesions With a Novel Paclitaxel-Coated Percutaneous Angioplasty (PTA) Balloon and in In-Stent Restenosis
Prospective, Controlled, Multi-Center, Open, Single Arm Study for the Treatment of Subjects Presenting De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries Using a Paclitaxel-Coated Percutaneous Angioplasty Catheter
Stellarex Vascular E-Registry
ProspectIve, Randomized, SingLe-Blind, U.S. MuLti-Center Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon Pivotal Post-Approval Study
Who cites it
28 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Sirolimus-Coated Versus Paclitaxel-Coated Balloons for Coronary Artery Disease: A Grade Assessed Systematic Review and Meta-Analysis.Critical pathways in cardiology · 2026Pooled it
- Drug-coated balloon angioplasty for failing haemodialysis access: meta-analysis of randomized clinical trials.The British journal of surgery · 2021Pooled it
- Update on paclitaxel for femoral-popliteal occlusive disease in the 15 months following a summary level meta-analysis demonstrated increased risk of late mortality and dose response to paclitaxel.Journal of vascular surgery · 2021Pooled it
- Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD.Journal of the American College of Cardiology · 2021Trial
- COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions.European heart journal · 2020Trial
- Applications and challenges of paclitaxel- coated balloons beyond coronary atherosclerotic heart disease.World journal of clinical cases · 2025Review
- Advances in drug-coated balloons for the treatment of coronary artery de novo large-vessel lesions.The Journal of international medical research · 2025Review
- Chronic Kidney Disease and Risk of Mortality and Major Adverse Limb Events After Femoral Artery Endovascular Revascularization for Peripheral Artery Disease: The Boston Femoral Artery Endovascular Revascularization Outcomes (Boston FAROUT) Study.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025Article
- Drug-eluting devices for lower limb peripheral arterial disease.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024Review
- Device regulation and surveillance in vascular care: Challenges and opportunities.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2024Review
- Risk of Mortality Related to Recurrent Limb Events After Endovascular Revascularization of the Superficial Femoral Artery for Peripheral Artery Disease: The Boston Femoral Artery Endovascular Revascularization Outcomes (Boston FAROUT) Study.The American journal of cardiology · 2023Article
- Drug-Coated Balloon versus Drug-Eluting Stent: The Debate of Leave Nothing Behind.Seminars in interventional radiology · 2023Review
- Repetition of Paclitaxel-Coated Devices for the Treatment of Lower Extremity Artery Disease: Mortality Outcomes and Predictors.Acta Cardiologica Sinica · 2023Article
- Single-Center Study Evaluating Long-Term Major Adverse Outcomes with the Use of Paclitaxel-Coated Balloons in Treating Infrainguinal Arterial Disease.The International journal of angiology : official publication of the International College of Angiology, Inc · 2023Article
- Data sources and applied methods for paclitaxel safety signal discernment.Frontiers in cardiovascular medicine · 2023Review
- A case of vasculitis after paclitaxel drug-coated balloon angioplasty.JAAD case reports · 2022Article
- Efficacy and safety of drug-coated balloon versus non-drug-coated balloon combined with bare metal stent implantation in treatment of patients with occlusions of the superficial femoral artery: a retrospective study in clinical practice.American journal of translational research · 2022Article
- One-year outcomes of drug-coated balloon treatment for long femoropopliteal lesions: a multicentre cohort and real-world study.BMC cardiovascular disorders · 2021Article
- Article
- Safety, effectiveness and mid-term follow-up in 136 consecutive patients with moderate to severely calcified lesions undergoing phoenix atherectomy.Heart and vessels · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA recent summary-level meta-analysis comprising randomized, controlled trials (RCTs) of femoropopliteal paclitaxel-coated balloon and stent intervention identified excess late mortality in the paclitaxel-treated patients.
methodsWe evaluated the safety of the Stellarex drug-coated balloon (DCB) for femoropopliteal artery disease with an independently performed meta-analysis of patient-level data from all patients in the Stellarex femoropopliteal clinical program. To compare mortality after DCB or uncoated percutaneous transluminal angioplasty (PTA), we aggregated data from 2 RCTs comprising 419 patients treated with DCB and 170 patients treated with PTA. In an additional analysis, data were aggregated from 6 poolable Stellarex DCB studies (2 RCTs, 3 single-arm studies, and 1 registry). All serious adverse events including deaths were adjudicated by a blinded, third-party, independent Clinical Events Committee. Kaplan-Meier estimates in the RCTs were compared with restricted mean survival time. Predictors of death were assessed with hazard ratios (HRs) and Cox proportional hazards modeling.
resultsBaseline characteristics were similar in the patients treated with DCB and PTA in the pooled RCT analysis, with the exception that the DCB cohort was younger (67.4±9.7 versus 69.4±9.4 years,
conclusionsThe mortality rates for patients treated with the DCB and uncoated PTA were indistinguishable over 3-year follow-up. Additional patient-level, adequately powered meta-analyses with larger RCT data sets will be needed to confirm the generalizability of these findings. CLINICAL
trial registrationURL: http://www.clinicaltrials.gov. Unique identifiers: NCT02110524, NCT01858363, NCT01858428, NCT03421561, NCT01912937, NCT01927068, and NCT02769273.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.