True-PTX Clinical Trial Results
TRUE-PTX is a comprehensive study comparing Paclitaxel Drug-Eluting and bare device treatment for Peripheral Artery Disease (PAD) using real-world data*. This analysis, which includes over 10,000 patients in the United States, examines 12-month amputation and readmission rates.
This large-scale, near-real-time clinical evidence leveraging Truveta aggregated electronic health record (EHR) data shows that PAD treatment with paclitaxel drug-eluting devices may reduce the risk of amputation and readmission vs. treatment with non-drug devices.
Treatment with a non-DE device increases odds for any amputation by
30%
Treatment with a non-DE device increases odds for readmission3 by
15%
TRUE-PTX Study Design and Population
The objective was to compare outcomes in patients with Peripheral Artery Disease (PAD) treated with Paclitaxel Drug-Eluting devices (DCB, DES) versus those treated with non-DE devices (BMS, PTA). The study design involved a comparative propensity score-matched analysis of de-identified electronic health record (EHR) data.
Patients with PAD undergoing endovascular femoropopliteal balloon or stent therapy (± paclitaxel)
N = 10,474
Data source was Truveta, which aggregates normalized EHR data from more than 120 million de-identified patient records across more than 30 U.S. health systems.
TRUE-PTX Comparative Analysis2 Results
Outcomes before propensity score matching
12-month amputations and readmissions occurred significantly less frequently for patients treated with a DE device
| DE | Non-DE | P-value | |
| Any Limb Amputation | 7.5% | 8.9% | 0.01 |
| Same Limb Amputation | 1.5% | 2.3% | 0.003 |
| Any Readmission | 53.8% | 57.8% | <0.001 |
| Readmission with a DE or non-DE intervention | 15.1% | 16.8% | 0.022 |
Mortality**
| DE | Non-DE | P-value | |
| 30 daysa | |||
| N | 5298 | 5145 | |
| Event rate 12 monthsb | 2.6% | 2.5% | 0.801 |
| N | 1306 | 1570 | |
| Event rate | 23.4% | 21.7% | 0.296 |
Outcomes after propensity score matching
Patients treated with non-DE devices were more likely to have any amputation, any readmission and readmission associated with a DE or non-DE procedure
Treatment with a non-DE device increases odds for any amputation by
30%
Treatment with a non-DE device increases odds for readmission3 by
15%
References
1. Exact matching method.
2. Brodmann, M. TRUE-PTX: the study of drug-eluting vs bare device therapies for PAD in the real world: 12-month amputation and readmission rates in a large population. Presented at LINC 28 Jan 2025.
3. Readmission with another DE or non-DE intervention
*Truveta aggregates normalized EHR data from more than 120 million de-identified patient records across more than 30 U.S. health systems
**No significant between-group differences for mortality.
Caution:
The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.