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Paclitaxel-Coated Zilver PTX Drug-Eluting Stent Treatment Does Not Result in Increased Long-Term All-Cause Mortality Compared to Uncoated Devices
- Source :
- Cardiovascular and Interventional Radiology
- Publication Year :
- 2019
-
Abstract
- Purpose Patient-level data from two large studies of the Zilver PTX drug-eluting stent (DES) with long-term follow-up and concurrent non-drug comparator groups were analyzed to determine whether there was an increased mortality risk due to paclitaxel. Methods Data from the Zilver PTX randomized controlled trial (RCT) and Zilver PTX and bare metal stent (BMS) Japan post-market surveillance studies were analyzed. Five-year follow-up is complete in both DES studies; follow-up for the BMS study was limited to 3 years and is complete. Kaplan–Meier analyses assessed mortality. A Cox proportional hazards model identified significant factors related to mortality. Results In the RCT, there were 336 patients treated with the DES and 143 patients treated with percutaneous transluminal angioplasty (PTA) or BMS. In Japan, there were 904 DES patients and 190 BMS patients. There was no difference in all-cause mortality for the DES compared to PTA/BMS in the RCT (19.1% DES versus 17.1% PTA/BMS through 5 years, p = 0.60) or Japan (15.8% DES versus 15.3% BMS through 3 years, p = 0.89). Cox proportional hazard models revealed that age, tissue loss, and congestive heart failure were significantly associated with mortality in the RCT, and critical limb ischemia, age, renal failure, and gender were significantly associated with mortality in Japan (all p p = 0.46 RCT, p = 0.49 Japan) nor paclitaxel dose (p = 0.86 RCT, p = 0.07 Japan) was associated with mortality. Conclusion Analyses of the Zilver PTX patient-level data demonstrated no increase in long-term all-cause mortality. Level of Evidence Zilver PTX RCT: Level 1, randomized controlled trial; Japan PMS studies: Level 3, post-market surveillance study.
- Subjects :
- Bare-metal stent
Male
medicine.medical_specialty
Percutaneous
Paclitaxel
medicine.medical_treatment
Urology
Kaplan-Meier Estimate
030204 cardiovascular system & hematology
030218 nuclear medicine & medical imaging
law.invention
03 medical and health sciences
Peripheral Arterial Disease
0302 clinical medicine
Randomized controlled trial
law
medicine
Humans
Radiology, Nuclear Medicine and imaging
Popliteal Artery
Prospective Studies
Clinical Investigation
Mortality
Vascular Patency
Aged
Peripheral artery disease
Proportional hazards model
business.industry
Angioplasty
Stent
Drug-Eluting Stents
Critical limb ischemia
Percutaneous transluminal angioplasty
medicine.disease
Tubulin Modulators
Femoral Artery
Treatment Outcome
Drug-eluting stent
Heart failure
Female
Stents
medicine.symptom
Cardiology and Cardiovascular Medicine
business
Follow-Up Studies
Bare metal stent
Subjects
Details
- ISSN :
- 1432086X
- Volume :
- 43
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Cardiovascular and interventional radiology
- Accession number :
- edsair.doi.dedup.....e4bd74071aaafb3a2c41f1eef33a5590