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PRIME: Comorbidities extensive but survival rates encouraging in CLI cohort
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CHICAGO — An interim analysis of the PRIME registry provided insight into current knowledge, the feasibility of ultrasound-guided access and the relationship between hemodynamics and response to endovascular therapy in critical limb ischemia.
“PRIME is a very special registry because we have been trying hard to get a registry that collects data on patients with CLI in a prospective fashion,” Jihad A. Mustapha, MD, FACC, FSCAI, director of cardiovascular research at Metro Health – University of Michigan Health in Wyoming, Michigan, said during a presentation at AMP: The Amputation Prevention Symposium.
The prospective, multicenter, observational PRIME registry is designed to explore advanced peripheral artery disease, defined as Rutherford category 3, and CLI and includes comprehensive clinical, diagnostic and procedural follow-up. Data collection began in 2013 and currently includes 3 years of follow-up. A total of 843 patients with 1,399 endovascular revascularizations are now enrolled.
“Unfortunately, this is the nature of CLI,” Mustapha said. “You can’t get away with a single procedure.”
Current knowledge
The researchers conducted an interim analysis of the first 328 patients with CLI (mean age, 70 years) enrolled in the registry. More than 50% of patients had diabetes, hypertension and/or dyslipidemia. Additionally, 70% were current smokers or had a history of smoking. The most common presentation was a wound, with patients presenting to the ED or being referred by a physician with an existing wound.
Data also showed that 45.2% of patients had multilevel disease, with an average of 1.5 lesions per procedure. The average stenosis was 92%, and more than 50% were chronic total occlusions.
Mortality was 1.2% at 30 days and 13.6% at 12 months, whereas major amputation-free survival was 84% at 12 months. Mustapha noted that the mortality rates were encouraging, as was the improvement in amputation-free survival, although more data are necessary.
Ultrasound-guided access
The researchers assessed the feasibility and immediate outcomes of ultrasound-guided access in 407 patients, of whom 58% had CLI. There were 649 endovascular revascularizations with 896 access sites.
“What’s interesting is that we found that the utilization of ultrasound-guided access is safe and effective regardless of arterial bed and approach,” Mustapha said.
Additionally, results indicated that success and complication rates of ultrasound-guided access were comparable to conventional retrograde common femoral artery access. There was also less contrast use, lower fluoroscopy time and shorter hospital stay with use of tibiopedal arterial minimally invasive ultrasound-guided retrograde revascularization, according to the data.
Hemodynamics
The interim analysis also suggested that limb hemodynamics were not associated with outcomes of endovascular therapy, Mustapha said.
In 100 patients with CLI and 175 infrapopliteal lesions, the researchers compared patient outcomes based on hemodynamic criteria. The first group had an ankle-brachial index up to 0.5, toe-brachial index up to 0.5 or toe pressure less than 50 mm Hg. The second group had ankle-brachial index of at least 0.5, toe brachial index of at least 0.5 or toe pressure more than 50 mm Hg.
“We found no observable difference in baseline characteristics between the two groups, so we were not surprised,” Mustapha said. “Ankle-brachial index and toe-brachial index did not indicate failure or success of therapy.”
Furthermore, high procedural success showed minimal increase in limb hemodynamics, according to the data.
Vessel recoil
Mustapha and colleagues conducted a comparison of vessel size at 30 days to determine vessel recoil and the rate of reintervention. The treatment group included 50 patients who required target lesion reintervention within 12 months, and the control group included 51 patients who did not require reintervention within 12 months.
According to the data, recoil and vessel diameter were significant predictors of reintervention within 12 months. The researchers also found a greater percentage of recoil in the distal vessels. – by Melissa Foster
Reference:
Mustapha JA. General Session: CLI in 2017. Presented at: AMP: The Amputation Prevention Symposium; Aug. 9-12, 2017; Chicago.
Disclosure: Mustapha reports being a consultant for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, Cardiovascular Systems Inc., Medtronic, Spectranetics and Terumo Medical.