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WASHINGTON – An all-comer observational study associated endovascular treatment of lower limb peripheral artery disease (PAD) with low event rates and substantial improvements in quality of life at 18 months, even in Rutherford stage 6 patients.
Although the proportion of patients with Rutherford stage 6 PAD was relatively small, the study results showed that peripheral vascular intervention “can be successful in this patient population as evidenced by a high freedom from major amputation,” reported William Gray, MD, system chief of the division of cardiovascular disease at the Lankenau Heart Group, Wynnewood, Pa., at CRT 2018, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“Many of the patients in this trial, particularly the Rutherford 6 patients, would never be included in the pivotal trial for endovascular devices,” Dr. Gray said. He called this “a unique study” in that it had almost no exclusions.
The study enrolled 1,204 patients with peripheral artery disease at 51 participating sites. After 18 months, follow-up data were available on 793 patients. These were divided by Rutherford classifications into three groups: 374 patients in the combined Rutherford 2 and 3 classifications (R2/3); 371 in the combined Rutherford 4 and 5 classifications (R4/5); and 48 in the Rutherford 6 classification (R6). Patients treated with any Food and Drug Administration–approved technology for treatment of claudication and critical limb ischemia for PAD were eligible.
The endpoints considered at 18 months included procedural and lesion success, major adverse events, and quality of life. Four core laboratories were responsible for an independent analysis of outcomes. A follow-up of 5 years is planned and will include an economic analysis.
The procedural success rates for were 84.4% for the R2/3 group, 76.9% for the R4/5 group, and 70.2% for the R6 group. Almost all of those in the R2/3 and R4/5 groups were discharged immediately after treatment. In the R6 group, approximately 25% of patients were held for complications or additional care.
At 18 months of follow-up, freedom from major adverse events, defined as death, major amputation, or a target vessel revascularization, was achieved by 76.9% of those in the R2/3 group, 68.2% of those in the R4/5 group, and 52.8% of those in the R6 group. The analysis also looked at specific events: The rates for freedom from amputation were 99.3%, 95.3%, and 81.7% in the R2/3, R4/5, and R6 groups, respectively; the freedom from death was 93.9%, 85.5%, and 76.2%; and the freedom from target vessel revascularization was 77.5%, 70.6%, ad 65.7%.
Those in R2/3 maintained the improvement in Rutherford classification observed at 30 days for the subsequent 12 months. Those in R2/3 and R4/5 showed continued improvement in Rutherford classification. For example, R4 represented approximately 50% of the patients in R3/4 classification at baseline but less than 20% of this group at 18 months.
The change in Rutherford classification was reflected in quality of life (QOL) analyses. As far as total QOL scores, the R6 group, which had lower scores at baseline, was no longer significantly different at 18 months from the R4/5 group. On the pain subdomain QOL score, which was incrementally worse at baseline for increased PAD severity, there were no differences at 18 months after improvements in all groups.
Overall, the LIBERTY 360 study “supports aggressive management” with endovascular procedures in symptomatic patients with PAD. This is important because PAD often is inadequately treated or left untreated, according to Dr. Gray. He cited data suggesting that up to 50% of patients who undergo amputation because of lower limb claudication never even undergo a vascular evaluation.
Although there was no control group to evaluate outcomes in patients not treated or treated with another intervention, such as surgery, Dr. Gray suggested that there are encouraging results in a study that was conducted to enroll patients “with as many confounders as possible.”
Dr. Gray reported financial relationships with Abbott Vascular, Cordis, Medtronic, WL Gore, and a number of other device manufacturers.
WASHINGTON – An all-comer observational study associated endovascular treatment of lower limb peripheral artery disease (PAD) with low event rates and substantial improvements in quality of life at 18 months, even in Rutherford stage 6 patients.
Although the proportion of patients with Rutherford stage 6 PAD was relatively small, the study results showed that peripheral vascular intervention “can be successful in this patient population as evidenced by a high freedom from major amputation,” reported William Gray, MD, system chief of the division of cardiovascular disease at the Lankenau Heart Group, Wynnewood, Pa., at CRT 2018, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“Many of the patients in this trial, particularly the Rutherford 6 patients, would never be included in the pivotal trial for endovascular devices,” Dr. Gray said. He called this “a unique study” in that it had almost no exclusions.
The study enrolled 1,204 patients with peripheral artery disease at 51 participating sites. After 18 months, follow-up data were available on 793 patients. These were divided by Rutherford classifications into three groups: 374 patients in the combined Rutherford 2 and 3 classifications (R2/3); 371 in the combined Rutherford 4 and 5 classifications (R4/5); and 48 in the Rutherford 6 classification (R6). Patients treated with any Food and Drug Administration–approved technology for treatment of claudication and critical limb ischemia for PAD were eligible.
The endpoints considered at 18 months included procedural and lesion success, major adverse events, and quality of life. Four core laboratories were responsible for an independent analysis of outcomes. A follow-up of 5 years is planned and will include an economic analysis.
The procedural success rates for were 84.4% for the R2/3 group, 76.9% for the R4/5 group, and 70.2% for the R6 group. Almost all of those in the R2/3 and R4/5 groups were discharged immediately after treatment. In the R6 group, approximately 25% of patients were held for complications or additional care.
At 18 months of follow-up, freedom from major adverse events, defined as death, major amputation, or a target vessel revascularization, was achieved by 76.9% of those in the R2/3 group, 68.2% of those in the R4/5 group, and 52.8% of those in the R6 group. The analysis also looked at specific events: The rates for freedom from amputation were 99.3%, 95.3%, and 81.7% in the R2/3, R4/5, and R6 groups, respectively; the freedom from death was 93.9%, 85.5%, and 76.2%; and the freedom from target vessel revascularization was 77.5%, 70.6%, ad 65.7%.
Those in R2/3 maintained the improvement in Rutherford classification observed at 30 days for the subsequent 12 months. Those in R2/3 and R4/5 showed continued improvement in Rutherford classification. For example, R4 represented approximately 50% of the patients in R3/4 classification at baseline but less than 20% of this group at 18 months.
The change in Rutherford classification was reflected in quality of life (QOL) analyses. As far as total QOL scores, the R6 group, which had lower scores at baseline, was no longer significantly different at 18 months from the R4/5 group. On the pain subdomain QOL score, which was incrementally worse at baseline for increased PAD severity, there were no differences at 18 months after improvements in all groups.
Overall, the LIBERTY 360 study “supports aggressive management” with endovascular procedures in symptomatic patients with PAD. This is important because PAD often is inadequately treated or left untreated, according to Dr. Gray. He cited data suggesting that up to 50% of patients who undergo amputation because of lower limb claudication never even undergo a vascular evaluation.
Although there was no control group to evaluate outcomes in patients not treated or treated with another intervention, such as surgery, Dr. Gray suggested that there are encouraging results in a study that was conducted to enroll patients “with as many confounders as possible.”
Dr. Gray reported financial relationships with Abbott Vascular, Cordis, Medtronic, WL Gore, and a number of other device manufacturers.
WASHINGTON – An all-comer observational study associated endovascular treatment of lower limb peripheral artery disease (PAD) with low event rates and substantial improvements in quality of life at 18 months, even in Rutherford stage 6 patients.
Although the proportion of patients with Rutherford stage 6 PAD was relatively small, the study results showed that peripheral vascular intervention “can be successful in this patient population as evidenced by a high freedom from major amputation,” reported William Gray, MD, system chief of the division of cardiovascular disease at the Lankenau Heart Group, Wynnewood, Pa., at CRT 2018, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“Many of the patients in this trial, particularly the Rutherford 6 patients, would never be included in the pivotal trial for endovascular devices,” Dr. Gray said. He called this “a unique study” in that it had almost no exclusions.
The study enrolled 1,204 patients with peripheral artery disease at 51 participating sites. After 18 months, follow-up data were available on 793 patients. These were divided by Rutherford classifications into three groups: 374 patients in the combined Rutherford 2 and 3 classifications (R2/3); 371 in the combined Rutherford 4 and 5 classifications (R4/5); and 48 in the Rutherford 6 classification (R6). Patients treated with any Food and Drug Administration–approved technology for treatment of claudication and critical limb ischemia for PAD were eligible.
The endpoints considered at 18 months included procedural and lesion success, major adverse events, and quality of life. Four core laboratories were responsible for an independent analysis of outcomes. A follow-up of 5 years is planned and will include an economic analysis.
The procedural success rates for were 84.4% for the R2/3 group, 76.9% for the R4/5 group, and 70.2% for the R6 group. Almost all of those in the R2/3 and R4/5 groups were discharged immediately after treatment. In the R6 group, approximately 25% of patients were held for complications or additional care.
At 18 months of follow-up, freedom from major adverse events, defined as death, major amputation, or a target vessel revascularization, was achieved by 76.9% of those in the R2/3 group, 68.2% of those in the R4/5 group, and 52.8% of those in the R6 group. The analysis also looked at specific events: The rates for freedom from amputation were 99.3%, 95.3%, and 81.7% in the R2/3, R4/5, and R6 groups, respectively; the freedom from death was 93.9%, 85.5%, and 76.2%; and the freedom from target vessel revascularization was 77.5%, 70.6%, ad 65.7%.
Those in R2/3 maintained the improvement in Rutherford classification observed at 30 days for the subsequent 12 months. Those in R2/3 and R4/5 showed continued improvement in Rutherford classification. For example, R4 represented approximately 50% of the patients in R3/4 classification at baseline but less than 20% of this group at 18 months.
The change in Rutherford classification was reflected in quality of life (QOL) analyses. As far as total QOL scores, the R6 group, which had lower scores at baseline, was no longer significantly different at 18 months from the R4/5 group. On the pain subdomain QOL score, which was incrementally worse at baseline for increased PAD severity, there were no differences at 18 months after improvements in all groups.
Overall, the LIBERTY 360 study “supports aggressive management” with endovascular procedures in symptomatic patients with PAD. This is important because PAD often is inadequately treated or left untreated, according to Dr. Gray. He cited data suggesting that up to 50% of patients who undergo amputation because of lower limb claudication never even undergo a vascular evaluation.
Although there was no control group to evaluate outcomes in patients not treated or treated with another intervention, such as surgery, Dr. Gray suggested that there are encouraging results in a study that was conducted to enroll patients “with as many confounders as possible.”
Dr. Gray reported financial relationships with Abbott Vascular, Cordis, Medtronic, WL Gore, and a number of other device manufacturers.
Key clinical point: An observational study supports endovascular strategies even in the most advanced cases of peripheral artery disease (PAD).
Major finding: In Rutherford stage 6 patients, low amputation rates and large improvements in quality of life were observed at 18 months of follow-up.
Data source: Prospective, observational multicenter study.
Disclosures: Dr. Gray reports financial relationships with Abbott Vascular, BioCardia, Boston Scientific, Cardiovascular Systems, Coherex Medical, Contego Cook, Cordis, Medtronic, Shockwave Medical, Silk Road Medical, and WL Gore.