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WASHINGTON — For patients with severe critical limb ischemia and medical comorbidities, subintimal angioplasty is a safer and less expensive alternative to bypass surgery, and is just as effective at preventing amputation, according to the results of a randomized, single-surgeon study.
“These findings have caused a paradigm shift in the way we manage critical limb ischemia in these patients,” Dr. Niamh Hynes said at a symposium sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The 5-year, randomized controlled trial compared subintimal angioplasty with bypass surgery in 309 patients with severe critical limb ischemia. The average age was 72 years, and all patients had severe lesions (level C and D according to the Transatlantic InterSociety Consensus [TASC] Classification system). Diabetes was present in 22%; all patients had a high medical comorbidity score.
Subintimal angioplasty was performed in 190 patients; 119 underwent bypass surgery, according to Dr. Hynes of University College Hospital, Galway, Ireland. The procedures were performed by a single surgeon, Dr. Sherif Sultan, at the hospital from 2002 to 2007.
At 5 years, primary patency rates were greater, but not significantly so, in the angioplasty group (73% vs. 65%). Neither the use of a stent nor the number of stents employed significantly affected patency rates. No blood marker (homocysteine, glucose level, C-reactive protein, or fibrinogen levels) was associated with patency rates.
Angioplasty also was associated with better primary assisted patency and secondary patency rates at 5 years, although these differences were not statistically significant.
Both interventions were effective at maintaining amputation-free survival (angioplasty 73%, bypass 71%) and all-cause survival (77% and 80%) at 5 years. At 5 years, 68% of angioplasty patients were free from major adverse events, compared with 57% of bypass patients, a significant difference.
When short-term results were considered, angioplasty appeared at least as successful as bypass surgery. All-cause 30-day mortality was half that seen with bypass, although the difference was not significant (1.6% vs. 3%). Length of hospital stay was significantly shorter (14 vs. 24 days).
Angioplasty was significantly less expensive than bypass surgery (&z.euro;11,650 vs. &z.euro;18,700). When cost was broken down by quality-adjusted life-year, angioplasty also was significantly less expensive (cost per QALY &z.euro;5,660 vs. &z.euro;9,170).
WASHINGTON — For patients with severe critical limb ischemia and medical comorbidities, subintimal angioplasty is a safer and less expensive alternative to bypass surgery, and is just as effective at preventing amputation, according to the results of a randomized, single-surgeon study.
“These findings have caused a paradigm shift in the way we manage critical limb ischemia in these patients,” Dr. Niamh Hynes said at a symposium sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The 5-year, randomized controlled trial compared subintimal angioplasty with bypass surgery in 309 patients with severe critical limb ischemia. The average age was 72 years, and all patients had severe lesions (level C and D according to the Transatlantic InterSociety Consensus [TASC] Classification system). Diabetes was present in 22%; all patients had a high medical comorbidity score.
Subintimal angioplasty was performed in 190 patients; 119 underwent bypass surgery, according to Dr. Hynes of University College Hospital, Galway, Ireland. The procedures were performed by a single surgeon, Dr. Sherif Sultan, at the hospital from 2002 to 2007.
At 5 years, primary patency rates were greater, but not significantly so, in the angioplasty group (73% vs. 65%). Neither the use of a stent nor the number of stents employed significantly affected patency rates. No blood marker (homocysteine, glucose level, C-reactive protein, or fibrinogen levels) was associated with patency rates.
Angioplasty also was associated with better primary assisted patency and secondary patency rates at 5 years, although these differences were not statistically significant.
Both interventions were effective at maintaining amputation-free survival (angioplasty 73%, bypass 71%) and all-cause survival (77% and 80%) at 5 years. At 5 years, 68% of angioplasty patients were free from major adverse events, compared with 57% of bypass patients, a significant difference.
When short-term results were considered, angioplasty appeared at least as successful as bypass surgery. All-cause 30-day mortality was half that seen with bypass, although the difference was not significant (1.6% vs. 3%). Length of hospital stay was significantly shorter (14 vs. 24 days).
Angioplasty was significantly less expensive than bypass surgery (&z.euro;11,650 vs. &z.euro;18,700). When cost was broken down by quality-adjusted life-year, angioplasty also was significantly less expensive (cost per QALY &z.euro;5,660 vs. &z.euro;9,170).
WASHINGTON — For patients with severe critical limb ischemia and medical comorbidities, subintimal angioplasty is a safer and less expensive alternative to bypass surgery, and is just as effective at preventing amputation, according to the results of a randomized, single-surgeon study.
“These findings have caused a paradigm shift in the way we manage critical limb ischemia in these patients,” Dr. Niamh Hynes said at a symposium sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The 5-year, randomized controlled trial compared subintimal angioplasty with bypass surgery in 309 patients with severe critical limb ischemia. The average age was 72 years, and all patients had severe lesions (level C and D according to the Transatlantic InterSociety Consensus [TASC] Classification system). Diabetes was present in 22%; all patients had a high medical comorbidity score.
Subintimal angioplasty was performed in 190 patients; 119 underwent bypass surgery, according to Dr. Hynes of University College Hospital, Galway, Ireland. The procedures were performed by a single surgeon, Dr. Sherif Sultan, at the hospital from 2002 to 2007.
At 5 years, primary patency rates were greater, but not significantly so, in the angioplasty group (73% vs. 65%). Neither the use of a stent nor the number of stents employed significantly affected patency rates. No blood marker (homocysteine, glucose level, C-reactive protein, or fibrinogen levels) was associated with patency rates.
Angioplasty also was associated with better primary assisted patency and secondary patency rates at 5 years, although these differences were not statistically significant.
Both interventions were effective at maintaining amputation-free survival (angioplasty 73%, bypass 71%) and all-cause survival (77% and 80%) at 5 years. At 5 years, 68% of angioplasty patients were free from major adverse events, compared with 57% of bypass patients, a significant difference.
When short-term results were considered, angioplasty appeared at least as successful as bypass surgery. All-cause 30-day mortality was half that seen with bypass, although the difference was not significant (1.6% vs. 3%). Length of hospital stay was significantly shorter (14 vs. 24 days).
Angioplasty was significantly less expensive than bypass surgery (&z.euro;11,650 vs. &z.euro;18,700). When cost was broken down by quality-adjusted life-year, angioplasty also was significantly less expensive (cost per QALY &z.euro;5,660 vs. &z.euro;9,170).