Infrapopliteal Angioplasty Shows Long-term Promise for Critical Limb Ischemia
Infrapopliteal angioplasty is an effective primary therapy for all but the most severe cases of critical limb ischemia (CLI), according to a study published online February 1, 2013, ahead of print in the Journal of Vascular Surgery.
Marc L. Schermerhorn, MD, of Beth Israel Deaconess Medical Center (Boston, MA), and colleagues looked at infrapopliteal angioplasty cases (14% stenting and 50% multilevel intervention) in 459 limbs (413 patients) from February 2004 to February 2012. Patients were categorized by suitability for bypass while lesions were classified according to the TransAtlantic Inter-Society Consensus (TASC) according to severity:
- TASC A: 16%
- TASC B: 22%
- TASC C: 27%
- TASC D: 34%
Clinical Outcomes Good in Most Lesions
Technical success was achieved in 93% (n = 427) of limbs. All of the 32 technical failures involved TASC D lesions and 26 were attributable to inability to cross an occlusion. After a mean follow-up of 15 months, in-hospital and 30-day mortality were 2% and 6%, respectively; post-operative clinical outcomes such as access site arterial injury (4%), AKI (2%), and AMI (1%) were low.
Bivariate analysis found higher 30-day mortality in patients who were:
- Older (< 60 years 2%; 61-70 years 1%; 71-80 years 4%; > 80 years 13%; P = 0.001)
- Had higher postoperative complications (21% vs. 4%; P < 0.001)
- Not prescribed postoperative clopidogrel on discharge (12% vs. 3%; P = 0.010)
- Not bypass candidates (10% vs. 4%; P = 0.034) including the subgroup of those who had a medical contraindication to bypass (21% vs. 5%; P = 0.004)
Survival was 49% at 5 years. TASC class was not associated with long-term mortality.
One- and 5-year primary patency rates were 57% and 38%, and limb salvage was 84% and 81%, respectively. Multivariate analysis found that predictors of loss of patency were TASC D lesions (HR 2.35; 95% CI 1.33-4.16; P = 0.003) and unsuitability for bypass (HR 2.01; 1.33-3.033; P = 0.001). The 30-day major amputation rate was 4%. Freedom from amputation was associated with TASC class (P = 0.006) with 1-year limb salvage rates of 95% for TASC A, 87% for TASC B, 81% for TASC C, and 80% for TASC D. Amputation rates were higher in patients who were not candidates for bypass (HR 4.39; 95% CI 2.57-7.48; P < 0.001) and with TASC D lesions (HR 3.75; 95% CI, 1.13-12.49; P = 0.003).
Restenosis was associated with TASC C (HR 2.16; 95% CI 1.20-3.88; P = 0.010) and TASC D (HR 2.42; 95% CI 1.32-4.43; P = 0.004) lesions.
Freedom from any subsequent revascularization was 74% and 50% at 1 and 5 years, respectively. Unsuitability for bypass was predictive of repeat angioplasty (HR 1.84; 95% CI 1.01-3.35; P = 0.047). Additionally, postoperative clopidogrel use was associated with lower rates of any subsequent revascularization (HR 0.46; 95% CI 0.25-0.83; P = 0.011).
‘Reasonable First-line Therapy’
“Infrapopliteal angioplasty can achieve limb salvage and survival rates at 5 years comparable to those of surgical bypass and, thus, can be considered a reasonable first-line therapy in the treatment of TASC A, B, and perhaps C lesions even in a patient with adequate conduit available,” the authors conclude. “TASC D lesions should preferably be treated with bypass in patients who are suitable candidates for surgery, with suitable distal targets, and adequate venous conduit.”
Patients who are not bypass candidates “should be counseled about their higher risk for repeat [angioplasty] and/or amputation,” they continue. “Comparisons of [angioplasty] with bypass should account for this potential difference in patient populations.”
But in an e-mail communication with TCTMD, Krishna J. Rocha-Singh, MD, of Prairie Heart Institute at St. John’s Hospital (Springfield, IL), said the study “raises numerous issues and, to my view, [is] a bit lacking in perspective.” Because it “uses outdated clinical endpoints, [the] article would have us believe that [angioplasty] and surgery have solved the CLI issue and there is no need for improvement,” he added.
“While our results are decent, . . . they are certainly far from great,” Dr. Schermerhorn told TCTMD in a telephone interview. “Some other therapy” is needed to improve results, he added, be it drug-eluting balloons, routine stenting with a tibial artery-specific stent, or some other biologic therapy.
Going forward, it will be important to better determine which patients are at risk for complications and if they are ultimately related to the intervention or another comorbidity, Dr. Schermerhorn added.
Multilevel intervention included concomitant angioplasty with or without stenting of the iliac, femoral, or popliteal vessels.
About one-third of patients had undergone at least 1 prior procedure (angioplasty, bypass graft, or minor amputation) on the ipsilateral limb. Of the 38 who had undergone a previous angioplasty, only 2 were infrapopliteal.
Lo RC, Darling J, Bensley RP, et al. Long-term outcomes following infrapopliteal angioplasty for critical limb ischemia. J Vasc Surg. 2013;Epub ahead of print.
- Dr. Schermerhorn reports serving as a consultant to Endologix and Medtronic.
- Dr. Rocha-Singh reports no relevant conflicts of interest.