Document Detail

Comparison of Orbital Atherectomy Plus Balloon Angioplasty vs. Balloon Angioplasty Alone in Patients With Critical Limb Ischemia: Results of the CALCIUM 360 Randomized Pilot Trial.
MedLine Citation:
PMID:  22891826     Owner:  NLM     Status:  In-Data-Review    
Purpose: To evaluate the role of orbital atherectomy in calcified infrapopliteal arteries in patients with critical limb ischemia compared to balloon angioplasty (BA) alone. Methods: A randomized multicenter study was undertaken to evaluate short and 1-year outcomes in 50 patients (32 men; mean age 71 years, range 40-90) with confirmed calcified lesions using 1∶1 randomization to the Diamondback 360° Orbital Atherectomy System followed by BA vs. BA alone. All patients had severe (≥50% stenosis) peripheral artery disease (Rutherford classification 4-6) in the popliteal, tibial, and/or peroneal arteries. The primary endpoint was defined as restoration of a normal lumen (residual stenosis ≤30%) with no bailout stenting or dissection types C through F. Scheduled follow-up visits were conducted according to a common protocol at 1, 6, and 12 months. Results: Procedural success was 93.1% (27/29 lesions) for atherectomy + BA patients and 82.4% (28/34 lesions) for BA alone (p = 0.27). Bailout stenting was needed in 2 (6.9%) of the 29 atherectomy + BA lesions and in 5 (14.3%) of the 35 BA-treated lesions (p = 0.44). At 1 year, there were no amputations in either group related to the index procedure. Estimates for freedom from target vessel revascularization and all-cause mortality were 93.3% and 100% in the atherectomy + BA group vs. 80.0% (p = 0.14) and 68.4% (p = 0.01) in the BA group, respectively. Proportional hazard models evaluating survival time vs. status of residual stenosis determined a hazard ratio for major adverse events of 5.6 for patients with an acute post-procedure residual stenosis >30% (p = 0.01). Conclusion: Debulking with orbital atherectomy appeared to increase the chance of reaching a desirable angioplasty result, with less acute need for bailout stenting and a higher procedure success. A negative association between procedure success and risk of serious adverse outcomes should encourage larger confirmatory studies.
Nicolas W Shammas; Russell Lam; Jihad Mustapha; Jonathan Ellichman; Gaurav Aggarwala; Ernesto Rivera; Khusrow Niazi; Nilesh Balar
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists     Volume:  19     ISSN:  1545-1550     ISO Abbreviation:  J. Endovasc. Ther.     Publication Date:  2012 Aug 
Date Detail:
Created Date:  2012-08-15     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100896915     Medline TA:  J Endovasc Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  480-8     Citation Subset:  IM    
Midwest Cardiovascular Research Foundation, Davenport, Iowa, USA.
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