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CONFIRM Series

Confirm-360-Series

A prospective, multi-center series of acute registries (CONFIRM I, II, and III) to evaluate the procedural outcomes of Orbital Atherectomy System (OAS) treatment in real-world patients with infrainguinal Peripheral Artery Disease (PAD).

Key Takeaways

  • Low rate of procedural complications
  • Overall 81% moderate to severely calcified infrainguinal lesions

Study Design

  • Three consecutive prospective registries conducted under a similar protocol from 2009 to 2011
  • Real-world patients with no inclusion/exclusion criteria
  • OAS used in accordance with approved indication
  • Three generations of the OAS device evaluated

Patient Population

Study Name# of Patients# of Lesions
CONFIRM I7331,146
CONFIRM II1,1271,734
CONFIRM III1,2751,886
Total3,1354,766

Lesions Treated

Study Name% Below-The-Knee (BTK)Severe, Moderate Calcium
CONFIRM I36%76%
CONFIRM II30%82%
CONFIRM III41%83%

 

Study Results

Study NameStudy OverviewKey Results
CONFIRM I
733 Patients
1,146 Lesions		Challenging Patient Population:
• 36% Renal Disease
• 61% Diabetic
• 90% Hypertension
• 82% Current or Past Smokers		Low bail-out stent rate due to dissection: 3.8%

Low rate of procedural events
• 0.9% Perforations
• 2.1% Abrupt Closure
CONFIRM II
1,127 Patients
1,734 Lesions		Challenging Patient Population:
• 37% Renal Disease
• 60% Diabetic
• 93% Hypertension
• 70% Current or Past Smokers		Low bail-out stent rate due to dissection: 5.8%

Low rate of procedural events
• 0.6% Perforations
• 1.2% Abrupt Closure
• 2.2% Embolization
CONFIRM III
1,275 Patients
1,886 Lesions		Challenging Patient Population:
• 35% Renal Disease
• 59% Diabetic
• 92% Hypertension
• 70% Current or Past Smokers		Low bail-out stent rate due to dissection: 5.2%

Low rate of procedural events
• 0.7% Perforations
• 1.4% Abrupt Closure
• 2.2% Embolization

Source

Das T, et al. Technique optimization of orbital atherectomy in calcified peripheral lesions of the lower extremities: the CONFIRM series, a prospective multicenter registry. Catheter Cardiovasc Interv. 2014;83(1):115-22.

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