CONFIRM Series Economic Evidence | CSI360
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CONFIRM Series Economic Evidence

The CONFIRM registry series is a database of patients with peripheral artery disease (PAD) who were treated with orbital atherectomy in both office-based laboratories (OBLs) and hospital settings. Statistical analyses assessed the outcomes of atherectomies performed in OBL compared to hospitals.

Key Takeaways

  • Final residual stenosis after adjunctive therapy was 10%±11% in the hospital group and 11±17% in the OBL group
  • Dissections occurred in 11.4% of the lesions in the hospital group vs. 6.5% in the OBL group
  • Adjusted logistic regressions showed no difference in any individual or overall complication rate
  • Orbital atherectomy treatment of PAD in an OBL was found comparable to treatment in a hospital setting

Study Design

  • Procedural data collected for 3,135 PAD patients at 212 sites in the US treated with OAS for at least one lesion
  • Statistical analyses included Student t test for continuous measures, Chi-square test for categorical measures and logistic regression for complication rates
  • Designed to assess the procedural outcomes of atherectomy in the OBL setting

Patient Population

PatientsHospital GroupOBL Group
Male (%)6061
Mean age (years)71.4
Previous or current smoker (%)7675
History of (%)
Diabetes6060
Coronary artery disease6664
Hypertension9288
Hyperlipidemia8185
Renal Disease3641

 

Study Results

Procedural ComplicationHospital GroupOffice-Based Laboratory Group
Dissection530/4,658 (11.4%)7/108 (6.5%)
Flow-limiting71/4,658 (1.5%)0/108 (0.0%)
Non-flow-limiting272/4,658 (5.8%)7/108 (6.5%)
Unknown187/4,658 (4.0%)0/108 (0.0%)
Perforation34/4,658 (0.7%)0/108 (0.0%)
Slow flow212/4,658 (4.6%)0/108 (0.0%)
Closure67/4,658 (1.4%)3/108 (2.8%)
Spasm297/4,658 (6.4%)4/108 (3.7%)
Embolism81/3,512* (2.3%)0/108 (0.0%)
Thrombus42/3,512* (1.2%)2/108 (1.9%)
Any complication1,030/4,658 (22.1%)14/108 (13.0%)

*Embolism and thrombus data not collected in CONFIRM I (n=1,146 lesions)

Source

Mayeda, G, & Pliagas, G. CRT-209 Procedural Outcomes of Orbital Atherectomy Treatment of Peripheral Arterial Disease in an Outpatient Office-Based vs. Hospital Setting. JACC: Cardiovascular Interventions, 2014;2(7), S36.

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