Risk of major amputation or death among patients with critical limb ischemia initially treated with endovascular intervention, surgical bypass, minor amputation, or conservative management.

Aims: Patients with critical limb ischemia (CLI) have an increased risk of major amputation. The initial treatment approach for CLI may significantly impact the subsequent risk of major amputation or death. The objective of this study was to describe the initial treatment approaches of patients with CLI and the limb outcomes associated with each approach.

Methods: Data from MarketScan Commercial and Medicare Supplemental Databases from January 2006-December 2014 was utilized. Cohorts of CLI patients were defined as follows: (1) peripheral vascular intervention (PVI); (2) peripheral vascular surgery (PVS); (3) minor amputation without concomitant PVI or PVS (MinAMP); and (4) Patients without PVI, PVS, or MinAMP (conservative therapy). The odds of major amputation or inpatient death were estimated using the Cox proportional hazards model. For those patients requiring a major amputation, the incremental expenditures per member per month (PMPM) were estimated using a gamma log-link model.

Results: Conservative therapy was associated with significantly higher odds of major amputation or inpatient death compared to patients who underwent minor amputation (1.59-times), PVI (2.08-times), or PVS (2.12-times). Patients treated with an initial strategy of minor amputation also had higher odds of major amputation or inpatient death compared to PVS (1.31-times) or PVI (1.33-times). The estimated incremental expenditures PMPM for patients with a major amputation was $5,165.

Conclusions: Revascularization reduces the risk of a major amputation or inpatient death for patients with CLI when compared to conservative therapy. Major amputation is also associated with significantly higher healthcare expenditures.