A delay of greater than 30 days between diagnosis with chronic limb-threatening ischemia (CLTI) and limb revascularization is associated with an increased risk of amputation, reports an analysis of real-world Medicare claims data. These findings were presented by Alexander Fanaroff, MD, MHS, from the University of Pennsylvania, on Tuesday at Cardiovascular Revascularization Technologies (CRT) 2024 in Washington, D.C. Speaking at CRT 2024, Fanaroff noted that the extent and consequences of ischemia in patients with CLTI may change rapidly, warning that delays from diagnosis to revascularization may worsen outcomes. “We sought to describe the association between time from diagnosis to endovascular lower-extremity revascularization (diagnosis-to-limb revascularization [D2L] time) and clinical outcomes in outpatients with CLTI,” said Fanaroff. “A delay of greater than 30 days from CLTI diagnosis to lower-extremity endovascular revascularization was associated with an increased risk of major lower-extremity amputation among patients undergoing outpatient endovascular revascularization,” he added. “Improving systems of care to reduce D2L time could reduce amputations.” Study details Fanaroff and colleagues used Medicare claims data to identify patients between 66 and 86 years old who were diagnosed with CLTI between 2010 and 2019 and underwent outpatient endovascular revascularization within 180 days of diagnosis. They then analyzed the risk-adjusted association between D2L time and clinical outcomes in the cohort using clinical outcomes including major lower-extremity amputation, all-cause death, any amputation and a composite of all-cause death and major lower extremity amputation. Cox proportional hazards models were used to determine the association between D2L time and clinical outcomes, adjusting for clinical and demographic variables, he noted. “Of 1.13 million patients with CLTI between 2010 and 2019, 99,221 (8.8%) underwent outpatient lower extremity revascularization within 180 days,” said Fanaroff, noting that 45,420 (45.8%) of patients underwent revascularization within 30 days of diagnosis, while 53,801 (54.2%) of patients underwent revascularization between 31 and 180 days. Among patients with D2L time <30 days, there was no association between D2L time and all-cause mortality or major lower-extremity amputation (hazard ratio [HR] 0.96, 95% confidence interval [CI] 0.909-1.010; p = 0.11 per 10-day increase in D2L time), he reported. However, among patients with D2L time >30 days, the analysis found that each additional 10-day increase in D2L time was associated with a 2.5% greater risk of major amputation (HR 1.025, [95% CI 1.014-1.036], p < 0.001). There was no association between D2L time and all-cause mortality, Fanaroff confirmed (<30 days HR: 1.01 [95% CI 0.98-1.04] per 10-day increase; >30 days HR: 1.00 [95% CI 0.99-1.00] per 10-day increase). Fanaroff concluded that a D2L time of greater than 30 days carried approximately the same risk to patients as a door-to-balloon (D2B) time of greater than 90 minutes in percutaneous coronary intervention (PCI) patients – noting an 8% increase in risk of death for every 10-minute increase in D2B beyond 90 minutes, and an approximate 7.5% increase in risk of amputation with every 30-day increase in D2L beyond 30-days. “In patients with CLTI, revascularization should be performed when possible, within 30 days of diagnosis, to minimize tissue loss,” he said, warning that similar efforts that have seen improved outcomes as a result of lowering of D2B are needed for D2L in CLTI patients. “CLTI care is fragmented among many different specialties, and arranging revascularization after CLTI diagnosis requires coordination,” he said. “Without process measures to assess this complex care process, limited incentives and information for stakeholders to develop collaborative patient-centered care pathways.” Photo Credit: Jason Wermers/CRTonline.org Photo Caption: Alexander Fanaroff, MD, MHS, presents findings from the CLIPPER study Tuesday at CRT 2024 in Washington, D.C.