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Zeller: IN.PACT Global Study: A 5-Year Sub-Analysis of Outcomes in Patients With CLI Versus Claudication
August 11, 2021 — On the first day of AMP 2021, Thomas Zeller, MD, from the University Heart Center Freiburg, Bad Groningen, Germany, shared with attendees a subanalysis of the 5-year outcomes from the IN.PACT Global Study, focusing specifically on the small subset of trial participants enrolled with critical limb ischemia (CLI).
The IN.PACT Global Study was a real-world, prospective, multicenter, single-arm study assessing the effectiveness and safety of the IN.PACT Admiral DCB (Medtronic) in complex femoropopliteal lesions.
Of the 1406 subject who comprise the intention-to-treat cohort of IN.PACT, 1246 had claudication (Rutherford classification 2-3) and 156 had CLI (Rutherford classification 4-5) at baseline.
Most studies of drug-coated balloons (DCBs) have included limited numbers of CLI patients and combined outcomes with patients with claudication. Hence, there are limited data on the long-term outcomes of DCBs in CLI, explained Zeller.
In the few studies that report longer-term data, the 3-year freedom from target lesion revascularization ranges from 57% to 72% after endovascular revascularization.
Overall 5-year freedom from clinically-driven target lesion revascularization (CD-TLR) through 5 years in IN.PACT was 69.4%, as previously presented by Dr. Zeller.
When divided according to claudicants versus CLI, the rates were 70.5% and 60.7%, respectively (log-rank p=0.006), showing an absolute difference of about 10% favoring the claudicants (Figure 1, below).
Interestingly, the event rates for the safety composite (freedom from device- and procedure-related death through 30 days, and freedom from target limb major amputation and CD-TVR through 60 months), and the individual components of the safety composite, were lower than 5-year rates reported in this population, noted Zeller.
He explained that this is not entirely surprising because the CLI population in this trial consisted mostly of patients with ischemic rest pain and very few patients with gangrene and nonhealing ulcers, both of which are known drivers of major amputation.
Freedom from all-cause mortality was 81.2% in the claudicant group and 60.0% in the RC 4-5 group Log rang p<0.001). Limb salvage rates through 5 years were “remarkable,” said Zeller, at 98.9% and 93.2%, respectively (Figure 2, below).
“The outcomes in this CLI cohort demonstrate that the IN.PACT Admiral DCB is a viable, long-term treatment option for this complex group of patients,” said Zeller. He noted that although the CLI numbers are small, this is one of the larger samples reporting long-term outcomes in CLI patients with femoropopliteal lesions.
