CHICAGO — Three-year data from the IN.PACT SFA trial demonstrated superior efficacy with drug-coated balloons, compared with standard percutaneous transluminal angioplasty balloons, for treatment of superficial femoral and proximal popliteal artery disease in women and patients with diabetes.
“This disease remains a challenge to manage in women and patients with diabetes…We’ve seen lower success rates in women as compared to men treated with DCBs in [the THUNDER and LEVANT] trials, and patients with diabetes typically present with more advanced peripheral artery disease affecting small vessels, resulting in an increased risk for mortality and limb loss,” Thomas Zeller, MD, from Universitaets-Herzzentrum Freiburg-Bad Krozingen, Germany, said during a presentation of the data at AMP: The Amputation Prevention Symposium. “A need exists to demonstrate evidence-based effectiveness of DCBs in these challenging populations.”
DCB vs. PTA in women
In a subanalysis of the prospective, multicenter, randomized IN.PACT SFA trial, Zeller and colleagues evaluated differences in outcomes with DCB (In.Pact Admiral DCB, Medtronic Peripheral) vs. PTA between sexes.
At 3 years, the primary endpoint of primary patency favored DCB over PTA in both men (71.8% vs. 46.7%; P < .001) and women (65.4% vs. 42.3%; P = .005).
Additionally, clinical benefit with DCB vs. PTA was observed in both sexes. At 3 years, rates of freedom from clinically driven target lesion revascularization for those treated with DCB vs. PTA were 86.4% vs. 75.5% (P = .021) in men and 86.1% vs. 59.4% (P = .004) in women. Zeller also noted there were more reinterventions with PTA vs. DCB by Kaplan-Meier estimate in men (clinically driven TLR, 25.7% vs. 13.3%; P = .033) and women (clinically driven TLR, 42.4% vs. 18%; P = .016).
There were also no differences in the safety endpoint of freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically-driven target vessel revascularization between men and women treated with DCB vs. PTA.
“There was a significant patency benefit with DCB over plain balloon angioplasty in both gender populations that were sustained out to 3 years with no catch-up for either gender,” Zeller said.
DCB vs. PTA in diabetes
Zeller and colleagues also conducted a subanalysis of patients with diabetes.
At 3 years, primary patency using Kaplan-Meier estimates in patients with diabetes treated with DCB was 63.6% vs. 42.1% in patients without diabetes treated with PTA (P < .01). Similarly, primary patency was 73.5% in patients without diabetes treated with DCB vs. 42.3% (P < .001) in patients without diabetes treated with PTA, according to the data.
Additionally, freedom from clinically driven TLR by Kaplan-Meier estimate in patients with diabetes treated with DCB was 81.1% vs. 69.8% in patients without diabetes treated with PTA (P = .055) and 86.5% in patients without diabetes treated with DCB vs. 71% in patients without diabetes treated with PTA (P = .004).
“These gender and diabetic analyses add to the robust body of independently adjudicated evidence for the IN.PACT Admiral DCB,” Zeller said. “The beneficial DCB treatment effect in historically challenging female patients is unique to the IN.PACT Admiral DCB. The DCB is also significantly more effective than PTA in patients with diabetes mellitus who typically present with more advanced PAD. This longer-term evidence has the potential to continue to drive a paradigm shift in SFA interventions.” – by Melissa Foster
Zeller T. General Session 4: Aortic iliac and below: Where do we stand? Presented at: AMP: The Amputation Prevention Symposium; Aug. 9-12, 2017; Chicago.
Disclosure: The IN.PACT trial was sponsored by Medtronic Endovascular. Zeller reports receiving honoraria and/or grant or research support from 480 Biomedical, Abbott Vascular, B. Braun, Bard Peripheral Vascular, Bayer Pharmaceuticals, Biotronik, Boston Scientific, Cardiovascular Systems Inc., Caveo Medical, Cordis, Contego Medical, Cook Medical, GLG, Intact Vascular, Innora, Medtronic, Mercator, Philips-Volcano, Pluristem, Spectranetics, Straub Medical, Terumo Medical, TriReme, Shockwave Medical, Veryan, VIVA Physicians and W.L. Gore and Associates.