Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study

Abstract

Purpose: To report a post hoc analysis comparing outcomes between subjects who would have been included in the IN.PACT SFA randomized controlled trial vs those who would have been excluded. Methods: The 1406 subjects enrolled in the IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) were retrospectively assigned to a standard-use group (n=281) based on the inclusion and exclusion criteria from the randomized IN.PACT SFA trial; the remaining 1125 patients were assigned to the broader-use group. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated at 12 months. The composite primary safety endpoint was freedom from 30-day device- and procedure-related death plus freedom from 12-month target limb major amputation and clinically-driven target vessel revascularization (CD-TVR). Functional outcomes were evaluated with dedicated questionnaires. Results: Compared with the standard-use cohort, the broader-use lesions were longer, more calcified, and had more popliteal involvement, bilateral disease, and in-stent restenosis (p<0.001 for all). Freedom from 12-month CD-TLR by Kaplan-Meier analysis was 96.6% for the standard-use group and 91.6% for the broader-use group (p=0.005). The safety endpoint was 96.2% in the standard-use group and 91.0% in the broader-use group (p=0.003). The 12-month CD-TLR (3.4% standard-use vs 8.5% broader-use, p=0.004) and CD-TVR (4.2% standard-use vs 9.1% broader-use, p=0.008) were increased in the broader-use group. Twelve-month all-cause mortality was not increased (3.8% standard-use vs 3.4% broader-use, p=0.852). Conclusion: Post hoc analysis of the IN.PACT Global Study of real-world patients demonstrated consistent outcomes with significant clinical improvement to 12 months in subjects with complex lesions typically excluded from a randomized controlled trial.

Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions

“…Recent data from prospective as well as retrospective registries/studies also demonstrated that DCB angioplasty provides consistent clinical benefit in cohorts of long lesions, 7,29 in-stent restenosis, 8 and other complex lesions. 9,30,31 Although only short-term outcomes (1 and 2 years) are available for these registries/studies; these results provide additional evidence that DCB is a viable treatment option for complex lesion/patient cohorts. Previously, we reported a superior treatment effect of DCB in patients with diabetes mellitus as compared with PTA.…”

Use of Paclitaxel-Eluting Technologies in the Femoropopliteal Segment Under Scrutiny Over Possible Link to Late All-Cause Mortality: Time to Panic or an Opportunity to Resurge?

“…In particular, 3 DCBs and 2 DES are currently supported by broad and robust evidence, beyond just first-in-human trials, consisting of rigorous, independently adjudicated randomized pivotal trials and large real-world datasets. [1][2][3][4][5][6][7][8][9][10] The most recently released practice guidelines from the Society for Cardiovascular Angiography and Interventions have therefore elected DCB as first line endovascular therapy with the highest level of recommendation (I-A) for a wide array of indications in the femoropopliteal segment. 11 Also noteworthy, several "no-class-effect" claims have been largely and consistently raised pertaining to paclitaxeleluting technologies, specifically based on the multitude of observed technical differences and related outcome variances demonstrated in preclinical and clinical trials.…”

Six-Month Angiographic and Clinical Outcomes of Therapeutic Ultrasound Pretreatment Associated With Plain Balloon Angioplasty for Below-the-Knee Lesions in Patients With Critical Limb Ischemia: A Prospective, Single-Center Pilot Study

“…8 Also, the Biolux P-II randomized trial, 9 which compared 36 patients treated with Passeo 18 DCBs and 36 treated with Passeo 18 plain balloons failed to demonstrate any advantage of the DCB. One theory to explain this gap between the BTK territory and the SFA, where improved patency was obtained with DCBs, 20,21 could be explained by the anatomic differences.…”

“…One theory to explain this gap between the BTK territory and the SFA, where improved patency was obtained with DCBs, 20,21 could be explained by the anatomic differences. Patients with CLI frequently present more severe lesions that are longer and more calcified compared to claudicants with SFA disease.…”