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

被引:23
作者
Ansel, Gary M. [1 ]
Brodmann, Marianne [2 ]
Keirse, Koen [3 ]
Micari, Antonio [4 ]
Jaff, Michael R. [5 ]
Rocha-Singh, Krishna [6 ]
Fernandez, Eric J. [7 ]
Wang, Hong [7 ]
Zeller, Thomas [8 ]
机构
[1] Riverside Methodist Hosp, Dept Med, Ohio Hlth, 3705 Olentangy River Rd Suite 100, Columbus, OH 43214 USA
[2] Med Univ, Dept Internal Med, Div Angiol, Graz, Austria
[3] Reg Hosp Heilig Hart, Dept Vasc Surg, Tienen, Belgium
[4] Maria Cecilia Hosp, GVM Care & Res, Cotignola, Italy
[5] Newton Wellesley Hosp, Newton, MA USA
[6] Prairie Heart Inst, Springfield, IL USA
[7] Medtron, Santa Rosa, CA USA
[8] Univ Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany
关键词
angioplasty; drug-coated balloon; femoropopliteal segment; peripheral artery disease; popliteal artery; superficial femoral artery; target lesion revascularization; stenting; ARTERIAL-DISEASE; PACLITAXEL; ANGIOPLASTY; RESTENOSIS; MULTICENTER; INHIBITION; DELIVERY; IMPACT;
D O I
10.1177/1526602818803119
中图分类号
R61 [外科手术学];
学科分类号
摘要
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.
引用
收藏
页码:673 / 682
页数:10
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