Long‐term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3‐year results from the STROLL study

Bunte, Matthew C.; Cohen, David J.; Jaff, Michael R.; Gray, William A.; Magnuson, Elizabeth A.; Li, Haiyan; Feiring, Andrew J.; Cioppi, Marco; Hibbard, Robert; Gray, Bruce H.; Khatib, Yazan; Jessup, David B.; Patarca, Roberto; Du, Jing; Stoll, Hans‐Peter; Massaro, Joseph M.; Safley, David M.; Investigators, Stroll Study

doi:10.1002/ccd.27569

Cited by 17 publications

(11 citation statements)

References 25 publications

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“…6,26,27,31 All-cause mortality from the DCB group in IN.PACT SFA Japan was also consistent with studies of other endovascular modalities that have reported outcomes at 36 months, including MAJESTIC (DES, 3.6%), RESILIENT (BMS, 10.0%), DURABILITY II (BMS, 10.1%), and STROLL (BMS, 10.1%). [32][33][34][35] The rate of thrombosis after DCB angioplasty in IN.PACT SFA Japan, while low (1.5%), was consistent with what has been reported for DCBs at 36 months (IN.PACT SFA 2.0%, IN.PACT Global 5.6%, not reported in REAL-PTX, ILLUMENATE EU, or ILLUMENATE US). 6,26,27,31 Efficacy outcomes from IN.PACT SFA Japan were consistent with other DCB studies at 36 months (Table 6).…”

Section: Discussionsupporting

confidence: 86%

Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty

et al. 2020

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Purpose: To evaluate the 3-year safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA) in a Japanese population with femoropopliteal occlusive disease. Materials and Methods: The multicenter, prospective, IN.PACT SFA Japan randomized controlled trial ( ClinicalTrials.gov identifier NCT01947478) was an independently adjudicated study evaluating Japanese participants randomized 2:1 to DCB (n=68) or PTA (n=32). The effectiveness endpoint was primary patency through 36 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis (by duplex ultrasound). The effectiveness endpoint was evaluated using the Kaplan-Meier method; estimates are presented with the 95% confidence intervals (CIs). The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization through 36 months. Results: Primary patency by Kaplan-Meier estimate was higher in the DCB group (68.9%, 95% CI 57.5% to 80.2%) vs the PTA group (46.9%, 95% CI 29.6% to 64.2%) at 36 months (log-rank p=0.001). The CD-TLR rates were 14.9% (10/67) for the DCB group and 20.7% (6/29) for PTA (p=0.554). The safety composite endpoint occurred in 83.6% (56/67) of DCB participants and 75.9% (22/29) of PTA participants (p=0.402). All-cause death was similar between groups at 36 months [DCB 6.0% (4/67) vs PTA 6.9% (2/29), p>0.999), with no device- or procedure-related deaths in either group. Conclusion: The final report of the IN.PACT SFA Japan trial showed that the IN.PACT Admiral DCB is safe and had durable outcomes through 3 years in Japanese participants with femoropopliteal occlusive disease.

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Section: Discussionsupporting

confidence: 86%

Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty

et al. 2020

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“…The CEC-adjudicated all-cause mortality of 11.6% in this study is consistent with the range of 3-year rates (3.9% to 12.5%) in other contemporary studies of both drug-coated and uncoated devices. 30 – 34 Causes of death were varied and congruent with the age and the high level of comorbidities in this patient population. A study-level meta-analysis 35 reported an association between paclitaxel-coated devices (DCB and DES) and mortality.…”

Section: Discussionmentioning

confidence: 88%

Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort

et al. 2020

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Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study ( ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.

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“…The IN.PACT Global study stands up to RCTs that studied BMS. The RESILIENT, 29 STROLL, 30 DURABILITY II, 31 and SUPERB 32 trials (mean lesion lengths of ~7–9 cm), which evaluated BMS at 36 months had estimated freedom from TLR rates of 75.5%, 75.8%, 69.7%, and 82%, respectively. The MAJESTIC trial 24 (Eluvia DES) had a promising 85.3% freedom from CD-TLR estimate at 36 months.…”

Section: Putting the Study To The Testmentioning

confidence: 99%

Commentary: Leave Nothing Behind: No Stent, No Restenosis, No Mortality

2020

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It is well-known and often argued by practicing physicians that the highly selected patients in the randomized controlled trials (RCTs) of lower extremity arterial disease do not often match the patients encountered in real-world practice. 1 Therefore, it is imperative to review and understand real-world studies to see if the proof of concept is carried on from the RCTs to the ground reality. Drug-coated balloon (DCB) angioplasty for femoropopliteal arterial disease can be considered a landmark endovascular treatment strategy in the field of symptomatic lower extremity occlusive disease. 1,2 In the October 2020 issue of the JEVT, Torsello et al 4 present the 3-year outcomes of the IN.PACT Global study of DCB angioplasty in a real-world femoropopliteal cohort. To put these results into perspective, we need to thread back into history. The IN.PACT Global study 2 (ClinicalTrials.gov identifier NCT01609296) was designed to see how DCB angioplasty fared in real-world, complex femoropopliteal disease, including long lesions (≥15 cm), in-stent restenoses (ISR), chronic total occlusions (CTOs) ≥5 cm long, calcified lesions, and TransAtlantic Inter-Society Consensus (TASC) C/D lesions, as well as in the setting of poor runoff, popliteal artery involvement, and bilateral disease. The clinical presentation in the 1535 participants was consistent with claudication and chronic limb-threatening ischemia (CLTI). The first publication from the IN.PACT Global study, 5 in a 131-patient ISR subgroup (mean lesion length 17.17 cm, 34% CTOs, 59.1% with calcifications, 88% with diffuse ISR, and 42% with TASC C/D lesions), 5 found a 1-year clinically-driven target lesion revascularization (CD-TLR) rate of 7.3%, with estimated primary patency of 88.7%. The primary safety outcomes were achieved in 92.7%. The 2-year outcomes reported by Micari et al 6 on 1406 patients (1773 lesions) in the clinical cohort study were promising, with estimated freedom from CD-TLR as high as 83.3% and meeting the composite safety endpoint in 81.7%. It is reassuring to know that these positive results were sustained through 36 months, 4 with estimated freedom from CD-TLR at 76.9% and a composite safety endpoint of 75.6%. Notably, the death rate climbed from 7.0% at 24 months to 11.6% at 36 months.

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Long‐term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3‐year results from the STROLL study

Abstract: In patients undergoing revascularization for moderately complex SFA disease, use of the self-expanding S.M.A.R.T® stent was associated with a high rate of target vessel patency through 3 years and led to substantial and sustained health status benefits.

Cited by 17 publications

References 25 publications

Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty

Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty

Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort

Commentary: Leave Nothing Behind: No Stent, No Restenosis, No Mortality

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