Drug-Eluting Stent Versus Drug-Coated Balloon Revascularization in Patients With Femoropopliteal Arterial Disease

Bausback, Yvonne; Wittig, Tim; Schmidt, Andrej; Zeller, Thomas; Bosiers, Marc; Peeters, Patrick; Brucks, Steffen; Lottes, Aaron E.; Scheinert, Dierk; Steiner, Sabine

doi:10.1016/j.jacc.2018.11.039

Cited by 126 publications

(70 citation statements)

References 20 publications

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“…[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). Primary patency was very similar between DCB groups in IN.PACT SFA Japan (68.9%), IN.PACT SFA (69.5%), ILLUMENATE EU (67.5%), and ILLUMENATE US (64.2%).…”

Section: Discussionsupporting

confidence: 81%

“…All-cause mortality in the DCB group from IN.PACT SFA Japan (6.0%) was within range of IN.PACT SFA (10.7%), IN.PACT Global (11.6%), REAL-PTX (10.7%), ILLUMENATE EU (9.4%), and ILLUMENATE US (10.1%). 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 – 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).…”

Section: Discussionsupporting

confidence: 76%

“…a Data are presented as the percent (number/sample) unless otherwise indicated.There were 66 evaluable participants at 2-year follow-up and 67 evaluable participants at 3-year follow-up. There were no deaths in the DCB group between 2 and 3 years.and 52.0% in DES arm; ISR not reported) compared with IN.PACT SFA Japan (16.2% occlusions, 0% ISR) 25,26,31.…”

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confidence: 92%

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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: 81%

Section: Discussionsupporting

confidence: 76%

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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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“…Auch in dieser Studie waren die 30-Tage-Komplikationsrate und die Hospitaldauer signifikant geringer in der endovaskulären Gruppe, während die Offenheitsund Reinterventionsraten nach 2 Jahren keinen Unterschied zeigten. Einen direkten Vergleich zwischen den Behandlungsergebnissen von DCB mit der chirurgischen Bypassanlage gibt es nicht, aber eine randomisierte Vergleichsstudie mit DES (ZilverPTX) [11]. Die REAL-PTX-Studie resultierte in einem 3-jährigen Verlaufszeitraum in vergleichbaren Offenheitsraten und Reinterventionsraten mit einem Trend für bessere Ergebnisse in Läsionen länger als 20 cm für die DES.…”

Section: A Femoralis Superficialisunclassified

Periphere arterielle Verschlusskrankheit der unteren Extremitäten

Zeller¹

2020

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“…10 However, even though DCBs exhibit promising primary patency rates after 1 year, the implantation of provisional stents remains necessary following DCB treatment in a substantial number of patients with complex lesions. [11][12][13] Because DCB therapy is associated with elastic recoil or the development of flowlimiting dissections, the quality of lesion preparation with non-coated normal balloons must be improved.…”

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confidence: 99%

Efficacy of Super Slow Inflation as Lesion Preparation for Drug-Coated Balloons in Femoropopliteal Lesions

et al. 2020

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Background: Drug-coated balloon strategies in endovascular therapy often result in severe dissection, so lesion preparation must be improved. We evaluated the efficacy of a gradual inflation method, termed "super slow inflation" (SSI), in preparing lesions to avoid severe dissections. Methods and Results: The association between balloon pressure and the dilatation of a model constricted vessel, as well as the load applied to the balloon surface, were determined using a burst leak detector for a quick inflation (QI; 1 atm/s) protocol and SSI (1 atm/20 s). A retrospective, single-center, non-randomized study evaluated differences in vessel dissection patterns after balloon angioplasty depending on inflation method in 81 consecutive patients (mean [±SD] age 74.6±9.2 years; 54 males) who underwent balloon angioplasty for de novo femoropopliteal lesions between January 2017 and March 2019. In the constricted vessel model, vessel dilatation increased gradually using SSI, with the maximum dilatation load being approximately 100 g lower for the SSI than QI protocol. In patients, the rate of severe vessel dissection was significantly lower in the SSI than non-SSI group (17.6% vs. 55.2%, respectively; P<0.001). Multivariate regression analysis revealed that SSI was an independent factor preventing severe dissection (odds ratio 0.18; 95% confidence interval 0.06-0.53; P=0.002). Conclusions: SSI is a gentle and effective method for the preparation of femoropopliteal lesions to reduce the incidence of severe angiographic dissection when using drug-coated balloons.

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Drug-Eluting Stent Versus Drug-Coated Balloon Revascularization in Patients With Femoropopliteal Arterial Disease

Cited by 126 publications

References 20 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

Periphere arterielle Verschlusskrankheit der unteren Extremitäten

Efficacy of Super Slow Inflation as Lesion Preparation for Drug-Coated Balloons in Femoropopliteal Lesions

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