Provisional focal stenting of complex femoropopliteal lesions using the Multi-LOC multiple stent delivery system – 12-month results from the LOCOMOTIVE EXTENDED study

Summary: Background: This study aimed to evaluate a Multiple Stent Delivery System for provisional focal stenting of the femoropopliteal artery. Patient and methods: The LOCOMOTIVE EXTENDED study (Multi-LOC for flOw liMiting Outcomes after plain old balloon angioplasty and/or drug-coated balloon Treatment in the infrainguinal position with the objectIVE to implant multiple stent segments) is a prospective, single-arm, multicentre observational study. The Multi-LOC Multiple Stent Delivery System (B.Braun, Melsungen, Germany) was used for provisional focal stenting of the femoropopliteal artery. We enrolled 357 patients with 449 femoropopliteal lesions; all had flow-limiting dissections or recoil following angioplasty. Eligibility included Rutherford classification 2 to 5 with a de novo or non-stented restenotic femoropopliteal lesion undergoing plain balloon or drug-coated balloon angioplasty. The 6- and 12-month efficacy endpoints encompassed target lesion revascularisation and primary patency rates. Results: The mean patient age was 71 ± 10 years. The mean lesion length was 16.0 ± 9.7 cm; 44.5% were TASC II C/D lesions and 31.4% were chronic total occlusions. By operator choice, 45% of the patients underwent drug-coated balloon angioplasty. On average, 4.0 stents (each 13 mm long) were placed in each lesion, resulting in a scaffolding proportion of 56% of the total lesion length with a technical success rate of 98.3%. At 6 and 12 months, the freedom from clinically driven target lesion revascularisation was 95.5% and 88.7% and the primary patency rates were 88.7% and 82.3%, respectively. At 12 months, significant improvements were noted in Rutherford categories and ankle-brachial indices. In multiple regression analyses, both diabetes mellitus and no distal run-off vessel showed a trend toward worse TLR, while other factors such as DCB predilation or the lesion length were not predictive. Conclusions: The LOCOMOTIVE EXTENDED study demonstrated the safety and efficacy of the Multi-LOC stent system for focal provisional stenting of complex femoropopliteal lesions.

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Effectiveness of the Pulsar-18 self-expanding stent with optional drug-coated balloon angioplasty in the treatment of femoropopliteal lesions – the BIOFLEX PEACE All-Comers Registry

VASA ◽

10.1024/0301-1526/a000785 ◽

2019 ◽

Vol 48 (5) ◽

pp. 425-432 ◽

Cited By ~ 1

Author(s):

Michael Lichtenberg ◽

Frank Breuckmann ◽

Veronika Kramer ◽

Stefan Betge ◽

Sebastian Sixt ◽

...

Keyword(s):

Balloon Angioplasty ◽

Target Lesion ◽

Primary Patency ◽

Walking Distance ◽

Limb Amputation ◽

Lesion Length ◽

Nitinol Stent ◽

Safety Outcome ◽

Patient Reported ◽

Drug Coated Balloon

Summary. Background: Previous studies showed favorable results after treatment of femoropopliteal lesions with the Pulsar-18 self-expanding (SE) nitinol stent. The objective of this registry was to evaluate whether these results will be confirmed in a real-world setting with varying stenting strategies. Patients and methods: In this prospective, observational trial, 160 patients with 186 femoropopliteal lesions were treated with the Pulsar-18 SE nitinol stent at 9 German sites. Mean lesion length was 116 ± 103 mm, and 41.9 % of the lesions were moderately or heavily calcified. Eighty lesions were concomitantly treated with drug-coated balloon (DCB). Main effectiveness outcome was primary patency at 12 months, and main safety outcome was freedom from the composite of device or procedure related death, major target limb amputation, and clinically driven target lesion revascularization (TLR) at 30 days and 6 months. Results: Kaplan-Meier estimate of primary patency was 89.1 %, 67.3 %, and 57.1 % at 6, 12, and 24 months. Freedom from TLR was 95.5 %, 91.4 %, and 85.2 % at 6, 12, and 24 months, respectively. Lesions, which were additionally treated with DCB (plus DCB-group), were longer (150 versus 82 mm on average, p < 0.0001), and associated with lower primary patency estimates than those without DCB angioplasty (stent-only-group) (log-rank p = 0.006). However, there was no difference in freedom from TLR between groups (log-rank p = 0.542). Improvement by ≥ 1 Rutherford category was achieved in 84.8 %, 81.0 %, and 81.7 % of patients at 6, 12, and 24 months, respectively. Walking distance and patient-reported pain improved persistently through 24 months (p < 0.001). Hemodynamic improvement was achieved in 68.2 %, 73.7 %, and 70.7 % of the patients at 6, 12, and 24 months, respectively. Conclusions: The Pulsar-18 self-expanding nitinol stent with optional drug-coated balloon angioplasty can be considered an efficacious and safe therapy option for endovascular treatment of femoropopliteal artery disease.

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Drug-Coated Balloon Angioplasty Compared With Uncoated Balloons in the Treatment of Infrapopliteal Artery Lesions (AcoArt II–BTK)

Journal of Endovascular Therapy ◽

10.1177/1526602820969681 ◽

2020 ◽

pp. 152660282096968

Author(s):

Xin Jia ◽

Baixi Zhuang ◽

Feng Wang ◽

Yongquan Gu ◽

Jiwei Zhang ◽

...

Keyword(s):

Balloon Angioplasty ◽

De Novo ◽

Randomized Study ◽

Balloon Catheter ◽

Target Lesion ◽

Primary Patency ◽

Control Group ◽

Lesion Length ◽

Significant Difference ◽

Drug Coated Balloon

Purpose To compare the safety and efficacy of drug-coated balloon (DCB) vs uncoated balloon angioplasty in the treatment of de novo and restenotic infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods The prospective, multicenter, randomized study AcoArt II–BTK study ( ClinicalTrials.gov identifier NCT02137577) enrolled 120 patients who were randomly assigned to angioplasty with either a DCB (n=61; mean age 70.7±7.4 years; 36 men) or a conventional balloon catheter (n=59; mean age 70.8±9.0 years; 36 men). There were no significant differences observed in baseline clinical or target lesion characteristics between the groups. The target lesion length was 169.95±86.35 mm in the DCB group vs 179.93±80.16 mm in the control group, and approximately three-quarters of the lesions were chronic occlusions. Primary patency was assessed by angiography at 6 months, and mortality and clinically-driven target lesion revascularization (CD-TLR) were evaluated at 12 months. Results Primary patency at 6 months was 75.0% in the DCB group and 28.3% in the control group (p<0.001), while late lumen loss was 0.43±0.62 mm for DCBs vs 0.99±0.55 mm for controls (p<0.001). Freedom from CD-TLR at 12 months was 91.5% in the DCB group vs 76.8% in the controls (p=0.03); there was no significant difference in mortality (1.7% DCB vs 3.6% controls; p=0.53). Conclusion This study demonstrated that the Litos/Tulip DCBs are safe and effective in treating infrapopliteal lesions, with improved angiographic and clinical outcomes vs plain balloon angioplasty. The DCBs demonstrated significantly higher primary patency with fewer CD-TLRs than conventional angioplasty. The safety of the DCBs was noninferior to that of the uncoated balloons after 1 year of follow-up.

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First-in-man experience of self-expanding nitinol stents combined with drug-coated balloon in the treatment of femoropopliteal occlusive disease

Vascular ◽

10.1177/1708538117705805 ◽

2017 ◽

Vol 26 (1) ◽

pp. 3-11 ◽

Cited By ~ 6

Author(s):

Bibombe Patrice Mwipatayi ◽

Kalpa Perera ◽

Ali Daneshmand ◽

Rhys Daniel ◽

Jackie Wong ◽

...

Keyword(s):

Target Lesion ◽

Bare Metal Stent ◽

Primary Patency ◽

Occlusive Disease ◽

Secondary Patency ◽

Target Lesion Revascularisation ◽

Metal Stent ◽

The Mean ◽

Drug Coated Balloon

Purpose The present study aimed to determine the safety and efficacy of a drug-coated balloon inflated within a thin-strut self-expanding bare-metal stent in patients with severe and complex femoropopliteal occlusive disease. Methods This prospective study used the Pulsar-self-expanding stent and Passeo-18 Lux drug-coated balloon in patients with severe and complex femoropopliteal occlusive disease. The primary endpoint was the 12-month primary patency, and the secondary endpoints included 24-month primary patency, assisted primary patency, secondary patency, and clinically associated target lesion revascularisation. Results The study included 44 patients (51 limbs). The mean age of the patients was 67.6 ± 10.2 years, with 73% men. Chronic limb severity was classified as Rutherford Category III in 41% of the patients, stage IV in 31%, and stage V in 27%. Lesions were predominantly Trans-Atlantic Inter-Society Consensus (TASC 2007) D (51%) and C (45%), with 32 (63%) chronic total occlusions. Procedural success was obtained in all cases. The mean lesion length was 200 ± 74.55 mm (95% CI = 167.09–208.01) with a mean number of stents per limb used of 1.57 ± 0.70 (95% CI = 1.37–1.76). Distal embolisation occurred in two patients. The primary patency rates at the 12- and 24-month follow-up were 94% (95% CI = 82.9–98.1) and 88% (95% CI = 75.7–94.5), respectively. The assisted primary was 94% (95% CI = 82.9–98.1) and secondary patency was 96% (95% CI = 85.2–99.0) at 24-month follow-up. The cumulative stent fracture rate at the 24-month follow-up was 10%. Freedom from clinically driven target lesion revascularisation was 94% (95% CI = 83–98%) at 12-month follow-up and 88% (95% CI = 76–94%) at 24-month follow-up, with two patients requiring a bypass graft. Conclusion Our novel approach involving the combination of a thin-strut bare-metal stent and a drug-coated balloon may be safe and effective, with sustainable and promising clinical outcomes up to 24 months after treatment.

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Association between post-balloon angioplasty dissection and primary patency in complex femoropopliteal artery disease: 2-year clinical outcomes of the AcoArt I trial

Journal of International Medical Research ◽

10.1177/03000605211006546 ◽

2021 ◽

Vol 49 (4) ◽

pp. 030006052110065

Author(s):

Hao Ren ◽

Jie Liu ◽

Jiwei Zhang ◽

Baixi Zhuang ◽

Weiguo Fu ◽

...

Keyword(s):

Balloon Angioplasty ◽

Cox Regression ◽

Target Lesion ◽

Transluminal Angioplasty ◽

Outcome Data ◽

Primary Patency ◽

Cox Regression Analysis ◽

Femoropopliteal Artery ◽

Artery Disease

Objective To assess the association between post-balloon angioplasty dissection and the mid-term results of the AcoArt I trial evaluating complex femoropopliteal artery disease. Methods The outcome data for 144 patients from the AcoArt 1 trial were reanalysed. These patients were randomly divided into percutaneous transluminal angioplasty (PTA) and drug-coated balloons (DCB) groups. The primary endpoint was the primary patency (PP) rate and clinically-driven target lesion revascularisation at 24 months. Results After 24 months of follow-up, the PP rate of dissection cases in the PTA group was lower vs non-dissection cases. In patients receiving a bailout stent for dissection, the PP rate in the PTA group was lower vs the DCB group. Cox regression analysis showed that dissection decreased the PP rate; mild dissection reduced the PP rate as follows: 52%, PTA group and 19%, DCB group. With severe dissection, the PP rate reduction was as follows: 75%, PTA group and 73%, DCB group. Conclusions The mid-term follow-up showed that post-balloon angioplasty dissection reduced the PP rate in the PTA group but not in the DCB group. Additionally, in patients receiving a bailout stent for dissection, the DCB group had a better PP rate than the PTA group.

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Atherectomy and Drug-Coated Balloon Angioplasty for the Treatment of Long Infrapopliteal Lesions: A Randomized Controlled Trial

Circulation Cardiovascular Interventions ◽

10.1161/circinterventions.120.010280 ◽

2021 ◽

Author(s):

Aljoscha Rastan ◽

Marianne Brodmann ◽

Tanja Böhme ◽

Roland Macharzina ◽

Elias Noory ◽

...

Keyword(s):

Balloon Angioplasty ◽

Duplex Ultrasound ◽

Target Lesion ◽

Primary Patency ◽

Primary Study ◽

Target Vessel ◽

Target Vessel Revascularization ◽

Infrapopliteal Artery ◽

Directional Atherectomy ◽

Drug Coated Balloon

Background: Prospective, randomized, multicenter trials show no beneficial impact of drug-coated balloon (DCB) therapy alone on the technical and clinical outcomes of infrapopliteal artery lesions in comparison to plain old balloon angioplasty. The aim of this study was to evaluate the performance of directional atherectomy (DA) plus DCB angioplasty versus DCB alone in treatment of long infrapopliteal artery lesions. Methods: We conducted a prospective, randomized, 2-center trial comparing the performance of DA+DCB and DCB alone in treatment of 80 patients with de novo infrapopliteal artery lesions. The primary study end point was the 6-month primary patency of the target lesion detected by angiography and duplex ultrasound. Secondary end points included clinically driven target vessel revascularization, amputation rates, and changes in Rutherford-Becker class at 1 year. A core laboratory provides independent analyses for all scheduled and unscheduled duplex ultrasound examinations and angiographies, and a research institute ensured independent data collection. Results: The mean target lesion length was 179.7±98.2 mm. Nine patients (11.3%) died during the follow-up period. At 6 months, primary patency was 49% (n=18) with DA+DCB versus 34% (n=12) with DCB alone ( P =0.241), and clinically driven target vessel revascularization was 8% (n=3) versus 14% (n=5; P =0.475), respectively. At 1 year, the TLR rates were 30% (n=10) versus 43% (n=12; P =0.308), the median in Rutherford-Becker class was 2 (0.25–5) versus 5 (0.25–5; P =0.329), and amputation rates were 22% (n=8) versus 32% (n=11; P =0.618) in the DA+DCB group and the DCB group, respectively. Conclusions: Treatment of long infrapopliteal artery lesions with DA+DCB versus DCB alone leads to comparable clinical and technical results at 6 months and 1 year. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01763476.

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Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis

Journal of Endovascular Therapy ◽

10.1177/1526602820931559 ◽

2020 ◽

Vol 27 (4) ◽

pp. 647-657

Author(s):

Stefanos Giannopoulos ◽

Sheila Ghanian ◽

Sahil A. Parikh ◽

Eric A. Secemsky ◽

Peter A. Schneider ◽

...

Keyword(s):

Balloon Angioplasty ◽

Meta Analysis ◽

Target Lesion ◽

Major Amputation ◽

Primary Patency ◽

Safety And Efficacy ◽

All Cause Mortality ◽

Procedural Success ◽

Random Effects Modeling ◽

Drug Coated Balloon

Purpose: To investigate the safety and efficacy of drug-coated balloons (DCB) for the treatment of femoropopliteal or infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A systematic literature search was conducted in PubMed, Scopus, and Cochrane Central up to January 2020 to identify randomized trials and observational studies presenting data on the effectiveness and safety of DCBs in the treatment of femoropopliteal or infrapopliteal lesions. A meta-analysis utilizing random effects modeling was conducted to investigate primary patency and all-cause mortality at 12 months; the results are reported as the odds ratios (ORs) and 95% confidence intervals (CIs). Secondary outcomes were procedural success, bailout stenting, target lesion revascularization (TLR), reocclusion, major amputation, wound healing, and major adverse limb events. Results: Twenty-six studies, 12 retrospective and 14 prospective, comprising 2108 CLTI patients treated with DCBs for femoropopliteal (n=1315) or infrapopliteal (n=793) lesions were analyzed. The average lesion lengths were 121±44 and 135±53 mm, respectively. The overall 12-month all-cause mortality and major amputation rates were 9% (95% CI 6% to 13%) and 5% (95% CI 2% to 8%), respectively. Primary patency rates were 82% (95% CI 76% to 87%) and 64% (95% CI 58% to 70%), respectively. A sensitivity analysis of the infrapopliteal lesions demonstrated no difference between DCB and balloon angioplasty in terms of primary patency, TLR, major amputation, or mortality over 12 months. However, patients with infrapopliteal lesions undergoing DCB angioplasty did have a significantly lower risk for reocclusion (10% vs 25%; OR 0.38, 95% CI 0.21 to 0.70, p=0.002). Conclusion: DCB angioplasty of femoropopliteal and infrapopliteal lesions in patients with CLTI results in acceptable 12-month patency rates, although comparative data have not shown a patency benefit for infrapopliteal lesions. The 12-month mortality rate of DCB vs balloon angioplasty was not significantly different, but studies with longer-term outcomes are necessary to determine any association between DCB use and mortality in patients with CLTI.

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Drug‐Coated Balloon Versus Plain Balloon Angioplasty for Hemodialysis Dysfunction: A Meta‐Analysis of Randomized Controlled Trials

Journal of the American Heart Association ◽

10.1161/jaha.121.022060 ◽

2021 ◽

Author(s):

Chenyu Liu ◽

Matthew Wolfers ◽

Bint‐e Zainab Awan ◽

Issa Ali ◽

Adrian Michael Lorenzana ◽

...

Keyword(s):

Randomized Controlled Trials ◽

Balloon Angioplasty ◽

Meta Analysis ◽

Target Lesion ◽

Primary Patency ◽

Target Lesion Revascularization ◽

Cochrane Library ◽

Controlled Trials ◽

Randomized Controlled ◽

Drug Coated Balloon

Background Both drug‐coated balloon (DCB) angioplasty and conventional plain balloon angioplasty (PBA) can be implemented to treat hemodialysis dysfunction. The present study aims to compare the safety and efficacy of these 2 approaches by conducting a meta‐analysis of available randomized controlled trials. Methods and Results PubMed, Cochrane Library, and Embase databases were queried from establishment to January 2021. A total of 18 randomized controlled trials including 877 and 875 patients in the DCB and PBA groups, respectively, were included in the present meta‐analysis. Target lesion primary patency, circuit patency, target lesion revascularization, and mortality were pooled. Odds ratios (ORs) were reported with 95% CIs. Publication bias was analyzed with funnel plot and Egger test. Target lesion primary patency was higher among patients who underwent DCB (OR, 2.93 [95% CI, 2.13–4.03], P <0.001 at 6 months; OR, 2.47 [95% CI, 1.53–3.99], P <0.001 at 1 year). Also, the DCB group had a higher dialysis circuit patency at 6 months (OR, 2.42; 95% CI, 1.56–3.77 [ P <0.001]) and 1 year (OR, 1.91; 95% CI, 1.22–3.00 [ P =0.005]). Compared with the PBA group, the DCB group had lower odds of target lesion revascularization during follow‐up (OR, 0.43 [95% CI, 0.23–0.82], P =0.001 at 6 months; OR, 0.74 [95% CI, 0.32–1.73], P =0.490 at 1 year). The OR of mortality was comparable between 2 groups at 6 months (OR, 1.18; 95% CI, 0.42–3.33 [ P =0.760]) and 1 year (OR, 0.93; 95% CI, 0.58–1.48 [ P =0.750]). Conclusions Based on evidence from 18 randomized controlled trials, DCB angioplasty is superior to PBA in maintaining target lesion primary patency and circuit patency among patients with dialysis circuit stenosis. DCB angioplasty also reduces target lesion revascularization with a similar risk of mortality compared with PBA.

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Comparison of drug-coated balloon angioplasty versus uncoated balloon angioplasty in treatment of total occlusions with severe femoropopliteal lesions: An additional analysis from the AcoArt I study

Vascular ◽

10.1177/1708538120953663 ◽

2020 ◽

pp. 170853812095366

Author(s):

Guoyi Sun ◽

Jie Liu ◽

Senhao Jia ◽

Jiwei Zhang ◽

Baixi Zhuang ◽

...

Keyword(s):

Balloon Angioplasty ◽

Chronic Total Occlusion ◽

Ankle Brachial Index ◽

Target Lesion ◽

Primary Patency ◽

Target Lesion Revascularization ◽

Total Occlusion ◽

Chronic Total Occlusions ◽

Late Lumen Loss ◽

Drug Coated Balloon

Objectives Femoropopliteal chronic total occlusions are challenging to treat, and evidence of the effectiveness of drug-coated balloon angioplasty for long femoropopliteal chronic total occlusion lesions is limited. We compared the midterm outcomes of drug-coated balloon angioplasty versus plain old balloon angioplasty (POBA) for femoropopliteal chronic total occlusions. Methods In total, 95 patients from the AcoArt I trial (ClinicalTrials.gov identifier NCT01850056) with ≥5-cm femoropopliteal chronic total occlusion lesions were enrolled in this post-hoc subset analysis (drug-coated balloon, n = 50; POBA, n = 45). The primary endpoints were primary patency and clinically driven target lesion revascularization (CD-TLR) at 24 months. The secondary endpoints were late lumen loss at six months and binary restenosis, major adverse events (composite of death and target limb amputation), change in the Rutherford class, and the ankle-brachial index at 24 months. Results Demographic, clinical, and lesion characteristics were matched (mean lesion length, 20 cm). The six-month late-lumen loss rate was lower in the drug-coated balloon than POBA group (0.18 ± 0.81 vs. 1.34 ± 0.94 mm, respectively; P < 0.001). The 24-month primary patency rate was significantly higher in the drug-coated balloon than POBA group (53.85% vs. 17.50%, respectively; P < 0.001). The CD-TLR rate in the drug-coated balloon and POBA groups was 12.77 and 45.24%, respectively ( P = 0.002). The 24-month overall mortality rate in the drug-coated balloon and POBA groups was 12.77% and 6.98%, respectively ( P = 0.360), with no device- or procedure-related deaths. One major amputation had occurred in each group by the 24-month follow-up. Conclusion The paclitaxel drug-coated balloon shows better primary patency and freedom from target lesion revascularization than POBA at 24 months after treatment of femoropopliteal chronic total occlusions (≥5 cm) lesion.

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Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Proximal Popliteal Arteries: One-Year Results of the MDT-2113 SFA Japan Randomized Trial

Journal of Endovascular Therapy ◽

10.1177/1526602817745565 ◽

2017 ◽

Vol 25 (1) ◽

pp. 109-117 ◽

Cited By ~ 34

Author(s):

Osamu Iida ◽

Yoshimitsu Soga ◽

Kazushi Urasawa ◽

Shigeru Saito ◽

Michael R. Jaff ◽

...

Keyword(s):

Percutaneous Transluminal Angioplasty ◽

De Novo ◽

Target Lesion ◽

Major Amputation ◽

Transluminal Angioplasty ◽

Primary Patency ◽

Lesion Length ◽

Japanese Cohort ◽

Percutaneous Transluminal ◽

Drug Coated Balloon

Purpose: To assess the safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) for the treatment of de novo and native artery restenotic lesions in the superficial femoral and proximal popliteal arteries vs percutaneous transluminal angioplasty (PTA) with an uncoated balloon in a Japanese cohort. Methods: MDT-2113 SFA Japan ( ClinicalTrials.gov identifier NCT01947478) is an independently adjudicated, prospective, randomized, single-blinded trial that randomized (2:1) 100 patients (mean age 73.6±7.0 years; 76 men) from 11 Japanese centers to treatment with DCB (n=68) or PTA (n=32). Baseline characteristics were similar between the groups, including mean lesion length (9.15±5.85 and 8.89±6.01 cm for the DCB and PTA groups, respectively). The primary effectiveness outcome was primary patency at 12 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasonography. The safety endpoint was a composite of 30-day device- and procedure-related death and target limb major amputation and clinically-driven target vessel revascularization within 12 months. Results: Patients treated with DCBs exhibited superior 12-month primary patency (89%) compared to patients treated with PTA (48%, p<0.001). The 12-month CD-TLR rate was 3% for DCB vs 19% for PTA (p=0.012). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Quality-of-life measures showed sustained improvement from baseline to 12 months in both groups. Conclusion: Results from the MDT-2113 SFA Japan trial showed superior treatment effect for DCB vs PTA, with excellent patency and low CD-TLR rates. These results are consistent with other IN.PACT SFA DCB trials and demonstrate the safety and effectiveness of this DCB for the treatment of femoropopliteal lesions in this Japanese cohort.

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Post-procedural quantitative flow ratio gradient and target lesion revascularization after drug-coated balloon or plain-old balloon angioplasty

European Heart Journal ◽

10.1093/ehjci/ehaa946.2446 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

H Kirigaya ◽

K Okada ◽

K Hibi ◽

E Akiyama ◽

Y Kimura ◽

...

Keyword(s):

Balloon Angioplasty ◽

Target Lesion ◽

Lesion Length ◽

Flow Ratio ◽

Post Procedure ◽

Physiological Indexes ◽

Plain Old Balloon Angioplasty ◽

Quantitative Flow Ratio ◽

Drug Coated Balloon ◽

Quantitative Flow

Abstract Background Balloon angioplasty, including drug-coated balloon (DCB), is an important option of percutaneous coronary interventions (PCI), even in the drug-eluting stent era. Although quantitative coronary angiography (QCA) has been frequently used to determine the optimal endpoint of balloon angioplasty, physiological assessment may add incremental prognostic values. Quantitative flow ratio (QFR) has evolved as a novel 3D QCA-based physiological index to estimate fractional flow reserve without hyperemia nor pressure guidewire, offering both anatomical and functional lesion assessments. This study aimed to characterize post-procedural anatomical and physiological indexes by QFR and to compare their prognostic impacts on long-term clinical outcomes. Methods This retrospective study included 98 patients with de novo (n=39) or in-stent restenosis (n=59) lesions who underwent PCI with DCB (n=69) or plain-old balloon angioplasty (POBA, n=29). All lesions were analyzed by QCA and QFR. QCA analysis measured lesion length, reference lumen diameter (RLD), minimum lumen diameter (MLD) and percent diameter stenosis (%DS) at pre- and post-procedures as anatomical indexes. QFR analysis measured post-procedural QFR of target vessel (QFR-vessel) and QFR-gradient (ΔQFR between proximal and distal segments of the lesion) as physiological indexes. Primary endpoint was target lesion revascularization (TLR) within 1-year post-procedure. Results Target lesion profiles were as follows: lesion length 26.3±16.6 mm, RLD 2.90±0.70 mm, MLD 0.94±0.32 mm and %DS 79.3±18.6%. At post-procedure, MLD, residual %DS, QFR-vessel and QFR-gradient of target lesions were 1.88±0.49 mm, 34.7±10.6%, 0.84±0.13 and 0.06±0.04, respectively. During 1 year post-procedure, TLR occurred in 19 (19%) patients. Patients with TLR showed smaller MLD (1.66±0.45 mm vs. 1.93±0.49 mm, p=0.028) and QFR-vessel (0.79±0.03 vs. 0.85±0.01, p=0.06), and greater residual %DS (42.7±11.3% vs. 32.8±9.5%, p=0.0002) and QFR-gradient (0.12±0.06 vs. 0.04±0.02, p<0.0001) at post-procedure compared with those without. In multivariate analysis including several clinical characteristics and anatomical indexes, QFR-gradient at post-procedure was independently associated with TLR within 1-year, demonstrating higher prognostic value compared with post-procedural MLD and residual %DS (Figure). The receiver-operating characteristics curve analysis identified the best cut-off value of QFR-gradient as 0.08 for predicting 1-year TLR after balloon angioplasty, irrespective of balloon type (DCB or POBA) (Figure 1). Conclusions Post-procedural QFR-gradient within the lesion was an independent and stronger predictor of subsequent TLR, compared with anatomical indexes. Further studies are warranted to investigate whether QFR guidance to optimize PCI procedure could improve clinical outcomes in patients with balloon angioplasty. Figure 1 Funding Acknowledgement Type of funding source: None

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