Self-Expanding Nitinol Stent vs Percutaneous Transluminal Angioplasty in the Treatment of Femoropopliteal Lesions: 3-Year Data From the SM-01 Trial

Iida, Osamu; Urasawa, Kazushi; Komura, Yasuo; Soga, Yoshimitsu; Inoue, Naoto; Hara, Hidehiko; Yajima, Junji; Nakamura, Shigeru; Ohki, Takao; Ando, Hiroshi; Hirano, Keisuke; Horita, Yuki; Kichikawa, Kimihiko; Yokoi, Yoshiaki; Miyamoto, Akira; Nakamura, Masato; Takahara, Mitsuyoshi; Mano, Toshiaki; Nanto, Shinsuke

doi:10.1177/1526602819826591

Cited by 23 publications

(18 citation statements)

References 28 publications

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“…Many other endovascular devices previously demonstrated lower performance in real-world settings than that shown in clinical trials. 5–8…”

Section: Introductionmentioning

confidence: 99%

“…Many other endovascular devices previously demonstrated lower performance in real-world settings than that shown in clinical trials. [5][6][7][8] Another unresolved issue with stent-graft therapy is the risk of stent thrombosis, 9 which attenuates the performance of the stent-graft and significantly affects the clinical results. 10 Stent thrombosis was reported to occur even with the use of sufficient antiplatelet therapy, indicating that the prothrombotic state under antiplatelet therapy can vary from patient to patient and affect the individual risk of thrombosis.…”

Section: Introductionmentioning

confidence: 99%

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One-Year Outcomes of Heparin-Bonded Stent-Graft Therapy for Real-World Femoropopliteal Lesions and the Association of Patency With the Prothrombotic State Based on the Prospective, Observational, Multicenter Viabahn Stent-Graft Placement for Femoropopliteal Diseases Requiring Endovascular Therapy (VANQUISH) Study

et al. 2020

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Purpose: To evaluate the real-world primary patency of heparin-bonded stent-graft therapy for femoropopliteal (FP) occlusive disease and identify any clinical factors, including the prothrombotic state, associated with the loss of patency. Materials and Methods: This multicenter study prospectively enrolled 424 limbs of 371 patients (mean age 75±8 years; 247 men) scheduled for Viabahn stent-graft placement in the FP segment. A full-coverage strategy using only a Viabahn stent-graft was preferred, but “spot stenting” with the Viabahn was also allowed. The prothrombotic state was assessed by measuring platelet reactivity. Vascular morphology was evaluated using intravascular ultrasound (IVUS). Primary patency was estimated using the Kaplan-Meier method in the subgroup of patients having full lesion stent-graft coverage (n=343 limbs, 81.1%). The secondary outcomes were major amputation, surgical reconstruction, target lesion revascularization (TLR), and thrombotic occlusion. Regression analyses were used to explore associations of baseline and clinical variables with loss of patency; the results are given as the odds ratio (OR) and 95% confidence interval (CI). Results: The 1-year primary patency estimate was 80.3% (95% CI 75.5% to 85.1%) in the full-coverage group. There were 7 surgical reconstructions, 46 TLRs, 21 acute thrombotic occlusions, and 1 major amputation during the 1-year follow-up in the full-coverage group. Only angiography- and IVUS-determined vessel diameters were significantly associated with loss of patency, with crude ORs of 0.64 (95% CI 0.45 to 0.89, p=0.009) and 0.67 (95% CI 0.51 to 0.90, p=0.009), respectively, per 1-mm increase, whereas other variables, including the prothrombotic state (p=0.74), were not. Multivariable analysis demonstrated that only IVUS-determined vessel diameter was independently associated with loss of patency (adjusted OR per 1-mm increase 0.72, 95% CI 0.52 to 1.00, p=0.049). Conclusion: FP stent-graft placement achieved acceptable patency at 1 year in a real-world setting. A smaller vessel size was significantly associated with loss of patency, whereas the prothrombotic state was not.

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“…Many other endovascular devices previously demonstrated lower performance in real-world settings than that shown in clinical trials. 5–8…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

One-Year Outcomes of Heparin-Bonded Stent-Graft Therapy for Real-World Femoropopliteal Lesions and the Association of Patency With the Prothrombotic State Based on the Prospective, Observational, Multicenter Viabahn Stent-Graft Placement for Femoropopliteal Diseases Requiring Endovascular Therapy (VANQUISH) Study

et al. 2020

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“…Acceptable results of stent-less treatment using drug-coated balloons 2 or atherectomy devices 13 have been reported recently, but longer follow-up results are still scant. The conventional stenting strategy has plenty of long-term data, 14,15 but its high ISR rate due to neointimal proliferation remains a major issue. In addition, stent placement can also result in unintended negative consequences because leaving a metallic stent behind could decrease future treatment options.…”

Section: Discussionmentioning

confidence: 99%

Impact of IVUS-Derived Vessel Size on Midterm Outcomes After Stent Implantation in Femoropopliteal Lesions

et al. 2020

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Purpose: To identify intravascular ultrasound (IVUS) findings that predict midterm stent patency in femoropopliteal (FP) lesions. Materials and Methods: A retrospective analysis was undertaken of 335 de novo FP lesions in 274 consecutive patients (mean age 72.4±8.2 years; 210 men) who had IVUS assessment before and after successful stent implantation. The mean lesion length was 13.2±9.8 cm. The primary outcome was primary patency at 24 months, defined as freedom from major adverse limb event (MALE) and in-stent restenosis (ISR). MALE was defined as major amputation or any target lesion revascularization (TLR). ISR was defined by a peak systolic velocity ratio >2.4 by duplex ultrasonography. Logistic regression analyses were performed to identify independent predictors of stent patency at 24 months; the results are presented as the odds ratio (OR) and 95% confidence interval (CI). Receiver operator characteristic (ROC) curve analysis was performed to determine the optimal threshold for prediction of stent patency at 24 months. Results: Over the 24-month follow-up, 18 (7%) patients died and 43 (15%) of 286 lesions were responsible for MALE (42 TLRs and 1 major amputation). Primary patency was estimated at 82.5% (95% CI 78.1% to 86.9%) at 12 months and 73.2% (95% CI 67.9% to 78.5%) at 24 months. Multivariable analysis revealed that longer lesion length (OR 0.89, 95% CI 0.82 to 0.97, p<0.01) was an independent predictor of declining patency, while cilostazol use (OR 3.45, 95% CI 1.10 to 10.78, p=0.03) and increasing distal reference external elastic membrane (EEM) area (OR 1.18, 95% CI 1.02 to 1.37, p=0.03) were associated with midterm stent patency. ROC curve analysis identified a distal reference EEM area of 29.0 mm2 as the optimal cut-point for prediction of 24-month stent patency (area under the ROC curve 0.764). Kaplan-Meier estimates of 24-month primary patency were 83.7% (95% CI 78.3% to 89.2%) in lesions with a distal EEM area >29.0 mm2 vs 53.1% (95% CI 42.9% to 63.3%) in those with a distal EEM area ≤29.0 mm2 (p<0.001). Conclusion: In FP lesions with a larger distal vessel area estimated with IVUS, stent implantation can be considered as a reasonable treatment option, with the likelihood of acceptable midterm results.

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“…A multitude of clinical trials have meticulously looked into comparisons of stenting vs simple angioplasty for a variety of different lesion subtypes. 3–5…”

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confidence: 99%

Commentary: Be Innovative, Stay Clinical! Time for a Patient-Specific SFA Treatment Algorithm?

2020

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Self-Expanding Nitinol Stent vs Percutaneous Transluminal Angioplasty in the Treatment of Femoropopliteal Lesions: 3-Year Data From the SM-01 Trial

Cited by 23 publications

References 28 publications

Impact of IVUS-Derived Vessel Size on Midterm Outcomes After Stent Implantation in Femoropopliteal Lesions

Commentary: Be Innovative, Stay Clinical! Time for a Patient-Specific SFA Treatment Algorithm?

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