التفاصيل البيبلوغرافية
| العنوان: |
Jetstream Atherectomy Followed by Paclitaxel-Coated Balloons versus Balloon Angioplasty Followed by Paclitaxel-Coated Balloons: Twelve-Month Exploratory Results of the Prospective Randomized JET-RANGER Study. |
| المؤلفون: |
Shammas, Nicolas W, Purushottam, Bhaskar, Shammas, W John, Christensen, Lori, Shammas, Gail, Weakley, Desyree, Jones-Miller, Sue |
| المصدر: |
Vascular Health & Risk Management; Aug2022, Vol. 18, p603-615, 13p |
| مصطلحات موضوعية: |
ATHERECTOMY, PACLITAXEL, TRANSLUMINAL angioplasty, HEALTH outcome assessment, ARTERIAL diseases |
| مستخلص: |
Background: It is unknown at this time whether Jetstream atherectomy (JET) and paclitaxel-coated balloon (PCB) provides a superior outcome to balloon angioplasty (PTA) followed by PCB in treating femoropopliteal (FP) arterial disease. Methods: The JET-RANGER study was a multicenter (eleven US centers) randomized trial, core lab–adjudicated, designed to demonstrate the superiority of JET + PCB versus PTA + PCB in treating FP arterial disease. The study intended to enroll 255 patients, but was stopped early because of poor enrollment due to COVID-19 and concerns about the association of paclitaxel with mortality. The data are thus considered exploratory. A total of 47 patients (48 lesions) with claudication (80.9%) or rest pain/ulcerations (19.2%) were randomly assigned 2:1 to JET + PCB (n=31) or PTA + PCB (n=16). The In.PACT (Medtronic) and Ranger (Boston Scientific) PCBs were used. Freedom from target-lesion revascularization (TLR) was evaluated at 1 year. Analysis was performed on intention to treat. Results: Mean lesion length was 10.8± 4.3 cm for JET + PCB and 11.2± 7.6 cm for PTA + PCB (P=0.858). There were no other differences in demographic or angiographic variables between the two groups. Procedural success was superior with JET + PCB (87.1%) vs PTA + PCB alone (52.9%; P=0.0147). Overall bailout stenting rate was 17% (0 JET + DCB versus 50% PCB, P< 0.0001). There was no distal embolization requiring treatment. There was no amputation or death in either group. Using KM analysis, the primary end point of freedom from TLR (bailout stent considered a TLR) at 1 year was 100% and 43.8% (P< 0.0001) for JET + PCB versus PTA + PCB, respectively. When bailout stent was not considered a TLR, freedom from TLR was 100% and 93.7%, respectively (P=0.327). Conclusion: A high rate of freedom from TLR was seen in the JET + PCB arm and the PTA + DCB arm at 1-year follow-up, with a significant reduction in bailout stenting following vessel prepping with the Jetstream. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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