Intracoronary β-irradiation with a rhenium-188-filled balloon catheter: a randomized trial in patients with de novo and restenotic lesions

Purpose: To evaluate the safety and efficacy of the Serranator Alto PTA Serration Balloon Catheter in subjects with peripheral artery disease in the superficial femoral and popliteal arteries. Materials and Methods: A prospective, multicenter, single-arm feasibility study enrolled 25 patients (mean age 66 years; 18 men) to evaluate Serranator inflation and postinflation effects under monitoring by independent core laboratories. Inclusion criteria were claudication or ischemic rest pain, de novo lesions or native artery restenosis, >70% stenosis, lesion length <10 cm, and a reference vessel diameter of 4 to 6 mm. Chronic total occlusions (CTO) up to 6 cm in length were allowed (n=8). The primary safety endpoint was 30-day major adverse events. Primary efficacy outcome was device success with final diameter stenosis <50%. The secondary objective was to confirm the presence of serrations across the lesions using optical coherence tomography (OCT) or intravascular ultrasound (IVUS) following treatment in a subset of 10 subjects. Follow-up evaluations were conducted at 30 days and 6 months. Results: Technical success of device delivery and retrieval was 100%. The primary safety endpoint was met, with no patients experiencing a major adverse event in the first 30 days. Pretreatment stenosis of 88% was reduced to 23%. One stent was implanted for grade D dissection in a CTO. The core laboratory–adjudicated primary patency was 100% at 1 month and 64% at 6 months. Serrations were confirmed in all 10 OCT/IVUS images reviewed by the core laboratory. The Rutherford category showed significant and sustained improvement at 6 months. Conclusion: The Serranator is a safe and efficacious angioplasty balloon catheter system. This new design provides an exciting potential for optimizing vessel preparation and aiding drug delivery.

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Abstract 1781: Nonprotected Left Main Stenosis: Multicenter Randomized Trial Between Total Arterial Revascularization and Interventional Treatment

Circulation ◽

10.1161/circ.116.suppl_16.ii_378 ◽

2007 ◽

Vol 116 (suppl_16) ◽

Author(s):

Enno Boudriot ◽

Gerhard Schuler ◽

Thomas Walther ◽

Volkmar Falk ◽

Christoph Liebetrau ◽

...

Keyword(s):

Randomized Trial ◽

De Novo ◽

Drug Eluting Stents ◽

Interventional Treatment ◽

Left Main ◽

Arterial Revascularization ◽

Left Main Stenosis ◽

Total Arterial Revascularization ◽

Drug Eluting

Background: Nonprotected left main coronary stenosis is still considered an indication for bypass surgery. We conducted a multicenter prospective randomized trial to compare total arterial revascularization (CABG) with interventional treatment (PCI) in these patients. Methods and Demographics: Between 8/2003 and 5/2007 a total of 156 pts with significant stenosis of the nonprotected left main coronary artery were recruited for the study. We report the first 111 pts whith one year follow up. They were randomized to undergo CABG or PCI using drug eluting stents (Sirolimus). Additional lesions in other locations were treated concurrently. Angiographic control was performed at 12 months. Primary endpoints were death, acute myocardial infarction and re-intervention at 12 months. Out of the 111 pts 55 pts were randomized for CABG and 56 for PCI. Mean age was 65 ± 7 years, diabetes was present in 35%. There were no significant differences between both groups with respect to other baseline variables. The lesion was located at the ostium in 17%, midshaft in 11%, and distally in 72%. An average of 2.4 ± 1.1 stents were implanted, and 2.4 ± 0.6 bypass grafts were performed. Of the operated patients 70% received complete arterial revascularization. Results: Early outcome revealed a procedural success of in all 55 pts for CABG and in 53 of 56 pts for PCI , three pts assigned to PCI had to be successfully converted to CABG. Early mortality in surgery was 1.8%, no patient died early after PCI. Periprocedural NSTEMI were noted in 2 pts after PCI and in six pts after CABG, of those one pt. underwent graft revision. After 12-month follow up control angiography was performed, in 2 pts (3,5%) after CABG and in 7 pts. after PCI (13,2%) reintervention was necessary. 5 pts required target vessel revascularization (TVR). 2 pts developed a de-novo lesion. One of the PCI cohort died at 10 months. MACE rate after 12 month was comparable for CABG group with 18,1% and 17,9% for the PCI group . Conclusions: In pts with nonprotected left main stenosis both CABG and PCI using drug eluting stents can be performed with few periprocedural complications, low mortality and at 12 months mace rate and survival compare favourably, reintervention rate is higher in PCI.

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