sirolimus and Intermittent-Claudication

The study investigated the long-term clinical impact of sirolimus-eluting stents (SES) in comparison with bare-metal stents (BMS) in treatment of focal infrapopliteal lesions.. There is evidence that SES reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. No data from randomized trials are available concerning the clinical impact of this finding during long-term follow-up.. The study extended the follow-up period of a prospective, randomized, multicenter, double-blind trial comparing polymer-free SES with placebo-coated BMS in the treatment of focal infrapopliteal de novo lesions. The main study endpoint was the event-free survival rate defined as freedom from target limb amputation, target vessel revascularization, myocardial infarction, and death. Secondary endpoints include amputation rates, target vessel revascularization, and changes in Rutherford-Becker class.. The trial included 161 patients. The mean target lesion length was 31 ± 9 mm. Thirty-five (23.3%) patients died during a mean follow-up period of 1,016 ± 132 days. The event-free survival rate was 65.8% in the SES group and 44.6% in the BMS group (log-rank p = 0.02). Amputation rates were 2.6% and 12.2% (p = 0.03), and target vessel revascularization rates were 9.2% and 20% (p = 0.06), respectively. The median (interquartile range) improvement in Rutherford-Becker class was -2 (-3 to -1) in the SES group and -1 (-2 to 0) in the BMS group, respectively (p = 0.006).. Long-term event-free survival, amputation rates, and changes in Rutherford-Becker class after treatment of focal infrapopliteal lesions are significantly improved with SES in comparison with BMS. (YUKON-Drug-Eluting Stent Below the Knee-Randomised Double-Blind Study [YUKON-BTX]; NCT00664963).

Topics: Aged; Aged, 80 and over; Angioplasty; Antibiotics, Antineoplastic; Double-Blind Method; Drug-Eluting Stents; Female; Humans; Intermittent Claudication; Ischemia; Leg; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Sirolimus

Preliminary reports indicate that sirolimus-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. We conducted a prospective, randomized, multi-centre, double-blind trial comparing a polymer-free sirolimus-eluting stent with a placebo-coated bare-metal stent in patients with either intermittent claudication or critical limb ischaemia who had a de-novo lesion in an infrapopliteal artery.. 161 patients were included in this trial. The mean target lesion length was 31 ± 9 mm. The main study endpoint was the 1-year primary patency rate, defined as freedom from in-stent-restenosis (luminal narrowing of ≥50%) detected with duplex ultrasound if not appropriate with angiography. Secondary endpoints included the 6-month primary patency rate, secondary patency rate, and changes in Rutherford-Becker classification after 1 year. Twenty-five (15.5%) patients died during the follow-up period. One hundred and twenty-five patients reached the 1-year examinations. The 1-year primary patency rate was significantly higher in the sirolimus-eluting stent group (80.6%) than in the bare-metal stent group (55.6%, P= 0.004), and the 1-year secondary patency rates were 91.9 and 71.4% (P= 0.005), respectively. The median (interquartile range) change in Rutherford-Becker classification after 1 year was -2 (-3 to -1) in the sirolimus-eluting stent group and -1 (-2 to 0) in the bare-metal stent group, respectively (P= 0.004).. Mid-term patency rates of focal infrapopliteal lesions are substantially improved with sirolimus-eluting stent compared with bare-metal stent. Corresponding to the technical results, the changes in Rutherford-Becker classification reveal a significant advantage for the sirolimus-eluting stent.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Arterial Occlusive Diseases; Double-Blind Method; Drug-Eluting Stents; Female; Graft Survival; Humans; Intermittent Claudication; Ischemia; Leg; Male; Popliteal Artery; Prospective Studies; Reperfusion; Secondary Prevention; Sirolimus; Treatment Outcome; Tubulin Modulators; Vascular Patency

Stent implantation for obstructive femoropopliteal artery disease has been associated with poor long-term outcomes. This study evaluated the effectiveness of shape memory alloy recoverable technology (SMART) nitinol self-expanding stents coated with a polymer impregnated with sirolimus (rapamycin) versus uncoated SMART Stents in superficial femoral artery obstructions.. Thirty-six patients were recruited for this double-blind, randomized, prospective trial. All patients had chronic limb ischemia and femoral artery occlusions (57%) or stenoses (average lesion length, 85 +/- 57 mm). Patients were eligible for randomization after successful guidewire passage across the lesion. Eighteen patients received sirolimus-eluting SMART Stents and 18 patients received uncoated SMART Stents. The primary end point of the study was the in-stent mean percent diameter stenosis, as measured by quantitative angiography at 6 months. The instent mean percent diameter stenosis was 22.6% in the sirolimus-eluting stent group versus 30.9% in the uncoated stent group (P = 0.294). The in-stent mean lumen diameter was significantly larger in the sirolimus-eluting stent group (4.95 mm versus 4.31 mm in the uncoated stent group; P = 0.047). No serious adverse events (death or prolonged hospitalization) were reported.. The use of sirolimus-eluting SMART Stents for superficial femoral artery occlusion is feasible, with a trend toward reducing late loss compared with uncoated stents. The coated stent also proved to be safe and was not associated with any serious adverse events.

Topics: Aged; Arterial Occlusive Diseases; Constriction, Pathologic; Drug-Eluting Stents; Female; Femoral Artery; Humans; Immunosuppressive Agents; Intermittent Claudication; Male; Radiography; Recurrence; Sirolimus; Stents; Treatment Outcome

A 59-year-old man with critical claudication underwent left femoro-anterior bypass grafting, which was uneventful. The graft was tunneled medially across the knee, then anterior to the tibia. His symptoms recurred 1 year later and he was found to have critical stenosis of the vein graft just proximal to the anterior tibial arterial anastomosis. This was treated with scaffolded balloon angioplasty and implantation of a coronary, zotarolimus-eluting balloon-expandable stent, which was also uneventful. However, his claudication again recurred 1 year later. Diagnostic angiography revealed crush, deformation and restenosis of the balloon-expandable stent requiring surgical revision of the bypass graft.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Computed Tomography Angiography; Critical Illness; Drug-Eluting Stents; Graft Occlusion, Vascular; Humans; Intermittent Claudication; Male; Middle Aged; Peripheral Arterial Disease; Prosthesis Design; Prosthesis Failure; Recurrence; Reoperation; Saphenous Vein; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Grafting; Vascular Patency

To assess the safety and efficacy of sirolimus-eluting stents (SESs) in the treatment of severe intermittent claudication and critical limb ischaemia with "below-the-knee" lesions, unsuitable for surgery.. Limited published evidence suggests that drug-eluting stents may offer significant improvements in the treatment of infrapopliteal lesions.. Thirty consecutive patients with either severe intermittent claudication or critical limb ischemia (CLI), category 3-6 of Rutherford classification, and multivessel disease of infrapopliteal arteries (> or = 2 vessels) were treated with SES. Sixty-two arteries were treated with 106 SES. Mean age was 73.9 years, 77% of patients were male and 36% diabetic. The primary endpoint was clinical improvement and healing of ulcers at short term (1 month) and mid term (7.7 months). The secondary endpoint was primary vessel patency rate (angiographic or duplex assessment). All patients received clopidogrel (75 mg daily) or ticlopidine (150 mg daily) for 2 months or longer.. Angiographic and procedural success was achieved in all patients. At 7 months (7.7 +/- 5.8), it was necessary to amputate 1 toe in one patient and 1 mid-foot in another. Limb salvage was obtained in 100% of patients. Other events were: two cardiac deaths unrelated to CLI, one stroke with hemiparesia, one initial reperfusion syndrome, one contralateral CLI, and three recurrent homolateral claudication cases. All surviving patients had a mid-term clinical improvement with 97% of primary patency (56 patent arteries on 58 arteries).. Treatment of "below-the-knee" lesions with SES may provide an alternative treatment for patients with CLI.

Topics: Adult; Aged; Aged, 80 and over; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Safety; Female; Follow-Up Studies; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Leg; Male; Middle Aged; Peripheral Vascular Diseases; Platelet Aggregation Inhibitors; Popliteal Artery; Prospective Studies; Research Design; Severity of Illness Index; Sirolimus; Stents; Time Factors; Treatment Outcome; Vascular Patency

Stent placement in a tibial artery for suboptimal angioplasty results has had a high rate of restenosis and occlusion due to neointimal hyperplasia. Drug-eluting stents may provide a new therapeutic option in this situation. We describe the use of a Cypher drug-eluting stent after suboptimal angioplasty result in a claudicant with a severe tibioperoneal trunk lesion and single-vessel runoff to the foot with 6-month follow-up.

Topics: Aged; Angiography; Catheterization; Humans; Immunosuppressive Agents; Intermittent Claudication; Leg; Male; Popliteal Artery; Sirolimus; Stents