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Objectives: The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone...

Objectives The purpose of this study is to compare post-dilation strategies of nitinol self-expanding stents implanted in the superficial femoral artery of diabetic patients with peripheral arterial disease. Background Endovascular treatment of superficial femoral artery disease with nitinol self-expanding stents is associated with high rates of in-stent restenosis in patients with diabetes mellitus. Methods We conducted a prospective, multicenter, randomized, controlled clinical trial of diabetic patients to investigate whether post-dilation of superficial femoral artery nitinol self-expanding stents using a cryoplasty balloon reduces restenosis compared to a conventional balloon. Inclusion criteria included diabetes mellitus, symptomatic peripheral arterial disease, and superficial femoral artery lesions requiring implantation of stents >5 mm in diameter and >60 mm in length. Primary endpoint was binary restenosis at 12 months, defined as ≥2.5-fold increase in peak systolic velocity by duplex ultrasonography. Results Seventy-four patients, with 90 stented superficial femoral artery lesions, were randomly assigned to post-dilation using cryoplasty (n = 45 lesions) or conventional balloons (n = 45 lesions). Mean lesion length was 148 ± 98 mm, mean stented length was 190 ± 116 mm, mean stent diameter was 6.1 ± 0.4 mm, and 50% of the lesions were total occlusions. Post-dilation balloon diameters were 5.23 ± 0.51 mm versus 5.51 ± 0.72 mm in the cryoplasty and conventional balloon angioplasty groups, respectively (p = 0.02). At 12 months, binary restenosis was significantly lower in the cryoplasty group (29.3% vs. 55.8%, p = 0.01; odds ratio: 0.36, 95% confidence interval: 0.15 to 0.89). Conclusions Among diabetic patients undergoing implantation of nitinol self-expanding stents in the superficial femoral artery, post-dilation with cryoplasty balloon reduced binary restenosis compared to conventional balloon angioplasty. (Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease [COBRA]; NCT00827853 )

Background The paclitaxel drug-eluting stent (Taxus, Boston Scientific) is FDA approved for treatment of coronary artery disease in simple, noncomplex coronary lesions. In this registry, we sought to investigate the procedural success and long-term outcomes of patients receiving the Taxus stent in the setting of acute ST-elevation myocardial infarction (STEMI) in a busy single-center interventional program. Methods This is a single-center retrospective analysis of prospectively collected in-hospital data with postdischarge follow-up achieved by phone calls and review of medical records. Data were audited by an independent monitor, and outcomes were adjudicated by an experienced interventional cardiologist. All patients with STEMI over the period of 2 years (2005 and 2006) with native de novo lesions who received the Taxus stent were included. Patients receiving bare metal stents were excluded. The primary outcome was the combined end point of cardiac death, recurrent nonfatal MI, and target lesion revascularization (TLR) on follow-up. Results Of 198 patients included in this study, follow-up data were obtained in 172 (86.9%) patients. The mean age was 63±14.9 years. There were 59.1% males. Patients had the following cardiac risk factors: diabetes 20.7%, hypertension 60.6%, hyperlipidemia 87.8%, and current smoking 48%. In-hospital complications included death 5.1%, acute closure with stent thrombosis 1%, vascular complications 2.9%, and cardiogenic shock 6.6%. The mean follow-up period (days) was 317.3±239.3. The primary end point of cardiac death, nonfatal MI, and TLR was met in 12.4%. Individual end points on follow-up were cardiac death 2.5%, total death 4.9%, TLR 8.1%, target vessel revascularization 19.9%, stroke 1.2%, nonfatal MI 5%, and acute stent thrombosis 5.5% (definite 4.3%, probable 0.6%, possible 0.6%; Academic Research Consortium definition). Conclusion The use of the Taxus stent in acute STEMI is associated with a low postdischarge combined end point of cardiac death, nonfatal MI, and TLR and a definite/probable 4.9% in-stent thrombosis rate, which is within the reported range of data published in "real-world" registry.

Objectives The aim of this study was to discern a target range of anticoagulation for enoxaparin during percutaneous coronary intervention (PCI) as measured by the Rapidpoint ENOX (Pharmanetics Inc., Morrisville, North Carolina), a new point-of-care test. Background In the U.S., enoxaparin has been used in only a small proportion of PCI procedures, partly because a rapid enoxaparin-specific assay was unavailable. Methods We analyzed data from 445 enrolled patients receiving subcutaneous or intravenous enoxaparin in a prospective, multicenter study. Serial anticoagulation measurements and clinical outcomes were recorded. Results The in-hospital composite occurrence of death, myocardial infarction, and urgent target vessel revascularization was 5.4%, and Thrombolysis In Myocardial Infarction (TIMI) major bleeding, minor bleeding, and any reported bleeding occurred in 0.2%, 1.3%, and 7.9% of patients, respectively. No significant association between procedural ENOX times and ischemic events was observed (p = 0.222), although the event rate was 4.0% among those with ENOX times between 250 to 450 s versus 7.2% for those outside this range (p = 0.134). Increasing ENOX time at sheath removal was correlated with any bleeding (p = 0.010) with a 1% increase for every ∼30-s rise. Conclusions Ischemic events were infrequent, and the rate appeared lowest in the mid-range of ENOX times. Bleeding events increased with increasing ENOX times. These observations, combined with a suggested procedural anti-Xa level of 0.8 to 1.8 IU/ml, translate into a recommended ENOX time range of 250 to 450 s for PCI and

Purpose: To report the results from a single-center prospective registry (PROTECT)established to evaluate the safety and effectiveness of embolic filter protection (EFP) inreducing distal embolization during percutaneous lower extremity interventions.Methods: Patients undergoing angioplasty, stenting, or SilverHawk atherectomy andadjunctive balloon angioplasty for infrainguinal occlusive disease were eligible if thelesion(s) met one or more of these angiographic criteria: (1) moderate or severecalcification of any length, (2) total occlusions of any length, (3) a filling defect, (4)irregular (ulcerated) lesions at least 30 mm in length, and/or (5) smooth, non-ulceratedlesions at least 50 mm in length. The primary angiographic outcome was the ability of thefilter to prevent angiographically visible distal embolization, slow flow, and loss of distaltibial runoff with or without capturing macrodebris.Results: Forty patients (23 men; mean age 71.4611.5 years) with 56 lesions (42 de novoand 14 restenotic) underwent treatment with angioplasty/stenting (groupA,n529; 43lesions) or SilverHawk atherectomy (group B, n511; 13 lesions). One filter was used perpatient (25 SpiderFX and 15 EmboShield). Macroembolization occurred in 22 (55.0%)patients, 11 (37.9%) in group A and 11 (100%) in group B (p,0.001). Clinically significant($2 mm in diameter) macrodebris was found in 18 (45.0%) patients: 8 (27.6%) in group Aand 10 (90.9%) in group B (p,0.001). All filters were retrieved successfully with nocomplications. One side-branch embolization occurred proximal to the filter. In anothercase, the filter was overfilled, resulting in no distal flow; it was retrieved, with subsequenttibial embolization when the procedure was continued without protection.Conclusion: Macroembolization is very frequent in patients undergoing lower extremityinterventions, particularly with SilverHawk atherectomy. EFP appears to be very effective incapturing macrodebris, and its use is associated with good acute angiographic outcome.The clinical significance of these findings needs to be determined in future studies.J Endovasc Ther 2008;15:270–276Key words: peripheral angioplasty, embolization, embolic filter protection, atherectomy,stent