Background. The combination of glycoprotein (GP) IIb/IIIa inhibition and direct thrombin inhibition (DTI) with bivalirudin (Angiomax,™ The Medicines Co., Cambridge, Massachusetts) have shown ischemic and hemorrhagic outcomes benefit in coronary interventions and may have similar benefits in percutaneous peripheral interventions (PPI). The high incidence of diabetes, chronic renal disease, platelet dysfunction, hypercoagulability, inflammation and a thrombus-rich environment make a GP IIb/IIIa and DTI combination with tirofiban (Aggrastat,® Merck & Co., Inc., Whitehouse Station, New Jersey) an attractive anticoagulation strategy in the PPI treatment of critical limb ischemia (CLI). Methods. Between May 1, 2001 and January 31, 2003, a CLI treatment group of 149 patients received PPI with bivalirudin (0.75 mg/kg bolus with 1.75 mg/kg/hour periprocedural infusion) and tirofiban (10 mcg/kg/minute bolus with 12-hour 0.1 mcg/kg/minute infusion) as an anticoagulation and antiplat

Background. Percutaneous peripheral arterial intervention (PPAI) has emerged as an effective and less invasive alternative to surgery for peripheral arterial disease (PAD), however, data on gender differences in outcome of PPAI, especially in the stent era, are limited. The purpose of this study was to assess the gender differences on in-hospital outcomes of patients undergoing PPAI. Methods. We analyzed data on 268 consecutive patients (women: 122; men: 146) who underwent PPAI for PAD between October 2001 and January 2004. A total of 405 lesions (women: 184; men: 221) were treated. Results. Background characteristics were similar except for less prevalent prior coronary intervention in women (18.0% versus 28.8%, p = 0.04), and more prevalent current smokers in women (22.1% versus 12.3%; p = 0.03). Upper extremities interventions were performed more often in women (9.2% versus 3.2%; p = 0.01). Procedure success was achieved in 89.3% of women and 89.7% of men (p = N

Graft disease remains a therapeutic challenge. Procedural complications and unsatisfactory patency rates are realized with both percutaneous intervention and repeat coronary artery bypass graft (CABG) surgery. The efficacy of sirolimus-eluting stents (SES) for the treatment of de novo coronary artery disease has been established, but the use of this technology to treat bypass graft disease remains undefined. The aim of this study was to evaluate the safety and feasibility of SES to treat patients with high-risk bypass graft disease. Methods. The compassionate use of SES (SECURE) study included patients with recurrent coronary disease and no acceptable alternative available treatment, including brachytherapy or CABG. Outcomes from 76 patients (n = 94 lesions) with graft lesions treated with SES in the U.S. were compared with the outcomes of 176 patients (n = 311 lesions) with only native vessels. IVUS follow-up was performed at 8 months in 14 patients with graft SES treatment. Results.

Background. Encouraging results with the use of the sirolimus-eluting stent (SES) have been recently presented in several multi-center trials. In the present study, the short- and mid-term clinical outcomes of the SES in everyday clinical practice of interventional cardiology were compared with a strategy using conventional bare metal stents. Methods. In a total of 530 consecutive patients (males 86%, mean age 61 ± 10 years) who had been treated with a SES were compared with a control group of 398 patients (males 87%, mean age 59 ± 11 years) treated with a bare metal stent before the use of SES. In-hospital results and clinical outcomes during follow-up (11.22 ± 3.4 versus 11.41 ± 3.1 months) were obtained. Results. Patients treated with SES had more risk factors for coronary artery disease or multivessel disease compared to those with treated bare metal stent. The clinical success rate was 99.6% in the SES group and 98.5% in the bare metal stent group (p = ns), an

Objective. To assess the effect of long-acting local anesthetic (levobupivacaine) in addition to lidocaine for the management of femoral artery sheaths during and after percutaneous coronary intervention (PCI). Background. Femoral artery sheaths are commonly used during PCI. Sheath removal is often delayed after the procedure by which time short-acting local anesthetic agents may no longer be effective. Methods. Sixty patients were randomized to either usual care or the administration of local levobupivacaine after PCI. Patients were asked to report their pain experienced on a visual analogue score. Results. Thirty patients received additional levobupivacaine (0.5%) and 30 received standard care. There were no procedural differences between the groups, except that more patients in the control group received intravenous (IV) morphine at the time of sheath removal. There was no difference between the control group and levobupivacaine group in pain scores at th

Background. The efficacy of sirolimus-eluting stents (SES) compared to paclitaxel-eluting stents (PES) remains unknown. We evaluated the clinical outcomes after implantation of 2.25 mm diameter SES and PES. Methods and Results. PES have been used as the stent of choice for all percutaneous coronary interventions as part of the prospective Taxus-Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) Registry. Ninety consecutive patients received at least one 2.25 mm PES (PES group), and were compared with 107 patients who received at least one 2.25 mm SES as part of the RESEARCH registry. The overall population presented high-risk characteristics commonly excluded from most studies. Populations were well-matched. There were 2 (2.2%) incidents of subacute stent thrombosis in the PES group (in a 2.25 mm stent), and none in the SES group. At one year, the cumulative incidence of major adverse cardiac events was 5.6% in the SES group, and 17.8 % in the PES group (p = 0.0

Background. The use of low-molecular weight heparin (LMWH) during percutaneous coronary intervention (PCI) has been limited by the presumed inability to monitor its anticoagulant effect using bedside assays. Objectives. This study was designed to compare the dose-response of enoxaparin, dalteparin and unfractionated heparin (UFH) on the activated clotting time (ACT), and to determine whether the ACT or aPTT can be used to monitor intravenous (IV) low molecular weight heparin (LMWH). Methods. A total of 130 patients undergoing cardiac catheterization were assigned to intravenous enoxaparin 0.5 mg/kg, dalteparin 50 international units/kg or UFH 50 units/kg. Of the 130 patients, 46 (35%) underwent PCI, all of whom received a glycoprotein (GP) IIb/IIIa inhibitor. We measured ACT, activated partial thromboplastin time (aPTT) and plasma anti-Xa levels after serial sampling. Results. Both enoxaparin and dalteparin induced a significant rise in the ACT and aPTT, with an AC

Diabetes mellitus is associated with endothelial dysfunction and platelet activation that may contribute to the occurrence of no-reflow. We postulate that optimal glycemic control is associated with the lower risk of no-reflow and better outcomes. Diabetic patients who underwent primary angioplasty for myocardial infarction from January 2001 to June 2004 were analyzed. No-reflow was defined as TIMI flow < 3 in the absence of mechanical obstruction. Patients were divided into 2 glycemic control groups according to the HbA1c value: optimal (? 7%), and suboptimal (> 7%). A total of 183 diabetic patients (93% noninsulin-requiring) were included for analysis. The median HbA1c of the optimal (n = 37) and suboptimal (n = 146) glycemic control groups were 6.5% and 8.5%, respectively. Compared to the suboptimal glycemic control group, the optimal glycemic control group was older, likely to have hypertension, previously suffered a stroke, have renal failure and a higher baseline creatinine. No