Bivalirudin in Peripheral Vascular Interventions

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Bivalirudin in Peripheral Vascular Interventions Excimer Laser-Assisted Angioplasty CME Applications of the Power Pulse Spray Technique for The CIS “LACI Equivalent” Experience Page xx Acute Venous and Arterial Thrombosis Page xx INSIGHT INTO THE DIAGNOSIS AND TREATMENT OF VASCULAR DISEASE MANAGEMENT OCTOBER 2004 Intracranial Middle Cerebral Artery Percutaneous Intervention Using a Drug-Eluting Stent Jacqueline Saw, MD, Jay S. Yadav, MD, Cypher™ sirolimus-eluting stent (Cordis Cameron Haery, MD, Derk W. Krieger, MD, Corporation, Miami, Florida) on April 24, Alex Abou-Chebl, MD. 2003, it has rapidly become the dominant coro- Department of Cardiovascular Medicine and nary stent in use today in the United States. By Interventional Neurology, the Cleveland Clinic the end of 2003, approximately 350,000 Foundation, Cleveland, Ohio. patients in the US had received a Cypher stent, at th representing about half of all coronary stents tion ABSTRACT: The use of bare-metal stents for used.2 Its popularity is due to its marked reduc- pati intracranial vessels is associated with relatively tion of restenosis. The only reported use of advi high restenosis rates. We report the first human drug-eluting stents in intracranial vessels was in use of a sirolimus-eluting stent for a sympto- canine models.1 We report the first human use of matic proximal middle cerebral artery stenosis. a Cypher™ stent during percutaneous interven- This stent was successfully delivered and tion of an intracranial stenosis in the middle deployed without complications, with excellent cerebral artery (MCA). one month angiographic results. CASE REPORT Multidetector Computerized Tomography for Intracranial angioplasty and stenting are A 43 year-old Caucasian female with hyper- the Evaluation of Cerebrovascular Disease increasingly being used to treat patients with lipidemia, hypertension, and a twenty pack-year A Case Study recurrent cerebral ischemia due to intracranial history of smoking presented seven months ear- atherosclerosis, which is a cause of 8-10% of all lier with an infarct involving the right parietal Corey Goldman, MD, PhD ischemic strokes. Since there are no commer- lobe. Noninvasive imaging with transcranial Director of Vascular Medicine, Ochsner Heart cially available stents designed specifically for Doppler (TCD) ultrasound showed elevated and Vascular Institute, New Orleans, Louisiana the cerebral vasculature, all such procedures velocities in the right MCA (192 cm/s). Cerebral have utilized conventional coronary stenting angiography showed a diffuse diffuse 80% dis- The patient is a 59 yo hypertensive diabetic white male systems. However, the incidence of stent tal right internal carotid artery (RICA) stenosis ex-smoker with a history of CABG in 1994. In 1997, he restenosis in the intracranial circulation can be continued on page xx underwent insertion of a pacemaker for bradycardia. In up to 40%.1 Since the FDA approval of the ap 1999, he presented with hoarseness and was diagnosed pr with squamous cell laryngeal cancer by biopsy. He under- to went laryngeal irradiation from 3/99 to 5/99 and required Bivalirudin in Peripheral Vascular insertion of a PEG tube relating to his irradiation. He m stopped smoking at that time. He did well until 5/03, at Interventions: A Single Center Experience Ca which time he complained of some worsening dysphonia, Nicolas W. Shammas, MS, MD, *Jon H. Lemke, PhD, Eric J. Dippel, MD, *Dawn E. McKinney, dizziness and diplopia. Workup at that time revealed MA, Vickie S. Takes, RN, Monica Youngblut, RN, Melodee Harris, RN hypothyroidism that was successfully treated with levothy- roxin by 7/03/03. Despite that, he continued to have visu- ABSTRACT: Unfractionated received bivalirudin as the pri- limb loss, emergent need for al disturbance and changes in his voice. Interestingly, he heparin is a widely utilized mary anticoagulant during revascularization of the same M complained of double vision only in his left visual field. An anticoagulant during peripher- PTA (0.75 mg/kg bolus, 1.75 vessel, embolic strokes, and tem ophthalmologic exam failed to explain his visual symptoms al angioplasty procedures mg/kg/h during the procedure). vascular complications (exact Ge and a neurological evaluation was suggested. (PTA). In contrast to heparin, Thirty-four (70.8%) had clau- 95% confidence intervals: continued on page xx bivalirudin is a direct thrombin dication and 6 (12.5%) had [0.0%,6.1%]). This compared inhibitor with predictable anti- ulceration. Thrombus was favorably to previously report- coagulation, does not activate angiographically seen in 3 ed data using unfractionated platelets, and inhibits both sol- (6.3%) patients. In-hospital heparin and the same serious uble and bound thrombin. serious procedural complica- procedural complications end- The experience with tions were limited to 2 (4.2%) points from our group at the bivalirudin during PTA (exact 95% confidence inter- same institution (9.2%). We remains limited. In this single- val: (0.5%,14.3%]) patients conclude that the use of center prospective study, 48 with major bleeding; none bivalirudin during PTA consecutive patients (60.4% (0.0%) of the other following continued on page xx males, mean age 70.0 ± 12.1) endpoints occurred: death, 18 V ASCULAR INTERVENTIONS OCTOBER 2004 Continued from page 1 2002 through August 6, 2002 at our Vascular Interventions institution, using bivalirudin as a pri- mary anticoagulant (0.75 mg/kg bolus, 1.75 mg/kg/hour during the appears feasible and safe. Large procedure) and did not meet one of the prospective registries are needed to following exclusion criteria: 1) confirm these findings. planned staged two or more peripher- This article is reprinted with permis- al procedures during the same hospital sion from the Journal of Invasive stay; 2) acute myocardial infarction Cardiology 2003;15:401-404. (MI) preceding the PTA; 3) the use of elective adjunctive intravenous glyco- Unfractionated heparin (UFH) is protein (GP) IIb/IIIa inhibitors during the current antithrombotic agent uti- the procedure; 4) concomitant coro- lized during peripheral angioplasty nary procedures; or 5) being on con- procedures (PTA). UFH has an unpre- tinuous intravenous heparin drip prior dictable anticoagulation response, is to the procedure. Clinical, angio- an indirect thrombin inhibitor, does graphic, and serious event rates were not inhibit bound thrombin and acti- collected prospectively. An interven- 1 vates platelets. We have recently tional cardiologist not involved in the Figure 1. Histogram for the overall age distribution and the current smokers' age distribution. reported our procedural complica- procedure adjudicated the in-hospital tions rate (9.2%) during PTA with the serious procedural complications use of UFH as a primary anticoagu- (SPC). SPC were defined as follows: The primary analysis of the study was Intraprocedural thrombus occurred lant.2 Our experience was in concor- • Major bleed: defined as requir- to estimate the rate of SPCs. in 6.3% of patients. Even though the dance with multiple published reports ing ≥ 2 units of PRBC transfu- Kruskal-Wallis tests were used to previous smokers were older than cur- showing a complication rate of sion, retroperitoneal bleed, or a compare age and body mass indices rent smokers, their durations of sur- 3.5–32.7%.3-9 drop of hemoglobin (Hb) after across pre-existing conditions. gery were similar. Any smoking (past Bivalirudin, a direct thrombin the procedure by more than 3 Kaplan-Meier plots and exact log- and current) had longer procedure inhibitor, has been recently shown to g/dL; rank tests were used to contrast proce- times (Figure 3). The difference in reduce both ischemic and bleeding •Vascular complications: defined dure times and lengths of stay. Fisher’s median procedure times was only 8 complications during coronary inter- as an AV fistula or pseudoa- exact tests were performed for com- minutes, but the difference is over an ventions when compared to UFH.10,11 neurysm after the procedure parisons of dichotomous and hour in the last quartiles of completed In contrast to UFH, bivalirudin has a when suspected clinically and unordered categorical variables. SPC procedures for the “never” versus short half-life, provides predictable confirmed by duplex ultra- rates are estimated with exact 95% “ever” smokers. The mean time of the anticoagulation response, and sound; confidence intervals. procedure was 82.4 minutes for inhibits free and bound thrombin. • Death due to procedural com- “never” smokers, but 108.1 minutes These properties provide potential plications; Results for the “ever” smokers. benefits over UFH during PTA where • Limb loss; Demographic and health history A total of 80 vessels were treated in thrombin activation is expected to •Need for in-hospital salvage characteristics of the population stud- 48 patients (mean of 1.7 vessels per be significant given the extent of ath- revascularization (angioplasty ied are shown in Table 1. Twenty nine patient). The 80 primary vessels treat- erosclerotic burden and large vessel or surgery) of the same treated (60.4%) patients were males. The ed were categorized as follows: size dilated with balloon angioplas- vessel; mean age was 70.0 ± 12.1 years; how- suprainguinal (n = 33), superficial ty. The short half-life of bivalirudin • Embolic stroke. ever, the age distribution is skewed femoral arteries and popliteal (n = 36), might also allow early sheath The following clinical variables with ages ranging from 41-89 and a and tibials (n = 11). The mean Ankle- removal, less bleeding complications were collected: age, gender, history of median age of 73 (Figure 1). There Brachial index was 0.7 ± 0.2. Closure than UFH, and a more reliable anti- diabetes, MI, angina, hypertension, were 32 (66.7%) patients with a doc- devices were used in 41 patients coagulation with no need for fre- hyperlipidemia, smoking (never, prior umented history of smoking (17 (85.4%). There were 90.2% of them quent activated clotting time (ACT) to the past year and within the past [35.4%]) current smokers, that is, who received the Perclose suturing measurements during long proce- year), prior cerebrovascular events, smoked within the past year).
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