Surgery News - November 2008 - (Page 24)

VASCULAR SURGERY NEWS • N O V E M B E R 2 0 0 8 Fluvastatin XL Cut Postsurgical Cardiac Events Wilmington, Del. “The results will require us to look at the issue of preoperative statins in vascular surgery patients and M U N I C H — The use of extended-re- maybe change our guidelines,” he added. lease fluvastatin before and after elective Current guidelines from the American major vascular surgery halved the post- College of Cardiology and American Heart Association rate statin surgical rate of cardiac death use in vascular surgery patients and myocardial infarctions in a as a IIB indication; the new randomized, controlled study data “may allow it to be with about 500 patients. bumped up to IIA,” he said in The 80-mg/day dosage of an interview. fluvastatin XL used was “comThe Dutch Echographic pletely safe” and led to reducCardiac Risk Evaluation Aptions in inflammatory markplying Stress Echo (DEers, suggesting that the CREASE) III trial randomized treatment’s benefit was bepatients who already were on cause of coronary-plaque staMyocardial bilization and prevention of ischemia occurred optimal medical treatment that plaque rupture following the in 19% of placebo did not include statin therapy stress of surgery, Dr. Don Pol- patients and 11% to either fluvastatin XL or placebo starting an average of dermans said at the annual of those treated meeting of the European So- with fluvastatin XL. 37 days before their scheduled surgery. Treatment continued ciety of Cardiology. DR. POLDERMANS until at least 30 days following Fluvastatin XL, the only extended-release statin formulation sold, was surgery but was interrupted for as long as chosen to give patients ongoing drug cov- patients were unable to take an oral pill erage during and right after surgery when during and after surgery. Fluvastatin treatment led to modest, they would be unable to receive an oral statin, said Dr. Poldermans, professor of average drops of about 20% in both total anesthesiology at Erasmus University Med- and LDL cholesterol levels, but these reical Centre in Rotterdam, the Netherlands. ductions were significantly greater than “This is important new information that were the average 3%-4% reductions in the was validated by a randomized, controlled placebo patients. The patients on active trial. It’s a very good study,” commented treatment also had an average 21% decline Dr. Timothy Gardner, an ACS Fellow and in their serum level of C-reactive protein, medical director of the Center for Heart and an average 33% fall in their serum levand Vascular Health at Christiana Care in el of interleukin-6, significantly greater BY MITCHEL L. ZOLER Else vier Global Medical Ne ws changes than in patients on placebo. During the first 30 days after surgery, the incidence of myocardial ischemia, the study’s primary end point, was 19% among the 247 placebo patients and 11% in the 250 fluvastatin XL–treated patients, a statistically significant difference. The secondary end point, the combined rate of myocardial infarction and cardiac death, occurred in 10% of placebo patients and 5% of those on fluvastatin XL, also a statistically significant difference. Additional analysis showed that treating 19 patients with fluvastatin XL avoided one episode of either cardiac death or myocardial infarction (see chart). The findings also raise the question of whether the results are a class effect for all statins or specific to fluvastatin XL because of its extended serum half life. Fluvastatin XL is not commonly prescribed in the United States, Dr. Gardner noted, although the drug has been available in the U.S. since its Food and Drug Administration approval in 2000. Fluvastatin XL (Lescol XL) is marketed by Novartis. Dr. Poldermans’s study, done entirely at Erasmus University, had no funding from Novartis. Dr. Poldermans has received educational grants from Novartis as well as other drug companies. “The risk profile of the treatment is so benign that we may need to consider changing the guidelines” for patients undergoing elective vascular surgery, said Dr. Marc E. Shelton, medical director of the Prairie Diagnostic Center at the Prairie Heart Institute in Springfield, Ill. ■ Outcomes of Vascular Surgery Patients Treated With Fluvastatin XL vs. Placebo Clinical outcome Myocardial ischemia (primary end point) Cardiovascular death or nonfatal MI (secondary end point) Odds ratio 0.53* Absolute risk reduction 8.0% Number needed to treat to prevent one event ELSEVIER GLOBAL MEDICAL NEWS 0.48* 5.3% * Statistically significant difference, compared with placebo group. Note: Based on a study of 497 patients. Source: Dr. Poldermans Endo Repair of Ruptured TAA Linked to Lower Mortality BY MARK LESNEY Strokes More Likely to Occur After CAS Than CEA BY MARK LESNEY Else vier Global Medical Ne ws S A N D I E G O — Endovascular repair of ruptured thoracic aortic aneurysms (rTAA) was associated with markedly reduced mortality and improved midterm survival when compared with the open surgical approach in a prospective intentto-treat longitudinal study. Since 2005, patients presenting with rTAA at the Vascular Institute for Health and Disease at Albany (N.Y.) Medical Center have primarily undergone thoracic endovascular aneurysm repair (TEVAR), study investigator Dr. Manish Mehta reported at the Vascular Annual Meeting. “Having the ability to treat ruptured thoracic aortic aneurysms by endovascular means has had a significant impact on improving patient survival when compared to the traditional open surgical repair,” Dr. Mehta, an ACS Fellow and director of endovascular services at Albany Medical Center, said in an interview. “I think this changing paradigm has had even a greater impact than endovascular treatment of ruptured AAA, in that we can expand on offering this treatment to patients with significant comorbidities” who otherwise might have been left untreated. The study comprised 121 patients who presented emergently with r-TAA and underwent repair via endovascular (43%) or open surgical (57%) approaches in the past decade. Before 2005, open surgical repair of r-TAA was the primary treatment of choice. Since 2005, the use of endovascular techniques for emergent treatment of r-TAA increased yearly (29% in 2005, 67% in 2006, and 90% in 2007). When compared with the open surgical group, the endovascular group had significantly higher preexisting defined comorbidities, including coronary artery disease (47% vs. 17%), hypertension (69% vs. 30%), chronic obstructive pulmonary disease (21% vs. 4%), and chronic renal insufficiency (16% vs. 4%). Neurologic complications, including paraplegia and stroke, occurred more frequently in the open surgical group (16% vs. 5%), and at 30 days there was a significant survival advantage in the endovascular group (71% vs. 44%). Furthermore, life table analysis indicated the cumulative survival in the endovascular group to be significantly better than that of the open surgical group (51% vs. 33% at 1 year, and 45% vs. 26% at 3 years). Dr. Mehta disclosed receiving research grants from W.L. Gore & Associates Inc. and Medtronic AVE Inc. Dr Mehta also serves on the advisory board, and is a speaker for W.L. Gore & Associates and Medtronic AVE. ■ Else vier Global Medical Ne ws S A N D I E G O — Patients who had had carotid artery–stenting treatment were 1.6 times more likely to have a stroke than were those having carotid endarterectomy, according to a database review of more than 80,000 carotid interventions. Researchers from the division of vascular surgery at the Robert Wood Johnson Medical School, New Brunswick, N.J., under the direction of Dr. Alan M. Graham, evaluated the 2005 Nationwide Inpatient Sample for hospitalization with an elective carotid-stenting procedure (CAS) or carotid endarterectomy (CEA) within 2 days of admission. All patients evaluated were 60 years of age or older, and procedures were analyzed with respect to patient demographics and associated complications. Such a national review was undertaken because most of the studies comparing carotid stenting and carotid endarterectomy have been derived from high-volume or single institutions, and their results may not be generalizable to all hospitals offering such treatment, according to Dr. Todd R. Vogel, an ACS Fellow who presented the findings at the Vascular Annual Meeting. In all, 80,498 interventions (73,929 CEA and 6,569 CAS) were identified. The over- all incidence of stroke was significantly different between CAS (4.16%) and CEA (2.66%). CAS was used significantly more often in octogenarians than in younger patients (8.55% in patients older than 80 years of age vs. 7.92% in patients aged 6069 years). Cardiac and pulmonary complications after CEA were significantly greater in octogenarians than in younger patients, but not significantly different after CAS. After adjusting for age, gender, complications, and Elixhauser comorbidities, CAS patients were 1.6 times more likely than CEA patients to have a stroke. Significant predictors of postoperative mortality were stroke (odds ratio, 3.5), cardiac complications (OR, 6.4), and pulmonary complications (OR, 3.5). Overall mortality steadily and significantly increased after CAS with increasing age (from 0.23% to 0.67%, P = .04), but remained stable after CEA. These findings suggest that the paradigm of less invasive procedures for the management of carotid disease in the elderly may not offer improved outcomes, according to Dr. Vogel. Further prospective analysis with emphasis on the aged is needed to determine the best management as the percentage of elderly in the U.S. population steadily grows over the next decade,” he added in an interview. ■

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Surgery News - November 2008

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