CAROTID ENDARTERECTOMY BETTER THAN STENTING IN SYMPTOMATIC PATIENTS

Better 30-Day Outcomes With Carotid Endarterectomy Than Stenting

February 6, 2009 (Watertown, Massachusetts) — Data from a national registry suggest that outcomes at 30 days are better with carotid endarterectomy (CEA) than with carotid artery stenting (CAS) [1]. Investigators report that the combined rate of death, stroke, and MI was significantly lower with the surgical approach vs the less invasive interventional technique.

"The debate about the interpretation of the results of this study as well as results of other CAS studies will continue until randomized trials such as International Carotid Stenting Study (ICSS) in Europe and [the Carotid Revascularization Endarterectomy vs Stenting Trial] CREST in North America are reported," note lead investigator Dr Anton Sidawy (Washington Veterans Affairs Medical Center, DC) and colleagues in the January 2009 issue of the Journal of Vascular Surgery.

The data, from the Society for Vascular Surgery (SVS), are the latest in a number of head-to-head comparisons between CEA and CAS that have often shown conflicting results. Two carotid-artery stenting studies--Stent-Supported Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy (SPACE) [2] and Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) [3]--were published in 2006, and both showed stenting to be inferior to endarterectomy.

Those findings contrasted with data from the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial, a study that compared carotid stenting using distal embolic protection with carotid endarterectomy in patients at high surgical risk [4]. Based on the findings from SAPPHIRE, the Food and Drug Administration approved the use of carotid stenting in patients with high-grade symptomatic stenosis who are at high operative risk.

In this analysis, the researchers obtained data from the SVS vascular registry for carotid procedures. Rates of death, stroke, and MI were significantly higher among patients who underwent stenting compared with those had an endarterectomy. Both symptomatic and asymptomatic patients had significantly higher 30-day procedure rates of death, stroke, and MI compared with CEA patients. Similarly, in an analysis of only patients with atherosclerosis, the death, stroke, and MI combined end point was significantly lower among those who underwent CEA.

Outcomes at 30 Days by Treatment Arm in the 30-Day Follow-up Cohort

Outcome	CAS, n=1450 (%)	CEA, n=1368 (%)	p
Combined death, stroke, and MI	5.72	2.63	<0.001>
Death	2.07	0.73	0.004
Stroke	3.52	1.68	0.003
MI	1.17	0.58	0.110
Transient ischemic attack	1.59	0.80	0.060

Highlighting the inconsistencies in the field, the 5.72% event rate among CAS patients is consistent with outcomes observed in the BEACH and MAVERIC studies, higher than that observed in SAPPHIRE and other studies, and lower than that observed in the ARCHER and CAPTURE trials.

More data are expected sometime this year with the results of CREST, a study of 2511 asymptomatic and symptomatic patients who are not at high risk for surgery. The ICSS study is a head-to-head comparison of carotid stenting and endarterectomy in approximately 1700 asymptomatic patients with carotid stenosis.

The researchers note that the SVS registry could possibly supplement randomized trials "by providing real-world comparisons of CAS and CEA," especially in important patient subsets.

RADIOTHERAPY FOR DCIS

Combination Surgery and Radiotherapy Benefits All Women With DCIS

NEW YORK (Reuters Health) Feb 05 - A literature review "confirms the benefit of adding radiotherapy to breast-conserving surgery for the treatment of all women diagnosed with ductal carcinoma in situ (DCIS);" this strategy substantially reduces the risk of breast cancer recurrence.

The review, conducted by Dr. Annabel Goodwin at The University of Sydney in Camperdown, Australia, and colleagues, is published in the latest online issue of The Cochrane Library, a publication of The Cochrane Collaboration.

Dr. Goodwin's group searched the Cochrane Breast Cancer Group Specialized Register (January 2008); the Cochrane Central Register of Controlled Trials (2008); MEDLINE (February 2008); EMBASE (February 2008) and abstracts from major cancer conferences.

The investigators identified four well-designed, randomized controlled trials involving 3,925 women that compared the addition of radiotherapy to breast-conserving surgery.

"All the subgroups analyzed benefited from addition of radiotherapy," Dr. Goodwin and colleagues report.

There was a statistically significant benefit with the addition of radiotherapy on all ipsilateral breast events, with a hazard ratio of 0.49, and ipsilateral DCIS recurrence, with a hazard ratio of 0.64. Recurrence of invasive cancer did not reach statistical significance.

There was no significant long-term toxicity from radiotherapy and no reports of short-term toxicity or adverse effects on the quality of life.

In a comment from the Health Behavior News Service, Dr. Monica Morrow of Memorial Sloan-Kettering Cancer Center in New York, New York, said that the review confirms what is currently recommend by most physicians for their patients with DCIS who undergo breast-conserving treatment.

"The best way to minimize the chance of recurrence is with radiation," Dr. Morrow said.

Most physicians will recommend breast-conserving surgery for DCIS. However, "studies show that the bigger the patient's role in decision-making, the greater the likelihood the patient will end up with mastectomy," she said.

"This is because most patients don't distinguish between DCIS and invasive breast cancer, because a lot of the stuff they find on the Internet is written about invasive cancer."

Dr. Morrow pointed out that there is little difference in survival rates between mastectomy and breast-conserving surgery for women with DCIS.

"What I tend to emphasize to my patients with DCIS is that no matter which treatment they choose, their risk over the next 15 years of dying of something else is greater than their risk of dying of breast cancer."

0.4 MONTH INCREASE IN DFS!!!

J Clin Oncol. 2009 Feb 2. [Epub ahead of print]

Related Articles, LinkOut

Phase III Trial of Cisplatin Plus Gemcitabine With Either Placebo or Bevacizumab As First-Line Therapy for Nonsquamous Non-Small-Cell Lung Cancer: AVAiL.

Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C.

Krankenhaus Grosshansdorf, Grosshansdorf; Asklepios Fachkliniken München-Gauting, Muenchen-Gauting; St. Vincentius-Kliniken, Karlsruhe; Heidelberg University Medical Center, Mannheim, Germany; Third Faculty of Medicine, Charles University, Postgraduate Medical School, Prague, Czech Republic; Wielkopolskie Centrum Chorob Pluc i Gruzlicy, Poznan, Poland; Cancer Research Center, Moscow, Russia; McGill University Health Centre-Royal Victoria Hospital, Montreal, Quebec; Princess Margaret Hospital, Toronto, Ontario, Canada; and F. Hoffmann-La Roche Ltd, Basel, Switzerland.

PURPOSE: Bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor, improves survival when combined with carboplatin/paclitaxel for advanced nonsquamous non-small-cell lung cancer (NSCLC). This randomized phase III trial investigated the efficacy and safety of cisplatin/gemcitabine (CG) plus bevacizumab in this setting. PATIENTS AND METHODS: Patients were randomly assigned to receive cisplatin 80 mg/m(2) and gemcitabine 1,250 mg/m(2) for up to six cycles plus low-dose bevacizumab (7.5 mg/kg), high-dose bevacizumab (15 mg/kg), or placebo every 3 weeks until disease progression. The trial was not powered to compare the two doses directly. The primary end point was amended from overall survival (OS) to progression-free survival (PFS). Between February 2005 and August 2006, 1,043 patients were randomly assigned (placebo, n = 347; low dose, n = 345; high dose, n = 351). RESULTS: PFS was significantly prolonged; the hazard ratios for PFS were 0.75 (median PFS, 6.7 v 6.1 months for placebo; P = .003) in the low-dose group and 0.82 (median PFS, 6.5 v 6.1 months for placebo; P = .03) in the high-dose group compared with placebo. Objective response rates were 20.1%, 34.1%, and 30.4% for placebo, low-dose bevacizumab, and high-dose bevacizumab plus CG, respectively. Duration of follow-up was not sufficient for OS analysis. Incidence of grade 3 or greater adverse events was similar across arms. Grade >/= 3 pulmonary hemorrhage rates were