Campen, D.

Graham, D.J.

Hui, R.

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ABSTRACTS
Gregory L. Moneta, MD, Abstracts Section Editor
Lifestyle, diabetes, and cardiovascular risk factors 10 years after bari-
atric surgery
Sjöström L, Lindroos A-K, Peltonen M, and The Swedish Obese Subjects
Study Scientific Group. N Engl J Med 2004;351:2683-93.
Conclusion: Bariatric surgery, when compared with conventional obe-
sity therapy, provides better long-term weight loss, improved lifestyle, and
amelioration of cardiovascular risk factors, with the exception of hypercho-
lesterolemia.
Summary: The Swedish Obese Subjects Study is a prospective investi-
gation involving obese subjects who underwent bariatric surgery or conven-
tional treatment for obesity. This report documents follow-up data for
subjects (mean age, 48 years; mean body mass index, 41 kg/m2) who were
enrolled in the study for at least 2 years (4047 subjects) or 10 years (1703
subjects). The follow-up rate for laboratory examinations was 86.6% at 2
years and 74.5% at 10 years.
After 2 years of follow-up, weight increased 0.1% in the control group
and decreased 23.4% in the surgery group (P .001). After 10 years, weight
had increased by 1.6% in the control group and had decreased by 16.1% in
the surgery group (P  .001). There were proportionally more physically
active subjects in the surgery group than in the control group throughout
the observation period. Two- to 10-year recovery rates from hypertriglycer-
idemia, low levels of high-density lipoprotein cholesterol, diabetes, hyper-
tension, and hyperuricemia were more favorable in the surgery than the
control group. There were no differences in recovery from hypercholester-
olemia in the control and surgery groups. The surgery group had lower 2-
and 10-year incidence rates of diabetes, hypertriglyceridemia, and hyperuri-
cemia than the control group. There were no differences between the groups
in the incidence of hypercholesterolemia and hypertension.
Comment: This was not a randomized study. The data, however,
strongly implicate bariatric surgery as an effective means of improving
cardiovascular risk factors in the morbidly obese. The study does not tell us
whether progression of established vascular disease in the morbidly obese
can be slowed by bariatric surgery. We are not currently at the point where
we can recommend bariatric surgery as a treatment to slow progression of
peripheral vascular disease. However, in patients with established cardiovas-
cular risk factors who are morbidly obese, bariatric surgery can be recom-
mended to diminish these risk factors and improve lifestyle.
Subintimal angioplasty in the treatment of patients with intermittent
claudication: Long-term results
Florenes T, Bay D, Sandbaek G, et al. Eur J Vasc Endovasc Surg 2004;28:
645-50.
Conclusion: Subintimal angioplasty should be the primary treatment
for patients with intermittent claudication when medical treatment alone has
been unsatisfactory.
Summary: The authors report the results of subintimal angioplasty
used for treatment of patients with intermittent claudication. The authors
performed 116 subintimal angioplasties in 104 patients from February 1997
to January 2000. The authors calculated primary assisted patency rates for
successful angioplasties, as well as calculated primary assisted patency rates,
on an intention-to-treat basis. Univariant and multivariant Cox regression
analysis was used to evaluate correlations of patency with comorbidities,
occlusion length, and runoff.
Technical success was achieved in 87% (n 101) of cases. There was no
early mortality. On an attention-to-treat basis (116 cases), primary assisted
patency at 6, 12, 36, and 60 months was 69%, 62%, 57%, and 54%,
respectively. In successfully recanalized cases (101 cases), primary assisted
patency at 6, 12, 36, and 60 months was 79%, 70%, 66%, and 64%. The risk
of reocclusion was related to length of occlusion, age, and male sex.
Periprocedural complications included seven hematomas, one requiring
surgical evacuation, and six perforations that did not require intervention.
Comment: The patency results in this study are reasonable, but overall
the paper is not all that helpful. We already know that subintimal angioplasty
can be successful. The goal of treatment in patients with intermittent
claudication, however, is improvement in walking and quality of life. The
authors do not even present hemodynamic data, much less data regarding
walking and quality of life. In a prospective study of treatment for intermit-
tent claudication, more functional data, and not just simple patency analysis,
should be included.
Risk of acute myocardial infarction and sudden cardiac death in pa-
tients treated with cyclo-oxygenase 2 selective and non-selective non-
steroidal inflammatory drugs: Nested case-control study
Graham DJ, Campen D, Hui R, et al. Lancet Online Publication, January
25, 2005
Conclusion: Compared with celecoxib, rofecoxib increases the risk of
serious coronary heart disease. Naproxen does not offer a protective effect
against coronary heart disease.
Summary: The Vioxx Gastrointestinal Outcomes Research Trial
(VIGOR) raised questions about the cardiovascular risk of COX-2–selective
drugs. In this trial, there was a fivefold difference in the incidence of acute
myocardial infarction in patients treated with rofecoxib 50 mg/d and
naproxen 1000 mg/d. There was no placebo group in this trial; therefore,
findings could suggest adverse effects of coxibs in general, an adverse effect
of rofecoxib, or a previously unrecognized protective effect of naproxen. The
authors sought to establish whether cardiovascular risk was increased with
rofecoxib at standard or high doses in comparison to remote nonsteroidal
anti-inflammatory drug (NSAID) use or celecoxib. Celecoxib was chosen as
a comparison drug to rofecoxib because celecoxib was the most common
alternative to rofecoxib.
This was a nested case-control study. Data were derived from Kaiser
Permanente in California. The authors assembled a cohort of all patients
aged 18 to 84 years treated with NSAIDs between January 1, 1999, and
December 31, 2001. Cases of serious coronary heart disease (defined as
acute myocardial infarction and cardiac death) were risk-set–matched for
age, sex, and health plan region. There were four controls for each case. The
authors compared current exposure to COX-2–selective and –nonselective
NSAIDS and to remote exposure to any NSAID. Rofecoxib was also
compared with celecoxib.
There were 2,302,029 person-years of follow-up. There were 8143
cases of serious coronary heart disease, 27.1% (n  2210) of which were
fatal. Multivariant adjusted odds ratios vs celecoxib were as follows: for
rofecoxib (any dose), 1.59 (95% CI, 1.1-2.32; P  .015); for rofecoxib 25
mg/d or less, 1.47 (95% CI, 0.99-2.17; P .054); and for rofecoxib greater
than 25 mg/d, 3.58 (95% CI, 1.27-10.11; P .016). For naproxen vs past
NSAID use, the adjusted odds ratio was 1.14 (95% CI, 1.00-1.30; P .05).
Comment: Parts of this article were first posted on the US Food and
Drug Administration (FDA) Web site on November 2, 2004. At that point,
the document was considered preliminary and was a source of great contro-
versy within the FDA. It is important to recognize that the current docu-
ment represents the opinion of the authors and not necessarily that of the
FDA and that the FDA did not participate in the study design, data
collection, analysis, or writing of this report. This study, however, obviously
has enormous implications for the entire class of COX-2 inhibitors and the
mechanisms of oversight used by the FDA.
Randomized clinical trial of intraoperative autotransfusion in surgery
for abdominal aortic aneurysm
Mercer KG, Spark JI, Berridge DC, et al. Br J Surg 2004;91:1443-8.
Conclusion: Autotransfusion effectively reduces the need for homol-
ogous blood transfusion (HBT) during repair of abdominal aortic aneurysm
(AAA). Use of autotransfusion was associated with a reduced incidence of
both the systemic inflammatory response syndrome (SIRS) and postopera-
tive infectious complications.
Summary: This was a randomized, single-center clinical trial of intra-
operative autotransfusion in patients undergoing repair of AAA. There were
40 patients randomized to intraoperative autotransfusion and 41 patients
who underwent surgery for AAA with homologous blood transfusion alone.
Patients in both groups received, when necessary, HBT to maintain hemo-
globin levels8 g/dL. Comparisons were made among transfusion require-
ments, the incidence of infection, and the incidence of SIRS between the
two groups.
Fewer patients in the intraoperative autotransfusion group required
HBT (21 vs 31; P  .038). The median blood requirement per patient was
two units lower in the patients undergoing intraoperative autotransfusion vs
those treated with HBT alone (P  .012). There was a higher incidence of
SIRS (20 vs 9 patients; P  .020) and a higher incidence of chest infection
(12 vs 4 patients; P  .049) in the HBT-alone group. The risk of SIRS was
related to aortic cross-clamp time in the intraoperative autotransfusion
group only.
Comment: The author’s finding that intraoperative autotransfusion is
associated with reduced postoperative infection is consistent with observa-
tional studies linking a diminished immunologic response to HBT. The
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Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal inflammatory drugs: Nested case-control study 

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Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal inflammatory drugs: Nested case-control study

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