The failure could easily been because they were using invalid endpoints like the Rankin scale.
The Rankin Scale has no useful discrimination at all. You should be using scans that show dead and damaged areas.
Outcomes of Argatroban Treatment in Patients With Atherothrombotic Stroke - Japan
Observational Nationwide Study in Japan
- Tomoki Wada, MD;
- Hideo Yasunaga, MD, PhD;
- Hiromasa Horiguchi, PhD;
- Takehiro Matsubara, MD, PhD;
- Kiyohide Fushimi, MD, PhD;
- Susumu Nakajima, MD, PhD;
- Naoki Yahagi, MD, PhD
+ Author Affiliations
- Correspondence to Tomoki Wada, MD, Department of Emergency and Critical Care Medicine, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan. E-mail wadat-eme@h.u-tokyo.ac.jp
Abstract
Background and Purpose—Argatroban,
a selective thrombin inhibitor, is recommended for the use in patients
with atherothrombotic stroke by the Japanese
Guidelines for the Management of Patients
with Acute Ischemic Stroke. We performed a nationwide Japanese study to
investigate
whether argatroban improved early stroke
outcomes in patients with acute atherothrombotic stroke.
Methods—This
retrospective observational study, using the Diagnosis Procedure
Combination database in Japan, included patients who
were hospitalized from July 1, 2010, to March
31, 2012, with a diagnosis of atherothrombotic stroke within 1 day of
stroke
onset. Patients were divided into 2 groups:
those receiving argatroban on admission (argatroban group), and those
who did
not receive argatroban during hospitalization
(control group). To balance the baseline characteristics and
concomitant treatments
during hospitalization between the 2 groups,
one-to-one propensity-score matching analyses were performed. The main
outcomes
were the modified Rankin Scale score at
discharge and the occurrence of hemorrhagic complications during
hospitalization.
An ordinal logistic regression analysis
evaluated the association between argatroban use and modified Rankin
Scale at discharge.
Results—After
propensity-score matching, 2289 pairs of patients were analyzed. There
were no significant differences in modified Rankin
Scale at discharge between the argatroban and
the control groups (adjusted odds ratio, 1.01; 95% confidence interval,
0.88–1.16).
The occurrence of hemorrhagic complications
did not differ significantly between the argatroban and the control
groups (3.5%
versus 3.8%; P=0.58).
Conclusions—The present study suggested that argatroban was safe, but had no added benefit in early outcomes after acute atherothrombotic
stroke.
