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(Circulation. 1998;98:2126-2132.)
© 1998 American Heart Association, Inc.
Clinical Investigation and Reports |
From the Department of Cardiology; La Tour Hospital, Genève, Switzerland (P.U.); Hospital Clinico San Carlos, Madrid, Spain (C.M.); Klinikum der Johannes-Gutenberg-Universität, Mainz, Germany (H.-J.R.); Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands (F.K.); Sahlgrenska Hospital, Gothenburg, Sweden (H.E.); Ospedale S. Maria della Misericordia, Udine, Italy (A.F.); Herzzentrum Bodensee, Kreuzlingen, Switzerland (M.P.); Sanofi Recherche, Paris, France (T.W.); and Sanofi, Paris, France (L.S.). Correspondence to Philip Urban, MD, Department of Cardiology, La Tour Hospital, 1 Ave JD Maillard, 1217 Meyrin-Geneva, Switzerland.
BackgroundAlthough the association of ticlopidine and aspirin has been shown to be superior to antivitamin K agents and aspirin after coronary stent implantation in low-risk patients, the latter combination has remained an unproven reference regimen for high-risk patients until recently.
Methods and ResultsWe randomized 350 high-risk patients within 6
hours after stent implantation to receive during 30 days either aspirin
250 mg and ticlopidine 500 mg/d (A+T group) or aspirin 250 mg/d and
oral anticoagulation (A+OAC group) targeted at an international
normalized ratio of 2.5 to 3. The primary composite end point was
defined as the occurrence of cardiovascular death,
myocardial infarction, or repeated
revascularization at 30 days. Patients were
eligible if (1) the stent(s) were implanted to treat abrupt closure
after PTCA; (2) the angiographic result after implantation was
suboptimal; (3) a long segment was stented (>45 mm and/or
3
stents); or (4) the largest balloon inflated in the stent had a nominal
diameter of
2.5 mm. The primary cardiac end point was reached
for 10 patients (5.6%) in the A+T group and 19 (11%) in the A+OAC
group (relative risk [RR], 1.9; 95% CI, 0.9 to 4.1;
P=0.07). Major vascular and bleeding complications were
less frequent in the A+T group (3 patients, 1.7%) than in the A+OAC
group (12 patients, 6.9%) (RR, 4.1; 95% CI, 1.2 to 14.3;
P=0.02).
ConclusionsHigh-risk patients should be treated with A+T rather than A+OAC after coronary stenting because the bleeding and vascular complications are significantly reduced and there is a marked trend suggesting a decrease in cardiac events.
Key Words: angioplasty anticoagulants platelets stents thrombosis
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