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Coronary Intervention with a Heparin-Coated Stent and <br />
Aspirin Only<br />
August 2003
The use of the antiplatelet agents ticlopidine and clopidogrel, in addition to aspirin, has been proven to reduce subacute stent thrombosis (SAT) rates to Patients. A total of 122 patients who had undergone an optimal BX-velocity heparin-coated coronary stent implantation for single native de novo or restenotic lesions in vessels >= 2.5 mm in diameter for stable angina or unstable angina or an acute myocardial infarction (MI) were enrolled in the study. Excluded were patients with an unprotected left main lesion, a bifurcation lesion, diffuse disease, no reflow phenomenon, known or suspected infection, and those who required balloon dilatation of segments distal or proximal to the implanted stent. Additionally, patients with a known sensitivity to aspirin or heparin and those enrolled in other medication or device studies were excluded. An optimal result was defined as a residual stenosis of 14 atmospheres) balloon inflation. Only one stent was permitted per lesion/patient. When additional stent implantation was required (e.g. because of malposition or edge dissection), the patient was excluded from the study. Coronary angiography was performed after 100–200 µg of intracoronary nitroglycerine, before angioplasty and optimal stent implantation. All angiograms were sent to the core laboratory (Diagram, Zwolle, The Netherlands) and the vessel reference diameter and minimum luminal diameter were measured using a computer-assisted, automated edge detection algorithm (CAAS II). The mean values of at least two orthogonal views were used for quantitative analysis. Intravascular ultrasound was permitted but not mandatory.
Aggressive management of coronary risk factors was encouraged. Continuation of other cardiac drugs (e.g. beta blockers) following the procedure was at the discretion of the physician. Blood was drawn for hematology, electrolytes and creatine kinase, and an electrocardiogram was performed before the procedure and the following morning before discharge. A non-Q wave MI was defined as an elevation of the creatine kinase to more than twice the upper limit of normal.
Patients returned after 30 days for a clinical assessment, physical examination and electrocardiogram. Symptoms according to the Canadian Cardiovascular Society, cardiac medications and the occurrence of any adverse events (MACE) were recorded. Statistical analysis was performed using SAS statistical software. Discrete variables are expressed as percent frequencies and continuous variables as mean ± standard deviation. The Chi-square test was used where appropriate. The Spearman correlation coefficient was used to measure associations. A p value of Appendix.
Recruiting centres: Auckland, New Zealand (Peter Ruygrok, James Stewart, Mark Webster, John Ormiston): 37 patients; Penang, Malaysia (Kui-Hian Sim, Nik Ahmad, Tuan Rosli): 26 patients; National Heart Centre, Singapore (Charles Chan, Koon-How Mak, Victor Lim): 20 patients; National Cardiac Center, Jakarta, Indonesia (Otte Rachman, M. Yusak): 14 patients; Soetomo General Hospital, Surabaya, Indonesia (Jeffrey Adipranoto, Iwan Boestan): 13 patients; Medistra Hospital, Jakarta, Indonesia (Hanafi Trisnohadi, Teguh Santoso, Irawan Sugeng): 12 patients.
Study coordinator and principal investigator: Harry Suryapranata, Isala Klinieken, Hospital De Weezenlanden, Zwolle, The Netherlands. Core laboratory: Diagram, Zwolle, The Netherlands. Supported by: Cordis Clinical Research Europe, Waterloo, Belgium.
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