Clinical Experience with Heparin-Coated Stents--The Benestent II Pilot Phase 1

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• 作者：enestent Study Group ; Hå ; kan Emanuelsson ; Patrick W. Serruys ; Jorge Belardi ; Hans Bonnier ; Antonio Colombo ; Jean Fajadet ; Jean-Jacques Goy ; Guy Heyndrickx ; Peter de Jaegere ; Victor Legr ; Cados Macaya ; Pierre Materne ; Wolfgang Rutsch ; Ulrich Sigwart ; Harry Suryapranata
• 刊名：Journal of the American College of Cardiology
• 出版年：1995
• 出版时间：February 1995
• 年：1995
• 卷：25
• 期：2, Supplement 1
• 页码：181A
• 全文大小：115 K

文摘

The purpose of the Benestent II Pilot Phase was to explore the safety of reducing antithrombotic therapy in conjunction with implantation of heparin-coated stents. The study consists of three phases, where resumption of heparin therapy after stent implantation was progressively delayed in a stepped care approach.

Material and Methods. Palmaz-Schatz stents with heparin coating were implanted in 51 patients (88 % male) with stable angina pectoris. Heparin treatment was withheld 6 hours following removal of the sheath introducer from the femoral artery. The mean age was 59 years, 10 % had a previous myocardial infarction, diabetes was prevalent in 8 % , hypertension in 24 % and 59 % were current or previous smokers. Target lesion was located in the left anterior descending artery in 51 % , left circumflex in 8 % and right coronary artery in 41 % . TIMI flow I-II was present in 14 % and TIMI III in 86 % . The mean pre-procedural minimal lumen diameter (MLD) was 1.10 mm and reference diameter 3.16 mm.

Results. Stent implantation was successful in all patients and following the procedure, mean MLD increased to 2.77 mm and percent diameter stenosis was reduced from 65 % to 19 % . The maximum balloon size was 3.45 ± 0.40 mm. Post-stent dilatation was performed in 40 patients (80 % ). High pressure (> 12 atm) was used in 22 of these cases (54 % ). Two patients needed a second stent; one for an occlusive distal dissection and one for a distal lesion. There were no major complications, i.e. death, myocardial infarction, urgent CABG, re-PTCA or cerebrovascular accident. Peripheral vascular complications required vascular surgery in 3 patients (5.9 % ) and blood transfusion in one (2 % ).

Conclusions. In this pilot study implantation of heparinized stents was associated with a 100 % success rate, absence of serious complications and a moderate incidence of vascular complications. Further reduction of antithrombotic treatment may be feasible.