Abstract
Background: The purpose of the Benestent-II Pilot Study was to evaluate the safety of delaying and eliminating anticoagulant therapy in patients receiving a heparin-coated stent in conjunction with antiplatelet drugs. Methods and Results: The study consisted of three initial phases (I, II, III) during which resumption of heparin therapy after sheath removal was progressively deferred by 6, 12, and 36 hours. In phase IV, coumadin and heparin were replaced by 250 mg ticlopidine and 100 mg aspirin. Of the 207 patients with stable angina pectoris and a de novo lesion in whom heparin- coated stent implantation was attempted, implantation was successful in 202 patients (98%). Stent thrombosis did not occur during all four phases, and the overall clinical success rate at discharge was 99%. Bleeding complications requiring blood transfusion or surgery fell from 7.9% in phase 1 to 5.9%, 4%, and 0% in the three following phases. Hospital stay was 7.4, 6.1, 7.2, and 3.1 days for the consecutive phases. The restenosis rate for the combined four phases was 13% (15% in phase I, 20% in phase II, 11% in phase III, and 6% in phase IV). The overall rate of reintervention for the four phases was 8.9%. At 6 months, 84%, 75%, 94%, and 92% of the patients of phases I to IV, respectively, were event free. For the four phases, the event-free rate was 86%, which compares favorably with the rate observed in the Benestent-1 study (80%; relative risk, 0.68 [0.45 to 1.04]). Conclusions: The implantation of stents coated with polyamine and end-point-attached heparin in stable patients with one significant de novo coronary lesion is well tolerated, is associated with no (sub)acute stent thrombosis and results in a favorable event-free survival after 6 months.
| Original language | English |
|---|---|
| Pages (from-to) | 412-422 |
| Number of pages | 11 |
| Journal | Circulation |
| Volume | 93 |
| Issue number | 3 |
| Publication status | Published - Feb 1 1996 |
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Keywords
- angina
- anticoagulants
- coating
- heparin
- stents
ASJC Scopus subject areas
- Physiology
- Cardiology and Cardiovascular Medicine
Cite this
Heparin-coated Palmaz-Schatz stents in human coronary arteries : Early outcome of the Benestent-II pilot study. / Serruys, Patrick W.; Emanuelsson, Håkan; Van Der Giessen, Wim; Lunn, Anthony C.; Kiemeney, Ferdinand; Macaya, Carlos; Rutsch, Wolfgang; Heyndrickx, Guy; Suryapranata, Harry; Legrand, Victor; Goy, Jean Jacques; Materne, Pierre; Bonnier, Hans; Morice, Marie Claude; Fajadet, Jean; Belardi, Jorge; Colombo, Antonio; Garcia, Eulogio; Ruygrok, Peter; De Jaegere, Peter; Morel, Marie Angèle.
In: Circulation, Vol. 93, No. 3, 01.02.1996, p. 412-422.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Heparin-coated Palmaz-Schatz stents in human coronary arteries
T2 - Early outcome of the Benestent-II pilot study
AU - Serruys, Patrick W.
AU - Emanuelsson, Håkan
AU - Van Der Giessen, Wim
AU - Lunn, Anthony C.
AU - Kiemeney, Ferdinand
AU - Macaya, Carlos
AU - Rutsch, Wolfgang
AU - Heyndrickx, Guy
AU - Suryapranata, Harry
AU - Legrand, Victor
AU - Goy, Jean Jacques
AU - Materne, Pierre
AU - Bonnier, Hans
AU - Morice, Marie Claude
AU - Fajadet, Jean
AU - Belardi, Jorge
AU - Colombo, Antonio
AU - Garcia, Eulogio
AU - Ruygrok, Peter
AU - De Jaegere, Peter
AU - Morel, Marie Angèle
PY - 1996/2/1
Y1 - 1996/2/1
N2 - Background: The purpose of the Benestent-II Pilot Study was to evaluate the safety of delaying and eliminating anticoagulant therapy in patients receiving a heparin-coated stent in conjunction with antiplatelet drugs. Methods and Results: The study consisted of three initial phases (I, II, III) during which resumption of heparin therapy after sheath removal was progressively deferred by 6, 12, and 36 hours. In phase IV, coumadin and heparin were replaced by 250 mg ticlopidine and 100 mg aspirin. Of the 207 patients with stable angina pectoris and a de novo lesion in whom heparin- coated stent implantation was attempted, implantation was successful in 202 patients (98%). Stent thrombosis did not occur during all four phases, and the overall clinical success rate at discharge was 99%. Bleeding complications requiring blood transfusion or surgery fell from 7.9% in phase 1 to 5.9%, 4%, and 0% in the three following phases. Hospital stay was 7.4, 6.1, 7.2, and 3.1 days for the consecutive phases. The restenosis rate for the combined four phases was 13% (15% in phase I, 20% in phase II, 11% in phase III, and 6% in phase IV). The overall rate of reintervention for the four phases was 8.9%. At 6 months, 84%, 75%, 94%, and 92% of the patients of phases I to IV, respectively, were event free. For the four phases, the event-free rate was 86%, which compares favorably with the rate observed in the Benestent-1 study (80%; relative risk, 0.68 [0.45 to 1.04]). Conclusions: The implantation of stents coated with polyamine and end-point-attached heparin in stable patients with one significant de novo coronary lesion is well tolerated, is associated with no (sub)acute stent thrombosis and results in a favorable event-free survival after 6 months.
AB - Background: The purpose of the Benestent-II Pilot Study was to evaluate the safety of delaying and eliminating anticoagulant therapy in patients receiving a heparin-coated stent in conjunction with antiplatelet drugs. Methods and Results: The study consisted of three initial phases (I, II, III) during which resumption of heparin therapy after sheath removal was progressively deferred by 6, 12, and 36 hours. In phase IV, coumadin and heparin were replaced by 250 mg ticlopidine and 100 mg aspirin. Of the 207 patients with stable angina pectoris and a de novo lesion in whom heparin- coated stent implantation was attempted, implantation was successful in 202 patients (98%). Stent thrombosis did not occur during all four phases, and the overall clinical success rate at discharge was 99%. Bleeding complications requiring blood transfusion or surgery fell from 7.9% in phase 1 to 5.9%, 4%, and 0% in the three following phases. Hospital stay was 7.4, 6.1, 7.2, and 3.1 days for the consecutive phases. The restenosis rate for the combined four phases was 13% (15% in phase I, 20% in phase II, 11% in phase III, and 6% in phase IV). The overall rate of reintervention for the four phases was 8.9%. At 6 months, 84%, 75%, 94%, and 92% of the patients of phases I to IV, respectively, were event free. For the four phases, the event-free rate was 86%, which compares favorably with the rate observed in the Benestent-1 study (80%; relative risk, 0.68 [0.45 to 1.04]). Conclusions: The implantation of stents coated with polyamine and end-point-attached heparin in stable patients with one significant de novo coronary lesion is well tolerated, is associated with no (sub)acute stent thrombosis and results in a favorable event-free survival after 6 months.
KW - angina
KW - anticoagulants
KW - coating
KW - heparin
KW - stents
UR - http://www.scopus.com/inward/record.url?scp=9044251603&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=9044251603&partnerID=8YFLogxK
M3 - Article
C2 - 8565157
AN - SCOPUS:9044251603
VL - 93
SP - 412
EP - 422
JO - Circulation
JF - Circulation
SN - 0009-7322
IS - 3
ER -