Heparin-coated Palmaz-Schatz stents in human coronary arteries: Early outcome of the Benestent-II pilot study

Patrick W. Serruys, Håkan Emanuelsson, Wim Van Der Giessen, Anthony C. Lunn, Ferdinand Kiemeney, Carlos Macaya, Wolfgang Rutsch, Guy Heyndrickx, Harry Suryapranata, Victor Legrand, Jean Jacques Goy, Pierre Materne, Hans Bonnier, Marie Claude Morice, Jean Fajadet, Jorge Belardi, Antonio Colombo, Eulogio Garcia, Peter Ruygrok, Peter De JaegereMarie Angèle Morel

Research output: Contribution to journalArticle

357 Citations (Scopus)

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 languageEnglish
Pages (from-to)412-422
Number of pages11
JournalCirculation
Volume93
Issue number3
Publication statusPublished - Feb 1 1996

Fingerprint

Stents
Heparin
Coronary Vessels
Thrombosis
Ticlopidine
Stable Angina
Platelet Aggregation Inhibitors
Polyamines
Warfarin
Blood Transfusion
Anticoagulants
Aspirin
Disease-Free Survival
Length of Stay
Hemorrhage
Safety
Therapeutics

Keywords

  • angina
  • anticoagulants
  • coating
  • heparin
  • stents

ASJC Scopus subject areas

  • Physiology
  • Cardiology and Cardiovascular Medicine

Cite this

Serruys, P. W., Emanuelsson, H., Van Der Giessen, W., Lunn, A. C., Kiemeney, F., Macaya, C., ... Morel, M. A. (1996). Heparin-coated Palmaz-Schatz stents in human coronary arteries: Early outcome of the Benestent-II pilot study. Circulation, 93(3), 412-422.

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 journalArticle

Serruys, PW, Emanuelsson, H, Van Der Giessen, W, Lunn, AC, Kiemeney, F, Macaya, C, Rutsch, W, Heyndrickx, G, Suryapranata, H, Legrand, V, Goy, JJ, Materne, P, Bonnier, H, Morice, MC, Fajadet, J, Belardi, J, Colombo, A, Garcia, E, Ruygrok, P, De Jaegere, P & Morel, MA 1996, 'Heparin-coated Palmaz-Schatz stents in human coronary arteries: Early outcome of the Benestent-II pilot study', Circulation, vol. 93, no. 3, pp. 412-422.
Serruys PW, Emanuelsson H, Van Der Giessen W, Lunn AC, Kiemeney F, Macaya C et al. Heparin-coated Palmaz-Schatz stents in human coronary arteries: Early outcome of the Benestent-II pilot study. Circulation. 1996 Feb 1;93(3):412-422.
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. / Heparin-coated Palmaz-Schatz stents in human coronary arteries : Early outcome of the Benestent-II pilot study. In: Circulation. 1996 ; Vol. 93, No. 3. pp. 412-422.
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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.",
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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

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AU - De Jaegere, Peter

AU - Morel, Marie Angèle

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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.

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