Tags

Type your tag names separated by a space and hit enter

Outcome and one year follow-up of intra-arterial staphylokinase in 191 patients with peripheral arterial occlusion.
Thromb Haemost. 2000 May; 83(5):666-71.TH

Abstract

Wild-type or equipotent variants of recombinant staphylokinase (rSak) were given intra-arterially (as a 2 mg bolus injection followed by an infusion of 1 mg/h or 0.5 mg/h overnight, with concomitant heparin [1000 IU/h]) to 191 patients of less than 80 years (62 +/- 1 years, mean +/- SEM), with a peripheral arterial occlusion (PAO) of less than 120 days (mean 14 +/- 1 days, median 11 days, 5 to 95 percentiles 3 to 30 days). Ninety nine patients presented with acute or subacute ischemia, 57 with severe claudication, 33 with chronic rest pain and 2 with gangrene. Occlusion occurred in 122 native arteries and in 69 grafts. Revascularization was complete in 83 percent (158/191), partial in 13 percent (24/191) and absent in 4 percent (7/191) after administration of 12 +/- 0.5 mg rSak over 14 +/- 0.7 h. Complete revascularization of acute occlusions of popliteal or more distal arteries was less frequent (60 percent, 15/25) than of acute occlusions of more proximal native arteries (95 percent, 37/39, p <0.001) or grafts (89 percent, 50/56, p = 0.005). Additional endovascular procedures were performed in 47 percent and subsequent elective bypass surgery in 23 percent of patients. Major bleeding occurred in 12 percent (23/191), one month mortality was 3.1 percent (6/191) and one year mortality was 6.9 percent (12/174). However, four patients (2.1 percent) had an intracranial bleeding following therapy: a 85 year old woman with severe diabetic arteriopathy, who was included in violation of the protocol, a 79 and a 74-year-old woman and a 74-year-old man, all with severe hypertension and limb threatening ischemia; these four patients died within two months after treatment. Amputations were performed within the first year in 16 of 162 surviving patients (9.8 percent): in 7 percent (7/96) with an occluded native artery and 14 percent (9/66) with an occluded graft (p = 0.19). No significant difference in lysis rate, one month mortality or one year amputation-free survival was observed in occlusions of recent onset (< or =14 days, n = 126) as compared to occlusions of longer duration (>14 days, n = 65). Treatment was interrupted prematurely in 4 patients because of a suspected allergic reaction. Fibrinogen levels remained unaffected during treatment (3.3 +/- 0.1 g/l before vs. 3.3 +/- 0.1 g/l after infusion, n = 167). In conclusion, rSak appears to be a highly effective thrombolytic agent in patients with PAO, resulting in a low one month mortality (3.1 percent) and a high one year amputation free survival (84 percent), with an acceptable incidence of major bleedings, but with occasional fatal intracranial hemorrhages.

Authors+Show Affiliations

Center for Transgene Technology and Gene Therapy, Flanders Interuniversity Institute for Biotechnology, KU Leuven, Belgium.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

10823259

Citation

Heymans, S, et al. "Outcome and One Year Follow-up of Intra-arterial Staphylokinase in 191 Patients With Peripheral Arterial Occlusion." Thrombosis and Haemostasis, vol. 83, no. 5, 2000, pp. 666-71.
Heymans S, Vanderschueren S, Verhaeghe R, et al. Outcome and one year follow-up of intra-arterial staphylokinase in 191 patients with peripheral arterial occlusion. Thromb Haemost. 2000;83(5):666-71.
Heymans, S., Vanderschueren, S., Verhaeghe, R., Stockx, L., Lacroix, H., Nevelsteen, A., Laroche, Y., & Collen, D. (2000). Outcome and one year follow-up of intra-arterial staphylokinase in 191 patients with peripheral arterial occlusion. Thrombosis and Haemostasis, 83(5), 666-71.
Heymans S, et al. Outcome and One Year Follow-up of Intra-arterial Staphylokinase in 191 Patients With Peripheral Arterial Occlusion. Thromb Haemost. 2000;83(5):666-71. PubMed PMID: 10823259.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Outcome and one year follow-up of intra-arterial staphylokinase in 191 patients with peripheral arterial occlusion. AU - Heymans,S, AU - Vanderschueren,S, AU - Verhaeghe,R, AU - Stockx,L, AU - Lacroix,H, AU - Nevelsteen,A, AU - Laroche,Y, AU - Collen,D, PY - 2000/5/24/pubmed PY - 2000/9/9/medline PY - 2000/5/24/entrez SP - 666 EP - 71 JF - Thrombosis and haemostasis JO - Thromb. Haemost. VL - 83 IS - 5 N2 - Wild-type or equipotent variants of recombinant staphylokinase (rSak) were given intra-arterially (as a 2 mg bolus injection followed by an infusion of 1 mg/h or 0.5 mg/h overnight, with concomitant heparin [1000 IU/h]) to 191 patients of less than 80 years (62 +/- 1 years, mean +/- SEM), with a peripheral arterial occlusion (PAO) of less than 120 days (mean 14 +/- 1 days, median 11 days, 5 to 95 percentiles 3 to 30 days). Ninety nine patients presented with acute or subacute ischemia, 57 with severe claudication, 33 with chronic rest pain and 2 with gangrene. Occlusion occurred in 122 native arteries and in 69 grafts. Revascularization was complete in 83 percent (158/191), partial in 13 percent (24/191) and absent in 4 percent (7/191) after administration of 12 +/- 0.5 mg rSak over 14 +/- 0.7 h. Complete revascularization of acute occlusions of popliteal or more distal arteries was less frequent (60 percent, 15/25) than of acute occlusions of more proximal native arteries (95 percent, 37/39, p <0.001) or grafts (89 percent, 50/56, p = 0.005). Additional endovascular procedures were performed in 47 percent and subsequent elective bypass surgery in 23 percent of patients. Major bleeding occurred in 12 percent (23/191), one month mortality was 3.1 percent (6/191) and one year mortality was 6.9 percent (12/174). However, four patients (2.1 percent) had an intracranial bleeding following therapy: a 85 year old woman with severe diabetic arteriopathy, who was included in violation of the protocol, a 79 and a 74-year-old woman and a 74-year-old man, all with severe hypertension and limb threatening ischemia; these four patients died within two months after treatment. Amputations were performed within the first year in 16 of 162 surviving patients (9.8 percent): in 7 percent (7/96) with an occluded native artery and 14 percent (9/66) with an occluded graft (p = 0.19). No significant difference in lysis rate, one month mortality or one year amputation-free survival was observed in occlusions of recent onset (< or =14 days, n = 126) as compared to occlusions of longer duration (>14 days, n = 65). Treatment was interrupted prematurely in 4 patients because of a suspected allergic reaction. Fibrinogen levels remained unaffected during treatment (3.3 +/- 0.1 g/l before vs. 3.3 +/- 0.1 g/l after infusion, n = 167). In conclusion, rSak appears to be a highly effective thrombolytic agent in patients with PAO, resulting in a low one month mortality (3.1 percent) and a high one year amputation free survival (84 percent), with an acceptable incidence of major bleedings, but with occasional fatal intracranial hemorrhages. SN - 0340-6245 UR - https://www.unboundmedicine.com/medline/citation/10823259/Outcome_and_one_year_follow_up_of_intra_arterial_staphylokinase_in_191_patients_with_peripheral_arterial_occlusion_ L2 - https://www.lens.org/lens/search?q=citation_id:10823259 DB - PRIME DP - Unbound Medicine ER -