Ultrasound-guided strategy for provisional stenting with focal balloon combination catheter: results from the randomized Strategy for Intracoronary Ultrasound-guided PTCA and Stenting (SIPS) trial
| Autor: | John McB. Hodgson, Christian P. Müller, Hans-Peter Bestehorn, Axel W. Frey, Helmut Roskamm |
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| Rok vydání: | 2000 |
| Předmět: |
Male
medicine.medical_specialty medicine.medical_treatment Coronary Disease Balloon Coronary Angiography law.invention Endosonography Time Restenosis Randomized controlled trial law Physiology (medical) Angioplasty medicine Humans Angioplasty Balloon Coronary Completely randomized design Vascular Patency business.industry Ultrasound Graft Occlusion Vascular Middle Aged medicine.disease Surgery Clinical trial Catheter Treatment Outcome Female Stents Radiology Cardiology and Cardiovascular Medicine business Follow-Up Studies |
| Zdroj: | Circulation. 102(20) |
| ISSN: | 1524-4539 |
| Popis: | Background —Intracoronary ultrasound (ICUS) has provided insights into vascular pathology and interventional therapy. The Strategy for ICUS-Guided PTCA and Stenting (SIPS) trial tested the hypothesis that routine ICUS guidance of coronary interventions improves outcome. Methods and Results —A single-center consecutive-patient randomized design (with 6-month angiographic and 2-year clinical follow-up) was used. Consecutive patients (no chronic total occlusions or emergency procedures) were randomized to ICUS-guided provisional stenting or standard angiographic guidance. Quantitative angiographic minimal lumen diameter (MLD), angiographic restenosis, clinically driven target lesion revascularization, and major adverse cardiac events (MACEs) were evaluated. A total of 291 procedures (356 lesions) were included. Procedure success was higher in the ICUS-guided group than the group randomized to standard guidance (94.7% versus 87.4%, respectively; P =0.033), whereas time (65.2±31.0 versus 60.5±34.0 minutes, P =0.18) and contrast use (209.3±94.1 versus 197.5±89.5 mL, P =0.23) were not significantly different. Stenting rates were similar (49.7% versus 49.5%, P =0.89). Acute gain was greater in the ICUS-guided group than in the standard guidance group (1.85±0.72 versus 1.67±0.76 mm, respectively; P =0.02). Angiographic 6-month analysis revealed no difference in MLD (1.71±0.94 versus 1.57±0.90, P =0.19) or binary restenosis rate (>50% diameter stenosis) (29% versus 35%, P =0.42). Clinical follow-up (602±307 days) showed a significant decrease in clinically driven target lesion revascularization in the ICUS group compared with the standard guidance group (17% versus 29%, respectively; P =0.02). Conclusions —Although angiographic MLD did not differ significantly after 6 months, ICUS-guided provisional stenting improved 2-year clinical results after intervention. |
| Databáze: | OpenAIRE |
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