The angiography-guided spot versus entire stenting in patients with long coronary lesions trial: Study design and rationale for a randomized controlled trial protocol
| Autor: | Byung Hee Hwang, Young Keun Ahn, Woong Gil Choi, Kyoung-Ha Park, Byoung Geol Choi, Cheol Ung Choi, Ju Yeol Baek, Seung Jin Lee, Ji Hoon Ahn, Won Ho Choi, Jae Woong Choi, Seung-Woon Rha, Young Hyo Lim, In Ho Chae |
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| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
medicine.medical_treatment Spot stenting Revascularization Article law.invention Percutaneous coronary intervention 03 medical and health sciences 0302 clinical medicine Restenosis Randomized controlled trial law Intravascular ultrasound medicine Clinical endpoint Long coronary lesion 030212 general & internal medicine Myocardial infarction cardiovascular diseases Pharmacology lcsh:R5-920 medicine.diagnostic_test business.industry Stent General Medicine medicine.disease equipment and supplies surgical procedures operative Radiology business lcsh:Medicine (General) 030217 neurology & neurosurgery |
| Zdroj: | Contemporary Clinical Trials Communications Contemporary Clinical Trials Communications, Vol 17, Iss, Pp-(2020) |
| ISSN: | 2451-8654 |
| Popis: | Background: /Purpose: Long-stenting, even with a second-generation drug-eluting stent (DES), is an independent predictor of restenosis and stent thrombosis in patients with long coronary lesions. Spot-stenting, i.e., selective stenting of only the most severe stenotic segments of a long lesion, may be an alternative to a DES. The purpose of this study is to compare the one-year clinical outcomes of patients with spot versus entire stenting in long coronary lesions using a second-generation DES. Method: This study is a randomized, prospective, multi-center trial comparing long-term clinical outcomes of angiography-guided spot versus entire stenting in patients with long coronary lesions (≥25 mm in length). The primary endpoint is target vessel failure (TVF) at 12 months, a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization (TVR). A total of 470 patients are enrolled for this study according to sample size calculations. This study will be conducted to evaluate the non-inferiority of spot stenting compared to entire stenting with zotarolimus-eluting stents (ZES). Results: This study is designed to evaluate the clinical impact of spot-stenting with ZESs for TVF due to possible edge restenosis or non-target lesion revascularization. Theoretically, spot-stenting may decrease the risk of TVR and the extent of endothelial dysfunction. Conclusion: This SPOT trial will provide clinical insight into spot-stenting with a current second-generation DES as a new strategy for long coronary lesions. Keywords: Spot stenting, Long coronary lesion, Percutaneous coronary intervention |
| Databáze: | OpenAIRE |
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