The angiography-guided spot versus entire stenting in patients with long coronary lesions trial: Study design and rationale for a randomized controlled trial protocol

Ju Yeol Baek, Seung Woon Rha, Byoung Geol Choi, Cheol Ung Choi, Kyoung Ha Park, Byung Hee Hwang, Seung Jin Lee, Young Keun Ahn, Jae Woong Choi, In Ho Chae, Won Ho Choi, Young Hyo Lim, Ji Hoon Ahn, Woong Gil Choi

Research output: Contribution to journalArticlepeer-review

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Abstract

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.

Original languageEnglish
Article number100523
JournalContemporary Clinical Trials Communications
Volume17
DOIs
StatePublished - Mar 2020

Bibliographical note

Funding Information:
This study is supported and funded by Medtronic Vascular, Inc.

Publisher Copyright:
© 2020 The Authors

Keywords

  • Long coronary lesion
  • Percutaneous coronary intervention
  • Spot stenting

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