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Long-term clinical outcomes after a percutaneous coronary intervention with a drug-eluting stent in patients with unprotected left main coronary artery disease excluded from clinical trials

Oh, Young Sooa; Lee, Hyun Jonga; Lee, Juneyoungb; Choi, Young Jina; Choi, Rak Kyeunga; Yu, Cheol Woongc; Park, Jinsika; Choi, Jin-Ohd; Kim, Je Sanga; Kim, Tae-Hoona; Jang, Ho-Juna; Park, Seung Wood; Lee, Sang Hoond

doi: 10.1097/MCA.0000000000000718
PCI
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Background Major randomized clinical trials assessing clinical outcomes in patients who underwent a percutaneous coronary intervention (PCI) for left main coronary artery disease excluded some high-risk subsets. Whether the effectiveness and safety of a percutaneous approach in this group of patients are comparable with those observed in clinical trials is unclear. We aimed to explore the long-term outcomes of contemporary drug-eluting stent (DES)-based revascularization for left main coronary artery disease in patients presenting with one or more clinical or angiographic characteristics who would have precluded inclusion in randomized trials.

Patients and methods Between April 2003 and December 2011, 340 consecutive patients with unprotected left main coronary artery stenosis of at least 50% who underwent successful PCI with DES at Sejong General Hospital (Bucheon, Republic of Korea) were included in this retrospective study. Patients were classified into the exclusion group (group E; n=120) and the inclusion group (group I; n=220) according to the prespecified inclusion and exclusion criteria utilized in clinical trials.

Results During the median follow-up of 86 (52–114) months, major adverse cardiac or cerebrovascular events occurred in 69 (31.4%) patients in group I and 46 (38.3%) patients in group E (P=0.155). In the propensity score-matched population, group E was not associated with a higher incidence of major adverse cardiac or cerebrovascular events (hazard ratio: 1.42, 95% confidence interval: 0.76–2.65, P=0.758). Definite or probable stent thrombosis occurred in five patients of group I, with no cases in group E.

Conclusion In our real-world registry, about a third of patients who underwent PCI for unprotected left main coronary artery stenosis had one or more high-risk characteristics or comorbid conditions that represent exclusion criteria of previous randomized trials. PCI using DES is feasible in these patients.

aDepartment of Internal Medicine, Division of Cardiology, Sejong General Hospital, Bucheon

Departments of bBiostatistics

cInternal Medicine, Division of Cardiology, Korea University Hospital, Korea University School of Medicine

dDepartment of Internal Medicine, Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

Correspondence to Hyun Jong Lee, MD, Department of Internal Medicine, Division of Cardiology, Sejong General Hospital, 91-121 Sosa 2-Dong, Sosa-Gu, Bucheon 422-711, Republic of Korea Tel: +82 323 401 812; fax: +82 323 401 236; e-mail: untouchables00@hanmail.net

Received October 22, 2018

Received in revised form January 3, 2019

Accepted January 13, 2019

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