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

Young Soo Oh, Hyun Jong Lee, Juneyoung Lee, Young Jin Choi, Rak Kyeung Choi, Cheol Woong Yu, Jinsik Park, Jin Oh Choi, Je Sang Kim, Tae Hoon Kim, Ho Jun Jang, Seung Woo Park, Sang Hoon Lee

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)239-248
Number of pages10
JournalCoronary artery disease
Volume30
Issue number4
DOIs
Publication statusPublished - 2019 Jun 1

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Drug-Eluting Stents
Percutaneous Coronary Intervention
Coronary Artery Disease
Clinical Trials
Coronary Stenosis
Propensity Score
Republic of Korea
Population Groups
General Hospitals
Stents
Registries
Thrombosis
Research Design
Randomized Controlled Trials
Retrospective Studies
Confidence Intervals
Safety

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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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 Soo; Lee, Hyun Jong; Lee, Juneyoung; Choi, Young Jin; Choi, Rak Kyeung; Yu, Cheol Woong; Park, Jinsik; Choi, Jin Oh; Kim, Je Sang; Kim, Tae Hoon; Jang, Ho Jun; Park, Seung Woo; Lee, Sang Hoon.

In: Coronary artery disease, Vol. 30, No. 4, 01.06.2019, p. 239-248.

Research output: Contribution to journalArticle

Oh, Young Soo ; Lee, Hyun Jong ; Lee, Juneyoung ; Choi, Young Jin ; Choi, Rak Kyeung ; Yu, Cheol Woong ; Park, Jinsik ; Choi, Jin Oh ; Kim, Je Sang ; Kim, Tae Hoon ; Jang, Ho Jun ; Park, Seung Woo ; Lee, Sang Hoon. / 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. In: Coronary artery disease. 2019 ; Vol. 30, No. 4. pp. 239-248.
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abstract = "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.",
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T1 - 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

AU - Oh, Young Soo

AU - Lee, Hyun Jong

AU - Lee, Juneyoung

AU - Choi, Young Jin

AU - Choi, Rak Kyeung

AU - Yu, Cheol Woong

AU - Park, Jinsik

AU - Choi, Jin Oh

AU - Kim, Je Sang

AU - Kim, Tae Hoon

AU - Jang, Ho Jun

AU - Park, Seung Woo

AU - Lee, Sang Hoon

PY - 2019/6/1

Y1 - 2019/6/1

N2 - 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.

AB - 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.

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