Clinical Outcomes in Low Risk Coronary Artery Disease Patients Treated with Different Limus-Based Drug-Eluting Stents - A Nationwide Retrospective Cohort Study Using Insurance Claims Database

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Abstract

The clinical outcomes of different limus-based drug-eluting stents (DES) in a real-world setting have not been well defined. The aim of this study was to investigate the clinical outcomes of three different limus-based DES, namely sirolimus-eluting stent (SES), Endeavor zotarolimus-eluting stent (E-ZES) and everolimus-eluting stent (EES), using a national insurance claims database. We identified all patients who received implantation of single SES, E-ZES or EES between January 1, 2007 and December 31, 2009 from the National Health Insurance claims database, Taiwan. Follow-up was through December 31, 2011 for all selected clinical outcomes. The primary end-point was all-cause mortality. Secondary end-points included acute coronary events, heart failure needing hospitalization, and cerebrovascular disease. Cox regression model adjusting for baseline characteristics was used to compare the relative risks of different outcomes among the three different limus-based DES. Totally, 6584 patients were evaluated (n=2142 for SES, n=3445 for E-ZES, and n=997 for EES). After adjusting for baseline characteristics, we found no statistically significant difference in the risk of all-cause mortality in three DES groups (adjusted hazard ratio [HR]: 1.14, 95% confidence interval [CI]: 0.94-1.38, p=0.20 in E-ZES group compared with SES group; adjusted HR: 0.77, 95% CI: 0.54-1.10, p=0.15 in EES group compared with SES group). Similarly, we found no difference in the three stent groups in risks of acute coronary events, heart failure needing hospitalization, and cerebrovascular disease. In conclusion, we observed no difference in all-cause mortality, acute coronary events, heart failure needing hospitalization, and cerebrovascular disease in patients treated with SES, E-ZES, and EES in a real-world population-based setting in Taiwan.

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Most cited references 30

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A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group.

Patrick W. Serruys, Peter P.T.h. de Jaegere, Ferdinand Kiemeneij … (1994)

Balloon-expandable coronary-artery stents were developed to prevent coronary restenosis after coronary angioplasty. These devices hold coronary vessels open at sites that have been dilated. However, it is unknown whether stenting improves long-term angiographic and clinical outcomes as compared with standard balloon angioplasty. A total of 520 patients with stable angina and a single coronary-artery lesion were randomly assigned to either stent implantation (262 patients) or standard balloon angioplasty (258 patients). The primary clinical end points were death, the occurrence of a cerebrovascular accident, myocardial infarction, the need for coronary-artery bypass surgery, or a second percutaneous intervention involving the previously treated lesion, either at the time of the initial procedure or during the subsequent seven months. The primary angiographic end point was the minimal luminal diameter at follow-up, as determined by quantitative coronary angiography. After exclusions, 52 patients in the stent group (20 percent) and 76 patients in the angioplasty group (30 percent) reached a primary clinical end point (relative risk, 0.68; 95 percent confidence interval, 0.50 to 0.92; P = 0.02). The difference in clinical-event rates was explained mainly by a reduced need for a second coronary angioplasty in the stent group (relative risk, 0.58; 95 percent confidence interval, 0.40 to 0.85; P = 0.005). The mean (+/- SD) minimal luminal diameters immediately after the procedure were 2.48 +/- 0.39 mm in the stent group and 2.05 +/- 0.33 mm in the angioplasty group; at follow-up, the diameters were 1.82 +/- 0.64 mm in the stent group and 1.73 +/- 0.55 mm in the angioplasty group (P = 0.09), which correspond to rates of restenosis (diameter of stenosis, > or = 50 percent) of 22 and 32 percent, respectively (P = 0.02). Peripheral vascular complications necessitating surgery, blood transfusion, or both were more frequent after stenting than after balloon angioplasty (13.5 vs. 3.1 percent, P < 0.001). The mean hospital stay was significantly longer in the stent group than in the angioplasty group (8.5 vs. 3.1 days, P < 0.001). Over seven months of follow-up, the clinical and angiographic outcomes were better in patients who received a stent than in those who received standard coronary angioplasty. However, this benefit was achieved at the cost of a significantly higher risk of vascular complications at the access site and a longer hospital stay.

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A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators.

David L Fischman, Martin Leon, Donald S Baim … (1994)

Coronary-stent placement is a new technique in which a balloon-expandable, stainless-steel, slotted tube is implanted at the site of a coronary stenosis. The purpose of this study was to compare the effects of stent placement and standard balloon angioplasty on angiographically detected restenosis and clinical outcomes. We randomly assigned 410 patients with symptomatic coronary disease to elective placement of a Palmaz-Schatz stent or to standard balloon angioplasty. Coronary angiography was performed at base line, immediately after the procedure, and six months later. The patients who underwent stenting had a higher rate of procedural success than those who underwent standard balloon angioplasty (96.1 percent vs. 89.6 percent, P = 0.011), a larger immediate increase in the diameter of the lumen (1.72 +/- 0.46 vs. 1.23 +/- 0.48 mm, P < 0.001), and a larger luminal diameter immediately after the procedure (2.49 +/- 0.43 vs. 1.99 +/- 0.47 mm, P < 0.001). At six months, the patients with stented lesions continued to have a larger luminal diameter (1.74 +/- 0.60 vs. 1.56 +/- 0.65 mm, P = 0.007) and a lower rate of restenosis (31.6 percent vs. 42.1 percent, P = 0.046) than those treated with balloon angioplasty. There were no coronary events (death; myocardial infarction; coronary-artery bypass surgery; vessel closure, including stent thrombosis; or repeated angioplasty) in 80.5 percent of the patients in the stent group and 76.2 percent of those in the angioplasty group (P = 0.16). Revascularization of the original target lesion because of recurrent myocardial ischemia was performed less frequently in the stent group than in the angioplasty group (10.2 percent vs. 15.4 percent, P = 0.06). In selected patients, placement of an intracoronary stent, as compared with balloon angioplasty, results in an improved rate of procedural success, a lower rate of angiographically detected restenosis, a similar rate of clinical events after six months, and a less frequent need for revascularization of the original coronary lesion.

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Validation of Acute Myocardial Infarction Cases in the National Health Insurance Research Database in Taiwan

Ching-Lan Cheng, Cheng-Han Lee, Po-Sheng Chen … (2014)

Background The aim of this study was to determine the validity of acute myocardial infarction (AMI) diagnosis coding in the National Health Insurance Research Database (NHIRD) by cross-comparisons of discharge diagnoses listed in the NHIRD with those in the medical records obtained from a medical center in Taiwan. Methods This was a cross-sectional study comparing records in the NHIRD and discharge notes in one medical center (DNMC) in the year 2008. Positive predictive values (PPVs) for AMI diagnoses were evaluated by reviewing the relevant clinical and laboratory data recorded in the discharge notes of the medical center. Agreement in comorbidities, cardiac procedures, and antiplatelet agent (aspirin or clopidogrel) prescriptions between the two databases was evaluated. Results We matched 341 cases of AMI hospitalizations from the two databases, and 338 cases underwent complete chart review. Of these 338 AMI cases, 297 were confirmed with clinical and lab data, which yielded a PPV of 0.88. The consistency rate for coronary intervention, stenting, and antiplatelet prescription at admission was high, yielding a PPV over 0.90. The percentage of consistency in comorbidity diagnoses was 95.9% (324/338) among matched AMI cases. Conclusions The NHIRD appears to be a valid resource for population research in cardiovascular diseases.

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Author and article information

Contributors

Ho-Chang Kuo: Role: Academic Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, CA USA )

ISSN (Electronic): 1932-6203

Publication date (Electronic): 7 April 2015

Publication date Collection: 2015

Volume: 10

Issue: 4

Electronic Location Identifier: e0122860

Affiliations

[1 ]Department of Internal Medicine and Center for Critical Care Medicine, National Taiwan University Hospital Hsin-Chu Branch, Hsin-Chu, Taiwan

[2 ]Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan

[3 ]Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan

[4 ]Department of Internal Medicine, Mennonite Christian Hospital, Hualien, Taiwan

[5 ]Institute of Health Policy and Management, College of Public Health, National Taiwan University, Taipei, Taiwan

[6 ]Center for Comparative Effectiveness Research, National Center of Excellence for Clinical Trial and Research, National Taiwan University Hospital, Taipei, Taiwan

[7 ]Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan

[8 ]Department of Medical Research, National Taiwan University Hospital, Taipei, Taiwan

[9 ]Graduate Institute of Oncology, College of Medicine, National Taiwan University, Taipei, Taiwan

Kaohsiung Chang Gung Memorial Hospital, TAIWAN

Author notes

Competing Interests: The authors have declared that no competing interests exist.

Conceived and designed the experiments: CLL CFW RNK YYY MFC KAC MSL. Performed the experiments: CLL CFW RNK YYY. Analyzed the data: RNK YYY. Contributed reagents/materials/analysis tools: RNK YYY MFC MSL. Wrote the paper: CLL CFW KAC.

* E-mail: mslai@ 123456ntu.edu.tw

Article

Publisher ID: PONE-D-14-49269

DOI: 10.1371/journal.pone.0122860

PMC ID: 4388589

PubMed ID: 25848942

SO-VID: d0d37f7c-54b9-4b42-9b46-e1b4813bdca2

License:

This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited

History

Date received : 7 November 2014

Date accepted : 15 February 2015

Page count

Figures: 3, Tables: 2, Pages: 14

Funding

This study was supported by grants from the Science and Technology Unit, Ministry of Health and Welfare, Executive Yuan, Taiwan (DOH101-TD-B-111-001 and DOH102-TD-B-111-001). The funding agency did not have any input in study design, data analysis, and interpretation of findings, or in the decision to submit the manuscript for publication.

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Data Availability The authors do not own the data underlying this study. All the data used in the study were released and approved by the Collaboration Center of Health Information Application (CCHIA), Ministry of Health and Welfare, Executive Yuan, Taiwan. The CCHIA must approval all applications for use of the database. The process of data analysis has to be conducted in specific offices provided by the CCHIA. Only the results of analysis are released after review by the CCHIA. The use of the database owned by the CCHIA is subject to related regulations of the CCHIA, including payment. The contact information of CCHIA is as follows: Address: No. 488, Sec. 6, Zhongxiao E. Rd., Nangang Dist. Taipei 11558, Taiwan; Tel: +886-2-85906825; e-mail: stcarolwu@ 123456mohw.gov.tw .

Clinical Outcomes in Low Risk Coronary Artery Disease Patients Treated with Different Limus-Based Drug-Eluting Stents - A Nationwide Retrospective Cohort Study Using Insurance Claims Database

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Most cited references 30

A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group.

A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators.

Validation of Acute Myocardial Infarction Cases in the National Health Insurance Research Database in Taiwan

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