Data on the impact of subclinical hypothyroidism on clinical outcomes following percutaneous coronary intervention

This article contains the data showing the different influence of subclinical hypothyroidism (SCH) on the risk of cardiovascular events after percutaneous coronary intervention (PCI) in various subgroups regarding myocardial infarction, previous PCI, the stent generation, total stent length, the extent of coronary artery disease, diabetes mellitus, obesity, a lipid reduction level and a C-reactive protein level. This article also contains the data showing the association between SCH and the risk of receiving repeat PCI for in-stent restenosis or de novo coronary stenosis. The data are supplemental to our original research article titled “Impact of Subclinical Hypothyroidism on Clinical Outcomes Following Percutaneous Coronary Intervention” (Lee et al., 2017) [1].


Specifications
Data also present whether the influence of SCH on repeat PCI may be different between in-stent restenosis lesion and de novo stenotic lesion of coronary arteries.
These data for the subgroup analysis and the different risk of repeat PCI between in-stent restenosis and de novo stenosis may provide a mechanistic insight into the negative influence of SCH on the clinical outcomes following PCI.

Data
The data presented include the influence of subclinical hypothyroidism (SCH) on the composite event consisting of cardiac death, non-fatal myocardial infarction (MI) and repeat revascularization in various subgroups (Fig. 1) and the probabilities of repeat percutaneous coronary interventions (PCIs) for in-stent restenosis, overall de novo stenotic lesions and de novo stenotic lesions in non-target coronary arteries in patients with SCH and those with euthyroidism (ET) (Fig. 2). SCH was associated with the risk of the composite event in patients with a diagnosis other than MI/ST-segment elevation MI (STEMI), prior PCI, single-vessel coronary artery diseases (CAD), total stent length (TSL) o38 mm, second-generation drug-eluting stent (DES) implantation, diabetes mellitus, body mass index (BMI) Z25 kg/m 2 , highly sensitive C-reactive protein (hsCRP) Z1.0 mg/l and low-density lipoprotein (LDL) reduction o26 mg/dl (Fig. 1). The risk of repeat PCI was higher in patients with SCH than in patients with ET for in-stent restenosis but not for de novo stenosis overall and in non-target coronary arteries (Fig. 2).

Study design, data collections and definitions
A prospective PCI registry has been operated in the Department of Cardiology, Hanyang University Hospital, Seoul, Republic of Korea since 2009 [2]. Patients enrolled in the registry who underwent PCI with simple balloon angioplasty or stent implantation between March 2010 and December 2013 were consecutively enrolled in this study. Thyroid-stimulating hormone (TSH) levels were measured before the index PCI in all patients. LDL cholesterol levels were measured at the time of index PCI and 3-12 months after PCI. Subclinical hypothyroidism was defined with a serum TSH level Z4.5 mIU/l and a normal free T4 level (0.7-1.8 mIU/l). Standardized definitions of clinical events that are frequently used in cardiovascular trials were used in this study, as described by Hicks et al. [3]. Cardiac death included death resulting from acute MI, heart failure or cardiogenic shock. MI was defined as a rise in cardiac troponin I levels to a level at least three times the upper limit of normal, with at least one clinical evidence consistent with myocardial ischemia, including symptoms characteristic of angina, ST-segment changes on electrocardiography and wall motion abnormalities on echocardiography. Repeat revascularization was defined as the performance of balloon angioplasty or stent implantation in the target vessel during the observation period. Repeat revascularization was performed when a lesion with a luminal narrowing Z70% or functional ischemia was present in the target vessel territory on any diagnostic test. The first clinical event that occurred after the index PCI was used as the patient's clinical event. A composite event was defined as a combination of cardiac death, non-fatal MI and repeat revascularization. Repeat PCI was defined as a PCI that was performed for any causes after index PCI. In-stent restenosis was defined as a re-narrowing 450% at a previously stented site and at the adjacent vascular segments 5 mm proximal and distal to the site.

Statistical analyses
Statistical analyses for this article were performed using statistical software R-3.4.0 and its dedicated packages, rms, KMsurv, survival and descr and are described in detail in the main article [1]. Kaplan-Mayer survival analysis was used to compare event-free survival rates between the ET group and the SCH group in various subsets. To evaluate the associations between SCH and adverse clinical outcomes, multiple Cox-regression analyses were performed with age, sex, current smoking status, diagnosis of STEMI, BMI, lipid profiles, diabetes mellitus, hypertension, hemoglobin levels, logtransformed BNP, renal impairment, left ventricular ejection fraction, TSL, multi-vessel CAD, left main coronary artery intervention, prior PCI and stent generation serving as covariates.
Kaplan-Meier survival curve analyses were performed to compare the risk of repeat PCI for instent restenosis, overall de novo stenotic lesions and de novo stenotic lesion in non-target coronary arteries between the SCH group and the ET group.

Acknowledgments
None. Repeat PCIs for ISR lesions (A) were more frequently performed in the SCH group than in the ET group, whereas the frequencies of repeat PCIs for de novo lesions overall (B) and in non-target vessels (C) were not different between the two groups. PCI, percutaneous coronary intervention; ISR, in-stent restenosis; SCH, subclinical hypothyroidism; ET, euthyroidism.

Transparency document. Supporting information
Transparency data associated with this article can be found in the online version at https://doi.org/ 10.1016/j.dib.2017.11.080.