Methods

The design and primary results of the ACUITY trial have been previously reported ( ClinicalTrials.gov identifier NCT00093158 ). In brief, 13,819 patients with moderate- and high-risk non–ST-segment elevation acute coronary syndromes undergoing an early invasive management strategy were randomly assigned to heparin plus glycoprotein IIb-IIIa inhibitors, bivalirudin plus glycoprotein IIb-IIIa inhibitors, or bivalirudin monotherapy before coronary angiography. Clinical follow-up examinations were performed at 30 days and 1 year. All MACE were adjudicated by an independent clinical events committee. Retrospectively, all stent thrombosis events were re-adjudicated using the Academic Research Consortium definitions. As a part of the present study, only PCI patients who had undergone quantitative coronary angiography (Cardiovascular Research Foundation, New York, New York) within the formal angiographic substudy of the ACUITY trial were included. In the ACUITY trial, quantitative coronary angiography was performed in 6,921 patients, including 3,664 PCI patients. After excluding those patients with a history of previous coronary artery bypass grafting (n = 862) and patients for whom the SS could not be calculated for technical reasons (n = 338), 2,627 patients remained available for analysis. Patients with infarct-related occluded arteries were considered to have total occlusion of undetermined duration. Lesions with in-stent restenosis were scored as de novo lesions. The SS was retrospectively calculated by 3 experienced interventional cardiologists who were unaware of the treatment assignment and clinical outcomes. To assess interobserver reproducibility among the 3 readers, a Fleiss kappa statistic value for multiple readers (tertile partitioning) was determined. Each lesion with ≥50% diameter stenosis in vessels ≥1.5 mm was scored using the SS algorithm, which has been fully described previously (available at: www.syntaxscore.com ). The Fleiss Kappa statistic (tertile partitioning), determined for the 3 readers from 50 films read independently, was 0.57, indicating that interobserver reproducibility was comparable to that previously reported from the SYNTAX trial. Continuous variables are expressed as the mean ± SD and were compared using the Student t test or the Mann-Whitney rank sum test, as appropriate. Categorical variables are presented as percentages and numbers per total and were compared using the chi-square test or Fisher’s exact test. Patients with SVD and MVD were separately grouped into SS tertiles. The 1-year outcomes were summarized as Kaplan-Meier estimates and compared using the log-rank test and hazards ratios. Stepwise Cox multivariate regression analyses were performed to assess the association between the SS and 1-year MACE, all-cause mortality, cardiac mortality, myocardial infarction, and target vessel revascularization in patients with SVD and MVD. Potential predictors were entered into the model with entry and stay criteria of 0.1. The following baseline and procedure variables were included in the models: SS (as a continuous variable), age, male gender, diabetes, renal insufficiency, left ventricular ejection fraction, baseline troponin elevation, ST-segment deviation, previous myocardial infarction, and previous PCI. The numbers of independent variables included in the models were carefully chosen to avoid overfitting (i.e., having too many covariates relative to the number of observations). To evaluate the predictive value of the SS compared with the number of diseased vessels disease, MVD versus SVD, as a covariate, was forced into the model of the 1-year clinical outcome for the entire population. All statistical tests were performed using Statistical Analysis Systems software, version 9.1 (SAS Institute, Cary, North Carolina), and p <0.05 denoted statistical significance.

Results

In the present analysis, SS was determined in 2,627 PCI patients, including 1,461 patients (55.6%) with SVD and 1,166 (44.4%) with MVD. For the patients with MVD, the median SS was 14, and was 7 for the patients with SVD. Figure 1 shows the distribution of the SS in those with SVD and MVD according the tertiles for the entire population (i.e., lowest [<7], middle [7 to 13], and highest [>13] SS). The baseline characteristics of the patients with SVD and MVD are listed in Table 1 . Patients with MVD had more co-morbidities and less favorable coronary anatomy. No significant differences were found in the in-hospital antithrombotic medication use between the 2 groups.

Distribution of the SS in patients with SVD and MVD of the entire population. Each point could represent >1 patient if the SS were identical.

The clinical outcomes stratified according to SS tertile in patients with SVD and MVD are listed in Table 2 and shown in Figures 2 and 3 .

Time-to-event curves for patients with MVD. One-year cumulative event curves for rates of (A) cardiac mortality, (B) myocardial infarction, (C) target vessel revascularization, and (D) MACE, stratified by SS tertiles.

Time-to-event curves for patients with SVD. One-year cumulative event curves for rates of (A) cardiac mortality, (B) myocardial infarction, (C) target vessel revascularization, and (D) MACE, stratified by SS tertiles.

Compared with patients in the first and second tertile, those in the third tertile had a greater incidence of MACE (13.4%, 15.3%, and 19.1%, respectively; p _trend = 0.01), death or myocardial infarction (5.5%, 8.5%, and 11.6%, respectively; p _trend = 0.003), myocardial infarction (4.4%, 7.7%, and 10.5%, respectively; p _trend = 0.002), and probable or definite stent thrombosis (0.2%, 0.6%, and 2.1%, respectively; p _trend = 0.01). Compared with patients in the lowest tertile, those in the intermediate and upper tertiles had a greater incidence of MACE (16.8%, 24.7%, and 23.7%, respectively; p _trend = 0.02), death or myocardial infarction (7.0%, 17.8%, and 14.9%, respectively; p _trend = 0.003), all-cause death (1.4%, 4.2%, and 4.6%, respectively; p = 0.046), cardiac death (0.6%, 2.6%, and 3.2%, respectively; p _trend = 0.04), myocardial infarction (6.2%, 15.2%, and 12.1%, respectively; p _trend = 0.002), and probable or definite stent thrombosis (1.1%, 2.0%, and 3.8%, respectively; p _trend = 0.05). The data shown in Figure 4 compare the incidence of MACE in those with SVD and MVD in each tertile of the overall population. The rates of MACE in the highest SS tertile were similar among those with SVD and MVD.

Clinical outcomes at 1 year in the overall population comparing MACE in those with SVD and MVD in each tertile.

The SS was an independent predictor of MACE, all-cause death, cardiac death, myocardial infarction, and target vessel revascularization in the overall population ( Table 3 ). Even after including the number of diseased vessels (MVD vs SVD) in the model, the SS remained a powerful predictor of ischemic events, but MVD was not. After adjusting for possible confounders, the SS was also an independent predictor of ischemic events in those with SVD and in those with MVD, separately ( Table 4 ).

Table 3

Multivariate predictors of 1-year clinical outcomes in the overall population

	HR (95% CI)	p Value
MACE
MVD vs SVD	1.19 (0.97–1.46)	0.09
SYNTAX score (1-point increment)	1.03 (1.01–1.04)	<0.0001
Diabetes	1.25 (1.03–1.53)	0.02
Renal insufficiency	1.59 (1.27–1.99)	<0.0001
Previous PCI	1.44 (1.19–1.74)	0.0002
All-cause death
MVD vs SVD	1.37 (0.71–2.65)	0.34
SYNTAX score (1-point increment)	1.03 (1.00–1.06)	0.03
Age (10-yr increment)	1.80 (1.38–2.33)	<0.0001
Diabetes	2.23 (1.25–3.98)	0.007
Left ventricular ejection fraction	0.97 (0.95–1.00)	0.019
Cardiac death
MVD vs SVD	2.16 (0.82–5.71)	0.12
Syntax score (1-point increment)	1.05 (1.01–1.08)	0.006
Age (10-yr increment)	1.45 (1.05–2.01)	0.02
Diabetes	2.21 (1.03–4.71)	0.04
Left ventricular ejection fraction	0.96 (0.93–0.99)	0.005
Myocardial infarction
MVD vs SVD	1.33 (1.00–1.78)	0.05
SYNTAX score (1-point increment)	1.03 (1.01–1.04)	0.0006
Age (10-yr increment)	0.85 (0.74–0.97)	0.01
Renal insufficiency	2.63 (1.83–3.77)	<0.0001
Previous PCI	1.40 (1.04–1.89)	0.03
Baseline troponin elevation or ST-segment deviation	1.48 (1.04–2.09)	0.03
Target vessel revascularization
MVD vs SVD	1.25 (0.97–1.61)	0.09
SYNTAX score (1-point increment)	1.03 (1.01–1.04)	<0.0001
Age (10-yr increment)	0.81 (0.72–0.91)	0.0005
Renal insufficiency	1.67 (1.17–2.38)	0.005
Previous PCI	1.89 (1.49–2.41)	<0.0001

Only gold members can continue reading. Log In or Register to continue

Share this:

• Click to share on Twitter (Opens in new window)
• Click to share on Facebook (Opens in new window)

Related

Related posts:

1. Frequency of Radial Artery Occlusion After Transradial Access in Patients Receiving Warfarin Therapy and Undergoing Coronary Angiography
2. Associations of Dietary Fiber Intake With Long-Term Predicted Cardiovascular Disease Risk and C-Reactive Protein Levels (from the National Health and Nutrition Examination Survey Data [2005–2010])
3. Outcome of Transcatheter Aortic Valve Implantation in Patients With Low-Gradient Severe Aortic Stenosis and Preserved Left Ventricular Ejection Fraction
4. Recognizing Pregnancy-Associated Cardiovascular Risk Factors

Stay updated, free articles. Join our Telegram channel

Join