Original Articles

Effectiveness of Preprocedural Statin Therapy on Clinical Outcomes for Patients With Stable Coronary Artery Disease After Percutaneous Coronary Interventions

Dennis T. Ko, Harindra C. Wijeysundera, Lingsong Yun, Peter C. Austin, Warren J. Cantor, Jack V. Tu
https://doi.org/10.1161/CIRCOUTCOMES.111.960740
Circulation: Cardiovascular Quality and Outcomes. 2011;4:459-466
Originally published July 19, 2011

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Abstract

Background—Data have shown that preprocedural statin therapy reduces periprocedural myocardial infarction after percutaneous coronary intervention (PCI). However, whether preprocedural statins improve clinical outcomes in patients with stable coronary artery disease (CAD) has not been established. We aimed to evaluate the clinical effectiveness of preprocedural statin therapy in patients with stable CAD undergoing PCI.

Methods and Results—We conducted an observational study of 12 980 patients, age >65 years with stable CAD, who underwent PCI from December 1, 2003, to March 31, 2008. Using propensity score–matching analysis, 3098 unique matched pairs (6196 patients) who had similar likelihood of receiving preprocedural statins were identified. Additional analyses adjusting for postprocedural statins as a time-varying variable were performed. The main outcome measure was a composite of death or recurrent acute coronary syndrome. In the propensity-matched cohort, at 90 days, the primary outcome of death and acute coronary syndrome occurred in 5.6% in the preprocedural statin group as compared with 7.4% in the no-pretreatment group (P=0.005). Improved clinical outcomes associated with preprocedural statins were still observed at 2 years (16.7% versus 19.3%, P=0.007). The effectiveness of preprocedural statins was most pronounced at 90 days after PCI (adjusted hazard ratio, 0.80; 95% confidence interval, 0.65 to 0.98) but was no longer significant at 1 year (adjusted hazard ratio, 0.92; 95% confidence interval, 0.79 to 1.07) after accounting for postprocedural statin therapy.

Conclusions—Preprocedural statin therapy was associated with significant reduction in the risk of death or recurrent acute coronary syndrome in stable CAD patients after PCI. These findings support the routine use of preprocedural statins for suitable candidates.

Introduction

Lipid-lowering therapy with statins has been demonstrated to benefit many patients with cardiovascular disease.1 However, the potential clinical benefits of preprocedural statins for patients with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) have not been fully established.2,3 Several randomized studies have shown that preprocedural statins is associated with a reduction in periprocedural myocardial infarction.4–8 These trials, even when combined, did not have adequate power to assess potential difference in clinical outcomes such as death or myocardial infarction.2,3 Although older observational studies have shown the beneficial effects of preprocedural statins in patients undergoing PCI, these studies included mostly patients with acute coronary syndrome (ACS), in which statins have been shown to improve clinical outcomes. Furthermore, no observational study has accounted for the potential difference in postprocedural statin use, which is also shown to have a substantial impact on improving clinical outcomes after PCI. Despite these gaps in knowledge, some investigators have advocated routine preprocedural statins on the basis that a reduction in periprocedural myocardial infarction will lead to improved clinical outcomes.4–6,9,10 In contrast, others have argued that such rationale may be misguided because periprocedural myocardial infarction is a surrogate for diffuse coronary artery disease, and treatment that reduces periprocedural events may not alter longer-term prognosis.11 Clinical practice guidelines currently recommend treatment with statins after PCI according to cholesterol levels but make no specific recommendations regarding the use of statin therapy before PCI.12

An improved understanding of whether preprocedural statin therapy is beneficial for stable patients undergoing PCI may have important implications for clinical practice, given that a large proportion of patients with stable coronary artery disease could benefit from treatment.13 Accordingly, the main objective of our study was to evaluate the association of preprocedural statin therapy in patients with coronary artery disease undergoing PCI on short- and longer-term clinical outcomes.

    WHAT IS KNOWN

  • Statin therapy before percutaneous coronary intervention procedures reduces the risk of periprocedural myocardial infarction, but uncertainties exist regarding other potential benefits.

  • Previous analyses were unable to examine other important health outcomes because of limited sample sizes and follow-up duration.

    WHAT THE STUDY ADDS

  • Through a comprehensive analysis of a large, population-based data set, we found that statin therapy initiated before percutaneous coronary intervention procedures was associated with the future risk of death and recurrent hospitalization for acute coronary syndrome.

  • The results of this observational study, while potentially limited by unmeasured confounding, provide additional support for initiating statin therapy before percutaneous coronary intervention.

Methods

Data Sources

We used data from the Cardiac Care Network of Ontario (CCN), a prospective registry that provides detailed clinical information on all PCI procedures in Ontario, Canada.14,15 The Ontario Drug Benefit (ODB) prescription claims data base, which contains comprehensive records of prescription medications dispensed to Ontario residents 65 years of age and older was used to determine medication utilization before and after PCI. The Canadian Institutes for Health Information hospital discharge abstract data base was used to identify additional comorbid conditions and recurrent hospitalizations after PCI. The Ontario Registered Persons Database was used to ascertain mortality. Linkages of the CCN clinical data base and other large administrative data bases were performed using unique encrypted patient identifiers to protect patient confidentiality. The need for informed patient consent was waived under Ontario's legislation regarding privacy of health information because participation in the CCN registry is mandatory. This study was approved by the research ethics board at the Sunnybrook Health Sciences Center.

Study Cohort

The initial study sample included patients age 66 years and older who received their initial PCI from December 1, 2003, to March 31, 2008. To identify patients with stable coronary artery disease, we excluded patients who were hospitalized for ACS (unstable angina or acute myocardial infarction), PCI, coronary artery bypass grafting surgery, or valve surgery in the year before the index PCI. This method of identifying stable or elective patients undergoing PCI was consistent with a prior study.16 Patients who had missing health card numbers were excluded because this would preclude data linkage.

Identification of Statin Therapy

To identify users of preprocedural statins, we identified patients who were dispensed any statin medications in the 90 days before PCI using the ODB prescription claims data base. This time frame was chosen on the basis of the assumption that 90 days would be a sufficient time period to capture the vast majority of preprocedural statin prescriptions. Combination medications that included statin formulations were considered in the same manner as noncombination medications. The ODB prescription claims data base includes prescription date and duration of prescription for each medication, which allowed us to determine “current” users of statin therapy.

Outcomes

The main outcome of interest was a composite of death or recurrent hospitalization for ACS. A diagnosis of recurrent ACS hospitalization was determined using the following International Classification of Disease-10th version codes (I20, I21, I22, I23.82, I24) (online-only Data Supplement Appendix 1).17 Complete follow-up information was available through March 31, 2009, for all patients.

Statistical Analysis

We used propensity score–matching analysis in our primary analysis to account for potential confounding and selection bias because preprocedural statin therapy was not randomly assigned.18,19 Possible confounders were chosen for their potential association with the outcome of interest based on clinical knowledge. The predicted probability of preprocedural statins was calculated by fitting a logistic regression model, using all clinically relevant variables as shown in Table 1. A greedy, nearest-neighbor 1:1 matching algorithm was used to match subjects on the basis of the logit of the propensity score. Patients were used in only 1 propensity score–matched pair, and those without a suitable match were excluded from the analysis. A standardized difference of <0.1 of the mean was used to indicate good balance in the matched sample. Appropriate statistical tests for matched data were used for comparisons of categorical variables, distribution of continuous variables, and survival curves.18,19

View this table:
Table 1.

Baseline Characteristics of the Unmatched Study Cohort

Additional analyses were performed in the propensity-matched cohort, using Cox proportional-hazard models adjusting for the postprocedural statin therapy. This was done because the propensity score method uses logistic regression models to regress the primary exposure (preprocedural statins) on baseline covariates. Postprocedural statin therapy is a time-varying exposure and not a baseline covariate and cannot be estimated using traditional propensity analyses. Modeling postprocedural statins as a time-varying covariate allowed us to account for the utilization and compliance of statins in the follow-up period. Different time frames (30 days, 3 months, 6 months, 12 months, and 24 months) were examined to allow us to examine effectiveness of preprocedural and postprocedural statins on clinical outcomes at short and longer term.

Sensitivity analyses were undertaken to examine the robustness of our results. First, we compared rates of colonoscopy and rates of hospitalization for lung or colorectal cancer after the index PCI procedure in the treatment groups. The intent of this analysis was to test for the presence of selection bias in baseline characteristics, whereby healthier patients are more likely to receive screening procedures and less likely to have other medical illnesses. Second, we examined the association of preprocedural statins and outcomes in different age groups. The intent of this analysis was to examine healthy user bias, which may be more pronounced in patients of older age groups. In all of these analyses, there were no significant differences between the treatment groups to indicate substantial residue-confounding biases.

SAS version 9.1 (SAS Institute, Cary, NC) was used for statistical analyses. A 2-sided probability value of ≤0.05 was considered as statistically significant in the comparison of outcomes.

Results

Study Cohort

From an original study sample of 69 933 patients who received their first PCI from 2003 to 2008, we excluded 29 636 patients who had ACS, PCI, coronary artery bypass grafting surgery, or valvular surgery in the year before index PCI. We also excluded 13 404 patients who were younger than 66 years of age and 424 patients who had missing information. Our final study cohort included a total of 12 980 patients with stable coronary artery disease who received PCI.

Characteristics Before Propensity Score Matching

The demographics, baseline, and procedural characteristics of patients before propensity score matching, stratified by preprocedural statin use, are shown in Table 1. The mean age of this cohort was 73.8 years, 66.7% were men, and 34.2% had diabetes. In this unselected cohort of patients with stable coronary artery disease, statin therapy was prescribed to 70.1% of patients before PCI. Patients who were prescribed preprocedural statins had significantly more medical comorbidites (diabetes, hypertension, peripheral vascular disease) and prior coronary revascularizations (PCI and coronary artery bypass surgery) (Table 1). They were also more likely to receive other evidence-based medical therapies (β-blockers, angiotensin-converting enzyme inhibitors, or angiotensin receptor blocker, thienopyridine) before PCI. In 2003 to 2004, utilization rate of statins before PCI was 70.1%, and in 2007 to 2008, utilization rate of statins was 72.5% (P=0.50 for trend).

Characteristics After Propensity Score Matching

We identified 3098 unique matched pairs (6,196 patients) who had similar likelihood of receiving preprocedural statins, using propensity score–matching analysis (Table 2). The mean age of the propensity-matched cohort was 74.1 years, 64.2% were men, and 30.2% had diabetes. All characteristics had standardized difference of the mean of <0.1, indicating excellent balance between the preprocedural statin group and the no-treatment group. The most common location for PCI was the left anterior descending artery, at 45.6%, and the use of drug-eluting stents was 42.3%. The majority of patients who received preprocedural statins were prescribed atorvastatin (57.7%), followed by simvastatin (18.3%) and rosuvastatin (16.1%).

View this table:
Table 2.

Baseline Characteristics of the Matched Study Cohort

Patients prescribed preprocedural statins in our study were significantly more likely to be prescribed statins after PCI. At 60 days, 77% of our propensity-matched cohort who received preprocedural statins received a statin prescription as compared with 62% in the no-pretreatment group (P<0.001). Utilization of other evidence-based medications differed to a smaller extent in the treatment groups. At 60 days, 56% in the preprocedural statin group were prescribed β-blockers; 59% were prescribed angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB); and 86% were prescribed thienopyridines. In the nontreatment group, utilization rates were 61% for β-blockers, 61% for ACE inhibitors or ARB, and 84% (P<0.001 for β-blockers (P=0.07 for ACE or ARB, P=0.24 for thienopyridines).

Preprocedural Statins and Clinical Outcomes After PCI

The Kaplan–Meier curves for death or recurrent ACS diverged early-favoring patients who were prescribed preprocedural statins compared with those without treatment (Figure 1). At 90 days, the primary outcome of death and ACS occurred in 5.6% among patients treated with preprocedural statins, as compared with 7.4% among patients without treatment (P=0.005) (Table 3). At 2 years, the primary outcome occurred in 16.7% in the preprocedural statin group versus 19.3% in the no-treatment group (P=0.007) (Table 3 and Figure 1).

Figure 1.
Figure 1.

Kaplan–Meier curve for death or recurrent ACS after index PCI in the propensity score–matched cohort of preprocedural statins and no preprocedural statin patients.

View this table:
Table 3.

Clinical Outcomes After Index Percutaneous Coronary Intervention

Similar trends favoring patients treated with preprocedural statins as compared with those with no statin treatment were also observed in individual outcomes of death and recurrent ACS (Table 3 and Figures 2 and 3). At 2 years, the rate of death was 8.8% in the preprocedural statin group versus 10.6% in the no-treatment group (P=0.01). The rate of recurrent ACS at 2 years was 9.1% in the preprocedural statin group versus 10.3% in the nontreatment group (P=0.07).

Figure 2.
Figure 2.

Kaplan–Meier curve for death after index PCI in the propensity score–matched cohort of preprocedural statins and no preprocedural statin patients.

Figure 3.
Figure 3.

Kaplan–Meier curve for recurrent ACS after index PCI in the propensity score–matched cohort of preprocedural statins and no preprocedural statin patients.

Additional Analysis

The results of additional analyses using Cox proportional hazard models in the propensity-matching cohort are shown in Table 4. In the analysis that accounted for confounding factors but not postprocedural statins, preprocedural statin use was associated with a significantly lower hazard of death or myocardial infarction at 90 days (hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.62 to 0.93), which was maintained until 2 years (HR, 0.84; 95% CI, 0.74 to 0.95). After adjusting for postprocedural statin therapy, the clinical benefits of preprocedural statin therapy were still observed at 90 days (HR, 0.80; 95% CI, 0.65 to 0.98) and 6 months (HR, 0.82; 95% CI, 0.69 to 0.98) but was not observed after 1 year. Postprocedural statin therapy was associated with substantial reduction in hazards of death or recurrent ACS after PCI that ranged from HRs of 0.39 at 30 days to 0.51 at 2 years.

View this table:
Table 4.

Clinical Outcomes Associated With the Use of Preprocedural Statins With and Without Adjusting for Postprocedural Therapy, Using Cox Proportional Hazards Models

Discussion

In this population-based cohort of patients with stable coronary artery disease, we found that preprocedural treatment with statins was associated with a significant reduction in the risk of death or recurrent ACS after PCI. The clinical benefits observed in the preprocedural statin group were evident at 90 days, which was maintained throughout the study period. In addition to the association of preprocedural statins with improved outcomes, the benefit observed in the preprocedural group was also explained by the fact that these patients were more likely to be prescribed statins after PCI, which was demonstrated to substantially reduce the hazard of death and recurrent ACS. Our findings lend strong support for the routine use of preprocedural statins for patients with stable coronary artery disease undergoing PCI. In addition, our study should reinforce the importance of statin therapy after PCI because of its strong association with improved clinical outcomes.

Our study extends previous knowledge by demonstrating the effectiveness of preprocedural statins on outcomes after PCI. Winchester et al2 recently published a comprehensive meta-analysis that included data from 10 smaller randomized trials evaluating the effectiveness preprocedural statins in patients undergoing PCI. Treatment strategies of these trials differed, which included preprocedural statins among statin-naive patients and reloading of high dose statins for patients already taking statins. Study populations also varied, including patients with stable coronary artery disease and ACS. Most of the small trials demonstrated lower risk of periprocedure myocardial infarction, and they combined to show that preprocedural statin treatment was associated with a 41% relative reduction (relative risk, 0.59; 95% CI, 0.47 to 0.74) in periprocedural myocardial infarction. However, no significant association between preprocedure statins and death was observed.2 Although our findings appeared contradictory, the inability to detect a difference in clinical outcome previously probably was due to inadequate study power. For example, Winchester actually found a 25% relative reduction the risk of death after PCI, but this estimate had a wide CI (relative risk, 0.75; 95% CI, 0.16 to 3.58) because it was only based on 46 deaths in the statin group and 74 deaths in the control group.2

Our study also addresses several knowledge gaps identified in previous observational studies. Chan et al20 performed one of the earliest and most comprehensive studies on the topic of statins and PCI by evaluating 5052 patients who received PCI at the Cleveland Clinic Foundation from 1993 to 1999. They found that patients treated with statin therapy before PCI had a significant reduction in mortality rate at 6 months, from 3.6% to 2.4%.20 However, the study included mostly patients who had unstable angina, in which statins are known to be effective in stabilizing culprit lesions and additional vulnerable plaques.21 Our study, which used strict criteria to exclude patients who had ACS and cardiac procedures, afforded a unique opportunity to examine the benefits of preprocedural statins on stable coronary artery disease.

In addition, none of the previous studies evaluated whether the benefits of preprocedural statins may relate to a difference in postprocedural statin use. Indeed, patients prescribed preprocedural statins in our study were significantly more likely to be prescribed statins after PCI. At 30 days, 59% of our propensity-matched cohort who received preprocedural statins received a statin prescription as compared with 56% in the no pretreatment group. This difference diverged even further over time, and, at 90 days, 90% in the preprocedural statin group received a prescription of statins versus only 65% in the no pretreatment group. Even after adjusting for the influence of postprocedural statins, we found that preprocedural statin use was associated with improved clinical outcomes at shorter term. In addition, we observed that postprocedural statin therapy has a continuing impact in lowering the hazards of adverse events after PCI by half.

Another important secondary finding of our study was the observation that despite the demonstration of the importance of medical therapy for patients with cardiovascular disease, 30% of our patients undergoing PCI were not prescribed statins, 38% were not prescribed β-blockers, 64% were not prescribed an ACE or ARB before PCI. Improved utilization of any of these medications may be an opportunity for improvement in care of patients with cardiovascular disease after PCI.

Several limitations of our study warrant consideration. First, nonrandomized studies are subject to the influence of selection biases. Accordingly, we took great care in our analyses and performed a vigorous propensity score–matched analysis to balance potential confounding factors between the treatment group and the no-treatment group. We further performed additional analyses account for postprocedural statin use to ensure that our results were robust. Second, we did not have data on cholesterol levels or inflammatory markers and therefore were unable to determine the mechanisms by which preprocedural statin therapy improves outcomes in PCI. However, it is generally believed that the effectiveness of statin is mediated through its pleiotropic effects (or non–lipid-lowering properties).9 Because coronary procedures such as PCI create endothelial injury, the inhibitory function of statin therapy on the inflammatory cascade by decreasing vascular reactivity and stabilizing plaque is thought to be the basis of myocardial protection and reduction of myocardial myonecrosis.9 Third, we did not have data on cardiac biomarkers and were unable to determine the association of preprocedure statin therapy on periprocedure myocardial infarction. Finally, we used prescription for statins to determine medication usage but were unable to determine whether patients actually took their medication once it was dispensed. Nonetheless, misclassification bias (ie, classifying users and nonusers) would tend to diminish the association between preprocedural statins and improved outcomes.

In summary, we found that both preprocedural statins and postprocedural statins were associated with lower future risk of death and death and recurrent ACS after PCI. Efforts to encourage adherence of statin therapy before and after PCI procedures may lead to improved outcomes.

Sources of Funding

This analysis of the study was funded by a Canadian Institutes of Health Research (CIHR) operating grant MOP 102487. Dr Ko was supported by a CIHR New Investigator Award. Dr Wijeysundera was supported by a CIHR Research Fellowship Award. Dr Austin received a Heart and Stroke Foundation of Ontario (HSFO) Career Investigator Award. Dr Tu was supported by a Canada Research Chair in Health Services Research and an HSFO Career Investigator Award.

Disclosures

None.

Acknowledgments

We acknowledge that the clinical registry data used in this publication are from the Cardiac Care Network of Ontario and its member hospitals. The Cardiac Care Network of Ontario serves as an advisory body to the MOHLTC and is dedicated to improving the quality, efficiency, access, and equity of adult cardiovascular services in Ontario, Canada. The Cardiac Care Network of Ontario is funded by the MOHLTC. The authors also acknowledge the support from the Ontario Health Technology Advisory Committee (OHTAC), the Medical Advisory Secretariat, and funding from the MOHLTC to the Programs for Assessment of Technology in Health (PATH) Research Institute.

Footnotes

  • Received January 25, 2011.
  • Accepted May 16, 2011.

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  • Effectiveness of Preprocedural Statin Therapy on Clinical Outcomes for Patients With Stable Coronary Artery Disease After Percutaneous Coronary Interventions
    Dennis T. Ko, Harindra C. Wijeysundera, Lingsong Yun, Peter C. Austin, Warren J. Cantor and Jack V. Tu
    Circulation: Cardiovascular Quality and Outcomes. 2011;4:459-466, originally published July 19, 2011
    https://doi.org/10.1161/CIRCOUTCOMES.111.960740
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