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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Effect of Intensive Statin Therapy on Clinical Outcomes Among Patients Undergoing Percutaneous Coronary Intervention for Acute Coronary Syndrome

PCI-PROVE IT: A PROVE IT–TIMI 22 (Pravastatin or Atorvastatin Evaluation and Infection Therapy–Thrombolysis In Myocardial Infarction 22) Substudy

C. Michael Gibson, MS, MD^_*,_*, Yuri B. Pride, MD^_*, Claudia P. Hochberg, MD^_*, Sarah Sloan, MA, MS, Marc S. Sabatine, MD, MPH, Christopher P. Cannon, MD for the TIMI Study Group

^_* TIMI Study Group, Cardiovascular Divisions, Departments of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts
Brigham & Women's Hospital, Harvard Medical School, Boston, Massachusetts

Manuscript received April 10, 2009; revised manuscript received September 1, 2009, accepted September 14, 2009.

^_* Reprint requests and correspondence: Dr. C. Michael Gibson, Director TIMI Data Coordinating Center, 350 Longwood Avenue, First Floor, Boston, Massachusetts 02115 (Email: mgibson{at}perfuse.org).

Objectives: The goal of this analysis was to determine whether intensive statin therapy, compared with moderate-dose statin therapy, leads to a reduction in major adverse cardiovascular events (MACE) among patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS).

Background: When compared with moderate-dose statins, intensive statin therapy reduces MACE among patients with ACS. The role of intensive statin therapy specifically among patients who undergo PCI for ACS is unknown.

Methods: Outcomes were compared in 2,868 patients who underwent PCI for ACS just prior to enrollment in the PROVE IT–TIMI 22 (Pravastatin or Atorvastatin Evaluation and Infection Therapy–Thrombolysis In Myocardial Infarction 22) trial, which randomized patients to either atorvastatin 80 mg or pravastatin 40 mg daily. The incidence of the primary composite end point of all-cause mortality, myocardial infarction, unstable angina leading to hospitalization, and revascularization after 30 days and stroke was evaluated, as was the incidence of target vessel revascularization (TVR) and non-TVR during follow-up.

Results: Treatment with 80 mg atorvastatin reduced the incidence of the composite end point (21.5% vs. 26.5%, hazard ratio: 0.78, 95% confidence interval: 0.67 to 0.91, p = 0.002) and lowered the incidence of both TVR (11.4% vs. 15.4%, p = 0.001) and non-TVR (8.0% vs. 10.5%, p = 0.017) compared with 40 mg pravastatin. After adjusting for on-treatment serum low-density lipoprotein cholesterol and C-reactive protein concentrations, the odds of TVR with high-dose statin therapy remained significant (odds ratio: 0.74, p = 0.015) while the odds of non-TVR did not (odds ratio: 0.92, p = 0.55).

Conclusions: Among patients with ACS who undergo PCI, intensive statin therapy reduces MACE compared with moderate-dose statin therapy. The reduction in the incidence of TVR was independent of low-density lipoprotein cholesterol and C-reactive protein lowering and may therefore be due, at least in part, to a pleiotropic effect of high-dose statin therapy. (PROVE IT–TIMI 22; NCT00382460)

Key Words: acute coronary syndrome • percutaneous coronary intervention • pleiotropic • statin

Abbreviations and Acronyms   ACS = acute coronary syndrome   CABG = coronary artery bypass grafting   CI = confidence interval   CRP = C-reactive protein   HR = hazard ratio   LDL-C = low-density lipoprotein cholesterol   MI = myocardial infarction   OR = odds ratio   PCI = percutaneous coronary intervention   TVR = target vessel revascularization

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