Published Online
on August 30, 2004

A more recent version of this article appeared on September 7, 2004

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Submitted on December 10, 2003
Revised on April 18, 2004
Accepted on May 21, 2004

Beyond Restenosis. Five-Year Clinical Outcomes From Second-Generation Coronary Stent Trials

Donald E. Cutlip MD^*, Amit G. Chhabra MBBS, MPH, Donald S. Baim MD, Manish S. Chauhan MD, Sachin Marulkar MBBS, MPH, Joseph Massaro PhD, Ameet Bakhai MD, David J. Cohen MD, MSc, Richard E. Kuntz MD, MSc, and Kalon K.L. Ho MD, MSc

From the Harvard Clinical Research Institute (D.E.C., A.G.C., D.S.B., M.S.C., S.M., J.M., A.B., D.J.C., R.E.K., K.K.L.H.), Beth Israel Deaconess Medical Center (D.E.C., D.J.C., K.K.L.H.), Brigham and Women’s Hospital (D.S.B., R.E.K.), Boston, Mass; and Lahey Clinic (M.S.C.), Burlington, Mass.

^* To whom correspondence should be addressed. E-mail: dcutlip{at}hcri.harvard.edu.

Background--In the first year after coronary stent implantation, clinical failures are driven mainly by procedural complications and restenosis, but the subsequent relative contributions of restenosis and disease progression to late failures are less clear.

Methods and Results--We observed 1228 patients for 5 years after the implantation of stents as part of pivotal second-generation coronary stent trials. Clinical events of death, myocardial infarction, repeat revascularization, and repeat hospitalization for acute coronary syndrome or congestive heart failure were attributed to the index stented (target) lesion or other distinct sites (either in the target or other coronary vessels) and further classified as procedural, restenosis, or nonrestenosis. During the first year the hazard rate was 18.3% for target-lesion events and 12.4% for events unrelated to the target lesion. After the first year the average annual hazard rate was 1.7% for target-lesion events and 6.3% for nontarget-lesion events. By the fifth year, restenosis events occurred in 20.3% of patients, whereas 30-day procedural complications or later nonrestenosis events occurred in 37.9%, including 11.4% who also experienced a restenosis event, for a combined cumulative event rate of 46.4%. Diabetes mellitus and multivessel disease were independently associated with increased risk for both restenosis and nonrestenosis events.

Conclusion--In a low-risk clinical trial population, the clinical outcome beyond 1 year after stenting is determined by a high rate of events related to disease progression in segments other than the stented lesion, which itself remains relatively stable.

Key words: stents • restenosis • prevention

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