Bainey KR, Norris CM, Graham MM, Ghali WA, Knudtson ML, Welsh RC for the APPROACH Investigators. Clinical in-stent restenosis with bare metal stents: Is it truly a benign phenomenon? Intl Journal of Cardiology, online publication August 2007.

Objective: In-stent restenosis (ISR) remains an important problem following percutaneous coronary intervention (PCI). Although it is generally believed that patients with ISR present with stable angina, this has not been well characterized. The aim of this study was to define the incidence, predictors, timing and clinical presentation of patients with ISR requiring repeat catheterization.

Design: Using a multiregion prospective database which captures all patients undergoing cardiac catheterization and revascularization in the Province of Alberta, Canada, consecutive bare metal stent (BMS) implantations from January 1, 1998 to December 31, 2002 were analyzed. All patients with a repeat angiogram within one year of the index PCI were reviewed for evidence of clinical-ISR (CISR), defined as ISR as the cause for clinical presentation at angiography.

Results: Of the 12,492 consecutive PCI patients reviewed, 2521 had repeat angiography and 744 patients (6.0%) had CISR by study definition. The mean time to repeat angiography in CISR patients was 5.4±2.7 months and multivariate analysis identified female gender, diabetes mellitus, and prior PCI as predictors. The majority of patients presented with an acute coronary syndrome: 52.2% unstable angina/non-ST elevation myocardial infarction and 18.5% ST elevation myocardial infarction. Only 25.3% presented with stable exertional angina.

Conclusion: Although the incidence of CISR within one year after BMS was relatively low, the recurrent clinical event in the majority of cases was a high-risk coronary syndrome. Thus, careful consideration of the risks of ISR to a specific patient against the cost implications of novel and expensive means to decrease its occurrence is required.

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