Bare-metal stent outcomes in an unselected patient population

Background: Randomized trials have shown that drug-eluting stents (DES) substantially reduce in-stent restenosis compared with bare-metal stents (BMS). Hypothesis: Revascularization event rates related to BMS restenosis may be higher in the trials setting than in real-world experience, calling into question the extent of benefit possible with widespread DES use in regular practice. Methods: Between December 1998 and March 2003, 17,102 patients with BMS registered in the Goodroe Healthcare Solutions Data Warehouse met the inclusion criteria for this retrospective study of catheterization laboratory data. We examined the database for evidence of diagnostic angiography or percutaneous coronary intervention (PCI) readmission within 1 year after stenting. Results: Repeat PCI was documented for 2,070 patients, and 232 were referred for coronary artery bypass graft surgery (CABG)-in sum, 13.5% of the cohort. Stented region revascularization was observed in 8.4%: 1,350 patients underwent subsequent PCI, and 84 of the patients referred for CABG had in-stent lesion recurrence. Only 1,207 (7.1%) patients required stent-related PCI after 30 days, the time frame consistent with restenosis. Conclusions: In this "real-world" series, reintervention of a stented region after the first follow-up month was documented in fewer than 8% of patients in a large cohort that had received BMS. The rate of clinical events potentially related to BMS in-stent restenosis in this large, unselected patient population is substantially lower than that in the control arms of some DES trials. The incremental benefit of widespread conversion from BMS to DES may be smaller in some patient populations than is suggested by the results of those trials.