Abstract 2169: Relationship Between Angiographic Restenosis and Clinical Outcomes Post-PCI in CAD Patients: A Pooled Analysis of Nine Trials Comparing Drug-Eluting vs. Bare-Metal Stents
Background: Drug-eluting stents (DES), as compared to bare-metal stents (BMS), reduce angiographic restenosis and target lesion revascularization (TLR) in patients undergoing PCI for de novo native coronary artery lesions, but it is unclear whether the significant reduction in angiographic restenosis with DES favorably impacts “hard” clinical outcomes (death or MI), as compared with BMS.
Methods: We performed a pooled analysis of 5,261 patients from 9 prospective, multicenter, randomized trials comparing DES vs. BMS (SIRIUS, RAVEL, C-SIRIUS, E-SIRIUS, TAXUS-I, TAXUS-II, TAXUS-IV, TAXUS-V, TAXUS- VI). The proportion of patients with stable CAD was ~50% and with unstable angina~30%. Statistical analysis was performed using binary logistic regression for both clinical end points (death, MI, TLR and major adverse cardiac event [MACE] rates [composite of death, MI, or TLR] during 9–12 month follow-up), as well as for angiographic restenosis (>50% of the target lesion during 6–9 month follow-up) in the DES vs. BMS groups.
Results: There was significant reduction in MACE among patients randomized to DES vs. BMS, but this difference was driven exclusively by a reduction in TLR, since there were no between-group differences in death or MI (Table⇓). As expected, angiographic restenosis and TLR were significantly reduced in DES compared to BMS patients (30.3% vs. 6.6% and 16% vs. 5.1%, respectively).
Conclusion: Compared to BMS patients undergoing PCI, those who were randomized to DES had a significantly greater reduction in angiographic restenosis as well as TLR, but these improvements did not translate into a clinical benefit on death or MI. Thus, there is no apparent association between the reduction in TLR/restenosis and death and/or MI among CAD patients randomized to DES as compared with BMS.