Journal of Invasive Cardiology

Several RCTs, some with follow-up out to 5 years have shown that DES implantation results in lower major adverse cardiac events (MACE) and the need for reintervention for ISR than BMS, in well-defined patient groups.19–23 A pooled-analysis of RAVEL, SIRIUS, E-SIRIUS and C-SIRIUS indicated that 91.7% of patients treated with a Cypher stent remained free from TLR compared to 75.4% of patients treated with a BMS equivalent.24 The NEW SIRIUS analysis (pooled E-SIRIUS and C-SIRIUS), showed that at 5 years 8% of the Cypher group required further PCI compared to 25.1% in the BMS group. Mortality was 7.6% vs 7.5% and Q-MI 3.1% and 1.8% respectively.25 A similar pooled-analysis of the results of TAXUS I, II, II-SR, IV and V indicated that after 4 years, 89.5% of DES patients remained free from ischemic TLR compared to 79.8% with BMS.26 Four year outcome data from TAXUS II confirmed a decrease in TLR rates (7.2% v 15.7%) over BMS, and cardiac death and MI rates of 1.6% v 1.5% and 4.7% v 6.7% respectively.27 At 5 years, TLR rates were 10.3% v 18.4% — a highly significant decrease of 44%, and MACE was 35% lower — 20.4% v 27.6%.22 Excellent clinical results can thus be expected for such “on-label” use of DES.

The studies that have randomized patients with certain specific complex lesion subsets have shown lower TLR rates in those treated with DES compared to BMS.5–9,28–31 However, as to what results can be expected in day-to-day clinical practice treating an even wider range of complex lesion subsets, we are dependent on registry studies and the analysis of “real-world” data following “off-label” use.12,13,32–40

In contemporary practice worldwide, “off-label” use of DES is common, and perhaps not surprisingly, workers have shown that compared with standard use, long-term effectiveness after DES is lower when they are used “off-label”. For example, Beohar et al reported that 1-year after DES implantation, the target vessel revascularization rate (TVR) was 7.6% for “off-label” use compared to 4.4% for standard use,10 and Win et al found that the composite clinical outcomes of death, MI or TVR/TLR were higher with “off-label” use compared to “on-label” use both during the index admission (10.9% vs 5.0%) and at 1-year (17.5% vs 8.9%).11 Our prospective study reports the results of DES in such a group of complex cases including those with single-vessel multilesion disease and/or multivessel disease, presenting with stable angina or an acute coronary syndrome. After a mean follow-up of 34.3 months, the majority of patients were free of angina or were symptomatically improved compared to pre-PCI. Only 3 patients had acute ST elevation/Q-wave MI after hospital-discharge due to LST or VLST (0.7%). They were treated successfully medically, with thrombolytic therapy or with PCI.