Late Outcomes after Drug-Eluting Stent Implantation in “Real-World” Clinical Practice
- Volume 20 - Issue 10 - October, 2008
- Posted on: 10/8/08
- 0 Comments
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ISR remains a problem after DES although it is less frequent than what might be expected with BMS in such difficult cases. It most often occurs in areas involving long segments of stenting with multiple overlapping stents. The delayed presentation of ISR and VLST (78.3% occurred more than 6 months post implant; 43.5% more than 12 months and 34.8% more than 18 months in this study) has been partly explained by insight into the pathophysiology and may have implications for long-term antiplatelet therapy and follow-up in patients treated with these first-generation DES. However, significant ISR may be rendered less frequent or indeed may be abolished by future generations of DES which may limit late lumen loss and prevent LST/VLST by allowing fibrointimal and endothelial cell covering of stent struts within the first few months of implantation due to the non-inflammatory PC polymer carrying the sirolimus analogue. The results from the Endeavor series of trials (using the Zotarolimus-eluting stent) compared to the RAVEL/SIRIUS and TAXUS I, II, IV and V trials (LST at 3 years of 0.08% compared to 0.97% and 0.6% for Cypher and Taxus respectively) and of the SPIRIT I-III trials with the Xience V — everolimus-eluting stent are encouraging. However, although the Endeavor III trial has shown that MI (0.6% v 3.6%) and MI/death (2.2% v 7.1%) were less frequent with the Endeavor compared to the Cypher stent42 and SPIRIT III that MACE at 12 months including cardiac death, MI or TLR were 43% lower in Xience V (5.8%) than Taxus (9.9%) patients, interestingly stent thrombosis occurred in 5/647 (0.8%) vs 2/317 (0.6%) in the two groups respectively in this latter study.43 Moreover, the Endeavor V Registry of “real-world” patients reports a 2.0% cardiac death rate, Q-MI 0.4%, TLR 3.8%, MACE 7.0% and stent thrombosis 1.1% in 1,989 patients after 12 months of follow-up44 which is not too dissimilar to the results of our own study. The results of SPIRIT IV which will examine the Xience V stent’s effectiveness in patients with multilesion/multivessel disease and/or bifurcation lesions will be of further interest.
In conclusion, the current study shows that similar results to those obtained with DES in RCTs or in large registries are being achieved by individual interventionalists in a “real-world” group of patients presenting with stable angina or an acute coronary syndrome and a wide variety of complex coronary lesions. The results include a low incidence of MACE during long-term follow-up including a very low incidence of late/very late stent thrombosis. The results cannot be extrapolated to patients with acute ST elevation MI. Time will tell whether the next generation of DES has more to offer us.