Title: A Randomized Comparison of the Endeavor Zotarolimus-Eluting Stent Versus the TAXUS Paclitaxel-Eluting Stent in de novo Native Coronary Lesions: 12-Month Outcomes From the ENDEAVOR IV Trial
Topic: Interventional Cardiology
Date Posted: 3/5/2010
Author(s): Leon MB, Mauri L, Popma JJ, et al., on behalf of the ENDEAVOR IV Investigators.
Citation: J Am Coll Cardiol 2009;55:543-54.
Clinical Trial: yes
Related Resources
JACC Article: A Randomized Comparison of the Endeavor Zotarolimus-Eluting Stent Versus the TAXUS Paclitaxel-Eluting Stent in De Novo Native Coronary Lesions: 12-Month Outcomes From the ENDEAVOR IV Trial
Trial: Randomized, Controlled Trial of the Medtronic Endeavor Drug-Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions (ENDEAVOR IV)
Study Question: What is the relative safety and efficacy of the zotarolimus-eluting stent (ZES) versus the paclitaxel-eluting stent (PES)?
Methods: The authors reported the 1-year results of the ENDEAVOR IV trial. This trial randomized 1,548 patients undergoing percutaneous coronary intervention to PES or ZES. The primary endpoint of the trial was 9-month target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization (TVR).
Results: ZES was noninferior to PES at 9 months, with a target vessel failure of 6.6% versus 7.1%, (p [noninferiority] < 0.001). Patients randomized to ZES had a lower risk of periprocedural myocardial infarctions (0.5% vs. 2.2%, p = 0.007). There was no difference in the incidence of cardiac death, myocardial infarction, TVR, or stent thrombosis. Binary angiographic restenosis was higher in patients treated with ZES (15.3% vs. 10.4%), but it did not translate into a difference in target lesion revascularization (4.5% vs. 3.2%) or TVR (6.2% vs. 6.8%).
Conclusions: Use of ZES is associated with a similar clinical outcome compared with PES.
Perspective: The long-term follow-up of this trial (Leon MB, et al., JACC Cardiovasc Interv 2009;2:1208-18), which interestingly was published before the 1 year data, clearly supports the clinical efficacy and safety of the ZES. More long-term data are needed to assess if the trend towards lower stent thrombosis with ZES seen in this trial will be maintained. While awaiting the results of the larger ongoing trials, these data provide an evidence context to support use of ZES in simple native coronary artery lesions. Hitinder S. Gurm, M.B.B.S., F.A.C.C.
Title: Increased Rate of Stent Thrombosis and Target Lesion Revascularization After Filter Protection in Primary Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction: 15-Month Follow-Up of the DEDICATION (Drug Elution and Distal Protection in ST Elevation Myocardial Infarction) Trial
Topic: Interventional Cardiology
Date Posted: 3/4/2010
Author(s): Kaltoft A, Kelbжk H, Klшvgaard L, et al.
Citation: J Am Coll Cardiol 2010;55:867-871.
Clinical Trial: No
Related Resources
JACC Article: Increased Rate of Stent Thrombosis and Target Lesion Revascularization After Filter Protection in Primary Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction: 15-Month Follow-Up of the DEDICATION Trial
Trial: Drug Elution and Distal Protection in ST-Elevation Myocardial Infarction (DEDICATION: Distal Protection Study)
Trial: Drug Elution and Distal Protection in Acute Myocardial Infarction (DEDICATION: Stent Study)
Study Question: What are the long-term effects of distal protection during percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI)?
Methods: The 626 STEMI patients were assigned to distal protection (DP) (n = 312) or conventional treatment (CT) (n = 314). Clinical follow-up was performed after 1, 6, and 15 months, and angiographic follow-up after 8 months. All target lesion revascularizations (TLRs) were clinically driven. They reported the prespecified endpoints of stent thrombosis according to the criteria of the Academic Research Consortium, TLR, and reinfarction after 15 months.
Results: The total number of stent thrombosis was 11 in the DP group and 4 in the CT group (p = 0.06). The rate of definite stent thrombosis was significantly increased in the DP group compared with the CT group, with 9 cases versus 1 (p = 0.01). Clinically driven TLRs (31 patients vs. 18 patients, p = 0.05) and clinically driven target vessel revascularizations (37 patients vs. 22 patients, p = 0.04) were more frequent in the DP group.
Conclusions: The authors concluded that in primary PCI for STEMI, the routine use of DP increased the incidence of stent thrombosis and clinically driven target lesion/vessel revascularization.
Perspective: The current study found no benefit of distal filter protection during primary PCI for STEMI with respect to short-, intermediate-, or long-term angiographic or clinical endpoints. Furthermore, there was a significantly increased rate of adverse cardiac events within 15 months in the group of patients treated with routine distal protection. Together with the results of the EMERALD, PROMISE, and PREMIAR trials, the results of this study demonstrate that routine use of a filter wire cannot be advocated and should be avoided with primary PCI for STEMI. On the contrary, aspiration thrombectomy appears to be beneficial in patients undergoing primary PCI and should be routinely considered. Debabrata Mukherjee, M.D., F.A.C.C.