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.

OBJECTIVES: The ENDEAVOR IV (Randomized Comparison of Zotarolimus-Eluting and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial evaluated the safety and efficacy of the zotarolimus-eluting stent (ZES) compared with the paclitaxel-eluting stent (PES). BACKGROUND: First-generation drug-eluting stents have reduced angiographic and clinical restenosis, but long-term safety remains controversial. A second-generation drug-eluting stent, which delivers zotarolimus, a potent antiproliferative agent, via a biocompatible phosphorylcholine polymer on a cobalt alloy thin-strut stent has shown promising experimental and early clinical results. METHODS: This is a prospective, randomized (1:1), single-blind, controlled trial comparing outcomes of patients with single de novo coronary lesions treated with ZES or PES. The primary end point was noninferiority of 9-month target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization. RESULTS: Among a total of 1,548 patients assigned to ZES (n = 773) or PES (n = 775), at 9 months, ZES was noninferior to PES with rates of target vessel failure 6.6% versus 7.1%, respectively (p(noninferiority) < or = 0.001). There were fewer periprocedural myocardial infarctions with ZES (0.5% vs. 2.2%; p = 0.007), whereas at 12 months, there were no significant differences between groups in rates of cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis. Although incidence of 8-month binary angiographic in-segment restenosis was higher in patients treated with ZES versus PES (15.3% vs. 10.4%; p = 0.284), rates of 12-month target lesion revascularization were similar (4.5% vs. 3.2%; p = 0.228), especially in patients without planned angiographic follow-up (3.6% vs. 3.2%; p = 0.756). CONCLUSIONS: These findings demonstrate that ZES has similar clinical safety and efficacy compared with PES in simple and medium complexity single de novo coronary lesions. (ENDEAVOR IV Clinical Trial; NCT00217269).

Late safety, efficacy, and cost-effectiveness of a zotarolimus-eluting stent compared with a paclitaxel-eluting stent in patients with de novo coronary lesions: 2-year follow-up from the ENDEAVOR IV trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions).

OBJECTIVES: The aim of this study was to assess, after 2 years of follow-up, the safety, efficacy, and cost-effectiveness of a zotarolimus-eluting stent (ZES) compared with a paclitaxel-eluting stent (PES) in patients with native coronary lesions. BACKGROUND: Early drug-eluting stents were associated with a small but significant incidence of very late stent thrombosis (VLST), occurring >1 year after the index procedure. The ZES has shown encouraging results in clinical trials. METHODS: The ENDEAVOR IV trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions), a randomized (1:1), single-blind, controlled trial (n = 1,548) compared ZES versus PES in patients with single de novo coronary lesions. Two-year follow-up was obtained in 96.0% of ZES and 95.4% of PES patients. The primary end point was target vessel failure (TVF), and safety end points included Academic Research Consortium-defined stent thrombosis. Economic end points analyzed included quality-adjusted survival, medical costs, and relative cost-effectiveness of ZES and PES. RESULTS: The TVF at 2 years was similar in ZES and PES patients (11.1% vs. 13.1%, p = 0.232). There were fewer myocardial infarctions (MIs) in ZES patients (p = 0.022), due to fewer periprocedural non-Q-wave MIs and fewer late MIs between 1 and 2 years. Late MIs were associated with increased VLST (PES: 6 vs. ZES: 1; p = 0.069). Target lesion revascularization was similar comparing ZES with PES (5.9% vs. 4.6%; p = 0.295), especially in patients without planned angiographic follow-up (5.2% vs. 4.9%; p = 0.896). The cost-effectiveness of ZES and PES was similar. CONCLUSIONS: After 2 years of follow-up, ZES demonstrated efficacy and cost-effectiveness comparable to PES, with fewer MIs and a trend toward less VLST. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).

Initial impact of drug-eluting stent use on the spectrum of patients undergoing percutaneous coronary intervention.

BACKGROUND: The availability of drug-eluting stents was expected to expand the application of percutaneous coronary intervention to a wider group of patients and lesion types. We sought to determine whether drug-eluting stents' availability has changed the practices of operators performing percutaneous coronary intervention with regard to patient selection and procedural factors. METHODS: We compared the clinical and angiographic characteristics of patients who underwent percutaneous coronary intervention at the Methodist Hospital, Houston, Texas, during three periods: June 2002-March 2003, June 2003-March 2004 and June 2004-March 2005. Sirolimus-eluting stents were available during the latter two periods. Paclitaxel eluting stents became available during the third period. RESULTS: A greater proportion of patients undergoing diagnostic catheterization were referred for percutaneous coronary intervention during the latter two periods (26.8%, 30.4%, 30.4%, respectively, P<0.0001). Patients undergoing stent placement during the latter two periods were more likely to have hypertension, hyperlipidemia or to have undergone previous percutaneous coronary intervention. The average implanted stent length was greater during the latter periods (14.5+/-4.6, 16.4+/-5.2, 16.8+/-5.5 mm, respectively, P<0.0001) and the average stent diameter was smaller (3.23+/-1.22, 3.13+/-1.16, 3.02+/-0.6 mm, respectively, P<0.0001). The frequency of percutaneous coronary intervention involving long lesions (>20 mm) and Left Anterior Descending (LAD) lesions was higher in the latter two periods and the frequency of multivessel stenting was higher in the last period. CONCLUSIONS: The spectrum of patients and coronary lesions that have undergone stenting has changed, particularly in the third period when both drug-eluting stent types were available. We observed a gradual shift toward higher-risk clinical and lesion characteristics following the introduction of drug-eluting stents.

Initial experience with a magnetic navigation system for percutaneous coronary intervention in complex coronary artery lesions.

OBJECTIVES: The aim of this study was to evaluate the feasibility of a magnetic-assisted navigation system during percutaneous coronary intervention (PCI) of tortuous and severely angulated coronary arteries. BACKGROUND: The magnetic navigation system consists of two 0.8-T permanent magnets which generate a magnetic field over the heart. Altering the magnetic vector deflects a coronary guidewire with a magnetic tip. METHODS: Patients were selected for magnetic-assisted intervention (MAI) for potentially difficult to cross lesions. The time required for placement of the guidewire, total procedure time, fluoroscopy time, and amount of contrast for the procedure were recorded. There were a total of 59 patients undergoing PCI of 68 lesions. RESULTS: Patients were grouped based on whether MAI was attempted as a first option ("primary attempt"; n = 46) or following failure to pass a conventional guidewire ("secondary attempt"; n = 13). The target lesion was successfully crossed in 49 of 55 lesions (89%) and 9 of 13 lesions (69%) in patients undergoing primary and secondary attempts, respectively. The procedural success rates were 84% and 62%, respectively. Most lesions were located in the circumflex artery territory (39% and 62% of lesions, respectively). The median (25th and 75th percentiles) time for crossing the lesion was longer in the secondary attempt group (14.8 [5, 15.5] vs. 28.9 [8, 38] min). Median fluoroscopy time and median contrast used were also higher among the secondary attempt group. CONCLUSIONS: This first report of MAI suggests that it may become a useful adjunct for wire placement in difficult coronary interventions.