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.
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.
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.
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.
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).
Objectives The authors investigated the relative safety and efficacy of different drug-eluting stents (DES) and bare metal stents (BMS) in patients with ST-segment elevation myocardial infarction ...(STEMI) using a network meta-analysis. Background The relative safety of DES and BMS in patients with STEMI continues to be debated, and whether advances have been made in this regard with second-generation DES is unknown. Methods Randomized controlled trials comparing currently U.S. approved DES or DES with BMS in patients with STEMI were searched using MEDLINE, EMBASE, and Cochrane databases. Information on study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. Results Twenty-two trials including 12,453 randomized patients were analyzed. At 1-year follow-up, cobalt-chromium everolimus eluting stents (CoCr-EES) were associated with significantly lower rates of cardiac death or myocardial infarction (MI) and stent thrombosis (ST) than BMS. Differences in ST were apparent as early as 30 days and were maintained for 2 years. CoCr-EES were also associated with significantly lower rates of 1-year ST than paclitaxel-eluting stents (PES). Sirolimus-eluting stents (SES) were also associated with significantly lower rates of 1-year cardiac death/myocardial infarction than BMS. CoCr-EES, PES, and SES, but not zotarolimus-eluting stents, had significantly lower rates of 1-year target vessel revascularization (TVR) than BMS, with SES also showing lower rates of TVR than PES. Conclusions In patients with STEMI, steady improvements in outcomes have been realized with the evolution from BMS to first-generation and now second-generation DES, with the most favorable safety and efficacy profile thus far demonstrated with CoCr-EES.
Abstract Background/Purpose Family history of coronary artery disease (CAD) is a well-established risk factor of future cardiovascular events. The authors sought to examine the relationship between ...family history of CAD and clinical profile and prognosis of patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Materials/Methods Baseline features and clinical outcomes at 30 days and at 3 years from 3601 patients with STEMI enrolled in the HORIZONS-AMI trial were compared in patients with and without family history of premature CAD, which was present in 1059 patients (29.4%). Results These patients were younger (median 56.7 vs. 62.1 years, P < 0.0001) and more often current smokers (52.4% vs. 43.5%, P < 0.0001), had more dyslipidemia (47.7% vs. 41.1%, P = 0.0003), less diabetes mellitus (14.1% vs. 17.5%, P = 0.01) and had shorter symptom onset to balloon times (median 213 vs. 225 min, P = 0.02). Patients with a family history of premature CAD had higher rates of final TIMI 3 flow (93.8% vs. 90.6%, P = 0.002), and myocardial blush grade 2 or 3 (83.2% vs. 78.0% P = 0.0008), and fewer procedural complications. Although the unadjusted 30-day and 3-year mortality rates were lower in patients with a family history of premature CAD (1.8% vs. 3.0%, P = 0.046 and 4.8% vs. 7.7%, P = 0.002, respectively), by multivariable analysis the presence of a family history of premature CAD was not an independent predictor of death at 3 years (HR 95%CI = 1.00 0.70, 1.44, P = 0.98). Conclusions A family history of premature CAD is not an independent predictor of higher mortality.
Percutaneous treatment of saphenous vein graft (SVG) lesions has been associated with higher rates of periprocedural complications and restenosis compared with non-SVG lesions. Whether these outcomes ...are similar in contemporary clinical practice, particularly when drug-eluting stents are used, is unknown. We evaluated outcomes of 110 consecutive patients who were treated with stent-assisted percutaneous coronary intervention for 145 SVG lesions (drug-eluting stents used in 91.0% of lesions). Embolic protection devices were used in 52.1% of treated grafts. Adverse events were recorded up to 1 year. Major or minor periprocedural myocardial necrosis occurred in 11 patients (10.9%). At 1-year clinical follow-up, we observed 13 myocardial infarctions (13.7%), 8 target lesion revascularizations (8.4%), 18 target vessel revascularizations (19.0%), 2 stent thromboses (2.1%), and 7 deaths (7.4%). The incidence of major adverse cardiac events, defined as death, myocardial infarction, or target vessel revascularization, was 30.5% at 1 year. By multivariable analysis, the presence of thrombus inside the graft before the procedure and the length of the stented segment were independent predictors of major adverse cardiac events at 1 year (hazard ratio for thrombus 4.07, 95% confidence interval 1.90 to 8.68, p = 0.0003; hazard ratio per millimeter of stented length 1.02, 95% confidence interval 1.01 to 1.03, p = 0.025). In conclusion, our data show that patients with SVG lesions remain a high-risk subgroup with worse outcomes after percutaneous coronary intervention compared with native vessel disease even in the era of drug-eluting stents.
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