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Long-term comparative effectiveness of Endeavor zotarolimus-eluting and everolimus-eluting stents in New York.

ABSTRACT: Endeavor zotarolimus-eluting stents (E-ZES) and everolimus-eluting stents (EES) as second-generation stents were approved for use in percutaneous coronary interventions (PCIs) in 2008. We aimed to evaluate the long-term outcomes of E-ZES vs. EES using New York State (NYS) cardiac registries and to compare long-term effectiveness of E-ZES vs. EES in six "off-label" and two "high-risk" subgroups.We created a longitudinal database by linking the NYS cardiac registries, the statewide hospital discharge data, the National Death Index, and the U.S. Census file (2010) for patients receiving either E-ZES or EES from July 2008 through December 2010. We examined outcome measures of all-cause mortality, acute myocardial infarction (AMI), target lesion PCI (TLPCI), and target vessel coronary artery bypass graft (TVCABG) surgery for 13,663 propensity score matched pairs in the 6-year follow-up period. We applied Kaplan-Meier methods and Cox proportional hazards regression for further adjustment of propensity-matched pairs.Compared with patients receiving EES, patients receiving E-ZES had a significantly higher rate of 6-year all-cause mortality (adjusted hazard ratio (AHR): 1.10, 95% confidence interval (CI): 1.04-1.17, P=0.003), AMI (AHR: 1.12, 95% CI: 1.02-1.23, P=0.01), TLPCI (AHR: 1.28, 95% CI: 1.18-1.39, P<0.001), and TVCABG (AHR: 1.47, 95% CI: 1.26-1.71, P<0.001). EES had better or similar long-term outcomes than E-ZES for the subgroups that were examined.At 6years, patients receiving EES generally had better or comparable mortality, AMI, TLPCI, and TVCABG outcomes compared with patients receiving E-ZES.

SUBMITTER: Qian F

PROVIDER: S-EPMC5490976 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Long-term comparative effectiveness of Endeavor zotarolimus-eluting and everolimus-eluting stents in New York.

Qian Feng F Zhong Ye Y Hannan Edward L EL

International journal of cardiology 20170323

<h4>Background</h4>Endeavor zotarolimus-eluting stents (E-ZES) and everolimus-eluting stents (EES) as second-generation stents were approved for use in percutaneous coronary interventions (PCIs) in 2008. We aimed to evaluate the long-term outcomes of E-ZES vs. EES using New York State (NYS) cardiac registries and to compare long-term effectiveness of E-ZES vs. EES in six "off-label" and two "high-risk" subgroups.<h4>Methods</h4>We created a longitudinal database by linking the NYS cardiac regist ...[more]

PMID: 28389121

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Project description:BackgroundWe sought to establish the long-term safety of drug-eluting stents compared with bare-metal stents in a usual care setting.MethodsUsing data from a prospective multicentre registry, we compared rates of death and of death or repeat revascularization during 3 years of follow-up of 6440 consecutive patients who underwent angioplasty with either drug-eluting or bare-metal stents between Apr. 1, 2003, and Mar. 31, 2006.ResultsDrug-eluting stents were inserted in 1120 patients and bare-metal stents in 5320. The drug-eluting stents were selected for patients who had a greater burden of comorbid illness, including diabetes mellitus (32.8% v. 20.8% in the bare-metal group, p < 0.001) and renal disease (7.4% v. 5.0%, p = 0.001). At 1-year follow-up, the drug-eluting stents were associated with a mortality of 3.0%, as compared with 3.7% with the bare-metal stents (adjusted odds ratio [OR] 0.62, 95% confidence interval [CI] 0.46-0.83). The rate of the composite outcome of death or repeat revascularization was 12.0% for the drug-eluting stents and 15.8% for the bare-metal stents (adjusted OR 0.40, 95% CI 0.33-0.49). In the subgroup of patients who had acute coronary syndromes, the adjusted OR for this composite outcome was 0.46 (95% CI 0.35-0.61). During the 3 years of observation, the relative risks for death and repeat revascularization varied over time. In year 1, there was an initial period of lower risk in the group with drug-eluting stents than in the group with bare-metal stents; this was followed by a shift toward outcome rates favouring bare-metal stents in years 2 and 3. The adjusted relative risk of the composite outcome of death or repeat revascularization associated with drug-eluting stents relative to bare-metal stents was 0.73 early in the first year of follow-up; it then rose gradually over time, to a peak of 2.24 at 3 years.InterpretationDrug-eluting stents are safe and effective in the first year following insertion. Thereafter, the possibility of longer term adverse events cannot be ruled out.

Project description:ObjectivesThe authors sought to evaluate the final 5-year safety and effectiveness of the platinum-chromium everolimus-eluting stent (PtCr-EES) in the randomized trial, as well as in 2 single-arm substudies that evaluated PtCr-EES in small vessels (diameter <2.5 mm; n = 94) and long lesions (24 to 34 mm; n = 102).BackgroundIn the multicenter, randomized PLATINUM (PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions), the PtCr-EES was noninferior to the cobalt-chromium everolimus-eluting stent (CoCr-EES) at 1 year in 1,530 patients undergoing percutaneous coronary intervention.MethodsPatients with 1 or 2 de novo coronary artery lesions (reference vessel diameter 2.50 to 4.25 mm, length ≤24 mm) were randomized 1:1 to PtCr-EES versus CoCr-EES. All patients in the substudies received PtCr-EES. The primary endpoint was target lesion failure (TLF), a composite of target vessel-related cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization.ResultsIn the randomized trial, the 5-year TLF rate was 9.1% for PtCr-EES and 9.3% for CoCr-EES (hazard ratio [HR]: 0.97; p = 0.87). Landmark analysis demonstrated similar TLF rates from discharge to 1 year (HR: 1.12; p = 0.70) and from 1 to 5 years (HR: 0.90; p = 0.63). There were no significant differences in the rates of cardiac death, myocardial infarction, target lesion or vessel revascularization, or stent thrombosis. PtCr-EES had 5-year TLF rates of 7.0% in small vessels and 13.6% in long lesions.ConclusionsPtCr-EES demonstrated comparable safety and effectiveness to CoCr-EES through 5 years of follow-up, with low rates of stent thrombosis and other adverse events. The 5-year event rates were also acceptable in patients with small vessels and long lesions treated with PtCr-EES. (The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions [PLATINUM]; NCT00823212; The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions in Small Vessels [PLATINUM SV]; NCT01498692; The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of Long De Novo Coronary Artery Lesions [PLATINUM LL]; NCT01500434).

Dataset Information

Long-term comparative effectiveness of Endeavor zotarolimus-eluting and everolimus-eluting stents in New York.

Publications

Long-term comparative effectiveness of Endeavor zotarolimus-eluting and everolimus-eluting stents in New York.

Similar Datasets

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