Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial.

Am Heart J. 2009 Oct;158(4):e43-50

Authors: Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G, De Luca G

BACKGROUND: Drug-eluting stent (DES) may offer benefits in terms of repeat revascularization, which may be counterbalanced by a potential higher risk of stent thrombosis, especially among patients with STEMI. No data have been reported so far on the long-term benefits and safety of DES in STEMI. The aim of the current study was to evaluate the short- and long-term benefits of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) as compared to bare-metal stent (BMS) in patients undergoing primary angioplasty. METHODS: Consecutive patients with STEMI admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary percutaneous coronary intervention capability were randomly assigned to BMS, PES, and SES. All patients received upstream glycoprotein IIb-IIIa inhibitors. Primary end point was target-lesion revascularization at 1-year follow-up. Secondary end points were (1) cumulative combined incidence of death and/or reinfarction; (2) cumulative incidence of in-stent thrombosis; and (3) major adverse cardiac events (MACE) (combined death and/or reinfarction and/or target lesion revascularization [TLR]) at long-term follow-up (up to 4 years). No patient was lost to follow-up. RESULTS: From October 1, 2003, to December 2005, 270 patients with STEMI were randomized to BMS (n = 90), PES (n = 90), or SES (n = 90). Procedural success was obtained in 93% to 95% of patients. Follow-up data were available for all patients. As compared to BMS (14.4%), both PES (4.4%, hazard ratio [HR] 0.29, 95% CI 0.095-0.89, P = .023) and SES (3.3%, HR 0.21, 95% CI 0.06-0.75, P = .016) were associated with a significant reduction in TLR at 1-year follow-up (primary study end point). At long-term follow-up (1,233 +/- 215 days), no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but as compared to BMS (21.1%), both PES (6.7%, HR 0.29, 95% CI 0.12-0.73, P = .008) and SES (5.6%, HR 0.24, 95% CI 0.09-0.63, P = .002), respectively, were associated with a significant reduction in TLR. CONCLUSIONS: This study shows that among patients with STEMI undergoing primary angioplasty, both SES and PES are safe and associated with significant benefits in terms of TLR up to 4 years' follow-up, as compared to BMS. Thus, until the results of further large randomized trials with long-term follow-up become available, DES may be considered among patients with STEMI undergoing primary angioplasty.

PMID: 19781402 [PubMed - in process]

Hospital performance recognition with the Get With The Guidelines Program and mortality for acute myocardial infarction and heart failure.

Am Heart J. 2009 Oct;158(4):546-53

Authors: Heidenreich PA, Lewis WR, LaBresh KA, Schwamm LH, Fonarow GC

BACKGROUND: Many hospitals enrolled in the American Heart Association's Get With The Guidelines (GWTG) Program achieve high levels of recommended care for heart failure, acute myocardial infarction (MI) and stroke. However, it is unclear if outcomes are better in those hospitals recognized by the GWTG program for their processes of care. METHODS: We compared hospitals enrolled in GWTG and receiving achievement awards for high levels of recommended processes of care with other hospitals using data on risk-adjusted 30-day survival for heart failure and acute MI reported by the Center for Medicare and Medicaid Services. RESULTS: Among the 3,909 hospitals with 30-day data reported by Center for Medicare and Medicaid Services 355 (9%) received GWTG achievement awards. Risk-adjusted mortality for hospitals receiving awards was lower for both heart failure (11.0% vs 11.2%, P = .0005) and acute MI (16.1% vs 16.5%, P < .0001) compared to those not receiving awards. After additional adjustment for hospital characteristics and noncardiac performance measures, the reduction in mortality remained significantly lower for GWTG award hospitals for acute myocardial infraction (-0.19%, 95% CI -0.33 to -0.05), but not for heart failure (-0.11%, 95% CI -0.25 to 0.02). Additional adjustment for cardiac processes of care reduced the benefit of award hospitals by 28% for heart failure mortality and 43% for acute MI mortality. CONCLUSIONS: Hospitals receiving achievement awards from the GWTG program have modestly lower risk adjusted mortality for acute MI and to a lesser extent, heart failure, explained in part by better process of care.

PMID: 19781413 [PubMed - in process]