Sorin J. Brener

Everolimus-eluting stents in patients undergoing percutaneous coronary intervention: Final 3-year results of the Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions trial

OBJECTIVES We compared the outcomes of patients treated with everolimus-eluting stents (EES) versus paclitaxel-eluting stents (PES) at 3 years from the large-scale randomized SPIRIT IV trial. BACKGROUND SPIRIT IV is the largest randomized trial comparing the outcomes of EES and PES. The present report represents the final long-term follow-up analysis from this study. METHODS A total of 3,687 patients were randomized 2:1 to EES or PES, stratified by presence of diabetes mellitus and lesion characteristics. Prespecified subgroups were compared for interaction with stent allocation. The primary end point was target lesion failure (TLF) (the composite of cardiac death, target vessel-related myocardial infarction [MI], or ischemia-driven target lesion revascularization). RESULTS At 3 years, TLF occurred in 9.2% versus 11.7% of EES- and PES-treated patients (hazard ratio [HR] 0.78 [0.63-0.97], P = .02). The incidence of death or MI was 5.9% versus 9.1%, respectively (HR 0.67 [0.52-0.85], P = .001), and there was a 64% reduction in stent thrombosis (Academic Research Consortium definite or probable definition) with EES (0.59% vs 1.60%, HR 0.36 [0.18-0.72], P = .003). The difference in target lesion revascularization at 3 years did not reach statistical significance (6.2% vs 7.8%, respectively, HR 0.78 [0.60-1.01], P = .06). There was no significant interaction between treatment allocation and any of the subgroups, including diabetes. CONCLUSIONS When compared with PES, EES provides durable and significant reduction in TLF, especially due to its enhanced safety profile, with lower rates of death or MI and stent thrombosis up to 3 years.

Impact of severity of renal dysfunction on determinants of in‐hospital mortality among patients undergoing percutaneous coronary intervention

Background: Chronic kidney disease (CKD) is a known prognostic indicator of poor outcomes following percutaneous coronary intervention (PCI) for coronary artery disease. However, it is unclear whether other predictors of mortality differ among patients with varying degrees of renal impairment. Thus, we aimed to identify determinants of in‐hospital mortality which are specific to patients with preserved renal function, moderate CKD, or end stage renal disease (ESRD) on dialysis, undergoing PCI. Methods: The study population included 25,018 patients who underwent PCI between January 1, 2004, and December 31, 2007, at four New York State hospitals. The primary endpoint of the study was in‐hospital mortality. Results: A total of 474 (1.9%) patients had ESRD on dialysis, 6,596 (26.4%) had moderate CKD (GFR<60 ml/min/1.73m2), and 17,948 (71.7%) had preserved renal function (GFR>60 ml/min/1.73m2). Patients with ESRD and moderate CKD were older, more often male, and had higher rates of prior coronary revascularization, peripheral vascular disease, congestive heart failure, prior stroke, and diabetes than those with preserved function. All‐cause in‐hospital mortality rates were significantly higher in patients with ESRD and moderate CKD compared to patients with GFR >60ml/min/1.73m2 (2.1% and 1.3%, respectively vs. 0.3%, p < 0.001). In multivariable analysis, ESRD (OR: 3.68, 95% CI 1.62–8.36) and moderate CKD (OR: 2.92, 95% CI 1.91–4.46) were independently associated with higher rates of in‐hospital mortality. Independent predictors of mortality were markedly distinct in each group and included female gender and myocardial infarction within the past 72 hr in the ESRD group, versus left ventricular ejection fraction, peripheral vascular disease, congestive heart failure, emergency PCI, and absence of prior PCI in the moderate CKD group and age, prior bypass graft surgery, congestive heart failure, emergency PCI, and absence of prior myocardial infarction in patients with preserved renal function Conclusions: Patients with moderate CKD or ESRD undergoing PCI have an approximately threefold increase in the risk of in‐hospital mortality compared with patients with preserved renal function, with radically different mortality predictors existing for varying levels of renal function.

Relationship between angiographic dynamic and densitometric assessment of myocardial reperfusion and survival in patients with acute myocardial infarction treated with primary percutaneous coronary intervention: the harmonizing outcomes with revascularization and stents in AMI (HORIZONS-AMI) trial.

OBJECTIVES We evaluated 2 different methods of assessing tissue myocardial perfusion (TMP) and its impact on long-term mortality in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND Although primary percutaneous coronary intervention restores brisk epicardial flow in approximately 90% of patients with STEMI, normal TMP is less commonly achieved. Tissue myocardial perfusion has been shown to correlate mostly with early clinical outcomes. METHODS We analyzed the outcomes of 3,267 patients in the HORIZONS-AMI study according to final TMP, assessed by angiographic dynamic (Dyn) and densitometric (Den) methods. Multivariable analysis was performed to identify the independent influence of TMP grade 2/3 on late survival. RESULTS Dyn TMP 2/3 was achieved in 2,600 patients (79.6%), whereas Den TMP 2/3 was achieved in 2,483 (76.0%). Mortality was significantly lower in those with Dyn TMP 2/3 compared with TMP 0/1 at 30 days (1.1% vs 6.9%, P < .0001) and at 3 years (5.1% vs 11.2%, P < .0001). Similar results were obtained with Den TMP. Dyn TMP 2/3 was an independent predictor of mortality at both time points (HR 0.21, 95% CI 0.12-0.37, P < .0001 and HR 0.53, 95% CI 0.38-0.73, P < .0001, respectively), as was Den TMP. Survival was comparable in patients with TMP 2 and TMP 3. CONCLUSIONS Angiographic TMP can be assessed reliably using either Dyn or Den methods and is a powerful, independent predictor of early and late mortality after primary percutaneous coronary intervention in STEMI.

Association of health insurance status with presentation and outcomes of coronary artery disease among nonelderly adults undergoing percutaneous coronary intervention

OBJECTIVE The aim of this study was to determine if insurance status is associated with adverse outcomes in patients with coronary artery disease. METHODS A cohort of 13,456 patients who underwent percutaneous coronary intervention (PCI) between January 1, 2004, and December 31, 2007, at 4 New York State teaching hospitals was retrospectively studied. The primary outcome of interest was in-hospital mortality from any cause. RESULTS Of the 13,456 patients studied, 11,927 (88.6%) were insured by private carriers, 1,036 (7.7%) patients were covered by Medicaid, and 493 (3.7%) were uninsured. Uninsured and Medicaid patients tended to be younger and more often nonwhite and Hispanic. They had a higher prevalence of congestive heart failure and worse left ventricular function. Compared with privately insured patients, uninsured and Medicaid patients had increased all-cause mortality (1.2% and 0.9%, respectively, vs 0.3%; P < .001). For all patients, lack of insurance (OR 3.02, 95% CI 1.10-8.28) and Medicaid (OR 4.39, 95% CI 1.93-9.99) were independently associated with mortality. Lack of insurance (OR 5.02, 95% CI 1.58-15.93) and Medicaid (OR 4.55, 95% CI 1.19-17.45) were also independently associated with increased mortality in patients undergoing emergent PCI. CONCLUSION Lack of insurance and Medicaid insurance are both independently associated with an increased risk of in-hospital mortality after PCI for coronary artery disease.

Impact of Scheduled Angiographic Follow‐Up in Patients Treated With Primary Percutaneous Coronary Intervention for ST‐Segment Elevation Myocardial Infarction

Routine scheduled angiographic follow-up (SAF) after percutaneous coronary intervention (PCI) has been associated with a higher rate of target vessel revascularization (TVR). Its benefits are not known. SAF at 13 months after ST-segment elevation myocardial infarction (STEMI) was planned in the first 1,800 successfully stented patients enrolled in the Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial. We compared the outcomes of patients with and without SAF at 1 year (before SAF) and at 3 years (after SAF). There were 1,197 patients (66.5% of expected) with and 2,207 patients without SAF. Prior to SAF, the 1-year composite rate of death or myocardial infarction (MI) was not significantly different between the 2 groups (2.7% vs. 3.9%, respectively, P=0.06), although the rate of death was lower (0.1% vs. 2.2%, P<0.0001), nor were there differences in the 1-year rates of TVR, stent thrombosis or major adverse cardiac and cerebral events). At 3 years, death or MI rates were again similar between the groups (8.3% vs. 9.5%, P=0.22), but TVR was more common in the SAF group (17.0% vs. 8.6%, P<0.0001), due to an increase in TVR at time of SAF. In the SAF group, patients in whom TVR was performed before or after the 13-month SAF window had markedly higher 3-year rates of MI and stent thrombosis than patients in whom TVR was performed during SAF or not at all. In conclusion, SAF after primary PCI in STEMI is associated with doubling of the rate of revascularization without an improvement in death or MI, and therefore cannot be recommended.

Precision and accuracy of risk scores for in-hospital death after percutaneous coronary intervention in the current era†

Background: Various risk assessment scores were proposed in the last decade for prediction of in‐hospital mortality in patients undergoing percutaneous coronary intervention (PCI). We sought to apply two validated scores, the Mayo Clinic Risk Score (MCRS) and the New York Risk Score (NYRS) to a contemporary cohort treated at a single institution and to simplify the NYRS, such that the parameters used in both scores are similar. Methods and Results: Patients undergoing PCI in 2005–2007 were included. MCRS and NYRS were calculated for each patient. A simplified NYRS, similar to MCRS, was constructed by deleting two variables (gender and left main coronary stenosis). Model discrimination was assessed by the C statistic and goodness‐of‐fit (calibration) was measured with the Hosmer‐Lemeshow test. There were 3,165 procedures. The in‐hospital mortality was 0.56% (95% CI 0.31–0.83%). Mean MCRS was 2.7 ± 2.4 (predicted mortality 0.3%). The C‐statistic for MCRS was 0.82 (0.71–0.94) and the model was well calibrated (P = 0.79). Mean NYRS was 5.1 ± 3.3, (predicted mortality 0.23%). The C‐statistic for NYRS was 0.83 (0.74–0.95), not different from MCRS (P = 0.62) and the model was well calibrated (P = 0.29). The mean simplified NYRS was 4.6 ± 3.1 among survivors and 10.9 ± 5.8 among those who died, P < 0.001. The score had a C‐statistic of 0.83 (0.71–0.95), not different from MCRS (P = 0.84) or NYRS (P = 0.27) and was well calibrated (P = 0.71). Conclusion: PCI risk scores utilizing easily collected variables are useful in discriminating risk and predicting death. NYRS might be simplified by removing the gender and left main coronary stenosis variables from its algorithm.

More Bad News for Patients With Diabetes and a Thin Silver Lining

D iabetes mellitus (DM) type 2 is an increasingly prevalent metabolic disease with vast implications for cardiovascular (CV) health in the developed and developing worlds. Patients with DM are 2to 4-fold more likely than patients without diabetes to develop coronary artery disease and to die from it (1,2). Besides increasing risk of death from CV diseases, DM also increases risk of cancer-related deaths, which highlights its general contribution to morbidity and mortality (3). The nearly 2-decades-old observation that having DM is prognostically equivalent to having already had a myocardial infarction (4) remains strongly entrenched (maybe less justifiably so now) in guidelines for prevention of coronary artery disease (5).