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Articles by S. P Marso
Total Records ( 4 ) for S. P Marso
  S. K Mehta , A. D Frutkin , J. B Lindsey , J. A House , J. A Spertus , S. V Rao , F. S Ou , M. T Roe , E. D Peterson , S. P Marso and on Behalf of the National Cardiovascular Data Registry
 

Background— Bleeding in patients undergoing percutaneous coronary intervention (PCI) is associated with increased morbidity, mortality, length of hospitalization, and cost. We identified baseline clinical characteristics associated with bleeding complications after PCI and developed a simplified, clinically useful algorithm to predict patient risk.

Methods and Results— Data were analyzed from 302 152 PCI procedures performed at 440 US centers participating in the National Cardiovascular Data Registry. As defined by the National Cardiovascular Data Registry, bleeding required transfusion, prolonged hospital stay, and/or a drop in hemoglobin >3.0 g/dL from any location, including percutaneous entry site, retroperitoneal, gastrointestinal, genitourinary, and other/unknown location. Bleeding complications occurred in 2.4% of patients. From the best-fitting model consisting of 15 clinical elements associated with post-PCI bleeding in a random 80% training cohort, we developed a parsimonious risk algorithm. Predictors of bleeding included age, gender, previous heart failure, glomerular filtration rate, peripheral vascular disease, no previous PCI, New York Heart Association/Canadian Cardiovascular Society Functional Classification class IV heart failure, ST-elevation myocardial infarction, non–ST-elevation myocardial infarction, and cardiogenic shock. The parsimonious model was validated in the remaining 20% of the population (c-statistic, 0.72) and in clinically relevant subgroups of patients. This simplified model was used to derive a clinical risk algorithm, with larger numbers corresponding with greater risk. In 3 categories, bleeding rates were greater in patients with higher estimates (≤7, 0.7%; 8 to 17, 1.8%; ≥18, 5.1%).

Conclusions— This report identifies baseline clinical factors associated with bleeding and proposes a clinically useful algorithm to estimate bleeding risk. This model is potentially actionable in altering therapeutic decision making and improving outcomes in patients undergoing PCI.

  J. M Stolker , K. F Kennedy , J. B Lindsey , S. P Marso , M. J Pencina , D. E Cutlip , L Mauri , N. S Kleiman , D. J Cohen and on behalf of the EVENT Investigators
  Background—

Prediction of restenosis after percutaneous coronary intervention (PCI) remains challenging, and existing risk assessment algorithms were developed before the widespread adoption of drug-eluting stents (DES).

Methods and Results—

We used data from the EVENT registry to develop a risk model for predicting target lesion revascularization (TLR) in 8829 unselected patients undergoing DES implantation between 2004 and 2007. Using a split-sample validation technique, predictors of TLR at 1 year were identified from two thirds of the subjects (derivation cohort) using multiple logistic regression. Integer point values were created for each predictor, and the summed risk score (range, 0 to 10) was applied to the remaining sample (validation cohort). At 1 year, TLR occurred in 4.2% of patients, and after excluding stent thrombosis and early mechanical complications, the incidence of late TLR (more likely representing restenosis-related TLR) was 3.6%. Predictors of TLR were age <60, prior PCI, unprotected left main PCI, saphenous vein graft PCI, minimum stent diameter ≤2.5 mm, and total stent length ≥40 mm. Comparison of observed versus predicted rates of TLR according to risk score demonstrated good model fit in the validation set. There was more than a 3-fold difference in TLR rates between the lowest risk category (score=0; TLR rate, 2.2%) and the highest risk category (score ≥5; TLR rate, 7.5%).

Conclusions—

The overall incidence of TLR remains low among unselected patients receiving DES in routine clinical practice. A simple risk model incorporating 6 readily available clinical and angiographic variables helps identify individuals at extremely low (<2%) and modestly increased (>7%) risk of TLR after DES implantation.

  A. C Salisbury , K. P Alexander , K. J Reid , F. A Masoudi , S. S Rathore , T. Y Wang , R. G Bach , S. P Marso , J. A Spertus and M. Kosiborod
  Background—

Anemia is common among patients hospitalized with acute myocardial infarction and is associated with poor outcomes. Less is known about the incidence, correlates, and prognostic implications of acute, hospital-acquired anemia (HAA).

Methods and Results—

We identified 2909 patients with acute myocardial infarction who had normal hemoglobin (Hgb) on admission in the multicenter TRIUMPH registry and defined HAA by criteria proposed by Beutler and Waalen. We used hierarchical Poisson regression to identify independent correlates of HAA and multivariable proportional hazards regression to identify the association of HAA with mortality and health status. At discharge, 1321 (45.4%) patients had HAA, of whom 348 (26.3%) developed moderate-severe HAA (Hgb <11 g/dL). The incidence of HAA varied significantly across hospitals (range, 33% to 69%; median rate ratio for HAA, 1.13; 95% confidence interval, 1.07 to 1.23, adjusting for patient characteristics). Although documented bleeding was more frequent with more severe HAA, fewer than half of the patients with moderate-severe HAA had any documented bleeding. Independent correlates of HAA included age, female sex, white race, chronic kidney disease, ST-segment elevation myocardial infarction, acute renal failure, use of glycoprotein IIb/IIIa inhibitors, in-hospital complications (cardiogenic shock, bleeding and bleeding severity), and length of stay. After adjustment for GRACE score and bleeding, patients with moderate-severe HAA had higher mortality rates (hazard ratio, 1.82; 95% confidence interval, 1.11 to 2.98 versus no HAA) and poorer health status at 1 year.

Conclusions—

HAA develops in nearly half of acute myocardial infarction hospitalizations among patients treated medically or with percutaneous coronary intervention, commonly in the absence of documented bleeding, and is associated with worse mortality and health status. Better understanding of how HAA can be prevented and whether its prevention can improve patient outcomes is needed.

  A. P Amin , S. P Marso , S. V Rao , J Messenger , P. S Chan , J House , K Kennedy , K Robertus , D. J Cohen and E. M. Mahoney
  Background—

Although bivalirudin compared with unfractionated heparin with glycoprotein IIb/IIIa inhibitors reduces bleeding and hospitalization costs in patients undergoing percutaneous coronary intervention (PCI), little is known about the economic impact of bivalirudin versus heparin alone and at what threshold of procedural bleeding risk bivalirudin would be considered cost-effective.

Methods and Results—

A validated model was used to predict risk of major bleeding for 81 628 National Cardiovascular Data Registry (NCDR) CathPCI Registry patients from 2004 to 2006 who received unfractionated heparin only. Costs were derived from multiple sources including wholesale acquisition costs (for drugs) and single-center data (for PCI-related complications). Based on ISAR-REACT 3, we assumed that bivalirudin would reduce the risk of major bleeding by 33% compared with unfractionated heparin alone. A Markov model was used to estimate lost life expectancy associated with a major bleed. Major bleeding was predicted to occur in 2.2% of patients. Bivalirudin for all patients was estimated to increase costs by $571 per patient, yielding cost-effectiveness ratios of $287 473 per bleeding event averted and $1 173 360 per quality-adjusted life-year gained. Bivalirudin was cost saving for patients with a predicted bleeding risk >20% (0.16% of CathPCI population). At willingness-to-pay thresholds of $50K and $100K per quality-adjusted life-year gained, bivalirudin was cost-effective for patients with a bleeding risk ≥8% (2.5% patients) and ≥5% (7.9% patients), respectively.

Conclusions—

This decision-analytic modeling study demonstrates that for patients undergoing PCI, substitution of bivalirudin for unfractionated heparin monotherapy is projected to increase costs for virtually all patients and would be considered cost-effective for only a minority of patients with a high bleeding risk. From a policy standpoint, studies such as this, aimed at identifying the appropriate risk threshold for initiating treatment, may help in the development of informed guidelines for the use of expensive therapies.

 
 
 
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