Thomas LaLonde

Renal function-based contrast dosing to define safe limits of radiographic contrast media in patients undergoing percutaneous coronary interventions.

OBJECTIVES The aim of this study was to evaluate the association between calculated creatinine clearance (CCC)-based contrast dose and renal complications in patients undergoing percutaneous coronary interventions (PCI). BACKGROUND Excess volumes of contrast media are associated with renal complications in patients undergoing cardiac procedures. Because contrast media are excreted by the kidney, we hypothesized that a dose estimation on the basis of CCC would provide a simple strategy to define a safe dose of contrast media. METHODS We assessed the association between CCC-based contrast dose and the risk of contrast-induced nephropathy (CIN) and need for in-hospital dialysis in 58,957 patients undergoing PCI and enrolled in the BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) registry from 2007 to 2008. Patients receiving dialysis at the time of the procedure were excluded. RESULTS The risk of CIN and nephropathy requiring dialysis (NRD) was directly associated with increasing contrast volume adjusted for renal function. The risk for CIN and NRD approached significance when the ratio of contrast dose/CCC exceeded 2 (adjusted odds ratio [OR] for CIN: 1.16, 95% confidence interval [CI]: 0.98 to 1.37, adjusted OR for NRD: 1.72, 95% CI: 0.9 to 3.27) and was dramatically elevated in patients exceeding a contrast to CCC ratio of 3 (adjusted OR for CIN: 1.46, 95% CI: 1.27 to 1.66, adjusted OR for NRD: 1.89, 95% CI: 1.21 to 2.94). CONCLUSIONS Our study supports the need for minimizing contrast dose in patients with renal dysfunction. A contrast dose on the basis of estimated renal function with a planned contrast volume restricted to less than thrice and preferably twice the CCC might be valuable in reducing the risk of CIN and NRD.

Trends in Door-to-Balloon Time and Mortality in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

BACKGROUND In patients with acute ST-elevation myocardial infarction (STEMI) who are undergoing percutaneous coronary intervention, current guidelines for reperfusion therapy recommend a door-to-balloon (DTB) time of less than 90 minutes. Considerable effort has focused on reducing DTB time with the assumption that a reduction in DTB time translates into a significant reduction in mortality; however, the clinical impact of this effort has not been evaluated. Therefore, our objective was to determine whether a decline in DTB time in patients with STEMI was associated with an improvement in clinical outcomes. METHODS We assessed the yearly trend in DTB time for 8771 patients with STEMI who were undergoing primary percutaneous coronary intervention from 2003 to 2008 as part of the Blue Cross Blue Shield of Michigan Cardiovascular Consortium and correlated it with trends in in-hospital mortality. Patients were stratified according to risk of death using a mortality model to evaluate whether patient risk factors affect the relationship between DTB time and mortality. RESULTS Median DTB time decreased each year from 113 minutes in 2003 to 76 minutes in 2008 (P < .001), and the percentage of patients who were revascularized with a DTB time of less than 90 minutes increased from 28.5% in 2003 to 67.2% in 2008 (P < .001). In-hospital mortality remained unchanged at 4.10% in 2003, 4.02% in 2004, 4.40% in 2005, 4.42% in 2006, 4.73% in 2007, and 3.62% in 2008 (P = .69). After the differences in baseline characteristics were adjusted for, there was no difference in the standardized mortality ratios (SMRs) across the study period (SMR, 1.00; 95% confidence interval [CI], 0.74-1.26 in 2003 compared with SMR, 0.95; 95% CI, 0.77-1.13 in 2008). CONCLUSIONS There has been a dramatic reduction in median DTB time and increased compliance with the related national guideline. Despite these improvements, in-hospital mortality was unchanged over the study period. Our results suggest that a successful implementation of efforts to reduce DTB time has not resulted in the expected survival benefit.

The relative safety and efficacy of abciximab and eptifibatide in patients undergoing primary percutaneous coronary intervention: insights from a large regional registry of contemporary percutaneous coronary intervention.

OBJECTIVES This study sought to assess whether the use of eptifibatide instead of abciximab is associated with a difference in outcomes of patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). BACKGROUND Pooled data from randomized controlled trials suggest that the use of abciximab may be associated with a survival advantage in patients undergoing primary PCI for acute STEMI. However, a large proportion of patients in the community are treated with eptifibatide, an agent that shares some but not all pharmacological properties with abciximab. METHODS We evaluated the outcomes of 3,541 patients who underwent primary PCI for STEMI from October 2002 to July 2006 in a large regional consortium and who were treated with abciximab (n = 729) or with eptifibatide (n = 2,812). RESULTS There was no difference in the incidence of in-hospital death (4.1% with abciximab vs. 3.5% with eptifibatide, p = 0.39), recurrent myocardial infarction (0.8% vs. 1.2%, p = 0.42), or stroke/transient ischemic attack (0.7% vs. 0.6%, p = 0.80). There was no difference in the need for blood transfusion (12.4% vs. 11.7%, p = 0.61), whereas there was a greater incidence of gastrointestinal bleeding with abciximab (4.8% vs. 2.8%, p = 0.01). In parsimonious risk-adjusted models, no significant difference between abciximab and eptifibatide was observed with respect to any of the outcomes measures. CONCLUSIONS Currently, eptifibatide is used as the adjunct antiplatelet agent in the majority of patients undergoing primary PCI. There is no apparent difference in early outcomes of patients treated with eptifibatide compared with patients treated with abciximab.

Impact of the prehospital ECG on door-to-balloon time in ST elevation myocardial infarction.

National guidelines have been set to achieve door‐to‐balloon time (D2B) is less than 90 minutes to improve outcomes for patients with STEMI. The purpose of this study is to see if a more aggressive approach utilizing prehospital ECGs could improve reperfusion times.

Risk of Acute Kidney Injury After Percutaneous Coronary Interventions Using Radial Versus Femoral Vascular Access Insights From the Blue Cross Blue Shield of Michigan Cardiovascular Consortium

Background—Transradial percutaneous coronary intervention (PCI [TRI]) does not involve catheter manipulation in the descending aorta, whereas transfemoral PCI (TFI) does. Therefore, the risk of acute kidney injury (AKI) after PCI might be influenced by vascular access site. We compared risks of AKI and nephropathy requiring dialysis (NRD) among patients treated with TRI and TFI. Methods and Results—We included patients across 47 hospitals in Michigan. Primary end point was AKI (serum creatinine increase ≥0.5 mg/dL). Secondary end points were NRD and postprocedural bleeding. Odds ratios (OR) for study end points were calculated for the entire and propensity-matched population, reported as crude, and values adjusted for preprocedural calculated AKI risk. Between 2010 and 2012, a total of 82 225 PCI procedures were performed, of which 8915 were TRI. After adjustment, TRI was associated with a reduction in AKI (OR, 0.76, 95% confidence intervals [0.62–0.92]) and bleeding with a trend toward lower NRD risk. The propensity-matched population consisted of 8857 procedures per group. In this population, TRI was associated with lower adjusted odds of AKI (OR, 0.74; 95% confidence intervals [0.58–0.96]), and bleeding (OR, 0.47; 95% confidence intervals [0.36–0.63]), but no difference in NRD was observed. Although postprocedural bleeding was independently associated with AKI (OR, 2.86; 95% confidence intervals [1.75–4.66]) in the propensity-matched population, the lower odds of AKI was not mediated by a reduction in bleeding with TRI. Sensitivity analysis demonstrated that the observed association between access site and AKI could potentially be explained by a moderately strong unknown confounder. Conclusions—The risk of AKI was significantly lower after TRI compared with TFI. This finding needs to be evaluated in randomized controlled trials.

Percutaneous Coronary Intervention Complications and Guide Catheter Size. Bigger Is Not Better

OBJECTIVES We evaluated the association between guiding catheter size and complications of percutaneous coronary intervention (PCI). BACKGROUND The association between guiding catheter size and complications of PCI in contemporary practice remains controversial. METHODS Procedure and outcome variables from 103,070 consecutive patients that underwent PCI with 6-F (n = 64,335), 7-F (n = 32,676), and 8-F (n = 6,059) guide catheters were compared. RESULTS Compared with 6-F guides, PCIs performed with 7- and 8-F guides were associated with incrementally more contrast agent use, and more post-PCI complications including contrast-induced nephropathy, vascular access site complications, bleeding, transfusion, major adverse cardiac event, and death. After multivariate analysis, the use of larger guides were associated with a higher risk of contrast-induced nephropathy (7-F odds ratio [OR]: 1.18, p = 0.0004; 8-F OR: 1.44, p < 0.0001), vascular complications (7-F OR: 1.19, p = 0.0002, 8-F OR: 1.68, p < 0.0001), decline in hemoglobin >3 g/dl (7-F OR: 1.12, p < 0.0001, 8-F OR: 1.72, p < 0.0001), and post-procedure blood transfusion (7-F OR: 1.08, p = 0.03; 8-F OR: 1.80, p < 0.0001), whereas major adverse cardiac events (7-F OR: 1.06, p = 0.13; 8-F OR: 1.37, p < 0.0001) and in-hospital mortality (7-F OR: 1.11, p = 0.13; 8-F OR: 1.34, p = 0.03) were increased with 8-F but not 7-F guides. CONCLUSIONS Compared with 6-F guides, PCIs performed with 7- and 8-F guides were associated with more contrast medium use, renal complications, bleeding, vascular access site complications, greater need for post-procedure transfusion, and 8-F guides with increased nephropathy requiring dialysis, in-hospital major adverse cardiac events, and mortality. These data suggest that selection of smaller guide catheters may result in improved clinical outcome in patients undergoing contemporary PCI.

Contemporary Use of Prasugrel in Clinical Practice Insights From the Blue Cross Blue Shield of Michigan Cardiovascular Consortium

Background— Prasugrel is a recently approved thienopyridine for use in patients with acute coronary syndromes undergoing percutaneous coronary intervention. There are no data on contemporary use of prasugrel in routine clinical practice. Methods and Results— We assessed the patterns of prasugrel use among 55 821 patients who underwent percutaneous coronary intervention and were discharged alive from January 2010 to December 2011 at 44 hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium. Potential inappropriate therapy was defined as use in patients who had a history of cerebrovascular disease, weighed <60 kg, or were aged ≥75 years old. Clopidogrel was prescribed to 83% (n=46 574) and 17% (n=9247) of patients received prasugrel on hospital discharge. A steady, linear increase in prasugrel use was seen during the study period, with discharge prescription increasing from 8.4% in quarter 1 of 2010 to 22.3% in quarter 4 of 2011. Of the total cohort, 69.1% of patients presented with acute coronary syndrome, and in this group, 17.2% received prasugrel. Among patients prescribed prasugrel, 28.3% (n=2614) received the medication for indications outside of acute coronary syndromes. One or more known contraindications to the drug were present in 6% to 10% of patients discharged on this agent. Conclusions— There has been a steady increase in the use of prasugrel with the drug being used in ≈22% of patients undergoing percutaneous coronary intervention by study end. Prasugrel use in patients with known contraindications is not uncommon and may be a suitable target for focused quality improvement efforts.

Temporal trends in the use of drug-eluting stents for approved and off-label indications: A longitudinal analysis of a large multicenter percutaneous coronary intervention registry

We sought to examine the temporal variations in the rate of both bare‐metal stent (BMS) and drug‐eluting stent (DES) use for off‐label indications after the reports of an increased risk of very late stent thrombosis in patients with DES at the 2006 meeting of the European Society of Cardiology (ESC).

A random forest based risk model for reliable and accurate prediction of receipt of transfusion in patients undergoing percutaneous coronary intervention

Background Transfusion is a common complication of Percutaneous Coronary Intervention (PCI) and is associated with adverse short and long term outcomes. There is no risk model for identifying patients most likely to receive transfusion after PCI. The objective of our study was to develop and validate a tool for predicting receipt of blood transfusion in patients undergoing contemporary PCI. Methods Random forest models were developed utilizing 45 pre-procedural clinical and laboratory variables to estimate the receipt of transfusion in patients undergoing PCI. The most influential variables were selected for inclusion in an abbreviated model. Model performance estimating transfusion was evaluated in an independent validation dataset using area under the ROC curve (AUC), with net reclassification improvement (NRI) used to compare full and reduced model prediction after grouping in low, intermediate, and high risk categories. The impact of procedural anticoagulation on observed versus predicted transfusion rates were assessed for the different risk categories. Results Our study cohort was comprised of 103,294 PCI procedures performed at 46 hospitals between July 2009 through December 2012 in Michigan of which 72,328 (70%) were randomly selected for training the models, and 30,966 (30%) for validation. The models demonstrated excellent calibration and discrimination (AUC: full model  = 0.888 (95% CI 0.877–0.899), reduced model AUC = 0.880 (95% CI, 0.868–0.892), p for difference 0.003, NRI = 2.77%, p = 0.007). Procedural anticoagulation and radial access significantly influenced transfusion rates in the intermediate and high risk patients but no clinically relevant impact was noted in low risk patients, who made up 70% of the total cohort. Conclusions The risk of transfusion among patients undergoing PCI can be reliably calculated using a novel easy to use computational tool (https://bmc2.org/calculators/transfusion). This risk prediction algorithm may prove useful for both bed side clinical decision making and risk adjustment for assessment of quality.

Differences in sex-related bleeding and outcomes after percutaneous coronary intervention: Insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) registry

BACKGROUND Bleeding after percutaneous coronary intervention (PCI) is more common in women than in men. However, the relationship of sex and bleeding with outcomes is less well studied. METHODS We examined the sex-related differences in the incidence of bleeding and its association with in-hospital outcomes among 96,637 patients undergoing PCI enrolled in the BMC2 registry (2010-2012). RESULTS Women had higher bleeding rate than did men (3.9% vs 1.8%) and thus received more blood transfusions (59% vs 41%). Both men (odds ratio [OR] 2.25, 95% CI 1.70-2.97) and women (OR 3.13, 95% CI 2.42-4.07) who bled had higher risk-adjusted death compared with their counterparts without bleeding. Although there was no difference in adjusted mortality between women and men without bleeding (OR 1.14, 95% CI 0.99-1.32), among patients who bled, adjusted death was higher in women (OR 1.28, 95% CI 1.11-1.47). Among patients with bleeding, transfusion was associated with similar increased risk of death in both men (OR 2.00, 95% CI 1.23-3.25) and women (OR 2.18, 95% CI 1.31-3.63) compared with their counterparts without transfusion(s). CONCLUSIONS Post-PCI bleeding was more common and associated with higher-than-expected in-hospital death in women compared with men with bleeding. This trend for higher death in women with bleeding was independent of transfusion. Quality efforts geared toward reducing bleeding in general, with a special focus on women, need to be explored to help reduce post PCI-bleeding and mortality and decrease sex-related disparity in adverse events.