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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., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.

Contrast-induced acute kidney injury (CI-AKI) is a common complication of percutaneous coronary intervention (PCI). Current guidelines support the use of iodixanol (Visipaque®, GE Healthcare, Princeton, New Jersey) in patients at high risk for CI-AKI. Recent trials and meta-analyses have shown no difference in CI-AKI when iodixanol is compared to low-osmolar contrast media (LOCM). We evaluated the incidence of CI-AKI, in-hospital dialysis and in-hospital death in 58,957 patients who underwent PCI in 2007 and 2008 in a large regional consortium of 31 hospitals and who were treated with iodixanol (n = 17,814) or LOCM (n = 41,143). Propensity-matched analysis was performed to adjust for differences in baseline variables. Patients treated with iodixanol compared to those treated with LOCM were slightly older, had more medical comorbidities and a higher baseline creatinine (1.35 ± 1.07 mg/dL versus 1.10 ± 0.85 mg/dL; p < 0.0001). In propensity-matched, risk-adjusted models, there was no significant difference between iodixanol and LOCM in the risk of CIAKI (4.54% vs. 4.14%; p = 0.14), need for dialysis (0.37% vs. 0.43%; p = 0.35) or death (1.46% vs. 1.39%; p = 0.18). Among patients undergoing PCI, the use of iodixanol was more frequent in older patients with more comorbidities and worse baseline renal function. There was no difference in the adjusted risk of CI-AKI among patients treated with iodixanol compared with those treated with LOCM.

Background: 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)., Hypothesis: To determine whether the decrease in use of DES has affected both on and off-label indications., Methods: The study cohort included patients undergoing coronary intervention in a large regional registry, the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2). Patient demographic and clinical characteristics for patients with DES in the third quarter of 2006 (pre-ESC) were compared to those from the fourth quarter of 2008 (post-guideline changes). Use of DES for off-label indications, such as ST-segment elevation myocardial infarction (STEMI), in-stent restenosis (ISR), and saphenous vein graft (SVG) interventions, were evaluated., Results: The overall deployment of DES fell sharply from 83% pre-ESC to a plateau of 58% in the first quarter of 2008. This corresponded to a rise in BMS use, while angioplasty procedures stayed the same. The STEMI subgroup showed the most dramatic change, from 78% to only 36%. Off-label use in SVGs showed a similar trend, from 74% to 43%. Drug-eluting stent deployment for ISR was less affected, though it also fell 25% (from 79%-56%)., Conclusions: The use of DES has fallen dramatically from June 2006 to December 2008, particularly for nonapproved indications. Our study provides a real-world assessment of contemporary change in DES use in response to the presentation of negative observational studies., (Copyright 2010 Wiley Periodicals, Inc.)

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.

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.

Objective: To evaluate the safety and efficacy of bivalirudin based therapy among patients undergoing percutaneous coronary intervention (PCI) for stable coronary artery disease in a large multicenter registry., Background: The REPLACE I trial demonstrated the non-inferiority of a strategy of bivalirudin compared with heparin and glycoprotein (GP) IIbIIIa inhibition in patients undergoing PCI. There is a paucity of outcome data with bivalirudin use in the setting of real-world PCI practice., Methods: We evaluated the outcome of 11,719 patients who underwent elective PCI for stable coronary artery disease (CAD) from 2002 to 2004 in a large regional consortium, and who were treated with bivalirudin (n = 2051) or with heparin and GP IIbIIIa inhibitors (n = 9,668). The primary endpoints were transfusion and in-hospital major adverse cardiovascular events (MACE) defined as the composite of death, MI, stroke, and any coronary artery bypass grafting (CABG) or target lesion revascularization., Results: Compared with patients who received heparin plus GP IIbIIIa inhibitors, patients who received bivalirudin had a similar incidence of post-procedural MI, stroke, in-hospital death, MACE (2.88 vs. 2.48, P = 0.30), or transfusion (2.83% vs. 2.41%, P = 0.27). Patients at greater risk of bleeding were more likely to be treated with bivalirudin. After adjusting for the propensity to receive bivalirudin and for baseline co-morbidities, there was no difference in the odds of MACE or the need for transfusion between the two groups., Conclusion: Compared with heparin plus GP IIbIIIa inhibition, use of bivalirudin in patients undergoing PCI for stable CAD is associated with similar ischemic and bleeding complications. Given the ease of administration and lower cost, bivalirudin provides an attractive treatment option in this patient population.

Background: With continuing technical advances in percutaneous coronary interventions (PCI) for coronary artery disease (CAD), patients undergoing coronary artery bypass surgery (CABG) often have complex coronary anatomy that is not ideal for PCI. Because of the complex anatomy, these patients have a higher risk of early graft occlusion. The feasibility of PCI in the treatment of early graft occlusion is not well established., Methods: A retrospective chart review was performed of patients presenting with recurrent ischemia within three months post-CABG and at one-year follow-up., Results: Forty-six patients with 156 grafts were identified. Three presented with STEMI, 21 with NSTEMI, 21 with unstable angina, and one with congestive heart failure. Sixty-three grafts were occluded or stenosed (>70%). Twenty-seven grafts (43%) in 17 patients were not amenable to PCI. The other 34 grafts (54%) in 23 patients underwent successful PCI. PCI was performed upon native vessels and occluded grafts with equal frequency. Six patients had patent grafts. At one-year follow-up, six of 23 patients in the PCI group were readmitted with ischemia; five vessels (14%) in four patients had restenosed. There were no deaths. In the group with no PCI, 11 of 23 patients were readmitted with ischemia with one death., Conclusion: PCI for early post-CABG occlusion was safely performed in slightly more than half of target vessels. PCI was performed upon native vessels and occluded grafts with equal frequency. After initial PCI success, the clinical target vessel restenosis rate was 14% at one-year follow-up.

Objectives: The aim of our study was to evaluate the volume-outcome relationship in a large, quality-controlled, contemporary percutaneous coronary interventions (PCI) database., Background: Whether the relationship between physician volume of PCI and outcomes still exists in the era of coronary stents is unclear., Methods: Data on 18,504 consecutive PCIs performed by 165 operators in calendar year 2002 were prospectively collected in a regional consortium. Operators' volume was divided into quintiles (1 to 33, 34 to 89, 90 to 139, 140 to 206, and 207 to 582 procedures/year). The primary end point was a composite of major adverse cardiovascular events (MACE) including death, coronary artery bypass grafting, stroke or transient ischemic attack, myocardial infarction, and repeat PCI at the same site during the index hospital stay., Results: The unadjusted MACE rate was significantly higher in quintiles one and two of operator volume when compared with quintile five (7.38% and 6.13% vs. 4.15%, p = 0.002 and p = 0.0001, respectively). A similar trend was observed for in-hospital death. After adjustment for comorbidities, patients treated by low volume operators had a 63% increased odds of MACE (adjusted odds ratio [OR] 1.63, 95% confidence interval [CI] 1.29 to 2.06, p < 0.0001 for quintile [Q]1; adjusted OR 1.63, 95% CI 1.34 to 1.90, p < 0.0001 for Q2 vs. Q5), but not of in-hospital death. Overall, high volume operators had better outcomes than low volume operators in low-risk and high-risk patients., Conclusions: Although the relationship between operator volume and in-hospital mortality is no longer significant, the relationship between volume and any adverse outcome is still present. Technological advancements have not yet completely offset the influence of procedural volume on proficiency of PCIs.

The safety of glycoprotein (GP) IIb/IIIa inhibitors has been well documented in clinical trials. Although these trials have included a broad patient population, the strict enrollment criteria may have resulted in exclusion of patients at a higher risk of bleeding complications. The authors conducted a retrospective chart review of 1020 consecutive patients who received GP IIb/IIIa inhibitors and underwent percutaneous coronary intervention in a large community hospital. They used Thrombolysis in Myocardial Infarction (TIMI) criteria to define major or minor bleeding complications. Bleeding complications developed in 214 (21%) patients, with major bleeding in 89 (9%). Univariate predictors of bleeding were older age, lower body weight, elevated serum creatinine, higher activated partial thromboplastin time (aPTT) level, history of diabetes mellitus (DM), peripheral vascular disease (PVD), congestive heart failure (CHF), and emergency procedure for acute myocardial infarction (AMI). Multivariate predictors of major bleeding were PVD (20% in bleeding group vs 11% in nonbleeders, odds ratio [OR] = 1.8, 95% confidence interval [CI] = 1.2-2.6, P < .004), age (68 +/- 2 years, 95% CI = 66-70 in bleeding group vs 63 +/- 13 years, 95% CI = 61.2-63 in nonbleeders, P < .001), and higher aPTT level (66 +/- 27 seconds, 95% CI = 63-70 in bleeding group vs 53 +/- 28 seconds, 95% CI = 51-56 in nonbleeders, P < .001). The risk of bleeding in the large community hospital setting may be higher than in randomized clinical trials. This increased risk is associated with higher hospitalization costs. Recognition of predictors of bleeding should further enhance the safety of these antiplatelet agents.

The safety of adjunct eptifibatide in the setting of rescue angioplasty (PTCA) with or without stenting after full-dose thrombolytic therapy is not well defined. Our study was undertaken to assess the risk of hemorrhagic complications following use of eptifibatide in patients undergoing rescue PTCA/stenting following failed thrombolysis. Clinical records of 43 consecutive patients (53% males) who received eptifibatide during rescue PTCA/stenting following full-dose fibrinolytic therapy were reviewed. Data were collected for: timing of rescue PTCA following fibrinolytic use; concomitant use of other antiplatelet agents; hospital length of stay; in-hospital mortality; and incidence of bleeding complications. Bleeding complications were categorized as major or minor according to Thrombolysis in Myocardial Infarction (TIMI) study group criteria. Overall bleeding complications developed in 13 patients (30%), with 4 patients (9%) experiencing major bleeding. Univariate predictors of major bleeding complications were: older age; female sex; lower baseline platelet count; and time to initiation of eptifibatide following failed thrombolysis. On multivariate analysis, the only predictors of bleeding were gender (27% in females versus 3% in males; odds ratio, 1.7; 95% confidence interval, 0.1-0.9) and time to initiation of eptifibatide following failed thrombolysis (4.6 +/- 2 hours versus 11 +/- 9 hours; p<0.04; 95% confidence interval, 2.1-11.4). Use of potent antiplatelet agents during rescue PTCA/stenting results in an increased risk of bleeding. Careful attention to predictors of bleeding and, in particular, delaying eptifibatide administration following full-dose fibrinolytic use may result in the reduction of major and minor bleeding complications.