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Robert J Applegate

Publications and source records attributed to Robert J Applegate.

16 recordsLinked to original sources
PubMed2006

Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: a randomized controlled trial.

OBJECTIVES: This trial examined the relative clinical efficacy, angiographic outcomes, and safety of zotarolimus-eluting coronary stents (ZES) with a phosphorylcholine polymer versus sirolimus-eluting stents (SES). BACKGROUND: Whether a cobalt-based alloy stent coated with the novel antiproliferative agent, zotarolimus, and a phosphorylcholine polymer may provide similar angiographic and clinical benefit compared with SES is undetermined. METHODS: A prospective, multicenter, 3:1 randomized trial was conducted to evaluate the safety and efficacy of ZES (n = 323) relative to SES (n = 113) in 436 patients undergoing elective percutaneous revascularization of de novo native coronary lesions with reference vessel diameters between 2.5 mm and 3.5 mm and lesion length > or =14 mm and < or =27 mm. The primary end point was 8-month angiographic in-segment late lumen loss. RESULTS: Angiographic in-segment late lumen loss was significantly higher among patients treated with ZES compared with SES (0.34 +/- 0.44 mm vs. 0.13 +/- 0.32 mm, respectively; p < 0.001). In-hospital major adverse cardiac events were significantly lower among patients treated with ZES (0.6% vs. 3.5%, p = 0.04). In-segment binary angiographic restenosis was also higher in the ZES cohort (11.7% vs. 4.3%, p = 0.04). Total (clinically and non-clinically driven) target lesion revascularization rates at 9 months were 9.8% and 3.5% for the ZES and SES groups, respectively (p = 0.04). However, neither clinically driven target lesion revascularization (6.3% zotarolimus vs. 3.5% sirolimus, p = 0.34) nor target vessel failure (12.0% zotarolimus vs. 11.5% sirolimus, p = 1.0) differed significantly. CONCLUSIONS: Compared with SES, treatment with a phosphorylcholine polymer-based ZES is associated with significantly higher late lumen loss and binary restenosis at 8-month angiographic follow-up. (The Endeavor III CR; http://clinicaltrials.gov/ct/show/NCT00265668?order=1?).

Aged↗
PubMed2006

Propensity score analysis of vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention 1998-2003.

OBJECTIVES: To evaluate the adjusted risk of vascular complications after manual compression and vascular closure devices for femoral artery access site management in a large contemporary cohort, using propensity score analysis. BACKGROUND: Vascular closure devices (VCD) allow early ambulation after cardiac procedures involving femoral artery access, but whether the benefit of use of vascular closure devices (VCD) is offset by reduced safety in contemporary practice remains uncertain. METHODS: Twenty one thousand eight hundred and forty one consecutive diagnostic cardiac catheterization (n = 13,124) and percutaneous coronary intervention procedures (n = 8,717) performed via a femoral access at a single site (WFUBMC) between 1998 and 2003 were evaluated. VCD's were used based on operator preference. Propensity to receive a vascular closure device (VCD) was calculated. The relative incidence of vascular complications was evaluated by logistic regression models, using the propensity score as a covariate. RESULTS: Overall, the unadjusted incidence of any vascular complication was 1.3% for VCD use and 1.4% for manual compression, p = NS. The propensity score-adjusted odds ratio for any vascular complication comparing VCD (n = 8,707) to manual compression (n = 13,034) was 0.86 (0.67-1.11) for all procedures, 0.80 (0.53-1.21) for diagnostic procedure, and 0.90 (0.65-1.26) for interventional procedures. CONCLUSIONS: In this large single-center, contemporary observational study, the risk-adjusted occurrence of vascular complications following VCD use for femoral artery access management is not increased by VCD use. Thus, in the current era, the benefit of VCD use is not offset by reduced safety.

Aged↗
PubMed2006

Vascular complications with newer generations of angioseal vascular closure devices.

OBJECTIVES: To evaluate the safety and efficacy of newer generations of a single vascular closure device (VCD), Angioseal, compared to contemporaneous manual compression. BACKGROUND: Previous assessment of VCD safety and efficacy has been based primarily on outcomes associated with the original VCD. Few data exist comparing safety and efficacy of modifications of the original VCDs. METHODS: We evaluated in-hospital outcomes of patients undergoing diagnostic cath and percutaneous coronary intervention at a single center: 3,898 with manual compression and 3,898 with the Angioseal VCD. Three generations of the Angioseal device were studied: Generation 1, 7/97-4/00; Generation 2, 5/00-6/02; and Generation 3, 7/02-12/03. Propensity analysis was used to match patients within each generation for clinical and procedural covariates. RESULTS: Closure success was 98.5% for Generation 1, 98.6% for Generation 2, and 98.1% for Generation 3, P = NS. The odds ratio for any vascular complication comparing Angioseal to manual compression was 0.92 (0.42-2.01) for Generation 1; 0.83 (0.49-1.41) for Generation 2; and 0.75 (0.32-1.77) for Generation 3. Multivariate logistic regression identified closure success and Angioseal device Generation 3 versus Generation 1 as predictive of reduced vascular complications during the entire study period. CONCLUSION: These data indicate that the newest generation of the Angioseal VCD is at least as effective as the original device. Moreover, use of the Angioseal VCD was associated with vascular complications similar to or lower than vascular complications following manual compression for each generation of Angioseal device analyzed.

Angioplasty, Balloon, Coronary↗
PubMed2006

PCI with and without abciximab after upstream eptifibatide use: outcomes in high-risk patients.

BACKGROUND: Abciximab is often used to treat high-risk patients during percutaneous coronary intervention (PCI). Recent data indicate, however, that upstream and postprocedural treatment with low-dose glycoprotein (GP) IIb/IIIa inhibitors may be more beneficial than abciximab during and after PCI. Whether abciximab can be used safely or effectively during PCI for high-risk patients after upstream treatment with eptifibatide in patients with acute coronary syndromes (ACS) is not known. METHODS: Clinical outcomes were evaluated in 289 patients with ACS who had upstream treatment with eptifibatide, and abciximab (EA) during PCI, and compared to 560 ACS patients who had both upstream and interventional treatment with eptifibatide (EE). RESULTS: Bleeding and vascular complications of the two groups were similar. Overall, 1-year major adverse cardiac event (MACE) rates were similar: 26.0% in the EA group and 25.2% in the EE group; p = 0.82. In patients with unstable angina, the hazard of MACE at 1 year was higher with EA than EE, 1.98 (1.23-3.18), due to significantly higher rates of repeat revascularization in the EA group. In patients with myocardial infarction (MI), the hazard of MI or death at 1 year was lower in the EA than the EE group, 0.50 (0.27-0.93). CONCLUSION: In this single-center observational study, the use of abciximab for PCI after upstream use of eptifibatide for ACS was safe. Abciximab was of no benefit in patients with unstable angina, but was associated with lower MI or death in patients with MI. These observations are consistent with recent findings indicating that abciximab is of benefit in patients with NSTEMI, but not lower-risk patients.

Abciximab↗
PubMed2005

Late outcomes after intervention of vein grafts in diabetics with abciximab use.

OBJECTIVES: We sought to evaluate late clinical outcomes following elective percutaneous coronary interventions for saphenous vein graft with planned abciximab use in diabetics. BACKGROUND: Diabetes adversely affects long-term outcomes after percutaneous coronary intervention including percutaneous coronary intervention of saphenous vein grafts. Glycoprotein IIb/IIIa inhibitors reduce adverse outcomes of native vessel percutaneous coronary intervention in diabetics; however, their effects in diabetic patients undergoing percutaneous coronary interventions of saphenous vein grafts is not known. METHODS: We evaluated 509 elective percutaneous coronary interventions of saphenous vein grafts. Glycoprotein IIb/IIIa inhibitors were used in 99% of the percutaneous coronary interventions. Distal protection devices were not used. Clinical follow-up (mean 30+/-20 months) was available in 369/397 (93%). RESULTS: Overall, procedural success rate was 97% and was similar for diabetics and non-diabetics. Procedural major adverse cardiac events occurred in 4.8% diabetics, and 4.1% non-diabetics (p = NS). Late outcomes were similar for diabetics and non-diabetics with major adverse cardiac event rates of 57.6%, and 54.9%, respectively, p=NS. Multivariate logistic regression identified graft age and the presence of thrombus as predictors of increased late major adverse cardiac events. CONCLUSIONS: Following routine use of abciximab, late outcomes after percutaneous coronary interventions of saphenous vein grafts were similar for diabetics and non-diabetics suggesting that the historically observed adverse effect of diabetes on late outcomes after percutaneous coronary interventions of saphenous vein grafts may be attenuated by glycoprotein IIb/IIIa use. Selective use of glycoprotein IIb/IIIa inhibitor should be considered for diabetics undergoing percutaneous coronary interventions of saphenous vein grafts.

Abciximab↗
PubMed2005

Preprocedural white blood cell count and major adverse cardiac events late after percutaneous coronary intervention in saphenous vein grafts.

Elevation of white blood cells (WBCs) is associated with worse outcomes in patients with coronary artery disease (CAD), including patients undergoing percutaneous coronary intervention (PCI) of native coronary arteries, but this relation has not been studied in patients with saphenous vein graft disease undergoing PCI. A total of 530 patients who underwent PCI of saphenous vein grafts from May 1997 to July 2002 were followed for >3 years. Major adverse coronary events (MACEs) were assessed as a composite of death, myocardial infarction, or revascularization during follow-up (mean 2.7 years). Patients with MACEs (n = 287) were younger and had more thrombotic and ostial lesions (p < 0.05) than those without MACEs (n = 243). The preprocedural WBC count was also significantly higher in the MACE group than in the non-MACE group (8.1 x 10(3)/mul, range 6.6 to 10.1, vs 7.0 x 10(3)/mul, range 5.6 to 8.2; p < 0.001). After adjusting for covariates, multiple logistic regression analysis revealed the preprocedural WBC count to be an independent predictor for MACEs (odds ratio 1.2; 95% confidence interval 1.1 to 1.3, p < 0.001). Patients in the highest quartile of the preprocedural WBC level had a significantly increased risk of MACEs (lowest vs highest quartile, 41.3% vs 72.4%; odds ratio 3.7; 95% confidence interval 2.2 to 6.3). Thus, an elevated preprocedural WBC count is associated with increased risk of MACEs in patients undergoing PCI for saphenous vein graft lesions.

Aged↗
PubMed2005

Closure devices and vascular complications among percutaneous coronary intervention patients receiving enoxaparin, glycoprotein IIb/IIIa inhibitors, and clopidogrel.

The objectives of this study were to explore the rate of vascular complications using closure devices (CDs) vs. manual compression (MC) among percutaneous coronary intervention (PCI) patients receiving enoxaparin, clopidogrel, aspirin, and GP IIb/IIIa inhibitors. The Evaluating Enoxaparin Clotting Times (ELECT) study enrolled patients receiving enoxaparin, clopidogrel, and GP IIb/IIIa inhibitors when necessary. Any approved CD or MC was allowed post-PCI, and clinical outcome data were prospectively collected. Four hundred forty-five patients had anti-Xa levels measured by a core laboratory and by a novel point-of-care device that reports ENOX times. All received enoxaparin, aspirin, and clopidogrel, and 75% received a concomitant GP IIb/IIIa inhibitor. Major and minor bleeding were defined according to TIMI criteria. "Any bleeding" included the occurrence of access site complications including hematoma, significant rebleeding, or bleeding delaying hospital discharge. TIMI major plus minor bleeding occurred in 1.5% of the patients who received CD vs. 1.8% of patients with MC (P = 0.83). Any bleeding occurred in 12.2% of CD vs. 5.7% MC (P = 0.02), and in 9.5% of patients receiving GP IIb/IIIa inhibitor vs. 2.8% (P = 0.01) among those who did not. For patients receiving both a GP IIb/IIIa inhibitor and CD, any bleeding was observed in 13.7% vs. 3.4% (P = 0.006) among patients who received neither. While minor and major TIMI bleeding remained very low in both groups, CD was associated with a twofold increase in risk of any-bleeding event when compared to MC, especially when using GP IIb/IIIa inhibitors.

Aged↗
PubMed2005

Safety of abciximab administration during PCI of patients with previous stroke.

OBJECTIVES: To examine the frequency of cerebrovascular complications among patients receiving abciximab (AB) undergoing PCI with prior intracranial hemorrhage (ICH) or recent (< 2 years) ischemic strokes. BACKGROUND: AB improves clinical outcomes in high-risk patients undergoing percutaneous coronary intervention (PCI); however, the safety of AB in patients with prior stroke has not been adequately studied. METHODS: A database review of 7,244 consecutive PCIs, from 7/97 to 10/01, identified 6,190 PCIs performed with AB among which 515 interventions were performed in patients with prior stroke history [ICH or recent ischemic stroke, (n = 101) and remote (> 2 years) ischemic stroke, (n = 414)]. RESULTS: The post-PCI stroke rate was significantly higher in patients with prior stroke (2.06% vs. 0.35%, p < 0.001 for all stroke; 0.38% vs. 0.03%, p = 0.023 for ICH). The incidence of ICH among the AB-treated group was 0.065%; a history of prior stroke did not increase the incidence of ICH in the AB-treated group (0.39% vs. 0.0%, p = ns). Moreover, the post-PCI stroke rate was similar between the prior ICH or recent ischemic stroke-group and remote ischemic stroke-group (2 vs. 1.9%; OR: 1.03; 95% CI: 0.21-4.90; p = ns for all strokes; 2% vs. 1.5%; OR: 1.4; 95% CI: 0.27-6.91; p = ns for ischemic stroke). Importantly, no ICH occurred in patients with recent ischemic or any prior ICH stroke. CONCLUSIONS: Abciximab, in addition to aspirin, heparin and ADP-inhibitors does not increase the risk of stroke in patients with prior stroke undergoing PCI.

Abciximab↗
PubMed2005

Differences in baseline characteristics and in-hospital outcomes in patients with or without prior stroke undergoing percutaneous coronary intervention.

BACKGROUND: Percutaneous coronary intervention (PCI) is increasingly used in patients with high-risk baseline characteristics. A prior stroke may identify patients who have a higher risk for post-PCI complications. However, no comparative data exist on post-PCI outcomes of patients with or without prior stroke. METHODS: Review of a PCI database of 9,088 consecutive PCIs from July 1997 to December 2002 identified 812 PCIs in patients with a history of prior stroke and 8,044 PCIs without prior stroke. RESULTS: Patients with prior stroke had high-risk baseline characteristics [diabetes, hypertension, hyperlipidemia, smoking, peripheral arterial disease, congestive heart failure, chronic renal failure, history of prior myocardial infarction and prior coronary artery bypass graft (CABG)] and high-risk coronary anatomy (p < 0.001 for each one). The triple composite (death, myocardial infarction and emergent CABG) and the triple composite plus post-PCI stroke were higher in patients with prior stroke (11.2% vs. 4.8%; p < 0.001; z = 7.617 and 12.1% vs. 5.0%; p < 0.001; z = 8.271, respectively. CONCLUSION: Patients with prior stroke constitute a high-risk PCI cohort with higher rates of in-hospital adverse events. A prior stroke history should be considered in evaluating potential candidates for PCI.

Aged↗
PubMed2004

Superior in-hospital and 30-day outcomes with abciximab versus eptifibatide: a contemporary analysis of 495 consecutive percutaneous coronary interventions.

BACKGROUND: Both abciximab (AB) and eptifibatide (EP) are approved for use during percutaneous coronary intervention (PCI) but comparative data between the 2 agents are limited. METHODS: We compared in-hospital and 30-day outcomes of contemporary 495 consecutive PCIs performed by a single operator between July 2001 and November 02 with AB and EP (242 with AB and 253 with EP). Cardiogenic shock patients who underwent a second procedure within 30 days from their first procedure were excluded. Selection of glycoprotein IIb/IIIa was at the operator's discretion. The initial 444 cases were performed with unfractionated heparin and the last 51 with bivalirudin. RESULTS: AB cases comprised a higher risk group with more patients with diabetes, peripheral vascular disease, ST-elevation myocardial infarction and renal failure (p<0.05 for each) and more rotablator use and longer lesions (p<0.01 for each). AB was associated with less in-hospital (4.6 versus 12.3%; OR: 0.34; 95% CI: 0.17-0.7; p=0.004) as well as 30-day (5.5 versus 14%; OR: 0.37; 95% CI: 0.19-0.71; p=0.003) major adverse cardiac events (sum of death, MI, urgent revascularization, all bleeding and stroke). CONCLUSION: Despite its use in higher risk PCI patients, AB resulted in superior short-term outcomes compared with EP. Our data suggest that significant efficacy differences may exist between these 2 agents and that a randomized comparison is warranted.

Abciximab↗
PubMed2003

A novel point-of-care enoxaparin monitor for use during percutaneous coronary intervention. Results of the Evaluating Enoxaparin Clotting Times (ELECT) Study.

OBJECTIVES: The aim of this study was to discern a target range of anticoagulation for enoxaparin during percutaneous coronary intervention (PCI) as measured by the Rapidpoint ENOX (Pharmanetics Inc., Morrisville, North Carolina), a new point-of-care test. BACKGROUND: In the U.S., enoxaparin has been used in only a small proportion of PCI procedures, partly because a rapid enoxaparin-specific assay was unavailable. METHODS: We analyzed data from 445 enrolled patients receiving subcutaneous or intravenous enoxaparin in a prospective, multicenter study. Serial anticoagulation measurements and clinical outcomes were recorded. RESULTS: The in-hospital composite occurrence of death, myocardial infarction, and urgent target vessel revascularization was 5.4%, and Thrombolysis In Myocardial Infarction (TIMI) major bleeding, minor bleeding, and any reported bleeding occurred in 0.2%, 1.3%, and 7.9% of patients, respectively. No significant association between procedural ENOX times and ischemic events was observed (p = 0.222), although the event rate was 4.0% among those with ENOX times between 250 to 450 s versus 7.2% for those outside this range (p = 0.134). Increasing ENOX time at sheath removal was correlated with any bleeding (p = 0.010) with a 1% increase for every approximately 30-s rise. CONCLUSIONS: Ischemic events were infrequent, and the rate appeared lowest in the mid-range of ENOX times. Bleeding events increased with increasing ENOX times. These observations, combined with a suggested procedural anti-Xa level of 0.8 to 1.8 IU/ml, translate into a recommended ENOX time range of 250 to 450 s for PCI and <200 to 250 s for sheath removal.

Angioplasty, Balloon, Coronary↗
PubMed2003

Restick following initial Angioseal use.

The Angioseal hemostatic device is currently in widespread use for arterial closure after both diagnostic and interventional procedures. Resticking of the artery in which an Angioseal device has been placed has been discouraged for up to 90 days after the initial device placement because of theoretical concerns of disruption or dislodgment of the hemostatic plug. However, no data are available to address this concern. We evaluated the incidence of vascular complications following restick of the artery in which an Angioseal device had been deployed </= 90 days previously in 181 patients. Restick occurred 1-7 days after device placement in 80 patients, 8-30 days in 34 patients, and 31-90 days in 66 patients. There were no major bleeding, vascular repair, vessel occlusion, or embolizations. Three large hematomas (1.7%) were noted. These data suggest that restick can be performed safely after initial Angioseal deployment.

Aged↗
PubMed2003

Evaluation of a novel point-of-care enoxaparin monitor with central laboratory anti-Xa levels.

BACKGROUND: Measurement of enoxaparin's anticoagulant activity has been limited to specialized coagulation laboratories and has been impractical for areas needing rapid results, such as during coronary angioplasty. A new point-of-care device, Rapidpoint ENOX, was recently developed to measure clotting times with enoxaparin use. OBJECTIVES: To correlate ENOX times with anti-Xa levels among patients receiving enoxaparin. METHODS: A total of 166 patients receiving enoxaparin for the prevention of deep venous thrombosis or as treatment during acute coronary syndromes or angioplasty were prospectively studied. Citrated and non-citrated whole-blood (CWB and NCWB) samples were obtained at baseline and peak enoxaparin activity. ENOX times were measured with whole-blood, and the Stachrom anti-Xa assay was performed on the plasma from the remainder of the samples. The Pearson correlation coefficient was used to assess the relationship between these two assays. RESULTS: There was a strong linear correlation between the ENOX times and the anti-Xa activities for both CWB (r=0.89, p<0.001) and NCWB (r=0.82, p<0.001) when considering all 332 samples (baseline and peak). When baseline samples were excluded, the correlation remained strong for CWB ENOX times and anti-Xa levels (r=0.84, p<0.001), but was only moderate for NCWB (r=0.73, p<0.001). A CWB ENOX time of </=160 s corresponded to anti-Xa level of </=0.5 IU/ml in 95% (188/197) of patients. A CWB ENOX time >/=200 s corresponded to anti-Xa levels >/=0.8 IU/ml in 96% (93/96) of patients. CONCLUSIONS: Rapidpoint ENOX times correlate strongly to anti-Xa activities measured by the Stachrom Heparin Assays for citrated whole-blood samples. This novel test can be used for rapid bedside measurements of enoxaparin anticoagulant activity.

Aged↗
PubMed2002

Vascular closure devices in patients treated with anticoagulation and IIb/IIIa receptor inhibitors during percutaneous revascularization.

OBJECTIVES: The study assessed clinical outcomes of closure device use following percutaneous coronary revascularization using current standards of anticoagulation and antiplatelet therapy. BACKGROUND: Evaluation of the outcomes of patients by use of vascular closure devices during coronary interventions employing current standards of anticoagulation and glycoprotein (GP) IIb/IIIa inhibitor therapy is limited. METHODS: We evaluated outcomes of 4,525 consecutive patients who underwent percutaneous coronary intervention between July 1997 and April 2000. All patients received anticoagulation with heparin and GP IIb/IIIa inhibitor therapy with abciximab. The closure method was manual in 1,824 patients, Angioseal in 524 patients and Perclose in 2,177 patients. Procedural and hospital vascular outcomes were evaluated. RESULTS: Closure device success was 97.1% Angioseal and 94.1% Perclose (p < 0.05). Minor vascular complications occurred in 1.8% of manual patients, 1.1% of Angioseal patients and 1.2% of Perclose patients (p = NS); major complications occurred in 1.3% of manual patients, 1.1% of Angioseal patients and 1.0% of Perclose patients (p = NS). Multivariate logistic regression identified only closure device failure as an independent predictor of a vascular complication. In patients with successful closure with a device, minor complications (0.8% vs. 1.8%, p < 0.05) and any complication (1.5% vs. 2.5%, p < 0.05) were reduced compared to manual compression. CONCLUSIONS: Arterial closure following coronary interventions using anticoagulation and GP IIb/IIIa inhibitor therapy can be safely and effectively performed, with vascular complication rates similar to or lower than with manual pressure. Additionally, vascular complication rates using GP IIb/IIIa inhibitor therapy regardless of the method of arterial closure are equivalent to or lower than previously published rates of vascular complications.

Abciximab↗