Collagenase Total Occlusion-1 (CTO-1) trial: a phase I, dose-escalation, safety study.

BACKGROUND: Percutaneous interventions for chronic total occlusions have low success rates, primarily because of failure of guide wire crossing. Collagen-rich matrix constitutes the main barrier to chronic total occlusion crossing. In preclinical studies, local delivery of a bacterial collagenase formulation improved guide wire crossing. The Collagenase Total Occlusion-1 (CTO-1) Trial is a phase I, dose-escalation trial to assess the safety and efficacy of collagenase therapy to facilitate guide wire crossing in coronary artery chronic occlusions. METHODS AND RESULTS: Twenty subjects with ≥1 previous failure of chronic total occlusion guide wire crossing were enrolled at 2 sites. Subjects were treated in 4 distinct cohorts of 5 patients, with escalation of collagenase dose in each cohort from 300 to 1200 µg. Collagenase was locally delivered into the occlusions with either an over-the-wire balloon system (n=8) or a fine-cross microcatheter (n=12) for a period of 30 minutes. Subjects were brought back to the catheterization laboratory for guide wire crossing and angioplasty the next day. Guide wire crossing was successfully achieved in 15 subjects (75%). A soft-tip guide wire (Whisper, Pilot-50, Fielder XT) was either the sole or predominant guide wire used in 75% of successful crossings. Non-ST-segment-elevation myocardial infarctions occurred in 3 patients as a result of side-branch ischemia during stenting. Computed tomographic angiography at 3 months showed no late complications and patent stents in successfully treated chronic total occlusion. Anginal improvement occurred with a reduction in Canadian Cardiovascular Society class from baseline to 3 months (2.5±0.6 versus 0.9±0.9; P<0.001). CONCLUSION: Local delivery of collagenase into coronary chronic total occlusion is feasible and safe with encouraging guide wire crossing results in previously failed cases. Larger clinical trials are required to determine efficacy. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01271335.

Angiographic and clinical outcomes after implantation of drug eluting stents in bifurcation lesions with crush or kissing stent technique.

BACKGROUND: Long-term outcome after bifurcation stenting with drug-eluting stents (DES) for obstructive coronary artery disease is poorly understood. In this study, we report 6-9-month angiographic follow-up and long-term clinical outcomes after implantation of drug-eluting stents by crush and kissing stent technique for coronary bifurcation lesions. METHODS: Consecutive patients undergoing bifurcation stenting with DES by crush or kissing stent technique were enrolled in a prospective registry. Angiographic follow-up was obtained at 6-9 months and clinical follow-up completed for a median of 38 months. RESULTS: A total of 86 patients participated in the study. Bifurcation stenting by crush technique was performed in 73 (85%) and by kissing stent in 13 (15%) patients. Stenting of left main bifurcation was applied in 24 (28%) patients. Angiographic follow-up was completed in 75 (87%) patients and showed restenosis in the main for 8 (11%) and side branch for 20 (27%) patients. Clinical follow-up was available for a median duration of 38 months. During follow-up, 2 (2%) patients died, 4 (5%) experienced myocardial infarction (MI), and 11 (13%) underwent target vessel revascularization (TVR) with an overall major adverse cardiac event (MACE) rate of 16%. In left main cohort, angiographic restenosis occurred in 9 (37%) patients, and 3 (12%) patients required TVR. There were no deaths or stent thrombosis. A comparison of crush and kissing stent technique showed significantly higher angiographic restenosis with crush (26% vs 13% in kissing stent patients, P = 0.046) and 95% of restenosis in crush group involved ostium of the side branch. There was no difference in clinical outcomes between the crush and kissing stent groups. Final kissing balloon dilatation (FKB) was successful in 65 (89%) patients in the crush group and associated with a significant reduction in MACE (8% in FKB successful vs 37% in FKB unsuccessful, P = 0.04) during follow-up. CONCLUSION: Bifurcation stenting with crush or kissing stent technique is safe and associated with a low rate of TLR and MACE on long-term follow-up. Crush stenting is associated with a significantly higher rate of side branch restenosis compared to kissing stent technique. FKB is associated with significant reduction in MACE during follow-up.

Intraluminal filling defects on coronary angiography: more than meets the eye.

Intraluminal filling defects are occasionally encountered on coronary angiography and often related with coronary thrombi. However, other conditions affecting the coronary arteries may present with similar angiographic findings causing diagnostic uncertainty. Accurate characterization of the angiographic filling defect is critical, particularly in patients planned for a percutaneous coronary intervention (PCI), as diagnosis of a coronary thrombus not only increases the risk of post procedural adverse events but also requires a specific therapeutic approach. In this paper, we report three patients in whom coronary angiography revealed intraluminal filling defects mimicking coronary thrombi. When further investigated with intravascular ultrasound (IVUS) as a part of the planned PCI, the thrombus was excluded and alternate etiology of the filling defect was confirmed in all patients. The angiographic "pseudothrombi" were produced by coronary dissection in one and by heavy calcification within the atherosclerotic plaque in two patients. The use of IVUS allowed accurate characterization of the angiographic filling defect and provided important information to guide management and optimize therapeutic approach.

Radial versus femoral access for emergent percutaneous coronary intervention with adjunct glycoprotein IIb/IIIa inhibition in acute myocardial infarction--the RADIAL-AMI pilot randomized trial.

BACKGROUND: Transradial percutaneous coronary intervention (PCI) results in fewer vascular complications, earlier ambulation, and improved patient comfort. Limited data exist for radial access in acute myocardial infarction, where reperfusion must occur quickly. METHODS: In a multicenter pilot trial, 50 patients with myocardial infarction requiring either primary or rescue PCI were randomized to radial or femoral access. All operators had previously performed at least 100 transradial cases. Procedure times were prospectively recorded. RESULTS: Thrombolysis was used in 66% of the cases and glycoprotein IIb/IIIa inhibitors in 94%. Crossover from radial to femoral access was required in one case. Percutaneous coronary intervention was performed in 47 patients, with stenting in 45. One procedural failure occurred with radial access because of inability to cross the occlusion. The time from local anesthesia to first balloon inflation was 32 (25th percentile 26, 75th percentile 38) minutes for radial access and 26 (22, 33) minutes for femoral access (P = .04). There were no significant differences in contrast use or fluoroscopy time. No patient experienced major bleeding or required transfusion. Doppler studies demonstrated 2 asymptomatic radial occlusions and 2 pseudoaneurysms (1 from each group). One patient in the femoral group died 2 days after PCI. At 30 days, there were no strokes or reinfarctions and no patient required bypass surgery or repeat PCI. CONCLUSIONS: Primary and rescue PCI can be performed with high success rates using either radial or femoral access. Although radial access was associated with a longer time to first balloon inflation, the difference was small and likely not clinically significant. In patients without shock, major bleeding and vascular complications are infrequent with either access site despite the high use of thrombolysis and glycoprotein IIb/IIIa inhibitors.

Bailout use of platelet glycoprotein IIb-IIIa inhibition during coronary stent implantation: observations from the ESPRIT trial.

Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention, rather than as prophylactic treatment. We sought to identify the characteristics and outcomes of patients requiring bailout treatment. The ESPRIT trial randomized 2,064 patients to receive eptifibatide or placebo starting immediately before percutaneous coronary intervention (PCI). Bailout therapy was used in 77 patients: 43 (4.2%) randomized to placebo and 34 (3.3%) to eptifibatide (p = 0.3). Bailout therapy for thrombosis was used more often in the placebo group (2.1% versus 1.0%; p = 0.03). Multivariable predictors of bailout included a greater than or equal to 90% stenosis, or visible thrombus on the baseline angiogram, and no aspirin pre-treatment before PCI. However, overall the model predicted bailout poorly (c-index = 0.64). The need for bailout cannot be reliably predicted using baseline characteristics. Patients experiencing complications have poor clinical outcomes despite bailout use of GP IIb/IIIa inhibitors.

Thrombin-activatable fibrinolysis inhibitor (TAFI): a novel predictor of angiographic coronary restenosis.

The fibrinolytic system is closely related to several processes that are involved in restenosis. We previously showed that low PAI-1 plasma levels predicted restenosis. Recently, a different fibrinolytic inhibitor, TAFI, has been described. The aims of this study were to evaluate the relationship between pre-procedural plasma levels of TAFI and late angiographic restenosis and the interaction between TAFI and PAI-1.We prospectively studied 159 patients with stable angina who underwent successful elective angioplasty or stenting of de novo native coronary artery lesions. TAFI and PAI-1 antigen levels were measured in plasma samples drawn before the procedure. Follow-up coronary angiography was performed in 92% of patients. There was a significant correlation between pre-procedural TAFI levels and 6-month % diameter stenosis (DS) (r = 0.21; p = 0.013). The overall angiographic restenosis rate (DS>50%) was 31%. Pre-procedural TAFI levels were significantly higher in patients with restenosis (108 +/- 33% versus 94+/-30%, p = 0.011). Restenosis rates for patients in the upper tertile of TAFI levels were 2-fold higher than for those in the lowest tertile (45% versus 22%; p = 0.016). A combination of high TAFI and low PAI-1 levels identified patients at the highest risk of restenosis (53%) compared to 14% in patients with low TAFI and high PAI-1 levels; p = 0.027. In conclusion, pre-procedural plasma TAFI antigen levels identify patients at increased risk for restenosis after PCI.

Do glycoprotein IIb/IIIa inhibitors interact with assays for myocardial necrosis?

OBJECTIVES: To determine whether glycoprotein (GP) IIB/IIIA inhibitors interact with cardiac marker assays: total creatine kinase (CK), CK-MB, and troponin-I (TnI). DESIGN AND METHODS: Two blood samples were collected during coronary angiography or angioplasty and analyzed for cardiac markers: one after arterial sheath insertion and the second 10 mins later. In the first phase (n=101), heparin and GP IIb/IIIa inhibitors were given between samples, in the second phase (n=45) only heparin was given, and in the third phase (n=54) neither drug was given. RESULTS: In each phase, there was a significant decline in total CK over the 10 min period. There were no consistent significant changes in CK-MB or TnI. CONCLUSIONS: Neither GP IIb/IIIa inhibitors nor i.v. heparin interact with cardiac marker assays. There is a small but significant decline in total CK levels within 10 mins of arterial puncture that is unrelated to administration of these drugs.

Thr325Ile polymorphism of the TAFI gene is related to TAFI antigen plasma levels and angiographic restenosis after percutaneous coronary interventions.

BACKGROUND: The fibrinolytic system is closely related to several processes that are involved in restenosis. We have previously shown that high pre-procedural plasma levels of thrombin-activatable fibrinolysis inhibitor (TAFI) antigen predicted angiographic restenosis. The aims of this study were to evaluate the relationship between Thr325Ile polymorphisms, plasma levels of TAFI antigen, and late angiographic restenosis after percutaneous coronary intervention (PCI). METHODS: We prospectively studied 159 patients with stable angina who underwent successful elective angioplasty or stenting of de novo native coronary artery lesions. Blood samples were drawn before the procedure. TAFI antigen levels were measured, as well as the presence of TAFI Ile325Thr genetic variation. Follow-up coronary angiography was performed in 90% of patients. RESULTS: The genotypes based on Ile325Thr substitution had significantly different TAFI antigen levels: genotype C/C>C/T>T/T (111+/-29%, 87+/-24%, and 59+/-22%, respectively, p<0.006). T/T genotype was associated with lower rates of restenosis compared to C/T and C/C genotypes (25% versus 37% and 33%, respectively, p<0.05). CONCLUSIONS: These data suggest that plasma TAFI antigen levels are genetically controlled. The T/T Thr325Ile polymorphism of the TAFI gene is associated with lower plasma levels of TAFI antigen and lower restenosis rates after PCI.

Chorea in a pregnant woman with rheumatic mitral stenosis.

Chorea gravidarum is a rare movement disorder of pregnancy with a broad differential diagnosis. Although often a benign condition, it may indicate underlying acute rheumatic fever, antiphospholipid antibody syndrome or a hypercoagulable state. However, now that rheumatic fever is rare in western countries, chorea gravidarum occurs most commonly in patients with chronic rheumatic heart disease. Heightened awareness of chorea gravidarum and the morbidity of the often associated rheumatic heart disease, particularly in immigrants from developing countries, is essential for early diagnosis and effective management. A case of chorea gravidarum in a woman with rheumatic mitral stenosis is described. The diagnostic approach, pathophysiology and management of this rare condition are discussed.

Radial versus femoral access for rescue percutaneous coronary intervention with adjuvant glycoprotein IIb/IIIa inhibitor use.

BACKGROUND: The transradial approach has not been evaluated for "rescue" percutaneous coronary intervention (PCI) with glycoprotein (GP) IIb/IIIa inhibitor following failed thrombolysis. OBJECTIVES: To compare the safety and procedural outcomes of the transradial and transfemoral approaches to rescue PCI. METHODS: Rescue PCI cases with adjuvant GP IIb/IIIa inhibitor performed at two centres were reviewed retrospectively, and the bleeding rates, equipment use and procedure times for the femoral and the radial approach were compared. RESULTS: Radial access was attempted in 47 of 111 cases (42%) and crossover to femoral access was required in two cases (4%). Major bleeding occurred in three patients in the radial group (6%) and in 12 patients in the femoral group (19%; P=0.06). Radial access was associated with less access site-related major bleeding (0% versus 9%; P=0.04) and fewer transfusions (4% versus 19%; P=0.02). After excluding patients with intra-aortic balloon pump, this difference was no longer statistically significant (4% versus 8%; P=0.7). Fluoroscopy times and contrast use were similar, and the time to first balloon inflation was slightly longer with radial access (33 min versus 30 min; P=0.07). CONCLUSIONS: In selected patients, the transradial approach for rescue PCI is safe and effective. The present findings warrant further study in a prospective, randomized trial.

Characterization of operator learning curve for transradial coronary interventions.

BACKGROUND: Transradial percutaneous coronary intervention (TR-PCI) improves clinical outcomes compared to the transfemoral (TF) approach. However, inadequate training and experience has limited widespread adoption by interventional cardiologists. METHODS AND RESULTS: Clinical and procedural characteristics for TR-PCI were prospectively collected from 1999 to 2008. To identify minimum case volume for optimum clinical benefit, single-vessel TR-PCI cases were chronologically ranked and stratified into 1 to 50, 51 to 100, 101 to 150 and 151 to 300 case volume groups for operators starting the TR approach at the study institution. Cases by operators with a >300 TR-PCI case volume comprised the control group. TR-PCI failure rates, contrast use, guide usage, and fluoroscopy time were compared among groups. A total of 1672 patients underwent TR-PCI by 28 operators. TR-PCI failure occurred in 4% and was higher in the 1 to 50 case volume group compared to the 51 to 100 (P=0.007) and control (P=0.01) groups. Contrast use was greater in the 1 to 50 group (180±79 mL) compared to the 151 to 300 (157±75 mL, P=0.02) and control (168±79 mL, P=0.05) groups. Fluoroscopy time was higher in the 1 to 50 group (15±10 minutes) compared to the 101 to 150 (13±10 minutes, P=0.04) and control (12±9 minutes, P=0.02) groups. Reasons for TR-PCI failure included spasm (38%), subclavian tortuousity (16%), poor guide support (16%), failed access (10%), and radial loop (7%). Case volume was significantly correlated with TR-PCI failure (ß=-0.0076, P=0.0028), and odds of failure was reduced by 32% for each 50 increments in case volume. CONCLUSIONS: TR-PCI success depends on operator experience, and a case volume of ≥50 cases is required to achieve outcomes comparable to experienced operators. These findings have implications both for PCI operators looking to expand their skills and for defining standards for training.

Characterization of clopidogrel hypersensitivity reactions and management with oral steroids without clopidogrel discontinuation.

OBJECTIVES: The purpose of this study was to characterize clopidogrel hypersensitivity and describe its successful management with oral steroids without clopidogrel discontinuation. BACKGROUND: Hypersensitivity reactions to clopidogrel are poorly understood and present difficulty in management. METHODS: Patients diagnosed with clopidogrel hypersensitivity after percutaneous coronary intervention underwent evaluation and received oral prednisone without clopidogrel discontinuation. Cutaneous testing was performed after completion of clopidogrel therapy for diagnosis and assessment of cross-reactivity. RESULTS: Sixty-two patients representing 1.6% of the percutaneous coronary intervention population developed clopidogrel hypersensitivity during the study period. The mean age was 62 ± 11 years, 71% of patients were male, and 35% reported prior adverse drug reaction. Clopidogrel hypersensitivity manifested as generalized exanthema in 79%, localized skin reaction in 16%, and angioedema or urticaria in 5% of patients. Biopsy of affected areas demonstrated a lymphocyte-mediated delayed hypersensitivity reaction. Complete resolution of hypersensitivity reaction was observed in 61 patients (98%) with a short course of oral prednisone. Cutaneous testing confirmed delayed hypersensitivity reaction to clopidogrel in 34 (81%) and immediate hypersensitivity in 3 of 42 patients (7%) tested. Allergenic cross-reactivity was observed for ticlopidine in 10 (24%), prasugrel in 7 (17%), and both ticlopidine and prasugrel in 3 patients (7%). Histological examination showed lymphocyte-mediated hypersensitivity in abnormal patch test areas. CONCLUSIONS: Clopidogrel hypersensitivity is manifested as generalized exanthema and is caused by a lymphocyte-mediated delayed hypersensitivity in most patients. This can be managed with oral steroids without clopidogrel discontinuation. Allergenic cross-reactivity with ticlopidine, prasugrel, or both is present in a significant number of patients with clopidogrel hypersensitivity.

Comparison of abciximab and eptifibatide on angiographic and clinical outcomes in rescue percutaneous coronary intervention for failed fibrinolytic therapy.

BACKGROUND: Adjunctive administration of the glycoprotein IIb/IIIa platelet receptor antagonist (GPA), abciximab, improves outcomes in patients undergoing rescue percutaneous coronary intervention (PCI). However, it is unknown if other GPAs provide a similar benefit in this setting. OBJECTIVE: We sought to compare angiographic and clinical outcomes of patients receiving abciximab or eptifibatide as an adjunct to rescue PCI. METHODS: In this prospective, nonrandomized study, consecutive patients who underwent rescue PCI and received adjunctive preprocedural GPA comprised the study population. Thrombolysis in myocardial infarction (TIMI) flow, corrected TIMI frame count (CTFC) and myocardial blush grade (MBG) were determined before and immediately after rescue PCI. Residual ST-segment elevation at 90-120 minutes and peak creatine kinase (CK) values for 48 hours after PCI were recorded. Major adverse cardiac events (MACE) including death, reinfarction and target vessel revascularization (TVR) were determined at discharge, 1 and 6 months. RESULTS: A total of 241 patients were included in the study. 162 patients received abciximab and 79 received eptifibatide. There were no differences in baseline clinical and angiographic characteristics between groups. Post-PCI TIMI flow was similar but post-PCI CTFC was significantly lower (17 +/- 10 vs. 22 +/- 18; p = 0.01) and post-PCI MBG significantly higher (2.8 +/- 0.5 vs. 2.6 +/- 0.6; p = 0.01) in the abciximab group. Patients in the abciximab group had less ST-segment elevation (1.0 +/- 0.9 vs. 1.5 +/- 1.0 mm; p = 0.003) and lower peak CK (2,484 +/- 2,176 vs. 2,650 +/- 2,798 U/L; p = 0.001) after PCI. On multivariate analyses, abciximab administration (OR = 0.50, CI = 0.26, 0.96; p = 0.03), pre-PCI TIMI 3 flow (OR = 0.22, CI = 0.05, 0.99; p = 0.04) and female gender (OR = 0.24, CI = 0.08, 0.66; p = 0.006) were positive and cardiogenic shock (OR = 2.76, CI = 1.16, 6.58; p = 0.02) was a negative predictor of normal epicardial perfusion post PCI. Abciximab administration (OR = 0.46, CI = 0.24, 0.87; p = 0.02) and pre-PCI CTFC < 25 (OR = 0.09, CI = 0.02, 0.31, 0.0001) were positive predictors and cardiogenic shock (OR = 3.96, CI = 1.55, 10.12; p = 0.004) was a negative predictor of normal myocardial perfusion post-PCI as determined by CTFC. Abciximab administration (OR = 0.31, CI = 0.15, 0.63; p = 0.001) and pre-PCI MBG 3 (OR = 0.07, CI = 0.02, 0.23; p < 0.0001) were positive predictors of normal myocardial perfusion post-PCI as determined by MBG. In-hospital, 1- and 6-month clinical events and MACE rates did not differ between groups. CONCLUSIONS: In the setting of rescue PCI, adjunctive administration of abciximab resulted in greater improvement in angiographic and electrical estimates of myocardial perfusion and smaller infarct size compared to eptifibatide. These findings suggest that all GPA may not provide equal benefit in rescue PCI.

Post-traumatic ventricular septal defects--review of the literature and a novel technique for percutaneous closure.

Post-traumatic ventricular septal defect (VSD) is infrequent, with clinical sequelae ranging from imminent death to complete spontaneous resolution. The most appropriate management strategy is unclear. Careful observation has been advocated in the management of these patients. We demonstrate this concept by reporting two different approaches in two patients with traumatic injuries to the chest and review the English-language literature of both spontaneous and percutaneous closure of these lesions. In our case of percutaneous closure, we report a novel technique involving a transseptal approach that does not require exteriorization and formation of an arteriovenous loop, thus avoiding loop-related complications.

Mechanism and predictors of failed transradial approach for percutaneous coronary interventions.

OBJECTIVES: The study aimed to determine the mechanism and predictors of procedural failure in patients undergoing percutaneous coronary intervention (PCI) from the transradial approach (TR). BACKGROUND: Transradial approach PCI reduces vascular complications compared with a transfemoral approach (TF). However, the mechanism and predictors of TR-PCI failure have not been well-characterized. METHODS: The study population consisted of patients undergoing TR-PCI by low-to-intermediate volume operators with traditional TF guide catheters. Baseline characteristics, procedure details, and clinical outcomes were prospectively collected. Univariate and multivariate analyses were performed to determine independent predictors of TR-PCI failure. RESULTS: A total of 2,100 patients underwent TR-PCI and represented 38% of PCI volume. Mean age was 64 +/- 12 years, and 17% were female. Vascular complications occurred in 22 (1%), and TR-PCI failure was observed in 98 (4.7%) patients. The mechanism of TR-PCI failure included inability to advance guide catheter to ascending aorta in 50 (51%), inadequate guide catheter support in 35 (36%), and unsuccessful radial artery puncture in 13 (13%) patients. The PCI was successful in 94 (96%) patients with TR-PCI failure by switching to TF. On multivariate analysis, age >75 years (odds ratio [OR]: 3.86; 95% confidence interval [CI]: 2.33 to 6.40, p = 0.0006), prior coronary artery bypass graft surgery (OR: 7.47; 95% CI: 3.45 to 16.19, p = 0.0002), and height (OR: 0.97; 95% CI: 0.95 to 0.99, p = 0.02) were independent predictors of TR-PCI failure. CONCLUSIONS: Transradial approach PCI can be performed by low-to-intermediate volume operators with standard equipment with a low failure rate. Age >75 years, prior coronary artery bypass graft surgery, and short stature are independent predictors of TR-PCI failure. Appropriate patient selection and careful risk assessment are needed to maximize benefits offered by TR-PCI.

Complete occlusion of the proximal subclavian artery post-CABG: presentation and treatment.

Atherosclerotic disease of the proximal left subclavian artery is an uncommon cause of angina in the post-coronary artery bypass graft patient, and is termed coronary-subclavian steal syndrome. Typical manifestations include cardiac symptoms of angina and noncardiac symptoms of lightheadedness, left arm numbness or weakness, and a difference in blood pressure of more than 20 mmHg between both arms. A case of complete proximal occlusion of the subclavian artery is reported. The clinical picture, investigations and treatment are described. Historical treatments of occlusive disease include surgical bypass graft and, more recently, percutaneous transluminal angioplasty. The patient underwent percutaneous transluminal angioplasty with stenting by a retrograde approach, with an excellent short-term response, but ultimately required a carotid subclavian bypass due to restenosis.

Comparison of radial versus femoral approach for percutaneous coronary interventions in octogenarians.

BACKGROUND: The safety and efficacy of a radial approach for percutaneous coronary intervention (PCI) in octogenarians is not well established. METHODS: To evaluate the benefits of a radial approach for preventing vascular complications after PCI, clinical, procedural, and outcome data were prospectively collected and compared for 228 octogenarians undergoing elective PCI either through a radial or a femoral approach. RESULTS: Radial approach was associated with longer cannulation (3.1 +/- 2.9 vs. 2.0 +/- 2.0 min, P < 0.001) and fluoroscopy times (19.3 +/- 16.1 vs. 16.1 +/- 11.8 min, P = 0.04), greater utilization of contrast media (224 +/- 46 vs. 182 +/- 20 ml, P < 0.001) and higher crossover rate (11 vs 4%, P = 0.03) to alternate access site compared with the femoral approach. However, ambulation time (5.2 +/- 3.1 vs. 11.6 +/- 6.3 hr, P < 0.001), access site bleeding (4 vs. 14%, P = 0.007), hematoma (1 vs. 11%, P = 0.001) or any vascular complication (5 vs 26%, P = 0.001) were significantly reduced with a radial approach. Procedural success rates were equivalent with both approaches. Multivariate regression analysis identified radial approach (OR = 0.23; CI = 0.08, 0.65) as an independent negative predictor of postprocedural vascular complications. CONCLUSION: Radial approach for PCI in octogenarians is technically challenging for the operator and exposes patients to greater volume of nephrotoxic contrast media. However, it results in early ambulation and significantly reduces vascular complications in this high risk population. These findings support a strategy of preprocedural risk assessment and use of radial approach for PCI in a select group of octogenarians to maximize benefits offered by this technique.

Bleeding complications in patients with acute coronary syndrome undergoing early invasive management can be reduced with radial access, smaller sheath sizes, and timely sheath removal.

OBJECTIVES: Our objective was to analyze the impact of arterial access site, sheath size, timing of sheath removal, and use of access site closure devices on high-risk patients with acute coronary syndromes (ACS). BACKGROUND: In the SYNERGY trial, 9,978 patients with ACS were randomly assigned to receive enoxaparin or unfractionated heparin. METHODS: This analysis includes 9,404 patients for whom sheath access information was obtained for the first PCI procedure or diagnostic catheterization. Comparisons of baseline, angiographic, and procedural characteristics were carried out according to access site and sheath size. RESULTS: Overall, 9,404 (94%) patients underwent angiography at a median of 21 hr (25th and 75th percentiles: 5, 42) and 4,687 (50%) underwent PCI at a median of 23 hr (6,49) of enrollment. The access site was femoral for 94.9% of cases, radial for 4.4%, and brachial for 0.7%. Radial access was associated with fewer transfusions than femoral access (0.9% vs. 4.8%, P=0.007). For femoral access, the rates of noncoronary artery bypass grafting (CABG)-related TIMI major bleeding by sheath size was 1.5% for 4 or 5 French (Fr), 1.6% for 6 Fr, 3.3% for 7 Fr, and 3.8% for >or=8 Fr (P<0.0001). After adjustment for baseline characteristics, femoral access site, larger sheath size, and delayed sheath removal were independent predictors of need for transfusion. CONCLUSIONS: Smaller sheaths, radial access, and timely sheath removal may mitigate the bleeding risk associated with potent antithrombotic/platelet therapy and early catheterization.

Failure of enoxaparin during coronary stenting: a case report.

A 90-year-old male underwent coronary stenting following a bout of coronary insufficiency. Coronary stenting was performed 6 hr following the last dose of low-molecular-weight heparin but was complicated by extensive intrastent clot formation. Low-molecular-weight heparin in the absence of a glycoprotein IIb/IIIa receptor blocker may be insufficient during percutaneous coronary intervention.