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We report a rare case of a ruptured giant left anterior descending coronary artery pseudoaneurysm that necessitated salvage operative repair. This case affirms the life-threatening nature of this clinically significant pathology, as well as the need for emergent repair before pseudoaneurysm rupture to maximize the likelihood of patient survival.

Background: This prospective study investigated the association between preprocedural biomarker levels and incident major adverse cardiac events (MACE) in complex patients undergoing percutaneous coronary intervention (PCI) with sirolimus-eluting stenting. Hypothesis: Lipoprotein(a) (Lp[a]), interleukin-10 (IL-10), and high-sensitivity C-reactive protein (CRP) have long-term prognostic value in patients undergoing PCI. Methods: Between April 2002 and February 2003, 161 patients were included in the study. Blood was drawn before the procedure, and biomarkers were measured. Patients were followed-up for MACE (death, nonfatal myocardial infarction, and repeat revascularization). Cox proportional hazard models were used to determine risk of MACE for tertiles of biomarkers. Both 1-year and long-term follow-up (median, 6 years; maximum, 8 years) were evaluated. Results: Mean age was 59 years, and 68% were men. During long-term follow-up, 72 MACE occurred (overall crude cumulative incidence: 45% [95% confidence interval (CI): 37%-52%]). Lp(a) was associated with a higher 1-year risk of MACE, with an adjusted hazard ratio (HR) of 3.1 (95% CI: 1.1-8.6) for the highest vs the lowest tertile. This association weakened and lost significance with long-term follow-up. IL-10 showed a tendency toward an association with MACE. The 1-year HR was 2.1 (95% CI: 0.92-5.0). Long-term follow-up rendered a similar result. The association of CRP with MACE did not reach statistical significance at 1-year follow-up. However, CRP was associated with long-term risk of MACE, with an HR of 1.9 (95% CI: 1.0-3.5). Conclusions: In this prospective study, preprocedural Lp(a) level was associated with short-term prognosis after PCI. The preprocedural CRP level was associated with long-term prognosis after PCI. Clin. Cardiol. 2012 DOI: 10.1002/clc.21988 The authors have no funding, financial relationships, or conflicts of interest to disclose.

Background: Invasive catheter based techniques for renal denervation have been extensively examined in treating patients with resistant hypertension, with mixed results and some periprocedural complications. New evidence suggested that not all renal nerves are in the range of invasive procedures limited to a distance 4 to 6 mm from the lumen. Aims: To evaluate the safety and efficacy of an entirely non-invasive approach to renal denervation using externally delivered focused ultrasound to the peri-renal artery tissue with real time Doppler-based image guidance. Methods and results: Twenty-seven patients with severe, treatment resistant hypertension, defined as persistent systolic blood pressure (BP) > 160 mmHg despite 3 or more antihypertensive medications, were treated non-invasively with the Kona Medical Surround Sound System™. Focused ultrasound energy was delivered to the renal arteries bilaterally and surrounding tissue using Doppler-based imaging and continuous tracking with automatic correction for kidney motion throughout treatment. Patients received conscious sedation during the treatment period. At this time, all patients have completed 24 weeks and 23 patients 52 weeks of follow up. Post-denervation, the mean changes from baseline BP (175/92 mmHg) were -16.8/-8.6 mmHg at 3 weeks, -23.2/-10.8 mmHg at 6 weeks, -29.7/-13.1 mmHg at 12 weeks, -21.6/-8.7 mmHg at 24 weeks and -25.6/-10.1 mmHg at 52 weeks . No serious device-related events have been reported to date. Forty-one percent of subjects (11/27) reported mild back pain immediately following the denervation treatment. The majority of cases (7/11) completely resolved within three days post treatment without any significant intervention and no case was associated with any motor, sensory deficits. Conclusions: This is the first study in humans using a non-invasive renal denervation system in severe resistant hypertension. Results showed clinically meaningful reductions from baseline in office BP through 52 weeks post-denervation. The procedure was well-tolerated with no serious adverse events. This technology should enable patients to benefit from renal denervation therapy without the invasive risks associated with catheter based techniques.

We present the case of a 26 year-old man who presented to hospital with monomorphic ventricular tachycardia (VT) at a rate of 170bpm after exercising on a treadmill. Multimodality imaging with transthoracic echocardiogram (TTE), cardiac magnetic resonance imaging (CMRI) and computed tomography coronary angiogram (CTCA) demonstrated two causes for ventricular tachycardia; hypertrophic cardiomyopathy (HCM) and an anomalous right coronary artery (RCA) arising from the left coronary sinus, with a potentially malignant interarterial course. Both conditions can be associated with sudden cardiac death (SCD). We discuss the management dilemmas in this unique patient.

Objectives The aim of this study was to determine the safety and efficacy of a novel pimecrolimus-eluting stent in a porcine coronary model and in a phase I clinical trial. Background Rapamycin- and paclitaxel-eluting stents reduce the need for repeat intervention by limiting neointimal hyperplasia but might cause delayed healing, pre-disposing patients to late stent thrombosis. Because inflammation plays a key role in restenosis, pimecrolimus, an anti-inflammatory drug, might reduce restenosis without adversely affecting re-endothelialization. Methods We evaluated a novel polymeric pimecrolimus-eluting stent covered with a thin parylene C diffusion barrier in a porcine coronary model and in a phase I human clinical trial. The clinical study was a prospective, nonrandomized, first-in-human hypothesis-generating study that enrolled 15 patients who had a single de novo native coronary stenosis. Results At 28 days and 3 months in the porcine model, histopathologic indicators predicted safety and biocompatibility when stents coated with polymer only, drug only, and 2 drug-polymer formulations were compared with bare-metal stents (BMS). In the phase I clinical trial, 15 patients had successful implantation of pimecrolimus-eluting stents. By 6 months, no patient suffered death, myocardial infarction, or stent thrombosis. However, the angiographic restenosis (61%), mean late loss (1.44 mm), and repeat target lesion revascularization (53%) were significantly higher than historical BMS controls. Whereas the primary end point was percent volume obstruction, restenosis was so severe that operators performed intravascular ultrasound examination in only 6 patients. Conclusions Pimecrolimus-eluting stents induced an exaggerated neointimal hyperplasia at 6 months in comparison with historical controls.

Objectives This study assessed the effect of pharmacogenetics on the antiplatelet effect of clopidogrel. Background Variability in clopidogrel response might be influenced by polymorphisms in genes coding for drug metabolism enzymes (cytochrome P450 [CYP] family), transport proteins (P-glycoprotein) and/or target proteins for the drug (adenosine diphosphate–receptor P2Y12). Methods Sixty patients undergoing elective percutaneous coronary intervention in the randomized PRINC (Plavix Response in Coronary Intervention) trial had platelet function measured using the VerifyNow P2Y12 analyzer after a 600-mg or split 1,200-mg loading dose and after a 75- or 150-mg daily maintenance dosage. Polymerase chain reaction–based genotyping evaluated polymorphisms in the CYP2C19, CYP2C9, CYP3A4, CYP3A5, ABCB1, P2Y12, and CES genes. Results CYP2C19*1*1 carriers had greater platelet inhibition 2 h after a 600-mg dose (median: 23%, range: 0% to 66%), compared with platelet inhibition in CYP2C19*2 or *4 carriers (10%, 0% to 56%, p = 0.029) and CYP2C19*17 carriers (9%, 0% to 98%, p = 0.026). CYP2C19*2 or *4 carriers had greater platelet inhibition with the higher loading dose than with the lower dose at 4 h (37%, 8% to 87% vs. 14%, 0% to 22%, p = 0.002) and responded better with the higher maintenance dose regimen (51%, 15% to 86% vs. 14%, 0% to 67%, p = 0.042). Conclusions Carriers of the CYP2C19*2 and *4 alleles showed reduced platelet inhibition after a clopidogrel 600-mg loading dose but responded to higher loading and maintenance dose regimens. Genotyping for the relevant gene polymorphisms may help to individualize and optimize clopidogrel treatment. (Australia New Zealand Clinical Trials Registry; ACTRN12606000129583)

Objectives This study evaluated the antiplatelet effect of a higher loading and maintenance dose regimen of clopidogrel and a possible drug interaction with verapamil. Background Clopidogrel loading doses above 600 mg have not resulted in more rapid or complete platelet inhibition. Higher maintenance dosages may be more effective than 75 mg/day. Methods A double-blind, randomized, placebo-controlled trial was undertaken in 60 patients undergoing percutaneous coronary intervention. All patients received clopidogrel 600 mg at the start of the procedure. Using a 2 × 2 design, patients were allocated to clopidogrel 600 mg given 2 h later or matching placebo, and to verapamil 5 mg intra-arterial or placebo. Platelet function was measured using the VerifyNow P2Y12 analyzer (Accumetrics Ltd., San Diego, California) at 2, 4, and 7 h. Patients were further randomized to receive a clopidogrel 75 or 150 mg once daily, with platelet function assessed after 1 week. Results Two hours after the second dose of clopidogrel or placebo, platelet inhibition was 42 ± 27% with clopidogrel, compared with 24 ± 22% with placebo (p = 0.0006). By 5 h after the second dose, platelet inhibition was 49 ± 30% with clopidogrel, compared with 29 ± 22% with placebo (p = 0.01). No drug interaction was seen with verapamil. A clopidogrel maintenance dosage of 150 mg daily for 1 week resulted in greater platelet inhibition than 75 mg daily (50 ± 28% vs. 29 ± 19%, p = 0.01). Conclusions In an unselected population undergoing percutaneous coronary intervention a clopidogrel 1,200-mg loading dose, given as two 600-mg doses 2 h apart, results in more rapid and complete platelet inhibition than a single 600-mg dose. A maintenance dosage of 150 mg daily produces greater platelet inhibition than 75 mg daily. (The PRINC trial; ACTRN12606000129583)

The Endeavor zotarolimus-eluting stent (ZES; Medtronic Vascular, Santa Rosa, CA) has been found to provide event-free clinical outcomes to 2 years for the treatment of symptomatic CAD by suppressing neointimal proliferation of the target lesion. The clinical outcomes of patients treated with the Endeavor ZES were evaluated at 4 years after implantation. One hundred consecutive patients with symptomatic ischemic heart disease due to de novo stenotic lesions of native coronary arteries were treated with the Endeavor ZES at 8 centers according to a standardized procedure. At 4 years, 3 patients were lost to follow-up analysis. The incidence of major adverse cardiac events (MACE; defined as death, myocardial infarction, emergent cardiac surgery, or repeat revascularization of the target lesion) was 2% at 4 months, 2% at 1 year, 3% at 2 years, 6.1% at 3 years, and 7.2% at 4 years. The difference in these rates was due to 4 deaths caused by cancer (metastatic melanoma, metastatic adenocarcinoma, small-cell cancer of the bladder, and lung carcinoma). From 2-4 years, there was an additional reported case of target lesion revascularization (TLR). A single case of stent thrombosis occurred at 10 days after the index procedure but no cases occurred thereafter. The treatment of patients with symptomatic CAD due to de novo lesions in native coronary arteries with the Endeavor ZES has sustained clinical benefits to 4 years, with very low rates of MACE and TLR.

The Kona Medical Surround Sound™ System is a non-invasive device for renal denervation that delivers externally focused ultrasound to the renal nerves using Doppler-based image guidance to track and correct for renal artery motion during the procedure. Aims: To evaluate the safety and efficacy of

OBJECTIVE To Evaluate the clinical outcome of patients with acute coronary syndrome (ACS) in the Coronary Care Unit (CCU) over three decades in Dunedin, New Zealand. DESIGN Registry study. SETTING AND PATIENTS all consecutive patients (n = 3,013) with ACS admitted to the CCU from 1979 to 1981 (n = 966) and from 1989 to 1991 (n = 1470) were included prospectively. Data on ACS patients managed in the CCU in 2001-2002 (n = 577) were obtained via medical chart review. RESULTS There was a rising proportion of older (> or = 75 years of age) patients with ACS (3.8% in 1979-1981, 15.2% in 1989-1991 and 25.6% in 2001-2002, P < 0.0005). However, we observed a progressive reduction of in-hospital mortality for ACS (10.7, 7.3 and 5.0%, P < 0.005) and for ST-elevation myocardial infarction (STEMI) (18.4, 16.1 and 6.6%, P < 0.005). The progressive fall in mortality rate was also observed amongst older patients, both for ACS (27, 19.2 and 11.5%, P = 0.011) and for STEMI (34.8, 30.9 and 15.4%, P < 0.005). Of concern, only 10% of patients presented within 1 h of symptom onset and 50% within 5 h, and this has not changed over three decades. The variables associated with < 5 h from symptom onset to presentation were men [odds ratio (OR) 1.25, 95% confidence interval (CI) 1.10-1.42, P = 0.001], a history of ischaemic heart disease (OR 1.25, 95% CI 1.09-1.43, P = 0.002) and STEMI (OR 1.41, 95% CI 1.18-1.67, P < 0.0001). Advanced age was not a predictor for late presentation. CONCLUSIONS Over the past three decades, more old patients were treated in the CCU. However, there was a decline in hospital mortality, particularly for STEMI. Further efforts are required to decrease the time to presentation.

Background — Because heterogeneous results have been reported, we assessed coronary flow velocity changes in individuals who underwent percutaneous transluminal coronary angioplasty (PTCA) and examined their impact on clinical outcome. Methods and Results — As part of the Doppler Endpoints Balloon Angioplasty Trial Europe (DEBATE) II study, 379 patients underwent Doppler flow–guided angioplasty. All patients were evaluated according to their coronary flow velocity reserve (CFVR) results (≥2.5 or P P P =0.034) and at 1 year (OR, 2.06; 95% CI, 1.16 to 3.66; P =0.014). After excluding MACE at 30 days, no difference in MACE at 1 year was observed between the patients with and without a CFVR Conclusions — A low postprocedural CFVR was associated with a worse periprocedural outcome (which was related to microcirculatory disturbances), but there was no significant difference at late follow-up.

Aims Primary percutaneous coronary intervention (PCI) is the optimal management for ST segment elevation myocardial infarction (STEMI) patients. We reviewed the largest primary PCI regional service in New Zealand: the Auckland/Northland service based at Auckland City Hospital, to assess patient management, in particular the door to reperfusion times (DTRTs), and predictors of death in hospital. Methods We obtained patient details from a comprehensive prospective database of all primary PCI patients admitted with STEMI from 1/1/12 to 31/12/12 to the Auckland City Hospital cardiac catheterisation laboratory. Of four District Health Boards (DHBs) within the region, two accessed this regional service at all times, and two accessed the Auckland City Hospital cardiac catheterisation laboratory ‘after hours’: all times except for 08:00 to 16:00 hours on Monday to Friday. Results A total of 401 adult patients underwent a primary PCI at the Auckland City Hospital Regional centre for a STEMI presentation, over the 12 months period. The median patient age was 61 years, 77% were male. Overall 183 (46%) (95% CI 41, 51) patients achieved a DTRT of 90 mins, and 266 (66%) (95% CI 61, 71) a DTRT of 120mins, with a clear geographical influence to these times. Of 27 patients with direct transfer to the catheter laboratory from the community, the DTRT was 120 mins in 24 (92%) (95% CI 72, 96) patients. In-hospital mortality was 24 (6%) patients (95% CI 4, 9). Conclusions The 2012 Auckland/Northland primary PCI service delivers good outcomes consistent with current Australasian standards. Although geographical isolation complicates door to reperfusion times, these may potentially be improved by more focus on direct transfer to the cardiac catheterisation laboratory, especially directly from the community.

Background —Restenosis after conventional stenting is almost exclusively caused by neointimal hyperplasia. β-Particle–emitting radioactive stents decrease in-stent neointimal hyperplasia at 6-month follow-up. The purpose of this study was to evaluate the 1-year outcome of 32 P radioactive stents with an initial activity of 6 to 12 μCi using serial quantitative coronary angiography and volumetric ECG-gated 3D intravascular ultrasound (IVUS). Methods and Results —Of 40 patients undergoing initial stent implantation, 26 were event-free after the 6-month follow-up period and 22 underwent repeat catheterization and IVUS at 1 year; they comprised half of the study population. Significant luminal deterioration was observed within the stents between 6 months and 1 year, as evidenced by a decrease in the angiographic minimum lumen diameter (−0.43±0.56 mm; P =0.028) and in the mean lumen diameter in the stent (−0.55±0.63 mm; P =0.001); a significant increase in in-stent neointimal hyperplasia by IVUS (18.16±12.59 mm 3 at 6 months to 27.75±11.99 mm 3 at 1 year; P =0.001) was also observed. Target vessel revascularization was performed in 5 patients (23%). No patient experienced late occlusion, myocardial infarction, or death. By 1 year, 21 of the initial 40 patients (65%) remained event-free. Conclusions —Neointimal proliferation is delayed rather than prevented by radioactive stent implantation. Clinical outcome 1 year after the implantation of stents with an initial activity of 6 to 12 μCi is not favorable when compared with conventional stenting.

Background Recently, a novel nonfluoroscopic 3-dimensional electromechanical mapping technique was introduced in the clinical arena. Although initial in vitro and in vivo studies suggested the reliability of the system in volumetric and hemodynamic evaluation of the left ventricle, no validation in human beings has been performed. Methods A nonfluoroscopic electromechanical mapping (NOGA, Biosense-Webster) procedure was performed in 44 patients. All patients received a contrast left ventriculogram during the same session. Volumetric (end-diastolic [EDV] and end-systolic volumes [ESV]) and hemodynamic (left ventricular ejection fraction [LVEF] and stroke volume) parameters of both systems were compared. Results Two uncomplicated pericardial effusions occurred with the first-generation mapping catheters. No procedural complications were noted with the new-generation mapping catheters. Significant correlations were found between mapping-derived and ventriculography-based measurements for both ESV (r = 0.67, P < .001) and LVEF (r = 0.78, P < .001). Absolute volumes, however, were only comparable for ESV (46.6 ± 25.3 mL vs 48.8 ± 37.0 mL, respectively; P = .13) but differed greatly for LVEF (35% ± 13% vs 65% ± 19%, respectively; P < .001), EDV (69.1 ± 28.6 mL vs 125.9 ± 53.4 mL, respectively; P < .001) and stroke volume (22.4 ± 9.9 mL vs 77.1 ± 33.7 respirations; P < .001). Moreover, Bland-Altman analysis showed the clinical noninterchangeability between these techniques for the measurement of hemodynamic parameters. Conclusion Measurement of hemodynamic parameters with nonfluoroscopic mapping of the left ventricle is feasible and safe. The system provides data that strongly correlate but that are in clinical disagreement with angiographic data. Therefore the interchangeability of these techniques may be questioned. (Am Heart J 2000;140:596-602.)

United States patent 5059166, issued October 22, 1991, to Robert and Tim Fischell, described an “intraarterial stent with the capability to inhibit intimal hyperplasia.”1 The proponents of this patent went on to say in their proposal: “Since radiation from a radioisotope source is capable of selectively inhibiting the growth of hyperproliferating cells as compared with normal cells, a radioisotope material which forms part of the stent can be used to decrease the rate of arterial reclosure. The radioisotope could be placed inside the stent, alloyed into the metal from which the stent is made, or preferably, it can be coated onto the stent’s exterior surface.” So began the story of the radioactive stent. Eight years and several animal species later, we are becoming aware of the bright and dark sides of this treatment modality in the human model. The safety and efficacy study by Albiero and colleagues2 describes the dose-related decrease noted at 6-month follow-up of intrastent neointimal hyperplasia after implantation of 32P radioactive stents at activities of 0.75 to 12 μCi. Whereas in-stent restenosis was all but obliterated at higher doses of radiation, intralesion restenosis was high because of late lumen loss at the stent edges. Aptly, the authors coined the term “candy wrapper” to describe this new restenotic pattern. It is possible that the animal workers who implanted the first radioactive stents observed this phenomenon. Unfortunately, the significance of this finding may not have been immediately apparent. The study by Albiero and colleagues reflects the courage of the investigators who, despite indifferent and at times contradictory results from animal work, persisted in their endeavor to discover whether radioactive stent implantation would be effective in humans. Previously, Hehrlein et al,3 4 using the rabbit iliac model, polyisotopic 55Co (elements 55Co, 56Co, 57 …

OBJECTIVESThe aims of the study were to determine the incidence of relocation of the minimal luminal diameter (MLD) after beta-radiation therapy following balloon angioplasty (BA) and to describe a new methodological approach to define the effect of brachytherapy on treated coronary stenoses.BACKGROUNDLuminal diameter of coronary lesions may increase over time following angioplasty and irradiatation. As a result, the MLD at follow-up may be relocated from its location preintervention, which may induce misleading results when a restricted definition of the target segment by quantitative coronary angiography (QCA) is performed.METHODSPatients treated with BA followed by intracoronary brachytherapy according to the Dose-Finding Study constituted the study population. A historical cohort of patients treated with BA was used as control group. To be included in the analysis, an accurate angiographic documentation of all instrumentations during the procedure was mandatory. In the irradiated patients, four regions were defined by QCA: vessel segment (VS), target segment (TS), injured segment (INS), and irradiated segment (IRS).RESULTSSixty-five patients from the Dose-Finding Study and 179 control patients were included. At follow-up, MLD was relocated more often in the radiation group (78.5% vs. 26.3%; p < 0.0001). The rate of >50% diameter stenosis differed among the four predefined regions: 3.1% in the TS; 7.7% in the INS; 9.2% in the IRS and 13.8% in the VS.CONCLUSIONSRelocation of the MLD is commonly demonstrated after BA and brachytherapy, and it should be taken into account during the analysis of the results of radiation clinical trials.

Intracoronary brachytherapy has recently emerged as a new therapy to prevent restenosis. Initial experimental work was achieved in animal models and the results were assessed by histomorphometry. Initial clinical trials used angiography to guide dosimetry and to assess efficacy. Intravascular ultrasound (IVUS) permits tomographic examination of the vessel wall, elucidating the true morphology of the lumen and transmural components, which cannot be investigated on the lumenogram obtained by angiography. This paper reviews the use of IVUS in the clinical studies of brachytherapy conducted to date. IVUS allows clinicians to make a thorough assessment of the remodeling of the vessel and appears to have a major role to play in facilitating understanding of the underlying mechanisms of action in this emerging field. The authors propose that state-of-the-art IVUS techniques should be employed to further knowledge of the mechanisms of action of brachytherapy in atherosclerotic human coronary arteries.

The application of &#103 -radiation in coronary arteries is a promising new technique for the treatment of in-stent restenosis. This is the first case in which the 5 F. delivery catheter of the Beta-Cath™ system was advanced through the struts of a stent, previously deployed in an adjacent branch, so as to deliver radiation to the target vessel. (Int J Cardiovasc Intervent 2000; 3: 121-125)

Background —Abnormal endothelium-dependent coronary vasomotion has been reported after balloon angioplasty (BA), as well as after intracoronary radiation. However, the long-term effect on coronary vasomotion is not known. The aim of this study was to evaluate the long-term vasomotion of coronary segments treated with BA and brachytherapy. Methods and Results —Patients with single de novo lesions treated either with BA followed by intracoronary β-irradiation (according to the Beta Energy Restenosis Trial-1.5) or with BA alone were eligible. Of these groups, those patients in stable condition who returned for 6-month angiographic follow-up formed the study population (n=19, irradiated group and n=11, control group). Endothelium-dependent coronary vasomotion was assessed by selective infusion of serial doses of acetylcholine (ACh) proximally to the treated area. Mean luminal diameter was calculated by quantitative coronary angiography both in the treated area and in distal segments. Endothelial dysfunction was defined as a vasoconstriction after the maximal dose of ACh (10 −6 mol/L). Seventeen irradiated segments (89.5%) demonstrated normal endothelial function. In contrast, 10 distal nonirradiated segments (53%) and 5 control segments (45%) demonstrated endothelium-dependent vasoconstriction (−19±17% and −9.0±5%, respectively). Mean percentage of change in mean luminal diameter after ACh was significantly higher in irradiated segments ( P =0.01). Conclusions —Endothelium-dependent vasomotion of coronary segments treated with BA followed by β-radiation is restored in the majority of stable patients at 6-month follow-up. This functional response appeared to be better than those documented both in the distal segments and in segments treated with BA alone.

While quantitative coronary angiography (QCA) remains the standard used to assess new interventional therapies, intracoronary ultrasound (ICUS) is gaining interest. The aim of the study was to determine the relationship between QCA and quantitative coronary ultrasound (QCU) measurements after stenting. Sixty-two consecutive patients with both QCA and QCU analysis after stent implantation were included in the study. The mean luminal diameter (QCU vs. QCA) were 2.74 +/- 0.46 mm and 2.41 +/- 0.49 mm (P < 0.0001), the minimal luminal diameter (MLD) 2.08 +/- 0.44 mm and 1.62 +/- 0.42 mm (P < 0. 0001), and the projected QCU MLD 1.90 +/- 0.42 mm (P < 0.0001 with respect to QCA). Percentage obstruction diameter (QCU vs. QCA) were 41.53% +/- 10.78% and 43.15% +/- 12.72% (P = NS). The stent diameter (QCU vs. QCA) were 3.54 +/- 0.65 mm and 3.80 +/- 0.37 mm (P = 0. 0004). Stent length measured by QCU were longer at 31.11 +/- 13.54 mm against 28.63 +/- 12.75 mm, P < 0.0001 with respect to QCA. In conclusion, while QCA and QCU appear to be comparable tools for measuring corrected stent diameters and stent lengths, smaller luminal diameters were found using QCA. This is of particular relevance to quantitative studies addressing absolute changes in vascular or luminal diameters. Cathet. Cardiovasc. Intervent. 48:133-142, 1999.

OBJECTIVES We aimed to identify periprocedural quantitative coronary angiographic (QCA) variables that have predictive value on long-term angiographic results and to construct multivariate models using these variables for postprocedural prognosis. BACKGROUND Coronary stent implantation has reduced the restenosis rate significantly as compared with balloon angioplasty in short de novo lesions in coronary arteries >3 mm in size. Although the postprocedural minimal luminal diameter (MLD) is known to have significant bearing on long-term angiographic results, no practically useful model exists for prediction of angiographic outcome based on the periprocedural QCA variables. METHODS The QCA data from patients who underwent Palmaz-Schatz stent implantation for short ( 3 mm and completed six months of angiographic follow-up in the four prospective clinical trials (BENESTENT I, BENESTENT II pilot, BENESTENT II and MUSIC) were pooled. Multiple models were constructed using multivariate analysis. The Hosmer-Lemeshow goodness-of-fit test was used to identify the model of best fit, and this model was used to construct a reference chart for prediction of angiographic outcome on the basis of periprocedural QCA variables. RESULTS Univariate analysis performed using QCA variables revealed that vessel size, MLD before and after the procedure, reference area before and after the procedure, minimal luminal cross-sectional area before and after the procedure, diameter stenosis after the procedure, area of plaque after the procedure and area stenosis after the procedure were significant predictors of angiographic outcome. Using multivariate analysis, the Hosmer-Lemeshow goodness-of-fit test showed that the model containing percent diameter stenosis after the procedure and vessel size best fit the data. A reference chart was then developed to calculate the expected restenosis rate. CONCLUSIONS Restenosis rate after stent implantation for short lesions can be predicted using the variables percent diameter stenosis after the procedure and vessel size. This meta-analysis indicates that the concept of “the bigger the better” holds true for coronary stent implantation. Applicability of the model beyond short lesions should be tested.

Background —Intracoronary brachytherapy appears to be a promising technology to prevent restenosis. Presently, limited data are available regarding the late safety of this therapeutic modality. The aim of the study was to determine the incidence of late (>1 month) thrombosis after PTCA and radiotherapy. Methods and Results —From April 1997 to March 1999, we successfully treated 108 patients with PTCA followed by intracoronary β-radiation. Ninety-one patients have completed at least 2 months of clinical follow-up. Of these patients, 6.6% (6 patients) presented with sudden thrombotic events confirmed by angiography 2 to 15 months after intervention (2 balloon angioplasty and 4 stent). Some factors (overlapping stents, unhealed dissection) may have triggered the thrombosis process, but the timing of the event is extremely unusual. Therefore, the effect of radiation on delaying the healing process and maintaining a thrombogenic coronary surface is proposed as the most plausible mechanism to explain such late events. Conclusions —Late and sudden thrombosis after PTCA followed by intracoronary radiotherapy is a new phenomenon in interventional cardiology.

The aim of this study was to determine the contribution of morphologic characteristics and location of plaque in remodeling of atherosclerotic coronary arteries. Consecutive intravascular ultrasound studies performed in native coronary arteries before an intervention were included in the study. Total vessel, lumen and plaque + media areas were measured at target lesion, and distal and proximal references. Remodeling index was calculated as target total vessel area/proximal reference total vessel area, and categorized into 3 groups based on relative total vessel-area ratio: (1) >1.1 (group A, adequate remodeling); (2) 0.9 to 1.1 (group B, failure of compensatory enlargement); and (3)

Objective: To evaluate the 5-year clinical outcomes of patients treated with the Endeavor zotarolimus-eluting stent (ZES) in the ENDEAVOR I first-in-human study. Background: ENDEAVOR I was a prospective, nonrandomized, multicenter study of the Endeavor ZES in 100 consecutive patients with symptomatic coronary artery disease (CAD) due to de novo, stenotic lesions in native coronary arteries. Methods: Patients with single or multivessel CAD were eligible to participate, but only one lesion per patient was treated. The lesion had to have ≥50% stenosis, be ≤15 mm in length, and located in a vessel with a reference diameter of 3.0–3.5 mm. Major adverse cardiac events (MACE), target lesion revascularization (TLR), target vessel failure (TVF), and stent thrombosis were evaluated 5 years after stent implantation. Results: The cumulative incidence of MACE was 2.0% at 1 year, 3.0% at 2 years, 6.1% at 3 years, 7.2% at 4 years, and 7.2% at 5 years. At 5 years, there were seven patients who had eight events; four noncardiac (cancer) deaths, three cases of TLR, of which one presented as a non-Q-wave MI because of a stent thrombosis at 10 days after the index procedure. There were no late or very late stent thromboses by any definition. TVF at 5 years was 5.2%. Conclusions: Use of the Endeavor ZES to treat symptomatic CAD due to de novo lesions in native coronary arteries resulted in sustained clinical benefits to 5 years, with low rates of MACE, TLR, TVF, and stent thrombosis. © 2009 Wiley-Liss, Inc.

The Endeavor I study was the first clinical study evaluating the safety and feasibility of the Endeavor stent system in the treatment of symptomatic coronary artery disease. The Endeavor Stent System comprises a new cytostatic, antiproliferative and immunosuppressive agent in the same class of drugs as sirolimus, (ABT-578), a phosphorylcholine polymer-based coating, and an established cobalt-alloy stent with thin struts, (Driver stent).One hundred consecutive patients with symptomatic ischemic heart disease due to de novo, obstructive lesions of native coronary arteries were treated with the Endeavor stent system at eight centers in Australia and New Zealand according to contemporary practice. The acute lesion, procedure, and device-deployment success rates were all 100%. Independent core laboratories analyzed quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) data immediately after stent implantation, and at 4 and 12 month follow-up. At 12 months, in-stent late lumen loss was 0.61+/-0.44 mm; in-segment late lumen loss was 0.43+/-0.44 mm, and neointimal hyperplasia volume was 14.2+/-11.8 mm3 (corresponding to a percent volume obstruction of 9.7%+/-8.5%). By QCA and IVUS, the pattern of neointimal hyperplasia was greatest within stent and not at the stent edges. The binary angiographic restenosis rate (defined as50% diameter stenosis) at 4 and 12 months was 2.1% (2/97) and 5.4% (5/93) respectively. The cumulative incidence of major adverse cardiac events (MACE, defined as death, myocardial infarction, emergent cardiac surgery or repeat revascularization of the index lesion), was 1% at 30 days and 2% at 4 and 12 months.This 100 patient pilot study demonstrates that the Endeavor stent system is a reliable and safe treatment for obstructive coronary disease, providing durable event free clinical outcomes to 12 months by suppression of neointimal proliferation of the target lesion. The results support further pivotal evaluation in larger randomized clinical trials.

The aim of this study was to determine the safety and efficacy of a novel pimecrolimus-eluting stent in a porcine coronary model and in a phase I clinical trial.Rapamycin- and paclitaxel-eluting stents reduce the need for repeat intervention by limiting neointimal hyperplasia but might cause delayed healing, pre-disposing patients to late stent thrombosis. Because inflammation plays a key role in restenosis, pimecrolimus, an anti-inflammatory drug, might reduce restenosis without adversely affecting re-endothelialization.We evaluated a novel polymeric pimecrolimus-eluting stent covered with a thin parylene C diffusion barrier in a porcine coronary model and in a phase I human clinical trial. The clinical study was a prospective, nonrandomized, first-in-human hypothesis-generating study that enrolled 15 patients who had a single de novo native coronary stenosis.At 28 days and 3 months in the porcine model, histopathologic indicators predicted safety and biocompatibility when stents coated with polymer only, drug only, and 2 drug-polymer formulations were compared with bare-metal stents (BMS). In the phase I clinical trial, 15 patients had successful implantation of pimecrolimus-eluting stents. By 6 months, no patient suffered death, myocardial infarction, or stent thrombosis. However, the angiographic restenosis (61%), mean late loss (1.44 mm), and repeat target lesion revascularization (53%) were significantly higher than historical BMS controls. Whereas the primary end point was percent volume obstruction, restenosis was so severe that operators performed intravascular ultrasound examination in only 6 patients.Pimecrolimus-eluting stents induced an exaggerated neointimal hyperplasia at 6 months in comparison with historical controls.

A dedicated bifurcation stent has the potential to simplify and improve the outcomes of percutaneous coronary bifurcation intervention. We report a patient from the first human use trial of a novel paclitaxel-eluting dedicated bifurcation stent. By 6 months, there were no adverse events and the stent lumen and, in particular, the side-branch ostium were widely patent on angiography and intravascular ultrasound. This device may offer superior results without the limitations of conventional stent techniques in the treatment of coronary bifurcation disease. © 2008 Wiley-Liss, Inc.

This study evaluated the antiplatelet effect of a higher loading and maintenance dose regimen of clopidogrel and a possible drug interaction with verapamil.Clopidogrel loading doses above 600 mg have not resulted in more rapid or complete platelet inhibition. Higher maintenance dosages may be more effective than 75 mg/day.A double-blind, randomized, placebo-controlled trial was undertaken in 60 patients undergoing percutaneous coronary intervention. All patients received clopidogrel 600 mg at the start of the procedure. Using a 2 x 2 design, patients were allocated to clopidogrel 600 mg given 2 h later or matching placebo, and to verapamil 5 mg intra-arterial or placebo. Platelet function was measured using the VerifyNow P2Y12 analyzer (Accumetrics Ltd., San Diego, California) at 2, 4, and 7 h. Patients were further randomized to receive a clopidogrel 75 or 150 mg once daily, with platelet function assessed after 1 week.Two hours after the second dose of clopidogrel or placebo, platelet inhibition was 42 +/- 27% with clopidogrel, compared with 24 +/- 22% with placebo (p = 0.0006). By 5 h after the second dose, platelet inhibition was 49 +/- 30% with clopidogrel, compared with 29 +/- 22% with placebo (p = 0.01). No drug interaction was seen with verapamil. A clopidogrel maintenance dosage of 150 mg daily for 1 week resulted in greater platelet inhibition than 75 mg daily (50 +/- 28% vs. 29 +/- 19%, p = 0.01).In an unselected population undergoing percutaneous coronary intervention a clopidogrel 1,200-mg loading dose, given as two 600-mg doses 2 h apart, results in more rapid and complete platelet inhibition than a single 600-mg dose. A maintenance dosage of 150 mg daily produces greater platelet inhibition than 75 mg daily. (The PRINC trial; ACTRN12606000129583).

To investigate if increased thrombotic events occurred after cessation of a 2-week course of clopidogrel treatment in patients who had implantation of bare metal stent.Dunedin Public Hospital, a tertiary referral centre in New Zealand.1000 consecutive patients undergoing percutaneous coronary intervention (PCI) with stent implantation from January 2000 to October 2003 were analysed. Those who had successful implantation of bare metal stent without clinical events in the first 24 hours and who received 2 weeks of clopidogrel treatment were included in the study (n=983).Stent thromboses between 24 hours and 6 weeks post PCI.There were 13 (1.3%) stent thromboses between 24 hours and 6 weeks post PCI, resulting in 3 deaths (23%), 2 ST-elevation acute coronary syndrome [ACS] (15%), and 8 non-ST elevation ACS (62%). The median time for stent thrombosis was 18 +/-s 14 days. Five of the 13 cases (38%) of stent thrombosis occurred after the first 2-weeks (1 in week 3, 1 in week 5, 3 in week 6), and all had predisposing factors for stent thrombosis (2 with stent lengthor = to 30 mm, 3 with stent diameteror = to 2.5mm and 2 with bifurcation stenting).Five of 13 (38%) stent thromboses occurred in week 3 to week 6 after cessation of a 2-week course of clopidogrel post bare metal stenting.

A case of late thrombosis of a sirolimus-eluting stent, 16 months after implantation, is described. Two weeks prior to presentation with stent thrombosis the patient had a 50% dose increase of longterm erythropoietin. The prothrombotic effect of erythropoietin may have precipitated the thrombotic event.

The aim of the study was to determine the safety and efficacy of a novel femoral artery closure device (StarClose, Abbott Vascular Devices, Redwood City, CA) following percutaneous coronary intervention employing aspirin, heparin, and glycoprotein (GP) IIb/IIIa inhibition. A prospective nonrandomized single-center pilot study of the StarClose device included a subset of patients undergoing percutaneous coronary intervention utilizing GP IIb/IIIa inhibitors. Those that fulfilled the inclusion criteria (age < 80, no periprocedural haematoma, puncture above the superficial femoral and profunda femoralis artery bifurcation, no significant femoral artery disease) underwent closure of the femoral artery puncture site with a StarClose device immediately on completion of the procedure. Time to hemostasis (TTH), bleeding, mobilization, and short-term clinical follow-up data were collected, and an ultrasound scan of the femoral artery was performed 2 weeks later. Twenty-five patients were recruited, of whom 23 underwent percutaneous coronary intervention (PCI). Their mean age was 58 ± 12 years, 84% were male, and 63% had unstable angina. All were on aspirin 100–150 mg daily and all PCI patients received i.v. heparin 4–10,000 units at commencement of the procedure and clopidogrel 600 mg on completion. Two patients were on a tirofiban infusion and 23 received a double bolus of eptifibatide, each 0.18 mg/kg, separated by 10 min. The procedural success was 100% and device success 23/25 (92%), with 1 failure due to technical error. The median device delivery time was 36 sec (range, 11–178) and median TTH 37 sec (range, 10–509 sec). There were no major adverse events. In 10 patients, a moderate amount of tract ooze required a short period of adjunctive manual compression. Follow-up ultrasound femoral artery scans revealed no compromise of the vessel lumen. Femoral artery closure with the device following coronary angiography and intervention using glycoprotein IIb/IIIa receptor inhibitors is safe and effective. A randomized trial of a larger number of patients is warranted. © 2005 Wiley-Liss, Inc.

Sirolimus-eluting stents appear to reduce substantially restenosis following percutaneous coronary bifurcation intervention. The crush technique was devised to reduce restenosis further by improving stent and drug application to the side-branch ostium. We aimed to investigate the performance of drug-eluting stent (DES) platforms with the crush technique, to identify deployment pitfalls, and to clarify the best deployment strategies. Each stage of the crush technique was photographed in a bifurcation phantom. Simultaneous side- and main-branch dilatation (kissing balloons) fully expanded the stent in the side-branch ostium, widened the gaps between stent struts covering the side branch, and eliminated main-branch distortion. With side branches angled at > 70 degrees , sequential (side- then main-branch) inflations may be needed to achieve best results. Postdilatation of the main branch with a balloon of narrower diameter than the deploying balloon caused main-branch stent distortion. These principles applied to all the bifurcation strategies and stent designs tested.

Spontaneous coronary artery dissection is a rare cause of myocardial ischemia or sudden cardiac death. We describe a patient with polycythemia vera and a chronic spontaneous coronary artery dissection who was treated with successful angioplasty and long stenting.

Background:Home based cardiac rehabilitation (CR) is an evidenced based intervention that provides further choice of CR interventions for patients after a cardiac event. Te Hononga O Tamaki Me Hoturoa is a kaupapa Maori non-government organisation that has been delivering home based CR for the past six years. Methods: Patients are referred from the Middlemore Hospital CR team following ACS, coronary intervention or valvular surgery and the nurse led team provide a structured level of home based CR based on the Heart Guide Aotearoa program within a whanau ora/holistic model. This includes access to experienced cardiac nurses, community health worker support and health psychologists review. Data is collected in a local data base and in the Anzac-QI system. Results: Between 1/1/13 and 1/1/14, 206 patients were referred, and 182 patients had full referral data available for analysis. The majority were male (53%), median age 66 years (IQR 57-76) and ethnicity was non-European/others 44%, Maori 25%, Pacific 19%, Indian 10%, and Asian 2%. 38% had type 2 diabetes, median HbA1c 7.5 (IQR 6.5-8.9), median BMI was 28.1 (IQR 25-32.7). and 19% were current smokers, 156 (83%)were able to be contacted and participated in the program. There was no statistical demographic difference between engaged and non-engaged patients. Conclusion: The program continues to provide a viable alternative for patients wanting a structured and in home approach to secondary prevention following a cardiac event. More work is needed to increase referrals, simplify data collection and to add a focus on outcome measures.

OBJECTIVES The study systematically compared different measures of ST segment depression from the treadmill exercise test. BACKGROUND The value of the treadmill exercise test for objectively measuring treatment effects is limited by random error in the measurement of ST depression and may be biased by regression to the mean or by the decision to terminate the test. METHODS Treadmill exercise was performed in 21 subjects with ischemic heart disease 1 h after isosorbide dinitrate 10 mg or placebo in a double-blind randomized crossover study. A 12-lead electrocardiogram (ECG) was recorded every 30 s during and at peak exercise. The relative sample size needed to detect the nitrate effect was compared for different summary measures of ST depression. RESULTS The ST depression measured from a single unmatched lead at longest equivalent sub-maximal exercise needed the lowest sample size to detect the nitrate effect in paired comparisons (p = 0.000006). Averaging over multiple leads or times did not improve detection of the nitrate effect. The rate of increase in ST depression (in mm/min) calculated by linear regression needed a similar sample size (×1.32, 95% CI 0.62 to 2.58). A larger sample size was needed for ST depression at peak exercise (×2.9, CI 1.3, 11.1) and exercise duration (×4.5, CI 1.5, 38). Time to 1-mm ST depression was the least efficient measurement (relative sample size ×15.5, CI 1.6, >1000). Comparison of matched leads resulted in >2-fold differences in estimates of the nitrate effect because of bias from regression to the mean. CONCLUSIONS Maximal ST depression at longest equivalent sub-maximal exercise and the maximal rate of increase in ST depression had less bias and random variation than did other commonly used measures. The rate of increase in ST depression is preferred because it can be calculated in either paired or unpaired studies.