The IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact (IMPROVE) trial: Study design and rationale.

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent major adverse cardiovascular events after PCI. However, IVUS utilization remains low. An increasing number of high-risk or complex coronary artery lesions are treated with PCI, and we hypothesize that the impact of IVUS in guiding treatment of these complex lesions will be of increased importance in reducing major adverse cardiovascular events while remaining cost-effective. The "IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact" trial (registered on clinicaltrials.gov: NCT04221815) is a multicenter, international, clinical trial randomizing subjects to IVUS-guided versus angiography-guided PCI in a 1:1 ratio. Patients undergoing PCI involving a complex lesion are eligible for enrollment. Complex lesion is defined as involving at least 1 of the following characteristics: chronic total occlusion, in-stent restenosis, severe coronary artery calcification, long lesion (≥28 mm), or bifurcation lesion. The clinical investigation will be conducted at approximately 120 centers in North America and Europe, enrolling approximately 2,500 to 3,100 randomized subjects with an adaptive design. The primary clinical end point is the rate of target vessel failure at 12 months, defined as the composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. The co-primary imaging end point is the final post-PCI minimum stent area assessed by IVUS. The primary objective of this study is to assess the impact of IVUS guidance on the PCI treatment of complex lesions.

Interventional Management of Unprotected Left Main Coronary Artery Disease: Patient Selection and Technique Optimization.

For many years, coronary artery bypass graft surgery has been the gold standard for revascularization of patients with left main disease; however, increasing evidence suggests that percutaneous coronary intervention with drug-eluting stents may be an acceptable alternative or even preferred in select cases. This review will present clinical evidence examining the outcomes of drug-eluting stents compared to coronary artery bypass graft surgery for unprotected left main coronary artery disease and discuss the anatomic factors, patient variables, and clinical strategies that may dictate choice of revascularization modality for patients with left main disease. If percutaneous coronary intervention is selected to treat unprotected left main disease, meticulous technique is essential to optimize outcomes, including use of procedural physiology and imaging guidance, optimal stent and adjunct pharmacology use, and expert management of the distal bifurcation. Finally, issues of equipoise and uncertainty are identified, representing areas for future investigation.

ACCF/SCCT/ACR/AHA/ASE/ASNC/NASCI/SCAI/SCMR 2010 Appropriate Use Criteria for Cardiac Computed Tomography. A Report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, the Society of Cardiovascular Computed Tomography, the American College of Radiology, the American Heart Association, the American Society of Echocardiography, the American Society of Nuclear Cardiology, the North American Society for Cardiovascular Imaging, the Society for Cardiovascular Angiography and Interventions, and the Society for Cardiovascular Magnetic Resonance.

The American College of Cardiology Foundation, along with key specialty and subspecialty societies, conducted an appropriate use review of common clinical scenarios where cardiac computed tomography (CCT) is frequently considered. The present document is an update to the original CCT/cardiac magnetic resonance appropriateness criteria published in 2006, written to reflect changes in test utilization, to incorporate new clinical data, and to clarify CCT use where omissions or lack of clarity existed in the original criteria. The indications for this review were drawn from common applications or anticipated uses, as well as from current clinical practice guidelines. Ninety-three clinical scenarios were developed by a writing group and scored by a separate technical panel on a scale of 1 to 9 to designate appropriate use, inappropriate use, or uncertain use. In general, use of CCT angiography for diagnosis and risk assessment in patients with low or intermediate risk or pretest probability for coronary artery disease was viewed favorably, whereas testing in high-risk patients, routine repeat testing, and general screening in certain clinical scenarios were viewed less favorably. Use of noncontrast computed tomography for calcium scoring was rated as appropriate within intermediate- and selected low-risk patients. Appropriate applications of CCT are also within the category of cardiac structural and functional evaluation. It is anticipated that these results will have an impact on physician decision making, performance, and reimbursement policy, and that they will help guide future research.

The side branch ostium: understanding the Achilles heel of treating bifurcation coronary disease.

Angioplasty of lesions involving a bifurcation remains one of the most challenging lesion subsets in the field of coronary intervention. A general approach to dealing with bifurcation lesions is to avoid intervention of the side branch (SB) if possible. Angiographic or flow criteria are used to determine SB intervention; however, angiographic evaluation alone can be inaccurate. Performing intravascular ultrasound prior to intervention is a useful strategy. This aids the interventional cardiologist in determining whether main branch stenting alone is sufficient or if stenting of the SB is also warranted.

Coronary circulation responses to binodenoson, a selective adenosine A2A receptor agonist.

The purpose of this study was to define binodenoson dosing regimens that produce coronary hyperemia comparable to those of adenosine and that are tolerated well by patients. An open-label, randomized, parallel-group, multicenter study enrolled adult patients who had completed diagnostic cardiac catheterization. Coronary blood flow velocity (CBFV) was measured with a Doppler flow wire, and CBFV reserve was determined before binodenoson administration. Patients (n = 133) received a 3-minute infusion of 0.3, 0.5, or 1 microg/kg/min or a bolus intravenous injection of 1.5 or 3 microg/kg. Coronary hyperemic responses were evident within seconds of administering binodenoson, and the magnitudes and durations of coronary hyperemic responses were dose related. The 1.5- and 3-microg/kg doses, by infusion or bolus, produced maximal coronary hyperemia equivalent to CBFV reserve. All doses transiently decrease blood pressure and increased heart rate and rate-pressure product. In conclusion, the 1.5-microg/kg binodenoson bolus dose produced nearly maximal coronary hyperemia by 4.5 +/- 3.7 minutes that was sustained for 7.4 +/- 6.86 minutes, was accompanied by modest changes in blood pressure, heart rate, and rate-pressure product, and produced no adverse changes on electrocardiogram, including no second- or third-degree atrioventricular block.

Women do have an improved long-term outcome after non-ST-elevation acute coronary syndromes treated very early and predominantly with percutaneous coronary intervention: a prospective study in 1,450 consecutive patients.

OBJECTIVES: This study sought to assess gender-based differences in long-term outcome after very early aggressive revascularization for non-ST-elevation acute coronary syndromes (NSTACS). BACKGROUND: The Fragmin and fast Revascularization during InStability in Coronary artery disease (FRISC) II study suggested that women have less to gain from an early invasive strategy. METHODS: We conducted a prospective cohort study in 1,450 consecutive patients with NSTACS undergoing coronary angiography and subsequent coronary stenting of the culprit lesion as the primary revascularization strategy within 24 h of admission. The combined primary end point was defined as death or nonfatal myocardial infarction (MI) and recorded for a mean of 20 months. RESULTS: Percutaneous coronary intervention was performed in more than 50% of patients in women and men and accompanied with stenting in 80%. The percutaneous coronary intervention:coronary artery bypass grafting ratio was 4:1 in men and 5:1 in women. The primary end point occurred in 29 (7.0%) women as compared with 108 (10.5%) men (hazard ratio for women, 0.65; 95% confidence interval [CI] 0.42 to 0.99; p = 0.045). Backward-stepwise multivariate Cox regression analysis identified female gender as an independent predictor of death or MI (hazard ratio for female gender, 0.51; 95% CI, 0.28 to 0.92; p = 0.024). Kaplan-Meier analysis showed that women had consistently lower event rates during the entire follow-up period (p = 0.037 by log-rank for death or MI). CONCLUSIONS: Women treated with very early aggressive revascularization with coronary stenting of the culprit lesion as the primary revascularization strategy have a better long-term outcome as compared with men.

Operator experience and long term outcome after percutaneous coronary intervention.

OBJECTIVES: To investigate the impact of operator experience on long term outcome of patients undergoing percutaneous coronary intervention (PCI). METHODS: Two hundred and fifty consecutive patients with 334 lesions undergoing elective PCI by three highly experienced (greater than 600 PCI, mean 1100) and three less experienced (fewer than 400 PCI, mean 250) high volume operators at a single tertiary care centre were prospectively studied. Quantitative assessment of the six-month angiography was possible in 273 lesions (82%). Clinical follow-up at 24 months was complete in all patients. RESULTS: Baseline characteristics of the 159 lesions treated by the highly experienced operators were comparable with the 175 lesions treated by the less experienced operators. Six months following PCI, the minimal lumen diameter at the lesion site was similar for both more experienced and less experienced operators (1.68+/-0.95 mm versus 1.63+/-0.89 mm, P=0.66), as was net lumen gain (0.97+/-1.02 mm versus 0.98+/-0.93 mm, P=0.96) and the rate of restenosis (33% versus 32%, P=0.87). By multivariate analysis, lower operator experience was not a predictor of restenosis (odds ratio 0.97, 95% CI 0.75 to 1.25, P=0.81). In addition, 24-month clinical follow-up did not reveal any relevant difference in the combined end point of death, myocardial infarction or clinically driven revascularization between more experienced (29 events in 116 patients) and less experienced operators (35 events in 134 patients; 25% versus 26%, P=0.84). CONCLUSIONS: Less experienced high volume operators seem to achieve similar long term results as more experienced high volume operators.

Door-to-balloon times under 90 min can be routinely achieved for patients transferred for ST-segment elevation myocardial infarction percutaneous coronary intervention in a rural setting.

OBJECTIVES: The purpose of this study was to demonstrate the feasibility of routine transfer of ST-segment elevation myocardial infarction (STEMI) patients to achieve percutaneous coronary intervention (PCI) in less than 90 min from presentation. BACKGROUND: Many PCI hospitals have achieved routine door-to-balloon times under 90 min for patients with STEMI presenting directly to the hospital. However, few patients transferred from a non-PCI center undergo PCI within 90 min of presentation. METHODS: Our rural PCI hospital implemented a program in 2005 for rapid triage, transfer, and treatment of STEMI patients and made additional improvements in 2006 and 2007. Intervals between milestones in the STEMI triage/transfer/treatment process were assessed before and after implementation of the program. RESULTS: During the 5-year study period, 676 patients with 687 STEMIs were transferred from 19 community hospitals and underwent PCI. Median door-to-balloon time decreased from 189 min to 88 min (p < 0.001). The time intervals reflecting efficiency of the referring hospitals, transfer services, and PCI hospital all significantly improved. In 2008, median door-to-balloon times were <90 min for 6 of the 7 most frequently referring hospitals. Delays during off-hours presentation in 2004 were abolished after the program was implemented in 2005. In-hospital mortality decreased from 6% before to 3% after implementation of the program. In multivariate modeling, presentation before initiation of the STEMI program predicted increased risk of in-hospital mortality (odds ratio: 3.74, 95% confidence interval: 1.22 to 11.51, p = 0.021). CONCLUSIONS: A program of rapid triage, transfer, and treatment of STEMI patients presenting to non-PCI hospitals can reduce in-hospital mortality and produce progressive improvements in door-to-balloon time such that median door-to-balloon times under 90 min are feasible.

ACCF/SCCT/ACR/AHA/ASE/ASNC/NASCI/SCAI/SCMR 2010 Appropriate Use Criteria for Cardiac Computed Tomography. A Report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, the Society of Cardiovascular Computed Tomography, the American College of Radiology, the American Heart Association, the American Society of Echocardiography, the American Society of Nuclear Cardiology, the North American Society for Cardiovascular Imaging, the Society for Cardiovascular Angiography and Interventions, and the Society for Cardiovascular Magnetic Resonance.

The American College of Cardiology Foundation (ACCF), along with key specialty and subspecialty societies, conducted an appropriate use review of common clinical scenarios where cardiac computed tomography (CCT) is frequently considered. The present document is an update to the original CCT/cardiac magnetic resonance (CMR) appropriateness criteria published in 2006, written to reflect changes in test utilization, to incorporate new clinical data, and to clarify CCT use where omissions or lack of clarity existed in the original criteria (1). The indications for this review were drawn from common applications or anticipated uses, as well as from current clinical practice guidelines. Ninety-three clinical scenarios were developed by a writing group and scored by a separate technical panel on a scale of 1 to 9 to designate appropriate use, inappropriate use, or uncertain use. In general, use of CCT angiography for diagnosis and risk assessment in patients with low or intermediate risk or pretest probability for coronary artery disease (CAD) was viewed favorably, whereas testing in high-risk patients, routine repeat testing, and general screening in certain clinical scenarios were viewed less favorably. Use of noncontrast computed tomography (CT) for calcium scoring was rated as appropriate within intermediate- and selected low-risk patients. Appropriate applications of CCT are also within the category of cardiac structural and functional evaluation. It is anticipated that these results will have an impact on physician decision making, performance, and reimbursement policy, and that they will help guide future research.