Michele Roesle

A Randomized Controlled Trial of a Paclitaxel-Eluting Stent Versus a Similar Bare-Metal Stent in Saphenous Vein Graft Lesions: The SOS (Stenting Of Saphenous Vein Grafts) Trial

OBJECTIVES The aim of this study was to compare the frequency of angiographic restenosis and clinical events between a paclitaxel-eluting stent (PES) and a similar bare-metal stent (BMS) in saphenous vein graft (SVG) lesions. BACKGROUND There are conflicting and mostly retrospective data on outcomes after drug-eluting stent implantation in SVGs. METHODS Patients requiring SVG lesion stenting were randomized to BMS or PES. The primary study end point was binary in-segment restenosis at 12-month follow-up quantitative coronary angiography. Secondary end points included death, myocardial infarction, ischemia-driven target vessel and lesion revascularization, and target vessel failure. RESULTS Eighty patients with 112 lesions in 88 SVGs were randomized to a BMS (39 patients, 43 grafts, 55 lesions) or PES (41 patients, 45 grafts, 57 lesions). Binary angiographic restenosis occurred in 51% of the BMS-treated lesions versus 9% of the PES-treated lesions (relative risk: 0.18; 95% confidence interval [CI]: 0.07 to 0.48, p < 0.0001). During a median follow-up of 1.5 years the PES patients had less target lesion revascularization (28% vs. 5%, hazard ratio: 0.38; 95% CI: 0.15 to 0.74, p = 0.003) and target vessel failure (46% vs. 22%, hazard ratio: 0.65; 95% CI: 0.42 to 0.96, p = 0.03), a trend toward less target vessel revascularization (31% vs. 15%, hazard ratio: 0.66; 95% CI: 0.39 to 1.05, p = 0.08) and myocardial infarction (31% vs. 15%, hazard ratio: 0.67; 95% CI: 0.40 to 1.08, p = 0.10), and similar mortality (5% vs. 12%, hazard ratio: 1.56; 95% CI: 0.72 to 4.11, p = 0.27). CONCLUSIONS In SVG lesions, PES are associated with lower rates of angiographic restenosis and target vessel failure than BMS.

Meta-analysis of clinical outcomes of patients who underwent percutaneous coronary interventions for chronic total occlusions

Successful percutaneous coronary intervention (PCI) for chronic total occlusions (CTOs) has been associated with clinical benefit. There are no randomized controlled trials on long-term clinical outcomes after CTO PCI, limiting the available evidence to observational cohort studies. We sought to perform a weighted meta-analysis of the long-term outcomes of successful versus failed CTO PCI. A total of 25 studies, published from 1990 to 2014, with 28,486 patients (29,315 CTO PCI procedures) were included. We analyzed data on mortality, subsequent coronary artery bypass grafting (CABG), myocardial infarction, major adverse cardiac events, angina pectoris, stroke, and target vessel revascularization using random-effects models. Procedural success was 71% (range 51% to 87%). During a weighted mean follow-up of 3.11 years, compared with unsuccessful, successful CTO PCI was associated with lower mortality (odds ratio [OR] 0.52, 95% confidence interval [CI] 0.43 to 0.63), less residual angina (OR 0.38, 95% CI 0.24 to 0.60), lower risk for stroke (OR 0.72, 95% CI 0.60 to 0.88), less need for subsequent coronary artery bypass grafting (OR 0.18, 95% CI 0.14 to 0.22), and lower risk for major adverse cardiac events (0.59, 95% CI 0.44 to 0.79). There was no difference in the incidence of target vessel revascularization (OR 0.66, 95% CI 0.36 to 1.23) or myocardial infarction (OR 0.73, 95% CI 0.52 to 1.03). Outcomes were similar in patients who underwent balloon angioplasty only or stenting with bare metal or drug-eluting stents. Compared with failed procedures, successful CTO PCIs are associated with a lower risk of death, stroke, and coronary artery bypass grafting and less recurrent angina pectoris.

Continued Benefit From Paclitaxel-Eluting Compared With Bare-Metal Stent Implantation in Saphenous Vein Graft Lesions During Long-Term Follow-Up of the SOS (Stenting of Saphenous Vein Grafts) Trial

OBJECTIVES This study sought to report the long-term outcomes after drug-eluting stent (DES) implantation in saphenous vein graft (SVG) lesions in the SOS (Stenting of Saphenous Vein Grafts) trial. BACKGROUND The long-term outcomes after DES implantation in SVGs are poorly studied. Apart from the SOS trial, the only other randomized trial comparing DES with bare-metal stents (BMS) in SVGs reported higher mortality in the DES group at 32 months. METHODS In the SOS trial, 80 patients with 112 lesions in 88 SVGs were randomized to a BMS or paclitaxel-eluting stent (PES) and demonstrated improved short-term angiographic and clinical outcomes with PES. Extended clinical follow-up was subsequently obtained. RESULTS Mean age was 67 ± 9 years, and all patients were men. The indications for stenting included acute coronary syndrome in 60% and stable angina in 31% of patients. The mean SVG age was 12 ± 6 years. The baseline characteristics of the patients in the 2 study groups were similar. Procedural success was achieved in 77 patients (96%). During a median follow-up of 35 months, compared with patients randomized to BMS, those receiving PES had a lower incidence of myocardial infarction (hazard ratio [HR]: 0.32, p = 0.01), target lesion revascularization (HR: 0.20, p = 0.004), target vessel revascularization (HR: 0.41, p = 0.03), and target vessel failure (HR: 0.34, p = 0.001) as well as a trend toward less definite or probable stent thrombosis (HR: 0.15, p = 0.08). All-cause mortality (HR: 2.04, p = 0.19) and cardiac mortality (HR: 0.62, p = 0.51) did not differ between groups. CONCLUSIONS During long-term follow-up, use of PES was associated with significantly better clinical outcomes than BMS in SVG lesions. (Stenting of Saphenous Vein Grafts Trial [SOS]; NCT00247208).

Prevalence and management of coronary chronic total occlusions in a tertiary veterans affairs hospital

We sought to determine the contemporary prevalence and management of coronary chronic total occlusions (CTO) in a veteran population.

Angiographic success and procedural complications in patients undergoing retrograde percutaneous coronary chronic total occlusion interventions: A weighted meta-analysis of 3482 patients from 26 studies

BACKGROUND The efficacy and safety profile of retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. We sought to perform a weighted meta-analysis of the success and complication rates of retrograde CTO PCI. METHODS We conducted a meta-analysis of 26 studies published between 2006 and April 2013 reporting in-hospital outcomes of retrograde CTO PCI. Data on procedural success, frequency of death, emergent coronary artery bypass graft surgery (CABG), stroke, myocardial infarction (MI), perforation, tamponade, stent thrombosis, major vascular or bleeding events, contrast nephropathy, and radiation skin injury were collected. RESULTS A total of 26 studies with 3482 patients and 3493 target CTO lesions were included. Primary retrograde CTO PCI was attempted in 52.4%. Pooled estimates of outcomes were as follows: procedural success 83.3% [95% confidence interval (CI): 79.0% to 87.7%]; death 0.7% (95% CI: 0.5% to 1.2%); urgent CABG 0.7% (95% CI: 0.4% to 1.2%); tamponade 1.4% (95% CI: 1.0% to 2.2%); collateral perforation 6.9% (95% CI: 4.6% to 10.4%); coronary perforation 4.3% (95% CI: 1.2% to 15.4%); donor vessel dissection 2% (95% CI: 0.9% to 4.5%); stroke 0.5% (95% CI: 0.2% to 1.0%); MI 3.1% (95% CI: 0.2% to 5.0%); Q wave MI 0.6% (95% CI: 0.4% to 1.1%); vascular access complications 2% (95% CI: 0.9% to 4.5%); contrast nephropathy 1.8% (95% CI: 0.8% to 3.7%); and wire fracture and equipment entrapment 1.2% (95% CI: 0.6% to 2.5%). CONCLUSIONS Retrograde CTO PCI is associated with high procedural success rate and acceptable risk for procedural complications.

Outcomes With the Use of the Retrograde Approach for Coronary Chronic Total Occlusion Interventions in a Contemporary Multicenter US Registry

Background—We sought to examine the efficacy and safety of chronic total occlusion percutaneous coronary intervention using the retrograde approach. Methods and Results—We compared the outcomes of the retrograde versus antegrade-only approach to chronic total occlusion percutaneous coronary intervention among 1301 procedures performed at 11 experienced US centers between 2012 and 2015. The mean age was 65.5±10 years, and 84% of the patients were men with a high prevalence of diabetes mellitus (45%) and previous coronary artery bypass graft surgery (34%). Overall technical and procedural success rates were 90% and 89%, respectively, and in-hospital major adverse cardiovascular events occurred in 31 patients (2.4%). The retrograde approach was used in 539 cases (41%), either as the initial strategy (46%) or after a failed antegrade attempt (54%). When compared with antegrade-only cases, retrograde cases were significantly more complex, both clinically (previous coronary artery bypass graft surgery prevalence, 48% versus 24%; P<0.001) and angiographically (mean Japan-chronic total occlusion score, 3.1±1.0 versus 2.1±1.2; P<0.001) and had lower technical success (85% versus 94%; P<0.001) and higher major adverse cardiovascular events (4.3% versus 1.1%; P<0.001) rates. On multivariable analysis, the presence of suitable collaterals, no smoking, no previous coronary artery bypass graft surgery, and left anterior descending artery target vessel were independently associated with technical success using the retrograde approach. Conclusions—The retrograde approach is commonly used in contemporary chronic total occlusion percutaneous coronary intervention, especially among more challenging lesions and patients. Although associated with lower success and higher major adverse cardiovascular event rates in comparison to antegrade-only crossing, retrograde percutaneous coronary intervention remains critical for achieving overall high success rates.

Clinical Presentation and Angiographic Characteristics of Saphenous Vein Graft Failure After Stenting: Insights From the SOS (Stenting Of Saphenous Vein Grafts) Trial

OBJECTIVES We sought to compare the clinical presentation and angiographic patterns of saphenous vein graft (SVG) failure after stenting with a paclitaxel-eluting stent (PES) versus a similar bare-metal stent (BMS). BACKGROUND The mode of SVG failure after stenting has been poorly characterized. METHODS The SOS (Stenting Of Saphenous Vein Grafts) trial enrolled 80 patients with 112 lesions in 88 SVGs who were randomized to a BMS or PES. Angiographic follow-up at 12 months was available in 83% of the patients. RESULTS Binary angiographic restenosis occurred in 51% (24 of 47) of BMS-treated lesions versus 9% (4 of 43) of PES-treated lesions (p < 0.0001). Graft occlusion occurred in 9 of the 21 SVGs (43%) that failed in the BMS group and in 2 of 4 SVGs (50%) that failed in the PES group. SVG failure after stenting presented as an acute coronary syndrome in 10 of the 24 patients (42%) (7 of those 10 patients presented with non-ST-segment elevation acute myocardial infarction), stable angina in 9 (37%) patients, and without symptoms in 5 (21%) patients. Of the 19 patients (with 20 grafts) who developed symptomatic graft failure, repeat SVG revascularization was successfully performed in all 13 (100%) subtotally obstructed SVGs but was attempted (and successful) in only 1 of 7 (14%) occluded SVGs. Revascularization of a native coronary artery was performed in an additional 4 of 7 (57%) symptomatic patients with an occluded SVG. CONCLUSIONS SVG failure after stenting often presents as acute myocardial infarction and with SVG occlusion. Compared with BMS, PES reduce SVG failure.

Prior coronary artery bypass graft surgery patients undergoing diagnostic coronary angiography have multiple uncontrolled coronary artery disease risk factors and high risk for cardiovascular events

Limited contemporary data exist on the cardiovascular risk of patients with prior coronary artery bypass grafting surgery (CABG) requiring diagnostic coronary angiography. We examined the prevalence and control of coronary artery disease risk factors and the outcomes of 367 prior CABG patients who underwent diagnostic coronary angiography between October 1, 2004 and May 31, 2007 at the Dallas Veterans Affairs Medical Center. Mean age was 65 ± 9 years, 97% were men, and the mean time from CABG to diagnostic angiography was 8.2 ± 6.1 years. Hypertension, low-density lipoprotein cholesterol, diabetes mellitus, smoking, and obesity were suboptimally controlled in 70%, 59%, 47%, 33%, and 50%, respectively. Intake of statins and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers was 88% and 81%, respectively. After a mean follow-up of 1.4 ± 0.8 years, the incidence of death and major cardiovascular events was 10% and 32%, respectively. In spite of significant improvement compared to previous studies and good compliance with indicated medications, contemporary prior CABG patients undergoing coronary angiography still have multiple and poorly controlled coronary artery disease risk factors and high risk for cardiovascular events. Novel pharmacologic and behavioral treatment strategies are needed.

Reproducibility of intravascular ultrasound virtual histology analysis

OBJECTIVE Intravascular ultrasound with virtual histology analysis (IVUS-VH) is a novel technology which allows for the identification of discrete atherosclerotic plaque components using radiofrequency backscatter data. Whether the composition of these plaques can be monitored accurately in a longitudinal fashion remains unclear. We sought to evaluate the reproducibility of plaque composition measurements as determined by IVUS-VH in a clinical setting. METHODS Sixteen consecutive patients who underwent percutaneous coronary intervention were included in this study. Prior to and then again following intervention, IVUS images with VH processing were obtained with motorized pullback. Up to 4 frames were selected for analysis for each patient, with a total of 24 IVUS frames used. An IVUS frame was chosen with visible angiographic and ultrasound landmarks. The matching frame on the second pullback was identified using these landmarks. For each frame, vessel and lumen area as well as plaque composition by VH were determined. RESULTS There was a high level of agreement between the two pullback measurements for lumen area, vessel area, and plaque burden (the Spearman rank-order correlation coefficients were 0.96, 0.96, and 0.95, respectively). Similarly, for plaque components by VH, the coefficients ranged from .90 to .97 and 0.84 to 0.92 for segmental volumetric analysis. The Bland-Altman plots indicated proportional error for the differences of the four measurements between the two pullback trials and were associated with high coefficients of reproducibility. CONCLUSIONS Discrete measurements of plaque compositional area and volume in the clinical setting appear to have reproducibility comparable to that of traditional IVUS measurements.

Optimizing Radiation Safety in the Cardiac Catheterization Laboratory: A Practical Approach.

Reducing radiation exposure during cardiovascular catheterization is of paramount importance for both patient and staff safety. Over the years, advances in equipment and application of radiation safety protocols have significantly reduced patient dose and operator exposure. This review examines the current status of radiation protection in the cardiac and vascular catheterization laboratory and summarizes best practices for minimizing radiation exposure.