Telephone-based reminder to improve safety after percutaneous coronary intervention.

Dual antiplatelet therapy (DAPT) is a class I guideline indication after percutaneous coronary intervention (PCI). Our population is high-risk for low medication adherence. With a multidisciplinary team we developed a telephone-based intervention to improve DAPT adherence post-PCI. Patients undergoing PCI at our center were contacted by nursing staff via telephone at 1 week, 30 days, and 60 days post-procedure. Calls included a reminder of the importance of DAPT and elicited any patient concerns. Concerns were relayed to the team who could take appropriate action. For patients filling their medications at any pharmacies within our closed system the proportion of days covered (PDC) was calculated. These were compared to data for patients undergoing PCI in the seven months prior to program initiation. Information on interventions performed as a result of calls was also collected. During the study period, 452 patients underwent PCI. Of these, 70% were contacted and 244 filled their prescription at our system pharmacies. Twelve-month median PDC was 74%, with 45% of patients having PDC > 80%. There was no significant difference when compared to the group prior to the intervention, median PDC 79% and 50% of patients having PDC > 80%. In 26 patients calls led to interventions, removing barriers that would have otherwise prevented continued adherence. A telephone-based reminder system led to directed interventions in nearly 1 in 10 patients contacted. It was not able to significantly improve PDC when compared to a contemporary sample. This highlights the difficulty in using PDC to detect barriers to adherence.

Evidence of Reduced Efferent Renal Sympathetic Innervation After Chemical Renal Denervation in Humans.

BACKGROUND: Renal denervation (RDN) is effective at lowering blood pressure. However, it is unknown if ablative procedures elicit sympathetic denervation of the kidneys in humans. The aim of this investigation was to assess sympathetic innervation of the renal cortex following perivascular chemical RDN, which may be particularly effective at ablating perivascular efferent and afferent nerves. METHODS: Seven hypertensive patients (4F:3M; 50-65 years) completed PET-CT sympathetic neuroimaging of the renal cortex using 11C-methylreboxetine (11C-MRB, norepinephrine transporter ligand) and 6-[18F]-fluorodopamine (18F-FDA; substrate for the cell membrane norepinephrine transporter) before and 8 weeks after chemical RDN (Peregrine System Infusion Catheter, Ablative Solutions; n = 4; 2F:2M) or control renal angiography (n = 3; 2F:1M). Patients completed physiological phenotyping including 24-hour ambulatory blood pressure, hemodynamics, muscle sympathetic nerve activity, and 24-hour urine collection. RESULTS: RDN decreased 11C-MRB-derived radioactivity by ~30% (Δ  11C-MRB/chamber: -0.95 a.u. confidence interval (CI): -1.36 to -0.54, P = 0.0002), indicative of efferent RDN. In contrast, 18F-FDA-derived radioactivity increased (Δ  18F-FDA/chamber: 2.72 a.u. CI: 0.73-4.71, P = 0.009), consistent with reduced vesicular turnover. Controls showed no change in either marker. Ambulatory systolic pressure decreased in 3 of 4 patients (-9 mm Hg CI: -27 to 9, P = 0.058), and central systolic pressure decreased in all patients (-23 mm Hg CI: -51 to 5, P = 0.095). CONCLUSIONS: These results are the first to show efferent sympathetic denervation of the renal cortex following RDN in humans. Further studies of mechanisms underlying variable blood pressure lowering in the setting of documented RDN may provide insights into inconsistencies in clinical trial outcomes. CLINICAL TRIALS REGISTRATION: Trial Number NCT03465917.

Clinical Outcomes and Cost Comparisons of Stent and Non-Stent Interventions in Infrainguinal Peripheral Artery Disease: Insights From the Excellence in Peripheral Artery Disease (XLPAD) Registry.

BACKGROUND: The contemporary limb outcomes and costs of stent-based vs non-stent based strategies in endovascular revascularization of femoropopliteal (FP) peripheral artery disease (PAD) are not well understood. METHODS AND RESULTS: We present data from the ongoing United States multicenter Excellence in Peripheral Artery Disease Registry between 2006-2016 to compare stent vs non-stent treatment outcomes and associated costs in FP interventions. A total of 2910 FP interventions were performed in 2162 patients (mean age, 66 years), comprising 1339 stent based (superficial femoral artery, 93%) in 1007 patients and 1571 non-stent interventions (superficial femoral artery, 85%) in 1155 patients. A growing trend for non-stent based interventions and a declining trend in repeat revascularization rate at 1 year were observed across years of registry enrollment. Stent implantation was the prevailing strategy in treating longer FP lesions (mean length, 152 mm vs 105 mm; P<.001) and chronic total occlusions (65% vs 40%; P<.001), while stent implantation was employed less frequently when treating in-stent restenotic lesions (14% vs 20%; P<.001). Stent and non-stent interventions had similar 1-year limb outcomes in all-cause death, target-limb revascularization, target-vessel revascularization, and major or minor amputation. The average procedure costs for the stent group were significantly higher than the non-stent group ($6215 vs $4790; P<.001). CONCLUSION: There is a growing trend for non-stent FP artery interventions, with a significant decline in 1-year target-limb revascularization rates over time. One-year limb outcomes in stent-based compared to non-stent interventions are similar; however, at a significantly higher procedural cost.

Comparative Effectiveness Study of Drug-Eluting and Bare-Metal Peripheral Artery Stents in Endovascular Femoropopliteal Artery Revascularization.

OBJECTIVES: Paclitaxel drug-eluting stents (DESs) have been shown to improve primary patency of femoropopliteal lesions compared to plain balloon angioplasty with provisional bare-metal stents (BMSs) in randomized controlled studies. However, data are lacking on patency outcomes of real-world DES use relative to BMS use. This study compared clinically driven target-lesion revascularization (TLR), target-vessel revascularization (TVR), and target-limb revascularization outcomes at 1 year between DES and BMS treatments in a real-world setting. METHODS: The study identified 174 DES (Zilver PTX; Cook Medical) and 784 BMS femoropopliteal interventions from the available 969 Excellence in Peripheral Artery Disease (XLPAD) registry patients between October 2013 and December 2016. We analyzed both unmatched (174 DES and 784 BMS) and propensity score (PS)-matched datasets (174 for each). RESULTS: This study found that patients who underwent DES femoropopliteal endovascular revascularization had significantly lower TLR rates in both unmatched (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.35-0.91; P=.02) and matched data (HR, 0.50 95% CI, 0.27-0.91; P=.02). The DES group had a 43% lower TVR risk than the BMS group in the PS matched cohort (HR, 0.57; 95% CI, 0.33-0.98; P=.04). Mortality rate in the DES group (5%) was significantly higher than the BMS group in both unmatched (2%; P=.04) and matched groups (1%; P=.046) at 1 year. CONCLUSIONS: Patients treated with DES had higher lesion and vessel patency than BMS after adjusting for confounding, which included complexity of lesion characteristics and operators' clinical decision-making regarding selection of treatment modalities, in femoropopliteal endovascular interventions in a real-world registry.

Radiation Safety in the Catheterization Laboratory: Current Perspectives and Practices.

BACKGROUND: There is great variability in radiation safety practices in cardiac catheterization laboratories around the world. METHODS: We performed an international online survey on radiation safety including interventional cardiologists, electrophysiologists, interventional radiologists, and vascular surgeons. RESULTS: A total of 570 responses were received from various geographic locations, including the United States (77.9%), Asia (7.9%), Europe (6.8%), Canada (2.8%), and Mexico and Central America (2.1%). Most respondents (73%) were interventional cardiologists and 23% were electrophysiologists, with 14.4 ± 10.2 years in practice. Most respondents (75%) were not aware of their radiation dose during the past year and 21.2% had never attended a radiation safety course; 58.9% are "somewhat worried" and 31.5% are "very worried" about chronic radiation exposure. Back pain due to lead use was reported by 43.0% and radiation-related health complications including cataracts and malignancies were reported by 6.3%. Only 37.5% of respondents had an established radiation dose threshold for initiating patient follow-up. When comparing United States operators with the other respondents, the former were more likely to attend radiation safety courses (P<.001), wear dosimeters (P<.001), know their annual personal radiation exposure (P<.001), and have an established patient radiation dose threshold (P<.001). They were also more likely to use the fluoro store function, under-table shields, leaded glasses, ceiling lead glass, and disposable radiation shields, and were more concerned about the adverse effects of radiation. CONCLUSIONS: Radiation safety is of concern to catheterization laboratory personnel, yet there is significant variability in radiation protection practices, highlighting several opportunities for standardization and improvement.

Comparative Assessment of Procedure Cost and Outcomes Between Guidewire and Crossing Device Strategies to Cross Peripheral Artery Chronic Total Occlusions.

OBJECTIVES: The aim of this study was to assess actual procedural costs and outcomes comparing wire-catheter and dedicated chronic total occlusion (CTO) device strategies to cross peripheral artery CTOs. BACKGROUND: Peripheral artery CTO interventions are frequently performed, but there are limited data on actual procedural costs and outcomes comparing wire-catheter and dedicated CTO devices. METHODS: The XLPAD (Excellence in Peripheral Artery Disease Intervention) registry (NCT01904851) was accessed to retrospectively compare cost and 30-day and 12-month outcomes of wire-catheter and crossing device strategies for treatment of infrainguinal peripheral artery CTO. RESULTS: Of all 3,234 treated lesions, 42% (n = 1,362) were CTOs in 1,006 unique patients. Wire-catheter approaches were used in 82% of CTOs, whereas dedicated CTO devices were used in 18% (p < 0.0001). CTO crossing device use was associated with significantly higher technical success (74% vs. 65%; p < 0.0001) and mean procedure cost ($7,800.09 vs. $4,973.24; p < 0.0001). Because 12-month repeat revascularization (11.3% vs. 17.2%; p = 0.02) and amputation rates (2.8% vs. 8.5%; p = 0.002) in the CTO crossing device arm were lower compared with the wire-catheter group, the net cost for an initial CTO crossing device strategy was $423.80 per procedure. CONCLUSIONS: An initial wire-catheter approach to cross a peripheral artery CTO is most frequently adopted. The use of dedicated CTO crossing devices provides significantly higher technical success and lower reintervention and amputation rates, at a net cost of $423.80 per procedure at 12 months.

Optical coherence tomography findings after chronic total occlusion interventions: Insights from the "AngiographiC evaluation of the everolimus-eluting stent in chronic Total occlusions" (ACE-CTO) study (NCT01012869).

BACKGROUND: There is limited information on optical coherence tomography (OCT) findings after percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs). OCT allows high resolution imaging that can enhance understanding of the vascular response after stenting of chronically occluded vessels. METHODS: The Angiographic Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions (ACE-CTO) study collected angiographic and clinical outcomes from 100 patients undergoing CTO PCI with the everolimus-eluting stent (EES). OCT was performed 8-months post stenting in 62 patients. Every third frame was analyzed throughout the course of the stented arterial segment. Lumen contours were semi-automatically traced and stent struts were manually delineated, with automatic measurement of the strut to lumen distance. Struts on the luminal side of the lumen contour were classified as malapposed if the distance to the lumen contour exceeded 0.108mm. RESULTS: A total of 44,450 struts in 6047 frames were analyzed, of which 4113 9.3%, 95% confidence intervals [CI] 9.0% to 9.5%) were malapposed and 1230 (2.8%, 95% CI 2.6% to 2.9%) were uncovered. Fifty-five of 62 patients (88.7%, 95% CI 78.5% to 98.4%) had at least one malapposed stent strut and 50 patients (80.7%, 95% CI 69.2% to 88.6%) had at least one uncovered stent strut. Mean strut-intimal thickness of the apposed and malapposed struts was 0.126±0.140mm and -0.491±0.440mm, respectively. CONCLUSION: High rates of stent strut malapposition and incomplete stent strut coverage were observed after CTO PCI using EES, highlighting unique challenges associated with stent implantation in CTOs.

Prospective Evaluation of the Impact of Side-Holes and Guide-Catheter Disengagement From the Coronary Ostium on Fractional Flow Reserve Measurements.

BACKGROUND: We prospectively examined the impact of side-holes and guide-catheter disengagement on fractional flow reserve (FFR) measurements. METHODS: Twenty-five patients undergoing clinically indicated FFR measurement for intermediate coronary artery stenosis were enrolled. Four FFR measurements were made in random order during intravenous adenosine infusion with: (a) an engaged side-hole guide catheter; (b) a disengaged side-hole guide catheter; (c) an engaged non-side-hole guide catheter; and (d) disengaged non-side-hole guide catheter. RESULTS: Mean patient age was 65 ± 9 years and 100% were men. The mean distal poststenotic pressure/proximal aortic pressure (Pd/Pa) at baseline was 0.93 ± 0.05 mm Hg. Using intravenous adenosine infusion, the mean FFR measured with engaged vs disengaged non-side-hole guide catheters was 0.87 ± 0.09 vs 0.83 ± 0.10, respectively (mean difference, 0.039 ± 0.04; P<.001). The mean FFR with engaged vs disengaged side-hole guide catheters was 0.85 ± 0.10 vs 0.83 ± 0.10 (mean difference, 0.020 ± 0.02; P<.001). The mean difference in FFR measurements was 0.024 ± 0.03 (P<.001) among engaged guide catheters and 0.005 ± 0.03 (P=.47) among disengaged guide catheters. CONCLUSIONS: When FFR measurements are performed with engaged guide catheters, side-hole catheters provide lower measurements. When FFR measurements are obtained with disengaged guide catheters, they are even lower and similar between guide catheter types.

Predictors and Outcomes of Side-Branch Occlusion in Coronary Chronic Total Occlusion Interventions.

OBJECTIVES: We investigated whether side-branch loss during chronic total occlusion (CTO) percutaneous coronary intervention (PCI) could adversely impact clinical outcomes. BACKGROUND: Side-branch occlusion during PCI has been associated with periprocedural myocardial infarction and higher incidence of major adverse cardiac event (MACE), but has received limited study in CTO-PCI. METHODS: We retrospectively reviewed the medical records and coronary angiograms for 109 consecutive CTOPCI cases performed at our institution during 2012 and 2013. Post-PCI patency of ≥1 mm diameter side branches and associated clinical outcomes were assessed. RESULTS: Mean age was 65 ± 8 years and 99.1% of the patients were men. The CTO target vessel was the right coronary artery (54%), circumflex (26%), and left anterior descending artery (20%). Side-branch loss occurred in 28 cases (25.7%) due to antegrade dissection/reentry (n = 9), retrograde dissection/reentry (n = 5), stenting over the branch (n = 12), and dissection during antegrade crossing attempts (n = 2). Recanalization of the occluded side branch was pursued in 8 cases (28.6%) and was successful in 4 patients. Patients with side-branch loss had higher post-PCI increase in CK-MB levels (8.4 ng/mL [interquartile range, 2.7-33.5 ng/mL] vs 1.8 ng/mL [interquartile range, 0.025-6.775 ng/mL]; P<.001) and higher 12-month incidence of all-cause death (17.3% vs 2.8%; P=.02) and cardiovascular death (7.4% vs 0.0%; P=.02). CONCLUSIONS: Side-branch loss occurs in approximately 1 in 4 CTO-PCIs and is associated with higher risk for periprocedural myocardial infarction and higher mortality.

Renal Production, Uptake, and Handling of Circulating αKlotho.

αKlotho is a multifunctional protein highly expressed in the kidney. Soluble αKlotho is released through cleavage of the extracellular domain from membrane αKlotho by secretases to function as an endocrine/paracrine substance. The role of the kidney in circulating αKlotho production and handling is incompletely understood, however. Here, we found higher αKlotho concentration in suprarenal compared with infrarenal inferior vena cava in both rats and humans. In rats, serum αKlotho concentration dropped precipitously after bilateral nephrectomy or upon treatment with inhibitors of αKlotho extracellular domain shedding. Furthermore, the serum half-life of exogenous αKlotho in anephric rats was four- to five-fold longer than that in normal rats, and exogenously injected labeled recombinant αKlotho was detected in the kidney and in urine of rats. Both in vivo (micropuncture) and in vitro (proximal tubule cell line) studies showed that αKlotho traffics from the basal to the apical side of the proximal tubule via transcytosis. Thus, we conclude that the kidney has dual roles in αKlotho homeostasis, producing and releasing αKlotho into the circulation and clearing αKlotho from the blood into the urinary lumen.

The AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusion (ACE-CTO) Study.

BACKGROUND: There are limited data on outcomes after implantation of second-generation drug-eluting stents in coronary chronic total occlusions (CTOs). We aimed to evaluate the frequency of angiographic restenosis and clinical outcomes after implantation of the everolimus-eluting stent (EES) in coronary CTOs. METHODS: One hundred patients undergoing successful CTO percutaneous coronary intervention using EES at our institution between 2009 and 2012 were enrolled. The primary study endpoint was binary in-segment restenosis at 8-month follow-up quantitative coronary angiography. Secondary endpoints included death, myocardial infarction, target-lesion and target-vessel revascularization, and symptom improvement. RESULTS: Mean age was 64 ± 7 years and 99% of the patients were men. The successful crossing technique was antegrade wiring in 51 patients, antegrade dissection/reentry in 24 patients, and retrograde in 25 patients. Binary angiographic restenosis occurred in 46% of the patients (95% confidence interval [CI], 35%-57%). The pattern of restenosis was focal, proliferative, and total occlusion in 19 lesions (46%), 14 lesions (34%), and 8 lesions (20%), respectively. At 12 months, the incidences of death, myocardial infarction, target-lesion revascularization, and target-vessel revascularization were 2%, 2%, 37%, and 39%, respectively. At 12 months, symptoms were improved, unchanged, or worse compared with baseline in 89 patients, 8 patients, and 1 patient, respectively (2 patients died before the 12-month follow-up). On multivariable analysis, smaller stent diameter was associated with higher risk for binary angiographic restenosis. CONCLUSION: High rates of angiographic restenosis and repeat revascularization were observed among patients receiving EES in coronary CTOs, but most had significant symptom improvement.

Impact of Chronic Total Occlusions and Coronary Revascularization on All-Cause Mortality and the Incidence of Ventricular Arrhythmias in Patients With Ischemic Cardiomyopathy.

Coronary chronic total occlusions (CTOs) have been associated with higher mortality in patients with ischemic cardiomyopathy and implantable cardioverter defibrillators (ICDs); yet the impact of CTO revascularization on subsequent clinical outcomes has not been studied. We evaluated the clinical characteristics and outcomes of patients with ischemic cardiomyopathy who also received an ICD for primary prevention of sudden death at the Dallas VA Medical Center from January 2002 to December 2013. On the basis of coronary angiography performed before device implantation, patients were divided into 3 groups: no CTOs, revascularized CTOs (with percutaneous coronary intervention or surgery), and unrevascularized CTOs. Primary and secondary outcomes were all-cause mortality and appropriate ICD therapy for sustained ventricular arrhythmias. A total of 307 patients (mean age 64.3 ± 8.1 years, 100% men) were included in the study. At least 1 CTO was present in 213 patients (69%) and was revascularized in 99 patients (32%). During a median follow-up of 4.1 years, 51 patients (17%) died and 98 (32%) had at least 1 episode of sustained ventricular arrhythmia. Mortality and incidence of ventricular arrhythmias were similar in the 3 study groups in both univariate and multivariate analyses. In conclusion, CTOs are commonly found in patients with ischemic cardiomyopathy. In contrast to previous studies, the presence of a CTO was not associated with higher mortality or incidence of ventricular arrhythmias. In addition, revascularization of CTOs was not associated with improved outcomes in this high-risk cohort.

Association between low ankle-brachial index and accelerometer-derived sedentary and exercise time in the asymptomatic general population.

Sedentary behavior is an adverse health risk factor that is independent of physical activity. The relationship between sedentary behavior, exercise activity and the ankle-brachial index (ABI) is not well understood. We analyzed data from the National Health and Nutrition Examination Survey (NHANES) 2003-2004. Accelerometer data were used to quantify exercise and sedentary time for each participant. A low ABI was defined as a value <1.0 (including borderline values). Multi-variable adjusted logistic regression analyses were performed with sedentary and exercise times as independent variables, adjusting for important confounders. There were 1443 asymptomatic participants (mean age 61 years, 49% female, 55% current/prior smokers) with mean daily sedentary and exercise times of 454 ± 144 and 18 ± 20 minutes, respectively. Of the participants, 23% had an ABI <1.0 (8.7% with ABI <0.9). Sedentary time was positively associated with a low ABI (odds ratio [OR] 1.22 per 1 standard deviation [SD], [95% confidence interval (CI), 1.03-1.43]; p=0.02) while exercise time was inversely associated with a low ABI (OR 0.71 per 1 SD, [95% CI, 0.57-0.89]; p=0.003). Sedentary time is associated with low ABI values in the asymptomatic population. This association appears to be independent of exercise time and warrants further investigation.

Stent and Non-Stent Based Outcomes of Infrainguinal Peripheral Artery Interventions From the Multicenter XLPAD Registry.

BACKGROUND: There are limited data regarding contemporary use of stent and non-stent based treatment strategies of infrainguinal peripheral artery disease (PAD). METHODS: We analyzed data from the ongoing multicenter XLPAD registry between July 2005 and October 2013 to report on the use of non-stent (atherectomy ± balloon angioplasty) and stent-based treatment of superficial femoral artery (SFA), popliteal, and below-the-knee (BTK) vessels in contemporary clinical practice. RESULTS: A total of 584 interventions (SFA, 82.5%; popliteal, 7.2%; BTK, 9.9%) were performed in 372 patients (mean age, 63.2 years; diabetes mellitus, 57.7%; Rutherford category 1-3, 73.5%; Rutherford category 4-6, 20.1%). Stents were deployed in 389 lesions (66.6%; SFA, 90.5%; popliteal, 5.1%; BTK, 4.1%) and non-stent strategy (atherectomy, 49%) in 195 lesions (33.4%; SFA, 66.7%; popliteal, 11.3%; BTK, 21.5%). In the stent and non-stent groups, mean lesion lengths were 133.9 mm and 86.0 mm (P<.001), chronic total occlusions (CTOs) constituted 63.0% and 49.7% (P<.01), and restenotic lesions were 12.6% and 32.3% (P<.001), respectively. At a mean follow-up of 260 ± 130 days, in the stent and non-stent treated patients, all-cause mortality was 4.3% and 3.5% (P=.65), clinically indicated repeat revascularization was 17.5% and 14.9% (P=.42), and amputation was 4.6% and 9.2% (P<.01), respectively. SFA lesion location, long lesion length, and CTO were associated with the use of stents. Advanced Rutherford class was associated with a non-stent treatment strategy. CONCLUSION: The majority of endovascular peripheral arterial interventions are performed in the SFA; most include a CTO and in patients with diabetes mellitus. Operators use stents to primarily treat complex SFA lesions with overall similar outcomes, except for fewer amputations compared to a non-stent strategy.

Increases in myocardial workload induced by rapid atrial pacing trigger alterations in global metabolism.

OBJECTIVE: To determine whether increases in cardiac work lead to alterations in the plasma metabolome and whether such changes arise from the heart or peripheral organs. BACKGROUND: There is growing evidence that the heart influences systemic metabolism through endocrine effects and affecting pathways involved in energy homeostasis. METHODS: Nineteen patients referred for cardiac catheterization were enrolled. Peripheral and selective coronary sinus (CS) blood sampling was performed at serial timepoints following the initiation of pacing, and metabolite profiling was performed by liquid chromatography-mass spectrometry (LC-MS). RESULTS: Pacing-stress resulted in a 225% increase in the median rate·pressure product from baseline. Increased myocardial work induced significant changes in the peripheral concentration of 43 of 125 metabolites assayed, including large changes in purine [adenosine (+99%, p = 0.006), ADP (+42%, p = 0.01), AMP (+79%, p = 0.004), GDP (+69%, p = 0.003), GMP (+58%, p = 0.01), IMP (+50%, p = 0.03), xanthine (+61%, p = 0.0006)], and several bile acid metabolites. The CS changes in metabolites qualitatively mirrored those in the peripheral blood in both timing and magnitude, suggesting the heart was not the major source of the metabolite release. CONCLUSIONS: Isolated increases in myocardial work can induce changes in the plasma metabolome, but these changes do not appear to be directly cardiac in origin. A number of these dynamic metabolites have known signaling functions. Our study provides additional evidence to a growing body of literature on metabolic 'cross-talk' between the heart and other organs.

Prevalence and outcomes of intermediate saphenous vein graft lesions: findings from the stenting of saphenous vein grafts randomized-controlled trial.

BACKGROUND: We sought to examine the prevalence and progression rate of intermediate saphenous vein graft (SVG) lesions in the Stenting Of Saphenous vein grafts (SOS) trial. METHODS: The baseline and follow-up angiograms of 80 patients participating in the SOS trial were analyzed to determine the prevalence of intermediate (30-60% angiographic diameter stenosis) SVG lesions and their progression rate. RESULTS: At least one intermediate SVG lesion was present in 31 of 143 (22%) SVGs in 27 of 80 (34%) patients. Most intermediate lesions were present in the SOS stented SVGs (20 grafts in 19 patients). During a median follow-up of 35 months, angiographic follow-up was available for 28 grafts in 25 patients. Progression (defined as percent diameter stenosis ≥ 70% but <100% at follow-up angiography) was seen in 11 of 28 SVGs (39%) in 11 of 25 patients (44%). Progression rate at 12, 24 and 36 months was 28% and 47% and 84%, respectively. Seven of 11 patients (64%) with intermediate SVG lesion progression presented with an acute coronary syndrome and 8 (73%) underwent PCI. Four of the 28 grafts with intermediate lesions at baseline were 100% occluded at follow-up; all of those SVGs had received a stent in another location in the SVG as part of the SOS trial. CONCLUSIONS: Intermediate SVG lesions are common in patients undergoing SVG stenting, have high rates of progression and frequently present with an acute coronary syndrome. Further study of pharmacologic and mechanical treatments to prevent progression of these lesions is needed.

Pilot trial of cryoplasty or conventional balloon post-dilation of nitinol stents for revascularization of peripheral arterial segments: the COBRA trial.

OBJECTIVES: The purpose of this study is to compare post-dilation strategies of nitinol self-expanding stents implanted in the superficial femoral artery of diabetic patients with peripheral arterial disease. BACKGROUND: Endovascular treatment of superficial femoral artery disease with nitinol self-expanding stents is associated with high rates of in-stent restenosis in patients with diabetes mellitus. METHODS: We conducted a prospective, multicenter, randomized, controlled clinical trial of diabetic patients to investigate whether post-dilation of superficial femoral artery nitinol self-expanding stents using a cryoplasty balloon reduces restenosis compared to a conventional balloon. Inclusion criteria included diabetes mellitus, symptomatic peripheral arterial disease, and superficial femoral artery lesions requiring implantation of stents>5 mm in diameter and >60 mm in length. Primary endpoint was binary restenosis at 12 months, defined as ≥2.5-fold increase in peak systolic velocity by duplex ultrasonography. RESULTS: Seventy-four patients, with 90 stented superficial femoral artery lesions, were randomly assigned to post-dilation using cryoplasty (n=45 lesions) or conventional balloons (n=45 lesions). Mean lesion length was 148±98 mm, mean stented length was 190±116 mm, mean stent diameter was 6.1±0.4 mm, and 50% of the lesions were total occlusions. Post-dilation balloon diameters were 5.23±0.51 mm versus 5.51±0.72 mm in the cryoplasty and conventional balloon angioplasty groups, respectively (p=0.02). At 12 months, binary restenosis was significantly lower in the cryoplasty group (29.3% vs. 55.8%, p=0.01; odds ratio: 0.36, 95% confidence interval: 0.15 to 0.89). CONCLUSIONS: Among diabetic patients undergoing implantation of nitinol self-expanding stents in the superficial femoral artery, post-dilation with cryoplasty balloon reduced binary restenosis compared to conventional balloon angioplasty. (Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease [COBRA]; NCT00827853).

Optical coherence tomography analysis of the stenting of saphenous vein graft (SOS) Xience V Study: use of the everolimus-eluting stent in saphenous vein graft lesions.

OBJECTIVES: The Stenting of Saphenous Grafts-Xience V (SOS-Xience V) trial prospectively examined the frequency of angiographic in-stent restenosis in saphenous vein graft (SVG) lesions 12 months after implantation of a Xience V everolimus-eluting stent (EES; Abbott Vascular). Optical coherence tomography (OCT) during follow-up angiography was added to the protocol after OCT was approved for clinical use in the United States. METHODS: Forty patients with 40 SVG lesions were enrolled in the study, of whom 27 underwent 12-month coronary angiography and 12 (only 1 of whom had in-stent restenosis) also had follow-up OCT evaluation. OCT strut-level analysis was performed to determine the percentage of strut coverage, malapposition, strut protrusion, neointimal thickness, and the existence of thrombus. RESULTS: Mean patient age was 67 ± 7 years, and 95% were men. A total of 2584 struts were evaluated by OCT. The percentages for uncovered, malapposed, and protruding struts were 4%, 9%, and 15%, respectively. The mean strut neointimal thickness was 0.094 ± 0.094 mm. Of the 12 stents analyzed, 4 (33%) showed full neointimal coverage, 2 (17%) had all the struts embedded, 7 (58%) had at least 1 malapposed strut, and 10 (83%) had at least 1 protruding strut. The mean difference between the stent area and the lumen area was 0.36 ± 1.6 mm². No thrombus was detected in the stented areas. CONCLUSIONS: Use of EES in SVGs is associated with high rates of stent strut coverage and high malapposition rates at 12 months post implantation.