Predictors of Revascularization in Lower-Extremity Peripheral Artery Disease: Insights From the PORTRAIT Study.

BACKGROUND: Peripheral artery disease (PAD) guidelines recommend revascularization only for patients with lifestyle-limiting claudication that is refractory to goal-directed medical therapy (class IIA, level of evidence A). However, real-world invasive treatment patterns and predictors of revascularization in patients with symptomatic lower-extremity PAD are still largely unknown. AIM: We aimed to examine rates, patient-level predictors, and site variability of early revascularization in patients with new or worsening PAD symptoms. METHODS: Among patients with new-onset or recent exacerbation of PAD in the 10-center Patient-centered Outcomes Related to TReatment practices in peripheral Arterial disease: Investigating Trajectories (PORTRAIT) study enrolled between June 2011 and September 2015, we classified early revascularization (endovascular or surgical) as procedures being performed within 3 months of presentation. Hierarchical logistic regression was used to identify patient characteristics associated with early revascularization. Variability across sites was estimated using the median odds ratio (OR). RESULTS: Among 797 participants, early revascularization procedures were performed in 224 (28.1%). Rutherford class 3 (vs Rutherford class 1; OR=1.86, 95% confidence interval [CI] 1.04-3.33) and having lesions in both iliofemoral and below-the-knee arterial segments (vs below the knee only; OR=1.75, 95% CI: 1.15-2.67) were associated with a higher odds of revascularization. Longer PAD duration >12 months (vs 1-6 months; OR=0.50, 95% CI: 0.32-0.77), higher ankle-brachial index scores (per 0.1 unit increase; OR=0.86, 95% CI: 0.78-0.96), and higher Peripheral Artery Questionnaire Summary scores (per 10 unit increase; OR=0.89, 95% CI: 0.80-0.99) were associated with a lower odds of revascularization. The raw rates for revascularization in different sites ranged from 6.25% to 66.28%, and the median OR was 1.88, 95% CI: 1.38-3.57. CONCLUSIONS: About 1 in 3 patients with symptomatic PAD received early revascularization. A more extensive disease and symptom burden were the main predictors of receiving early revascularization in PAD. There was significant site variability in revascularization patterns, and further studies will better understand the source of this variability and optimal selection criteria for early revascularization. CLINICAL IMPACT: Real world patterns and predictors of early revascularization in peripheral artery disease are not well understood. In this retrospective analysis of the POTRAIT study, about 1 out of 3 patients with PAD symptoms received early revascularization, with significant site variability. A more extensive disease and symptom burden were the main predictors of receiving early revascularization in PAD.

Development and validation of a predictive model for bleeding after peripheral vascular intervention: A report from the National Cardiovascular Data Registry Peripheral Vascular Interventions Registry.

OBJECTIVES: To develop a model to predict risk of in-hospital bleeding following endovascular peripheral vascular intervention. BACKGROUND: Peri-procedural bleeding is a common, potentially preventable complication of catheter-based peripheral vascular procedures and is associated with increased mortality. We used the National Cardiovascular Data Registry (NCDR) Peripheral Vascular Interventions (PVI) Registry to develop a novel risk-prediction model to identify patients who may derive the greatest benefit from application of strategies to prevent bleeding. METHODS: We examined all patients undergoing lower extremity PVI at 76 NCDR PVI hospitals from 2014 to 2017. Patients with acute limb ischemia (n = 1600) were excluded. Major bleeding was defined as overt bleeding with a hemoglobin (Hb) drop of ≥ 3 g/dl, any Hb decline of ≥ 4 g/dl, or a blood transfusion in patients with pre-procedure Hb ≥ 8 g/dl. Hierarchical multivariable logistic regression was used to develop a risk model to predict major bleeding. Model validation was performed using 1000 bootstrapped replicates of the population after sampling with replacement. RESULTS: Among 25,382 eligible patients, 1017 (4.0%) developed major bleeding. Predictors of bleeding included age, female sex, critical limb ischemia, non-femoral access, prior heart failure, and pre-procedure hemoglobin. The model demonstrated good discrimination (optimism corrected c-statistic = 0.67), calibration (corrected slope = 0.98, intercept of -0.04) and range of predicted risk (1%-18%). CONCLUSIONS: Post-procedural PVI bleeding risk can be predicted based upon pre- and peri-procedural patient characteristics. Further studies are needed to determine whether this model can be utilized to improve procedural safety through developing and targeting bleeding avoidance strategies.

Treatment decisions for patients with peripheral artery disease and symptoms of claudication: Development process and alpha testing of the SHOW-ME PAD decision aid.

Patients with peripheral artery disease (PAD) face a range of treatment options to improve survival and quality of life. An evidence-based shared decision-making tool (brochure, website, and recorded patient vignettes) for patients with new or worsening claudication symptoms was created using mixed methods and following the International Patient Decision Aids Standards (IPDAS) criteria. We reviewed literature and collected qualitative input from patients (n = 28) and clinicians (n = 34) to identify decisional needs, barriers, outcomes, knowledge, and preferences related to claudication treatment, along with input on implementation logistics from 59 patients and 27 clinicians. A prototype decision aid was developed and tested through a survey administered to 20 patients with PAD and 23 clinicians. Patients identified invasive treatment options (endovascular or surgical revascularization), non-invasive treatments (supervised exercise therapy, claudication medications), and combinations of these as key decisions. A total of 65% of clinicians thought the brochure would be useful for medical decision-making, an additional 30% with suggested improvements. For patients, those percentages were 75% and 25%, respectively. For the website, 76.5% of clinicians and 85.7% of patients thought it would be useful; an additional 17.6% of clinicians and 14.3% of patients thought it would be useful, with improvements. Suggestions were incorporated in the final version. The first prototype was well-received among patients and clinicians. The next step is to implement the tool in a PAD specialty care setting to evaluate its impact on patient knowledge, engagement, and decisional quality. ClinicalTrials.gov Identifier: NCT03190382.

Long-term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3-year results from the STROLL study.

OBJECTIVES: To evaluate the clinical and health status outcomes of patients undergoing superficial femoral artery (SFA) revascularization using the Shape Memory Alloy Recoverable Technology (S.M.A.R.T.®) nitinol self-expanding stent through 3 years of follow-up. BACKGROUND: Limited long-term data are available describing the durability of benefits after femoropopliteal revascularization. METHODS: In a multicenter, prospective, core-lab adjudicated study, 250 subjects with de novo or restenotic femoropopliteal arterial lesions were treated with the S.M.A.R.T.® stent. The primary endpoint of target vessel patency, a composite of ultrasound-assessed patency and freedom from clinically driven target lesion revascularization (TLR), was evaluated through 3 years. Secondary endpoints included stent fracture and health status. Health status was measured using generic and disease-specific instruments, including the Peripheral Artery Questionnaire (PAQ). RESULTS: At 3-year follow-up, Kaplan-Meier estimated target vessel patency was 72.7%, freedom from clinically driven TLR was 78.5%, and the incidence of stent fracture was 3.6%. The PAQ summary score was markedly impaired at baseline (mean 37.3 ± 19.6 points) and improved substantially at 1 month (mean change from baseline of 31.4 points, 95% CI: 28.5-34.3; P < 0.001). Disease-specific health status benefits assessed by the PAQ were largely preserved through 3 years of follow-up (mean change from baseline, 28.0 points, 95% CI: 24.3-31.7; P < 0.0001). CONCLUSIONS: In patients undergoing revascularization for moderately complex SFA disease, use of the self-expanding S.M.A.R.T® stent was associated with a high rate of target vessel patency through 3 years and led to substantial and sustained health status benefits.

Association between health status and long-term mortality after percutaneous revascularization of peripheral artery disease.

OBJECTIVES: To explore the association of health status change and long-term survival among patients with symptomatic peripheral artery disease (PAD). BACKGROUND: Early gains in health status after successful endovascular therapy (EVT) for symptomatic PAD can be maintained up to 1 year. Whether such health status improvements are associated with long-term survival benefits is unknown. METHODS: Between February 2001 and August 2004, 258 patients with symptomatic PAD treated with EVT participated in a prospective study evaluating baseline and 1 year health status using the Peripheral Artery Questionnaire (range 0-100, higher scores = better). All-cause mortality was assessed for all patients at a median of 9.4 years following EVT. RESULTS: The mean age at enrollment was 68 ± 11 years; 61% were male, 97% were Caucasian, and 38% had diabetes. Patients with a clinically meaningful health status improvement (≥8 points) 1 year after their index procedure (79%) were identified as responders. Responders had a significantly better 10 year survival compared with nonresponders (60% vs 38%, p = 0.025). Responder status was associated with a survival advantage that persisted in risk-adjusted analysis (adjusted hazard ratio for long-term mortality, 0.66 [95% CI, 0.45-0.97]; p = 0.036). CONCLUSIONS: Among patients with symptomatic PAD undergoing EVT, improvement of PAD-specific health status at 1 year follow-up was associated with improved long-term survival. Whether additional treatment for patients with poor response to EVT could improve long-term survival warrants further investigation. © 2016 Wiley Periodicals, Inc.

Quality of life benefits of percutaneous coronary intervention for chronic occlusions.

OBJECTIVES: We aimed to compare quality of life benefits of percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) with non-CTO PCI. BACKGROUND: Data quantifying the benefits of PCI of CTO are inconsistent. METHODS: We leveraged a 10-center prospective PCI registry including Seattle Angina Questionnaire (SAQ) assessment at the time of PCI and in follow-up. We propensity matched attempted CTO PCIs with up to 10 non-CTO PCIs. The primary analysis compared changes between baseline and 6 months in SAQ Physical Limitation (PL), Quality of Life (QoL); Angina Frequency (AF) scores as well as the Rose Dyspnea scores (RDS) and the EQ5D Visual Analogue Scale (VAS). Noninferiority was assessed for quality of life changes between CTO and non-CTO PCI. RESULTS: In 3,303 patients enrolled, 167 single-vessel CTOs were attempted; 147 (88%) were matched with 1,616 non-CTO PCI. Baseline PL (73.0 vs. 77.4, P = 0.039) and VAS (66.4 vs. 70.8, P = 0.005) scores were lower for CTO. There was no difference in AF, QoL, or RDS scores. At 6-month follow-up, all SAQ scores improved (P < 0.05 vs. baseline for all) and were equivalent for CTO and Non-CTO (P = NS for all). VAS scores remained lower for CTO, but improved in both groups (P < 0.05 vs. baseline for both). Formal noninferiority testing demonstrated that CTO PCI was not inferior to non-CTO PCI (P ≤ 0.02 for all). CONCLUSIONS: Symptoms, function, QoL, and dyspnea improve to the same degree following CTO PCI as compared with non-CTO PCI. Symptom relief supports CTO PCI to improve patients' quality of life.

Comparison of costs between transradial and transfemoral percutaneous coronary intervention: a cohort analysis from the Premier research database.

BACKGROUND: Transradial intervention (TRI) for percutaneous coronary intervention (PCI) is associated with shorter length of stay, fewer bleeding complications, and higher patient satisfaction. Less is known about the economic implications of TRI in contemporary practice. METHODS: This is a retrospective inpatient cohort analysis using medical data from the Premier research database (Premier Inc, Charlotte, NC), which contains approximately one-fifth of all acute care hospitalizations in the US annually. The database was queried to identify patients undergoing PCI from 2004 to 2009. Patients with TRI were identified by center-level charge codes for radial-specific devices and matched one-to-many with patients undergoing transfemoral intervention (TFI). Adjusted total hospitalization costs were compared between patients undergoing TRI and TFI. Patients were additionally classified by periprocedural risk of bleeding as low (<1%), moderate (1%-3%), and high (>3%). RESULTS: There were 609 TRI cases matched with 60,900 TFI cases. Total adjusted costs for TRI were $11,736 ± $6,748 vs $12,288 ± $23,418 for TFI, a difference of $553 favoring TRI (95% CI $45-$1,060, P = .033). Day-of-procedure costs were similar, at $17 higher for TRI compared with TFI (95% CI -$318 to $353, P = .37); however, costs from the following day until discharge were significantly lower for TRI (-$571, 95 % CI -$912 to $229, P = .001). Postprocedure costs were lower for patients with TRI vs patients with TFI at moderate (-$478, 95% CI -$887 to $69, P = .022) and high (-$917, 95% CI -$1,814 to $19, P = .045) risk of bleeding. CONCLUSIONS: In a nationwide administrative hospital database, transradial compared with transfemoral PCI access was associated with lower average direct hospital costs and shorter length of hospital stay. Postprocedure costs associated with TRI were also lower in patients at greater bleeding risk.

Association of Disease-Specific Health Status With Long-Term Survival in Peripheral Artery Disease.

Background While peripheral artery disease (PAD) is associated with increased cardiovascular morbidity with mortality remaining high and challenging to predict, accurate understanding of serial PAD-specific health status around the time of diagnosis may prognosticate long-term mortality risk. Methods and Results Patients with new or worsening PAD symptoms enrolled in the PORTRAIT Registry across 10 US sites from 2011 to 2015 were included. Health status was assessed by the Peripheral Artery Questionnaire (PAQ) Summary score at baseline, 3-month, and change from baseline to 3-month follow-up. Kaplan-Meier using 3-month landmark and hierarchical Cox regression models were constructed to assess the association of the PAQ with 5-year all-cause mortality. Of the 711 patients (mean age 68.8±9.6 years, 40.9% female, 72.7% white; mean PAQ 47.5±22.0 and 65.9±25.0 at baseline and 3-month, respectively), 141 (19.8%) died over a median follow-up of 4.1 years. In unadjusted models, baseline (HR, 0.90 per-10-point increment; 95% CI, 0.84-0.97; P=0.008), 3-month (HR [95% CI], 0.87 [0.82-0.93]; P<0.001) and change in PAQ (HR [95% CI], 0.92 [0.85-0.99]; P=0.021) were each associated with mortality. In fully adjusted models including combination of scores, 3-month PAQ was more strongly associated with mortality than either baseline (3-month HR [95% CI], 0.85 [0.78-0.92]; P<0.001; C-statistic, 0.77) or change (3-month HR [95% CI], 0.79 [0.72-0.87]; P<0.001). Conclusions PAD-specific health status is independently associated with 5-year survival in patients with new or worsening PAD symptoms, with the most recent assessment being most prognostic. Future work is needed to better understand how this information can be used proactively to optimize care.

Changes in myocardial ischemic burden following percutaneous coronary intervention of chronic total occlusions.

OBJECTIVES: We assessed the potential for percutaneous coronary intervention (PCI) of a chronic total occlusion (CTO) to decrease myocardial ischemia and established objective criteria to predict post-procedure improvement. BACKGROUND: Optimal treatment for CTO of coronary arteries is controversial, and selection criteria for PCI of CTO are subjective. METHODS: All patients undergoing CTO PCI at a single center between 2002 and 2007 were included if myocardial perfusion imaging (MPI) was performed within 12 ± 3 months before and a follow-up study within 12 ± 3 months after PCI. Average summed difference scores were calculated and converted to percent ischemic myocardium to classify patients as having normal/minimal, mild, moderate, or severe ischemia. A significant improvement in ischemia following PCI was classified as an absolute ≥5% decrease in ischemic myocardium. Receiver operating characteristic (ROC) curves were used to identify ischemic thresholds predictive of decreased and increased ischemic burden on follow-up MPI. RESULTS: In 301 patients, average baseline ischemic burden was 13.1% ± 11.9% and decreased to 6.9% ± 6.5% (P < 0.001) during follow-up. Overall, 53.5% of patients met criteria for improvement following PCI. These patients were more likely to be male, without diabetes, with CTO in the left anterior descending artery, and classified as having high ischemic burden at baseline. ROC analysis identified a baseline 12.5% ischemic burden as optimal in identifying those most likely to have a significantly decreased ischemic burden post-PCI. Those with a baseline ischemic burden less than 6.25% were more likely to have an increased ischemic burden post-PCI. CONCLUSIONS: Ischemic burden is reduced following CTO PCI, and the decrease is greater at high ischemic burden. A threshold of 12.5% ischemic burden is suggested as a criterion for performing PCI in the setting of CTO.

Percutaneous transluminal angioplasty: association between depressive symptoms and diminished health status benefits.

Depressive symptoms are known to compromise health status in cardiac disease, but this relationship has not been described in peripheral artery disease (PAD). Depressive symptoms (PHQ-9) and disease-specific health status (Peripheral Artery Questionnaire, PAQ) were assessed in 242 PAD patients undergoing percutaneous transluminal angioplasty (PTA) at baseline and 1 year. Patients were classified by baseline and follow-up depression status (moderate-severe depressive symptoms = PHQ ≥ 10). Changes were categorized as no depression/improvement of depression versus persistent/worsened depression. At baseline, 20% of patients were depressed; at 1 year, 17% of patients experienced persistent/worsened depression. Although this group improved on most PAQ subscales, they improved to a significantly lesser degree than those without depressive symptoms or those who improved by 1 year (p-values < 0.05). Baseline depressive symptoms (B(per 5-point increment) = -11.9, 95% CI -15.3, -8.5, p < 0.0001) and changes in depression were independently associated with a decrease in 1-year health status (B(per 5-point increment) = -11.7, 95% CI -14.3, -9.2, p < 0.0001). In conclusion, depressive symptoms are associated with less improvement in health status 1 year after undergoing a peripheral endovascular revascularization (PER) as compared with those having no depression or whose depressive symptoms improve. Efforts to improve depression detection and treatment among patients with PAD may improve the health status outcomes of these patients.

Acute Kidney Injury Following In-Patient Lower Extremity Vascular Intervention: From the National Cardiovascular Data Registry.

OBJECTIVES: The authors analyzed data from the NCDR (National Cardiovascular Data Registry) PVI Registry and defined acute kidney injury (AKI) as increased creatinine of ≥0.3 mg/dl or 50%, or a new requirement for dialysis after PVI. BACKGROUND: AKI is an important and potentially modifiable complication of peripheral vascular intervention (PVI). The incidence, predictors, and outcomes of AKI after PVI are incompletely characterized. METHODS: A hierarchical logistic regression risk model using pre-procedural characteristics associated with AKI was developed, followed by bootstrap validation. The model was validated with data submitted after model creation. An integer scoring system was developed to predict AKI after PVI. RESULTS: Among 10,006 procedures, the average age of patients was 69 years, 58% were male, and 52% had diabetes. AKI occurred in 737 (7.4%) and was associated with increased in-hospital mortality (7.1% vs. 0.7%). Reduced glomerular filtration rate, hypertension, diabetes, prior heart failure, critical or acute limb ischemia, and pre-procedural hemoglobin were independently associated with AKI. The model to predict AKI showed good discrimination (optimism corrected c-statistic = 0.68) and calibration (corrected slope = 0.97, intercept of -0.07). The integer point system could be incorporated into a useful clinical tool because it discriminates risk for AKI with scores ≤4 and ≥12 corresponding to the lower and upper 20% of risk, respectively. CONCLUSIONS: AKI is not rare after PVI and is associated with in-hospital mortality. The NCDR PVI AKI risk model, including the integer scoring system, may prospectively estimate AKI risk and aid in deployment of strategies designed to reduce risk of AKI after PVI.

Appropriate Use Criteria and Health Status Outcomes Following Chronic Total Occlusion Percutaneous Coronary Intervention: Insights From the OPEN-CTO Registry.

BACKGROUND: The American College of Cardiology/American Heart Association Appropriate Use Criteria were designed to aid clinical decision-making, yet their association with health status outcomes after chronic total occlusion percutaneous coronary intervention (PCI) is unknown. METHODS: We analyzed 769 patients with baseline and 1-year health status data after chronic total occlusion PCI. Procedures were categorized as appropriate, may be appropriate, or rarely appropriate. Mean changes in patient-reported health status, assessed by the Seattle Angina Questionnaire (SAQ), were compared across appropriate use criteria categories from baseline to 1 year. Change in SAQ summary score was stratified as little to no benefit (≤10 points), intermediate (10-19 points), large (20-29 points), and very large (≥30 points). RESULTS: The appropriate use criteria indication was appropriate in 573 patients (74.5%), may be appropriate in 191 (24.8%), and rarely appropriate in 5 (0.7%). Patients in the appropriate group reported greater improvement in SAQ summary scores (27.3±21.3 points) at 1 year compared with the may be appropriate (22.5±20.9; P=0.01). A similar pattern was noted for SAQ angina frequency (mean change 24.0±27.2 versus 18.7±25.6; P=0.02). The appropriate group had the highest proportion of very large improvements in SAQ summary scores (44.5% versus 33.3%; P=0.01). CONCLUSIONS: Among patients undergoing chronic total occlusion PCI, the rate of rarely appropriate PCI was low. The rate of appropriate PCI was high and was associated with the greatest health status improvement at 1 year. A substantial proportion of patients in the may be appropriate group experienced meaningful health status benefits as well.

Adherence to Guideline-Recommended Therapy-Including Supervised Exercise Therapy Referral-Across Peripheral Artery Disease Specialty Clinics: Insights From the International PORTRAIT Registry.

Background Underuse of guideline-recommended therapy in peripheral artery disease (PAD) in administrative and procedural databases has been described, but reports on medically managed patients and referral to supervised exercise therapy (SET) in PAD are lacking. We aimed to document the use of PAD guideline-recommended therapy, including SET in patients with PAD symptoms consulting a specialty clinic across 3 countries. Methods and Results The 16-center PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry enrolled 1275 patients with new or an exacerbation of PAD symptoms (2011-2015). We prospectively documented antiplatelet medications, statins, smoking cessation counseling and/or therapy, and referral to SET: "2 quality measures" referred to the use of both statin and antiplatelet medications; "4 quality measures" to receiving all 4 measures. Median odds ratios were calculated to quantify treatment variation across sites. A total of 89% patients were on antiplatelets, 83% on statins, and 23% had been referred to SET. Of 455 current smokers, 342 (72%) patients received smoking cessation therapy/counseling. Overall, 77.2% of patients received "2 quality measures" and 19.7% "4 quality measures." The median odds ratio for 2 quality measures was 2.13 (95% CI, 1.61-3.56; P<0.001) and for 4 quality measures was 5.43 (95% CI, 2.84-17.91; P<0.001). Variability in adherence was not explained by country, except for referral to SET. The odds for SET referral in The Netherlands (70% referral rate) was nearly 100 times greater than in US sites (2% referral rate). Conclusions Not all patients who have undergone a PAD workup at a specialty care facility are treated with evidence-based care, especially so for SET.

Quantifying improvement in symptoms, functioning, and quality of life after peripheral endovascular revascularization.

BACKGROUND: Patients with peripheral arterial disease often undergo peripheral endovascular revascularization (PER) to alleviate symptoms. Despite the growth of PER, little information exists quantifying the health status benefits after the procedure. METHODS AND RESULTS: From February 2001 to August 2004, 477 consecutive patients underwent PER for symptomatic peripheral arterial disease. Of these, 300 consented to participate in a longitudinal follow-up study of their health status. Health status was quantified with the disease-specific Peripheral Artery Questionnaire and the generic Short Form-12 and the EuroQol 5 Dimensions (EQ5D)questionnaire. Scores range from 0 to 100; higher scores represent fewer symptoms and better health status. The average age of the cohort was 68+/-11 years (mean+/-SD); 186 (62%) were male, 288 (96%) were white, and 118 (39%) were diabetic. Clinical follow-up was attained in 99% of patients; health status assessments were made in 86%. Mean Peripheral Artery Questionnaire summary scores improved significantly after revascularization from 31+/-19 to 62+/-27 at 1 year (P<0.0001). Generic health status scores also improved significantly (P<0.001 for all). Despite a technically successful procedure in 98% of patients, 21% of patients did not achieve the minimal clinically important improvement of an 8-point change in Peripheral Artery Questionnaire Summary score after PER (35+/-19 at baseline versus 31+/-16 at 1 year; P=0.09). CONCLUSIONS: For most patients, significant and sustained improvements in symptoms, functioning, and quality of life occur after PER. Identifying and counseling patients less likely to benefit from PER is an important future research direction.

Outcomes of 1,090 consecutive, elective, nonselected percutaneous coronary interventions at a community hospital without onsite cardiac surgery.

We evaluated the efficacy and safety of elective percutaneous coronary intervention (PCI) at a hospital without onsite cardiac surgery. A growing number of hospitals without onsite cardiac surgery perform elective PCI. Few hospitals have reported outcomes, despite controversy surrounding this practice. From August 2003 to December 2005, 1,090 elective PCI were performed at Saint Luke's South Hospital (SLS), a hospital without onsite cardiac surgery, for which the referral center is the Mid America Heart Institute (MAHI). The elective PCI program used experienced interventionalists, technicians, and nurses; a tested helicopter transport protocol; a well-equipped catheterization laboratory; and a quality assurance process. Baseline characteristics, procedural success, and adverse clinical outcomes were compared. Observed frequencies of in-hospital death, a combined end point of Q-wave myocardial infarction (MI)/emergency coronary artery bypass grafting (CABG) surgery, and vascular complications were compared with prediction models. SLS, with lower risk characteristics than MAHI, had unadjusted frequencies of procedural success (93% vs 94%, p = NS), Q-wave MI (0.3% vs 0.3%, p = NS), emergency CABG surgery (0.2% vs 0.03%, p = 0.09), vascular complications (0.6% vs 0.6%, p = NS), and in-hospital death (0.1% vs 0.8%, p = 0.002) that compared favorably with MAHI. Two patients transferred from SLS to MAHI for emergency CABG surgery without adverse effects. Fewer in-hospital deaths and vascular complications were observed at SLS than predicted by models. In conclusion, favorable clinical outcomes were achieved for elective PCI at a hospital without onsite cardiac surgery that used strict program requirements.

Guideline-directed statin intensification in patients with new or worsening symptoms of peripheral artery disease.

BACKGROUND: The ACC/AHA cholesterol guidelines recommend patients with peripheral artery disease (PAD) be treated with a moderate to high-intensity statin. The extent to which patients with new or worsening PAD symptoms are offered guideline therapy is unknown. HYPOTHESIS: There is significant variability in rate of guideline-directed statin intensification across clinical practices. METHODS: In the PORTRAIT registry, patterns of statin therapy were assessed in 1144 patients at 16 PAD specialty clinics between June 2011 and December 2015 before and after an evaluation for new or worsening claudication symptoms. We documented whether patients were treated with a guideline statin as well as the incidence of statin intensification. Statin intensification was defined as transitioning from no statin or low-intensity statin to moderate or high-intensity statin treatment. Patient factors associated with intensification were examined. Site and provider-level variation in intensification was summarized using an adjusted median odds ratio (aMOR). RESULTS: Among 1144 patients, 810 (70.8%) were initially on guideline therapy compared to 334 (29.2%) that were not. In the latter, 103 (30.8%) received intensification following evaluation. Patients with typical symptoms displayed greater odds of intensification (OR 3.74; 95% CI: 1.23-11.41) while older patients had lower odds of intensification (OR 0.60/decade; 95% CI: 0.41-0.88). Site variability for statin intensification was observed across sites (aMOR = 3.15; 95% CI 1.22-9.60, [P = 0.02]) but not providers (aMOR = 1.89; 95% CI 1.00-3.90, [P = 0.14]). CONCLUSIONS: Most patients evaluated at a PAD specialty clinic for new or worsening claudication symptoms arrived on guideline statin therapy. Only 31% not receiving appropriate therapy underwent statin intensification. These findings highlight an important opportunity to optimize medical therapy for patients with PAD.

Randomized Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusions: The CrossBoss First Trial.

OBJECTIVES: The authors performed a multicenter, randomized-controlled, clinical trial comparing upfront use of the CrossBoss catheter versus antegrade wire escalation for antegrade crossing of coronary chronic total occlusions. BACKGROUND: There is equipoise about the optimal initial strategy for crossing coronary chronic total occlusions. METHODS: The primary endpoints were the time required to cross the chronic total occlusion or abort the procedure and the frequency of procedural major adverse cardiovascular events. The secondary endpoints were technical and procedural success, total procedure time, fluoroscopy time required to cross and total fluoroscopy time, total air kerma radiation dose, total contrast volume, and equipment use. RESULTS: Between 2015 and 2017, 246 patients were randomized to the CrossBoss catheter (n = 122) or wire escalation (n = 124) at 11 U.S. centers. The baseline clinical and angiographic characteristics of the study groups were similar. Technical and procedural success were 87.8% and 84.1%, respectively, and were similar in the 2 groups. Crossing time was similar: 56 min (interquartile range: 33 to 93 min) in the CrossBoss group and 66 min (interquartile range: 36 to 105 min) in the wire escalation group (p = 0.323), as was as the incidence of procedural major adverse cardiovascular events (3.28% vs. 4.03%; p = 1.000). There were no significant differences in the secondary study endpoints. CONCLUSIONS: As compared with wire escalation, upfront use of the CrossBoss catheter for antegrade crossing of coronary chronic total occlusions was associated with similar crossing time, similar success and complication rates, and similar equipment use and cost.

Costs Associated With Access Site and Same-Day Discharge Among Medicare Beneficiaries Undergoing Percutaneous Coronary Intervention: An Evaluation of the Current Percutaneous Coronary Intervention Care Pathways in the United States.

OBJECTIVES: The aim of this study was to examine the independent impact of various care pathways, including those involving transradial intervention (TRI) and same-day discharge (SDD) after elective percutaneous coronary intervention (PCI), on hospital costs. BACKGROUND: PCI is associated with costs of $10 billion annually. Alternative payment models for PCI are being implemented, but few data exist on strategies to reduce costs. Various PCI care pathways, including TRI and SDD, exist, but their association with costs and outcomes is unknown. METHODS: In total, 279,987 PCI patients eligible for SDD in the National Cardiovascular Data Registry CathPCI Registry linked to Medicare claims files were analyzed. Hospital costs in 2014 U.S. dollars were estimated using cost-to-charge ratios. Propensity scores for TRI and SDD, with propensity adjustment via inverse probability weighting, was performed. RESULTS: Of the 279,987 PCI procedures, TRI was used in 9.0% (13.5% of which were SDD), and SDD was used in 5.3% of cases (23.1% of which were TRI). TRI (vs. transfemoral intervention) was associated with lower adjusted costs of $916 (95% confidence interval [CI]: $778 to $1,035), as was SDD ($3,502; 95% CI: $3,486 to $3,902). The adjusted cost associated with TRI and SDD was $13,389 (95% CI: $13,161 to $13,607), while the cost associated with transfemoral intervention and non-same-day discharge was $17,076 (95% CI: $16,999 to $17,147), a difference of $3,689 (95% CI: $3,486 to $3,902; p < 0.0001). Shifting current practice from transfemoral intervention non-same-day discharge to TRI SDD by 30% could potentially save a hospital performing 1,000 PCIs each year $1 million and the country $300 million annually. CONCLUSIONS: Among Medicare beneficiaries, TRI with SDD was independently associated with fewer complications and lower in-hospital costs. These findings have important implications for changing the current PCI care pathways to improve outcomes and reduce costs.

Success rates of percutaneous coronary intervention of chronic total occlusions and long-term survival in patients with diabetes mellitus.

The objectives of this study were to evaluate angiographic and clinical outcomes among patients with diabetes mellitus (DM) who underwent percutaneous coronary intervention (PCI) for a chronic total occlusion (CTO). We compared them with matched patients undergoing PCI of a non-CTO lesion. All patients had documented DM. Matching was performed using a propensity score for CTO. There were 506 patients with DM and CTO who were matched with a non-CTO group. Results showed that angiographic success rates were lower with CTO (75% vs. 93%, p<0.001). In-hospital major adverse cardiac event (MACE - death, urgent bypass surgery, Q-wave myocardial infarction or target vessel revascularisation) rates were equivalent (CTO 3.2% vs. non-CTO 2.6%, p=0.57). Survival was not different five years after revascularisation of CTO (75%) vs. non-CTO (79%) (p=0.20). In addition, when DM patients with CTO were analysed according to angiographic success of PCI, there were no significant differences in either in-hospital (success 1.6% vs. failure 2.4%, p=0.7) or 1-year mortality (success 22.2% vs. failure 26.8%, p=0.3). We conclude that PCI of CTO is safe in patients with DM. Angiographic failure is not associated with an increase in MACE rates or mortality as compared to matched non-CTO patients. However, there is not a measurable improvement in survival in this DM-CTO population.