Publications by authors named "Manesh R Patel"

465 Publications

Prognostic value of coronary computed tomography angiographic derived fractional flow reserve: a systematic review and meta-analysis.

Heart 2021 Oct 22. Epub 2021 Oct 22.

Cardiology, Glostrup University Hospital, Glostrup, Denmark.

Objectives: To obtain more powerful assessment of the prognostic value of fractional flow reserve testing we performed a systematic literature review and collaborative meta-analysis of studies that assessed clinical outcomes of CT-derived calculation of FFR (FFR) (HeartFlow) analysis in patients with stable coronary artery disease (CAD).

Methods: We searched PubMed and Web of Science electronic databases for published studies that evaluated clinical outcomes following fractional flow reserve testing between 1 January 2010 and 31 December 2020. The primary endpoint was defined as 'all-cause mortality (ACM) or myocardial infarction (MI)' at 12-month follow-up. Exploratory analyses were performed using major adverse cardiovascular events (MACEs, ACM+MI+unplanned revascularisation), ACM, MI, spontaneous MI or unplanned (>3 months) revascularisation as the endpoint.

Results: Five studies were identified including a total of 5460 patients eligible for meta-analyses. The primary endpoint occurred in 60 (1.1%) patients, 0.6% (13/2126) with FFR>0.80% and 1.4% (47/3334) with FFR ≤0.80 (relative risk (RR) 2.31 (95% CI 1.29 to 4.13), p=0.005). Likewise, MACE, MI, spontaneous MI or unplanned revascularisation occurred more frequently in patients with FFR ≤0.80 versus patients with FFR >0.80. Each 0.10-unit FFR reduction was associated with a greater risk of the primary endpoint (RR 1.67 (95% CI 1.47 to 1.87), p<0.001).

Conclusions: The 12-month outcomes in patients with stable CAD show low rates of events in those with a negative FFR result, and lower risk of an unfavourable outcome in patients with a negative test result compared with patients with a positive test result. Moreover, the FFR numerical value was inversely associated with outcomes.
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http://dx.doi.org/10.1136/heartjnl-2021-319773DOI Listing
October 2021

Reduction in Acute Limb Ischemia with Rivaroxaban versus Placebo in Peripheral Artery Disease after Lower Extremity Revascularization: Insights from VOYAGER PAD.

Circulation 2021 Oct 12. Epub 2021 Oct 12.

Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, CO; CPC Clinical Research, Aurora, CO.

Patients with peripheral artery disease (PAD) are at heightened risk of acute limb ischemia (ALI), a thrombotic event associated with amputation, disability, and mortality. Prior lower extremity revascularization (LER) is associated with increased ALI risk in chronic PAD. However, the pattern of risk, clinical correlates, and outcomes after ALI early after LER are not well-studied, and effective therapies to reduce ALI post-LER are lacking. VOYAGER PAD (NCT02504216) randomized patients with PAD undergoing LER to rivaroxaban 2.5 mg twice daily or placebo on a background of low-dose aspirin. The primary outcome was a composite of ALI, major amputation of vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. ALI was prospectively ascertained and adjudicated by a blinded committee. The cumulative incidence of ALI was calculated using Kaplan Meier estimates, and Cox proportional-hazards models were used to generate hazard ratios and associated confidence intervals. Analyses were performed as intention-to-treat. Among 6,564 patients followed for a median of 2.3 years, 382 (5.8%) had a total of 508 ALI events. In placebo patients, the 3-year cumulative incidence of ALI was 7.8%. After multivariable modeling, prior LER, baseline ABI <0.50, surgical LER, and longer target lesion length were associated with increased risk of ALI. Incident ALI was associated with subsequent all-cause mortality (HR 2.59, 95% CI 1.98-3.39) and major amputation (HR 24.87, 95% CI 18.68-33.12). Rivaroxaban reduced ALI relative to placebo by 33% (absolute risk reduction 2.6% at 3 years, HR 0.67, 95% CI 0.55-0.82, P=0.0001), with benefit starting early (HR 0.45, 95% CI 0.24-0.85, P=0.0068 at 30 days). Benefit was present for severe ALI (associated with death, amputation, or prolonged hospitalization and ICU stay, HR 0.58, 95% CI 0.40-0.83, P=0.003) and regardless of LER type (surgical vs endovascular revascularization, p-interaction=0.42) or clopidogrel use (p-interaction=0.59). After LER for symptomatic PAD, ALI is frequent, particularly early after LER, and is associated with poor prognosis. Low-dose rivaroxaban plus aspirin reduces ALI after LER, including ALI events associated with the most severe outcomes. The benefit of rivaroxaban for ALI appears early, continues over time, and is consistent regardless of revascularization approach or clopidogrel use.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.121.055146DOI Listing
October 2021

Clinician specialty, access to care, and outcomes among patients with peripheral artery disease.

Am J Med 2021 Oct 7. Epub 2021 Oct 7.

Department of Population Health Sciences, Duke University School of Medicine, Durham, NC; Division of Cardiology, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Durham, NC.

Background: Understanding the relationship between patterns of peripheral artery disease patterns and outcomes is an essential step towards improving care and outcomes. We hypothesized that clinician specialty would be associated with occurrence of major adverse vascular events (MAVE).

Methods: Patients with at least 1 peripheral artery disease-related encounter in our health system and fee-for-service Medicare were divided into groups based on the specialty of the clinician (cardiologist, surgeon, podiatrist, primary care, or other) providing a plurality of peripheral artery disease-coded care in the year prior to index encounter. The primary outcome was MAVE (a composite of all-cause mortality, myocardial infarction, stroke, lower extremity revascularization, and lower extremity amputation).

Results: The cohort included 1,768 patients, of whom 30.0% were Black, 23.9% were Medicaid dual-enrollment eligible, and 31.1% lived in rural areas. Patients receiving a plurality of their care from podiatrists had the highest 1-year rates of MAVE (34.4%, p<.001), hospitalization (65.9%, p<.001), and amputations (22.6%, p<.001). Clinician specialty was not associated with outcomes after adjustment. Patients who were Medicaid dual-eligible had higher adjusted risks of mortality (HR 1.54, 95%CI 1.11-2.14) and all-cause hospitalization (HR 1.20, 95%CI 1.03-1.40) and patients who were Black had a higher adjusted risk of amputation (HR 1.49, 95%CI 1.03-2.15).

Conclusions: Clinician specialty was not associated with worse outcomes after adjustment, but certain socioeconomic factors were. The effects of clinician specialty and socioeconomic status were likely attenuated by the fact that all patients in this study had health insurance; these analyses require confirmation in a more representative cohort.
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http://dx.doi.org/10.1016/j.amjmed.2021.08.025DOI Listing
October 2021

Crossing Peripheral Chronic Total Occlusions: More Tolls and More Questions.

J Am Heart Assoc 2021 Oct 6;10(20):e023423. Epub 2021 Oct 6.

Division of Cardiology Duke University School of Medicine Durham NC.

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http://dx.doi.org/10.1161/JAHA.121.023423DOI Listing
October 2021

Instantaneous wave-free ratio compared with fractional flow reserve in PCI: A cost-minimization analysis.

Int J Cardiol 2021 Sep 30. Epub 2021 Sep 30.

Department of Cardiology, Lund University, Skåne University Hospital, Lund, Sweden. Electronic address:

Background: Coronary physiology is a routine diagnostic tool when assessing whether coronary revascularization is indicated. The iFR-SWEDEHEART trial demonstrated similar clinical outcomes when using instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) to guide revascularization. The objective of this analysis was to assess a cost-minimization analysis of iFR-guided compared with FFR-guided revascularization.

Methods: In this cost-minimization analysis we used a decision-tree model from a healthcare perspective with a time-horizon of one year to estimate the cost difference between iFR and FFR in a Nordic setting and a United States (US) setting. Treatment pathways and health care utilizations were constructed from the iFR-SWEDEHEART trial. Unit cost for revascularization and myocardial infarction in the Nordic setting and US setting were derived from the Nordic diagnosis-related group versus Medicare cost data. Unit cost of intravenous adenosine administration and cost per stent placed were based on the average costs from the enrolled centers in the iFR-SWEDEHEART trial. Deterministic and probabilistic sensitivity analyses were carried out to test the robustness of the result.

Results: The cost-minimization analysis demonstrated a cost saving per patient of $681 (95% CI: $641 - $723) in the Nordic setting and $1024 (95% CI: $934 - $1114) in the US setting, when using iFR-guided compared with FFR-guided revascularization. The results were not sensitive to changes in uncertain parameters or assumptions.

Conclusions: IFR-guided revascularization is associated with significant savings in cost compared with FFR-guided revascularization.
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http://dx.doi.org/10.1016/j.ijcard.2021.09.054DOI Listing
September 2021

Etiology and Outcomes of Amputation in Patients With Peripheral Artery Disease: Insights From the EUCLID Trial.

J Vasc Surg 2021 Sep 28. Epub 2021 Sep 28.

CPC Clinical Research, Aurora, Colo; Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colo.

Objective: Amputation remains a frequent and feared outcome in patients with peripheral artery disease (PAD). Although typically characterized as major or minor on the extent of tissue loss, the etiologies and outcomes after amputation by extent are not well-understood. In addition, emerging data suggest that the drivers and outcomes of amputation in patients with PAD may differ in those with and without diabetes mellitus (DM).

Methods: The EUCLID trial randomized 13,885 patients with symptomatic PAD, including 5345 with concomitant diabetes, to ticagrelor or clopidogrel and followed them for long-term outcomes. Amputations were prospectively reported by trial investigators. Their primary and contributing drivers were adjudicated using safety data, including infection, ischemia, or multifactorial etiologies. Outcomes following major and minor amputations were analyzed, including recurrent amputation, major adverse limb events, adverse cardiovascular events, and mortality. Multivariable logistic regression models were used to identify independent predictors of minor amputations. Analyses were performed overall and stratified by the presence or absence of DM at baseline.

Results: Of the patients randomized, 398 (2.9%) underwent at least one lower extremity nontraumatic amputation, for a total of 511 amputations (255 major and 256 minor) over a median of 30 months. A history of minor amputation was the strongest independent predictor for a subsequent minor amputation (odds ratio, 7.29; 95% confidence interval, 5.17-10.30; P < .001) followed by comorbid DM (odds ratio, 4.60; 95% confidence interval, 3.16-6.69; P < .001). Compared with patients who had a major amputation, those with a minor amputation had similar rates of subsequent major amputation (12.2% vs 13.6%), major adverse limb events (15.1% vs 14.9%), and major adverse cardiovascular events (17.6% vs 16.3%). Ischemia alone was the primary driver of amputation (51%), followed by infection alone (27%), and multifactorial etiologies (22%); however, infection was the most frequent driver in those with DM (58%) but not in those without DM (15%).

Conclusions: Outcomes after amputation remain poor regardless of whether they are categorized as major or minor. The pattern of amputation drivers in PAD differs by history of DM, with infection being the dominant etiology in those with DM and ischemia in those without DM. Greater focus is needed on the prognostic importance of minor amputation and of the multifactorial etiologies of amputation in PAD. Nomenclature with anatomical description of amputations and eliminating terms "major" or "minor" would seem appropriate.
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http://dx.doi.org/10.1016/j.jvs.2021.08.096DOI Listing
September 2021

Ambient temperature and infarct size, microvascular obstruction, left ventricular function and clinical outcomes after ST-segment elevation myocardial infarction.

Coron Artery Dis 2021 Sep 23. Epub 2021 Sep 23.

Clinical Trials Center, Cardiovascular Research Foundation Division of Cardiology, Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, USA Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig University Heart Center Lübeck, and the German Center for Cardiovascular Research, Lübeck, Germany Division of Cardiology, Department of Medicine, Duke University Hospital, Durham, North Carolina The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, USA.

Objectives: Incidence and prognosis of ST-segment elevation myocardial infarction (STEMI) vary according to ambient temperature and season. We sought to assess whether season and temperature on the day of STEMI are associated with infarct size, microvascular obstruction (MVO), left ventricular ejection fraction (LVEF) and clinical outcomes after primary percutaneous coronary intervention (PCI).

Methods: Individual patient data from 1598 patients undergoing primary PCI in six randomized clinical trials were pooled. Infarct size was evaluated by cardiac magnetic resonance within 30 days in all trials. Patients were categorized either by whether they presented on a day of temperature extremes (minimum temperature <0 °C or maximum temperature >25 °C) or according to season.

Results: A total of 558/1598 (34.9%) patients presented with STEMI on a day of temperature extremes, and 395 (24.7%), 374 (23.4%), 481 (30.1%) and 348 (21.8%) presented in the spring, summer, fall and winter. After multivariable adjustment, temperature extremes were independently associated with larger infarct size (adjusted difference 2.8%; 95% CI, 1.3-4.3; P < 0.001) and smaller LVEF (adjusted difference -2.3%; 95% CI, -3.5 to -1.1; P = 0.0002) but not with MVO (adjusted P = 0.12). In contrast, infarct size, MVO and LVEF were unrelated to season (adjusted P = 0.67; P = 0.36 and P = 0.95, respectively). Neither temperature extremes nor season were independently associated with 1-year risk of death or heart failure hospitalization (adjusted P = 0.79 and P = 0.90, respectively).

Conclusion: STEMI presentation during temperature extremes was independently associated with larger infarct size and lower LVEF but not with MVO after primary PCI, whereas season was unrelated to infarct severity.
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http://dx.doi.org/10.1097/MCA.0000000000001099DOI Listing
September 2021

Termination Based on Event Accrual in Per Protocol Versus Intention to Treat in the ROCKET AF Trial.

J Am Heart Assoc 2021 Oct 25;10(19):e022485. Epub 2021 Sep 25.

Duke Clinical Research Institute Duke University Durham NC.

Background In event-driven clinical trials, study termination is based on accrual of a target number of primary efficacy events. For noninferiority trials in which superiority is conditionally examined, the ideal cohort in which to track event accrual is unclear. We used data from the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial to determine the effect of primary efficacy-event tracking in the per-protocol cohort during the on-treatment period versus the intention-to-treat (ITT) cohort during the ITT period. Methods and Results ROCKET AF was terminated after accruing 429 primary efficacy events (stroke or systemic embolism) in the per-protocol cohort during the on-treatment period for noninferiority. We identified the date on which 429 events occurred in the ITT cohort during the ITT period. We performed noninferiority and superiority analyses based on hypothetical study termination on this date. ROCKET AF would have terminated 226 days earlier if events were tracked during the ITT period. Similar to the main trial findings, rivaroxaban would have met noninferiority versus warfarin for the primary efficacy end point (hazard ratio [HR], 0.77; 95% CI, 0.62-0.96; <0.001). In contrast to the main trial findings, rivaroxaban would have met superiority for the primary efficacy end point (HR, 0.82; 95% CI, 0.68-0.99; =0.038). In both termination scenarios, rivaroxaban was associated with a lower risk of intracranial hemorrhage and similar risk of other safety end points. Conclusions Clinical trial termination based on event accrual in the ITT cohort versus the per-protocol cohort may have important implications on trial results depending on rates of study drug discontinuation and event rates off treatment.
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http://dx.doi.org/10.1161/JAHA.121.022485DOI Listing
October 2021

Trans-lesional fractional flow reserve gradient as derived from coronary CT improves patient management: ADVANCE registry.

J Cardiovasc Comput Tomogr 2021 Sep 2. Epub 2021 Sep 2.

Department of Radiology, St. Paul's Hospital and University of British Columbia, Vancouver, British Columbia, Canada; Department of Cardiology, Fiona Stanley Hospital, Harry Perkins Institute of Medical Research, University of Western Australia, Perth, Australia.

Background: The role of change in fractional flow reserve derived from CT (FFR) across coronary stenoses (ΔFFR) in guiding downstream testing in patients with stable coronary artery disease (CAD) is unknown.

Objectives: To investigate the incremental value of ΔFFR in predicting early revascularization and improving efficiency of catheter laboratory utilization.

Materials: Patients with CAD on coronary CT angiography (CCTA) were enrolled in an international multicenter registry. Stenosis severity was assessed as per CAD-Reporting and Data System (CAD-RADS), and lesion-specific FFR was measured 2 ​cm distal to stenosis. ΔFFR was manually measured as the difference of FFR across visible stenosis.

Results: Of 4730 patients (66 ​± ​10 years; 34% female), 42.7% underwent ICA and 24.7% underwent early revascularization. ΔFFR remained an independent predictor for early revascularization (odds ratio per 0.05 increase [95% confidence interval], 1.31 [1.26-1.35]; p ​< ​0.001) after adjusting for risk factors, stenosis features, and lesion-specific FFR. Among the 3 models (model 1: risk factors ​+ ​stenosis type and location ​+ ​CAD-RADS; model 2: model 1 ​+ ​FFR; model 3: model 2 ​+ ​ΔFFR), model 3 improved discrimination compared to model 2 (area under the curve, 0.87 [0.86-0.88] vs 0.85 [0.84-0.86]; p ​< ​0.001), with the greatest incremental value for FFR 0.71-0.80. ΔFFR of 0.13 was the optimal cut-off as determined by the Youden index. In patients with CAD-RADS ≥3 and lesion-specific FFR ≤0.8, a diagnostic strategy incorporating ΔFFR >0.13, would potentially reduce ICA by 32.2% (1638-1110, p ​< ​0.001) and improve the revascularization to ICA ratio from 65.2% to 73.1%.

Conclusions: ΔFFR improves the discrimination of patients who underwent early revascularization compared to a standard diagnostic strategy of CCTA with FFR, particularly for those with FFR 0.71-0.80. ΔFFR has the potential to aid decision-making for ICA referral and improve efficiency of catheter laboratory utilization.
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http://dx.doi.org/10.1016/j.jcct.2021.08.003DOI Listing
September 2021

World regional differences in outcomes for patients with peripheral artery disease: Insights from the EUCLID trial.

Vasc Med 2021 Sep 13:1358863X211038620. Epub 2021 Sep 13.

Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.

Regional variations exist in the epidemiology of peripheral artery disease (PAD), in comorbidities, use of secondary prevention, and outcomes. Large studies of these variations in worldwide populations are rare. The EUCLID (Examining Use of tiCagreLor In peripheral artery Disease) trial included 13,885 patients with PAD from four geographical regions (Central/South America, Europe, Asia, North America) and compared monotherapy with ticagrelor and clopidogrel. Inclusion criteria were either an ankle-brachial index < 0.80 or a prior revascularization. The primary efficacy endpoint was time to first occurrence of any event in the composite of cardiovascular death, myocardial infarction, or ischemic stroke and did not differ between the study arms. This post hoc analysis of EUCLID confirmed that regional differences occurred in the inclusion criteria with more prior revascularization in North America (73.9%) and Asia (72.5%) compared with Central/South America (34.0%) and Europe (51.6%). The characteristics of patients also differed. Prior amputation at baseline was most frequent in Central/South America (6.3%) compared with other regions (1.6-2.8%). A history of stroke was most common in Asia, coronary heart disease in North America, and diabetes in Central/South America compared with other regions. The incidence of outcomes in patients with PAD varied by region. North America had the highest rate of the primary combined endpoint (5.97 events/100 patient-years). Corresponding rates were 4.80, 3.95, and 3.87 for Asia, Europe, and Central/South America, respectively. Hospitalization for acute limb ischemia (events/100 patient-years) was most frequent in Europe (0.75) and North America (0.74) compared with Asia (0.60) and Central/South America (0.33). Adjustment for inclusion criteria and relevant PAD characteristics did not have a major impact on these regional differences. Further adjustment for concomitant disease, risk factors, and preventive medication modified the regional differences only marginally. In conclusion, substantial regional differences were found in cardiovascular and limb outcomes in patients with PAD and were not explained by variation in the category of included patients, concomitant disease, risk factors, and prevention. Such differences, which may be due to variation in other factors such as background population rates or clinical care, need to be considered when designing and interpreting large international studies ().
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http://dx.doi.org/10.1177/1358863X211038620DOI Listing
September 2021

Utility of High-Sensitivity Troponin Among Stable Patients With Chest Pain Undergoing Stress Imaging (from PROMISE).

Am J Cardiol 2021 11 25;158:148-149. Epub 2021 Aug 25.

Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina; Department of Medicine, Duke University School of Medicine, Durham, North Carolina. Electronic address:

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http://dx.doi.org/10.1016/j.amjcard.2021.07.032DOI Listing
November 2021

Low-dose rivaroxaban plus aspirin in older patients with peripheral artery disease undergoing acute limb revascularization: insights from the VOYAGER PAD trial.

Eur Heart J 2021 10;42(39):4040-4048

CPC Clinical Research, 2115 N Scranton Street, Suite 2040, Aurora, CO, USA.

Aims: In this secondary analysis of the VOYAGER trial, rivaroxaban 2.5 mg twice/day plus aspirin 100 mg/day was assessed in older adults. Advanced age is associated with elevated bleeding risk and unfavourable net benefit for dual antiplatelet therapy in chronic coronary artery disease. The risk-benefit of low-dose rivaroxaban in patients ≥75 years with peripheral artery disease (PAD) after lower extremity revascularization (LER) has not been described.

Methods And Results: The primary endpoint was a composite of acute limb ischaemia, major amputation, myocardial infarction, ischaemic stroke, or cardiovascular death. The principal safety outcome was thrombolysis in myocardial infarction (TIMI) major bleeding analysed by the pre-specified age cut-off of 75 years. Of 6564 patients randomized, 1330 (20%) were >75 years. Absolute 3-year Kaplan-Meier cumulative incidence rates for primary efficacy (23.4% vs. 19.0%) and safety (3.5% vs. 1.5%) endpoints were higher in elderly vs. non-elderly patients. Efficacy of rivaroxaban (P-interaction 0.83) and safety (P-interaction 0.38) was consistent irrespective of age. The combination of intracranial and fatal bleeding was not increased in patients >75 years (2 rivaroxaban vs. 8 placebo). Overall, benefits (absolute risk reduction 3.8%, number needed to treat 26 for the primary endpoint) exceeded risks (absolute risk increase 0.81%, number needed to harm 123 for TIMI major bleeding).

Conclusion: Patients ≥75 years with PAD are at both heightened ischaemic and bleeding risk after LER. No excess harm with respect to major, intracranial or fatal bleeding was seen in older patients yet numerically greater absolute benefits were observed. This suggests that low-dose rivaroxaban combined with aspirin should be considered in PAD after LER regardless of age.
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http://dx.doi.org/10.1093/eurheartj/ehab408DOI Listing
October 2021

Cardiovascular risk and outcomes in symptomatic patients with suspected coronary artery disease and non coronary vascular disease: A report from the PROMISE trial.

Am Heart J 2021 Aug 9;242:82-91. Epub 2021 Aug 9.

Duke Clinical Research Institute, Durham, NC; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC.

Background: Non-coronary vascular disease (NCVD) is associated with adverse cardiovascular events. Little is known about physician risk assessment, prevalence of coronary artery disease (CAD), cardiac catheterization, and the performance of the atherosclerotic cardiovascular disease (ASCVD) risk score in patients with NCVD.

Methods: Retrospective analysis of outpatients with angina and no known CAD from the PROMISE trial. NCVD included carotid artery stenosis ≥50%, or history of stroke or peripheral artery disease. Multivariable models of physician estimates of the probability of obstructive CAD, prevalence of non-obstructive and obstructive CAD, referral to cardiac catheterization, and all-cause death/myocardial infarction/unstable angina were performed.

Results: Among 10,001 patients in the PROMISE trial, 379 (3.8%) patients had NCVD. Only 8.5% of participants with NCVD were categorized as high-risk for obstructive CAD by physicians, though 15.5% (25/161) had obstructive CAD in those randomized to coronary computed tomography (CTA). NCVD was independently associated with non-obstructive (aOR = 1.58; 95% CI 1.18-2.61; P = .006) but not obstructive CAD by CTA. Adjusted referral to cardiac catheterization was similar with and without NCVD (aOR 1.04; 95% CI 0.88-1.94, P = .19). NCVD was associated with an increased risk of all-cause death/MI/UA (aOR 2.03; 95% CI 1.37-3.01, P < .001). There was no interaction between NCVD status and ASCVD risk score.

Conclusions: Among patients with NCVD and angina, NCVD had increased adjusted risks of CAD and adverse outcomes which were not well described by ASCVD risk score and were underrecognized by physicians. Increased awareness and better risk stratification tools for patients with NCVD may be necessary to recognize the associated CV risk and optimize diagnostic testing and therapies.
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http://dx.doi.org/10.1016/j.ahj.2021.07.010DOI Listing
August 2021

Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial.

Circulation 2021 Oct 12;144(14):1104-1116. Epub 2021 Aug 12.

CPC Clinical Research, Aurora, CO (M.R.N., N.G., W.H.C., T.B., N.J., C.N.H., W.R.H., M.P.B.).

Background: Patients with peripheral artery disease requiring lower extremity revascularization (LER) are at high risk of adverse limb and cardiovascular events. The VOYAGER PAD trial (Vascular Outcomes Study of ASA [Acetylsalicylic Acid] Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) demonstrated that rivaroxaban significantly reduced this risk. The efficacy and safety of rivaroxaban has not been described in patients who underwent surgical LER.

Methods: The VOYAGER PAD trial randomized patients with peripheral artery disease after surgical and endovascular LER to rivaroxaban 2.5 mg twice daily plus aspirin or matching placebo plus aspirin and followed for a median of 28 months. The primary end point was a composite of acute limb ischemia, major vascular amputation, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was Thrombolysis in Myocardial Infarction major bleeding. International Society on Thrombosis and Haemostasis bleeding was a secondary safety outcome. All efficacy and safety outcomes were adjudicated by a blinded independent committee.

Results: Of the 6564 randomized, 2185 (33%) underwent surgical LER and 4379 (67%) endovascular. Compared with placebo, rivaroxaban reduced the primary end point consistently regardless of LER method (-interaction, 0.43). After surgical LER, the primary efficacy outcome occurred in 199 (18.4%) patients in the rivaroxaban group and 242 (22.0%) patients in the placebo group with a cumulative incidence at 3 years of 19.7% and 23.9%, respectively (hazard ratio, 0.81 [95% CI, 0.67-0.98]; =0.026). In the overall trial, Thrombolysis in Myocardial Infarction major bleeding and International Society on Thrombosis and Haemostasis major bleeding were increased with rivaroxaban. There was no heterogeneity for Thrombolysis in Myocardial Infarction major bleeding (-interaction, 0.17) or International Society on Thrombosis and Haemostasis major bleeding (-interaction, 0.73) on the basis of the LER approach. After surgical LER, the principal safety outcome occurred in 11 (1.0%) patients in the rivaroxaban group and 13 (1.2%) patients in the placebo group; 3-year cumulative incidence was 1.3% and 1.4%, respectively (hazard ratio, 0.88 [95% CI, 0.39-1.95]; =0.75) Among surgical patients, the composite of fatal bleeding or intracranial hemorrhage (=0.95) and postprocedural bleeding requiring intervention (=0.93) was not significantly increased.

Conclusions: The efficacy of rivaroxaban is associated with a benefit in patients who underwent surgical LER. Although bleeding was increased with rivaroxaban plus aspirin, the incidence was low, with no significant increase in fatal bleeding, intracranial hemorrhage, or postprocedural bleeds requiring intervention. Registration: URL: http://www.clinicaltrials.gov; Unique Identifier: NCT02504216.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.121.054835DOI Listing
October 2021

Younger patients with chronic limb threatening ischemia face more frequent amputations.

Am Heart J 2021 Aug 8;242:6-14. Epub 2021 Aug 8.

Department of Population Health Sciences, Duke University School of Medicine, Durham, NC; Division of Cardiology, Duke University School of Medicine, Durham, NC.

Introduction: Amputations among younger patients with chronic limb threatening ischemia (CLTI) may carry higher personal and societal costs, but younger patients are often not included in CLTI research because of dataset limitations. We aimed to characterize and compare outcomes between younger (<65 years old) and older patients with CLTI.

Methods: This retrospective cohort study identified patients with CLTI between July 1, 2014 and December 31, 2017 in the MarketScan commercial claims database, a proprietary set of claims for over 50 million patients with private insurance in the United States. The primary outcome was major adverse limb events (MALE); secondary outcomes included amputations, major adverse cardiovascular events, and statin prescription fills.

Results: The study cohort included 64,663 people with CLTI, of whom 25,595 (39.6%) were <65 years old. Younger patients were more likely to have diabetes mellitus (54.1% versus 49.9%, P<.001) but less likely to have other comorbidities. A higher proportion of younger patients suffered MALE (31.7% versus 30.2%, P=.002), specifically amputation (11.5% versus 9.3%, P<.001). After adjustment, age <65 years old was associated with a 24% increased risk of amputation (HR 1.24, 95%CI 1.18-1.32, P<.001) and a 10% increased risk of MALE (HR 1.10, 95%CI 1.07-1.14, P<.001).

Conclusions: A significant proportion of commercially insured patients with CLTI are under the age of 65, and younger patients have worse limb-related outcomes. These findings highlight the importance of aggressively treating risk factors for atherosclerosis and intentionally including younger patients with CLTI in future analyses to better understand their disease patterns and outcomes.
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http://dx.doi.org/10.1016/j.ahj.2021.08.002DOI Listing
August 2021

Pharmacotherapy for diabetes and stroke risk: Results from ROCKET AF.

Heart Rhythm O2 2021 Jun 20;2(3):215-222. Epub 2021 Apr 20.

Duke University Medical Center, Duke University School of Medicine, Durham, North Carolina.

Background: Insulin use may be a better predictor of stroke risk and morbidity and mortality than diabetes in patients with atrial fibrillation (AF).

Objectives: Determine if the increased risk of stroke observed in patients with AF and diabetes is restricted to those treated with insulin.

Methods: We analyzed the association between diabetes and treatment and the occurrence of stroke/systemic embolism, myocardial infarction (MI), all-cause death, vascular death, composite outcomes, and bleeding risk in the ROCKET AF trial.

Results: In a cohort of 14,264 patients, there were 40.3% (n = 5746) with diabetes, 5.9% (n = 842) on insulin, 18.9% (n = 2697) on oral medications, and 11.9% (n = 1703) diet-controlled. Compared to those without diabetes, patients with non-insulin-treated diabetes had increased risks of stroke (hazard ratio [HR] 1.33, 95% confidence interval [CI] 1.06-1.68), MI (HR 1.64, 95% CI 1.17-2.30), all-cause death (HR 1.26, 95% CI 1.08-1.46), vascular death (HR 1.33, 95% CI 1.11-1.60), and composite outcomes (HR 1.37, 95% CI 1.18-1.157). Patients with insulin-treated diabetes had a significantly higher risk of MI (HR 2.31, 95% CI 1.33-4.01) and composite outcomes (HR 1.57, 95% CI 1.19-2.08) compared to those without diabetes. There were no significant differences between insulin-treated and non-insulin-treated diabetes for any outcome.

Conclusion: Among patients with AF and diabetes, there were no significant differences in outcomes in insulin-treated diabetes compared to non-insulin-treated diabetes.
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http://dx.doi.org/10.1016/j.hroo.2021.04.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8322824PMC
June 2021

Assessment of North American Clinical Research Site Performance During the Start-up of Large Cardiovascular Clinical Trials.

JAMA Netw Open 2021 Jul 1;4(7):e2117963. Epub 2021 Jul 1.

Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.

Importance: Randomized clinical trials (RCTs) are critical in advancing patient care, yet conducting such large-scale trials requires tremendous resources and coordination. Clinical site start-up performance metrics can provide insight into opportunities for improved trial efficiency but have not been well described.

Objective: To measure the start-up time needed to reach prespecified milestones across sites in large cardiovascular RCTs in North America and to evaluate how these metrics vary by time and type of regulatory review process.

Design, Setting, And Participants: This cohort study evaluated cardiovascular RCTs conducted from July 13, 2004, to February 1, 2017. The RCTs were coordinated by a single academic research organization, the Duke Clinical Research Institute. Nine consecutive trials with completed enrollment and publication of results in their target journal were studied. Data were analyzed from December 4, 2019, to January 11, 2021.

Exposures: Year of trial enrollment initiation (2004-2007 vs 2008-2012) and use of a central vs local institutional review board (IRB).

Main Outcomes And Measures: The primary outcome was the median start-up time (from study protocol delivery to first participant enrollment) as compared by trial year and type of IRB used. The median start-up time for the top 10% of sites was also reported. Secondary outcomes included time to site regulatory approval, time to contract execution, and time to site activation.

Results: For the 9 RCTs included, the median site start-up time shortened only slightly over time from 267 days (interquartile range [IQR], 185-358 days) for 2004-2007 trials to 237 days (IQR, 162-343 days) for 2008-2012 trials (overall median, 255 days [IQR, 177-350 days]; P < .001). For the top 10% of sites, median start-up time was 107 days (IQR, 95-121 days) for 2004-2007 trials vs 104 days (IQR, 84-118 days) for 2008-2012 trials (overall median, 106 days [IQR, 90-120 days]; P = .04). The median start-up time was shorter among sites using a central IRB (199 days [IQR, 140-292 days]) than those using a local IRB (287 days [IQR, 205-390 days]; P < .001).

Conclusions And Relevance: This cohort study of North American research sites in large cardiovascular RCTs found a duration of nearly 9 months from the time of study protocol delivery to the first participant enrollment; this metric was only slightly shortened during the study period but was reduced to less than 4 months for top-performing sites. These findings suggest that the use of central IRBs has the potential to improve RCT efficiency.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.17963DOI Listing
July 2021

Lymphatic Dysregulation in Patients With Heart Failure: JACC Review Topic of the Week.

J Am Coll Cardiol 2021 07;78(1):66-76

Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USA.

The lymphatic system is an integral part of the circulatory system and plays an important role in the volume homeostasis of the human body. The complex anatomy and physiology paired with a lack of simple diagnostic tools to study the lymphatic system have led to an underappreciation of the contribution of the lymphatic system to acute and chronic heart failure (HF). Herein, we discuss the physiological role of the lymphatic system in volume management and the evidence demonstrating the dysregulation of the lymphatic system in HF. Further, we discuss the opportunity to target the lymphatic system in the management of HF and different potential approaches to accessing the lymphatic system.
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http://dx.doi.org/10.1016/j.jacc.2021.04.090DOI Listing
July 2021

National trends in repair for type B aortic dissection.

Clin Cardiol 2021 Aug 26;44(8):1058-1068. Epub 2021 Jun 26.

Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USA.

Background: Thoracic endovascular aortic repair (TEVAR) first gained in popularity for repair of type B aortic dissections (TBADs) in the early 2000's. We aimed to describe patients undergoing open repair, TEVAR, and no repair and analyze factors associated with repair within 14 days of presentation in the contemporary era.

Methods: We used the MarketScan database to find patients with TBAD between 2014 and 2017. To assess factors associated with early repair, univariable, and multivariable log-binomial regression were used.

Results: There were 2613 patients admitted with TBAD between 2014 and 2017 across the United States, of whom 38.4% underwent repair within 14 days of admission (25.3% open repair and 13.1% TEVAR). The incidence of repair within 14 days decreased over the study period (43% of the study cohort in 2014 to 26.4% in 2017) primarily due to a decrease in open repairs from 30.8% of patients in 2014 to 12.5% in 2017. In multivariable analysis, older age, Middle Atlantic location, diabetes mellitus, insulin use, antiplatelet use, and more recent year were associated with lower likelihood of early repair; male sex, peripheral vascular disease, and the presence of extremity ischemia, rupture, shock, and acidosis were associated with higher likelihood of repair.

Conclusions: Overall, repair of TBAD within 14 days of presentation declined from 2014 to 2017, with a steady rate of TEVAR but declining rate of open repairs. Further investigation into provider- and hospital-specific factors as they relate to likelihood of repair is needed.
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http://dx.doi.org/10.1002/clc.23672DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8364733PMC
August 2021

Effectiveness of Blood Lipid Management in Patients With Peripheral Artery Disease.

J Am Coll Cardiol 2021 Jun;77(24):3016-3027

Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA; CPC Clinical Research, Aurora, Colorado, USA.

Background: Low-density lipoprotein cholesterol (LDL-C) is associated with heightened risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in peripheral artery disease (PAD). Lipid-lowering therapies (LLT) that reduce LDL-C decrease this risk.

Objectives: The authors examined LLT use and actual achieved LDL-C in PAD.

Methods: PAD patients in MarketScan from 2014 to 2018 were identified. Outcomes included LLT use, defined as high-intensity (HI) (high-intensity statin, statin plus ezetimibe, or PCSK9 inhibitor), low-intensity (any other lipid regimen), or no therapy, and follow-up LDL-C. Factors associated with LDL-C <70 mg/dl were identified with multivariable logistic regression.

Results: Among 250,103 PAD patients, 20.5% and 39.5% were treated at baseline with HI and low-intensity LLT, respectively; 40.0% were on no LLT. Over a 15-month median follow-up period, HI LLT use increased by 1.5%. Among 18,747 patients with LDL-C data, at baseline, 25.1% were on HI LLT, median LDL-C was 91 mg/dl, and 24.5% had LDL-C <70 mg/dl. Within the HI LLT subgroup, median LDL-C was 81 mg/dl, and 64% had LDL-C ≥70 mg/dl. At follow-up, HI LLT use increased by 3.7%, median LDL-C decreased by 4.0 mg/dl, and an additional 4.1% of patients had LDL-C <70 mg/dl. HI LLT use was greater after follow-up MACE (55.0%) or MALE (41.0%) versus no ischemic event (26.1%). After MACE or MALE, LDL-C was <70 mg/dl in 41.5% and 36.1% of patients, respectively, versus 27.1% in those without an event. Factors associated with follow-up LDL-C <70 mg/dl included smoking, hypertension, diabetes, prior lower extremity revascularization, and prior myocardial infarction but not prior acute or critical limb ischemia.

Conclusions: In PAD, LLT use is suboptimal, LDL-C remains elevated, and LLT intensity is a poor surrogate for achieved LDL-C. Less aggressive lipid management was observed in PAD versus cardiovascular disease, highlighting missed opportunities for implementation of proven therapies in PAD.
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http://dx.doi.org/10.1016/j.jacc.2021.04.060DOI Listing
June 2021

Impact of chronic kidney disease on hemoglobin among patients with peripheral artery disease treated with P2Y inhibitors: Insights from the EUCLID trial.

Vasc Med 2021 Jun 3:1358863X211017641. Epub 2021 Jun 3.

CPC Clinical Research, Aurora, CO, USA.

Patients with chronic kidney disease may develop new or more severe anemia when treated with antiplatelet agents due to blood loss in conjunction with impaired erythropoiesis. Because anemia independently predicts limb amputation and mortality among patients with peripheral artery disease (PAD), we evaluated the relationship between estimated glomerular filtration rate (eGFR) and hemoglobin (Hb) levels in the EUCLID trial in which patients with symptomatic PAD were randomized to ticagrelor or clopidogrel. At baseline, 9025, 1870, and 1000 patients had eGFR ⩾ 60, 45-59, and < 45 mL/min/1.73 m, respectively. The mean fall in Hb during the trial was 0.46 ± 1.68 g/dL and did not differ by baseline eGFR category, although Hb fall ⩾ 10% was more frequent among patients with lower eGFR ( for trend < 0.0001). On-study treatment with iron, erythropoiesis-stimulating agents, and/or red blood cell transfusion was reported for 479 (5.3%), 165 (8.8%), and 129 (12.9%) patients in the three eGFR categories, respectively ( for trend < 0.0001). After adjustment for baseline and post-randomization effects, those not receiving anemia treatment had a smaller reduction in Hb from baseline than those receiving anemia treatment ( < 0.0001). Other determinants of Hb reduction included absence of on-study myocardial infarction, coronary or peripheral revascularization, residence outside North America, male sex, and baseline eGFR. We conclude that among patients with PAD treated with P2Y inhibitors, lower baseline eGFR was associated with a greater reduction in Hb. .
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http://dx.doi.org/10.1177/1358863X211017641DOI Listing
June 2021

Association of Heart Failure With Outcomes Among Patients With Peripheral Artery Disease: Insights From EUCLID.

J Am Heart Assoc 2021 06 31;10(12):e018684. Epub 2021 May 31.

Duke Heart Center Duke University Medical CenterDuke Clinical Research InstituteDuke University School of Medicine Durham NC.

Background Peripheral artery disease (PAD) and heart failure (HF) are each independently associated with poor outcomes. Risk factors associated with new-onset HF in patients with primary PAD are unknown. Furthermore, how the presence of HF is associated with outcomes in patients with PAD is unknown. Methods and Results This analysis examined risk relationships of HF on outcomes in patients with symptomatic PAD randomized to ticagrelor or clopidogrel as part of the EUCLID (Examining Use of Ticagrelor in Peripheral Arterial Disease) trial. Patients were stratified based on presence of HF at enrollment. Cox models were used to determine the association of HF with outcomes. A separate Cox model was used to identify risk factors associated with development of HF during follow-up. Patients with PAD and HF had over twice the rate of concomitant coronary artery disease as those without HF. Patients with PAD and HF had significantly increased risk of major adverse cardiovascular events (hazard ratio [HR], 1.31; 95% CI, 1.13-1.51) and all-cause mortality (HR, 1.39; 95% CI, 1.19-1.63). In patients with PAD, the presence of HF was associated with significantly less bleeding (HR, 0.65; 95% CI, 0.45-0.96). Characteristics associated with HF development included age ≥66 (HR, 1.29; 95% CI, 1.18-1.40 per 5 years), diabetes mellitus (HR, 1.85; 95% CI, 1.41-2.43), and weight (bidirectionally associated, ≥76 kg, HR, 0.77; 95% CI, 0.64-0.93; <76 kg, HR, 1.12; 95% CI, 1.07-1.16). Conclusions Patients with PAD and HF have a high rate of coronary artery disease with a high risk for major adverse cardiovascular events and death. These data support the possible need for aggressive treatment of (recurrent) atherosclerotic disease in PAD, especially patients with HF.
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http://dx.doi.org/10.1161/JAHA.120.018684DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8477881PMC
June 2021

The association of healthcare disparities and patient-specific factors on clinical outcomes in peripheral artery disease.

Am Heart J 2021 09 27;239:135-146. Epub 2021 May 27.

Division of Cardiology, Duke University Health System, Durham, NC; Duke Clinical Research Institute, Durham, NC. Electronic address:

Background: PAD increases the risk of cardiovascular mortality and limb loss, and disparities in treatment and outcomes have been described. However, the association of patient-specific characteristics with variation in outcomes is less well known.

Methods: Patients with PAD from Duke University Health System (DUHS) between January 1, 2015 and March 31, 2016 were identified. PAD status was confirmed through ground truth adjudication and predictive modeling using diagnosis codes, procedure codes, and other administrative data. Symptom severity, lower extremity imaging, and ankle-brachial index (ABI) were manually abstracted from the electronic health record (EHR). Data was linked to Centers for Medicare and Medicaid Services data to provide longitudinal follow up. Primary outcome was major adverse vascular events (MAVE), a composite of all-cause mortality, myocardial infarction (MI), stroke, lower extremity revascularization and amputation.

Results: Of 1,768 patients with PAD, 31.6% were asymptomatic, 41.2% had intermittent claudication (IC), and 27.3% had chronic limb-threatening ischemia (CLTI). At 1 year, patients with CLTI had higher rates of MAVE compared with asymptomatic or IC patients. CLTI and Medicaid dual eligibility were independent predictors of mortality. CLTI and Black race were associated with amputation.

Conclusions: Rates of MAVE were highest in patients with CLTI, but patients with IC or asymptomatic disease also had high rates of adverse events. Black and Medicaid dual-eligible patients were disproportionately present in the CLTI subgroup and were at higher risk of amputation and mortality, respectively. Future studies must focus on early identification of high-risk patient groups to improve outcomes in patients with PAD.
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http://dx.doi.org/10.1016/j.ahj.2021.05.014DOI Listing
September 2021

Total Ischemic Event Reduction With Rivaroxaban After Peripheral Arterial Revascularization in the VOYAGER PAD Trial.

J Am Coll Cardiol 2021 Jul 16;78(4):317-326. Epub 2021 May 16.

CPC Clinical Research, Aurora, Colorado, USA; Department of Medicine, Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USA. Electronic address:

Background: Patients with peripheral artery disease (PAD) undergoing lower extremity revascularization (LER) are at high risk of major adverse limb and cardiovascular events. The VOYAGER PAD (Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities) trial demonstrated that rivaroxaban 2.5 mg twice daily reduced first events by 15%. The benefit of rivaroxaban on total (first and subsequent) events in this population is unknown.

Objectives: This study sought to evaluate the total burden of vascular events in patients with PAD after LER and the efficacy of low-dose rivaroxaban on total events.

Methods: VOYAGER PAD randomized patients with PAD undergoing LER to rivaroxaban 2.5 mg twice daily plus aspirin or aspirin alone. The primary endpoint was time to first event of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The current analysis considered all events (first and subsequent) for components of the primary endpoint as well as additional vascular events including peripheral revascularizations and venous thromboembolism. HRs were estimated by marginal proportional hazards models.

Results: Among 6,564 randomized events, there were 4,714 total first and subsequent vascular events including 1,614 primary endpoint events and 3,100 other vascular events. Rivaroxaban reduced total primary endpoint events (HR: 0.86; 95% CI: 0.75-0.98; P = 0.02) and total vascular events (HR: 0.86; 95% CI: 0.79-0.95; P = 0.003). An estimated 4.4 primary and 12.5 vascular events per 100 participants were avoided with rivaroxaban over 3 years.

Conclusions: Patients with symptomatic PAD who are undergoing LER have a high total event burden that is significantly reduced with rivaroxaban. Total event reduction may be a useful metric to quantify the efficacy of rivaroxaban in this setting. (Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities [VOYAGER PAD]; NCT02504216).
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http://dx.doi.org/10.1016/j.jacc.2021.05.003DOI Listing
July 2021

A prospective multicenter validation study for a novel angiography-derived physiological assessment software: Rationale and design of the radiographic imaging validation and evaluation for Angio-iFR (ReVEAL iFR) study.

Am Heart J 2021 09 13;239:19-26. Epub 2021 May 13.

Department of Cardiology, National University of Ireland, Galway, Galway (NUIG), Ireland.

Angiography-derived physiological assessment of coronary lesions has emerged as an alternative to wire-based assessment aiming at less-invasiveness and shorter procedural time as well as cost effectiveness in physiology-guided decision making. However, current available image-derived physiology software have limitations including the requirement of multiple projections and are time consuming. METHODS/DESIGN: The ReVEAL iFR (Radiographic imaging Validation and EvALuation for Angio-iFR) trial is a multicenter, multicontinental, validation study which aims to validate the diagnostic accuracy of the Angio-iFR medical software device (Philips, San Diego, US) in patients undergoing angiography for Chronic Coronary Syndrome (CCS). The Angio-iFR will enable operators to predict both the iFR and FFR value within a few seconds from a single projection of cine angiography by using a lumped parameter fluid dynamics model. Approximately 440 patients with at least one de-novo 40% to 90% stenosis by visual angiographic assessment will be enrolled in the study. The primary endpoint is the sensitivity and specificity of the iFR and FFR for a given lesion compared to the corresponding invasive measures. The enrollment started in August 2019, and was completed in March 2021. SUMMARY: The Angio-iFR system has the potential of simplifying physiological evaluation of coronary stenosis compared with available systems, providing estimates of both FFR and iFR. The ReVEAL iFR study will investigate the predictive performance of the novel Angio-iFR software in CCS patients. Ultimately, based on its unique characteristics, the Angio-iFR system may contribute to improve adoption of functional coronary assessment and the workflow in the catheter laboratory.
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http://dx.doi.org/10.1016/j.ahj.2021.05.004DOI Listing
September 2021

Establishing Thresholds for Minimal Clinically Important Differences for the Peripheral Artery Disease Questionnaire.

Circ Cardiovasc Qual Outcomes 2021 05 5;14(5):e007232. Epub 2021 May 5.

Vascular Medicine Outcomes (VAMOS) Program, Section of Cardiovascular Medicine, Yale University, New Haven, CT (C.M.-H., Q.-U.-A.J., K.G.S.).

Background: Understanding minimum clinically important differences (MCID) in patient-reported outcomes is essential in interpreting the magnitude of changes in these measures. No MCID from patients' perspectives has ever been published for peripheral artery disease-specific health status assessment tools. The Peripheral Artery Questionnaire (PAQ) is a commonly used, validated peripheral artery disease-specific health status instrument for which we sought to prospectively establish its MCID from patients' perspectives.

Methods And Results: Patients presenting to vascular clinics with new or worsened claudication in the US cohort of the PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry who completed baseline and follow-up PAQ assessments along with the Global Assessment of Functioning scale were included. Mean change in PAQ summary scores from 3- to 6-month follow-up was calculated according to Global Assessment of Functioning category. MCID was defined as the mean difference in scores between those with small improvement or deterioration and those with no change. Multivariable linear regression was used to provide an MCID estimate after adjusting for patients' 3-month PAQ score. Of the 483 patients who completed the Global Assessment of Functioning score at 6 months and who had available 3- and 6-month PAQ assessments, the mean age was 69 years, 42% were female, and 71% were White. The MCIDs for PAQ summary scale improvement and worsening were 8.7 (2.9-14.5) and -11.0 (-18.6 to -3.3), respectively. After multivariable adjustment, these were 8.9 (3.0-14.8) and -11.2 (-18.2 to -4.2), respectively. There was no significant interaction between treatment (invasive versus noninvasive) and Global Assessment of Functioning response (=0.75).

Conclusions: In patients with new or worsened claudication, a 10-point change in PAQ summary score represents an MCID. This estimate needs external validation and may inform the interpretation of PAQ scores when used as outcomes in clinical trials or in routine clinical care. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01419080.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.007232DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8254614PMC
May 2021

SCAI expert consensus update on best practices in the cardiac catheterization laboratory: This statement was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society (HRS) in April 2021.

Catheter Cardiovasc Interv 2021 08 19;98(2):255-276. Epub 2021 May 19.

Division of Cardiovascular Medicine, Perelman School of Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.

The current document commissioned by the Society for Cardiovascular Angiography and Interventions (SCAI) and endorsed by the American College of Cardiology, the American Heart Association, and Heart Rhythm Society represents a comprehensive update to the 2012 and 2016 consensus documents on patient-centered best practices in the cardiac catheterization laboratory. Comprising updates to staffing and credentialing, as well as evidence-based updates to the pre-, intra-, and post-procedural logistics, clinical standards and patient flow, the document also includes an expanded section on CCL governance, administration, and approach to quality metrics. This update also acknowledges the collaboration with various specialties, including discussion of the heart team approach to management, and working with electrophysiology colleagues in particular. It is hoped that this document will be utilized by hospitals, health systems, as well as regulatory bodies involved in assuring and maintaining quality, safety, efficiency, and cost-effectiveness of patient throughput in this high volume area.
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http://dx.doi.org/10.1002/ccd.29744DOI Listing
August 2021

Splanchnic nerve modulation in heart failure: mechanistic overview, initial clinical experience, and safety considerations.

Eur J Heart Fail 2021 07 9;23(7):1076-1084. Epub 2021 May 9.

Duke University Hospital, Durham, NC, USA.

Volume recruitment from the splanchnic compartment is an important physiological response to stressors such as physical activity and blood loss. In the setting of heart failure (HF), excess fluid redistribution from this compartment leads to increased cardiac filling pressures with limitation in exercise capacity. Recent evidence suggests that blocking neural activity of the greater splanchnic nerve (GSN) could have significant benefits in some patients with HF by reducing cardiac filling pressures and improving exercise capacity. However, to date the long-term safety of splanchnic nerve modulation (SNM) in the setting of HF is unknown. SNM is currently used in clinical practice to alleviate some forms of chronic abdominal pain. A systematic review of the series where permanent SNM was used as a treatment for chronic abdominal pain indicates that permanent SNM is well tolerated, with side-effects limited to transient diarrhoea or abdominal colic and transient hypotension. The pathophysiological role of the GSN in volume redistribution, the encouraging findings of acute and chronic pilot SNM studies and the safety profile from permanent SNM for pain provides a strong basis for continued efforts to study this therapeutic target in HF.
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http://dx.doi.org/10.1002/ejhf.2196DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8298285PMC
July 2021
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