Publications by authors named "Michael R Jaff"

351 Publications

Case 30-2021: A 47-Year-Old Man with Recurrent Unilateral Head and Neck Pain.

N Engl J Med 2021 Sep;385(14):1317-1325

From the Departments of Medicine (M.E.L., D.M.D.), Pediatrics (M.E.L., J.V.T.), Radiology (B.C.Y.), and Surgery (M.R.J.), Massachusetts General Hospital, and the Departments of Medicine (M.E.L., D.M.D., M.R.J.), Pediatrics (M.E.L., J.V.T.), and Radiology (B.C.Y.), Harvard Medical School - both in Boston.

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http://dx.doi.org/10.1056/NEJMcpc2107347DOI Listing
September 2021

Analysis of Costs and Payments for Inferior Vena Cava Filter Retrieval in the Medicare Population.

J Vasc Interv Radiol 2021 Aug;32(8):1164-1169

Dotter Department of Interventional Radiology, Oregon Health and Science University, Portland, Oregon.

Over the past decade, inferior vena cava (IVC) filter retrieval has been increasing, in part due to Food and Drug Administration recommendations and legal pressure. The costs and margin of IVC filter removal are poorly understood. Medicare claims data from 2016 for the 103 highest volume centers for IVC filter retrieval were examined. Pooled mean charges, costs, payments, and margin were calculated by institution. Mean ± SD charges, costs, and payments were $14,138.00 ± $8,400.48, $3,693.28 ± $2,294.27, and $1,949.82 ± $702.91, respectively. Average (range) margin was -$1,706.18 (-$7,509.93 to $362.77). The margin was negative in 99 of the 103 (96%) institutions evaluated. The most significant contributors to the total procedure cost were operating room, supplies, and recovery (44.5%, 23.5%, and 10.4%, respectively). While IVC filter retrieval is often medically indicated, it is typically associated with a financial loss under current reimbursement structure.
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http://dx.doi.org/10.1016/j.jvir.2021.05.009DOI Listing
August 2021

Clinical Impact of Contralateral Carotid Occlusion in Patients Undergoing Carotid Artery Revascularization.

J Am Coll Cardiol 2021 02;77(7):835-844

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA; Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. Electronic address:

Background: The presence of a contralateral carotid occlusion (CCO) is an established high-risk feature for patients undergoing carotid endarterectomy (CEA) and is traditionally an indication for carotid artery stenting (CAS). Recent observational data have called into question whether CCO remains a high-risk feature for CEA.

Objectives: The purpose of this study was to determine the clinical impact of CCO among patients undergoing CEA and CAS in a contemporary nationwide registry.

Methods: All patients undergoing CEA or CAS from 2007 to 2019 in the NCDR CARE (National Cardiovascular Data Registry Carotid Artery Revascularization and Endarterectomy) and PVI (Peripheral Vascular Intervention) registries were included. The primary exposure was the presence of CCO. The outcome was a composite of in-hospital death, stroke, and myocardial infarction. Multivariable logistic regression and inverse-probability of treatment weighting were used to compare outcomes.

Results: Among 58,423 patients who underwent carotid revascularization, 4,624 (7.9%) had a CCO. Of those, 68.9% (n = 3,185) underwent CAS and 31.1% (n = 1,439) underwent CEA. The average age of patients with CCO was 69.5 ± 9.7 years, 32.6% were women, 92.8% were Caucasian, 51.7% had a prior transient ischemic attack or stroke, and 45.4% presented with symptomatic disease. Over the study period, there was a 41.7% decrease in the prevalence of CCO among patients who underwent carotid revascularization (p < 0.001), but CAS remained the primary revascularization strategy. Unadjusted composite outcome rates were lower in patients with CCO after CAS (2.1%) than CEA (3.6%). Following adjustment, CCO was associated with a 71% increase in the odds of an adverse outcome after CEA (95% confidence interval: 1.27 to 2.30; p < 0.001) compared with no increase after CAS (adjusted odds ratio: 0.94; 95% confidence interval: 0.72 to 1.22; p = 0.64).

Conclusions: CCO remains an important predictor of increased risk among patients undergoing CEA, but not CAS.
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http://dx.doi.org/10.1016/j.jacc.2020.12.032DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7899080PMC
February 2021

Modern multidisciplinary team approach is crucial in treatment for critical limb threatening ischemia.

J Cardiovasc Surg (Torino) 2021 Apr 26;62(2):124-129. Epub 2021 Jan 26.

Division of Interventional Radiology, Miami Cardiac and Vascular Institute, FIU Herbert Wertheim College of Medicine, Miami, FL, USA.

The aim of this study was to provide a brief overview of the history the multidisciplinary team approach, highlighting the benefit to the patient with critical limb threatening ischemia in relation to health care economics. Furthermore, we provided a description of the requisites and key components, showing how to build a multidisciplinary team.
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http://dx.doi.org/10.23736/S0021-9509.21.11725-2DOI Listing
April 2021

Time-Restricted Salutary Effects of Blood Flow Restoration on Venous Thrombosis and Vein Wall Injury in Mouse and Human Subjects.

Circulation 2021 Mar 15;143(12):1224-1238. Epub 2021 Jan 15.

Cardiovascular Research Center, Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston (W.L., C.W.K., M.O., L.W., A.T., F.A.J.).

Background: Up to 50% of patients with proximal deep vein thrombosis (DVT) will develop the postthrombotic syndrome characterized by limb swelling and discomfort, hyperpigmentation, skin ulcers, and impaired quality of life. Although catheter-based interventions enabling the restoration of blood flow (RBF) have demonstrated little benefit on postthrombotic syndrome, the impact on the acuity of the thrombus and mechanisms underlying this finding remain obscure. In experimental and clinical studies, we examined whether RBF has a restricted time window for improving DVT resolution.

Methods: First, experimental stasis DVT was generated in C57/BL6 mice (n=291) by inferior vena cava ligation. To promote RBF, mice underwent mechanical deligation with or without intravenous recombinant tissue plasminogen activator administered 2 days after deligation. RBF was assessed over time by ultrasonography and intravital microscopy. Resected thrombosed inferior vena cava specimens underwent thrombus and vein wall histological and gene expression assays. Next, in a clinical study, we conducted a post hoc analysis of the ATTRACT (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) pharmacomechanical catheter-directed thrombolysis (PCDT) trial (NCT00790335) to assess the effects of PCDT on Venous Insufficiency Epidemiological and Economic Study quality-of-life and Villalta scores for specific symptom-onset-to-randomization timeframes.

Results: Mice that developed RBF by day 4, but not later, exhibited reduced day 8 thrombus burden parameters and reduced day 8 vein wall fibrosis and inflammation, compared with controls. In mice without RBF, recombinant tissue plasminogen activator administered at day 4, but not later, reduced day 8 thrombus burden and vein wall fibrosis. It is notable that, in mice already exhibiting RBF by day 4, recombinant tissue plasminogen activator administration did not further reduce thrombus burden or vein wall fibrosis. In the ATTRACT trial, patients receiving PCDT in an intermediate symptom-onset-to-randomization timeframe of 4 to 8 days demonstrated maximal benefits in Venous Insufficiency Epidemiological and Economic Study quality-of-life and Villalta scores (between-group difference=8.41 and 1.68, respectively, <0.001 versus patients not receiving PCDT). PCDT did not improve postthrombotic syndrome scores for patients having a symptom-onset-to-randomization time of <4 days or >8 days.

Conclusions: Taken together, these data illustrate that, within a restricted therapeutic window, RBF improves DVT resolution, and PCDT may improve clinical outcomes. Further studies are warranted to examine the value of time-restricted RBF strategies to reduce postthrombotic syndrome in patients with DVT.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.049096DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7988304PMC
March 2021

American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism.

Blood Adv 2020 10;4(19):4693-4738

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.

Background: Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), occurs in ∼1 to 2 individuals per 1000 each year, corresponding to ∼300 000 to 600 000 events in the United States annually.

Objective: These evidence-based guidelines from the American Society of Hematology (ASH) intend to support patients, clinicians, and others in decisions about treatment of VTE.

Methods: ASH formed a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline development process, including updating or performing systematic evidence reviews. The panel prioritized clinical questions and outcomes according to their importance for clinicians and adult patients. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess evidence and make recommendations, which were subject to public comment.

Results: The panel agreed on 28 recommendations for the initial management of VTE, primary treatment, secondary prevention, and treatment of recurrent VTE events.

Conclusions: Strong recommendations include the use of thrombolytic therapy for patients with PE and hemodynamic compromise, use of an international normalized ratio (INR) range of 2.0 to 3.0 over a lower INR range for patients with VTE who use a vitamin K antagonist (VKA) for secondary prevention, and use of indefinite anticoagulation for patients with recurrent unprovoked VTE. Conditional recommendations include the preference for home treatment over hospital-based treatment for uncomplicated DVT and PE at low risk for complications and a preference for direct oral anticoagulants over VKA for primary treatment of VTE.
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http://dx.doi.org/10.1182/bloodadvances.2020001830DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7556153PMC
October 2020

Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty.

J Endovasc Ther 2020 Dec 31;27(6):946-955. Epub 2020 Aug 31.

Fukuoka Sanno Hospital, Fukuoka, Japan.

Purpose: To evaluate the 3-year safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA) in a Japanese population with femoropopliteal occlusive disease.

Materials And Methods: The multicenter, prospective, IN.PACT SFA Japan randomized controlled trial ( identifier NCT01947478) was an independently adjudicated study evaluating Japanese participants randomized 2:1 to DCB (n=68) or PTA (n=32). The effectiveness endpoint was primary patency through 36 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis (by duplex ultrasound). The effectiveness endpoint was evaluated using the Kaplan-Meier method; estimates are presented with the 95% confidence intervals (CIs). The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization through 36 months.

Results: Primary patency by Kaplan-Meier estimate was higher in the DCB group (68.9%, 95% CI 57.5% to 80.2%) vs the PTA group (46.9%, 95% CI 29.6% to 64.2%) at 36 months (log-rank p=0.001). The CD-TLR rates were 14.9% (10/67) for the DCB group and 20.7% (6/29) for PTA (p=0.554). The safety composite endpoint occurred in 83.6% (56/67) of DCB participants and 75.9% (22/29) of PTA participants (p=0.402). All-cause death was similar between groups at 36 months [DCB 6.0% (4/67) vs PTA 6.9% (2/29), p>0.999), with no device- or procedure-related deaths in either group.

Conclusion: The final report of the IN.PACT SFA Japan trial showed that the IN.PACT Admiral DCB is safe and had durable outcomes through 3 years in Japanese participants with femoropopliteal occlusive disease.
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http://dx.doi.org/10.1177/1526602820948240DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7649941PMC
December 2020

Paclitaxel Drug-Coated Balloon Angioplasty Suppresses Progression and Inflammation of Experimental Atherosclerosis in Rabbits.

JACC Basic Transl Sci 2020 Jul 10;5(7):685-695. Epub 2020 Jun 10.

Cardiovascular Research Center, Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.

Paclitaxel drug-coated balloons (DCBs) reduce restenosis, but their overall safety has recently raised concerns. This study hypothesized that DCBs could lessen inflammation and reduce plaque progression. Using 25 rabbits with cholesterol feeding- and balloon injury-induced lesions, DCB-percutaneous transluminal angioplasty (PTA), plain PTA, or sham-PTA (balloon insertion without inflation) was investigated using serial intravascular near-infrared fluorescence-optical coherence tomography and serial intravascular ultrasound. In these experiments, DCB-PTA reduced inflammation and plaque burden in nonobstructive lesions compared with PTA or sham-PTA. These findings indicated the potential for DCBs to serve safely as regional anti-atherosclerosis therapy.
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http://dx.doi.org/10.1016/j.jacbts.2020.04.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7393431PMC
July 2020

Total IN.PACT All-Subjects One-Year Analysis and Standard vs Broader Implications.

J Invasive Cardiol 2020 Jul;32(7):243-248

Case Western Reserve University School of Medicine, University Hospitals, 11100 Euclid Avenue, Lakeside 3rd Floor, Cleveland, OH 44106 USA.

Drug-coated balloons (DCBs) have been shown to be superior to percutaneous transluminal angioplasty (PTA) for symptomatic femoropopliteal disease in randomized clinical trials; however, their clinical effectiveness and safety in more complex disease is less defined. The study sought to conduct a patient-level pooled analysis of all prospective randomized and single-arm studies evaluating the safety and efficacy of IN.PACT Admiral DCB (Medtronic) worldwide and in patients with complex disease. Subjects were treated with either IN.PACT Admiral DCB (n = 1837) or PTA (n = 143). The primary endpoint was freedom from clinically driven target-lesion revascularization (CD-TLR) within 12 months. The primary safety composite endpoint was freedom from device- and procedure-related death through 30 days, and freedom from major target-limb amputation, clinically driven target-vessel revascularization, and thrombosis within 12 months. Subsequently, we examined "real-life" complex lesions in a subgroup analysis, with standard use defined as simple, single de novo lesions (n = 712) and broader use defined as bilateral or multiple lesions (n = 1125). DCB when compared with PTA had significantly higher rates of freedom from CD-TLR through 12 months (93.8% vs 80.2%, respectively; P<.001). The DCB group did note higher rates of mortality at 1 year (3.1% DCB vs 0.0% PTA; P=.03). Notably, the broader use group showed superiority over the PTA group for freedom from CD-TLR (91.7% vs 80.2%; P<.001). IN.PACT Admiral DCB showed clinical superiority to PTA in the largest patient-level pooled analysis. Additionally, despite more complex and challenging lesions, DCB was superior to PTA. However, further adequately powered randomized studies are needed to confirm these results.
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July 2020

Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort.

J Endovasc Ther 2020 10 25;27(5):693-705. Epub 2020 Jun 25.

Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.

To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study ( identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.
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http://dx.doi.org/10.1177/1526602820931477DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7545651PMC
October 2020

Endovascular Intervention for the Treatment of Trans-Atlantic Inter-Society Consensus (TASC) D Femoropopliteal Lesions: A Systematic Review and Meta-Analysis.

Cardiovasc Revasc Med 2021 01 12;22:52-65. Epub 2020 Jun 12.

Division of Cardiology, Rocky Mountain Regional VA Medical Center, University of Colorado, Denver, CO, USA. Electronic address:

Purpose: Advancements in the endovascular treatment of femoropopliteal atherosclerotic lesions have led to treatment of more complex lesions, particularly long lesions. The aim of this study was to determine the meta-analytic primary patency and need for re-intervention among patients treated for very long lesions (>200 mm) at the femoropopliteal segment and to identify potential risk factors for loss of patency.

Methods: This study was performed according to the PRISMA guidelines. A random effects model meta-analysis was conducted, and the I-square was used to assess heterogeneity.

Results: Fifty-one studies comprised of 3029 patients were included. The mean lesion length was 269 mm. The primary patency rate at 30 days, 6 m, 1-, 2- and 5-years of follow-up was 98%, 76%, 62%, 55%, and 39% respectively. The incidence of TLR was 16% at one year and 32% at two years. The secondary patency rate at 1, 2, 3 and 5 years was 85%, 71%, 64%, and 64% respectively. Heparin bonded ePTFE covered stents (69%) and paclitaxel eluting stents (73%) demonstrated higher 1-year primary patency rates than self-expanding nitinol stents (55%) or uncoated percutaneous transluminal angioplasty (PTA) with provisional stenting (54%). Lesions treated with a heparin bonded ePTFE covered stent had statistically significant higher odds of remaining patent at 1-year of follow-up (OR: 2.74; 95%CI: 1.63-4.61; p < 0.001) than lesions treated with BMS or PTA. Patients with long femoropopliteal lesions causing critical limb ischemia (CLI) developed restenosis or occlusion more often than patients treated for claudication (HR: 1.63; 95%CI: 1.06-2.49; p = 0.026) during an average follow-up of 26 months.

Conclusion: Primary stenting of femoropopliteal TASC D lesions using drug eluting stents or covered stents results in sustained patency over time. PTA or uncoated nitinol stents demonstrated lower patency rates. However, additional comparative studies are needed to determine the efficacy of newer technologies for the treatment of complex femoropopliteal lesions and provide evidence for the most optimal treatment approach.
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http://dx.doi.org/10.1016/j.carrev.2020.06.014DOI Listing
January 2021

Digital Subtraction Angiography Prior to an Amputation for Critical Limb Ischemia (CLI): An Expert Recommendation Statement From the CLI Global Society to Optimize Limb Salvage.

J Endovasc Ther 2020 Aug 29;27(4):540-546. Epub 2020 May 29.

Division of Interventional Radiology, Miami Cardiac and Vascular Institute, Miami, FL, USA.

Despite recent guideline updates on peripheral artery disease (PAD) and critical limb ischemia (CLI) treatment, the optimal treatment for CLI is still being debated. As a result, care is inconsistent, with many CLI patients undergoing an amputation prior to what many consider to be mandatory: consultation with an interdisciplinary specialty care team and a comprehensive imaging assessment. More importantly, quality imaging is critical in CLI patients with below-the-knee disease. Therefore, the CLI Global Society has put forth an interdisciplinary expert recommendation for superselective digital subtraction angiography (DSA) that includes the ankle and foot in properly indicated CLI patients to optimize limb salvage. A recommended imaging algorithm for CLI patients is included.
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http://dx.doi.org/10.1177/1526602820928590DOI Listing
August 2020

Three-Year Efficacy and Safety of the Misago Peripheral Stent for Superficial Femoral Artery Disease: Final Results from the OSPREY Trial.

J Vasc Interv Radiol 2020 Jun 12;31(6):978-985. Epub 2020 May 12.

Department of Surgery, Jikei University, Tokyo, Japan.

Purpose: This study evaluated the long-term outcomes of the Misago peripheral stent trial (Terumo) for atherosclerotic lesions in the superficial femoral artery (SFA) in patients with claudication.

Materials And Methods: This was a prospective multicenter, single-arm, clinical trial of primary stent placement for de novo cases of SFA disease conducted in the United States and Asia. The primary endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) at 36 months. Secondary outcomes were ankle-brachial index (ABI), Rutherford score, Walking Impairment Questionnaire (WIQ), a quality of life survey, and rate of device fracture.

Results: A total of 276 patients (64.4% male; mean age, 69.3 ± 10.1 years) were enrolled. Freedom from CD-TLR was 78.5% (95% confidence interval [CI], 73.0%-83.0%) at 24 months and 75.4% (95% CI, 69.6%-80.2%) at 36 months. Baseline ABI was 0.7 ± 0.1 and 0.98 ± 0.20 (P < .001) at 30 days after the procedure. Baseline Rutherford score was 3.6 ± 0.6 and 1.6 ± 1.0 30 at 30 days after the procedure (P < .001). Mean (and changed) ABI and Rutherford score at 36 months compared to day 30 after the procedure were, respectively, 0.91 (-0.1 ± 0.2) and 1.5 (-0.2 ± 1.1). WIQ score at baseline was 21.49 ± 26.30 and 50.51 ± 38.49 at 30 days after the procedure ( P < .001). The mean WIQ score at 2 years was 46.65 ± 37.31 (P = .12). Stent fracture rate at 36 months was 2.0% (4 of 202 patients).

Conclusions: OSPREY (Occlusive-Stenotic Peripheral Artery Revascularization Study) 36-month data demonstrated persistent freedom from CD-TLR and sustained improvement in ABI and Rutherford score with primary stent placement for SFA lesions.
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http://dx.doi.org/10.1016/j.jvir.2020.01.004DOI Listing
June 2020

Mortality and Paclitaxel-Coated Devices: An Individual Patient Data Meta-Analysis.

Circulation 2020 06 6;141(23):1859-1869. Epub 2020 May 6.

Cardiovascular Division, Vanderbilt University Medical Center, Nashville, TN (J.A.B.).

Background: Paclitaxel-containing devices (PTXDs) significantly reduce reintervention in patients with symptomatic femoropopliteal peripheral artery disease. A recent aggregate-data meta-analysis reported increased late mortality in patients with peripheral artery disease treated with PTXDs. We performed an individual patient data meta-analysis to evaluate mortality.

Methods: Manufacturers of US Food and Drug Administration-approved and commercially available devices in the United States provided deidentified individual patient data for independent analysis. Cox proportional hazards 1-stage meta-analysis models using intention-to-treat methods were used for the primary analysis. A secondary analysis of recovered missing vital status data was performed. The impact of control crossover to PTXDs, cause-specific mortality, and drug dose mortality were assessed.

Results: A total of 2185 subjects and 386 deaths from 8 PTXD trials with 4-year median follow-up were identified. The primary analysis indicated a 38% (95% CI, 6% to 80%) increased relative mortality risk, corresponding to 4.6% absolute increase, at 5 years associated with PTXD use. Control and treatment arm loss to follow-up and withdrawal were 24% and 23%, respectively. With inclusion of recovered vital status data, the excess relative mortality risk was 27% (95% CI, 3%-58%). This observation was consistent across various scenarios, including as-treated analyses, with no evidence of increased risk over time with PTXDs. Mortality risk tended to be increased for all major causes of death. There were no subgroup differences. No drug dose-mortality association was identified.

Conclusions: This individual patient data meta-analysis, based on the most complete available data set of mortality events from PTXD randomized controlled trials, identified an absolute 4.6% increased mortality risk associated with PTXD use.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.119.044697DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8029645PMC
June 2020

Outcomes of catheter-directed versus systemic thrombolysis for the treatment of pulmonary embolism: A real-world analysis of national administrative claims.

Vasc Med 2020 08 27;25(4):334-340. Epub 2020 Apr 27.

Department of Medicine, Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.

Catheter-directed thrombolysis (CDT) and systemic thrombolysis (ST) are used to treat intermediate/high-risk pulmonary embolism (PE) in the absence of comparative safety and effectiveness data. We utilized a large administrative database to perform a comparative safety and effectiveness analysis of catheter-directed versus systemic thrombolysis. From the Optum Clinformatics Data Mart private-payer insurance claims database, we identified 100,744 patients hospitalized with PE between 2004 and 2014. We extracted demographic characteristics, high-risk PE features, components of the Elixhauser Comorbidity Index, and outcomes including intracranial hemorrhage (ICH), all-cause bleeding, and mortality among all patients receiving CDT and ST. We used propensity score methods to compare outcomes between matched cohorts adjusted for observed confounders. A total of 1915 patients (1.9%) received either CDT ( = 632) or ST ( = 1283). Patients in the CDT group had fewer high-risk features including less shock (5.4 vs 11.1%; < 0.001) and cardiac arrest (6.8 vs 11.0%; = 0.004). In 1:1 propensity-matched groups, ICH rates were 1.9% in both the CDT and ST groups ( = 1.0). All-cause bleeding was higher in the CDT group (15.9 vs 8.7%; < 0.001), while in-hospital mortality was lower (6.5 vs 10.0%; = 0.02). Among a nationally representative cohort of patients with PE at higher risk for mortality, CDT was associated with similar ICH rates, increased all-cause bleeding, and lower short and intermediate-term mortality when compared with ST. The competing risks and benefits of CDT in real-world practice suggest the need for large-scale randomized clinical trials with appropriate comparator arms.
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http://dx.doi.org/10.1177/1358863X20903371DOI Listing
August 2020

Thrombolytics for venous thromboembolic events: a systematic review with meta-analysis.

Blood Adv 2020 04;4(7):1539-1553

Department of Internal Medicine and Centro Evidencia Unversidad Católica, Pontificia Universidad Católica de Chile, Santiago, Chile; and.

Thrombolytic therapy might reduce venous thromboembolism-related mortality and morbidity, but it could also increase the risk of major bleeding. We systematically reviewed the literature to evaluate the effectiveness and safety of thrombolytics in patients with pulmonary embolism (PE) and/or deep venous thrombosis (DVT). We searched Medline, Embase, and Cochrane databases for relevant randomized controlled trials up to February 2019. Multiple investigators independently screened and collected data. We included 45 studies (4740 participants). Pooled estimates of PE studies indicate probable reduction in mortality with thrombolysis (risk ratio [RR], 0.61; 95% confidence interval [CI], 0.40-0.94) (moderate certainty) and possible reduction in nonfatal PE recurrence (RR, 0.56; 95% CI, 0.35-0.89) (low certainty). Pooled estimates of DVT studies indicate the possible absence of effects on mortality (RR, 0.77; 95% CI, 0.26-2.28) (low certainty) and recurrent DVT (RR, 0.99; 95% CI, 0.56-1.76) (low certainty), but possible reduction in postthrombotic syndrome (PTS) with thrombolytics (RR, 0.70; 95% CI, 0.59-0.83) (low certainty). Pooled estimates of the complete body of evidence indicate increases in major bleeding (RR, 1.89; 95% CI, 1.46-2.46) (high certainty) and a probable increase in intracranial bleeding (RR, 3.17; 95% CI 1.19-8.41) (moderate certainty) with thrombolytics. Our findings indicate that thrombolytics probably reduce mortality in patients with submassive- or intermediate-risk PE and may reduce PTS in patients with proximal DVT at the expense of a significant increase in major bleeding. Because the balance between benefits and harms is profoundly influenced by the baseline risks of critical outcomes, stakeholders involved in decision making would need to weigh these effects to define which clinical scenarios merit the use of thrombolytics.
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http://dx.doi.org/10.1182/bloodadvances.2020001513DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7160254PMC
April 2020

SCAI publications committee manual of standard operating procedures.

Catheter Cardiovasc Interv 2020 07 14;96(1):145-155. Epub 2020 Feb 14.

Cardiovascular Associates of Alabama, Birmingham, Alabama.

Evidence-based recommendations for clinical practice are intended to help health care providers and patients make decisions, minimize inappropriate practice variation, promote effective resource use, improve clinical outcomes, and direct future research. The Society for Cardiovascular Angiography and Interventions (SCAI) has been engaged in the creation and dissemination of clinical guidance documents since the 1990s. These documents are a cornerstone of the society's education, advocacy, and quality improvement initiatives. The publications committee is charged with oversight of SCAI's clinical documents program and has created this manual of standard operating procedures to ensure consistency, methodological rigor, and transparency in the development and endorsement of the society's documents. The manual is intended for use by the publications committee, document writing groups, external collaborators, SCAI representatives, peer reviewers, and anyone seeking information about the SCAI documents program.
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http://dx.doi.org/10.1002/ccd.28754DOI Listing
July 2020

Ultrasound-Accelerated Thrombolysis and Venoplasty for the Treatment of the Postthrombotic Syndrome: Results of the ACCESS PTS Study.

J Am Heart Assoc 2020 02 25;9(3):e013398. Epub 2020 Jan 25.

VasCore The Vascular Ultrasound Core Laboratory Massachusetts General Hospital Boston MA.

Background Postthrombotic syndrome is a common complication of deep vein thrombosis, with limited treatment options. Methods and Results ACCESS PTS (Accelerated Thrombolysis for Post-Thrombotic Syndrome Using the Acoustic Pulse Thrombolysis Ekosonic Endovascular System) is a multicenter, single-arm, prospective study evaluating patients with chronic deep vein thrombosis and postthrombotic syndrome (Villalta score ≥8) who received minimum 3 months of anticoagulation. Patients underwent percutaneous transluminal venoplasty and ultrasound-accelerated thrombolysis, with data collected on clinical characteristics, postthrombotic syndrome, imaging, and quality of life to 1 year. The primary efficacy outcome was a reduction of ≥4 points in the Villalta score 30 days after procedure. The primary safety outcomes were major bleeding episodes within 72 hours and symptomatic pulmonary embolism during the index hospitalization. A total of 82 limbs (78 patients) were treated (age, 54.6±12.7 years; 32.1% women; mean Villalta score, 15.5±5.2). The primary end point was met in 64.6% (51/79). At 1 year, 77.3% (51/66) of limbs continued with a Villalta reduction ≥4. At 365 days, >90% of segments had patency with ultrasound flow present. Baseline to 1-year Physical Component Summary mean score of the Short Form-36 increased from 38.9±9.5 to 45.2±9.8 (≤0.0001), and mean VEINES-QOL (Venous Insufficiency Epidemiological and Economic Study-Quality of Life) increased from 61.9±19.7 to 82.6±20.8 at 1 year (<0.0001). Iliofemoral venous stenting was performed in 42 patients, with similar improvements seen in all outcomes, regardless of stenting status. One patient developed severe bleeding within 72 hours of the intervention and died at 32 days after procedure (1.3% mortality rate). Conclusions Percutaneous transluminal venoplasty and ultrasound-accelerated thrombolysis resulted in successful recanalization of chronic venous obstruction with improved postthrombotic syndrome severity and quality of life. Results were sustained at 1-year after procedure. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02159521.
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http://dx.doi.org/10.1161/JAHA.119.013398DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7033890PMC
February 2020

Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis.

J Vasc Surg Venous Lymphat Disord 2020 01;8(1):8-23.e18

Mallinckrodt Institute of Radiology, Washington University in St. Louis, St. Louis, Mo.

Background: After deep venous thrombosis (DVT), many patients have impaired quality of life (QOL). We aimed to assess whether pharmacomechanical catheter-directed thrombolysis (PCDT) improves short-term or long-term QOL in patients with proximal DVT and whether QOL is related to extent of DVT.

Methods: The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial was an assessor-blinded randomized trial that compared PCDT with no PCDT in patients with DVT of the femoral, common femoral, or iliac veins. QOL was assessed at baseline and 1 month, 6 months, 12 months, 18 months, and 24 months using the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) disease-specific QOL measure and the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary general QOL measures. Change in QOL scores from baseline to assessment time were compared in the PCDT and no PCDT treatment groups overall and in the iliofemoral DVT and femoral-popliteal DVT subgroups.

Results: Of 692 ATTRACT patients, 691 were analyzed (mean age, 53 years; 62% male; 57% iliofemoral DVT). VEINES-QOL change scores were greater (ie, better) in PCDT vs no PCDT from baseline to 1 month (difference, 5.7; P = .0006) and from baseline to 6 months (5.1; P = .0029) but not for other intervals. SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 2.4; P = .01) but not for other intervals. Among iliofemoral DVT patients, VEINES-QOL change scores from baseline to all assessments were greater in the PCDT vs no PCDT group; this was statistically significant in the intention-to-treat analysis at 1 month (difference, 10.0; P < .0001) and 6 months (8.8; P < .0001) and in the per-protocol analysis at 18 months (difference, 5.8; P = .0086) and 24 months (difference, 6.6; P = .0067). SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 3.2; P = .0010) but not for other intervals. In contrast, in femoral-popliteal DVT patients, change scores from baseline to all assessments were similar in the PCDT and no PCDT groups.

Conclusions: Among patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later. In patients with iliofemoral DVT, PCDT led to greater improvement in disease-specific QOL during 24 months.
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http://dx.doi.org/10.1016/j.jvsv.2019.03.023DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7681916PMC
January 2020

Tibiopedal arterial minimally invasive retrograde revascularization (TAMI) in patients with peripheral arterial disease and critical limb ischemia. On behalf of the Peripheral Registry of Endovascular Clinical Outcomes (PRIME).

Catheter Cardiovasc Interv 2020 02 13;95(3):447-454. Epub 2019 Dec 13.

Metro Health-University of Michigan Health, Wyoming, Michigan.

Objectives And Background: Complex peripheral arterial disease (PAD) and critical limb ischemia (CLI) are associated with high morbidity and mortality. Endovascular techniques have become prevalent in treatment of advanced PAD and CLI, and use of techniques such as tibiopedal minimally invasive revascularization (TAMI), have been proven safe in small, single-center series. However, its use has not been systematically compared to traditional approaches.

Methods And Results: This is a retrospective, multicenter analysis which enrolled 744 patients with advanced PAD and CLI who underwent 1,195 endovascular interventions between January 2013 and April 2018. Data was analyzed based on access used for revascularization: 840 performed via femoral access, 254 via dual access, and 101 via TAMI. The dual access group had the highest median Rutherford Class and lowest number of patent tibial vessels. Median fluoroscopy time, procedure time, hospital stay, and contrast volume were significantly lower in the TAMI access group when compared to both femoral/dual access groups. There was also a significant difference between all groups regarding location of target lesions: Femoropopliteal lesions were most commonly treated via femoral access; infrapopliteal lesions, via TAMI, and multilevel lesions via dual access.

Conclusions: Stand-alone TAMI or tibial access as an integral part of a dual access treatment strategy, is safe and efficacious in the treatment of patients with advanced PAD and CLI who have infrapopliteal lesions. Larger prospective and randomized studies may be useful to further validate this approach.
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http://dx.doi.org/10.1002/ccd.28639DOI Listing
February 2020

Response to Gwozdz and colleagues.

Vasc Med 2020 02 5;25(1):90-91. Epub 2019 Nov 5.

Mallinckrodt Institute of Radiology, Washington University School of Medicine, Saint Louis, MO, USA.

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http://dx.doi.org/10.1177/1358863X19882743DOI Listing
February 2020

Cost-Effectiveness of Pharmacomechanical Catheter-Directed Thrombolysis Versus Standard Anticoagulation in Patients With Proximal Deep Vein Thrombosis: Results From the ATTRACT Trial.

Circ Cardiovasc Qual Outcomes 2019 10 8;12(10):e005659. Epub 2019 Oct 8.

Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V., D.J.C.).

Background: In patients with acute deep vein thrombosis (DVT), pharmacomechanical catheter-directed thrombolysis (PCDT) in conjunction with anticoagulation therapy is increasingly used with the goal of preventing postthrombotic syndrome. Long-term costs and cost-effectiveness of these 2 treatment strategies from the perspective of the US healthcare system have not been compared.

Methods And Results: Between 2009 and 2014, the ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) randomized 692 patients with acute proximal DVT to PCDT plus anticoagulation (n=337) or standard treatment with anticoagulation alone (n=355). Costs (2017 US dollars) were assessed over a 24-month follow-up period using a combination of resource-based costing, hospital bills, Medicare reimbursement rates, and the Drug Topics Red Book. Health state utilities were obtained from the Short Form-36. In-trial results and US life tables were used to develop a Markov cohort model to evaluate lifetime cost-effectiveness. For the PCDT group, mean costs of the initial procedure were $13 600; per-patient costs associated with the index hospitalization were $21 509 for PCDT and $3877 for standard care (difference=$17 632; 95% CI, $16 117-$19 243). The 24-month difference in costs was $20 045 (95% CI, $16 093-$24 120). Utility scores increased significantly between baseline and 6 months for both groups, with no significant differences between groups at any follow-up time point. Projected differences in lifetime costs of $16 740 and quality-adjusted life years (QALYs) of 0.08, yield an incremental cost-effectiveness ratio for PCDT of $222 041/QALY gained. In probabilistic sensitivity analysis, the probability that PCDT would achieve a lifetime incremental cost-effectiveness ratio <$50 000/QALY or <$150 000/QALY was 1% and 25%, respectively. For iliofemoral DVT, QALY gains with PCDT were greater, yielding an incremental cost-effectiveness ratio of $137 526/QALY; for femoral-popliteal DVT, standard therapy was an economically dominant strategy.

Conclusions: With an incremental cost-effectiveness ratio >$200 000/QALY gained, PCDT is not an economically attractive treatment for proximal DVT. PCDT may be of intermediate value in patients with iliofemoral DVT. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT00790335.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.119.005659DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6788761PMC
October 2019

Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years.

Circulation 2019 10 30;140(14):1145-1155. Epub 2019 Sep 30.

Cleveland Clinic, OH (S.P.L.).

Background: A recent summary-level meta-analysis comprising randomized, controlled trials (RCTs) of femoropopliteal paclitaxel-coated balloon and stent intervention identified excess late mortality in the paclitaxel-treated patients.

Methods: We evaluated the safety of the Stellarex drug-coated balloon (DCB) for femoropopliteal artery disease with an independently performed meta-analysis of patient-level data from all patients in the Stellarex femoropopliteal clinical program. To compare mortality after DCB or uncoated percutaneous transluminal angioplasty (PTA), we aggregated data from 2 RCTs comprising 419 patients treated with DCB and 170 patients treated with PTA. In an additional analysis, data were aggregated from 6 poolable Stellarex DCB studies (2 RCTs, 3 single-arm studies, and 1 registry). All serious adverse events including deaths were adjudicated by a blinded, third-party, independent Clinical Events Committee. Kaplan-Meier estimates in the RCTs were compared with restricted mean survival time. Predictors of death were assessed with hazard ratios (HRs) and Cox proportional hazards modeling.

Results: Baseline characteristics were similar in the patients treated with DCB and PTA in the pooled RCT analysis, with the exception that the DCB cohort was younger (67.4±9.7 versus 69.4±9.4 years, =0.02), smoked more frequently (86.6% versus 78.8%, =0.02), and were less often treated for recurrent lesions (8.8% versus 14.7%, =0.04). In the RCTs, patients treated with DCB had all-cause mortality rates that were not different from those of patients treated with PTA (Kaplan-Meier estimates 1.8±0.7% versus 1.3±0.9%, 6.5±1.2% versus 5.9±1.9%, and 9.3±1.5% versus 9.9±2.4% at 1, 2, and 3 years, respectively, =0.86). All-cause mortality rates were similar in a 1906-patient pooled nonrandomized DCB data set (Kaplan-Meier estimates of 2.1%, 4.9%, and 7.0% at 1, 2, and 3 years, respectively). Clinical Events Committee-adjudicated causes of death were balanced between the DCB and PTA cohorts. Multivariable Cox modeling identified age (HR, 1.06; 95% CI, 1.04-1.08; <0.001), diabetes mellitus (HR, 1.42; 95% CI, 1.01-2.00; =0.04), congestive heart failure (HR, 1.88; 95% CI, 1.12-3.16; =0.02), and renal insufficiency (HR, 2.00; 95% CI, 1.33-3.01; <0.001) as predictors of mortality. Paclitaxel exposure was unrelated to mortality (HR, 1.04; 95% CI, 0.98-1.10; =0.23).

Conclusions: The mortality rates for patients treated with the DCB and uncoated PTA were indistinguishable over 3-year follow-up. Additional patient-level, adequately powered meta-analyses with larger RCT data sets will be needed to confirm the generalizability of these findings.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT02110524, NCT01858363, NCT01858428, NCT03421561, NCT01912937, NCT01927068, and NCT02769273.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.119.040518DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6784772PMC
October 2019

Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts.

J Vasc Surg 2019 10;70(4):1177-1191.e9

Harvard Medical School, Boston, Mass.

Objective: Randomized controlled trials have shown that drug-coated balloons (DCBs) provide superior results compared with percutaneous transluminal angioplasty (PTA) for the treatment of femoropopliteal artery disease. However, these trials have generally included short lesions, few occlusions, and small sample sizes. The present study was an individual-level pooled analysis of duplex ultrasonography (DUS) core laboratory-adjudicated and clinical events committee-adjudicated IN.PACT Admiral DCB subjects across two randomized controlled trials and two single-arm prospective studies to characterize the safety and effectiveness of DCB compared with PTA.

Methods: The subjects were treated with DCB (n = 926) or PTA (n = 143). The end points through 12 months included DUS core laboratory-adjudicated primary patency and clinically driven target lesion revascularization (CD-TLR) using Kaplan-Meier estimates and primary safety using proportions. A propensity-matched analysis of DCB (n = 466) to PTA (n = 136) was conducted to address confounders.

Results: At 12 months, DCB compared with PTA had significantly greater primary patency (88.8% vs 53.9%; P < .001), freedom from CD-TLR (94.3% vs 80.2%; P < .001), and better primary safety composite end point (94.1% vs 78.0%; P < .001). After propensity-matched analysis, DCB remained superior to PTA at 12 months for primary patency (90.5% vs 53.8%; P < .001), freedom from CD-TLR (96.9% vs 80.7%; P < .001), and the primary safety composite end point (96.3% vs 78.4%; P < .001). Across multiple prespecified subgroup analyses, including provisional stenting, DCB remained persistently superior to PTA.

Conclusions: In the largest, DUS core laboratory-adjudicated, multiethnic, pooled DCB series to date, the IN.PACT Admiral DCB demonstrated significantly greater primary patency, freedom from CD-TLR, and better composite safety at 12 months compared with PTA.
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http://dx.doi.org/10.1016/j.jvs.2019.02.030DOI Listing
October 2019

Paclitaxel-Coated Zilver PTX Drug-Eluting Stent Treatment Does Not Result in Increased Long-Term All-Cause Mortality Compared to Uncoated Devices.

Cardiovasc Intervent Radiol 2020 Jan 9;43(1):8-19. Epub 2019 Sep 9.

Universitaets-Herz-Zentrum Freiburg - Bad Krozingen, Bad Krozingen, Germany.

Purpose: Patient-level data from two large studies of the Zilver PTX drug-eluting stent (DES) with long-term follow-up and concurrent non-drug comparator groups were analyzed to determine whether there was an increased mortality risk due to paclitaxel.

Methods: Data from the Zilver PTX randomized controlled trial (RCT) and Zilver PTX and bare metal stent (BMS) Japan post-market surveillance studies were analyzed. Five-year follow-up is complete in both DES studies; follow-up for the BMS study was limited to 3 years and is complete. Kaplan-Meier analyses assessed mortality. A Cox proportional hazards model identified significant factors related to mortality.

Results: In the RCT, there were 336 patients treated with the DES and 143 patients treated with percutaneous transluminal angioplasty (PTA) or BMS. In Japan, there were 904 DES patients and 190 BMS patients. There was no difference in all-cause mortality for the DES compared to PTA/BMS in the RCT (19.1% DES versus 17.1% PTA/BMS through 5 years, p = 0.60) or Japan (15.8% DES versus 15.3% BMS through 3 years, p = 0.89). Cox proportional hazard models revealed that age, tissue loss, and congestive heart failure were significantly associated with mortality in the RCT, and critical limb ischemia, age, renal failure, and gender were significantly associated with mortality in Japan (all p < 0.05). Neither treatment with Zilver PTX (p = 0.46 RCT, p = 0.49 Japan) nor paclitaxel dose (p = 0.86 RCT, p = 0.07 Japan) was associated with mortality.

Conclusion: Analyses of the Zilver PTX patient-level data demonstrated no increase in long-term all-cause mortality.

Level Of Evidence: Zilver PTX RCT: Level 1, randomized controlled trial; Japan PMS studies: Level 3, post-market surveillance study.
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http://dx.doi.org/10.1007/s00270-019-02324-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6940321PMC
January 2020

Propensity Score-Adjusted Comparison of Long-Term Outcomes Among Revascularization Strategies for Critical Limb Ischemia.

Circ Cardiovasc Interv 2019 09 9;12(9):e008097. Epub 2019 Sep 9.

Department of Medicine, Newton-Wellesley Hospital, MA (M.R.J.).

Background: Few studies have compared long-term outcomes among specific treatment modalities for critical limb ischemia. The aim of this study was to compare long-term outcomes with percutaneous transluminal angioplasty (PTA), stent placement, atherectomy, or surgical bypass in patients diagnosed with critical limb ischemia.

Methods: In this observational study using Medicare claims data, we identified incident cases with a primary critical limb ischemia diagnosis who received PTA, stent placement, atherectomy, or surgical bypass. We used propensity score weighting to determine the association of treatment type with all-cause mortality and major (above ankle) amputation over 4 years follow-up.

Results: Among 36 860 patients (10 904 PTA; 11 295 stent placement; 4422 atherectomy; 10 239 surgical bypass), all-cause mortality over 4 years was 49.3% with atherectomy, 51.4% with surgical bypass, 53.7% with stent placement, and 54.7% with PTA (P<0.05 for all pairwise comparisons). Major amputation rates over 4 years were 6.8% with atherectomy, 7.8% with stent placement, 8.1% with PTA, and 10.8% with surgical bypass (P<0.05 for all pairwise comparison except PTA versus stent).

Conclusions: Among Medicare beneficiaries who received PTA, stent placement, atherectomy, or surgical bypass for critical limb ischemia, high mortality and major amputation rates were observed with minor differences among treatment groups. Statistically significant group differences of uncertain clinical importance were observed for several comparisons. Results from observational research may be susceptible to bias because of unmeasured confounders and, therefore, these comparative results should be interpreted with caution.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008097DOI Listing
September 2019

Expanding opportunities to understand quality and outcomes of peripheral vascular interventions: The ACC NCDR PVI Registry.

Am Heart J 2019 10 22;216:74-81. Epub 2019 Jul 22.

University of Colorado and Institute for Health Research, Kaiser Permanente Colorado, Denver, CO.

Lower extremity peripheral artery disease (PAD) and cerebrovascular disease (CeVD) are prevalent conditions in the United States, and both are associated with significant morbidity (eg, stroke, myocardial infarction, and limb loss) and increased mortality. With a growth in invasive procedures for PAD and CeVD, this demands a more clear responsibility and introduces an opportunity to study how patients are treated and evaluate associated outcomes. The American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry is a prospective, independent collection of data elements from individual patients at participating centers, and it is a natural extension of the already robust NCDR infrastructure. As of September 20, 2018, data have been collected on 45,316 lower extremity PVIs, 12,417 carotid artery stenting procedures, and 11,027 carotid endarterectomy procedures at 208 centers in the United States. The purpose of the present report is to describe the patient and procedural characteristics of the overall cohort and the methods used to design and implement the registry. In collecting these data, ACC and ACC PVI Registry have the opportunity to play a pivotal role in scientific evidence generation, medical device surveillance, and creation of best practices for PVI and carotid artery revascularization.
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http://dx.doi.org/10.1016/j.ahj.2019.07.007DOI Listing
October 2019

Drug-Coated vs Uncoated Percutaneous Transluminal Angioplasty in Infrapopliteal Arteries: Six-Month Results of the Lutonix BTK Trial.

J Invasive Cardiol 2019 Aug;31(8):205-211

Advanced Cardiac and Vascular Centers for Amputation Prevention, 1525 E. Beltline, NE, Suite 101, Grand Rapids, MI 49525 USA.

Objectives: We hypothesized that a drug-coated balloon (DCB) could improve treatment efficacy while maintaining safety when compared with percutaneous transluminal angioplasty (PTA) for the treatment of atherosclerotic infrapopliteal arterial lesions.

Methods: A total of 442 patients with angiographically significant lesions were randomized (2:1) to DCB or PTA. The primary safety and efficacy endpoints were freedom from major adverse limb events and perioperative death (MALE-POD) at 30 days, and freedom from vessel occlusion, clinically driven target-lesion revascularization (CD-TLR), and above-ankle amputation measured at 6 months. Success was achieved if safety between groups was non-inferior (margin 12%), and efficacy was statistically significant either for the overall intention-to treat (ITT) or the proximal-segment DCB groups (ie, the proximal two-thirds of the below-knee arterial pathways).

Results: Freedom from MALE-POD for the DCB group (99.3%) was non-inferior to PTA (99.4%; non-inferiority P<.001). Proportional analysis of the primary efficacy endpoint was statistically significant for the proximal-segment DCB group (76%) vs PTA (62.9%; one-sided P<.01; Bayesian P-value for success of .0085) while not statistically significant for the overall ITT group (74.5% for DCB vs 63.5% for PTA; one-sided P=.02). Kaplan-Meier analyses demonstrated superior efficacy for DCB in both the overall ITT and proximal-segment groups at 6 months. Primary patency and CD-TLR, hypothesis-tested secondary endpoints, were also statistically better for the DCB group compared with PTA at 6 months (one-sided P<.025).

Conclusions: DCB treatment for symptomatic infrapopliteal arterial lesions produced non-inferior safety at 30 days and a statistically significant difference in the primary efficacy endpoint when compared with PTA at 6 months.
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August 2019

Relationships between the use of pharmacomechanical catheter-directed thrombolysis, sonographic findings, and clinical outcomes in patients with acute proximal DVT: Results from the ATTRACT Multicenter Randomized Trial.

Vasc Med 2019 10 27;24(5):442-451. Epub 2019 Jul 27.

Harvard Medical School, Boston, MA, USA.

Few studies have documented relationships between endovascular therapy, duplex ultrasonography (DUS), post-thrombotic syndrome (PTS), and quality of life (QOL). The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial randomized 692 patients with acute proximal deep vein thrombosis (DVT) to receive anticoagulation or anticoagulation plus pharmacomechanical catheter-directed thrombolysis (PCDT). Compression DUS was obtained at baseline, 1 month and 12 months. Reflux DUS was obtained at 12 months in a subset of 126 patients. Clinical outcomes were collected over 24 months. At 1 month, patients who received PCDT had less residual thrombus compared to Control patients, evidenced by non-compressible common femoral vein (CFV) (21% vs 35%, < 0.0001), femoral vein (51% vs 70%, < 0.0001), and popliteal vein (61% vs 74%, < 0.0001). At 12 months, in the ultrasound substudy, valvular reflux prevalence was similar between groups (85% vs 91%, = 0.35). CFV non-compressibility at 1 month was associated with higher rates of any PTS (61% vs 46%, < 0.001), a higher incidence of moderate-or-severe PTS (30% vs 19%, = 0.003), and worse QOL (difference 8.2 VEINES-QOL (VEnous INsufficiency Epidemiological and Economic Study on Quality of Life) points; = 0.004) at 24 months. Valvular reflux at 12 months was associated with moderate-or-severe PTS at 24 months (30% vs 0%, = 0.01). In summary, PCDT results in less residual thrombus but does not reduce venous valvular reflux. CFV non-compressibility at 1 month is associated with more PTS, more severe PTS, and worse QOL at 24 months. Valvular reflux may predispose to moderate-or-severe PTS. .
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http://dx.doi.org/10.1177/1358863X19862043DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6943930PMC
October 2019
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