Real-world study of mortality after the Use of Paclitaxel-coated Devices in Peripheral Vascular Intervention

OBJECTIVES: To examine outcomes after peripheral vascular intervention (PVI) with paclitaxel-coated devices (PCD) and non-PCD and evaluate heterogeneity of treatment effect in populations of interest. DESIGN: Observational cohort study. METHODS: We included patients undergoing percutaneous transluminal angioplasty and/or stent placement during 1/10/2015-31/12/2018 in the Vascular Quality Initiative Registry linked to Medicare claims. We determined differences in patient mortality and ipsilateral major amputation after PVI with PCD and non-PCD using Kaplan-Meier analyses and Cox regressions with inverse probability weighting in three cohorts: (A) patients treated for femoropopliteal or infrapopliteal occlusive disease with/without any other concurrent treatment (n=11 452), (B) those treated for isolated superficial-femoral or popliteal artery disease (n=5 519), and (C) patients with inclusion criteria designed to approximate RCT populations (n=2 278). RESULTS: The mean age of patients was 72.3 (SD=10.9) years, and 40.6% were female. In cohort A, patients receiving PCD had lower mortality (HR 0.88, 95% CI 0.79-0.98) than those receiving non-PCD. There was no significant difference in mortality between groups in cohort B (HR 0.91, 95% CI 0.80-1.04) and C (HR 1.10, 95% CI 0.84-1.43). Patients receiving PCD did not have a significantly elevated risk of major amputation compared with those receiving non-PCD (Cohort A: HR=0.84, 95% CI 0.70-1.00; B: HR=0.84, 95% CI 0.67-1.06; C: HR=1.05, 95% CI 0.51-2.14). CONCLUSIONS: We did not find increased patient mortality or major amputation at three years after PVI with PCD vs. non-PCD in this large, linked registry-claims study, after accounting for heterogeneity of treatment effect by population. Our analysis and results from three cohorts intended to mirror the cohorts of prior studies provide robust and niche real-world evidence on PCD safety and help understand and reconcile previously discrepant findings

Vascular Quality Initiative Surveillance of Femoropopliteal Artery Paclitaxel Devices

OBJECTIVES: This study sought to determine the safety and efficacy of paclitaxel (PTX) devices in the treatment of peripheral artery disease involving the femoropopliteal artery. BACKGROUND: A meta-analysis of PTX devices for the treatment of femoropopliteal artery disease reported a mortality signal. METHODS: This was a multicenter cohort study using an integrated clinical data surveillance system to conduct a prospective, propensity score-matched survival analysis of 2,456 patients in the Society for Vascular Surgery Vascular Quality Initiative from January 2017 to May 2020. The study compared PTX drug-coated balloon angioplasty versus percutaneous transluminal balloon angioplasty, PTX drug-eluting stents versus bare-metal stents, and any PTX device versus any non-PTX device. The primary outcome was 2-year survival. Secondary endpoints were successful ambulation and interventional success. RESULTS: Treatment with any PTX device versus any non-PTX device was associated with increased 2-year survival (89.5% vs 86.7%; HR: 0.79; 95% CI: 0.72-0.87; P = 0.004), improved interventional success (81.6% vs 77.6%; HR: 0.82; 95% CI: 0.74-0.91; P \u3c 0.001), and higher rates of independent ambulation at 1 year (86.0% vs 83.4%; HR: 0.85; 95% CI: 0.79-0.91; P = 0.008). Treatment with PTX drug-coated balloon angioplasty was associated with improved survival at 2 years (88.9% vs 85.7%; HR: 0.77; 95% CI: 0.70-0.86; P = 0.005), while PTX drug-eluting stent therapy was associated with similar survival compared with bare-metal stent therapy (91.3% vs 89.6%; HR: 0.84; 95% CI: 0.70-1.01; P = 0.36). CONCLUSIONS: In this prospective, active surveillance of a national clinical registry, PTX-containing devices were associated with increased survival at 2 years and improved clinical outcomes at 1 year. (VQI DELTA Paclitaxel Device Safety Analysis [VQI-PTX]; NCT04110288)

Registry Assessment of Peripheral Interventional Devices Objective Performance Goals for Superficial Femoral and Popliteal Artery Peripheral Vascular Interventions.

BACKGROUND: The Superficial Femoral Artery-Popliteal EvidencE Development (SPEED) Study Group developed contemporary objective performance goals (OPG) for peripheral vascular interventions (PVI) for superficial femoral (SFA)-popliteal artery disease utilizing the Registry Assessment of Peripheral Interventional Devices (RAPID). METHODS: The Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) PVI Registry from January 2010-October 2016 was used to develop OPGs based on SFA-popliteal procedures (N= 21, 377) for claudication (IC) and critical limb ischemia (CLI). OPGs included one-year rates for target lesion revascularization (TLR), major amputation, and one and four-year survival. OPGs were calculated for the SFA and popliteal arteries and stratified by four treatments: angioplasty alone (PTA), self-expanding stenting, atherectomy, and any treatment type.. Outcomes were illustrated by unadjusted Kaplan-Meier analyses. RESULTS: Cohorts included PTA (N= 7,505), stenting (N= 9,217), atherectomy (N= 2,510) and any treatment (N= 21,377). The mean age was 69 years, 58% were male, 79% were white and 52% had CLI. The freedom from TLR OPGs at one year in the SFA were 80.3% (PTA), 83.2% (stenting), 83.9% (atherectomy), and 81.9% (any treatments). The freedom from TLR OPGs at one year in the popliteal were 81.3% (PTA), 81.3% (stenting), 80.2% (atherectomy), and 81.1% (any treatments). The freedom from major amputation OPGs at one year after SFA PVI were 93.4% (PTA), 95.7% (stenting), 95.1% (atherectomy), and 94.8%, (any treatments). The freedom from major amputation OPG at one year after popliteal PVI were 90.5% (PTA), 93.7% (stenting), 91.8% (atherectomy), and 91.8%, (any treatments). Four-year survival OPGs after SFA PVI were 76% (PTA), 80% (stenting), 82% (atherectomy), and 79% (any treatments) and for the popliteal artery were 72% (PTA), 77% (stenting), 82% (atherectomy), and 75% (any treatment). In multivariable analysis, which included patient level, leg level and lesion level covariates, CLI was the single independent factor associated with increased TLR, amputation and mortality. CONCLUSIONS: The SPEED OPGs define a new, contemporary benchmark for SFA-popliteal interventions utilizing a large subset of real-world evidence to inform more efficient peripheral device clinical trial designs to support regulatory and clinical decision making. It is appropriate to discuss proposals intended for regulatory approval with the FDA to refine the OPG to match the specific trial population. The OPGs may be updated using coordinated registry networks to assess long-term real-world device performance

Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies

The accumulation of data through a prospective, multicenter coordinated registry network is a practical way to gather real world evidence on the performance of novel prostate ablation technologies. Urological oncologists, targeted biopsy experts, industry representatives and representatives of the FDA (Food and Drug Administration) convened to discuss the role, feasibility and important data elements of a coordinated registry network to assess new and existing prostate ablation technologies. A multiround Delphi consensus approach was performed which included the opinion of 15 expert urologists, representatives of the FDA and leadership from high intensity focused ultrasound device manufacturers. Stakeholders provided input in 3 consecutive rounds with conference calls following each round to obtain consensus on remaining items. Participants agreed that these elements initially developed for high intensity focused ultrasound are compatible with other prostate ablation technologies. Coordinated registry network elements were reviewed and supplemented with data elements from the FDA common study metrics. The working group reached consensus on capturing specific patient demographics, treatment details, oncologic outcomes, functional outcomes and complications. Validated health related quality of life questionnaires were selected to capture patient reported outcomes, including the IIEF-5 (International Index of Erectile Function-5), the I-PSS (International Prostate Symptom Score), the EPIC-26 (Expanded Prostate Cancer Index Composite-26) and the MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Dysfunction). Group consensus was to obtain followup multiparametric magnetic resonance imaging and prostate biopsy approximately 12 months after ablation with additional imaging or biopsy performed as clinically indicated. A national prostate ablation coordinated registry network brings forth vital practice pattern and outcomes data for this emerging treatment paradigm in the United States. Our multiple stakeholder consensus identifies critical elements to evaluate new and existing energy modalities and devices