Society for Vascular Surgery’s VQI adds new analysis to paclitaxel device discussion

Daniel Bertges

The Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI), with its large multicentre registries has produced several datasets for analysis of vascular patient care in the USA. This year, at the SVS Vascular Annual Meeting (VAM; 12–15 June, National Harbor, USA), new data produced with the use of the VQI was presented by Daniel Bertges (University of Vermont Medical Center, Burlington, USA) aimed to provide further insight into mortality following peripheral vascular interventions using paclitaxel devices. This study “highlights the potential use of the VQI for surveillance of the safety of new peripheral arterial devices”, the investigators state in their abstract.

Bertges et al performed a retrospective, propensity matched analysis of the SVS VQI Peripheral Vascular Intervention Registry from October 2016 to December 2017. “We chose this timeframe”, Bertges explained, “because this is when the devices were captured with specificity within the registry with linkage to the Global Universal Device Identifier.”

The sole outcome was all-cause mortality in three comparators. Firstly, paclitaxel-coated balloons (DCB) versus plain balloon angioplasty (PTA); secondly, paclitaxel-eluting stents versus (DES) bare metal stents (BMS); and thirdly, any paclitaxel device versus any non-drug device. The cohort of 8,376 patients included superficial femoral and popliteal interventions, and Bertges highlighted the exclusion of 2,082 patients with prior interventions in these arteries “in order to avoid the possibility of improperly assigning the drug exposure to the control group”. Mean follow-up was 12.4 months.

In the DCB versus PTA group, Bertges et al observed “no statistical difference in mortality”, with a rate of 9.6% vs. 12.6% for DCB and PTA, respectively (p=0.14). The same observation was made for DES versus BMS, with 8.8% vs. 9.8% mortality for DES and BMS, respectively (p=0.75). Finally, the propensity matched survival for pooled paclitaxel versus non-drug devices saw “a mortality advantage in the drug treatment group”, said Bertges, with a rate of 8.5% vs. 11.5% in the non-drug device cohort (p=0.03).

Concluding, Bertges said “in this large real-world sample there is no difference in mortality at a mean of 12.4 months, the results are similar for patients treated with paclitaxel DCB or DES. Certainly, a longer registry follow-up is required and ongoing, and we hope that the VQI Peripheral Vascular Interventions Registry will be part of that cumulative body of evidence on this important topic.”

Outlining next steps, Bertges noted there would be a presentation to the upcoming US Food and Drug Administration (FDA) Circulatory Systems Device Panel (19–20 June, Washington, DC, USA). Additional VQI analysis plans to “assess for mortality differences at later time points”, extending the duration of mortality follow-up. The VQI is working to embed risk adjusted models into the registry for near real-time surveillance of this mortality signal. In the future there is potential to do so proactively for other peripheral devices adding a new utility to the SVS VQI.


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