Investigators of SWEDEPAD have announced the conclusion of their safety committee analysis, which recommends the halted trials resume enrolment.
This decision to consider resuming enrolment in the SWEDEPAD trials came twelve days after a dedicated session called “Paclitaxel: The last word” took place at the Charing Cross Symposium (CX; 15–18 April, London, UK). At this meeting, Mårten Falkenberg (Gothenburg, Sweden) provided an update on the status of the SWEDEPAD trials. Speaking on 16 April, he told the CX audience that the decision to halt enrolment was predicated on the findings of the Katsanos et al meta-analysis published in the Journal of the American Heart Association (JAHA) late last year, which suggested that there is an increased risk of death at two and five years following the use of paclitaxel-coated balloons and stents in the femoropopliteal artery. He added that, despite keeping up with the ongoing international conversation, at the time of his presentation the investigators were still trying to determine the best course of action, and that no obvious consensus had emerged at the time.
However, whilst the SWEDEPAD investigators have since reached the conclusion to begin the process of recommencing their trial in the weeks following CX, at the time of publication, there has been no update from the BASIL-3 trial—this is the only other randomised controlled trial investigating drug-eluting devices to halt in response to the Katsanos et al meta-analysis published late last year. Indeed, at CX, the decision to stop enrolment in BASIL-3 was explained by statistician Jon Deeks (Birmingham, UK) as being based on the assumption that the signal seen in the Katsanos et al meta-analysis could be real.
The SWEDEPAD announcement
Writing on their website, the investigators of the SWEDEPAD trials announced (originally in Swedish): “Decision made to investigate possibilities of commencing inclusion in SWEDEPAD! On 28 April, 2019, SWEDEPAD’s Security Committee (DSMC) carried out a new analysis of mortality among patients randomised into SWEDEPAD 1 and 2. Based on this, the DSMC recommended the trial to resume inclusion.”
In their recent announcement indicating that enrolment will recommence, the SWEDEPAD triallists explain: “This means that our currently available data do not support the conclusions of the meta-analysis published in December 2018 on increased late mortality among patients treated with paclitaxel-treated balloon or stent. After meeting in SWEDEPAD’s steering group on 2 May, and after open discussion during the Swedish vascular meeting in Båstad on 10 May, we have decided to investigate the possibilities of resuming inclusion in SWEDEPAD.
“We will first (1) update patient information, (2) send a supplementary application to the ethical review board, and (3) share our information with regulatory authorities. So the plan is to resume, but a lot of work remains before that can be realised.”