SWEDEPAD 1 and SWEDEPAD 2 trials halt inclusion after Katsanos et al’s meta-analysis on paclitaxel-coated devices and interim safety analysis

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Interventional News has learned that inclusion into the SWEDEPAD studies, that are examining benefits of drug-eluting technology for peripheral arterial disease patients, has been halted.

As outlined in the public domain, the SWEDEPAD (Swedish drug-elution trial in peripheral arterial disease) project is designed to test the hypothesis that drug-eluting technology is superior to conventional endovascular treatment in terms of important clinical outcomes, when applied on infrainguinal (femoropopliteal and/or infrapopliteal) obstructive vascular lesions. The SWEDEPAD  project consists of two separate parallel studies, SWEDEPAD 1 and SWEDEPAD 2, each defined by the severity of peripheral arterial disease. As noted on clinicaltrials.gov, “patients with critical limb ischaemia are allocated to SWEDEPAD 1 and patients with intermittent claudication are allocated to SWEDEPAD 2.” The trials had a planned enrolment of 3,800 participants.

An update on the SWEDEPAD website (when translated into English) reads: “Inclusion in SWEDEPAD studies stop! On the occasion of the Katsano’s [sic] systematic literature review published today, the study management has today met with the Data Safety Monitoring Committee (DSMC) in SWEDEPAD. After DSMC performed an interim safety analysis of the study’s prespecified and monitored safety variables (occlusion rate, amputation rate and mortality by 30 days and one year) distributed on treatment allocation, the recommendation from DSMC is to promptly pause further inclusion in both SWEDEPAD 1 and SWEDEPAD 2.

“The study management is of the same opinion as DSMC and has today decided to stop inclusion in both substudies. On Monday, [10 December 2018], SWEDEPAD’s steering committee meets and discusses the state of progress and further actions that need to be taken in response to this.”

 

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