Concept Medical has announced the enrolment of the first patient in the SirPAD (Sirolimus in peripheral arterial disease) trial. According to a press release, SirPAD is the first all-comer randomised controlled clinical trial (RCT) investigating major adverse limb events in PAD patients with lesions below the inguinal ligament.
SirPAD is an investigator-initiated, single-centre, randomised, non-inferiority, open-label clinical trial investigating whether the use of MagicTouch PTA sirolimus-coated balloon catheters in patients with peripheral arterial disease of the femoropopliteal or below-the-knee segment is not inferior to that of uncoated balloon catheters for major clinical outcomes (unplanned major amputation, target limb revascularisation).
A total of 1,132 patients (1,200 after factoring for a 5% drop-out rate) are to be randomised 1:1 (566 [600 after factoring drop-out rate] patients per treatment group).
The primary objective is to evaluate whether the use of sirolimus-coated balloon catheters (MagicTouch PTA) is non-inferior to uncoated balloon catheters in infra-inguinal angioplasty to prevent one-year major adverse limb events (MALE), including unplanned major amputation of the target limb and target lesion revascularisation for critical limb ischaemia, in a representative population of patients with PAD (‘all-comers’).
If the criterion for non-inferiority is confirmed, the study will test whether sirolimus-coated catheters (MagicTouch PTA) are superior to uncoated catheters for important secondary outcomes and for the primary outcome itself according to pre-specified criteria for hierarchical analysis.
The index patient was successfully enrolled on 3 November 2020 at University Hospital Zurich (Zurich, Switzerland). The study was initiated by Nils Kucher (also the principal investigator) in charge of the Clinic of Angiology at University Hospital Zurich.
Kucher was excited to initiate the study and said, “Over the past decade, a few RCTs have compared the efficacy and safety of drug-coated (mainly paclitaxel-coated) devices versus that of uncoated ones, and demonstrated a significant reduction in restenosis rates, late lumen loss, and incidence of target lesion revascularisation. However, the size of these trials was often too small to draw firm conclusions concerning major clinical outcomes. Moreover, substantial heterogeneity of the study populations and too restrictive eligibility criteria limited their external validity, leading to a difficult interpretation of the results of meta-analyses. Indeed, these trials adopted as the primary outcome surrogate (and rather subjective) outcomes, such as vessel patency and target limb revascularisation, which may be difficult to objectively adjudicate in the setting of an open-label trial, rather than ‘hard’ objective clinical endpoints, such as major amputation or urgent revascularisation due to critical limb ischaemia.
“The aim of the SirPAD trial is to compare the efficacy, as defined by a composite of clinically relevant non-subjective ‘hard’ outcomes (major amputation and target lesion revascularisation for critical limb ischaemia), of sirolimus-coated versus uncoated balloon angioplasty for peripheral arterial disease.”