No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE–MD (Coordinating Research and Evidence for Medical Devices)

“… 28 Currently, INFINITY-SWEDEHEART is using a similar approach for a head-to-head comparison of a novel device against an established product, and there are RRCTs in orthopaedic 29 and cardiothoracic surgery. 30 The term ‘nested trials’ has typically been used to describe trials using other sources such as electronic medical records. 31…”

The evolving evidence base for coronary artery bypass grafting and arterial grafting in 2021: How to improve vein graft patency

“…27 Although a majority of the early NT-SVG experience and reports stem from the same center, 2 major ongoing RCTs will add further to our knowledge of NT-SVG. In Sweden and Denmark, SWEDEGRAFT 20 has recruited 902 patients to assess graft failure by computed tomography angiography, repeat target vessel revascularization, or death at 2 years as the primary composite endpoints and leg wound assessment scores as secondary endpoints (ClinicalTrials.gov identifier…”

“… 27 Although a majority of the early NT-SVG experience and reports stem from the same center, 2 major ongoing RCTs will add further to our knowledge of NT-SVG. In Sweden and Denmark, SWEDEGRAFT 20 has recruited 902 patients to assess graft failure by computed tomography angiography, repeat target vessel revascularization, or death at 2 years as the primary composite endpoints and leg wound assessment scores as secondary endpoints ( ClinicalTrials.gov identifier NCT03501303 ). In China, Wang and colleagues 21 have recruited 2655 patients in a multicenter RCT with graft occlusion at 3 months as the primary endpoint and a major adverse cardiovascular and cerebrovascular event (MACCE) at 3 and 12 months postoperatively and graft occlusion at 12 months postoperatively as secondary endpoints ( ClinicalTrials.gov identifier NCT03126409 ).…”

The “No-touch” Harvesting Technique Revives the Position of the Saphenous Vein as an Important Conduit in CABG Surgery: 30-year Anniversary

“…Initially there appeared little acceptance for this technique with it being used solely in the department of thoracic and cardiac surgery at Örebro University Hospital, where it was developed. Following publication of both the randomized clinical trials and the basic science studies, considerable interest has been raised worldwide whereby the NT technique is recognized and has been adopted in many countries, especially in Sweden [ 12 , 13 ] ), Japan [ 14 ] , China [ 15 ] , and South Korea [ 16 ] . Currently, two large randomized multicenter trials are ongoing to evaluate the NT technique.…”

“…The first one is being performed in China, which included 2,655 patients and the one-year results was recently published [ 15 ] . The second similar ongoing randomized trial is in Sweden and 900 patients were included [ 13 ] . However, the data of this trial will not be analyzed until 2023.…”