{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T20:56:06Z","timestamp":1785876966887,"version":"3.56.0"},"reference-count":49,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2022,9,2]],"date-time":"2022-09-02T00:00:00Z","timestamp":1662076800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2022,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Percutaneous coronary intervention (PCI) with drug\u2010eluting stent (DES) implantation is a widely adopted strategy for the treatment of de novo coronary artery disease. DES implantation conveys an inherent risk for short\u2010 and long\u2010term complications, including in\u2010stent restenosis and stent thrombosis. Drug\u2010coated balloons are emerging as an alternative approach to fulfill the \u201cleaving nothing behind\u201d principle and avoid long\u2010term DES\u2010related complications.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>TRANSFORM II is an investigator\u2010initiated, multicenter, noninferiority, randomized clinical trial, testing a sirolimus\u2010coated balloon (SCB) versus the standard of care for native coronary vessels with a 2\u20133\u2009mm diameter, in terms of 12\u2010month target lesion failure (TLF; primary endpoint) and net adverse cardiovascular events (coprimary endpoint). Patients undergoing PCI will be randomized to be treated with either SCB or new\u2010generation everolimus\u2010eluting stent and will be followed up clinically for up to 60 months. Assuming a TLF rate of 8% at 12 months with DES, a sample size of 1325 patients was chosen to ensure an 80% power to detect a 1.5% lower incidence in the SCB group with a type I error rate of 0.05. The TRANSFORM II trial is registered on <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">clinicaltrials.gov<\/jats:ext-link> (identification number NCT04893291). Several substudies, including an optical coherence tomography assessment at 9 months (intracoronary imaging substudy), will investigate the study device in different clinical and lesion settings.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The randomized TRANSFORM II trial will determine whether a novel SCB is noninferior to a current everolimus\u2010eluting stent when adopted for the treatment of de novo lesions in coronary vessels with a diameter between 2 and 3\u2009mm.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.30358","type":"journal-article","created":{"date-parts":[[2022,9,2]],"date-time":"2022-09-02T17:38:17Z","timestamp":1662140297000},"page":"544-552","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":39,"title":["Sirolimus\u2010coated balloon versus everolimus\u2010eluting stent in de novo coronary artery disease: Rationale and design of the TRANSFORM II randomized clinical trial"],"prefix":"10.1002","volume":"100","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2926-9428","authenticated-orcid":false,"given":"Antonio","family":"Greco","sequence":"first","affiliation":[{"name":"Division of Cardiology, A.O.U. 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