De Novo Stenosis Clinical Trial
Official title:
Bail-Out Stenting and Target-vessel Failure After Drug Coated Balloon Coronary percutaneouS Angioplasty for de Novo Lesions: the BOSS Study
The goal of this observational retrospective and prospective multicentric trial is to learn about the impact of bail-out stenting (BOS) after drug coated balloon (DCB) percutaneous coronary angioplasty (PCI) in de novo coronary stenosis.The main question to answer is: - if BOS PCI leads to an higher rate of 1-year target vessel failure that DCB-only PCI. Partecipants will recieve DCB PCI in de novo coronary stenosis. Treatments they'll be given should be: - DCB-only PCI - BOS PCI Reaserchers will compare DCB-only and BOS group to see if addictive stent implantation for DCB-PCI complication is relate to an higher rate of target vessel failure. Target vessel is the primary endpoint, defined as: - cardiovascular death - target vessel myocardial infarction - clinical driven target vessel revascularization - angiographic restenosis
Drug coated balloon (DCB) percutaneous coronary intervention (PCI) has been shown to be as effective as last generation drug eluting stent (DES) PCI in many randomized trials. However a not negligible rate of patients must recieve a bail-out stenting (BOS) implantation after DCB-PCI. Only some studies report that the rate of MACE of these patients is higher than DCB-only or DES-PCI ones. Even if the BOS patients MACE rate is two times more than DCB-only or DES-only, due to the small amount of BOS patients in these studies there were not a statistically significant difference. According to these evidence, BOSS study reaserchers will compare target vessel failure (TVF) rate in DCB-only and BOS group resulting from all vessel size de novo coronary artery stenosis DCB-PCI. TVF as primary endpoint will include: - cardiovascular death - target vessel myocardial infarction (TV-MI). According to the third universal definition of myocardial infarction TV-MI will be considered a non fatal myocardial infarction with the evidence of myocardial necrosis in the vascular territory of previously treated target vessel - clinical driven target vessel revascularization (CD-TVR). CD-TVR will be considered as any repeat intervention of any segment of the target vessel, defined as the entire major coronary vessel proximal and distal to the target lesion. - Angiographic restenosis. It will considered in case of restenosis as either a > 50% loss of initial gain of the target lesion. The trial will enroll all patients who recieved a de novo DCB-PCI from January 2020 to December 2023. The population will be divided into two groups: - DCB-only PCI - BOS PCI Bail-out stenting will be done in case of high grade coronary dissection (> or equal to NHLBI grade C) or in case of > 30% recoil, according with International DCB Consensus. ;
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