bail-out stenting and target-vessel failure after drug coated balloon coronary percutaneous angioplasty for de novo lesions

Conditions: DCB; De Novo Stenosis; PCI

Summary: 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. participants will receive dcb pci in de novo coronary stenosis. treatments they\&#39;ll be given should be: * dcb-only pci * bos pci researchers 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 receive 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 researchers 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 \&gt; 50% loss of initial gain of the target lesion. the trial will enroll all patients who received 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 (\&gt; or equal to nhlbi grade c) or in case of \&gt; 30% recoil, according with international dcb consensus.

Eligibility criteria:
inclusion criteria: * de novo dcb pci of at least one coronary artery * hybrid pci of bifurcation (main branch stent and side branch dcb) * hybrid pci of coronary artery with more than one stenosis (at least 10 mm of distance between edge of stent and dcb pci segment) exclusion criteria: * in-stent restenosis * more than 1 year life expectancy

Keywords: dcb pci de novo bail-out stenting tvf