Citation: Cardiovascular Revascularization Medicine. 2020 Jan 16.Journal: Cardiovascular revascularization medicine : including molecular interventions.Published: ; 2020ISSN: 1878-0938.Full author list: Yerasi C; Case BC; Forrestal BJ; Kolm P; Dan K; Torguson R; Weintraub WS; Garcia-Garcia HM; Waksman R.UI/PMID: 32317227.Subject(s): IN PROCESS -- NOT YET INDEXEDInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal Article | ReviewOnline resources: Click here to access onlineDigital Object Identifier: https://dx.doi.org/10.1016/j.carrev.2020.01.012 (Click here)Abbreviated citation: Cardiovasc Revasc Med. 2020 Jan 16.Local Holdings: Available in print through MWHC library: 2002 - present.Abstract: A recent meta-analysis showed increased mortality with paclitaxel drug-coated balloons (PCB) in peripheral arterial disease. With the absence of a definitive study evaluating the risk of mortality with PCB in de novo coronary artery disease, we performed a systematic review and critical appraisal of the literature analyzing this risk. In this review, we included 17 trials with a total of 1573 patients. Cardiac mortality was reported in 16 studies and all-cause mortality in 14 studies. Eleven studies had <12months' follow-up; 6 had >=12months' follow-up. None of the studies was powered to evaluate any differences in mortality. The majority of the included studies have a Jadad scale <=2. Ten of 17 studies had no mortality, 4 had numerically higher mortality with PCB, and 3 had lower or same mortality with PCB, when compared to drug-eluting stents. A standard meta-analysis cannot be performed, as most studies did not report hazard ratios or Kaplan-Meier survival plots on mortality. With the available literature, conclusions cannot be made in identifying the association of mortality with PCB in de novo coronary artery disease. There is an urgent need for well-designed studies with long-term follow-up for PCB in de novo coronary artery disease. A recent meta-analysis showed increased mortality with paclitaxel drug-coated balloon (PCB) in peripheries. No studies to date evaluate the risk of mortality with PCB in de novo coronary artery disease. In this systematic review and critical appraisal of literature, we outline why the risk cannot be elucidated from the available literature. A standard meta-analysis using inverse variance method would be incorrect to use, as mortality is a time-to-event data point, and only 1 out of 17 studies reported a Kaplan-Meier survival plot. Copyright (c) 2020. Published by Elsevier Inc.