TY  - BOOK
AU  - Case, Brian C
AU  - Dan, Kazuhiro
AU  - Forrestal, Brian J
AU  - Garcia-Garcia, Hector M
AU  - Kolm, Paul
AU  - Torguson, Rebecca
AU  - Waksman, Ron
AU  - Weintraub, William S
AU  - Yerasi, Charan
TI  - Risk of mortality with paclitaxel drug-coated balloon in de novo coronary artery disease. [Review]
SN  - 1878-0938
PY  - 2020///
KW  - *Angioplasty, Balloon, Coronary/is [Instrumentation]
KW  - *Cardiovascular Agents/ad [Administration & Dosage]
KW  - *Coated Materials, Biocompatible
KW  - *Coronary Artery Disease/th [Therapy]
KW  - *Paclitaxel/ad [Administration & Dosage]
KW  - Aged
KW  - Angioplasty, Balloon, Coronary/ae [Adverse Effects]
KW  - Angioplasty, Balloon, Coronary/mo [Mortality]
KW  - Cardiovascular Agents/ae [Adverse Effects]
KW  - Coronary Artery Disease/dg [Diagnostic Imaging]
KW  - Coronary Artery Disease/mo [Mortality]
KW  - Female
KW  - Humans
KW  - Male
KW  - Middle Aged
KW  - Paclitaxel/ae [Adverse Effects]
KW  - Randomized Controlled Trials as Topic
KW  - Risk Assessment
KW  - Risk Factors
KW  - Time Factors
KW  - Treatment Outcome
KW  - MedStar Heart & Vascular Institute
KW  - Journal Article
KW  - Review
N1  - Available in print through MWHC library: 2002 - present
N2  - 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
UR  - https://dx.doi.org/10.1016/j.carrev.2020.01.012
UR  - https://dx.doi.org/10.1016/j.carrev.2020.01.012
ER  -