Risk of mortality with paclitaxel drug-coated balloon in de novo coronary artery disease. [Review]

MedStar author(s):
Citation: Cardiovascular Revascularization Medicine. 21(4):549-555, 2020 04.PMID: 32317227Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | ReviewSubject headings: *Angioplasty, Balloon, Coronary/is [Instrumentation] | *Cardiovascular Agents/ad [Administration & Dosage] | *Coated Materials, Biocompatible | *Coronary Artery Disease/th [Therapy] | *Paclitaxel/ad [Administration & Dosage] | Aged | Angioplasty, Balloon, Coronary/ae [Adverse Effects] | Angioplasty, Balloon, Coronary/mo [Mortality] | Cardiovascular Agents/ae [Adverse Effects] | Coronary Artery Disease/dg [Diagnostic Imaging] | Coronary Artery Disease/mo [Mortality] | Female | Humans | Male | Middle Aged | Paclitaxel/ae [Adverse Effects] | Randomized Controlled Trials as Topic | Risk Assessment | Risk Factors | Time Factors | Treatment OutcomeYear: 2020Local holdings: Available in print through MWHC library: 2002 - presentISSN:
  • 1878-0938
Name of journal: Cardiovascular revascularization medicine : including molecular interventionsAbstract: 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.All authors: Case BC, Dan K, Forrestal BJ, Garcia-Garcia HM, Kolm P, Torguson R, Waksman R, Weintraub WS, Yerasi COriginally published: Cardiovascular Revascularization Medicine. 2020 Jan 16Fiscal year: FY2020Digital Object Identifier: Date added to catalog: 2020-07-09
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 32317227 Available 32317227

Available in print through MWHC library: 2002 - present

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.

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