Systematic Review and Meta-analysis of the Outcomes of Drug-Eluting Stent Versus Drug-Coated Balloon Angioplasty for Lower Extremity Peripheral Artery Diseases


      Recent evidence raised the concern that paclitaxel-containing therapy was associated with an increased risk of mortality in patients with peripheral artery diseases (PADs). However, it is unclear whether drug-eluting stent (DES) versus drug-coated balloon (DCB) have a different effect on mortality of PAD patients. Our study aimed to systematically review current literature comparing clinical outcomes of patients treated with DES versus DCB for PAD.


      MEDLINE and Embase were searched for eligible studies from January 2000 to December 31, 2020. Randomized controlled trials (RCTs) or cohort studies that reported outcomes of DES versus DCB were included in our study. The primary outcome was 12-month all-cause mortality. A random-effect model was used to pool the odds ratios (ORs) and related 95% confidence intervals (CIs).


      Our review included 7 studies, involving 2 RCTs and 5 cohort studies. A total of 4,237 patients with DES and 9,234 patients with DCB were analyzed. All included cohort studies were of high quality with Newcastle-Ottawa scores from 7 to 8. No significant difference in 12-month all-cause mortality was found between DES and DCB without significant heterogeneity (OR 1.02, 95% CI 0.91–1.14, I2 = 0%). As for primary patency, no significant difference between treatments was observed (OR 1.27, 95% CI 0.75–2.15, I2 = 55%). Similar results were observed for freedom from target lesion revascularization (OR 0.94, 95% CI 0.64–1.40, I2 = 0%).


      This systematic review and meta-analysis suggest that no significant difference in 12-month all-cause mortality was found between DES and DCB. Primary patency and freedom from target lesion revascularization of lower extremity PAD were also comparable between the 2 groups.
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        • Fowkes F.G.
        • Rudan D.
        • Rudan I.
        • et al.
        Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis.
        Lancet. 2013; 382: 1329-1340
        • Dake M.D.
        • Ansel G.M.
        • Jaff M.R.
        • et al.
        Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results.
        Circ Cardiovasc Interv. 2011; 4: 495-504
        • Kayssi A.
        • Al-Jundi W.
        • Papia G.
        • et al.
        Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for the treatment of in-stent restenosis of the femoropopliteal arteries.
        Cochrane Database Syst Rev. 2019; 1: CD012510
        • Micari A.
        • Brodmann M.
        • Keirse K.
        • et al.
        Drug-coated balloon treatment of femoropopliteal lesions for patients with intermittent claudication and ischemic rest pain: 2-year results from the IN.PACT global study.
        JACC Cardiovasc Interv. 2018; 11: 945-953
        • Chou H.H.
        • Huang H.L.
        • Hsieh C.A.
        • et al.
        Drug-coated balloon vs. conventional balloon angioplasty in dialysis patients with symptomatic femoropopliteal disease — a matched comparison.
        Circ J. 2018; 82: 1908-1916
        • Ott I.
        • Cassese S.
        • Groha P.
        • et al.
        ISAR-PEBIS (Paclitaxel-Eluting balloon versus conventional balloon angioplasty for in-stent restenosis of superficial femoral artery): a randomized trial.
        J Am Heart Assoc. 2017; 6: e006321
        • Kinstner C.M.
        • Lammer J.
        • Willfort-Ehringer A.
        • et al.
        Paclitaxel-eluting balloon versus standard balloon angioplasty in in-stent restenosis of the superficial femoral and proximal popliteal artery: 1-year results of the PACUBA trial.
        JACC Cardiovasc Interv. 2016; 9: 1386-1392
        • Mohapatra A.
        • Saadeddin Z.
        • Bertges D.J.
        • et al.
        Nationwide trends in drug-coated balloon and drug-eluting stent utilization in the femoropopliteal arteries.
        J Vasc Surg. 2020; 71: 560-566
        • Tepe G.
        • Zeller T.
        • Albrecht T.
        • et al.
        Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg.
        N Engl J Med. 2008; 358: 689-699
        • Katsanos K.
        • Spiliopoulos S.
        • Kitrou P.
        • et al.
        Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials.
        J Am Heart Assoc. 2018; 7: e011245
        • Schneider P.A.
        • Laird J.R.
        • Doros G.
        • et al.
        Mortality not correlated with paclitaxel exposure: an independent patient-level meta-analysis of a drug-coated balloon.
        J Am Coll Cardiol. 2019; 73: 2550-2563
        • Gray W.A.
        • Jaff M.R.
        • Parikh S.A.
        • et al.
        Mortality assessment of paclitaxel-coated balloons: patient-level meta-analysis of the ILLUMENATE clinical program at 3 years.
        Circulation. 2019; 140: 1145-1155
        • Rocha-Singh K.J.
        • Duval S.
        • Jaff M.R.
        • et al.
        Mortality and paclitaxel-coated devices: an individual patient data meta-analysis.
        Circulation. 2020; 141: 1859-1869
        • Giacoppo D.
        • Alfonso F.
        • Xu B.
        • et al.
        Drug-coated balloon angioplasty versus drug-eluting stent implantation in patients with coronary stent restenosis.
        J Am Coll Cardiol. 2020; 75: 2664-2678
        • Giacoppo D.
        • Alfonso F.
        • Xu B.
        • et al.
        Paclitaxel-coated balloon angioplasty vs. drug-eluting stenting for the treatment of coronary in-stent restenosis: a comprehensive, collaborative, individual patient data meta-analysis of 10 randomized clinical trials (DAEDALUS study).
        Eur Heart J. 2019; 41: 3715-3728
        • Mantel N.
        • Haenszel W.
        Statistical aspects of the analysis of data from retrospective studies of disease.
        J Natl Cancer Inst. 1959; 22: 719-748
        • Higgins J.P.
        • Thompson S.G.
        • Deeks J.J.
        • et al.
        Measuring inconsistency in meta-analyses.
        BMJ. 2003; 327: 557-560
        • Ioannidis J.P.
        Interpretation of tests of heterogeneity and bias in meta-analysis.
        J Eval Clin Pract. 2008; 14: 951-957
        • Zeller T.
        • Rastan A.
        • Macharzina R.
        • et al.
        Drug-coated balloons vs. drug-eluting stents for treatment of long femoropopliteal lesions.
        J Endovasc Ther. 2014; 21: 359-368
        • Secemsky E.A.
        • Kundi H.
        • Weinberg I.
        • et al.
        Association of survival with femoropopliteal artery revascularization with drug-coated devices.
        JAMA Cardiol. 2019; 4: 332-340
        • Phair J.
        • Carnevale M.
        • Lipsitz E.C.
        • et al.
        Amputation-free survival in patients with critical limb ischemia treated with paclitaxel-eluting stents and paclitaxel-coated balloons.
        Ann Vasc Surg. 2020; 62: 8-14
        • Liistro F.
        • Angioli P.
        • Porto I.
        • et al.
        Drug-eluting balloon versus drug-eluting stent for complex femoropopliteal arterial lesions: the DRASTICO study.
        J Am Coll Cardiol. 2019; 74: 205-215
        • Freisinger E.
        • Koeppe J.
        • Gerss J.
        • et al.
        Mortality after use of paclitaxel-based devices in peripheral arteries: a real-world safety analysis.
        Eur Heart J. 2019; 41: 3732-3739
        • Bertges D.J.
        • Sedrakyan A.
        • Sun T.
        • et al.
        Mortality after paclitaxel coated balloon angioplasty and stenting of superficial femoral and popliteal artery in the vascular quality initiative.
        Circ Cardiovasc Interv. 2020; 13: e008528
        • Bausback Y.
        • Wittig T.
        • Schmidt A.
        • et al.
        Drug-eluting stent versus drug-coated balloon revascularization in patients with femoropopliteal arterial disease.
        J Am Coll Cardiol. 2019; 73: 667-679
        • Conte M.S.
        • Bradbury A.W.
        • Kolh P.
        • et al.
        Global vascular guidelines on the management of chronic limb-threatening ischemia.
        J Vasc Surg. 2019; 69: 3S-125S.e140
        • Conte M.S.
        • Bradbury A.W.
        • Kolh P.
        • et al.
        Global vascular guidelines on the management of chronic limb-threatening ischemia.
        Eur J Vasc Endovasc Surg. 2019; 58: S1-S109.e133
        • Anantha-Narayanan M.
        • Shah S.M.
        • Jelani Q.U.
        • et al.
        Drug-coated balloon versus plain old balloon angioplasty in femoropopliteal disease: an updated meta-analysis of randomized controlled trials.
        Catheter Cardiovasc Interv. 2019; 94: 139-148
        • Beckman J.A.
        • White C.J.
        Paclitaxel-coated balloons and eluting stents: is there a mortality risk in patients with peripheral artery disease?.
        Circulation. 2019; 140: 1342-1351
        • Klumb C.
        • Lehmann T.
        • Aschenbach R.
        • et al.
        Benefit and risk from paclitaxel-coated balloon angioplasty for the treatment of femoropopliteal artery disease: a systematic review and meta-analysis of randomised controlled trials.
        EClinicalMedicine. 2019; 16: 42-50
        • Dangas G.D.
        • Claessen B.E.
        • Caixeta A.
        • et al.
        In-stent restenosis in the drug-eluting stent era.
        J Am Coll Cardiol. 2010; 56: 1897-1907
        • Seidlitz A.
        • Kotzan N.
        • Nagel S.
        • et al.
        In vitro determination of drug transfer from drug-coated balloons.
        PLoS One. 2013; 8: e83992
        • Kempin W.
        • Kaule S.
        • Reske T.
        • et al.
        In vitro evaluation of paclitaxel coatings for delivery via drug-coated balloons.
        Eur J Pharm Biopharm. 2015; 96: 322-328
        • Kelsch B.
        • Scheller B.
        • Biedermann M.
        • et al.
        Dose response to Paclitaxel-coated balloon catheters in the porcine coronary overstretch and stent implantation model.
        Invest Radiol. 2011; 46: 255-263
        • Heinrich A.
        • Engler M.S.
        • Guttler F.V.
        • et al.
        Systematic evaluation of particle loss during handling in the percutaneous transluminal angioplasty for eight different drug-coated balloons.
        Sci Rep. 2020; 10: 17220
        • Gongora C.A.
        • Shibuya M.
        • Wessler J.D.
        • et al.
        Impact of paclitaxel dose on tissue pharmacokinetics and vascular healing: a comparative drug-coated balloon study in the Familial hypercholesterolemic swine model of superficial femoral in-stent restenosis.
        JACC Cardiovasc Interv. 2015; 8: 1115-1123