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. 2019 Oct 17:16:42-50.
doi: 10.1016/j.eclinm.2019.09.004. eCollection 2019 Nov.

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

Christof Klumb  1 , Thomas Lehmann  2 , René Aschenbach  1 , Niklas Eckardt  1 , Ulf Teichgräber  1
Affiliations

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

Christof Klumb et al. EClinicalMedicine. .

Abstract

Background: Paclitaxel-coated balloons (DCB) are suitable to reduce the risk of restenosis after angioplasty of atherosclerotic femoropopliteal lesions. However, numerous types of DCBs are distinguished by drug density and coating. Conflicting evidence exists about the risk of mortality. This study sought to evaluate benefit and risk of DCB angioplasty compared to plain old balloon angioplasty (POBA).

Methods: Randomised trials published between January 1, 2005 and February 3, 2019 were identified by searching MEDLINE, CENTRAL, and Clinical.trials.gov. Studies on DCB versus POBA for the treatment of femoropopliteal artery disease were included, and those focused on in-stent restenosis or critical limb ischemia were excluded. Random-effects meta-analysis was conducted to assess the main outcomes of freedom from target lesion revascularisation (FfTLR) and all-cause mortality.

Findings: Of 552 identified records, 14 studies including 2504 patients were eligible. DCB significantly increased the risk of FfTLR with substantial heterogeneity (12-month: risk ratio [RR] 1·24 [95% CI 1·14-2·27], I 2 = 66%; 24-month RR 1·39 [95% CI 1·39-1·52], I 2 = 21%). The risk of 24-month all-cause mortality was increased after DCB (random-effects model: RR 1·53 [95% CI 0·94-2·50], p = 0·09; fixed-effect model: RR 1·74 [95% CI 1·08-2·81], p = 0·02).

Interpretation: Efficacy of DCB differs substantially across studies. Effect size depends on the type of DCB, treatment strategy, and lesion complexity. The risk of 2-year all-cause mortality at 2 years was increased, but without evidence of causation.

Keywords: Angioplasty; Intermittent claudication; Meta-analysis; Paclitaxel; Peripheral artery disease.

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Conflict of interest statement

All authors declare no competing interests.

Figures

Fig 1
Fig. 1
Study selection process.
Fig 2
Fig. 2
Risk of bias. Detection bias regarding the outcome measure of late lumen loss (LLL) was assessed from nine studies that provided results on LLL, all other risks of bias was assessed from all included studies.
Fig 3
Fig. 3
Forest plots showing the effect of DCB angioplasty versus POBA on freedom from target lesion revascularisation. Data are presented for the 12-month (A) and 24-month (B) follow-ups. DCB = drug coated balloon angioplasty; POBA = plain old balloon angioplasty.
Fig 4:
Fig. 4
Effect of DCB angioplasty on clinical improvement. Forest plot illustrates 12-month incidence of clinical improvement by at least one Rutherford category after DCB angioplasty versus POBA. Rutherford classification: category 0 = asymptomatic, category 1 = mild, category 2 = moderate, category 3 = severe claudication, category 4 = ischemic rest pain, category 5 = ischemic ulceration, category 5 = ischemic gangrene, DCB = drug coated balloon angioplasty; POBA = plain old balloon angioplasty.
Fig 5
Fig. 5
Forest plots showing the effect of DCB angioplasty versus POBA on all-cause death. Data are presented for the 12-month (A) and 24-month (B) follow-ups. DCB = drug coated balloon angioplasty; POBA = plain old balloon angioplasty.
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