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
Background Several randomized controlled trials (RCTs) have already shown that paclitaxel‐coated balloons and stents significantly reduce the rates of vessel restenosis and target lesion revascularization after lower extremity interventions. Methods and Results A systematic review and meta‐analysis...
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| Format: | Article |
| Language: | English |
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Wiley
2018-12-01
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| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| Subjects: | |
| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.118.011245 |
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| author | Konstantinos Katsanos Stavros Spiliopoulos Panagiotis Kitrou Miltiadis Krokidis Dimitrios Karnabatidis |
| author_facet | Konstantinos Katsanos Stavros Spiliopoulos Panagiotis Kitrou Miltiadis Krokidis Dimitrios Karnabatidis |
| author_sort | Konstantinos Katsanos |
| collection | DOAJ |
| description | Background Several randomized controlled trials (RCTs) have already shown that paclitaxel‐coated balloons and stents significantly reduce the rates of vessel restenosis and target lesion revascularization after lower extremity interventions. Methods and Results A systematic review and meta‐analysis of RCTs investigating paclitaxel‐coated devices in the femoral and/or popliteal arteries was performed. The primary safety measure was all‐cause patient death. Risk ratios and risk differences were pooled with a random effects model. In all, 28 RCTs with 4663 patients (89% intermittent claudication) were analyzed. All‐cause patient death at 1 year (28 RCTs with 4432 cases) was similar between paclitaxel‐coated devices and control arms (2.3% versus 2.3% crude risk of death; risk ratio, 1.08; 95% CI, 0.72–1.61). All‐cause death at 2 years (12 RCTs with 2316 cases) was significantly increased in the case of paclitaxel versus control (7.2% versus 3.8% crude risk of death; risk ratio, 1.68; 95% CI, 1.15–2.47; —number‐needed‐to‐harm, 29 patients [95% CI, 19–59]). All‐cause death up to 5 years (3 RCTs with 863 cases) increased further in the case of paclitaxel (14.7% versus 8.1% crude risk of death; risk ratio, 1.93; 95% CI, 1.27–2.93; —number‐needed‐to‐harm, 14 patients [95% CI, 9–32]). Meta‐regression showed a significant relationship between exposure to paclitaxel (dose‐time product) and absolute risk of death (0.4±0.1% excess risk of death per paclitaxel mg‐year; P<0.001). Trial sequential analysis excluded false‐positive findings with 99% certainty (2‐sided α, 1.0%). Conclusions There is increased risk of death following application of paclitaxel‐coated balloons and stents in the femoropopliteal artery of the lower limbs. Further investigations are urgently warranted. Clinical Trial Registration URL: www.crd.york.ac.uk/PROSPERO. Unique identifier: CRD42018099447. |
| first_indexed | 2024-12-22T21:37:04Z |
| format | Article |
| id | doaj.art-ecb54c04521646cfa096741b98b6cb20 |
| institution | Directory Open Access Journal |
| issn | 2047-9980 |
| language | English |
| last_indexed | 2024-12-22T21:37:04Z |
| publishDate | 2018-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj.art-ecb54c04521646cfa096741b98b6cb202022-12-21T18:11:42ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802018-12-0172410.1161/JAHA.118.011245Risk 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 TrialsKonstantinos Katsanos0Stavros Spiliopoulos1Panagiotis Kitrou2Miltiadis Krokidis3Dimitrios Karnabatidis4Patras University Hospital Rion GreeceAttikon University Hospital Athens GreecePatras University Hospital Rion GreeceCambridge University Hospitals NHS Foundation Trust Cambridge UKPatras University Hospital Rion GreeceBackground Several randomized controlled trials (RCTs) have already shown that paclitaxel‐coated balloons and stents significantly reduce the rates of vessel restenosis and target lesion revascularization after lower extremity interventions. Methods and Results A systematic review and meta‐analysis of RCTs investigating paclitaxel‐coated devices in the femoral and/or popliteal arteries was performed. The primary safety measure was all‐cause patient death. Risk ratios and risk differences were pooled with a random effects model. In all, 28 RCTs with 4663 patients (89% intermittent claudication) were analyzed. All‐cause patient death at 1 year (28 RCTs with 4432 cases) was similar between paclitaxel‐coated devices and control arms (2.3% versus 2.3% crude risk of death; risk ratio, 1.08; 95% CI, 0.72–1.61). All‐cause death at 2 years (12 RCTs with 2316 cases) was significantly increased in the case of paclitaxel versus control (7.2% versus 3.8% crude risk of death; risk ratio, 1.68; 95% CI, 1.15–2.47; —number‐needed‐to‐harm, 29 patients [95% CI, 19–59]). All‐cause death up to 5 years (3 RCTs with 863 cases) increased further in the case of paclitaxel (14.7% versus 8.1% crude risk of death; risk ratio, 1.93; 95% CI, 1.27–2.93; —number‐needed‐to‐harm, 14 patients [95% CI, 9–32]). Meta‐regression showed a significant relationship between exposure to paclitaxel (dose‐time product) and absolute risk of death (0.4±0.1% excess risk of death per paclitaxel mg‐year; P<0.001). Trial sequential analysis excluded false‐positive findings with 99% certainty (2‐sided α, 1.0%). Conclusions There is increased risk of death following application of paclitaxel‐coated balloons and stents in the femoropopliteal artery of the lower limbs. Further investigations are urgently warranted. Clinical Trial Registration URL: www.crd.york.ac.uk/PROSPERO. Unique identifier: CRD42018099447.https://www.ahajournals.org/doi/10.1161/JAHA.118.011245balloon angioplastypaclitaxelpaclitaxel‐coated balloonpaclitaxel‐eluting stent |
| spellingShingle | Konstantinos Katsanos Stavros Spiliopoulos Panagiotis Kitrou Miltiadis Krokidis Dimitrios Karnabatidis 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 Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease balloon angioplasty paclitaxel paclitaxel‐coated balloon paclitaxel‐eluting stent |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | balloon angioplasty paclitaxel paclitaxel‐coated balloon paclitaxel‐eluting stent |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.118.011245 |
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