Study . | N . | With Diabetes, % . | With CLTI, %* . | Intervention, n (% With Diabetes) . | Control, n (% With CLTI) . | Major Outcomes . | |
---|---|---|---|---|---|---|---|
RCTs | |||||||
Dake et al., 2011 (88), and Dake et al., 2016 (89,90) | 474 | 46 | 8 | Paclitaxel DES, 236 (49) | PTA, 238 (42) | †Patency 1 y 83.1 vs. 32.8% (P <0.01) Patency 5 y 66.4 vs. 43.4% (P <0.01) | Mortality 1 y 3.8 vs. 1.7% (P = 0.17) Mortality 5 y 16.9 vs. 10.2 (P = 0.03) |
Gray et al., 2018 (92) | 465 | 42 | <10 | Eluvia DES, 309 (42) | Zilver DES, 156 (44) | †Patency 1 y 87 vs. 77.6% (P <0.05) | Mortality 1 y 2.1 vs. 4% (P = 0.23) |
Rosenfield et al., 2015 (96) | 476 | 43 | 8 | Paclitaxel DCB, 316 (43) | PTA, 160 (42) | †Patency 1 y 65.2 vs. 52.6% (P = 0.02) | Mortality 1 y 2.4 vs. 2.8% (P = 0.82) |
Tepe et al., 2015 (97), Laird et al., 2015 (98), Schneider et al., 2018 (99), and Laird et al., 2019 (100) | 331 | 43 | 5 | Paclitaxel DCB, 220 (40) | PTA, 111 (49) | †Patency 1 y 88.2 vs. 52.4% (P <0.01) Patency 2 y 78.9 vs. 50.1% (P <0.01) Patency 3 y 69.5 vs. 45.1% (P <0.01) TLR 5 y 25.5 vs. 34.7% (P = 0.02) | — Mortality 2 y 8.1 vs. 0.9% (P <0.01) Mortality 3 y 10.7 vs. 1.9% (P <0.01) Mortality 5 y 14.6 vs. 10.2% (P = 0.2) |
Tepe et al., 2020 (101) | 88 | 44 | 9 | Paclitaxel DCB, 47 (43) | PTA, 41 (46) | TLR 2 y 52 vs. 75% (P = 0.1) | Mortality 6 m 8 vs. 9% (P = 0.9) |
Randomized registry | |||||||
Nordanstig et al., 2020 (109) | 2,289 | 45 | 65 | Paclitaxel devices, 1,149 (46) | Uncoated devices, 1,140 (45) | Mortality 2.5 y HR 1.06 (95% CI 0.92–1.22) | — |
Prospective studies | |||||||
Müller-Hülsbeck et al., 2017 (91) | 57 | 35 | 4 | Eluvia DES, 57 (35) | — | Patency 2 y for patients with diabetes 76.5% | TLR 3 y for patients with diabetes 82.5% |
Micari et al., 2012 (93), and Micari et al., 2013 (94) | 105 | 49 | 8 | Paclitaxel DCB, 105 (49) | — | †Patency 1 y 83.7% Patency 2 y 72.4% | Mortality 1 y 2.2% Mortality 2 y 2.2% |
Scheinert et al., 2018 (95) | 157 | 41 | 17 | Paclitaxel DCB, 157 (41) | — | †Patency 1 y 91.1% | Mortality 1 y 4.5% |
Grotti et al., 2016 (102) | 86 | 100 | 70 | DCB, 44 (100) | PTA, 42 (100) | TLR 3 y 40 vs. 43% (P = 0.8) | Mortality 3 y 20 vs. 21% (P = 1.0) |
Retrospective studies | |||||||
Bertges et al., 2020 (103) | 2,976 1,196 | 61 53 | 34 50 | Paclitaxel DCB, 1,488 (61) Paclitaxel DES, 598 (53) | PTA, 1,488 (61) BMS, 598 (53) | Mortality 15 m HR 0.84 (95% CI 0.66–1.06) Mortality 15 m HR 0.93 (95% CI 0.62–1.41) | — — |
Secemsky et al., 2019 (105) | 16,560 | 59 | 51 | Drug-coated devices, 5,989 (61) | Uncoated devices, 10,571 (58) | Mortality 1 y HR 0.97 (95% CI 0.91–1.04) | — |
Secemsky et al., 2019 (106) | 51,456 | 39 | 60 | DES, 4,105 (NR) | BMS, 4,7351 (NR) | Mortality 2 y 51.7 vs 50.1% (P = 0.16) | — |
Meta-analyses | |||||||
Kastanos et al., 2018 (78) | 4,663 | 21–77 | 11 | Paclitaxel devices, 2,552 (44) | Uncoated devices, 2,006 (42) | Mortality 1 y RR 1.08 (95% CI 0.72–1.61) Mortality 2 y RR 1.68 (95% CI 1.15–2.47) | Mortality 5 y RR 1.93 (95% CI 1.27–2.93) |
Schneider et al., 2019 (104) | 855 | 43 | 7 | Paclitaxel DCB, 712 (41) | PTA 143 (50) | TLR 5 y HR 0.51 (95% CI 0.36–0.72) Mortality 3 y HR 3.76 (95% CI 1.22–11.55) | Mortality 5 y HR 1.52 (95% CI 0.82–2.82) |
Dinh et al., 2020 (107) | 1,450 | 30–95 | 94 | Paclitaxel devices, 866 (NR) | Uncoated devices, 584 (NR) | Mortality 1 y RR 1.07 (95% CI 0.74–1.52) | Mortality 5 y RR 0.91 (95% CI 0.75–1.10) |
Rocha-Singh et al., 2020 (108) | 2,185 | 37–58 | 6 | Paclitaxel devices, 1,382 (NR) | Uncoated devices, 803 (NR) | — | Mortality 5 y HR 1.38 (95% CI 1.06–1.80) |
Study . | N . | With Diabetes, % . | With CLTI, %* . | Intervention, n (% With Diabetes) . | Control, n (% With CLTI) . | Major Outcomes . | |
---|---|---|---|---|---|---|---|
RCTs | |||||||
Dake et al., 2011 (88), and Dake et al., 2016 (89,90) | 474 | 46 | 8 | Paclitaxel DES, 236 (49) | PTA, 238 (42) | †Patency 1 y 83.1 vs. 32.8% (P <0.01) Patency 5 y 66.4 vs. 43.4% (P <0.01) | Mortality 1 y 3.8 vs. 1.7% (P = 0.17) Mortality 5 y 16.9 vs. 10.2 (P = 0.03) |
Gray et al., 2018 (92) | 465 | 42 | <10 | Eluvia DES, 309 (42) | Zilver DES, 156 (44) | †Patency 1 y 87 vs. 77.6% (P <0.05) | Mortality 1 y 2.1 vs. 4% (P = 0.23) |
Rosenfield et al., 2015 (96) | 476 | 43 | 8 | Paclitaxel DCB, 316 (43) | PTA, 160 (42) | †Patency 1 y 65.2 vs. 52.6% (P = 0.02) | Mortality 1 y 2.4 vs. 2.8% (P = 0.82) |
Tepe et al., 2015 (97), Laird et al., 2015 (98), Schneider et al., 2018 (99), and Laird et al., 2019 (100) | 331 | 43 | 5 | Paclitaxel DCB, 220 (40) | PTA, 111 (49) | †Patency 1 y 88.2 vs. 52.4% (P <0.01) Patency 2 y 78.9 vs. 50.1% (P <0.01) Patency 3 y 69.5 vs. 45.1% (P <0.01) TLR 5 y 25.5 vs. 34.7% (P = 0.02) | — Mortality 2 y 8.1 vs. 0.9% (P <0.01) Mortality 3 y 10.7 vs. 1.9% (P <0.01) Mortality 5 y 14.6 vs. 10.2% (P = 0.2) |
Tepe et al., 2020 (101) | 88 | 44 | 9 | Paclitaxel DCB, 47 (43) | PTA, 41 (46) | TLR 2 y 52 vs. 75% (P = 0.1) | Mortality 6 m 8 vs. 9% (P = 0.9) |
Randomized registry | |||||||
Nordanstig et al., 2020 (109) | 2,289 | 45 | 65 | Paclitaxel devices, 1,149 (46) | Uncoated devices, 1,140 (45) | Mortality 2.5 y HR 1.06 (95% CI 0.92–1.22) | — |
Prospective studies | |||||||
Müller-Hülsbeck et al., 2017 (91) | 57 | 35 | 4 | Eluvia DES, 57 (35) | — | Patency 2 y for patients with diabetes 76.5% | TLR 3 y for patients with diabetes 82.5% |
Micari et al., 2012 (93), and Micari et al., 2013 (94) | 105 | 49 | 8 | Paclitaxel DCB, 105 (49) | — | †Patency 1 y 83.7% Patency 2 y 72.4% | Mortality 1 y 2.2% Mortality 2 y 2.2% |
Scheinert et al., 2018 (95) | 157 | 41 | 17 | Paclitaxel DCB, 157 (41) | — | †Patency 1 y 91.1% | Mortality 1 y 4.5% |
Grotti et al., 2016 (102) | 86 | 100 | 70 | DCB, 44 (100) | PTA, 42 (100) | TLR 3 y 40 vs. 43% (P = 0.8) | Mortality 3 y 20 vs. 21% (P = 1.0) |
Retrospective studies | |||||||
Bertges et al., 2020 (103) | 2,976 1,196 | 61 53 | 34 50 | Paclitaxel DCB, 1,488 (61) Paclitaxel DES, 598 (53) | PTA, 1,488 (61) BMS, 598 (53) | Mortality 15 m HR 0.84 (95% CI 0.66–1.06) Mortality 15 m HR 0.93 (95% CI 0.62–1.41) | — — |
Secemsky et al., 2019 (105) | 16,560 | 59 | 51 | Drug-coated devices, 5,989 (61) | Uncoated devices, 10,571 (58) | Mortality 1 y HR 0.97 (95% CI 0.91–1.04) | — |
Secemsky et al., 2019 (106) | 51,456 | 39 | 60 | DES, 4,105 (NR) | BMS, 4,7351 (NR) | Mortality 2 y 51.7 vs 50.1% (P = 0.16) | — |
Meta-analyses | |||||||
Kastanos et al., 2018 (78) | 4,663 | 21–77 | 11 | Paclitaxel devices, 2,552 (44) | Uncoated devices, 2,006 (42) | Mortality 1 y RR 1.08 (95% CI 0.72–1.61) Mortality 2 y RR 1.68 (95% CI 1.15–2.47) | Mortality 5 y RR 1.93 (95% CI 1.27–2.93) |
Schneider et al., 2019 (104) | 855 | 43 | 7 | Paclitaxel DCB, 712 (41) | PTA 143 (50) | TLR 5 y HR 0.51 (95% CI 0.36–0.72) Mortality 3 y HR 3.76 (95% CI 1.22–11.55) | Mortality 5 y HR 1.52 (95% CI 0.82–2.82) |
Dinh et al., 2020 (107) | 1,450 | 30–95 | 94 | Paclitaxel devices, 866 (NR) | Uncoated devices, 584 (NR) | Mortality 1 y RR 1.07 (95% CI 0.74–1.52) | Mortality 5 y RR 0.91 (95% CI 0.75–1.10) |
Rocha-Singh et al., 2020 (108) | 2,185 | 37–58 | 6 | Paclitaxel devices, 1,382 (NR) | Uncoated devices, 803 (NR) | — | Mortality 5 y HR 1.38 (95% CI 1.06–1.80) |
CLTI includes Rutherford classes 4–6 and Fontaine stages III–IV.
Study primary end point. m, month(s); NR, not reported; RR, relative risk; y, year(s).