Long‐Term Follow‐up of the PADI Trial: Percutaneous Transluminal Angioplasty Versus Drug‐Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia
BackgroundClinical outcomes reported after treatment of infrapopliteal lesions with drug‐eluting stents (DESs) have been more favorable compared with percutaneous transluminal angioplasty with a bailout bare metal stent (PTA‐BMS) through midterm follow‐up in patients with critical limb ischemia. In...
| Main Authors: | , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2017-04-01
|
| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| Subjects: | |
| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.116.004877 |
| _version_ | 1811275110636584960 |
|---|---|
| author | Marlon I. Spreen Jasper M. Martens Bob Knippenberg Lukas C. van Dijk Jean‐Paul P. M. de Vries Jan Albert Vos Gert Jan de Borst Evert‐Jan P. A. Vonken Okker D. Bijlstra Jan J. Wever Randolph G. Statius van Eps Willem P. Th. M. Mali Hendrik van Overhagen |
| author_facet | Marlon I. Spreen Jasper M. Martens Bob Knippenberg Lukas C. van Dijk Jean‐Paul P. M. de Vries Jan Albert Vos Gert Jan de Borst Evert‐Jan P. A. Vonken Okker D. Bijlstra Jan J. Wever Randolph G. Statius van Eps Willem P. Th. M. Mali Hendrik van Overhagen |
| author_sort | Marlon I. Spreen |
| collection | DOAJ |
| description | BackgroundClinical outcomes reported after treatment of infrapopliteal lesions with drug‐eluting stents (DESs) have been more favorable compared with percutaneous transluminal angioplasty with a bailout bare metal stent (PTA‐BMS) through midterm follow‐up in patients with critical limb ischemia. In the present study, long‐term results of treatment of infrapopliteal lesions with DESs are presented. Methods and ResultsAdults with critical limb ischemia (Rutherford category ≥4) and infrapopliteal lesions were randomized to receive PTA‐BMS or DESs with paclitaxel. Long‐term follow‐up consisted of annual assessments up to 5 years after treatment or until a clinical end point was reached. Clinical end points were major amputation (above ankle level), infrapopliteal surgical or endovascular reintervention, and death. Preserved primary patency (≤50% restenosis) of treated lesions was an additional morphological end point, assessed by duplex sonography. In total, 74 limbs (73 patients) were treated with DESs and 66 limbs (64 patients) were treated with PTA‐BMS. The estimated 5‐year major amputation rate was lower in the DES arm (19.3% versus 34.0% for PTA‐BMS; P=0.091). The 5‐year rates of amputation‐ and event‐free survival (survival free from major amputation or reintervention) were significantly higher in the DES arm compared with PTA‐BMS (31.8% versus 20.4%, P=0.043; and 26.2% versus 15.3%, P=0.041, respectively). Survival rates were comparable. The limited available morphological results showed higher preserved patency rates after DESs than after PTA‐BMS at 1, 3, and 4 years of follow‐up. ConclusionsBoth clinical and morphological long‐term results after treatment of infrapopliteal lesions in patients with critical limb ischemia are improved with DES compared with PTA‐BMS. Clinical Trial RegistrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00471289. |
| first_indexed | 2024-04-12T23:32:14Z |
| format | Article |
| id | doaj.art-03d90ae6adfe48839dae75b9c2e2aace |
| institution | Directory Open Access Journal |
| issn | 2047-9980 |
| language | English |
| last_indexed | 2024-04-12T23:32:14Z |
| publishDate | 2017-04-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj.art-03d90ae6adfe48839dae75b9c2e2aace2022-12-22T03:12:14ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802017-04-016410.1161/JAHA.116.004877Long‐Term Follow‐up of the PADI Trial: Percutaneous Transluminal Angioplasty Versus Drug‐Eluting Stents for Infrapopliteal Lesions in Critical Limb IschemiaMarlon I. Spreen0Jasper M. Martens1Bob Knippenberg2Lukas C. van Dijk3Jean‐Paul P. M. de Vries4Jan Albert Vos5Gert Jan de Borst6Evert‐Jan P. A. Vonken7Okker D. Bijlstra8Jan J. Wever9Randolph G. Statius van Eps10Willem P. Th. M. Mali11Hendrik van Overhagen12Department of Radiology, Haga Teaching Hospital, The Hague, The NetherlandsDepartment of Radiology, Haga Teaching Hospital, The Hague, The NetherlandsDepartment of Vascular Surgery, Haga Teaching Hospital, The Hague, The NetherlandsDepartment of Radiology, Haga Teaching Hospital, The Hague, The NetherlandsDepartment of Vascular Surgery, Sint Antonius Hospital, Nieuwegein, The NetherlandsDepartment of Radiology, Sint Antonius Hospital, Nieuwegein, The NetherlandsDepartment of Vascular Surgery, University Medical Centre Utrecht, Utrecht, The NetherlandsDepartment of Radiology, University Medical Centre Utrecht, Utrecht, The NetherlandsFaculty of Medicine, Leiden University, Leiden, The NetherlandsDepartment of Vascular Surgery, Haga Teaching Hospital, The Hague, The NetherlandsDepartment of Vascular Surgery, Haga Teaching Hospital, The Hague, The NetherlandsDepartment of Radiology, University Medical Centre Utrecht, Utrecht, The NetherlandsDepartment of Radiology, Haga Teaching Hospital, The Hague, The NetherlandsBackgroundClinical outcomes reported after treatment of infrapopliteal lesions with drug‐eluting stents (DESs) have been more favorable compared with percutaneous transluminal angioplasty with a bailout bare metal stent (PTA‐BMS) through midterm follow‐up in patients with critical limb ischemia. In the present study, long‐term results of treatment of infrapopliteal lesions with DESs are presented. Methods and ResultsAdults with critical limb ischemia (Rutherford category ≥4) and infrapopliteal lesions were randomized to receive PTA‐BMS or DESs with paclitaxel. Long‐term follow‐up consisted of annual assessments up to 5 years after treatment or until a clinical end point was reached. Clinical end points were major amputation (above ankle level), infrapopliteal surgical or endovascular reintervention, and death. Preserved primary patency (≤50% restenosis) of treated lesions was an additional morphological end point, assessed by duplex sonography. In total, 74 limbs (73 patients) were treated with DESs and 66 limbs (64 patients) were treated with PTA‐BMS. The estimated 5‐year major amputation rate was lower in the DES arm (19.3% versus 34.0% for PTA‐BMS; P=0.091). The 5‐year rates of amputation‐ and event‐free survival (survival free from major amputation or reintervention) were significantly higher in the DES arm compared with PTA‐BMS (31.8% versus 20.4%, P=0.043; and 26.2% versus 15.3%, P=0.041, respectively). Survival rates were comparable. The limited available morphological results showed higher preserved patency rates after DESs than after PTA‐BMS at 1, 3, and 4 years of follow‐up. ConclusionsBoth clinical and morphological long‐term results after treatment of infrapopliteal lesions in patients with critical limb ischemia are improved with DES compared with PTA‐BMS. Clinical Trial RegistrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00471289.https://www.ahajournals.org/doi/10.1161/JAHA.116.004877critical limb ischemiadrug‐eluting stentendovascular treatmentperipheral artery disease |
| spellingShingle | Marlon I. Spreen Jasper M. Martens Bob Knippenberg Lukas C. van Dijk Jean‐Paul P. M. de Vries Jan Albert Vos Gert Jan de Borst Evert‐Jan P. A. Vonken Okker D. Bijlstra Jan J. Wever Randolph G. Statius van Eps Willem P. Th. M. Mali Hendrik van Overhagen Long‐Term Follow‐up of the PADI Trial: Percutaneous Transluminal Angioplasty Versus Drug‐Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease critical limb ischemia drug‐eluting stent endovascular treatment peripheral artery disease |
| title | Long‐Term Follow‐up of the PADI Trial: Percutaneous Transluminal Angioplasty Versus Drug‐Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia |
| title_full | Long‐Term Follow‐up of the PADI Trial: Percutaneous Transluminal Angioplasty Versus Drug‐Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia |
| title_fullStr | Long‐Term Follow‐up of the PADI Trial: Percutaneous Transluminal Angioplasty Versus Drug‐Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia |
| title_full_unstemmed | Long‐Term Follow‐up of the PADI Trial: Percutaneous Transluminal Angioplasty Versus Drug‐Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia |
| title_short | Long‐Term Follow‐up of the PADI Trial: Percutaneous Transluminal Angioplasty Versus Drug‐Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia |
| title_sort | long term follow up of the padi trial percutaneous transluminal angioplasty versus drug eluting stents for infrapopliteal lesions in critical limb ischemia |
| topic | critical limb ischemia drug‐eluting stent endovascular treatment peripheral artery disease |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.116.004877 |
| work_keys_str_mv | AT marlonispreen longtermfollowupofthepaditrialpercutaneoustransluminalangioplastyversusdrugelutingstentsforinfrapopliteallesionsincriticallimbischemia AT jaspermmartens longtermfollowupofthepaditrialpercutaneoustransluminalangioplastyversusdrugelutingstentsforinfrapopliteallesionsincriticallimbischemia AT bobknippenberg longtermfollowupofthepaditrialpercutaneoustransluminalangioplastyversusdrugelutingstentsforinfrapopliteallesionsincriticallimbischemia AT lukascvandijk longtermfollowupofthepaditrialpercutaneoustransluminalangioplastyversusdrugelutingstentsforinfrapopliteallesionsincriticallimbischemia AT jeanpaulpmdevries longtermfollowupofthepaditrialpercutaneoustransluminalangioplastyversusdrugelutingstentsforinfrapopliteallesionsincriticallimbischemia AT janalbertvos longtermfollowupofthepaditrialpercutaneoustransluminalangioplastyversusdrugelutingstentsforinfrapopliteallesionsincriticallimbischemia AT gertjandeborst longtermfollowupofthepaditrialpercutaneoustransluminalangioplastyversusdrugelutingstentsforinfrapopliteallesionsincriticallimbischemia AT evertjanpavonken longtermfollowupofthepaditrialpercutaneoustransluminalangioplastyversusdrugelutingstentsforinfrapopliteallesionsincriticallimbischemia AT okkerdbijlstra longtermfollowupofthepaditrialpercutaneoustransluminalangioplastyversusdrugelutingstentsforinfrapopliteallesionsincriticallimbischemia AT janjwever longtermfollowupofthepaditrialpercutaneoustransluminalangioplastyversusdrugelutingstentsforinfrapopliteallesionsincriticallimbischemia AT randolphgstatiusvaneps longtermfollowupofthepaditrialpercutaneoustransluminalangioplastyversusdrugelutingstentsforinfrapopliteallesionsincriticallimbischemia AT willempthmmali longtermfollowupofthepaditrialpercutaneoustransluminalangioplastyversusdrugelutingstentsforinfrapopliteallesionsincriticallimbischemia AT hendrikvanoverhagen longtermfollowupofthepaditrialpercutaneoustransluminalangioplastyversusdrugelutingstentsforinfrapopliteallesionsincriticallimbischemia |