Original article
A registry on distal popliteal and infrapopliteal revascularization with coronary drug-eluting stents Arturo Giordanoa,b, Stefano Messinaa,b, Michele Polimenoa,b, Nicola Corcionea,b, Paolo Ferraroa,b, Giuseppe Biondi-Zoccaic and Gabriele Giordanoa,b Aims Endovascular therapy for popliteal and infrapopliteal artery disease in patients with critical limb ischemia (CLI) remains challenging, given the high risk of adverse events. Favorable results for coronary balloon-expandable drugeluting stents (DESs) in this arterial district have been reported in selected studies, but uncertainty persists on their risk-benefit balance in real-world patients. We, thus, sought to appraise our outcomes with DES implantation for distal popliteal or infrapopliteal lesions. Methods Our institutional databases were retrospectively queried to identify patients undergoing DES implantation for distal popliteal or infrapopliteal artery disease. Baseline, lesion, procedural, and outcome data were systematically collected.
1 month and in 22 (88.0%) patients at long-term (28.8 W 20.6 months). In this highly selected case series, no repeat revascularizations or unplanned amputations were recorded, whereas two (8.0%) patients died, the first 15.5 months and the second 19.5 months after the procedure. Conclusion Implantation of coronary balloon-expandable DES appears feasible, safe, and effective in selected patients with focal lesions in the distal popliteal and infrapopliteal arteries. J Cardiovasc Med 2014, 15:822–827 Keywords: coronary artery disease, drug-eluting stent, infrapopliteal disease, peripheral artery disease, popliteal artery, stent
Results A total of 25 patients were treated with coronary DES, 12 (48.0%) for distal popliteal and 13 (52.0%) for infrapopliteal lesions. Four (16.0%) patients received two stents, whereas the others only one. Breakdown of DES was as follows: biolimus-eluting, everolimus-eluting, paclitaxeleluting, and sirolimus-eluting stents in, respectively, two (8.0%), one (4.0%), one (4.0%), and 21 (84.0%), with an average stent length of 33.6 W 13.1 mm. Improvement in Fontaine stage was achieved in 23 (92.0%) patients at
a Unita` Operativa di Interventistica Cardiovascolare, Presidio Ospedaliero Pineta Grande, Castelvolturno, bUnita` Operativa di Emodinamica, Casa di Salute Santa Lucia, San Giuseppe Vesuviano and cDepartment of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy
Introduction
selected patients treated in few tertiary care centers.4,6 In addition, whereas several reports are available for tibial and peroneal coronary DES implantation,7 there is uncertainty on the risk-benefit profile of these devices in distal popliteal lesions. Indeed, popliteal artery disease is a challenging subset within the already challenging group of lower limb atherosclerotic lesion.8
The management of patients with critical limb ischemia (CLI) is centered on surgical or endovascular revascularization as a means to improve symptoms and functional status, as well as prevent or delay amputation.1,2 Coronary balloon-expandable drug-eluting stents (DESs), despite being originally developed for stable coronary artery disease and relatively simple lesions, have proved after more than 10 years of routine clinical use as highly versatile, safe, and effective devices, yielding beneficial results in several types of conditions and disease locations, including upper and lower limb vessels.3,4 These favorable results and the lack of satisfactory devices for patients with infrapopliteal disease have led to the hypothesis that coronary DES could be fruitful also in this challenging vascular location. Indeed, several studies have also provided favorable details on firstgeneration and second-generation coronary DES in patients with CLI,5 but the external validity of these findings is limited given that they stem from highly 1558-2027 ß 2014 Italian Federation of Cardiology
Correspondence to Dr Arturo Giordano, Unita` Operativa di Interventistica Cardiovascolare, Presidio Ospedaliero Pineta Grande, Strada Statale Domiziana Km 30, 81030 Castelvolturno, Italy E-mail: [email protected] Received 13 July 2013 Revised 20 February 2014 Accepted 20 February 2014
We began several years ago treating patients with CLI due to below-the-knee (BTK) disease with coronary DES, as we chose them in patients with focal lesions in the distal popliteal, tibial, or peroneal arteries. We, thus, retrospectively reviewed our institutional databases on BTK coronary DES implantation to appraise their safety and efficacy.
Methods Design
This was a retrospective observational study stemming from our experience in treating BTK disease with DOI:10.2459/JCM.0000000000000060
Copyright © Italian Federation of Cardiology. Unauthorized reproduction of this article is prohibited.
Coronary drug-eluting stent in below-the-knee Giordano et al. 823
coronary DES. Ethical approval was waived and all patients provided informed consent. Patients and procedures
Patients in whom coronary DES implantation in the BTK district was attempted (being successful or not) were retrieved from our institutional database. No patient was excluded. Patients with moderate-to-severe claudication failing maximal medical therapy, ischemic rest pain, ulcer, or tissue loss were admitted for invasive angiography and, after collegial discussion, treated with percutaneous transluminal angioplasty (PTA) with coronary DES implantation, referred for bypass surgery, or managed with maximal medical therapy. After contralateral access or, very occasionally, ipsilateral access,9 the target lesion was imaged selectively with a suitably sized JR4 or MP1 coronary guiding catheter (VistaBrite Tip; Cordis, Miami, Florida, USA). After selective wiring with a ‘0.01400 guidewire’ (BMW or Pilot 50; Abbott Vascular, Santa Clara, California, USA), the lesion was usually, but not always, predilated with semicompliant balloons aiming at a balloon-to-artery ratio of 0.8–0.9. Inflations lasted between 1 and 3 min, and reached up to 16 atmospheres. Coronary DESs were typically used with a bail-out indication in lesions failing standard balloon-only PTA (in case of persistent significant angiographic stenosis or flow-limiting dissection), and were reserved for focal (200 m), stage IIb (intermittent claudication without pain on resting, but with claudication at a distance
A registry on distal popliteal and infrapopliteal revascularization with coronary drug-eluting stents Arturo Giordanoa,b, Stefano Messinaa,b, Michele Polimenoa,b, Nicola Corcionea,b, Paolo Ferraroa,b, Giuseppe Biondi-Zoccaic and Gabriele Giordanoa,b Aims Endovascular therapy for popliteal and infrapopliteal artery disease in patients with critical limb ischemia (CLI) remains challenging, given the high risk of adverse events. Favorable results for coronary balloon-expandable drugeluting stents (DESs) in this arterial district have been reported in selected studies, but uncertainty persists on their risk-benefit balance in real-world patients. We, thus, sought to appraise our outcomes with DES implantation for distal popliteal or infrapopliteal lesions. Methods Our institutional databases were retrospectively queried to identify patients undergoing DES implantation for distal popliteal or infrapopliteal artery disease. Baseline, lesion, procedural, and outcome data were systematically collected.
1 month and in 22 (88.0%) patients at long-term (28.8 W 20.6 months). In this highly selected case series, no repeat revascularizations or unplanned amputations were recorded, whereas two (8.0%) patients died, the first 15.5 months and the second 19.5 months after the procedure. Conclusion Implantation of coronary balloon-expandable DES appears feasible, safe, and effective in selected patients with focal lesions in the distal popliteal and infrapopliteal arteries. J Cardiovasc Med 2014, 15:822–827 Keywords: coronary artery disease, drug-eluting stent, infrapopliteal disease, peripheral artery disease, popliteal artery, stent
Results A total of 25 patients were treated with coronary DES, 12 (48.0%) for distal popliteal and 13 (52.0%) for infrapopliteal lesions. Four (16.0%) patients received two stents, whereas the others only one. Breakdown of DES was as follows: biolimus-eluting, everolimus-eluting, paclitaxeleluting, and sirolimus-eluting stents in, respectively, two (8.0%), one (4.0%), one (4.0%), and 21 (84.0%), with an average stent length of 33.6 W 13.1 mm. Improvement in Fontaine stage was achieved in 23 (92.0%) patients at
a Unita` Operativa di Interventistica Cardiovascolare, Presidio Ospedaliero Pineta Grande, Castelvolturno, bUnita` Operativa di Emodinamica, Casa di Salute Santa Lucia, San Giuseppe Vesuviano and cDepartment of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy
Introduction
selected patients treated in few tertiary care centers.4,6 In addition, whereas several reports are available for tibial and peroneal coronary DES implantation,7 there is uncertainty on the risk-benefit profile of these devices in distal popliteal lesions. Indeed, popliteal artery disease is a challenging subset within the already challenging group of lower limb atherosclerotic lesion.8
The management of patients with critical limb ischemia (CLI) is centered on surgical or endovascular revascularization as a means to improve symptoms and functional status, as well as prevent or delay amputation.1,2 Coronary balloon-expandable drug-eluting stents (DESs), despite being originally developed for stable coronary artery disease and relatively simple lesions, have proved after more than 10 years of routine clinical use as highly versatile, safe, and effective devices, yielding beneficial results in several types of conditions and disease locations, including upper and lower limb vessels.3,4 These favorable results and the lack of satisfactory devices for patients with infrapopliteal disease have led to the hypothesis that coronary DES could be fruitful also in this challenging vascular location. Indeed, several studies have also provided favorable details on firstgeneration and second-generation coronary DES in patients with CLI,5 but the external validity of these findings is limited given that they stem from highly 1558-2027 ß 2014 Italian Federation of Cardiology
Correspondence to Dr Arturo Giordano, Unita` Operativa di Interventistica Cardiovascolare, Presidio Ospedaliero Pineta Grande, Strada Statale Domiziana Km 30, 81030 Castelvolturno, Italy E-mail: [email protected] Received 13 July 2013 Revised 20 February 2014 Accepted 20 February 2014
We began several years ago treating patients with CLI due to below-the-knee (BTK) disease with coronary DES, as we chose them in patients with focal lesions in the distal popliteal, tibial, or peroneal arteries. We, thus, retrospectively reviewed our institutional databases on BTK coronary DES implantation to appraise their safety and efficacy.
Methods Design
This was a retrospective observational study stemming from our experience in treating BTK disease with DOI:10.2459/JCM.0000000000000060
Copyright © Italian Federation of Cardiology. Unauthorized reproduction of this article is prohibited.
Coronary drug-eluting stent in below-the-knee Giordano et al. 823
coronary DES. Ethical approval was waived and all patients provided informed consent. Patients and procedures
Patients in whom coronary DES implantation in the BTK district was attempted (being successful or not) were retrieved from our institutional database. No patient was excluded. Patients with moderate-to-severe claudication failing maximal medical therapy, ischemic rest pain, ulcer, or tissue loss were admitted for invasive angiography and, after collegial discussion, treated with percutaneous transluminal angioplasty (PTA) with coronary DES implantation, referred for bypass surgery, or managed with maximal medical therapy. After contralateral access or, very occasionally, ipsilateral access,9 the target lesion was imaged selectively with a suitably sized JR4 or MP1 coronary guiding catheter (VistaBrite Tip; Cordis, Miami, Florida, USA). After selective wiring with a ‘0.01400 guidewire’ (BMW or Pilot 50; Abbott Vascular, Santa Clara, California, USA), the lesion was usually, but not always, predilated with semicompliant balloons aiming at a balloon-to-artery ratio of 0.8–0.9. Inflations lasted between 1 and 3 min, and reached up to 16 atmospheres. Coronary DESs were typically used with a bail-out indication in lesions failing standard balloon-only PTA (in case of persistent significant angiographic stenosis or flow-limiting dissection), and were reserved for focal (200 m), stage IIb (intermittent claudication without pain on resting, but with claudication at a distance
