madman
Super Moderator
ABSTRACT
Background: Arteriogenic erectile dysfunction is a common disease oftentimes not satisfactorily treatable with medical therapy.
Aim: To assess the safety and clinical success rate of endovascular revascularization of erection-related arteries with the angiolite BTK stent in patients with arteriogenic erectile dysfunction.
Methods: A total of 100 consecutive men (61.8 ± 10 years) with atherosclerotic lesions in erection-related arteries agreed to participate and were included in a single-center all-comers registry. Endovascular therapy with angiolite BTK drug-eluting stents were performed on a total of 211 lesions. Patients received a baseline International Index of Erectile Function (IIEF)-15 questionnaire at first presentation and 3 and 12 months after stenting. An improvement by 4 points in the erectile function domain consisting of 6 questions (IIEF-6) was defined as minimal clinically important difference. A total of 24 patients with 52 stented arterial lesions underwent angiographic follow-up of the initially treated arterial side during secondary revascularization of the contralateral side (angiographic sub-study).
Outcome: Clinical improvement of erections in 100 patients undergoing endovascular revascularization of erection-related arteries.
Results: No major adverse events occurred during endovascular revascularization or within 30 days thereafter. Technical success was achieved in all lesions and procedural success in all patients. At 1 year, 55 of 97 patients (56.7%) improved by at least 4 points in IIEF-6 score and thus achieved a clinically relevant improvement of erectile function. In the angiographic sub-study, arterial patency and binary restenosis were observed in 46 of 52 (88.5%) and in 8 of 52 (15.4%), respectively, after a mean follow-up of 9.6 ± 5.8 months.
Clinical Implications: In patients with arteriogenic erectile dysfunction, endovascular therapy with a novel thinstrut sirolimus-eluting stent is a safe and feasible treatment option.
Strengths & Limitations: This real-world arterial revascularization registry included patients with a multitude of risk factors for ED, thereby representing the heterogeneity in patients in the clinical practice, which is one of its strengths but also one of its weaknesses. Another strength was the focus being laid on analyzing outcomes of patients with arteriogenic ED using only a single endovascular device. Further studies are warranted to better define subgroups of patients with impaired clinical outcomes.
Conclusion: Within the present all-comers registry, endovascular therapy of erectile dysfunction with the angiolite BTK stent was shown to be a safe and feasible treatment option resulting in clinical improvement rates comparable to earlier clinical trials although also showing that further research is warranted to define patient subgroups with particular benefits of endovascular therapy.
INTRODUCTION
In the year 1995, 150 million men worldwide were estimated to suffer from erectile dysfunction (ED). By the year 2025, this number is estimated to have risen to 322 million men.1
ED is a common disease, with prevalences ranging from 2% in men in their twenties up to over 80% in men older than 75 years.2 Recognized risk factors for ED include age, depression, diabetes mellitus, dyslipidemia, arterial hypertension, obesity, sedentary lifestyle, and active as well as passively smoking.2-7 Thus, risk factors are similar to those of coronary heart disease and peripheral arterial disease.
Among the different pathogenic mechanisms of ED, vascular pathologies represent the most common cause and account for 60-80% of ED.8
2 of the main clinical difficulties patients with ED may experience is the reduced ability to achieve an erection sufficient for penetration and the reduced ability to maintain an erection during intercourse.9 Treatment options for ED range from lifestyle changes (ie, dietary measures and risk factor modification as well as physical exercise), over oral medication with phosphodiesterase-5-inhibitors (PDE-5-I), or intracavernosal application prostaglandins to penile implantation surgery.3,10-12
However, 30-35% of patients on PDE-5-I do not respond to conservative treatment or report insufficient erections for intercourse and may have drug-related side-effects. 13
With the development and down-sizing of endovascular devices suited for the complex anatomy of the inner pelvic arteries, endovascular therapy is proposed as an alternative strategy in patients presenting with arteriogenic ED and failure of PDE-5-I therapy or contraindications for PDE-5-I.9,14-18
To date, no specific guidance based on clinical studies exists, as to whether stenting is superior to balloon angioplasty in these oftentimes small-caliber arteries. Balloon angioplasty of the pudendal artery was shown to restore blood flow and substantially improve the symptoms of ED during short-term follow-up.19
In our experience, the use of plain balloon angioplasty alone or an approach using drug-coated balloons is not ideal because the pudendo-penile arteries are prone to elastic recoil.16 This process had also been observed in the coronary arteries and has led to a direct drug-eluting stenting approach for most de-novo coronary artery obstructions nowadays.
The purpose of the present study was to assess the clinical and the angiographic utility of drug-eluting stenting of erection-related arteries in an all-comers registry.
Description of Stent
The angiolite BTK Sirolimus-eluting Stent (iVascular S. L. U., Barcelona, Spain, CE Mark reference number: 2014 12 0833 ED) is made from a cobalt-chromium alloy backbone (L605), with a strut thickness of 75-80 mm. The stent is manufactured from a metal tube that is laser cut and subjected to various treatments providing a smooth, glossy surface finish. The stent structure has been modified to consist of 8 crowns linked by 3 rows of nonconcatenated connectors in a noncontinuous sinusoid fashion.
This feature confers a slightly higher metal-to-artery ratio, enabling improved drug distribution to the vessel wall. The metallic backbone is coated with a biostable, durable fluoroacrylate-based polymer. The stent is coated with sirolimus at a dose of 1.4 mg/mm2 , with >80% of the drug being released 60 days after implantation.
A preclinical trial was conducted in which the efficacy and safety of the angiolite drug-eluting stent (DES) were demonstrated in comparison with DES on the market.22
Also, 2 coronary clinical trials have been conducted, the ANgiolite Drug-Eluting Stent: an Optical CoHerence TOmogRaphy study, a first-in-man evaluation of the mechanical and clinical performance of the angiolite DES. The latter is a multicenter prospective observational trial, which includes 103 patients that are evaluated randomized at 3 or 6 months for quantitative coronary arteriography, optical coherence tomography, and clinical behavior and the ANGIOLITE TRIAL, a randomized clinical trial with 223 patients to compare the efficacy of angiolite stent vs Xience stent in patients with an indication for percutaneous coronary intervention at 6, 12, and 24 months.23,2
DISCUSSION
Endovascular revascularization of erection-related arteries is an emerging interventional option for patients with arteriogenic ED. The recent development of flexible and thin-strut DES has facilitated endovascular therapy of more complex disease patterns and small-diameter vessels such as erection-related arteries. Within the present investigation, the safety and clinical efficacy of the angiolite BTK stent was assessed in an all-comers cohort of 100 consecutive patients. Endovascular revascularization of erection-related arteries was shown to be safe, technically feasible, and clinically effective in most patients. Moreover, angiographic restenosis rates were shown to be lower than those reported in previous studies.
In the present series, procedural success was achieved in all patients, and no MAEs were observed. Complications were limited to puncture-site complications mostly attributable to dual antiplatelet therapy. Structural puncture site complications requiring further medical attention were observed in 3.7% of patients. This finding is well in line with experiences from endovascular revascularization approaches in other arterial beds.32
In addition, no local ischemic complications associated with revascularization of erection-related arteries was observed. Thus, inexperienced hands, endovascular therapy for ED can be considered equally safe when compared with endovascular revascularization for peripheral arterial disease.
In conclusion, within this real-world all-comers registry, endovascular therapy of ED with the angiolite BTK stent was shown to be safe and technically feasible. Clinical improvement of ED was shown in about 60% of patients. This result is comparable to those of earlier studies. In the angiographic substudy, the use of a novel thin-strut DES was associated with restenosis rates lower than those reported with thicker-strut stents
Background: Arteriogenic erectile dysfunction is a common disease oftentimes not satisfactorily treatable with medical therapy.
Aim: To assess the safety and clinical success rate of endovascular revascularization of erection-related arteries with the angiolite BTK stent in patients with arteriogenic erectile dysfunction.
Methods: A total of 100 consecutive men (61.8 ± 10 years) with atherosclerotic lesions in erection-related arteries agreed to participate and were included in a single-center all-comers registry. Endovascular therapy with angiolite BTK drug-eluting stents were performed on a total of 211 lesions. Patients received a baseline International Index of Erectile Function (IIEF)-15 questionnaire at first presentation and 3 and 12 months after stenting. An improvement by 4 points in the erectile function domain consisting of 6 questions (IIEF-6) was defined as minimal clinically important difference. A total of 24 patients with 52 stented arterial lesions underwent angiographic follow-up of the initially treated arterial side during secondary revascularization of the contralateral side (angiographic sub-study).
Outcome: Clinical improvement of erections in 100 patients undergoing endovascular revascularization of erection-related arteries.
Results: No major adverse events occurred during endovascular revascularization or within 30 days thereafter. Technical success was achieved in all lesions and procedural success in all patients. At 1 year, 55 of 97 patients (56.7%) improved by at least 4 points in IIEF-6 score and thus achieved a clinically relevant improvement of erectile function. In the angiographic sub-study, arterial patency and binary restenosis were observed in 46 of 52 (88.5%) and in 8 of 52 (15.4%), respectively, after a mean follow-up of 9.6 ± 5.8 months.
Clinical Implications: In patients with arteriogenic erectile dysfunction, endovascular therapy with a novel thinstrut sirolimus-eluting stent is a safe and feasible treatment option.
Strengths & Limitations: This real-world arterial revascularization registry included patients with a multitude of risk factors for ED, thereby representing the heterogeneity in patients in the clinical practice, which is one of its strengths but also one of its weaknesses. Another strength was the focus being laid on analyzing outcomes of patients with arteriogenic ED using only a single endovascular device. Further studies are warranted to better define subgroups of patients with impaired clinical outcomes.
Conclusion: Within the present all-comers registry, endovascular therapy of erectile dysfunction with the angiolite BTK stent was shown to be a safe and feasible treatment option resulting in clinical improvement rates comparable to earlier clinical trials although also showing that further research is warranted to define patient subgroups with particular benefits of endovascular therapy.
INTRODUCTION
In the year 1995, 150 million men worldwide were estimated to suffer from erectile dysfunction (ED). By the year 2025, this number is estimated to have risen to 322 million men.1
ED is a common disease, with prevalences ranging from 2% in men in their twenties up to over 80% in men older than 75 years.2 Recognized risk factors for ED include age, depression, diabetes mellitus, dyslipidemia, arterial hypertension, obesity, sedentary lifestyle, and active as well as passively smoking.2-7 Thus, risk factors are similar to those of coronary heart disease and peripheral arterial disease.
Among the different pathogenic mechanisms of ED, vascular pathologies represent the most common cause and account for 60-80% of ED.8
2 of the main clinical difficulties patients with ED may experience is the reduced ability to achieve an erection sufficient for penetration and the reduced ability to maintain an erection during intercourse.9 Treatment options for ED range from lifestyle changes (ie, dietary measures and risk factor modification as well as physical exercise), over oral medication with phosphodiesterase-5-inhibitors (PDE-5-I), or intracavernosal application prostaglandins to penile implantation surgery.3,10-12
However, 30-35% of patients on PDE-5-I do not respond to conservative treatment or report insufficient erections for intercourse and may have drug-related side-effects. 13
With the development and down-sizing of endovascular devices suited for the complex anatomy of the inner pelvic arteries, endovascular therapy is proposed as an alternative strategy in patients presenting with arteriogenic ED and failure of PDE-5-I therapy or contraindications for PDE-5-I.9,14-18
To date, no specific guidance based on clinical studies exists, as to whether stenting is superior to balloon angioplasty in these oftentimes small-caliber arteries. Balloon angioplasty of the pudendal artery was shown to restore blood flow and substantially improve the symptoms of ED during short-term follow-up.19
In our experience, the use of plain balloon angioplasty alone or an approach using drug-coated balloons is not ideal because the pudendo-penile arteries are prone to elastic recoil.16 This process had also been observed in the coronary arteries and has led to a direct drug-eluting stenting approach for most de-novo coronary artery obstructions nowadays.
The purpose of the present study was to assess the clinical and the angiographic utility of drug-eluting stenting of erection-related arteries in an all-comers registry.
Description of Stent
The angiolite BTK Sirolimus-eluting Stent (iVascular S. L. U., Barcelona, Spain, CE Mark reference number: 2014 12 0833 ED) is made from a cobalt-chromium alloy backbone (L605), with a strut thickness of 75-80 mm. The stent is manufactured from a metal tube that is laser cut and subjected to various treatments providing a smooth, glossy surface finish. The stent structure has been modified to consist of 8 crowns linked by 3 rows of nonconcatenated connectors in a noncontinuous sinusoid fashion.
This feature confers a slightly higher metal-to-artery ratio, enabling improved drug distribution to the vessel wall. The metallic backbone is coated with a biostable, durable fluoroacrylate-based polymer. The stent is coated with sirolimus at a dose of 1.4 mg/mm2 , with >80% of the drug being released 60 days after implantation.
A preclinical trial was conducted in which the efficacy and safety of the angiolite drug-eluting stent (DES) were demonstrated in comparison with DES on the market.22
Also, 2 coronary clinical trials have been conducted, the ANgiolite Drug-Eluting Stent: an Optical CoHerence TOmogRaphy study, a first-in-man evaluation of the mechanical and clinical performance of the angiolite DES. The latter is a multicenter prospective observational trial, which includes 103 patients that are evaluated randomized at 3 or 6 months for quantitative coronary arteriography, optical coherence tomography, and clinical behavior and the ANGIOLITE TRIAL, a randomized clinical trial with 223 patients to compare the efficacy of angiolite stent vs Xience stent in patients with an indication for percutaneous coronary intervention at 6, 12, and 24 months.23,2
DISCUSSION
Endovascular revascularization of erection-related arteries is an emerging interventional option for patients with arteriogenic ED. The recent development of flexible and thin-strut DES has facilitated endovascular therapy of more complex disease patterns and small-diameter vessels such as erection-related arteries. Within the present investigation, the safety and clinical efficacy of the angiolite BTK stent was assessed in an all-comers cohort of 100 consecutive patients. Endovascular revascularization of erection-related arteries was shown to be safe, technically feasible, and clinically effective in most patients. Moreover, angiographic restenosis rates were shown to be lower than those reported in previous studies.
In the present series, procedural success was achieved in all patients, and no MAEs were observed. Complications were limited to puncture-site complications mostly attributable to dual antiplatelet therapy. Structural puncture site complications requiring further medical attention were observed in 3.7% of patients. This finding is well in line with experiences from endovascular revascularization approaches in other arterial beds.32
In addition, no local ischemic complications associated with revascularization of erection-related arteries was observed. Thus, inexperienced hands, endovascular therapy for ED can be considered equally safe when compared with endovascular revascularization for peripheral arterial disease.
In conclusion, within this real-world all-comers registry, endovascular therapy of ED with the angiolite BTK stent was shown to be safe and technically feasible. Clinical improvement of ED was shown in about 60% of patients. This result is comparable to those of earlier studies. In the angiographic substudy, the use of a novel thin-strut DES was associated with restenosis rates lower than those reported with thicker-strut stents
