Single-use flexible ureteroscopes: update and perspective in developing countries. A narrative review.

Flexible ureteroscopy is a well-established method for treatment of urinary stones but flexible ureteroscopes are expensive and fragile devices with a very limited lifetime. Since 2006 with the advent of digital flexible ureteroscopes a great evolution has occurred. The first single-use flexible ureteroscope was launched in 2011 and new models are coming to the market. The aim of this article is to review the characteristics of these devices, compare their results with the reusable devices and evaluate the cost-benefits of adopting single-use flexible ureteroscopes in developing countries. MATERIALS AND METHODS: an extensive review of articles listed at PubMed and published between 2000 and 2021 was performed. RESULTS: Single-use flexible ureteroscopes have a shaft with 65 to 68cm length and weight between 119 and 277g. Their deflection goes up to 300 degrees. Their stone-free rates vary between 60 and 95% which is comparable to reusable scopes and operative times ranges from 54 to 86 minutes which are lower when compared to reusable flexible scopes. Their costs vary between 800 and 3180 US dollars. CONCLUSION: single-use flexible ureteroscopes are lighter and have superior quality of image when compared to fiberoptic ones. There are no definite data showing a higher stone-free rate or less complications with the use of single-use flexible ureteroscopes. Each institution must perform a cost-benefit analysis before making the decision of adopting or not such devices depending on the local circumstances.

The Impact of Distraction on Laparoscopic Skills in Veterinary Medical Students.

OBJECTIVE: To investigate the impact of distraction on the performance of a simulator-based laparoscopic task in veterinary students. STUDY DESIGN: Prospective, randomized trial. SAMPLE POPULATION: Years 1-4 veterinary students (n=41). METHODS: Participants repeated a simulated laparoscopic peg transfer task to eliminate any learning effects and were subsequently randomized to receive either a cognitive (double-digit addition questions, n=21) or sensory distraction (dogs barking and anesthesia monitor alerts, n=20). The laparoscopic task scores were compared between baseline and in the presence and absence of each distraction. The number of addition questions attempted, and the number of questions answered correctly in 1 minute were compared between baseline and during a concurrent laparoscopic task. RESULTS: Baseline laparoscopic task scores were not significantly different between groups (P=.09). Laparoscopic task scores were significantly lower than baseline when performed with the cognitive distraction (P<.001) and significantly higher than baseline when performed with the sensory distraction (P=.005). Participants undergoing cognitive distraction attempted significantly fewer addition questions (P<.001) and answered significantly fewer addition questions correctly (P<.001) when a concurrent laparoscopic task was performed. CONCLUSION: Cognitive distraction had a negative impact on the performance of a laparoscopic task in this cohort of veterinary students, whereas sensory distraction had a positive effect.

The use of internal stents in chronic ureteral obstruction.

PURPOSE: Despite the lack of a well delineated definition, chronic ureteral obstruction imposes significant quality of life loss, increased pathological morbidity and risk of mortality as well as substantial economic burden. Ureteral stenting serves as an important therapeutic option to alleviate obstruction. Thus, we assessed the recently published literature on chronic ureteral obstruction; treatment options; types, benefits and shortcomings of current ureteral stents; as well as outcomes and complications of chronic ureteral stenting, with the goal of providing concise management guidelines. MATERIALS AND METHODS: A systemic literature review was performed on Embase™, PubMed®, Cochrane Controlled Trials Register and Google Scholar™ on ureteral obstruction and internal ureteral stents. Relevant reviews, original research articles and their cited references were examined, and a synopsis of original data was generated on a clinically oriented basis. RESULTS: Chronic ureteral obstruction can be classified into compression that is either intrinsic or extrinsic to the ureteral wall, or obstruction that is of a benign or malignant origin. Patients with malignant ureteral obstruction generally have a poor prognosis and are often difficult to treat. The aim of stenting is to adequately drain the upper urinary tracts while minimizing hospitalization and the negative impact on quality of life. Facing the challenge of chronic ureteral obstruction, novel stents with new compositions, materials, coatings and designs have been developed. Metallic stents are emerging as efficacious and financially viable alternatives. Early stent related complications include iatrogenic injury, stent migration or patient discomfort, while late complications include infection, difficulties with stent exchange, hardware malfunction, infection and stent encrustation. CONCLUSIONS: Stenting in chronic ureteral obstruction is a complex and challenging problem. Much work is being done in this area and many options are being explored.

Risk Factors for Postoperative Complications of Percutaneous Nephrolithotomy at a Tertiary Referral Center.

PURPOSE: We sought to describe and evaluate the complications related to percutaneous nephrolithotomy and identify risk factors of morbidity according to the modified Clavien scoring system. We also sought to specify which perioperative factors are associated with minor and major complications. MATERIALS AND METHODS: We retrospectively analyzed data on patients who underwent percutaneous nephrolithotomy from 1990 to 2013. Descriptive statistics were used to analyze patient characteristics, medical comorbidities and perioperative features. Complications were categorized according to the Clavien score for percutaneous nephrolithotomy. The Mann-Whitney and Fisher exact tests were used as appropriate. Logistic regression analysis was performed to look for prognostic factors associated with major complications. RESULTS: A total of 2,318 surgeries were evaluated. Mean age of the population was 53.7 years. The stone-free rate at hospital discharge was 81.6%. The overall complication rate was 18.3%. Two deaths occurred. Patients with any postoperative complications were older, had more comorbidities, were more likely to have staghorn calculi and had longer operative time and hospital stay on univariate analysis (p<0.05). Age 55 years or older and upper pole access were independent predictors of major complications on multivariate analysis. Other factors such as a history of urinary tract infections, body mass index, stone composition, previous percutaneous nephrolithotomy and multiple tracts were not associated with a major complication. CONCLUSIONS: At our center percutaneous nephrolithotomy is an excellent option for complex kidney stone management with a low overall complication rate. Older patient age and upper pole access are significantly associated with an increased risk of a major complication.

The Post-Ureteroscopic Lesion Scale (PULS): a multicenter video-based evaluation of inter-rater reliability.

PURPOSE: The Post-Ureteroscopic Lesion Scale (PULS) offers a simple grading system for the description of ureteral lesions after ureteroscopy. In this article, we present the results of a video-based multicenter evaluation of the inter-rater reliability of clinically important PULS grades 0-3. METHODS: Video sequences at the end of ureteroscopy (final passage) were recorded for 100 consecutive patients at a single institution and assessed by experienced urologists (n = 20) and senior residents (n = 17) at 19 international centers. The cohort included only patients with lesions grades 0-3 (with grades 2 and 3 subsumed as 2 + since distinction is defined by an extravasation of contrast medium in fluoroscopy). The gradings were evaluated for inter-rater reliability and in terms of simplicity, validity, comprehensibility, reproducibility, and usefulness. RESULTS: Overall, inter-rater reliability was high (Kendall's W = 0.69, p < 0.001) and was comparable between specialists (Kendall's W = 0.69, p < 0.001) and residents (Kendall's W = 0.71, p < 0.001). The matched ratings showed grade 0 in 43.0 % of patients and grades 1 or 2 + in 44.0 and 13.0 % of patients, respectively. Results of the questionnaires indicated a high degree of acceptance, with an overall rating of 1.76 (1.64-1.93 for different items, scale 1-6). CONCLUSIONS: Inter-rater reliability of the endoscopically assessable PULS was high among urologists with different levels of experience in different countries worldwide. The validated PULS system may be used for standardized reporting of ureteral lesions/injuries after ureteroscopy. In addition, PULS will enable more selective standardization of indications for postoperative DJ stenting based on the randomized controlled trials.

Standardizing the reporting of percutaneous nephrolithotomy complications.

Accurate reporting of complications is an essential component to critical appraisal and innovation in surgery and specifically with percutaneous nephrolithotomy (PCNL). We review the evolution of complication reporting for PCNL and suggest future directions for innovation. A selective review was carried out using Pubmed. Key search terms and their combinations included percutaneous, anatrophic, nephrolithotomy, PCNL, complications, Clavien, Martin score, bleeding, bowel injury, perforation, fever, sepsis. The references from relevant papers and reviews as well as AUA and EAU guidelines were also scanned for inclusion. PCNL has become the procedure of choice for large renal stones owing to decreased morbidity over alternative procedures. Both common and rare complications have been described in large case series, small randomized controlled trials, and case reports in an unstandardized form. Although these reports have provided an informative starting point, a standardized complication reporting methodology is necessary to enable appropriate comparisons between institutions, time periods, or innovations in technique. The Clavien-Dindo grading system has become widely accepted in urology and has facilitated the study of PCNL complications. Future research should focus on adaptions of this system to render it more comprehensive and applicable to PCNL.

Thulium fiber laser lithotripsy: Is it living up to the hype?

Objective: The holmium:yttrium-aluminium-garnet laser (Ho:YAG) has been the gold standard for laser lithotripsy over the last three decades. After demonstrating good in vitro efficacy, the thulium fiber laser (TFL) has been recently released in the market and the initial clinical results are encouraging. This article aims to review the main technology differences between the Ho:YAG laser and the TFL, discuss the initial clinical results with the TFL as well as the optimal settings for TFL lithotripsy. Methods: We reviewed the literature focusing on the technological aspects of the Ho:YAG laser and TFL as well as the results of in vitro and in vivo studies comparing both technologies. Results: In vitro studies show a technical superiority of TFL compared to the Ho:YAG laser and encouraging results have been demonstrated in clinical practice. However, as TFL is a new technology, limited studies are currently available, and the optimal settings for lithotripsy are not yet established. Conclusion: TFL has the potential to be an alternative to the Ho:YAG laser, but more reports are still needed to determine the optimal laser for lithotripsy of urinary tract stones when considering all parameters including effectiveness, safety, and costs.

Multi-site microbiota alteration is a hallmark of kidney stone formation.

BACKGROUND: Inquiry of microbiota involvement in kidney stone disease (KSD) has largely focussed on potential oxalate handling abilities by gut bacteria and the increased association with antibiotic exposure. By systematically comparing the gut, urinary, and oral microbiota of 83 stone formers (SF) and 30 healthy controls (HC), we provide a unified assessment of the bacterial contribution to KSD. RESULTS: Amplicon and shotgun metagenomic sequencing approaches were consistent in identifying multi-site microbiota disturbances in SF relative to HC. Biomarker taxa, reduced taxonomic and functional diversity, functional replacement of core bioenergetic pathways with virulence-associated gene markers, and community network collapse defined SF, but differences between cohorts did not extend to oxalate metabolism. CONCLUSIONS: We conclude that multi-site microbiota alteration is a hallmark of SF, and KSD treatment should consider microbial functional restoration and the avoidance of aberrant modulators such as poor diet and antibiotics where applicable to prevent stone recurrence. Video Abstract.

In focus: perplexing increase of urinary stone disease in children, adolescent and young adult women and its economic impact.

Background: Urinary stone disease (USD) historically has affected older men, but studies suggest recent increases in women, leading to a near identical sex incidence ratio. USD incidence has doubled every 10 years, with disproportionate increases amongst children, adolescent, and young adult (AYA) women. USD stone composition in women is frequently apatite (calcium phosphate), which forms in a higher urine pH, low urinary citrate, and an abundance of urinary uric acid, while men produce more calcium oxalate stones. The reasons for this epidemiological trend are unknown. Methods: This perspective presents the extent of USD with data from a Canadian Province and a North American institution, explanations for these findings and offers potential solutions to decrease this trend. We describe the economic impact of USD. Findings: There was a significant increase of 46% in overall surgical interventions for USD in Ontario. The incidence rose from 47.0/100,000 in 2002 to 68.7/100,000 population in 2016. In a single United States institution, the overall USD annual unique patient count rose from 10,612 to 17,706 from 2015 to 2019, and the proportion of women with USD was much higher than expected. In the 10-17-year-old patients, 50.1% were girls; with 57.5% in the 18-34 age group and 53.6% in the 35-44 age group. The roles of obesity, diet, hormones, environmental factors, infections, and antibiotics, as well as the economic impact, are discussed. Interpretation: We confirm the significant increase in USD among women. We offer potential explanations for this sex disparity, including microbiological and pathophysiological aspects. We also outline innovative solutions - that may require steps beyond typical preventive and treatment recommendations.

The CROES percutaneous nephrolithotomy global study: the influence of body mass index on outcome.

PURPOSE: In addition to more commonly forming stones, obese patients present a number of challenges when undergoing percutaneous nephrolithotomy. We evaluated percutaneous nephrolithotomy outcomes in 3,709 patients stratified by body mass index. MATERIALS AND METHODS: A prospective database administered by CROES (Clinical Research Office of the Endourological Society) captured data on 5,803 patients treated with percutaneous nephrolithotomy between November 2007 and December 2009. Patients with known solitary kidney, previous percutaneous nephrolithotomy and congenital abnormalities were excluded from analysis. For statistical analysis patients were categorized as normal weight--body mass index 18.5 to 25 kg/m(2), overweight--25 to 30, obese--30 to 40 and super obese--greater than 40. RESULTS: During the study period 5,803 patients underwent percutaneous nephrolithotomy, of whom 3,709 met the inclusion criteria. As expected, obesity was associated with significantly higher rates of comorbid conditions and anticoagulant use (p < 0.001). Operative time was significantly longer in obese patients and use of a balloon device for tract dilation was more common (each p < 0.001). The stone-free rate decreased with obesity (p = 0.009), corresponding to a significantly higher re-treatment rate in this group (p < 0.001). No difference was seen in length of stay or the transfusion rate. No significant difference was seen in the overall complication rate among the 4 groups (p = 0.707). CONCLUSIONS: Percutaneous nephrolithotomy may be done safely in obese patients, although with a longer operative time, an inferior stone-free rate and a higher re-intervention rate.

The use of triclosan eluting stents effectively reduces ureteral stent symptoms: a prospective randomized trial.

UNLABELLED: What's known on the subject? and What does the study add? Infection, encrustation and ureteral-stent-related symptoms (USRS) including pain, urgency and frequency are all major problems associated with stent use. No current ureteral stent or exogenously applied therapy adequately deals with these problems and antibiotic use is ineffective once a bacterial biofilm forms on the device. Triclosan is a broad spectrum antibacterial agent widely used in numerous healthcare products and has been previously shown to reduce inflammation on the skin and in the oral cavity. This study tested a triclosan-impregnated ureteral stent for its ability to reduce infection, encrustation and USRS. This study shows that while a triclosan-impregnated ureteral stent cannot reduce infection rates alone compared with antibiotic use, the stent can reduce several USRS including pain during indwelling. This study suggests that the triclosan eluting stent may have a role in treating patients, perhaps in combination with standard antibiotic therapy. OBJECTIVE: To evaluate the capacity of triclosan-loaded ureteral stents to reduce stent-associated bacterial attachment, biofilm formation and encrustation, thereby potentially reducing infection development and other device-related sequelae. PATIENTS AND METHODS: Twenty subjects requiring short-term stenting (7-15 days) were randomized to receive either a Percuflex Plus(®) non-eluting stent (control) or a Triumph(®) triclosan eluting stent. Control-stented subjects received 3 days of levofloxacin prophylaxis (500 mg once daily) while Triumph(®)-stented subjects did not. All subjects were assessed for positive urine and stent cultures, stent biofilm development and encrustation. Following device removal, each subject completed an analogue-scale symptom assessment questionnaire. RESULTS: Ureteral stenting was performed after nine ureteroscopic and one extracorporeal shock wave lithotripsy procedure in the control group and eight ureteroscopic and two shock wave lithotripsy procedures in the triclosan group. No significant differences were observed for culture, biofilm and encrustation between the two groups. Subjects in the triclosan group reported significant reductions in lower flank pain scores during activity (58.1% reduction, P = 0.017) and urination (42.6%, P = 0.041), abdominal pain during activity (42.1%, P = 0.042) and urethral pain during urination (31.7%, P = 0.049). CONCLUSIONS: In this study, the use of the Triumph(®) triclosan eluting stent had no marked impact on biofilm formation, encrustation or infection development in short-term stented patients. The Triumph(®) device led to significant reductions in several common ureteral-stent-related symptoms, supporting its use in this patient population.

Portable Endoscopic Simulator for Urologic Training: A Face/Content and Construct Validity Study.

Mastering a surgical skill requires experience and repetition, yet opportunities for surgical trainees to gain real experience are variable and limited by case load. Surgical simulators have emerged in an attempt to overcome these limitations. However, the few currently available skills simulators for flexible endoscopy are costly, have limited accessibility and versatility, lack portability, and require dedicated time for practice. The use of a portable skills simulator to teach flexible endoscopy may provide a feasible alternative. This study introduces a novel, low-cost, portable, endoscopic simulation system for training basic endoscopic skills. Using custom software, the simulator presents a virtual environment featuring 3D models of anatomy, endoscopes, and endoscopic tools. The virtual endoscope and its tools are directly controlled in the simulation by motion input from a custom-manufactured portable endoscopic controller that communicates data via a Bluetooth interface. This two-part study presents proof of concept and initial pilot data examining the face/content validity and preliminary construct validity of the portable endoscopic simulator. In part 1, experts (n = 2) and novices (n = 6) provided ratings of fidelity and utility as a training tool. In part 2, experts (n = 4) and novices (n = 4) completed 10 simulated sequential basic endoscopic tasks, and time to completion was assessed. Findings indicate that the simulator has good utility as a training tool, but some features require modification to be more realistic. Furthermore, both novices and experts improved on the task with repeated measurements (p < 0.001), but there were no significant differences between experts and novices in time to completion. Although more robust validation is required, this simulator appears promising as a feasible and cost-effective tool for providing simulation training on basic endoscopic skills.

Classification and standardized reporting of percutaneous nephrolithotomy (PCNL): International Alliance of Urolithiasis (IAU) Consensus Statements.

BACKGROUND: The aim of this study was to reach a consensus in the classification and standardized reporting for the different types of PCNLs. METHODS: The RAND/UCLA appropriateness methodology was used to reach a consensus. Thirty-two statements were formulated reviewing the literature on guidelines and consensus on PCNLs, and included procedure specific details, outcome measurements and a classification for PCNLs. Experts were invited to two rounds of input, the first enabled independent modifications of the proposed statements and provided the option to add statements. The second round facilitated scoring of all statements. Each statement was discussed in the third round to decide which statements to include. Any suggestion or disagreement was debated and discussed to reach a consensual agreement. RESULTS: Twenty-five recommendations were identified to provide standardized reporting of procedure and outcomes. Consensual scoring above 80% were strongly agreed upon by the panel. The top treatment related outcomes were size of sheath used (99.1%) and position for PCNL (93.5%). The highest ranked Outcome Measures included definition of postoperative hospital length of stay (94.4%) and estimated blood loss (93.5%). CONCLUSIONS: The consensus statements will be useful to clarify operative technique, in the design of clinical trials and standardized reporting, and presentation of results to compare outcomes of different types of PCNLs.

European Association of Urology Section of Urolithiasis and International Alliance of Urolithiasis Joint Consensus on Percutaneous Nephrolithotomy.

CONTEXT: Although percutaneous nephrolithotomy (PCNL) has been performed for decades and has gone through many refinements, there are still concerns regarding its more widespread utilization because of the long learning curve and the potential risk of severe complications. Many technical details are not included in the guidelines because of their nature and research protocol. OBJECTIVE: To achieve an expert consensus viewpoint on PCNL indications, preoperative patient preparation, surgical strategy, management and prevention of severe complications, postoperative management, and follow-up. EVIDENCE ACQUISITION: An international panel of experts from the Urolithiasis Section of the European Association of Urology, International Alliance of Urolithiasis, and other urology associations was enrolled, and a prospectively conducted study, incorporating literature review, discussion on research gaps (RGs), and questionnaires and following data analysis, was performed to reach a consensus on PCNL. EVIDENCE SYNTHESIS: The expert panel consisted of 36 specialists in PCNL from 20 countries all around the world. A consensus on PCNL was developed. The expert panel was not as large as expected, and the discussion on RGs did not bring in more supportive evidence in the present consensus. CONCLUSIONS: Adequate preoperative preparation, especially elimination of urinary tract infection prior to PCNL, accurate puncture with guidance of fluoroscopy and/or ultrasonography or a combination, keeping a low intrarenal pressure, and shortening of operation time during PCNL are important technical requirements to ensure safety and efficiency in PCNL. PATIENT SUMMARY: Percutaneous nephrolithotomy (PCNL) has been a well-established procedure for the management of upper urinary tract stones. However, according to an expert panel consensus, core technical aspects, as well as the urologist's experience, are critical to the safety and effectiveness of PCNL.

European Association of Urology Section of Urolithiasis and International Alliance of Urolithiasis Joint Consensus on Retrograde Intrarenal Surgery for the Management of Renal Stones.

BACKGROUND: Retrograde intrarenal surgery (RIRS) has become the preferred treatment modality for nephrolithiasis. However, because of ongoing uncertainties regarding the optimal perioperative management, operative technique, and postoperative follow-up, as well as a lack of standardization for outcome reporting, consensus is needed to achieve more uniform clinical practice worldwide. OBJECTIVE: To develop recommendations for RIRS on the basis of existing data and expert consensus. DESIGN, SETTING, AND PARTICIPANTS: A protocol-driven, three-phase study was conducted by the European Association of Urology Section of Urolithiasis (EULIS) and the International Alliance of Urolithiasis (IAU). The process included: (1) a nonsystematic review of the literature to define domains for discussion; (2) a two-round modified Delphi survey involving experts in this field; and (3) an additional group meeting and third-round survey involving 64 senior representative members to formulate the final conclusions. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The results from each previous round were returned to the participants for re-evaluation of their decisions during the next round. The agreement threshold was set at 70%. RESULTS AND LIMITATIONS: The panel included 209 participants who developed 29 consensus statements on the following topics of interest: (1) perioperative infection management; (2) perioperative antithrombotic therapy; (3) fundamentals of the operative technique; and (4) standardized outcome reporting. Although this consensus can be considered as a useful reference for more clinically oriented daily practice, we also acknowledge that a higher level of evidence from further clinical trials is needed. CONCLUSIONS: The consensus statements aim to guide and standardize clinical practice and research on RIRS and to recommend standardized outcome reporting. PATIENT SUMMARY: An international consensus on the best practice for minimally invasive surgery for kidney stones was organized and developed by two international societies. It is anticipated that this consensus will provide further guidance to urologists and may help to improve clinical outcomes for patients.

Randomized controlled, multicentre clinical trial comparing a dual-probe ultrasonic lithotrite with a single-probe lithotrite for percutaneous nephrolithotomy.

OBJECTIVES: • To compare the Cyberwand (Gyrus/ACMI, Southborough, MA, USA), a dual-probe ultrasonic lithotrite, with a single-probe ultrasonic lithotrite. • The Cyberwand incorporates coaxial high- and low-frequency ultrasonic probes that work synergistically. PATIENTS AND METHODS: • An institutional review board-approved, multicentre, randomized controlled trial to compare the Cyberwand to the Olympus LUS-II (Olympus America, Inc., Melville, NY, USA) single-probe lithotrite was performed. • Patients undergoing a percutaneous nephrolithotomy (PCNL) with a target stone > 2 cm in diameter were eligible for the study. • The primary outcome was the time to removal of the targeted stone. RESULTS: • A total of 57 PCNLs were performed after randomization: 25 Cyberwand and 32 LUS-II. • There was no difference (P > 0.05) observed between the two devices for target stone surface area (Cyberwand 526.6 cm³ vs LUS-II 540.1 cm³), time to clearance of target stone (Cyberwand 15.8 min vs LUS-II 14.2 min) and target stone clearance rate (Cyberwand 61.9 mm²/min vs LUS-II 75.8 mm²/min). • Of the patients with stone analysis, hard stones (calcium oxalate monohydrate, brushite and cystine) were noted in 14 (56.0%) of the 25 Cyberwand and 18 (62.1%) of the 29 LUS-II patients. • Fifteen of the 25 (60.0%) Cyberwand and 20 of the 32 (62.5%) LUS-II patients were stone-free after the initial PCNL. • Those patients not rendered stone-free went on to receive a secondary PCNL. • Device malfunction occurred in eight of 25(32.0%) Cyberwand and five of 32 (15.6%) LUS II patients. • Complications were similar in both treatment groups. CONCLUSION: • No appreciable difference between the dual-probe Cyberwand and the standard ultrasonic Olympus LUS-II lithotrites can be identified.

A novel drug eluting ureteral stent: a prospective, randomized, multicenter clinical trial to evaluate the safety and effectiveness of a ketorolac loaded ureteral stent.

PURPOSE: We evaluated the short-term safety and efficacy of a ketorolac loaded ureteral stent compared to a standard stent (control). MATERIALS AND METHODS: In this prospective, multicenter, double-blind study patients were randomized 1:1 to ketorolac loaded or control stents after ureteroscopy. The primary end point was an intervention for pain defined as unscheduled physician contact, change in pain medication or early stent removal. Secondary end points included medication use and pain visual analog score. A total of 20 patients underwent serum safety testing for ketorolac levels. RESULTS: None of the safety cohort had detectable serum ketorolac levels. Among the 276 patients there was no difference in primary (9.0% ketorolac loaded vs 7.0% control, p = 0.66) or secondary (22.6% ketorolac loaded vs 25.2% control, p = 0.67) intervention rates. Mean pain pill count at day 3 was lower in the ketorolac loaded stent group than in the control group (p <0.05). A higher number (p = 0.057) of patients with ketorolac loaded (32%) stents used no or limited pain medications compared to controls (22%). A higher number of male patients with ketorolac loaded stents used no pain medication on days 3 and 4 compared to female patients with ketorolac loaded stents, and male and female control patients (p <0.05). CONCLUSIONS: The overall safety of the ketorolac loaded stent was confirmed. Although there was no significant difference in primary or secondary intervention rates, a trend toward a treatment benefit was noted for patients receiving drug loaded stents. Specifically young male patients appeared to require less pain medication when the ketorolac loaded stent was used. Future studies with higher drug concentrations or alternative drug eluting stents may prove beneficial.