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PubMed2026

F-URS with FANS versus mPCNL for 2-3 cm UUTS: a RCT with a subgroup analysis of 2-2.5 cm stones.

OBJECTIVE: To evaluate the safety and efficacy of flexible ureteroscopy (f-URS) with a flexible and navigable suction ureteral access sheath (FANS) compared with mini-percutaneous nephrolithotomy (mPCNL) in the treatment of 2-3 cm upper urinary tract stones (UUTS), with a prespecified subgroup analysis for stones ≥2 to <2.5 cm. METHODS: This randomized controlled trial enrolled 326 patients with 2-3 cm UUTS between June 2023 and December 2025. Patients were randomly assigned in a 1:1 ratio to undergo either f-URS with FANS or mPCNL. A prespecified subgroup analysis was conducted for stones measuring ≥2 to <2.5 cm. The primary outcomes were the immediate and 1-month stone-free rate (SFR). Secondary outcomes included the operative duration, decrease in haemoglobin, hospital stay, and complication rate. RESULTS: The baseline characteristics were comparable between the two groups. In the overall 2-3 cm cohort, the FANS group achieved immediate and 1-month SFRs comparable to those of the mPCNL group. Although the operative time was longer in the FANS group, it was associated with significantly less haemoglobin loss and a shorter hospital stay, with no significant difference in infection-related complications. Notably, in the subgroup of stones ≥2 to <2.5 cm, the FANS group demonstrated a non-inferior SFR at both time points, and the operative time was not significantly longer than that of the mPCNL group. CONCLUSION: For 2-3 cm UUTS, f-URS with FANS offers a SFR comparable to that of mPCNL, along with the advantages of reduced blood loss and shorter hospitalization. In the ≥2 to <2.5 cm subgroup, FANS shows comprehensive benefits over mPCNL. These findings support FANS as an effective alternative to mPCNL for 2-3 cm stones and a potentially preferred option for stones measuring 2-2.5 cm.

Humans↗

PubMed2026

Comparative efficacy of percutaneous vertebroplasty combined with minimally invasive pedicle screw fixation versus percutaneous vertebroplasty alone in the treatment of elderly osteoporotic vertebral compression fractures.

The study aimed to assess the comparative efficacy of percutaneous vertebroplasty (PVP) combined with minimally invasive pedicle screw fixation versus PVP alone in elderly patients with osteoporotic vertebral compression fractures (OVCF). Ninety-four elderly patients with OVCF were randomly classified into the control (47 patients) and combined (47 patients) groups. The control group received PVP, while the combined group received PVP combined with minimally invasive pedicle screw fixation. Perioperative indicators such as intraoperative blood lose, operative time, and hospitalization time were recorded. Pain was assessed using the VAS before and at baseline and 1, 3, and 7 days postoperatively. At 1 and 3 days postoperatively, Serum CRP levels, WBC, and neutrophil counts were measured postoperatively. Radiographic outcomes (vertebral height ratio and Cobb angle), ADL scores, JOA scores, and ODI were evaluated preoperatively and at 3 months post-operation. Postoperative complications were documented. Baseline characteristics were comparable. The combined group showed superior pain relief, vertebral height restoration, Cobb angle correction, functional recovery, and reduced inflammatory markers (CRP, WBC, neutrophils) postoperatively (all P < 0.05). Blood loss and hospital stay were shorter in the combined group, though operative time was longer (P < 0.05). Complication rates did not differ significantly (P > 0.05). PVP combined with minimally invasive pedicle screw fixation yields better outcomes in elderly OVCF patients by enhancing pain control, vertebral height, and functional recovery without increasing perioperative risk.

Humans↗

PubMed2026

Retrograde intrarenal surgery with flexible and navigable suction access sheaths vs mini-percutaneous nephrolithotomy for large upper urinary tract stones: a systematic review and meta-analysis.

OBJECTIVE: To conduct a meta-analysis comparing the efficacy and perioperative outcomes of contemporary flexible and navigable suction access sheath-assisted retrograde intrarenal surgery (FANS-RIRS) against percutaneous nephrolithotomy (PCNL) for the management of large upper urinary tract stones, as despite technological advances in RIRS such as high-powered lasers and FANS that have substantially enhanced its performance, current guidelines continue to recommend PCNL as first-line treatment for renal stones >2cm. METHODS: MEDLINE, Embase, and the Cochrane Library were searched for studies performing direct comparisons of FANS-RIRS against PCNL in adult patients until September 2025. Primary outcomes included stone-free rates (SFRs) and need for ancillary procedures. Secondary outcomes included operative time, length of postoperative hospitalisation, and postoperative complications. RESULTS: A total of 10 studies (three randomised control trials, seven retrospective cohort studies) comprising 2347 patients were included; preoperative stone sizes were predominantly 2-3 cm. All PCNL procedures in the studies included were performed as mini-PCNL. The SFRs for FANS-RIRS were comparable with mini-PCNL across all stone sizes (odds ratio [OR] 0.90, 95% confidence interval [CI] 0.70-1.17) and stones ≥2 cm (OR 0.80, 95% CI 0.60-1.08), with low heterogeneity. Ancillary procedures rates were similar (OR 1.22, 95% CI 0.61-2.44). FANS-RIRS was associated with significantly fewer overall complications, specifically smaller haemoglobin decline, need for transfusion, and shorter hospital stay. However, mini-PCNL demonstrated shorter operative times for stones ≥2 cm. Urosepsis rates were low and similar between both groups. Limitations include predominance of Asian studies, variability of practice, and inclusion of non-randomised studies. CONCLUSIONS: Contemporary FANS-RIRS achieves SFRs comparable to mini-PCNL even for 2-3 cm stones, while offering superior safety profiles and shorter hospitalisation; this supports FANS-RIRS as a viable primary treatment in selected patients.

Humans↗

PubMed2026

Temporal evolution of minimally invasive pediatric urolithiasis treatment over 30 years.

Urolithiasis in children has increased substantially over the past 30 years, and surgical management maintains an important role in treatment. Technological advances such as lasers and miniaturization have broadened treatment options, and researchers investigate the best indications for each procedure. The aim was to identify publication trends in the field and explore reasons why Extracorporeal Shockwave Lithotripsy is being gradually less applied in the treatment of pediatric urolithiasis. A Reverse Systematic Review of the literature was conducted regarding the surgical treatment of urolithiasis in children. Five databases were screened, gathering all articles from inception that were evaluated in systematic reviews. We examined 123 publications, 197 reports, and 15,878 procedures, consisting of the largest studied population in the field. There was an increasing number of publications, although in progressively less prestigious journals. The number of studies on miniaturized percutaneous techniques and flexible ureteroscopy has increased closely with the rise in popularity of these procedures worldwide, mainly driven by studies from Asia, Europe, and North America. A trend of self-renewed interest is fueled by technological innovation and has led to fewer publications on Extracorporeal Shockwave Lithotripsy over the years. This review highlights the fact that, despite positive results in recent studies, the low popularity of ESWL within the scientific community is driving a decline in the technique's indications. Moreover, based on the findings of this study, key research priorities include continued reporting of high-quality outcomes, and technological progress in ESWL would contribute meaningfully to the field.

Humans↗

PubMed2026

Emphysematous pyelonephritis in children: Lessons from a case report and systematic review.

BACKGROUND: Emphysematous pyelonephritis (EPN) is a rare, life-threatening gas-producing renal infection. Literature on pediatric EPN remains scarce. OBJECTIVE: To describe a case of pediatric EPN and systematically review the data on clinical presentations, diagnostic modalities, management strategies, and prognosis in pediatric emphysematous pyelonephritis. METHODS: A comprehensive search in PubMed, Embase and Web of Science using defined search terms was done, along with the Joanna Briggs Institute (JBI) critical appraisal checklist for quality assessment. RESULTS: Of 100 records, 20 studies (n = 21) were included in the review. The median (IQR) age of presentation was 48 (8-138) months. The major risk factor was reflux/obstructive nephropathy (52.3 %), and E. coli was the common organism. Management included antibiotics (47.6 %), minimally invasive procedures (33.3 %), or nephrectomy (19 %). We additionally report an adolescent girl with Type 1 diabetes mellitus and class 3A right-sided EPN. She improved with antibiotics and percutaneous nephrostomy (PCN) insertion. CONCLUSION: Obstructive or reflux nephropathy is a major risk factor for pediatric EPN. Antibiotics are the mainstay for treatment with supportive management. Refractory cases may require percutaneous drainage or partial/total nephrectomy.

Humans↗

PubMed2026

Minimally invasive versus open surgery for gallbladder cancer: A systematic review and meta-analysis.

INTRODUCTION: Minimally invasive surgery (MIS) is increasingly being used in gallbladder cancer (GBC) for radical tumour extirpation. However, there are conflicting results on the morbidity outcomes following MIS. The aim of this meta-analysis was to compare the post-operative morbidity and mortality in patients undergoing radical surgery for GBC between MIS and open surgery. MATERIAL AND METHODS: Studies comparing MIS (laparoscopic, robotic or both techniques) to open surgery were included. The databases of MEDLINE, Cochrane and EMBASE were searched from 2001 till March 2025. The primary end point was post-operative morbidity and mortality. The secondary end points were hospital stay, blood loss, operative time and R1 resection rates. Random effect models were used for analysis. The risk of bias was assessed using the Newcastle-Ottawa scale. RESULTS: Thirty-two studies (laparoscopic [n = 19], robotic [n = 6] or both [n = 7]) involving 8568 (MIS = 3287 and open = 5281) patients were included. For overall and major morbidity (Clavian-Dindo >/ = III), the odds ratio (OR) of 0.60 (95% CI: 0.46-0.78) and 0.72 (95% CI: 0.52-1.0) respectively was obtained, favouring the MIS approach. Similarly, MIS showed lower odds for mortality [OR:0.62 (95% CI: 0.40-0.95)] compared to open surgery. MIS was associated with shorter hospital stay (less by mean of 3 days) and lesser blood loss (less by mean of 115 ml) but longer operative time (higher by mean of 5.8 min) and higher R1 resection rates (OR: 1.34; 95% CI: 1.05-1.71). Oncological outcomes, however, were comparable. The certainty of evidence was very low to low across the studies. CONCLUSION: MIS for GBC was associated with relatively lower post operative morbidity and mortality with similar oncological outcomes but with a small but heightened risk of margin positive (R1) resection, especially in primary GBC. The certainty of evidence was very low to low across the included studies. Future prospective studies are needed to overcome the clinical heterogeneity and possible selection bias.

Humans↗

PubMed2026

Effects of low-dose esketamine on early quality of recovery following minimally invasive esophagectomy: a multicenter, randomized controlled study.

BACKGROUND: Patients undergoing minimally invasive esophagectomy (MIE) frequently experience moderate-to-severe postoperative pain and anxiety-depressive symptoms, compromising postoperative quality of recovery (QoR). Esketamine is a promising adjunct for analgesia and anxiolysis; however, the effect of low-dose esketamine on patient-centered recovery outcomes in MIE remains unclear. METHODS: In this double-blinded, multicenter randomized controlled trial, patients scheduled for elective McKeown esophagectomy were allocated to esketamine (0.25 mg/kg loading dose and 0.125 mg/kg/h continuous infusion during surgery) or placebo (equivalent volume and rate of saline). The primary outcome was the QoR-15 score on postoperative day (POD) 2. Secondary outcomes included QoR-15 scores on POD 1, 3, 7 and 30. Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) and Depression Subscale (HADS-D) scores, numeric rating scale (NRS) pain scores, and the Brief Pain Inventory (BPI) scores on POD 1 to 3, and safety evaluations. RESULTS: A total of 198 patients were analyzed (esketamine, n = 98; placebo, n = 100). Intraoperative esketamine significantly improved QoR-15 scores on POD 2 (116.9 ± 9.4 vs. 110.2 ± 9.8, p < 0.001) and POD 3 (123.6 ± 7.2 vs. 116.8 ± 8.4, p < 0.001) compared with placebo. HADS-A and HADS-D scores were lower in the esketamine group on POD 1 to 3 (all p < 0.001). Additionally, esketamine recipients reported significantly lower NRS scores at rest and during movement and BPI scores for pain severity and pain interference items (all p < 0.001). There were no significant between-group differences in safety outcomes. CONCLUSIONS: Intraoperative low-dose esketamine improved early, patient-reported recovery after MIE by enhancing analgesia and reducing postoperative anxiety and depression without increasing adverse events. TRIAL REGISTRATION: Chinese Clinical Trial Register (identifier: ChiCTR2400088916).

Humans↗

PubMed2026

Contemporary surgical decision-making for hallux valgus and hallux rigidus in Switzerland: A national cross-sectional survey using standardized clinical scenarios.

BACKGROUND: Surgical management of hallux valgus and hallux rigidus is influenced by deformity severity, surgeon training, and evolving techniques. Previous surveys in Australia (2012), Switzerland (2015), and Israel (2023) using identical hypothetical cases demonstrated marked regional differences and a recent rise in minimally invasive Chevron-Akin (MICA). Whether these advances have altered contemporary Swiss practice remains unclear. METHODS: An electronic survey replicating the original questionnaire was distributed to members of the Swiss Foot and Ankle Society. Three standardized clinical cases were presented: mild hallux valgus, severe hallux valgus, and hallux valgus et rigidus. Respondents selected nonoperative versus operative management and specified procedures and fixation methods. Demographics, subspecialty training, and surgical volume were recorded. Current results were compared with prior Swiss data to assess temporal change. RESULTS: Eighty surgeons completed the survey (94% foot and ankle specialists). For mild hallux valgus, 87.7% recommended surgery; Scarf osteotomy remained most common (49.4%), followed by Chevron (21.0%) and Minimally Invasive Hallux Valgus correction (14.8%). Minimally Invasive adopters were predominantly mid-career (83% aged 41-50), high-volume surgeons. For severe hallux valgus, 95.1% favoured surgery; MTPJ arthrodesis was preferred (50.6% isolated; 11.1% with Lapidus), while Minimally Invasive Hallux Valgus correction was rarely chosen (2.5%). In hallux valgus et rigidus, 96% selected MTPJ fusion, most commonly plate-and-screw fixation (45.1%). Compared with 2015, fixation strategies evolved, yet procedure selection remained largely unchanged. CONCLUSION: Despite global expansion of minimally invasive bunion surgery, Swiss surgeons continue to favour established open techniques, particularly Scarf osteotomy and fusion-based strategies. Adoption of MIS remains limited and concentrated among high-volume, mid-career specialists, indicating a cautious national diffusion pattern. LEVEL OF EVIDENCE: IV, survey study.

Hallux Valgus↗

PubMed2026

Standardized visual overlays enhance laparoscopic instruction: A mixed-methods evaluation.

Effective communication during laparoscopic procedures is frequently undermined by spatial disorientation and inconsistent terminology between instructors and trainees. This study examined whether standardized visual overlays on endoscopic monitors could enhance communication and learning. We conducted a three-phase mixed-methods study: qualitative observation of 20 laparoscopic teaching cases; a randomized trial of 63 second-year medical students assigned to control, clock, or alphanumeric grid (AG) overlays during three trials of a standardized transfer task; and intraoperative implementation in 44 cases (30 AG, 14 clock) with post-case surveys and qualitative feedback. In simulation, the clock overlay produced the fastest completion times, whereas the AG yielded the lowest error scores, and both overlays outperformed the control. Intraoperatively, the AG was rated higher than the clock for communication clarity, spatial orientation, perceived operative efficiency, and trainee confidence. Standardized visual overlays, particularly the AG, appear to support intraoperative teaching by providing a shared spatial frame of reference.

Laparoscopy↗

PubMed2026

Effect of protective ventilation throughout the intubation period on perioperative oxygenation in patients undergoing MIDCABG: a randomised controlled trial.

INTRODUCTION: Minimally invasive direct coronary artery bypass grafting (MIDCABG) requires prolonged one-lung ventilation (OLV), increasing postoperative pulmonary complications (PPCs) risk. We investigated whether protective lung ventilation (PLV) throughout intubation benefits MIDCABG patients. METHODS: In this single-center randomized study, MIDCABG patients received PLV (low tidal volume of 6-8 mL·kg-1, PEEP of 6 cm H2O, alveolar recruitment maneuvers) or conventional mechanical ventilation (CMV, tidal volume of 8-10 mL·kg-1, without PEEP or maneuvers) from tracheal intubation to extubation. The primary outcome was perioperative oxygenation, assessed by the PaO2/FiO2 ratio. RESULTS: Sixty patients (n = 30 per group) were enrolled. Compared with CMV, PLV improved PaO2/FiO2 ratios (mean difference at OLV60: 34.56 mmHg; 95% CI: 11.78-57.33; p < 0.01), shortened median durations of postoperative mechanical ventilation (median difference: -4.5 h, 95% CI: -8.5 to -0.5; p = 0.013) and hospital stay (median difference: -3.0 days, 95% CI: -5.0 to -1.0; p = 0.019). PLV also reduced driving pressure, airway pressure and intrapulmonary shunt during OLV (all p < 0.05). Desaturation occurred in 23.3% of CMV patients and 13.3% of PLV patients (p = 0.506). Hemodynamic parameters were generally comparable between groups, except for lower MPAP and PVRI in the PLV group during OLV and after ICU admission (p < 0.05). The incidence of PPCs did not differ between groups. CONCLUSIONS: In patients undergoing MIDCABG, PLV applied throughout intubation improved perioperative oxygenation and shortened the duration of postoperative mechanical ventilation and hospital stay, but did not reduce PPCs. CLINICAL TRIAL REGISTRATION: ChiCTR1900022005.

Humans↗

PubMed2026

Transabdominal lumbar approach (TALA) versus retroperitoneal approach for robot-assisted renal surgery: a prospective randomised controlled trial.

PURPOSE: Common robotic nephrectomy approaches access the kidney via transperitoneal (TP) or retroperitoneal (RP) routes, each with distinct trade-offs. We developed the transabdominal lumbar approach (TALA), combining advantages of both accesses with improved visualisation and strategic trocar placement, and compared it with conventional RP in a prospective randomised controlled trial using technique-oriented intraoperative endpoints. METHODS: In this single-centre, prospective, open-label RCT, 40 patients were randomised to TALA (n = 18) or conventional RP (n = 22). Eligible patients were ≥ 18 years with a renal tumour or non-functional kidney requiring robot-assisted total or partial nephrectomy. Exclusions included prior surgery on the affected kidney, renal vein tumour thrombus, and pregnancy. Both groups were followed for 30 days. The primary endpoint was time from first skin incision to renal artery identification. RESULTS: TALA achieved a median time saving of 16 min compared to conventional RP (38 vs. 54 min, p = 0.001). Perioperative safety was comparable between groups, with three patients (7.5%) experiencing Clavien-Dindo grade III-IV complications. CONCLUSIONS: TALA met its primary endpoint with a significantly shorter time to renal artery identification than conventional RP access, and improving perceived surgical exposure and instrument handling.

Humans↗

PubMed2026

Response to Letter to the editor to comment on "Is arthroscopically-assisted reduction and internal fixation (ARIF) superior to percutaneous fixation in talar neck fractures? A proportional meta-analysis".

Explore the source record for details and available documents.

Letter↗

PubMed2026

Comparative effectiveness of percutaneous coronary intervention strategies for coronary small-vessel disease: a network meta-analysis of randomized trials.

BACKGROUND: Coronary small-vessel disease (SVD) remains challenging for percutaneous coronary intervention (PCI) because small lumens magnify restenosis and ischemic risk. Multiple devices are available, yet their comparative performance is uncertain. This study evaluated and ranked PCI strategies for SVD. METHODS: A systematic review and network meta-analysis was conducted in accordance with PRISMA. PubMed, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, and Google Scholar were searched from inception to 15 August 2025. Eligible studies were English-language randomized controlled trials enrolling adults with angiographic SVD defined as reference vessel diameter ≤3.0 mm, comparing PCI strategies, and reporting target lesion revascularization (TLR), binary restenosis (BR), or myocardial infarction (MI). A frequentist random-effects network meta-analysis generated odds ratios (ORs) with 95% confidence intervals (CIs) and treatment rankings using the surface under the cumulative ranking curve (SUCRA). RESULTS: Thirty-nine trials including 14,503 patients met the criteria. For TLR (37 studies; 11,980 patients), the highest SUCRA values were observed with sirolimus-eluting stents (SES 90.1%), zotarolimus-eluting stents (ZES 83.9%), and everolimus-eluting stents (EES 82.2%). For BR (32; 6,468), SES, ZES, and paclitaxel-coated balloons (DCB-PTX) ranked highest (95.0%, 80.0%, and 78.3%). For MI (37; 11,602), SES, DCB-PTX, and ZES ranked highest (79.0%, 78.7%, and 68.5%). Representative effects showed SES reduced TLR versus bare-metal stents (BMS) (OR, 0.25; 95% CI, 0.15-0.43) and MI versus BMS (OR, 0.41; 95% CI, 0.21-0.79). Conventional approaches such as BMS, plain old balloon angioplasty (POBA), and gold-plated balloon angioplasty (GPBA) ranked lowest across outcomes. CONCLUSION: SES provides the most consistent clinical benefit for coronary SVD. ZES, EES, and DCB-PTX are effective alternatives in selected settings, whereas BMS, POBA, and GPBA are less effective. These findings offer comparative evidence to guide device selection in SVD.

Humans↗

PubMed2026

Antegrade dissection and re-entry vs retrograde strategy in chronic total occlusion percutaneous coronary intervention: Rationale and design of the ADRENALINE randomized study.

RATIONALE: While antegrade wiring (AW) is the most common initial strategy for chronic total occlusion (CTO) percutaneous coronary intervention (PCI), difficult CTO lesions frequently require either antegrade dissection and re-entry (ADR) or a retrograde strategy. Comparative data between ADR and the retrograde approach remain limited. DESIGN: The Antegrade Dissection vs Retrograde re-ENtry And Load of Interventionalist Effort (ADRENALINE) is a prospective, multicenter randomized study with a superiority design. It is planned to enroll 121 patients with difficult coronary CTO (J-CTO score ≥2) referred for CTO-PCI in accordance with the hybrid algorithm. Subjects undergoing successful AW will be included in the observational arm. Patients with failed or unattempted AW will be randomized 1:1 to ADR or retrograde CTO crossing strategy (n = 74). All patients will undergo pre- and postprocedural laboratory testing (including cardiac troponin T and creatine kinase-MB), cardiac magnetic resonance (CMR) for late gadolinium enhancement, and health status assessment by the Seattle Angina Questionnaire and the Rose Dyspnea Scale. The co-primary endpoints are total procedure time and successful guidewire crossing. Additionally, the relationship between different recanalization strategies and stress among interventional cardiologists will be explored. CONCLUSION: ADRENALINE is the first randomized study of ADR vs retrograde strategy for difficult CTO PCI, assessing procedural outcomes, CMR-detected myocardial infarction, and 3-month quality of life. ENROLMENT STATUS: The first patient was enrolled on July 29, 2025. As of June 14, 2026, 45 patients (26 randomized, 19 observational) of the planned 121 patients have been enrolled. TRIALS REGISTRATION: Clinicaltrials.gov: Identifier, NCT06878729.

Humans↗

PubMed2026

Efficacy and safety of rib-guided percutaneous thoracic sympathetic radiofrequency thermocoagulation at two different targets for primary palmar hyperhidrosis: a randomized controlled trial.

OBJECTIVES: To compare the efficacy and safety of computed tomography-guided percutaneous thoracic sympathetic radiofrequency thermocoagulation (RFT) targeting the upper versus lateral margin of the fourth rib head for severe primary palmar hyperhidrosis (PPH). METHODS: Patients with severe PPH were randomly divided into Group U (upper margin target) and Group L (lateral margin target). Outcome measures included 1-year recurrence rate, Hyperhidrosis Disease Severity Scale (HDSS), Dermatology Life Quality Index (DLQI), palm skin temperature, finger perfusion index (PI), compensatory hyperhidrosis and patient satisfaction. RESULTS: Both groups (n = 55 each, 110 sides) successfully underwent RFT. No preprocedural PI differences were found (p > 0.05). Immediately post-RFT, PI in Group L was significantly higher than in Group U (left p = 0.025, right p = 0.013). No significant differences in HDSS grades were observed between groups before and at 1 day, 2 weeks, 1 month and 3 months post-procedure. However, at 6 and 12 months, Group L showed significantly lower HDSS grades (left p = 0.033 and 0.016; right p = 0.039 and 0.025) and lower DLQI scores (p = 0.037 and 0.024) than Group U. Patient satisfaction did not differ within 6 months, but Group L had significantly higher satisfaction at 12 months (p = 0.036). CONCLUSIONS: Targeting the lateral margin of the fourth rib head for RFT achieved greater efficacy, better quality of life and higher patient satisfaction compared to the upper margin target.

Humans↗

PubMed2026

Intravenous Nicorandil in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary PCI: The CLEAN Randomized Clinical Trial.

BACKGROUND: Nicorandil, an adenosine triphosphate-sensitive potassium-channel opener with nitrate-like properties, may reduce reperfusion injury and microvascular obstruction in ST-segment elevation myocardial infarction (STEMI), but large-scale randomized evidence on long-term clinical outcomes is inconclusive. OBJECTIVES: The CLEAN trial aimed to assess whether adjunctive intravenous nicorandil improves 12-month clinical outcomes in patients with STEMI undergoing primary percutaneous coronary intervention. METHODS: In this multicenter, randomized, double-blind, placebo-controlled trial conducted at 49 hospitals in China, patients aged 18 to 80 years with STEMI within 12 hours of symptom onset were randomly assigned (1:1) to receive intravenous nicorandil (6 mg bolus before reperfusion followed by 6 mg/h infusion for 48 h) or matching placebo. Oral nicorandil was prohibited during follow-up. The primary outcome was a composite of cardiovascular death, nonfatal myocardial infarction, target vessel revascularization, or unplanned hospitalization for heart failure within 12 months. RESULTS: Between January 2021 and December 2023, 1,503 patients were enrolled and randomly assigned to nicorandil (n = 748) or placebo (n = 755). The primary composite outcome occurred in 98 patients (13.1%) in the nicorandil group (113 events over 717.2 person-years) and 99 (13.1%) in the placebo group (136 events over 710.3 person-years), with no significant difference between groups (rate ratio: 0.869; 95% CI: 0.650-1.162; P = 0.3429). Among secondary outcomes, nominal reductions were observed in cardiovascular death (1.9% vs 3.6%; HR: 0.515; 95% CI: 0.269-0.983) and target-vessel revascularization (1.1% vs 3.0%; HR: 0.322; 95% CI: 0.143-0.727), whereas rates of nonfatal myocardial infarction and unplanned hospitalization for heart failure were similar between groups. Adverse events did not differ between groups. CONCLUSIONS: In patients with STEMI undergoing primary percutaneous coronary intervention, adjunctive intravenous nicorandil did not significantly reduce the 12-month primary composite outcome. These findings do not support routine use of intravenous nicorandil in unselected patients with STEMI. (Clinical Efficacy and sAfety of Intravenous Nicorandil; NCT04665648).

Humans↗

PubMed2026

Bivalirudin Versus Heparin in Low and Non-Low Bleeding Risk Patients Undergoing Primary PCI for STEMI: The BRIGHT-4 Trial.

BACKGROUND: In the BRIGHT-4 trial, among 6,016 patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) with a radial artery approach, procedural anticoagulation with bivalirudin plus a post-PCI high-dose infusion for 2 to 4 hours reduced the 30-day primary composite outcome of all-cause death or Bleeding Academic Research Consortium (BARC) types 3 to 5 bleeding, as well as death and bleeding individually, compared with heparin monotherapy. OBJECTIVES: We sought to determine whether the benefits of bivalirudin apply principally to patients who are at low bleeding risk (LBR) as well as non-LBR. METHODS: In a prespecified analysis from BRIGHT-4, outcomes were examined by baseline bleeding risk, with LBR defined as a CRUSADE score <30. RESULTS: At baseline, 4,581 patients (76.1%) were categorized as LBR. Non-LBR patients had higher rates of the 30-day primary endpoint (8.6% vs 2.2%; HR: 4.08 [95% CI: 3.14-5.31]; P < 0.0001), driven by both greater mortality and BARC types 3 to 5 bleeding. In non-LBR patients, the primary outcome occurred in 8.1% of patients randomized to bivalirudin vs 9.2% of those randomized to heparin (difference: -1.1% [95% CI: -4.0% to 1.8%]; HR: 0.88 [95% CI: 0.62-1.26]). In LBR patients, the primary outcome occurred in 1.4% of patients randomized to bivalirudin vs 2.9% of those randomized to heparin (difference: -1.5% [95% CI: -2.3% to -0.6%]; HR: 0.49 [95% CI: 0.32-0.75]) (Pabsolute interaction = 0.81; Prelative interaction = 0.04). The effects of bivalirudin compared with heparin in reducing all-cause death were as robust in LBR patients compared with non-LBR patients (Pabsolute interaction = 0.67; Prelative interaction = 0.06). CONCLUSIONS: Among patients with STEMI undergoing primary PCI with radial artery access, procedural anticoagulation with bivalirudin plus a high-dose post-PCI infusion for 2 to 4 hours reduced the 30-day risk of all-cause death and major bleeding in patients at low bleeding risk as well as in patients at higher-risk of bleeding. (Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI [BRIGHT-4; NCT03822975]).

Humans↗

PubMed2026

Impact of renal dysfunction on immediate versus staged revascularization of non-culprit lesions in patients with ST segment elevation myocardial infarction: a pre-specified subgroup analysis of the randomized MULTISTARS AMI trial.

BACKGROUND: Renal dysfunction might affect outcomes in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) undergoing percutaneous coronary intervention (PCI). METHODS: In MULTISTARS AMI, patients with STEMI and MVD were randomized to immediate or staged PCI of non-culprit lesions. In this pre-specified analysis, patients were stratified according to the presence of renal dysfunction at baseline, defined at an estimated glomerular filtration rate (eGFR) of 60 ml/min/1.73 m2. Patients with an eGFR < 30 ml/min/1.73 m2 were excluded from the trial. The primary endpoint was a composite of death, non-fatal myocardial infarction, stroke, unplanned revascularization, or hospitalization for heart failure at 1 year. RESULTS: In MULTISTARS AMI, 108 (13%) of 832 patients had renal dysfunction. The primary endpoint occurred more frequently in patients with renal dysfunction (19.4% vs. 11.2%, unadjusted HR 1.82, 95% CI 1.13-2.94), primarily driven by higher rates of death. Among patients with renal dysfunction, the rates of the primary end point were 14.5% and 24.5% in the immediate and staged PCI groups (unadjusted HR 0.55, 95% CI 0.23-1.33). There was no interaction between renal dysfunction and the randomized treatment assignment with respect to the primary end point (adjusted HR 1.30, 95% CI 0.8-2.20, pint 0.82). The occurrence of acute renal insufficiency was statistically similar in patients with renal dysfunction who underwent immediate and staged PCI (10.9% vs. 18.9%, unadjusted HR 0.61, 95% CI 0.22-1.72, pint 0.09). Renal dysfunction at baseline emerged as a strong risk factor for the development of acute renal insufficiency (adjusted HR 5.0, 95% CI 2.30-10.70, p < 0.01). CONCLUSIONS: Outcomes with immediate compared to staged multivessel PCI did not appear significantly altered by the presence of renal dysfunction at baseline. (Supported by Boston Scientific; MULTISTARS AMI ClinicalTrials.gov number, NCT03135275).

Humans↗