Randomized Trials
RCT | Videolaryngoscopy improves first-pass tracheal intubation success compared with direct laryngoscopy
21 Mar, 2023 | 13:21h | UTC
RCT | A 10-y comparison of paclitaxel-coated balloon, paclitaxel-eluting stent, and plain balloon angioplasty for DES in-stent restenosis
20 Mar, 2023 | 13:42h | UTCSummary: The ISAR-DESIRE 3 trial aimed to compare the 10-year efficacy and safety of plain balloon (PB), paclitaxel-coated balloon (PCB), and paclitaxel-eluting stent (PES) for percutaneous coronary intervention (PCI) of drug-eluting stent (DES) in-stent restenosis (ISR).
A total of 402 patients with DES-ISR were randomized to the different treatment groups: 134 patients to PB angioplasty (160 lesions), 137 patients to PCB angioplasty (172 lesions), and 131 patients to PES implantation (168 lesions).
PCB angioplasty and PES implantation had comparable 10-year results in the device-oriented composite endpoint including cardiac death, target vessel myocardial infarction, target lesion thrombosis, or target lesion revascularization, and significantly reduced the incidence of repeat target lesion revascularization compared to PB angioplasty alone. However, an excess of mortality within 5 years associated with PES warrants further investigation.
Article: Coronary artery restenosis treatment with plain balloon, drug-coated balloon, or drug-eluting stent: 10-year outcomes of the ISAR-DESIRE 3 trial – European Heart Journal (free for a limited period)
Commentary on Twitter
Coronary artery restenosis treatment with plain balloon, drug-coated balloon, or drug-eluting stent: 10-year outcomes of the ISAR-DESIRE 3 trial ?https://t.co/NHQpCIaNod #EHJ #ESCYoung @ehj_ed @rladeiraslopes
— European Society of Cardiology Journals (@ESC_Journals) March 8, 2023
RCT | Intermittent IV ibuprofen reduces morphine consumption and provides pain relief after surgery
20 Mar, 2023 | 13:39h | UTCSummary: The article describes a randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy and safety of different doses of intravenous ibuprofen (IVIB) in treating acute postoperative pain. The trial involved patients who underwent abdominal or orthopedic surgery and were randomized to placebo, IVIB 400 mg, or IVIB 800 mg. The first dose was given intravenously 30 minutes before surgery ended, followed by IV administration every 6 hours for a total of 8 doses.
The study found that IV administration of ibuprofen 400 mg or 800 mg significantly reduced morphine consumption and relieved pain without increasing the incidence of adverse events.
The study’s strengths were its multicenter, randomized, controlled, and prospective design. However, the extensive list of exclusion criteria suggests that the study was made in a relatively healthy population, making it difficult to extrapolate the safety results for more fragile patients.
Post-hoc analysis | Could SGLT2 inhibitors have a beneficial effect on gout symptoms?
17 Mar, 2023 | 13:02h | UTCRelated: Post-hoc analysis | Can SGLT2 inhibitors reduce the risk of hyperuricemia and gout?
RCT | Adjunctive Cariprazine for the treatment of patients with major depressive disorder
17 Mar, 2023 | 13:01h | UTCAdjunctive Cariprazine for the Treatment of Patients With Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study – American Journal of Psychiatry (link to abstract – $ for full-text)
Commentary on Twitter
RCT: Adjunctive cariprazine (1.5 mg/d) demonstrated efficacy in reducing depressive symptoms in adults with MDD and inadequate response to ADs vs. placebo at week 6 (−14.1 vs. −11.5) https://t.co/k4QST25FeF
— PfOL (@psychopharmacol) March 3, 2023
RCT | Preliminary study suggests early methylene blue administration reduces vasopressor duration in septic shock patients
16 Mar, 2023 | 13:25h | UTCSummary: The study aimed to evaluate the efficacy and safety of early adjunctive methylene blue (MB) administration in patients with septic shock. In this single-center randomized controlled trial, 91 patients were randomly assigned to receive MB or placebo, with the primary outcome being the time to vasopressor discontinuation at 28 days.
The study found that the MB group had a significantly shorter time to vasopressor discontinuation, one more day of vasopressor-free days at day 28, a shorter length of stay in the ICU and hospital, and no serious adverse effects related to MB administration.
However, the study was limited by its small sample size and single-center design. Therefore, larger multicenter randomized clinical trials are needed to confirm the potential benefit of MB as an early adjunctive therapy in patients with septic shock.
RCT | Impact of two ketogenic diet types in refractory childhood epilepsy
16 Mar, 2023 | 13:13h | UTCImpact of two ketogenic diet types in refractory childhood epilepsy – Pediatric Research
Related:
Efficacy and Safety of Dietary Therapies for Childhood Drug-Resistant Epilepsy: A Systematic Review and Network Meta-analysis – JAMA Pediatrics (link to abstract – $ for full-text)
Safety, Efficacy, and Tolerability of Modified Atkins Diet in Persons With Drug-Resistant Epilepsy: A Randomized Controlled Trial – Neurology (link to abstract – $ for full-text)
RCT | Intra-articular 10 mg triamcinolone acetonide non-inferior to 40 mg for knee osteoarthritis pain relief
16 Mar, 2023 | 12:55h | UTC
RCT | Nirogacestat for desmoid tumors
15 Mar, 2023 | 14:57h | UTCNirogacestat, a γ-Secretase Inhibitor for Desmoid Tumors – New England Journal of Medicine (link to abstract – $ for full-text)
News Release: Nirogacestat Improves Outcomes for Patients With Desmoid Tumors – Memorial Sloan Kettering Cancer Center
Commentary on Twitter
In a randomized, placebo-controlled trial, oral nirogacestat twice daily led to 41% of patients having a tumor response, and 2-year progression-free survival was 76%. Most adverse events were low grade. https://t.co/wtt7solTHW pic.twitter.com/qkRchfnXU2
— NEJM (@NEJM) March 10, 2023
RCT | Immersive virtual reality intervention reduces pain among pediatric patients undergoing venipuncture
15 Mar, 2023 | 14:46h | UTCCommentary: Immersive Virtual Reality Beneficial for Children Undergoing Venipuncture – HealthDay
RCT | Immediate complete revascularization non-inferior to staged approach in ACS patients with multivessel disease
13 Mar, 2023 | 15:10h | UTCSummary: Patients with an acute coronary syndrome and multivessel disease not presenting with cardiogenic shock usually benefit from complete revascularization by percutaneous coronary intervention (PCI). Complete revascularization involves treating all significant blockages in the coronary arteries, including those not causing symptoms (non-culprit lesions).
The BIOVASC randomized non-inferiority trial investigated whether patients with acute coronary syndrome and multivessel coronary disease should undergo immediate complete revascularization during the index procedure or undergo a staged approach with PCI of the culprit lesion only during the index procedure followed by another procedure within 6 weeks of all non-culprit lesions deemed to be clinically significant. The exclusion criteria were:
- Previous coronary artery bypass surgery.
- Cardiogenic shock.
- Single-vessel coronary disease.
- The presence of a chronic coronary total occlusion.
A total of 1525 patients with acute coronary syndrome and multivessel coronary disease were randomly assigned to either an immediate complete revascularization group (764 patients) or a staged complete revascularization group (761 patients). The primary outcome was a composite of all-cause mortality, myocardial infarction, unplanned ischemia-driven revascularization, or cerebrovascular events at 1 year after the index procedure. The study found that immediate complete revascularization was non-inferior to staged complete revascularization for the primary outcome.
Article: Immediate versus staged complete revascularisation in patients presenting with acute coronary syndrome and multivessel coronary disease (BIOVASC): a prospective, open-label, non-inferiority, randomised trial – The Lancet (free registration required)
Commentaries:
Revascularisation in acute coronary syndromes: change in practice? – The Lancet (free registration required)
No Downside to Immediate Complete Revascularization in ACS: BIOVASC – TCTMD
Immediate Complete Revascularization Non-Inferior to Staged Procedure in BIOVASC Trial – HCP Live
Related:
One-Year Outcomes after PCI Strategies in Cardiogenic Shock – New England Journal of Medicine
RCT | Induction therapy with olamkicept vs. placebo in patients with active ulcerative colitis
13 Mar, 2023 | 14:48h | UTCEffect of Induction Therapy With Olamkicept vs Placebo on Clinical Response in Patients With Active Ulcerative Colitis: A Randomized Clinical Trial – JAMA (free for a limited period)
Commentary on Twitter
Among patients with active ulcerative colitis, biweekly infusion of olamkicept 600 mg, but not 300 mg, resulted in a greater likelihood of clinical response at 12 weeks compared with placebo. https://t.co/I9h3jTZxlL pic.twitter.com/hgMvFhdzDa
— JAMA (@JAMA_current) March 8, 2023
RCT | Sulfadoxine-pyrimethamine vs. dihydroartemisinin-piperaquine for preventive treatment of malaria in pregnant women in Africa
13 Mar, 2023 | 14:43h | UTC
RCT | Efficacy of methotrexate alone vs. methotrexate plus low-dose prednisone in patients with alopecia areata
13 Mar, 2023 | 14:34h | UTCEfficacy of Methotrexate Alone vs Methotrexate Plus Low-Dose Prednisone in Patients With Alopecia Areata Totalis or Universalis: A 2-Step Double-Blind Randomized Clinical Trial – JAMA Dermatology (link to abstract – $ for full-text)
Commentary: Low-Cost Treatment Option for Alopecia Universalis, Totalis Identified in Clinical Trial – HCP Live
Commentary on Twitter
Methotrexate combined with low-dose prednisone may be an inexpensive and effective therapeutic option in patients with chronic and recalcitrant alopecia areata totalis or universalis. https://t.co/k1QWHJQjfP
— JAMA Dermatology (@JAMADerm) March 8, 2023
RCT | Treat-to-target strategy is noninferior to high-intensity statin therapy in patients with coronary artery disease
10 Mar, 2023 | 14:44h | UTCSummary: This randomized, multicenter, noninferiority trial in South Korea enrolled 4,400 patients with known coronary artery disease. Patients were randomly assigned to one of two groups: a treat-to-target group and a high-intensity statin group.
The treat-to-target group received moderate or high-intensity statins and titrated their medication to achieve an LDL-C goal of 50-70 mg/dL, while the high-intensity statin group received rosuvastatin 20 mg or atorvastatin 40 mg. The primary endpoint was a 3-year composite of death, myocardial infarction, stroke, or coronary revascularization.
The study found that the primary endpoint occurred in 8.1% of the treat-to-target group and 8.7% of the high-intensity statin group, indicating that the treat-to-target strategy was noninferior to the high-intensity statin strategy.
Overall, the results of this study indicate that a treat-to-target strategy could be an appropriate substitute for high-intensity statin therapy in patients with coronary artery disease. This approach enables a personalized treatment plan that accounts for variations in individual drug response to statin therapy.
Article: Treat-to-Target or High-Intensity Statin in Patients With Coronary Artery Disease: A Randomized Clinical Trial – JAMA (free for a limited period)
Commentaries:
Not all patients with coronary artery disease require high intensity statins – MedicalResearch.com
Commentary on Twitter
Among patients with coronary artery disease, a treat-to-target LDL-C strategy was noninferior to a high-intensity statin strategy for major clinical outcomes. https://t.co/Orv8IeF4Gv #ACC23 #WCCardio pic.twitter.com/NVEEJfQYfJ
— JAMA (@JAMA_current) March 6, 2023
RCT | The effect of skin traction on pain relief in patients with isolated intertrochanteric fractures
10 Mar, 2023 | 14:24h | UTC
RCT | Tranexamic acid did not significantly reduce blood loss in pancreaticoduodenectomy
10 Mar, 2023 | 14:05h | UTCTranexamic acid and blood loss in pancreaticoduodenectomy: TAC-PD randomized clinical trial – British Journal of Surgery (link to abstract – $ for full-text)
RCT | Transanal vs. laparoscopic total mesorectal excision for mid and low rectal cancer
10 Mar, 2023 | 14:03h | UTCTransanal versus laparoscopic total mesorectal excision for mid and low rectal cancer (Ta-LaTME study): multicentre, randomized, open-label trial – British Journal of Surgery (link to abstract – $ for full-text)
Crossover RCT | Atrial pacing to increase exercise HR did not improve performance in HFpEF patients with chronotropic incompetence
9 Mar, 2023 | 14:22h | UTCSummary: The RAPID-HF randomized clinical trial investigated whether implanting and programming a pacemaker for rate-adaptive atrial pacing would improve exercise performance in patients with heart failure with preserved ejection fraction (HFpEF) and chronotropic incompetence.
The study involved 29 patients with symptomatic HFpEF and chronotropic incompetence who underwent pacemaker implantation for the study and then were randomized to atrial rate responsive pacing or no pacing for four weeks, followed by a four-week washout period and then crossover for an additional four weeks.
The study found that atrial pacing increased early and peak exercise heart rate, but there was no improvement in exercise performance or quality of life. Despite a higher exercise heart rate, there was no increase in exercise cardiac output due to a decrease in stroke volume. Moreover, pacemaker implantation was associated with adverse events.
Article: Rate-Adaptive Atrial Pacing for Heart Failure With Preserved Ejection Fraction: The RAPID-HF Randomized Clinical Trial – JAMA (free for a limited period)
Editorial: Rate-Adaptive Pacing for Heart Failure With Preserved Ejection Fraction – JAMA (free for a limited period)
Commentaries:
RAPID-HF: Rate-Adaptive Pacing Doesn’t Help in HFpEF – TCTMD
Atrial Pacing for HFpEF Shows Lack of Benefit on Exercise Capacity – HCP Live
Commentary on Twitter
In patients with HFpEF and inadequate response of heart rate to exertion (chronotropic incompetence), implantation of a pacemaker to enhance exercise heart rate did not improve exercise capacity, symptoms, or exercise cardiac output. https://t.co/odBbeuuCPO #ACC23 #WCCardio
— JAMA (@JAMA_current) March 5, 2023
RCT | Assessment of a text message–based smoking cessation intervention for adult smokers
9 Mar, 2023 | 14:09h | UTC
Commentary on Twitter
RCT: Personalized text messages for a smoking cessation intervention in China improves biochemically-verified continuous abstinence at 6 months, 7% vs 3% with non-personalized messaged. https://t.co/DFTQoGfT7x
— JAMA Network Open (@JAMANetworkOpen) March 1, 2023
RCT/extended follow-up | Lenvatinib plus pembrolizumab vs. sunitinib in patients with advanced renal cell carcinoma
9 Mar, 2023 | 14:03h | UTCLenvatinib plus pembrolizumab versus sunitinib as first-line treatment of patients with advanced renal cell carcinoma (CLEAR): extended follow-up from the phase 3, randomised, open-label study – The Lancet Oncology (link to abstract – $ for full-text)
Original Study: Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma – New England Journal of Medicine (link to abstract – $ for full-text)
Commentary on Twitter
NEW: In extended FU of the CLEAR trial (+7 mo), median PFS was 23·3 mo (95% CI 20·8–27·7) with first-line lenvatinib + pembrolizumab and 9·2 mo (6·0–11·0) with sunitinib (stratified HR 0·42, 95% CI 0·34–0·52) in pts w/ advanced renal cell carcinoma. #rccsmhttps://t.co/gbwBIIqSK8 pic.twitter.com/78OijM9Rtm
— The Lancet Oncology (@TheLancetOncol) February 28, 2023
RCT | Bempedoic acid shows modest reduction in cardiovascular events for statin-intolerant patients
8 Mar, 2023 | 14:39h | UTCSummary:
Bempedoic acid is an ATP citrate lyase inhibitor that reduces LDL cholesterol levels and is associated with a low incidence of muscle-related adverse events. The study enrolled 13,970 patients at increased cardiovascular risk, with 6,992 randomized to bempedoic acid and 6,978 randomized to placebo, with a median duration of follow-up of 40.6 months.
The study found that bempedoic acid was associated with a statistically significant 13% reduction in the primary endpoint of major adverse cardiovascular events, which included death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization. However, the absolute risk reduction of events was modest, at 1.6% over nearly four years.
The study also reported higher incidences of gout and cholelithiasis with bempedoic acid compared to placebo, as well as small increases in serum creatinine, uric acid, and hepatic-enzyme levels.
Article: Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients – New England Journal of Medicine (link to abstract – $ for full-text)
Commentaries:
CLEAR Positives and Cautions With Bempedoic Acid for Statin Intolerance – Medscape (recommended reading – free registration required)
Cardiovascular Outcomes After “Statin-Intolerant” Patients Take Bempedoic Acid – NEJM Journal Watch (free for a limited period)
Commentary on Twitter
Bempedoic acid showed a modest absolute reduction in CV outcomes, relative to placebo, in patients “unable or unwilling” to take a statin. https://t.co/hQUfvFwz68 #ACC23 @hmkyale @NEJM #CardioTwitter pic.twitter.com/YMoNsce8MI
— NEJM Journal Watch (@JWatch) March 7, 2023
#ACC23 – RCT | Intravascular imaging–guided vs. angiography-guided complex PCI
7 Mar, 2023 | 13:20h | UTCIntravascular Imaging–Guided or Angiography-Guided Complex PCI – New England Journal of Medicine (link to abstract – $ for full-text)
Commentary on Twitter
In RENOVATE-COMPLEX-PCI, a randomized trial of imaging-guided or angiography-guided PCI for complex coronary lesion revascularization procedures, imaging-guided PCI led to a lower risk of target-vessel failure than angiography-guided PCI. https://t.co/GaE2cthB5t #ACC23/#WCCardio pic.twitter.com/EB1qb9dY21
— NEJM (@NEJM) March 5, 2023
#ACC23 – RCT | Transcatheter repair for patients with tricuspid regurgitation
6 Mar, 2023 | 14:29h | UTCTranscatheter Repair for Patients with Tricuspid Regurgitation – New England Journal of Medicine (link to abstract – $ for full-text)
Commentaries:
The TRILUMINATE Transcatheter Tricuspid Repair Trial: Positive but No Benefit? – Medscape (recommended reading – free registration required)
TRILUMINATE Pivotal: TEER With the TriClip Benefits Patients With Severe TR – TCTMD
Commentary on Twitter
In the TRILUMINATE trial, patients with tricuspid regurgitation who were treated with transcatheter edge-to-edge repair had more favorable clinical outcomes at 1 year than did patients who received medical therapy. Full trial results: https://t.co/ZWObb9Xl6T #ACC23/#WCCardio pic.twitter.com/O2E9QSumpQ
— NEJM (@NEJM) March 4, 2023
RCT | Hydrochlorothiazide is not effective for the prevention of kidney-stone recurrence
6 Mar, 2023 | 14:26h | UTCSummary:
This study aimed to assess the effectiveness of hydrochlorothiazide, a thiazide diuretic, in preventing the recurrence of calcium-containing kidney stones. The trial randomly assigned 416 patients with recurrent kidney stones to receive hydrochlorothiazide at a dose of 12.5 mg, 25 mg, or 50 mg once daily, or a placebo once daily, and followed them for a median of 2.9 years.
The results showed that the incidence of kidney stone recurrence did not differ significantly between the hydrochlorothiazide and placebo groups, regardless of the dose. Furthermore, patients who received hydrochlorothiazide were more likely to experience side effects such as hypokalemia, gout, new-onset diabetes mellitus, skin allergy, and a plasma creatinine level exceeding 150% of the baseline level.
Therefore, the effectiveness of hydrochlorothiazide in preventing kidney stone recurrence may be limited, and the common practice of prescribing it for these patients should be reevaluated.
Article: Hydrochlorothiazide and Prevention of Kidney-Stone Recurrence – New England Journal of Medicine (link to abstract – $ for full-text)
Video Summary: Hydrochlorothiazide and Kidney-Stone Recurrence | NEJM
Commentary: Hydrochlorothiazide and Prevention of Kidney Stones – NEJM Resident 360