30:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/1855-ogyi8eh4.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/25a3ozcrvi1ff.js","/_next/static/immutable/chunks/2r4wx50nvjh_4.js","/_next/static/immutable/chunks/23fsw06hsi5b1.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/3ezsiz-7shkna.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2lxntcm3pd1_h.js","/_next/static/immutable/chunks/00dgco8irq3jw.js","/_next/static/immutable/chunks/00nwe-kq0rboc.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 2f:T42b,{"@context":"https://schema.org","@type":"CollectionPage","name":"Randomized Controlled Trial (Prespecified Subgroup Analysis): study design Research & Clinical Takeaways","description":"Explore peer-reviewed papers on Randomized Controlled Trial (Prespecified Subgroup Analysis) (study design). Clinician-written summaries and actionable practice insights. Updated daily.","url":"https://www.reachrx.ai/hub/tag/study_design/Randomized%20Controlled%20Trial%20(Prespecified%20Subgroup%20Analysis)","breadcrumb":{"@type":"BreadcrumbList","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https://www.reachrx.ai"},{"@type":"ListItem","position":2,"name":"Research Hub","item":"https://www.reachrx.ai/hub"},{"@type":"ListItem","position":3,"name":"Study Designs","item":"https://www.reachrx.ai/hub/tag/study_design"},{"@type":"ListItem","position":4,"name":"Randomized Controlled Trial (Prespecified Subgroup Analysis)","item":"https://www.reachrx.ai/hub/tag/study_design/Randomized%20Controlled%20Trial%20(Prespecified%20Subgroup%20Analysis)"}]}}31:T447,This predefined subgroup included 3655 patients (1849 in the evolocumab group and 1806 in the placebo group) with a median age of 65 years (57% female). Among those in the lipid substudy, the median LDL-C level at 48 weeks was 52 mg/dL in the evolocumab group vs 111 mg/dL in the placebo group (P < .001). A 3-P MACE event occurred in 83 patients (5-year Kaplan-Meier estimate, 5.0%) in the evolocumab group compared with 117 patients (5-year Kaplan-Meier estimate, 7.1%) in the placebo group (hazard ratio [HR], 0.69 [95% CI, 0.52-0.91]; P = .009; between-group difference, 2.1% [95% CI, 0.4%-3.8%]). A 4-P MACE event occurred in 127 patients (5-year Kaplan-Meier estimate, 7.6%) in the evolocumab group compared with 178 patients (5-year Kaplan-Meier estimate, 10.5%) in the placebo group (HR, 0.69 [95% CI, 0.55-0.86]; P = .001; between-group difference, 2.9% [95% CI, 0.9%-4.9%]). There were 136 deaths (5-year Kaplan-Meier estimate, 7.8%) in the evolocumab group compared with 172 deaths (5-year Kaplan-Meier estimate, 10.1%) in the placebo group (HR, 0.76 [95% CI, 0.61-0.95]).32:Taee,Intensive lowering of low-density lipoprotein cholesterol (LDL-C) levels with PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors for cardiovascular event reduction has largely been reserved for patients with significant atherosclerosis. To investigate whether evolocumab could prevent a first major cardiovascular event (MACE) in patients without known significant atherosclerosis. VESALIUS-CV was a randomized, double-blind, placebo-controlled trial of evolocumab conducted across 774 sites in 33 countries and enrolling 12 257 patients with no prior myocardial infarction or stroke, LDL-C level 90 mg/dL or greater, and qualifying atherosclerosis or high-risk diabetes. This prespecified subgroup analysis examined outcomes in patients without known significant atherosclerosis (none of the following: prior arterial revascularization, arterial stenosis ≥50%, or coronary artery calcium score ≥100 Agatston units), all of whom had diabetes. Enrollment started in June 2019 and the last patient visit was July 2025, with a median follow-up of 4.8 years. Patients were randomized in a 1:1 ratio to subcutaneous administration of either evolocumab (140 mg every 2 weeks) or matching placebo added to optimally tolerated statin therapy. The dual primary end points were composites of coronary heart disease death, myocardial infarction, or ischemic stroke (3-P MACE) and 3-P MACE plus ischemia-driven arterial revascularization (4-P MACE). Secondary end points included all-cause mortality. This predefined subgroup included 3655 patients (1849 in the evolocumab group and 1806 in the placebo group) with a median age of 65 years (57% female). Among those in the lipid substudy, the median LDL-C level at 48 weeks was 52 mg/dL in the evolocumab group vs 111 mg/dL in the placebo group (P < .001). A 3-P MACE event occurred in 83 patients (5-year Kaplan-Meier estimate, 5.0%) in the evolocumab group compared with 117 patients (5-year Kaplan-Meier estimate, 7.1%) in the placebo group (hazard ratio [HR], 0.69 [95% CI, 0.52-0.91]; P = .009; between-group difference, 2.1% [95% CI, 0.4%-3.8%]). A 4-P MACE event occurred in 127 patients (5-year Kaplan-Meier estimate, 7.6%) in the evolocumab group compared with 178 patients (5-year Kaplan-Meier estimate, 10.5%) in the placebo group (HR, 0.69 [95% CI, 0.55-0.86]; P = .001; between-group difference, 2.9% [95% CI, 0.9%-4.9%]). There were 136 deaths (5-year Kaplan-Meier estimate, 7.8%) in the evolocumab group compared with 172 deaths (5-year Kaplan-Meier estimate, 10.1%) in the placebo group (HR, 0.76 [95% CI, 0.61-0.95]). In high-risk patients without known significant atherosclerosis and with diabetes, evolocumab reduced the risk of a first major cardiovascular event. ClinicalTrials.gov Identifier: NCT03872401.33:T11e8, Importance Intensive lowering of low-density lipoprotein cholesterol (LDL-C) levels with PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors for cardiovascular event reduction has largely been reserved for patients with significant atherosclerosis. Objective To investigate whether evolocumab could prevent a first major cardiovascular event (MACE) in patients without known significant atherosclerosis. Design, Setting, and Participants VESALIUS-CV was a randomized, double-blind, placebo-controlled trial of evolocumab conducted across 774 sites in 33 countries and enrolling 12 257 patients with no prior myocardial infarction or stroke, LDL-C level 90 mg/dL or greater, and qualifying atherosclerosis or high-risk diabetes. This prespecified subgroup analysis examined outcomes in patients without known significant atherosclerosis (none of the following: prior arterial revascularization, arterial stenosis ≥50%, or coronary artery calcium score ≥100 Agatston units), all of whom had diabetes. Enrollment started in June 2019 and the last patient visit was July 2025, with a median follow-up of 4.8 years. Intervention Patients were randomized in a 1:1 ratio to subcutaneous administration of either evolocumab (140 mg every 2 weeks) or matching placebo added to optimally tolerated statin therapy. Main Outcomes and Measures The dual primary end points were composites of coronary heart disease death, myocardial infarction, or ischemic stroke (3-P MACE) and 3-P MACE plus ischemia-driven arterial revascularization (4-P MACE). Secondary end points included all-cause mortality. Results This predefined subgroup included 3655 patients (1849 in the evolocumab group and 1806 in the placebo group) with a median age of 65 years (57% female). Among those in the lipid substudy, the median LDL-C level at 48 weeks was 52 mg/dL in the evolocumab group vs 111 mg/dL in the placebo group ( P &lt; .001). A 3-P MACE event occurred in 83 patients (5-year Kaplan-Meier estimate, 5.0%) in the evolocumab group compared with 117 patients (5-year Kaplan-Meier estimate, 7.1%) in the placebo group (hazard ratio [HR], 0.69 [95% CI, 0.52-0.91]; P = .009; between-group difference, 2.1% [95% CI, 0.4%-3.8%]). A 4-P MACE event occurred in 127 patients (5-year Kaplan-Meier estimate, 7.6%) in the evolocumab group compared with 178 patients (5-year Kaplan-Meier estimate, 10.5%) in the placebo group (HR, 0.69 [95% CI, 0.55-0.86]; P = .001; between-group difference, 2.9% [95% CI, 0.9%-4.9%]). There were 136 deaths (5-year Kaplan-Meier estimate, 7.8%) in the evolocumab group compared with 172 deaths (5-year Kaplan-Meier estimate, 10.1%) in the placebo group (HR, 0.76 [95% CI, 0.61-0.95]). Conclusions and Relevance In high-risk patients without known significant atherosclerosis and with diabetes, evolocumab reduced the risk of a first major cardiovascular event. 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inaccessible; safety and tolerability data (e.g., adverse events) could not be extracted and are not reflected in the summary.","value_numeric":null},{"paper_doi":"10.1001/jama.2026.3277","tag_type":"warning","value":"The median age of 65 years and 57% female composition may not represent all diabetic patient populations seen in primary prevention settings.","value_numeric":null},{"paper_doi":"10.1001/jama.2026.3277","tag_type":"warning","value":"The 'practice_changing' flag is applied cautiously — this subgroup analysis supports a shift in PCSK9 inhibitor use to primary prevention in diabetic patients, but guideline updates will be needed to confirm broad adoption.","value_numeric":null},{"paper_doi":"10.1001/jama.2026.3277","tag_type":"warning","value":"This is a prespecified subgroup analysis, not the primary trial result — findings should be interpreted with appropriate caution regarding statistical power and multiple comparisons.","value_numeric":null}],"summaries":{"what_studied":"This prespecified subgroup analysis of the VESALIUS-CV RCT evaluated whether evolocumab (140 mg subcutaneously every 2 weeks) vs placebo, added to optimally tolerated statin therapy, could prevent a first major cardiovascular event (MACE) in 3,655 patients with diabetes but **no** known significant atherosclerosis (no prior MI or stroke, no revascularization, no arterial stenosis ≥50%, no CAC ≥100), followed for a median of 4.8 years.","key_result":"Evolocumab reduced 3-P MACE (CHD death, MI, ischemic stroke) by 31% vs placebo (5.0% vs 7.1%; HR 0.69 [95% CI 0.52–0.91]; absolute difference 2.1%). It also cut 4-P MACE by 31% (7.6% vs 10.5%; HR 0.69 [95% CI 0.55–0.86]; absolute difference 2.9%) and showed a mortality signal (7.8% vs 10.1%; HR 0.76 [95% CI 0.61–0.95]). Median LDL-C at 48 weeks was 52 mg/dL (evolocumab) vs 111 mg/dL (placebo).","limitations":"- This is a **prespecified subgroup** of the main VESALIUS-CV trial, so statistical power was designed for the overall cohort, not this subgroup alone.\n- All patients in this subgroup had diabetes, limiting generalizability to non-diabetic patients without significant atherosclerosis.\n- Full-text safety and tolerability data were not accessible from the available abstract.","practice_takeaway":"Consider evolocumab as a primary prevention option in patients with diabetes and elevated LDL-C (≥90 mg/dL) who lack known significant atherosclerosis — a population previously excluded from routine PCSK9 inhibitor use. A 2.1% absolute reduction in 3-P MACE over ~5 years translates to roughly 1 event prevented per 48 patients treated."}}],"initialOffset":1,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"study_design","value":"Randomized Controlled Trial (Prespecified Subgroup Analysis)"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Study Designs","href":"/hub/tag/study_design"},{"name":"Randomized Controlled Trial (Prespecified Subgroup Analysis)"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"study_design","hub_tag_value":"Randomized Controlled Trial (Prespecified Subgroup Analysis)"}}}]]

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