Randomised, controlled trial of erenumab for the prevention of episodic migraine in patients from Asia, the Middle East, and Latin America: The EMPOwER study

Objective EMPOwER, a double-blind, randomised, phase 3 study, evaluated the efficacy and safety of erenumab in adults with episodic migraine from Asia, the Middle East, and Latin America. Methods Randomised patients (N = 900) received monthly subcutaneous injections of placebo, erenumab 70 mg, or 140 mg (3:3:2) for 3 months. Primary endpoint was change from baseline in monthly migraine days at Month 3. Other endpoints included achievement of ≥50%, ≥75%, and 100% reduction in monthly migraine days, change in monthly acute migraine-specific medication treatment days, patient-reported outcomes, and safety assessment. Results At baseline, mean (standard deviation) age was 37.5 (9.9) years, 81.9% were women, and monthly migraine days was 8.2 (2.8). At Month 3, change from baseline in monthly migraine days (primary endpoint) was −3.1, −4.2, and −4.8 days for placebo, erenumab 70 mg, and erenumab 140 mg, respectively, with a statistically significant difference for erenumab versus placebo (P = 0.002 [70 mg], P < 0.001 [140 mg]). Both erenumab doses were also significantly superior to placebo on all secondary endpoints, including the proportion of patients achieving ≥50% reduction from baseline in monthly migraine days, change from baseline in monthly acute migraine-specific medication treatment days and change from baseline in the Headache Impact Test-6™ scores. The safety profile of erenumab was comparable with placebo; no new safety signals were observed. Conclusions This study of erenumab in patients with episodic migraine from Asia, the Middle East, and Latin America met all primary and secondary endpoints. A consistent numerical benefit was observed with erenumab 140 mg versus erenumab 70 mg across all efficacy endpoints. These findings extend evidence of erenumab’s efficacy and safety to patients under-represented in previous trials. ClinicalTrials.gov identifier: NCT03333109

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Prospective, Randomized, Double Blind, Multicenter Study for an Autocrosslinked Polysaccharide Gel to Evaluate Antiadhesive Effect and Safety Compared to Poloxamer/Sodium Alginate After Thyroidectomy

International Surgery ◽

10.9738/intsurg-d-17-00065.1 ◽

2019 ◽

Vol 103 (9) ◽

pp. 452-460

Author(s):

Woo Young Kim ◽

Jae Bok Lee ◽

Hoon Yub Kim ◽

Pyoung Jae Park ◽

Seung Pil Jung ◽

...

Keyword(s):

Sodium Alginate ◽

Primary Endpoint ◽

Esophageal Motility ◽

Phase Iii ◽

Efficacy And Safety ◽

Double Blind ◽

Significant Difference ◽

Secondary Endpoints ◽

Double Blinded ◽

Voice Range

The aim of the study was to compare the efficacy and safety between an autocrosslinked polysaccharide (ACP) gel (Hyalobarrier) and a poloxamer/sodium alginate (P/SA: Guardix-SG) in preventing adhesions after thyroidectomy and demonstrate the noninferiority of ACP gel to P/SA. To identify differences of antiadhesive efficacy and safety between the ACP gel and P/SA, we investigated various variables such as the proportion of normal esophageal motility as assessed using marshmallow esophagography, swallowing impairment, adhesion severity and so on. This prospective, randomized, double-blinded, multicenter, phase III study investigated the antiadhesive efficacy and safety of ACP gel compared with those of P/SA for 12 weeks. Subjects were randomly assigned to receive either ACP gel (n = 97) or P/SA (n = 96). The primary endpoint was the proportion of normal esophageal motility as assessed using marshmallow esophagography, while the secondary endpoints included swallowing impairment, adhesion severity, laryngoscopic assessment of the vocal cords, and voice range profile. Safety endpoints included adverse events. There was no significant difference between the ACP gel and P/SA groups in the proportion of normal esophageal motility as the primary endpoint (P = 0.7428). In addition, there were no differences in the secondary or safety endpoints between the 2 groups. It was demonstrated that ACP gel was not inferior to P/SA. ACP gel appears both effective and safe for use in preventing adhesions after thyroidectomy.

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Efficacy and Safety of Different Doses of Bevacizumab Combined With Pemetrexed and Platinum in First-Line Treatment of Advanced NSCLC: A Retrospective-Real World Study

Frontiers in Pharmacology ◽

10.3389/fphar.2021.727102 ◽

2021 ◽

Vol 12 ◽

Author(s):

Chun-Hua Zhou ◽

Feng Yang ◽

Wen-Juan Jiang ◽

Yong-Chang Zhang ◽

Hai-Yan Yang ◽

...

Keyword(s):

Primary Endpoint ◽

Statistical Significance ◽

Progression Free Survival ◽

Efficacy And Safety ◽

First Line ◽

Free Survival ◽

Significant Difference ◽

Secondary Endpoints ◽

The Cost ◽

Different Doses

Background: Bevacizumab was demonstrated to have efficacy in patients with NSCLC. However, application of different doses of bevacizumab in different clinical trials was overlooked. This study aims to investigate the effects and safety of different doses of bevacizumab in the treatment.Methods: From January 2016 to March 2020, 79 patients with NSCLC received first-line combination treatment with chemotherapy (pemetrexed + platinum) and bevacizumab for four cycles; patients without progression after four cycles were randomly assigned to maintenance therapy with bevacizumab combined with pemetrexed, of which 57 patients received bevacizumab at a dose of 7.5 mg/kg and 22 patients at a dose of 15 mg/kg. The primary endpoint was progression-free survival, and secondary endpoints were overall response rate, disease control rate, and adverse events.Results: There was no significant difference between two groups in effectiveness; Median PFS in 7.5 mg/kg group and in 15 mg/kg group were 8.0 and 8.7 months, respectively (p = 0.663), reaching the primary endpoint. The ORR and DCR in the bevacizumab 7.5 and 15 mg/kg group were 45.46 and 86.0% vs. 50 and 90.9% showing no statistical significance (p = 0.804 and 0.717). Most of side effects were tolerable. The incidences of overall toxicities were higher in 15 mg/kg group (p = 0.001). No new safety signals were observed.Conclusion: We did not detect significant difference of efficacy and safety between 7.5 mg/kg group and 15 mg/kg group for bevacizumab administration, the cost-effectiveness of the 7.5 mg/kg group was significantly better than that of the 15 mg/kg group.

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ARISE: A Phase 3 randomized trial of erenumab for episodic migraine

Cephalalgia ◽

10.1177/0333102418759786 ◽

2018 ◽

Vol 38 (6) ◽

pp. 1026-1037 ◽

Cited By ~ 154

Author(s):

David W Dodick ◽

Messoud Ashina ◽

Jan Lewis Brandes ◽

David Kudrow ◽

Michel Lanteri-Minet ◽

...

Keyword(s):

Physical Function ◽

Episodic Migraine ◽

Physical Impairment ◽

Acute Migraine ◽

Phase 3 ◽

Medication Treatment ◽

Everyday Activities ◽

Point Reduction ◽

Calcitonin Gene ◽

Specific Medication

Background Calcitonin gene-related peptide plays an important role in migraine pathophysiology. Erenumab, a human monoclonal antibody that inhibits the calcitonin gene-related peptide receptor, is being evaluated for migraine prevention. Methods In this randomized, double-blind, placebo-controlled, phase 3 study, 577 adults with episodic migraine were randomized to placebo or 70 mg erenumab; 570 patients were included in efficacy analyses. Primary endpoint was change in monthly migraine days. Secondary endpoints were ≥50% reduction in monthly migraine days, change in acute migraine-specific medication treatment days, and ≥5-point reduction in Physical Impairment and Impact on Everyday Activities domain scores measured by the Migraine Physical Function Impact Diary. All endpoints assessed change from baseline at month 3. Results Patients receiving erenumab experienced −2.9 days change in monthly migraine days, compared with −1.8 days for placebo, least-squares mean (95% CI) treatment difference of −1.0 (−1.6, −0.5) ( p < 0.001). A ≥ 50% reduction in monthly migraine days was achieved by 39.7% (erenumab) and 29.5% (placebo) of patients (OR:1.59 (95% CI: 1.12, 2.27) ( p = 0.010). Migraine-specific medication treatment days were reduced by −1.2 (erenumab) and −0.6 (placebo) days, a treatment difference of −0.6 (−1.0, −0.2) ( p = 0.002). The ≥5-point reduction rates in Migraine Physical Function Impact Diary – Physical Impairment were 33.0% and 27.1% (OR:1.33 (0.92, 1.90) ( p = 0.13) and in Migraine Physical Function Impact Diary – Everyday Activities were 40.4% and 35.8% (OR:1.22 (0.87, 1.71) ( p = 0.26). Safety and adverse event profiles of erenumab were similar to placebo. Most frequent adverse events were upper respiratory tract infection, injection site pain, and nasopharyngitis. Conclusions As a preventive treatment of episodic migraine, erenumab at a dosage of 70 mg monthly significantly reduced migraine frequency and acute migraine-specific medication use. (Funded by Amgen). Trial registration ClinicalTrials.gov, NCT02483585.

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Efficacy and safety of erenumab (AMG334) in episodic migraine patients with prior preventive treatment failure: A subgroup analysis of a randomized, double-blind, placebo-controlled study

Cephalalgia ◽

10.1177/0333102419835459 ◽

2019 ◽

Vol 39 (7) ◽

pp. 817-826 ◽

Cited By ~ 12

Author(s):

Peter J Goadsby ◽

Koen Paemeleire ◽

Gregor Broessner ◽

Jan Brandes ◽

Jan Klatt ◽

...

Keyword(s):

Placebo Response ◽

Preventive Treatment ◽

Episodic Migraine ◽

Prior Treatment ◽

Controlled Study ◽

Study Phase ◽

Acute Migraine ◽

Efficacy And Safety ◽

Double Blind ◽

Specific Medication

Background Erenumab was effective and well tolerated in a pivotal clinical trial of episodic migraine that included subjects both naïve to, and those who had failed, previous preventives. Here we evaluated the efficacy and safety of erenumab (70 mg or 140 mg) versus placebo in the subgroup of patients who had previously failed preventive treatment(s): ≥1 or ≥2 prior failed migraine preventive categories, and in patients who had never failed. Methods Prespecified subgroup analyses evaluated change from baseline to months 4–6 (the primary endpoint of the blinded study phase) in monthly migraine days, achievement of ≥50% and ≥75% reduction in monthly migraine days, and change from baseline in acute migraine-specific medication days. Adverse events were also evaluated. Results Treatment with both doses of erenumab resulted in greater reductions in monthly migraine days at months 4–6 (treatment difference versus placebo [95% CI], never failed subgroup: −0.9 [−1.5, −0.3] for 70 mg and −1.3 [−1.9, −0.7] for 140 mg; ≥1 prior failed medication categories subgroup: −2.0 [−2.8, −1.2] for 70 mg and −2.5 [−3.4, −1.7] for 140 mg; ≥2 prior failed medication categories subgroup: −1.3 [−2.6, 0.0] for 70 mg and −2.7 [−4.0, −1.4] for 140 mg). Similar results were observed in the monthly acute migraine-specific medication days endpoint, and in the achievement of ≥50% and ≥75% reduction in monthly migraine days. For the ≥50% reduction in monthly migraine day endpoint, placebo response in the no prior treatment failed group was 32.6%, in the ≥1 failed treatment 17.5%, and in the ≥2 failed treatments 11.1%. Conclusion Erenumab showed consistent efficacy in episodic migraine patients who had failed prior preventive treatments and was well tolerated across subgroups. The data suggest prior patients with prior treatment failures have lower placebo response rates.

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Abstract 2365: Impact of Socioeconomic Level on Cardiovascular Risk in Ischemic Stroke Patients: The OPTIC Registry

Stroke ◽

10.1161/str.43.suppl_1.a2365 ◽

2012 ◽

Vol 43 (suppl_1) ◽

Author(s):

Pierre Amarenco ◽

Halim Abboud ◽

Julien Labreuche ◽

Antonio Arauz ◽

Alan Bryer ◽

...

Keyword(s):

South Africa ◽

Latin America ◽

Health Insurance ◽

Cardiovascular Risk ◽

Middle East ◽

Rural Area ◽

North Africa ◽

Primary Endpoint ◽

Stroke Patients ◽

Insurance Cover

Background : The impact of socioeconomic factors (SEF) on the risk of future vascular events in stroke patients has been understudied. The Outcomes in Patients with TIA and Cerebrovascular disease (OPTIC) registry included patients in secondary prevention of stroke. Objective : to stratify the risk of vascular event recurrence in patients with cerebral infarction according to presence of PAD, ankle-brachial index (ABI), known coronary artery disease (CAD), involvement of several arterial beds, geographic variations and SEF. Method : Between January 2007 and December 2008, 3635 patients aged 45 years or older were enrolled in the OPTIC registry from 245 sites in 17 countries in the following regions: Latin America (1543 patients), Middle East (1041 patients), North Africa (834 patients), and South Africa (217 patients). PAD was present in 7.8%, ABI in 22%, CAD in 12.8%, and 31.1% were unemployed, 26.2% had less than 2 school years, 23% of patients had no health insurance, 12.8% lived in rural area, 8.4% lived alone, 7.5% did not live in a house/flat. Primary endpoint included vascular death (VD), myocardial infarction (MI) and stroke. Results : During median follow-up of 731 days, 524 patients had at least 1 primary event; 190 patients had VD, 88 nonfatal MI, and 296 nonfatal stroke. The estimated risk of primary endpoint was 15.6% (95%CI, 14.4-17.0%) at 2-year. The risk increased with the number of vascular beds involved from 13.1% to 30.7% (p for trend<0.001). Using patients from Latin America as reference, age-sex-adjusted HR was 1.29 (95%CI, 1.04-1.60) for Middle East, 1.31 (95%CI, 0.90-1.89) for South Africa, and 1.64 (95%CI, 1.32-2.04) for North Africa. The absolute additional risk of having a primary endpoint ranged between, 4.7% for unemployed patients to 17.5% for patients not living in a house/flat. In multivariate analysis, living in rural area, not living in a house/flat, unemployment status, no health insurance cover, and less than 2-years school were associated with an increased cardiovascular risk (all adjusted p<0.004). There was a stepwise increase in the primary endpoint with the number of low SEF ranging from 13% to 62% (adjusted p-value for trend<0.001). Conclusions : vascular risk in stroke patients in North and South Africa, Middle East and Latin America varies not only with the number of arterial beds involved but also with socio-economic variables, particularly poor health insurance cover, not living in a house/flat and low education level

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Efficacy and safety of galcanezumab for prevention of migraine headache in Japanese patients with episodic migraine: A phase 2 randomized controlled clinical trial

Cephalalgia Reports ◽

10.1177/2515816320932573 ◽

2020 ◽

Vol 3 ◽

pp. 251581632093257 ◽

Cited By ~ 1

Author(s):

Fumihiko Sakai ◽

Akichika Ozeki ◽

Vladimir Skljarevski

Keyword(s):

Migraine Headache ◽

Japanese Patients ◽

Episodic Migraine ◽

Secondary Outcome ◽

Controlled Study ◽

Controlled Clinical Trial ◽

Life Questionnaire ◽

Efficacy And Safety ◽

Double Blind ◽

Secondary Endpoints

Objective: This study was designed to assess the efficacy and safety of galcanezumab in comparison with placebo for the prevention of migraine in Japanese patients with episodic migraine. Methods: In this double-blind, placebo-controlled study, which was conducted over 6 months, randomized adult patients received subcutaneous injections of galcanezumab (120 mg n = 115, 240 mg n = 114) or placebo ( n = 230) once monthly. The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days. The key secondary outcome measures were response rates (≥50%, ≥75%, and 100%); the Migraine-Specific Quality-of-Life Questionnaire Role Function-Restrictive score; monthly migraine headache days requiring acute treatment; and Patient Global Impression of Severity (PGI-S). Results: The mean change from baseline in monthly migraine headache days over months 1–6 was significantly ( p < 0.001) greater for the 120-mg galcanezumab dose (−3.60 days) and the 240-mg galcanezumab dose (−3.36 days) compared with placebo (−0.59 days). Both the 120-mg and 240-mg doses of galcanezumab were superior compared with placebo for each of the key secondary endpoints except for PGI-S (only the 240-mg dose was superior). The most commonly reported treatment-emergent adverse events were local injection-site reactions; erythema, swelling, pruritus, and pain were more commonly reported by patients who were treated with galcanezumab than those treated with placebo. Conclusion: The number of monthly migraine headache days was reduced with both doses of galcanezumab, and both doses were safe and well tolerated in Japanese patients with episodic migraine.

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A prospective study to evaluate the efficacy and safety of oral acetyl-L-carnitine (ALC) in treatment of chemotherapy-induced peripheral neuropathy (CPIN).

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.9017 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 9017-9017 ◽

Cited By ~ 4

Author(s):

Yuanjue Sun ◽

Baorui Liu ◽

Ping Liu ◽

Changping Wu ◽

Rongsheng Zheng ◽

...

Keyword(s):

Peripheral Neuropathy ◽

Oral Administration ◽

Primary Endpoint ◽

Side Effect ◽

Karnofsky Performance Status ◽

Performance Status ◽

Controlled Study ◽

Efficacy And Safety ◽

Cancer Related Fatigue ◽

Significant Difference

9017 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a major side effect of many commonly used chemotherapeutic. This side effect of chemotherapy can be debilitating and effective treatment for CIPN remains elusive. Previous studies demonstrated that Acetyl-L-Carnitine (ALC) is effective in attenuating CIPN, controlled study is needed to substantiate ALC’s effect in treatment of CIPN. Methods: This study was designed to evaluate the efficacy and safety of Acetyl-L-Carnitine (ALC) Hydrochloride Enteric-coated Tablet (oral administration) in the treatment of CIPN. It was a prospective, randomized, double-blinded, placebo-controlled and paralleled clinical study (registration No. 2007L03540). Of 239 subjects enrolled in the study (NCI grade 2 or above), 118 subjects received 3g/day ALC orally for 8 weeks and 121 received placebo. Primary endpoint was set as improvement of peripheral neuropathy at least 1 grade and assessment was made in week 4, 8 and 12 after enrollment. Results: In full analyses set (FAS) and per-proposal set (PPS), the peripheral sensory neuropathy was significantly ameliorated in ALC group with 50.5% and 51.6% patients meeting the primary endpoint at week 8 and 12 respectively while only 24.1% and 23.1% of patients in the placebo group at week 8 and 12 respectively (p<0.001 in both sets). Secondary endpoint such as nerve electrophysiological test and Physical Condition Score (Karnofsky performance status, KPS) were also significantly improved in patients with ALC treatment (in FAS, P=0.0463 and P=0.022; in PPS, P=0.0076and P=0.0064, respectively). Cancer-related fatigue was significantly alleviated after ALC treatment in PPS (P=0.0135). Safety: 236 subjects were included in safety assessment and 41 patients experienced 62 adverse events during the course of study. There was no significant difference in AE/SAE incidence between the two groups (P=0.3903). Conclusions: Oral administration of ALC is effective in attenuating CIPN as well as in reducing cancer-related fatigue and improving physical conditions in cancer patients. The treatment of oral ALC is safe and well tolerated.

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Bevacizumab biosimilar and reference bevacizumab in subjects with stage IIIB/IV no squamous non-small cell lung cancer (NSCLC) (STELLA study): Results for the primary endpoint in a confirmatory, double-blind, randomized, controlled study.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e21542 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e21542-e21542

Author(s):

Susana Millan ◽

Dmytro Trukhin ◽

Oleksii Kolesnik ◽

Elena Poddubskaya ◽

Andric Zoran ◽

...

Keyword(s):

Primary Endpoint ◽

Objective Response ◽

Stage Iiib ◽

Study Endpoint ◽

Controlled Study ◽

Primary Study ◽

Double Blind ◽

Study Results ◽

Significant Difference ◽

Secondary Endpoints

e21542 Background: MB02 is a proposed biosimilar of the reference bevacizumab. A multinational, double-blind, randomized, parallel group clinical study (STELLA) is undergoing to confirm clinical similarity between MB02 and bevacizumab in patients with stage IIIB/IV no squamous NSCLC. Methods: Subjects were randomized 1:1 to MB02 or bevacizumab (15 mg/kg) plus chemotherapy (paclitaxel [P] 200 mg/m2 and carboplatin [C] AUC6) on Day 1 of every 3-week cycle for 6 cycles (Week 18) followed by MB02/bevacizumab in blinded monotherapy until disease progression, treatment intolerance, death, patient withdrawal or end of study (Week 52). As primary study endpoint, the efficacy by means of the objective response rate (ORR) evaluated by an independent radiological committee (IRC) was compared between arms at Week 18. Secondary endpoints were Progression Free Survival (PFS) and Overall Survival (OS), safety and immunogenicity (assessed at 18 and 52 weeks). Results: 627 patients were randomized: MB02 (n = 315) and bevacizumab (n = 312). Demographic and baseline characteristics were well balanced between arms. The ORR results were comparable for subjects receiving MB02 or bevacizumab plus P/C. A Risk Ratio (RR) of 1.013 (90% CI: -0.037% to 0.059) and a Risk Difference (RD) of 0.011 (90% CI: -0.037% to 0.059), were within the similarity margin predefined by FDA (0.73, 1.36) and EMA (-12%, +12%) respectively. This ORR assessed by IRC was consistent with the investigator assessment criteria. There was no significant difference between arms for secondary efficacy endpoints (PFS/OS) at week 18. Up to primary endpoint cut-off point, the safety assessment showed no significant differences between MB02 and bevacizumab arms (including the immunogenicity assessment) in terms of nature, frequency and severity of the adverse events (AE), being anaemia and hypertension the most common IMP-related AEs, with a RD between treatment groups < 5%. New signals or observable trends were no reported for MB02-treated subjects. Additional information on the secondary endpoints will be available at week 52 (end of monotherapy period). Conclusions: The statistical analysis executed for ORRs confirm the equivalence of MB02 and bevacizumab, supporting the clinical activity of MB02 treatment. MB02 was well tolerated with manageable AEs in patients with Stage IIIB/IV NSCLC. Clinical trial information: NCT03296163.

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Efficacy and safety of erenumab (AMG334) in chronic migraine patients with prior preventive treatment failure: A subgroup analysis of a randomized, double-blind, placebo-controlled study

Cephalalgia ◽

10.1177/0333102418788347 ◽

2018 ◽

Vol 38 (10) ◽

pp. 1611-1621 ◽

Cited By ~ 44

Author(s):

Messoud Ashina ◽

Stewart Tepper ◽

Jan Lewis Brandes ◽

Uwe Reuter ◽

Guy Boudreau ◽

...

Keyword(s):

Chronic Migraine ◽

Preventive Treatment ◽

Controlled Study ◽

Acute Migraine ◽

Efficacy And Safety ◽

Double Blind ◽

Double Blind Placebo ◽

Safety Issues ◽

Subgroup Analyses ◽

Specific Medication

Background Erenumab was effective and well tolerated in a pivotal clinical trial of chronic migraine. Here, we evaluated efficacy and safety of monthly erenumab (70 mg or 140 mg) versus placebo in the subgroup of patients who had previously failed preventive treatment(s) (≥ 1, ≥ 2 prior failed medication categories) and in patients who had never failed. Methods Subgroup analyses evaluated change from baseline in monthly migraine days; achievement of ≥ 50% and ≥ 75% reduction in monthly migraine days; and change in monthly acute migraine-specific medication days. Adverse events were evaluated for each subgroup. Results Treatment with both doses of erenumab resulted in greater reductions in monthly migraine days (primary endpoint) at Month 3 (treatment difference [95% CI], never failed subgroup: −2.2 [−4.1, −0.3] for 70 mg and −0.5 [−2.4, 1.5] for 140 mg; ≥ 1 prior failed medication categories subgroup: −2.5 [−3.8, −1.2], for 70 mg and −3.3 [−4.6, −2.1] for 140 mg; ≥ 2 prior failed medication categories subgroup: −2.7 [−4.2, −1.2], for 70 mg and −4.3 [−5.8, −2.8] for 140 mg). Similar results were observed in the monthly acute migraine-specific medication days endpoint, and in the achievement of ≥ 50% and ≥ 75% reduction in monthly migraine days. There were no new or unexpected safety issues. Conclusion Erenumab showed consistent efficacy in chronic migraine patients who had failed prior preventive treatments and was well tolerated across subgroups.

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The impact of catheter ablation for patients with asymptomatic atrial fibrillation: subanalysis of kansai plus atrial fibrillation (kpaf) registry

European Heart Journal ◽

10.1093/ehjci/ehaa946.0442 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

M Pak ◽

A Kobori ◽

S Shizuta ◽

Y Sasaki ◽

T Toyota ◽

...

Keyword(s):

Atrial Fibrillation ◽

Catheter Ablation ◽

Primary Endpoint ◽

Hazard Analysis ◽

Secondary Endpoint ◽

Asymptomatic Patients ◽

Significant Difference ◽

Secondary Endpoints ◽

The Impact

Abstract Background Catheter ablation (CA) of atrial fibrillation (AF) for symptomatic patients improves the quality of life and prognosis of patients with heart failure. However, the impact of CA for asymptomatic patients is still controversial. Purpose We aimed to investigate the clinical outcomes of CA of AF for asymptomatic patients compared to those for symptomatic patients. Methods A total of 5,013 patients from the Kansai Plus Atrial Fibrillation (KPAF) Registry who underwent CA were screened. The patients were divided into three groups by type of AF; paroxysmal (PAF), persistent (PEAF) and long standing (LSAF) and the patients in each type of AF were divided into two groups: asymptomatic and symptomatic. The primary endpoint was recurrent supraventricular tachyarrhythmias lasting for more than 30 seconds during follow-up 4 years after CA. The secondary endpoint was a composite of cardiovascular, cerebral, and gastrointestinal events during follow-up 4 years after CA. The incidence of complications related to CA between asymptomatic and symptomatic patients was also evaluated. Kaplan–Meier analysis was employed to estimate the primary and secondary endpoints. The statistical differences in primary and secondary endpoints between asymptomatic and symptomatic patients were evaluated using a log–rank test. The impact of symptom due to AF on the primary and secondary endpoint was evaluated using a Cox hazard analysis. The difference in incidence of complications between asymptomatic and symptomatic patients was evaluated using a chi–square test. Results In this study population, PAF was the most frequent at 64.4%, followed by PEAF (22.7%) and LSAF (13.0%). There were some significant differences in the baseline characteristics between asymptomatic and symptomatic patients in each type of AF. The proportion of male was significantly higher in asymptomatic patients than symptomatic patients in PAF (81.2% versus 67.2%, p<0.001) and PEAF (86.4% versus 74.3%, p<0.001). Left atrial diameter was larger in asymptomatic patients than symptomatic patients only in PAF (40±6mm versus 38±6mm, p<0.001). In all types of AF, there was no significant difference in primary endpoint between asymptomatic and symptomatic patients as follows: 37.5% versus 40.6% (p=0.6) in PAF, 45.2% versus 55.1% (p=0.09) in PEAF and 59.3% versus 63.6% (p=1.0) in LSAF. There was also no significant difference in secondary endpoint between asymptomatic and symptomatic patients: 7.1% versus 6.8% (p=0.7) in PAF, 5.4% versus 8.7% (p=0.3) in PEAF and 4.4% versus 5.1% (p=0.5) in LSAF. In a Cox hazard analysis, the symptom did not affect both of the primary and secondary endpoints in each type of AF. In regard to the incidence of complications related to CA, there was no significant difference between asymptomatic and symptomatic patients in each type of AF. Conclusion CA of AF for asymptomatic patients can be safe and can lead to equivalent outcomes as well as symptomatic patients. Funding Acknowledgement Type of funding source: None

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