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PADCEV™ Plus KEYTRUDA™, Given Before and After Surgery, Cuts the Risk of Recurrence, Progression or Death by 60% and the Risk of Death by 50% for Certain Patients with Bladder Cancer Pfizer
IO102-IO103, a cancer vaccine, plus pembrolizumab (Keytruda) yieleded a clinically menaingful improvement in median progression-free survival (PFS) vs pembrolizumab alone in patients with treatment-naïve advanced melanoma, according to results from the phase 3 IOB-013/KN-D18 trial (NCT05155254) presented at the European Society for Medical Oncology Congress 2025.
“These data support the potential benefit of this immune-modulatory cancer vaccine in combination with pembrolizumab for patients with untreated, advanced melanoma,” stated Jessica C. Hassel, MD, in her presentation of the findings at the meeting.
Hassel works in the Department of Dermatology at Heidelberg University, as well as at the National Centre for Tumor Diseases in Heidelberg, Germany.
After a median follow-up of approximately two years, the combination of IO102-IO103 and pembrolizumab improved median PFS by 8.4 months compared with pembrolizumab monotherapy. Median PFS in the experimental arm was 19.4 months (95% CI, 9.7–not reached [NR]) vs 11.0 months (95% CI, 6.0–14.8) for pembrolizumab alone (HR, 0.77; 95% CI, 0.58-1.00; P = .0558). Although the pre-specified statistical significance threshold was not met, the PFS improvement favored the combination regimen across all predefined subgroups.
Among patients with PD-L1–negative disease, the median PFS was 16.6 months with the combination vs 3.0 months with pembrolizumab alone (HR, 0.54; 95% CI, 0.35-0.85).
Additionally, the overall response rate (ORR) was 44.8% in the vaccine arm and 41.2% in the pembrolizumab monotherapy arm.
Safety Findings from the Phase 3 IOB-013/KN-D18 Trial
It was further reported that the combination regimen did not result in an increased frequency of immune-mediated or treatment-related adverse events (AEs) compared with pembrolizumab monotherapy.
Immune-mediated AEs occurred in 34.0% of patients receiving the combination versus 38.4% receiving pembrolizumab alone, and grade 3 or higher treatment-related AEs occurred in 14.5% and 15.6% of patients, respectively. Injection-site reactions related to the vaccine were predominantly reported to be grades 1 and 2 in severity.
IO102-IO103 Mechanism of Action
IO102-IO103, Hassel explained, is an off-the-shelf immune-modulatory cancer vaccine designed to target both tumor cells and immune-suppressive cells within the tumor microenvironment. The vaccine stimulates activation and expansion of T cells against IDO1-positive and PD-L1–positive cells, enhancing antitumor immune activity.
IOB-013/KN-D18 Trial Design, Patient Eligibility, and Additional Efficacy Results
The phase 3 IOB-013/KN-D18 trial enrolled 407 patients with treatment-naïve advanced melanoma across approximately 100 global sites. Patients were randomized 1:1 to receive either subcutaneous IO102-IO103 (85 μg of each component) in combination with pembrolizumab (200 mg intravenously every three weeks; n = 203) or pembrolizumab alone (n = 204) for up to two years.
The primary end point was PFS as assessed by blinded independent central review (BICR) per RECIST v1.1, with a data cutoff of May 30, 2025. Secondary end points included overall survival (OS), ORR by BICR, duration of response (DoR), and safety. Vaccine-specific immune response in peripheral blood mononuclear cells served as an exploratory end point.
Eligible patients had unresectable stage III or metastatic stage IV melanoma, measurable disease, and an ECOG performance status of 0 or 1. Prior adjuvant or neoadjuvant therapy was permitted if the last dose occurred more than six months before study entry. Patients with stable central nervous system (CNS) disease were eligible.
Baseline demographics and disease characteristics were balanced between treatment arms. The median age was 71 years (range, 59-78) in the combination arm and 69 years (range, 60-78) in the pembrolizumab-alone arm. Most patients were male (combination, 67.0%; pembrolizumab-alone, 58.8%) and had cutaneous melanoma (86.2%; 85.3%). PD-L1 positivity was observed in 63.5% and 62.3% of patients in the respective arms.
According to ClinicalTrials.gov, the trial began in May 2022, reached its primary completion in May 2025. The study is expected to conclude in September 2027.
References
Hassel, JC, Arance, AM, Carlino, MS, et al., LBA53 – IO102-IO103 cancer vaccine plus pembrolizumab for first-line (1L) advanced melanoma: Primary phase III results (IOB-013/KN-D18). Presented at the European Society for Medical Oncology (ESMO) Congress 2025; October 17-21, 2025; Berlin, Germany. Abstract LBA53.
IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18), clinicaltrials.gov., accessed Oct. 20, 2025; https://clinicaltrials.gov/study/NCT05155254
EU countries have spent €56 billion of a huge pandemic stimulus package on research and innovation, a new report shows. But investments have differed widely, with some science laggards barely spending any on research.
Countries had to draw up plans in line with EU green and digital priorities on how they would spend this money and, in the end, 8.6% of it has gone towards research and innovation, a new report from the European Commission shows.
Secondary prevention of coronary heart disease (CHD) aims to prevent recurrent coronary events following a clinical diagnosis [,]. High adherence to secondary prevention interventions, particularly aggressive lifestyle modifications and evidence-based pharmacotherapy, can substantially reduce the incidence of recurrent coronary events []. However, cardiac rehabilitation and secondary prevention programs, typically conducted during outpatient visits, have been underutilized due to challenges such as low accessibility and limited availability, especially in China [-]. Moreover, effective self-management of cardiovascular risk factors by patients is often challenging without structured support. The INTERASPIRE study [] revealed inadequate implementation of guideline standards for secondary prevention within the first year of post-CHD hospitalization, highlighting geographic disparities. In the Chinese cohort, only 36.1% achieved the blood pressure target (<130/80 mmHg), 46.4% met the LDL-C goal (<1.4 mmol/L), and 46.9% attained glycemic control (HbA1c <7.0%). Among those who were smokers at hospitalization, 60.4% continued smoking at follow-up interviews. Participation in cardiac rehabilitation was notably low, reported by only 2% of patients []. Furthermore, the utilization of key classes of evidence-based medications—including antiplatelet or anticoagulant agents, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), and lipid-lowering drugs—was significantly lower among Chinese patients with CHD than among their counterparts in other participating countries [].
Given the escalating burden of CHD coupled with an aging population, there is an urgent need for new and effective intervention strategies aimed at enhancing postdischarge management in patients with CHD []. Despite advancements in percutaneous coronary intervention (PCI), the long-term risk of subsequent cardiovascular events remains elevated among individuals with CHD [], primarily due to poor adherence to secondary prevention strategies and restricted access to follow-up care. Consequently, innovative and effective interventions are critically required to address these challenges in the future.
Emerging technologies, such as web-based remote patient management systems, have demonstrated efficacy in promoting better self-management by providing health education and facilitating interactions between patients and health care providers []. Over the past decade, cardiac rehabilitation and secondary prevention programs utilizing mobile health (mHealth) solutions have been developed, yielding promising results in areas such as medication adherence, smoking cessation, weight loss, physical activity engagement, and health education [,-]. Furthermore, these programs have shown potential in enhancing the risk factor profiles of patients with CHD, while possibly reducing their mortality rates over time []. However, their impact on clinical outcomes, specifically recurrent cardiovascular events and bleeding incidents, has yet to be fully elucidated.
Therefore, we established a multicomponent medical intervention framework on a web-based platform for patients with CHD based on standardized management guidelines. This model has the potential to enhance the existing care workforce by integrating patients’ cardiovascular health information and facilitating digital communication between healthcare professionals and patients. We hypothesized that these interventions would be more effective in improving clinical outcomes than usual care alone in patients with CHD. To test this hypothesis, we conducted a single-center, open-label, randomized trial.
Methods
Study Design and Participants
This study was conducted at The First Affiliated Hospital of the University of Science and Technology of China (USTC), a prominent tertiary hospital located in Anhui Province, China. Patients were included if they met all the following inclusion criteria: (1) aged between 18 and 79 years (inclusive); (2) presented with clinical manifestations consistent with CHD and successfully underwent PCI; (3) signed an informed consent form, demonstrated the ability to complete follow-up visits, and arrived at the hospital independently; and (4) possessed proficiency in using smartphones and WeChat, a widely used social interaction application in China.
Patients who met any of the following exclusion criteria were not eligible for participation: (1) inability to use the smart management system; (2) New York Heart Association (NYHA) functional class IV; (3) experiencing unstable conditions or complications post-PCI during their current hospitalization; (4) having cardiovascular diseases such as stroke, heart failure, or severe arrhythmias (eg, high-degree atrioventricular block or ventricular tachycardia) within the past three months; (5) having chronic renal insufficiency (creatinine >265 µmol/L); (6) women who are pregnant or breastfeeding; (7) presenting other contraindications for trial participation including thyroid disease requiring medication, acute infectious diseases, psychiatric disorders, psychological conditions, or a history of tumor disease within five years; and (8) having a spouse already enrolled in this study.
All participants were required to possess at least one personal smartphone equipped with an active WeChat account, a widely used social interaction platform in China, and to demonstrate adequate proficiency in the Chinese language to communicate effectively with healthcare providers via WeChat.
For all eligible patients, recruitment and written informed consent were obtained by clinical research coordinators prior to hospital discharge. Subsequently, an independent research coordinator, who was not involved in recruitment, performed the randomization. Using a centralized, computer-generated schedule created with SPSS (version 29.0; IBM Corp), participants were allocated in a 1:1 ratio to either the intervention group (which received remote patient management plus usual care) or the control group (which received usual care only). This process ensured allocation concealment, meaning the recruiting investigators were blinded to the group assignment.
Ethical Considerations
This study was approved by the Ethics Committee of The First Affiliated Hospital of the University of Science and Technology of China (Approval No. 2022-ky233) and registered with the Chinese Clinical Trial Registry (ChiCTR2200065344). All participants provided written informed consent prior to enrollment. All participants were informed of their right to withdraw from the study at any point. No financial compensation was offered to avoid coercion; telemedicine services were provided free of charge as part of the research intervention.
All data collection, storage, and transmission procedures were conducted in strict compliance with the key data protection and privacy laws of the People’s Republic of China [-]. These relevant laws and regulations mandate informed consent, data minimization, encryption, and access control to safeguard participants’ personal and medical information. Only authorized study personnel had access to deidentified data, and no third-party commercial use was permitted.
Treatment
The treatment strategy and stenting techniques used during hospitalization were determined at the discretion of the attending physician. Following PCI, lifelong aspirin therapy was recommended, and P2Y12 antagonists (either clopidogrel or ticagrelor) were prescribed for a duration of one year. Long-term statin therapy was also recommended. The decision regarding the use of other medications, such as beta-blockers, angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), or angiotensin receptor neprilysin inhibitors (ARNIs), was made by the physicians responsible for patient care.
Usual Care
Before hospital discharge, the standard care provided by ward nurses included guidance on lifestyle modifications and self-management strategies, as recommended for patients with CHD by contemporary clinical guidelines [-]. At 1, 3, 6, and 12 months post-discharge, all participants received follow-up calls from health care providers. During these telephone interviews, self-reported information regarding clinical events, symptoms, management of cardiovascular disease risk factors, and prescribed medications was collected. Patients assessed to be at high risk were advised to seek further consultation at their local hospital’s outpatient clinic during follow-up calls. All patients received standard care throughout the study.
Telemedical Interventional Management
Telemedical interventional management was facilitated through our web-based management platform developed in collaboration with the hospital and Xunfei Healthcare Technology Co. Ltd. (Xunfei Healthcare) to enable remote interventions. The platform () provided health care providers with access to comprehensive cardiovascular health information for patients, including hospitalization records, medications, and laboratory results from their current admission. This access allowed for more informed decision-making regarding diagnosis and ongoing management.
Figure 1. Workflow of the telemedicine platform for post-discharge management. AI: artificial intelligence.
Additionally, the platform offered educational resources and tools aimed at empowering patients to self-manage their conditions while regularly overseeing chronic disease follow-up, supervision, medication reminders, and consultations for most patients. This functionality enabled individuals to engage with personalized self-learning health management materials tailored to their specific conditions and receive precise recommendations for lifestyle modifications ( and ).
Figure 2. 90-day post-discharge care pathway for coronary heart disease patients undergoing percutaneous coronary intervention.
The digital platform also dispatched automated follow-up questionnaires (as illustrated in ), designed to monitor patients’ adherence to medication regimens, lifestyle choices, and clinical events, which are particularly critical for poststent patients. For older adults or less technologically adept individuals (eg, those experiencing difficulties using WeChat) who did not respond to these follow-up questionnaires, data collection was supported through Intelligent Language Tracking and Follow-Up.
Patients in the intervention group were encouraged to seek guidance on lifestyle modifications, symptom management, medications, vital sign monitoring, including heart rate, blood pressure, weight changes, mood assessments, and physical activity tracking ( and ). Artificial intelligence (AI) capabilities were available on the platform to address inquiries related to general diseases and rehabilitation knowledge (); however, questions specifically concerning cardiovascular disease diagnosis and evaluation were addressed by qualified health care professionals. Only patients randomized to the intervention group received telemedical intervention management services.
Personnel Roles in Telemedical Management
The telemedical intervention was performed by a multidisciplinary team with clearly defined roles. The responsibilities of the personnel involved in delivering the telemedical intervention were as follows:
Acted as primary contacts for patients
Monitored patient data
Triaged inquiries
Addressed questions regarding vital signs, medications, physical discomfort, and general health knowledge
Escalated complex cases to clinicians
Coordinated follow-ups, reminders, and educational materials
Provided expert nursing guidance
Responded to clinical nursing inquiries
Reinforced patient education, and supported health managers
Offered physician consultations
Addressed complex clinical queries, including diagnosis, symptom evaluation, test results, and medical adjustments
Made clinical recommendations
Reviewed escalated cases
Remained available for urgent consultations during daytime hours
Ensured the appropriateness of AI-driven clinical decisions
Outcome
The primary outcome was a composite of major adverse cardiac or cerebral events (MACCE), a composite of cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), or stroke, assessed during the 1-year follow-up after randomization.
Secondary outcomes included (1) all-cause death, (2) non-cardiac death, (3) stent thrombosis, (4) the first unplanned heart failure or angina hospitalization, (5) bleeding as defined by the Bleeding Academic Research Consortium (BARC) definition [], (6) smoking and drinking status, (7) office blood pressure, and (8) adherence to cardioprotective medication. All secondary outcomes were assessed at the one-year follow-up after randomization.
Cardiac death was defined as any death with a clear relationship to underlying coronary heart disease (including sudden, unobserved, and unexpected deaths). Noncardiac death was defined as any death in which the primary cause was clearly related to another condition (eg, trauma, cancer, or suicide). MI was defined according to the Fourth Universal Definition of Myocardial Infarction []. TVR was defined as the performance of either second PCI or coronary artery bypass grafting (CABG) due to restenosis at the target lesion or any segment of the same major coronary artery. Stroke was defined as a new focal neurological deficit lasting >24 hours, confirmed by neuroimaging and adjudicated by neurologists. Both ischemic and hemorrhagic strokes were considered endpoints, and adjudication was required to differentiate between the two types. Stent thrombosis was defined for additional analyses based on the modified Academic Research Consortium (ARC) definitions []. Only definite stent thrombosis was considered an endpoint in this study.
All MACCE and bleeding events were reviewed by an independent Clinical Endpoint Committee (CEC) comprising cardiologists, neurologists, and interventionalists blinded to treatment allocation.
Estimated Sample Size
The sample size was determined based on a comparative analysis of the incidence rates of cardiovascular events following one year of treatment in prior studies [,]. We postulated that the rate of MACCE in the usual care group would be 6.5% at one year, with an anticipated reduction of this rate by 40% due to remote patient management. Assuming a two-sided alpha level of .05 and a statistical power of 80%, along with a 1:1 allocation ratio between the usual care and remote management groups, we calculated that the required sample size would be 1044 participants per group. After factoring in an estimated attrition rate of 5%, the final sample size was established as 1100 cases per group, resulting in a total study population of 2200 participants.
Statistical Analysis
Primary analysis was performed on the full analysis set (FAS) using an intention-to-treat (ITT) approach. It only included those subjects with data at baseline and set one year as the time span to analyze changes in blood pressure, medication, and lifestyle of these participants at the one-year follow-up visit. SPSS software (version 29.0; IBM Corp) was used for statistical analysis. Categorical variables were described as the number of cases and percentages, and continuous variables were described as the mean and SD or median and IQR. The χ2 test or Fisher exact test were used to compare the count data between groups, and the t-test or Mann-Whitney U-test of nonparametric statistics was used to compare the groups of continuous variables. Kaplan-Meier (K-M) curves were used to estimate the incidence of endpoint events during the follow-up period in both groups. All tests were two-sided, and differences were considered statistically significant at P<.05.
Results
Between November 2022 and June 2023, 2086 inpatients diagnosed with CHD who underwent PCI were enrolled in the study (). The participants were randomly assigned to two groups: the intervention group, which received remote patient management in addition to usual care (n=1040), and the control group, which received only usual care (n=1046). The baseline clinical and laboratory characteristics as well as the use of cardiovascular medications were comparable between the two groups ( and ).
Table 1. Basic clinical and medication characteristics.
Variable
Remote patient management (n=1040)
Usual care (n=1046）
P value
Demographics
Age(y), mean (SD)
62.24 (11.09)
62.00 (10.99)
.61
Sex (Male), n (%)
742 (71.3)
778 (74.5)
.12
Marital status, n (%)
.51
Married
872 (83.8)
888 (84.9)
Divorced/Widowed/Singlehood
168 (16.2)
158 (15.1)
Monthly household income, ¥, n (%)
.16
≤5000
467 (44.9)
506 (48.4)
5000 to <10,000
462 (44.4)
449 (42.9)
≥10,000
111 (10.7)
91 (8.7)
Education, n (%)
.78
Junior high school or less
635 (61.1)
645 (61.7)
High school or higher
405 (38.9)
401 (38.3)
Clinical data
Heart rate, mean (SD)
80.90 (16.97)
79.59 (16.89)
.40
Blood pressure (mmHg), mean (SD)
Systolic
129.90 (19.59)
129.11 (20.85)
.40
Diastolic
79.88 (12.31)
79.79 (12.89)
.93
Distribution of BP, n (%)
Proportion of patients with BP＞140/90 mmHg
356 (34.2)
355 (33.9)
.89
Proportion of patients with BP＞130/80 mmHg
634 (61.0)
612 (58.5)
.25
BMI (kg/m2), mean (SD)
24.82 (3.44)
24.64 (3.46)
.32
Hemoglobin A1c (%), mean (SD)
6.56 (1.38)
6.77 (1.58)
.17
Blood lipids (mmol/L), mean (SD)
Total cholesterol
4.26 (1.71)
4.27 (1.28)
.90
Triglycerides
1.70 (1.08)
1.76 (1.41)
.40
LDL-C(mmol/L)
2.34 (0.96)
2.39 (0.87)
.28
Hemoglobin(g/L), mean (SD)
129.99 (18.42)
131.24 (23.30)
.22
eGFR (ml/min/1.73 m2), mean (SD)
103.54 (34.44)
100.91 (35.08)
.21
LVEF (%), median (IQR)
57.00 (48.00‐66.00)
60.50 (49.00‐67.00)
.15
Coronary heart disease types, n (%)
.210
STEMI
356 (34.2)
397 (38.0)
NSTEMI
182 (17.5)
159 (15.2)
Unstable angina pectoris
431 (41.4)
429 (41.0)
Stable angina pectoris
71 (6.8)
61 (5.8)
Comorbid conditions, n (%)
Hypertension
678 (65.2)
675 (64.5)
.75
Diabetes
301 (28.9)
287 (27.4)
.45
History of stroke
109 (10.5)
102 (9.8)
.58
Anemia
154 (14.8)
152 (14.5)
.86
Lifestyle, n (%)
Current smoking
316 (30.4)
305 (29.2)
.54
Current drinking
308 (29.6)
290 (27.7)
.34
Discharge medications, n (%)
Aspirin
1021 (98.2)
1023 (97.8)
.55
P2Y12 antagonists
1020 (98.1)
1026 (98.1)
.99
Statins
962 (92.5)
955 (91.3)
.32
ACEI/ARB/ARNI
688 (66.2)
658 (62.9)
.12
Beta-blockers
764 (73.5)
753 (72.0)
.45
aLDL-C: low-density lipoprotein cholesterol.
beGFR: estimated glomerular filtration rate. eGFR was calculated from serum creatinine (sCr) concentration using the Modified Chinese Equation for GFR Estimation: eGFR (ml/min/1.73 m2)=175×(sCr)−1.234×(age)−0.179×(0.79 if the patient is female).
fAnemia was defined as hemoglobin <110 g/L for women or hemoglobin <120 g/L for men.
gCurrent smokers were defined as those who smoked at least one cigarette per day.
hCurrent drinkers were defined as those who drank alcohol at least twice a week for ≥4 consecutive weeks.
iACEI: angiotensin-converting enzyme inhibitor.
jARB: angiotensin II receptor blocker.
kARNI: angiotensin receptor neprilysin inhibitor.
Table 2. Procedural characteristics.
Outcomes
Remote patient management (n=1040)
Usual care (n=1046)
P value
IRA, n (%)
.22
Left main
56 (5.4)
48 (4.6)
Left anterior descending
518 (49.8)
566 (54.1)
Left circumflex
189 (18.2)
166 (15.9)
Right
277 (26.6)
266 (25.4)
Disease extent, n (%)
.11
1-vessel disease
355 (34.1)
335 (32.0)
2-vessel disease
299 (28.7)
345 (33.0)
3-vessel disease
386 (37.1)
366 (35.0)
Average stent number, median (IQR)
2 (1-3)
2 (1-3)
.60
Total stent length (mm), median (IQR)
57 (33-84)
57 (33‐72)
.28
aIRA: Infarction related artery.
Throughout the study, four health managers served as full-time staff members at the telemedical center during daytime hours. Additionally, three registered nurses and three registered doctors were tasked with providing health education and addressing patients’ inquiries throughout their hospitalization and during the online follow-up period.
During the trial, all participants in the intervention group received health materials—either text messages or videos—and follow-up questionnaires were sent to them. Among these patients, 81% (843/1040) reported having read the health messages, while the response rate for the follow-up questionnaire was 68% (708/1040). Furthermore, 46% (479/1040) of the patients made inquiries. The total number of online counseling questions in the remote management group was 1973; notably, AI-generated responses accounted for 39% (770/1973) of these answers. Responses from health managers constituted 53% (1046/1973), whereas those from doctors represented only 8% (157/1973). Specifically, inquiries related to illness and cardiac rehabilitation knowledge comprised 47% (928/1973) of all consultation questions posed, consultations regarding vital signs (such as blood pressure and heart rate) and test reports accounted for 19% (375/1973), medication guidance comprised 14% (276/1973), and queries concerning physical discomfort represented 10% (198/1973).
During the one-year follow-up after discharge, 91 MACCE were recorded: 55 MACCE (5.3%) in the usual care group and 36 MACCE (3.5%) in the remote patient management group ( and ). The difference between the two groups was statistically significant (P=.04). This significance primarily stemmed from a reduction in cardiac death rates (10/1040, 1.0% vs 24/1046, 2.3%, P=.02) and myocardial infarction occurrences (8/1040, 0.8% vs 19/1046, 1.8%, P=.03) within the remote patient management group compared to the usual care group.
Figure 4. Kaplan-Meier curve for the primary composite endpoint (MACCE). HR: hazard risk; MACCE:major adverse cardiac or cerebral events.
Table 3. Adverse events at 1-year follow-up visit.
Outcomes
Remote patient management (n=1040)
Usual care (n=1046)
P value
MACCE, n (%)
36 (3.5)
55 (5.3)
.04
Cardiac death
10 (1.0)
24 (2.3)
.02
Myocardial infarction
8 (0.8)
19 (1.8)
.03
Target vessel revascularization
14 (1.4)
17 (1.7)
.59
Stroke
10 (1.0)
14 (1.4)
.41
All-cause mortality, n (%)
19 (1.8)
29 (2.8)
.15
Non-Cardiac death, n (%)
9 (0.9)
5 (0.5)
.29
First unplanned heart failure or angina hospitalization, n (%)
61 (5.9)
66 (6.4)
.65
Stent thrombosis, n (%)
3 (0.3)
5 (0.5)
.48
Any bleeding, n (%)
96 (9.3)
92 (8.9)
.68
BARC1
54 (5.2)
54 (5.2)
.95
BARC2
36 (3.5)
22 (2.1)
.06
BARC3-5
6 (0.6)
16 (1.6)
.03
aMACCE: major adverse cardiac and cerebrovascular events.
bBARC: Bleeding Academic Research Consortium.
No significant differences were observed in stroke incidence (10/1040, 1.0% vs 14/1046, 1.4%), target vessel revascularization (TVR) rates (14/1040, 1.4% vs 17/1046, 1.7%), stent thrombosis (3/1040, 0.3% vs 5/1046, 0.5%), or noncardiac death rates (9/1040, 0.9% vs 5/1046, 0.5%) between the groups, with all comparisons yielding P>.05.
Furthermore, no significant difference was noted in BARC 1 bleeding events between the groups (54/1040, 5.2% vs 54/1046, 5.2%, P=.95). The remote patient management approach exhibited an increasing trend in BARC 2 bleeding events (36/1040, 3.5% vs 22/1046, 2.1%, P=.06) but demonstrated a reduction in BARC 3‐5 bleeding events (6/1040, 0.6% vs 16/1046, 1.6%, P=.03).
A total of 1021 patients in the remote patient management group and 1017 in the usual care group completed the extended follow-up. During the one-year follow-up period, significant lifestyle changes were observed among the participants (). The follow-up data indicated that the remote patient management group exhibited notable differences compared to the usual care group regarding alcohol consumption (119/1021, 11.7% vs 168/1017, 16.5%, P=.002). Additionally, remote patient management demonstrated a strong trend towards a reduction in smoking rates (114/1021, 11.2% vs 142/1017, 14.0%, P=.06).
Table 4. Changes in blood pressure, medication, and lifestyle factors among participants at 1-year follow-up visit.
Lifestyle change
Remote patient management (n=1021)
Usual care (n=1017)
P value
Current smoking, n (%)
114 (11.2)
142 (14.0)
.06
Current drinking, n (%)
119 (11.7)
168 (16.5)
.002
Blood pressure control achieved
Blood pressure(mmHg), mean (SD)
Systolic
117.74 (13.80)
121.46 (16.85)
.002
Diastolic
73.60 (10.18)
75.72 (10.45)
.02
Distribution of BP, n (%)
Proportion of patients with BP
>140/90 mmHg
123 (12.0)
188 (18.5)
<.001
Proportion of patients with BP
>130/80 mmHg
310 (30.4)
442 (43.5)
<.001
Medication adherence, n (%)
Aspirin
896 (87.8)
858 (84.4)
.03
P2Y12 antagonists
847 (83.0)
812 (79.8)
.07
Statins
810 (79.3)
776 (76.3)
.10
ACEI/ARB/ARNI
489 (47.9)
442 (43.5)
.045
Beta-blockers
533 (52.2)
516 (50.7)
.51
aCurrent smokers were defined as those who smoked at least one cigarette per day.
bCurrent drinkers were defined as those who drank alcohol at least twice a week for ≥4 consecutive weeks.
cAdherence was defined as having medication available to take on ≥80% of the days during the follow-up period (ie, Proportion of Days Covered ≥80%). The Proportion of Days Covered (PDC) for each medication was calculated as the days covered by filled prescriptions divided by the follow-up period from discharge to the last interview, unless therapy was discontinued for ≥3 months. Discontinued medications and approximate discontinuation dates were recorded through interviews and clinical records review.
dACEI: angiotensin-converting enzyme inhibitor.
eARB: angiotensin II receptor blocker.
fARNI: angiotensin receptor neprilysin inhibitor.
In addition, there were significant reductions in both systolic (mean 117.74, SD 13.80 vs mean 121.46, SD 16.85 mmHg, P=.002) and diastolic blood pressure (mean 73.60, SD 10.18 vs mean 75.72, SD 10.45 mmHg, P=.02) in the remote patient management group compared to the usual care group. At the one-year follow-up, the proportion of patients with blood pressure exceeding 140/90 mmHg was 12.0% (123/1021) in the remote patient management group versus 18.5% (188/1017) in the usual care group. Similarly, a lower percentage of patients in the remote patient management group recorded blood pressure readings above 130/80 mmHg at one year (310/1021, 30.4% vs 442/1017, 43.5%). Both between-group differences remained significant (P<.001).
Notably, participants in the remote management group demonstrated higher adherence rates to cardioprotective medications, such as aspirin (896/1021, 87.8% vs 858/1017, 84.4%, P=.03) and ACEI, ARB, or ARNI (489/1021, 47.9% vs 442/1017, 43.5%, P=.045) after one year of treatment. Furthermore, adherence rates for P2Y12 antagonists (847/1021, 83.0% vs 812/1017, 79.8%, P=.07) and statins (810/1021, 79.3% vs 776/1017, 76.3%, P=.10) also tended to be greater within the remote patient management cohort; however, these differences did not achieve statistical significance. No significant difference was noted in the adherence rates for beta-blockers.
Discussion
Key Findings
Remote medical interventional management demonstrated significant benefits in reducing the incidence of cardiac mortality and myocardial infarction over a one-year study period. Additionally, it led to improvements in BARC 3‐5 bleeding events, blood pressure control, medication adherence, smoking cessation, and reduction of heavy drinking among patients with coronary heart disease following percutaneous coronary intervention.
Our multicomponent interventions delivered through a web-based platform can provide real-time medical guidance to patients, thereby enhancing patient engagement and adherence to chronic CHD management strategies. More importantly, the follow-up period in this trial offers substantial evidence regarding the medium- to long-term clinical effects of technology-assisted cardiac rehabilitation and secondary prevention services on large patient populations.
Significance of Telemedical Interventional Management
Individuals with CHD have a significantly elevated risk of subsequent cardiovascular events, including myocardial infarction, stroke, and cardiovascular mortality [,]. Research indicates that the recurrence rate of acute myocardial infarction can reach as high as 2.5% within one year post-discharge, despite advancements in pharmacological treatments and invasive procedures. Notably, nearly one-third of these recurrent events occur within the first 30 days following discharge; moreover, the one-year mortality rate may be as high as 2.8% [].
Secondary prevention of CHD focuses on preventing recurrent coronary events after clinical diagnosis. High adherence to secondary prevention interventions, particularly active lifestyle modifications and pharmacotherapy, can lead to a substantial reduction in recurrent coronary incidents. International guidelines strongly endorse evidence-based secondary prevention strategies aimed at mitigating these risks through proven pharmacological therapies, optimization of cardiovascular risk factors, cardiac rehabilitation programs, and strict adherence to dietary and physical activity recommendations []. Consequently, long-term follow-up management of patients with CHD after discharge is essential []. However, poor treatment adherence and low control rates of cardiovascular risk factors remain prevalent in this patient population [, ]. This situation often arises from insufficient engagement with outpatient services due to inadequate coordination, communication barriers, or limited access []. Therefore, innovative and scalable strategies, such as telemedicine, are urgently needed to bridge the gap in post-discharge care and improve the implementation of guideline-directed secondary prevention.
Efficacy of Telemedical Interventional Management
Secondary prevention in CHD has undergone significant advancements with the introduction of telemedical technologies, which provide innovative and flexible approaches to care. A study involving patients who experienced acute myocardial infarction revealed that those who participated in a digital telerehabilitation intervention demonstrated markedly improved self-health management and a 52% reduction in the risk of readmission within 30 days postdischarge []. The SMART-CR/SP (Smartphone and social media-based cardiac rehabilitation and secondary prevention in China) study [] used smartphones to deliver remote cardiac rehabilitation and secondary prevention guidance services for patients following PCI for CHD. The findings indicated that smartphone-based remote cardiac rehabilitation and secondary prevention significantly enhanced exercise capacity, knowledge of cardiovascular disease prevention and control, blood pressure regulation, heart rate management, lipid control, and adherence to secondary prevention medications among patients with coronary artery disease. Similarly, a recent meta-analysis [] further illustrated that telemedical interventional management effectively reduced both readmission rates and out-of-hospital mortality in individuals experiencing acute coronary syndromes.
This study extends previous observations by demonstrating that web-based remote patient management is a viable and effective enhancement to standard secondary prevention, significantly improving hard cardiovascular outcomes and reducing major bleeding complications. Several mechanisms might underlie these benefits.
First, our data demonstrated promising effects on medication adherence and the modification of risk factors, including changes in blood pressure and cessation of smoking and alcohol consumption, within this large cohort study. Our findings align with the existing literature. Numerous trials have indicated that remote telehealth interventions play a significant role in reducing cardiovascular risk factors and enhancing adherence to lifestyle modifications, such as medication compliance [,], smoking cessation [], and blood pressure management[,,]. Effective management of these risk factors has been shown to decrease the incidence of coronary disease complications, myocardial infarction, and overall mortality [,].
Second, remote patient management transcends the basic concept of patient monitoring and encompasses a comprehensive array of interventions pertinent to patient care. This includes patient education, concurrent medication management, assessment of comorbidities, and personalized recommendations []. In our study, participants in the intervention group were afforded the opportunity to access educational resources and consult healthcare providers remotely. Health care professionals can deliver customized educational materials, guidance on lifestyle modifications, and self-management strategies through various platforms. These additional components of remote patient management likely played a significant role in contributing to the observed benefits in our trial.
Third, the telemedicine platform can provide a supportive environment for patients to ask questions, seek clarifications, and receive guidance on effectively managing their conditions. In cardiovascular emergencies, telemedicine can facilitate timely consultations and advice for individuals experiencing abnormalities. Our study revealed that remote patient management was associated with an increased risk of BARC 2 bleeding events (bleeding is classified as minor if it falls under BARC 1‐2 and considered major or fatal if it involves BARC 3‐5 []. Specifically, BARC 1 bleeding occurs when the patient does not seek treatment, whereas BARC 2 bleeding necessitates intervention or hospital admission []. However, patient adherence to bleeding management protocols and antiplatelet treatment strategies may also contribute to preventing the exacerbation of bleeding episodes. Consequently, this has led to a reduction in the incidence of BARC 3‐5 bleeding events. Similarly, online consultation platforms enable health care providers to promptly assess medical risks and offer immediate recommendations to patients with CHD experiencing chest pain (angina), heart failure, or other serious coronary symptoms. These platforms guide patients or caregivers on the appropriate actions to take prior to reaching a healthcare facility. This approach has the potential to enhance outcomes and decrease mortality rates in critical situations [].
Overall, web-based remote patient management empowers individuals to assume a more proactive role in overseeing their cardiovascular health, while simultaneously enabling health care professionals to provide personalized and timely care.
Strengths and Limitations
Our study has both strengths and limitations. This study was a relatively large-scale investigation with a cohort of 2086 patients followed for one year. It primarily focused on evaluating the feasibility, acceptability, and impact of remote management in CHD. To our knowledge, this is the first study to assess the effects of remote health management on bleeding outcomes in patients with CHD following PCI. Additionally, we conducted an in-depth analysis of the determinants and patterns of remote health management. This not only has significant clinical implications but also contributes to establishing a framework for the remote management of patients with CHD.
Our study has certain limitations in the following aspects. First, the findings may not be universally applicable across all cultures, as they are specific to the Chinese context; patients from different cultural or geographic backgrounds may exhibit entirely distinct healthcare management practices. Second, data on several indicators relevant to the development of CHD, such as patients’ lipid levels, glycated hemoglobin, and BMI, were not collected during the follow-up consultations. Consequently, we were unable to discuss the changes in these values. Fortunately, previous studies have provided evidence supporting the association between reduced cardiovascular risk and telemedicine interventions [,,]. Third, some data regarding lifestyle changes and medication adherence were based on self-reports from patients, which could have introduced recall bias. Fourth, although we employed a multi-component intervention design, we could not precisely assess the independent contributions of each component or elucidate the mechanisms that effectively capture change. Finally, although our study demonstrated the benefits associated with telemedicine interventions, air pollution factors were excluded from our analysis. Strong evidence indicates that exposure to PM₂.₅ independently increases recurrent cardiovascular risk in patients with CHD []. The absence of regional air quality data and individual exposure assessments hindered our ability to evaluate the potential confounding effects on MACCE outcomes.
Future Directions
Future studies are recommended to further elucidate the efficacy of telemedical interventional management systems by enhancing the following aspects: First, researchers may incorporate objective measures, such as electronic adherence monitoring, pharmacy refill records, and wearable-derived vital signs, to mitigate self-report bias. Second, they should prospectively collect longitudinal data on risk factors (including lipids, HbA1c, hepatic and renal function, BMI, diet quality, physical activity, and household air pollution) to clarify potential mediators. Third, it is advisable to use study designs that isolate component effects—such as factorial or Sequential Multiple Assignment Randomized Trials—which require predefined component and mediation analyses. These analyses would explore deeper associations among various intervention components and identify the factors that play a pivotal role in enhancing patient prognosis. Finally, researchers can assess generalizability and durability through multicenter studies conducted in diverse geographic and cultural contexts. Additionally, they should routinely capture post-12-month platform engagement metrics to inform long-term optimization efforts.
Conclusion
In this randomized controlled trial, we compared a comprehensive telemedical interventional management system with usual care in patients with CHD. The telemedicine group exhibited a significant reduction in the composite incidence of MACCE, primarily attributed to the lower rates of cardiac death and myocardial infarction at one year. Additionally, improvements were noted in bleeding events (BARC 3‐5), as well as in the control over systolic and diastolic blood pressure, medication adherence (including aspirin and ACEI, ARB, or ARNI), and alcohol consumption. These findings suggest that telemedical interventions can effectively enhance secondary prevention outcomes in patients with CHD following PCI. Future multicenter studies are warranted to validate these results and optimize the telemedicine frameworks for broader clinical implementation.
We would like to thank Xunfei Healthcare Technology Co., Ltd. chief executive officer (Xiaoliang Lu) and members (Shenbo Qiao, Nefei Ma, Ershan Wu) who have contributed to the design and implementation of the telemedicine platform, and the health managers (Shanshan, Li , Min Liu, Yingying, Huang, Yaohui, Wang) who participated in the success of post-diagnosis management structure for patients with coronary artery disease, disease tracking and management, and patient counseling. This study was supported by the Joint Fund for Medical Artificial Intelligence (MAI2022Q013 and MAI2022Z001), Anhui Science and Technology Breakthrough Plan (Grant No.202423k09020030), Research Funds of Centre for Leading Medicine and Advanced Technologies of IHIM(2023IHM01063), and China Heart House-Chinese Cardiovascular Association HX fund (2022-CCA-HX-077).
The datasets used in the current study are available from the corresponding author upon reasonable request. Further inquiries should be directed to the corresponding authors.
None declared.
Edited by Andrew Coristine; submitted 17.Jun.2024; peer-reviewed by Jing Yang, Long Cheng, Lukasz Kuzma; final revised version received 02.Sep.2025; accepted 12.Sep.2025; published 20.Oct.2025.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research (ISSN 1438-8871), is properly cited. The complete bibliographic information, a link to the original publication on https://www.jmir.org/, as well as this copyright and license information must be included.
Stocks including Tesla , Netflix and General Motors are among the largest companies in the market that could see sharp swings this week on the back of their quarterly earnings reports. Earnings are revving up this week, and investors are keeping a close eye on results that could be the catalyst to keep markets churning higher. After the first week of the third-quarter earnings season, 76% of the 58 companies in the S & P 500 that have posted results so far have beaten earnings expectations, exceeding the first-week average of 68% and slightly higher than last quarter’s 73% figure, according to Bank of America. Looking at forecast moves based on options market pricing, CNBC Pro screened for companies whose stocks could see large losses or gains this week after reporting results. Take a look below for the list of stocks with strong potential moves ahead: Netflix, up 40% this year, reports results Tuesday after the market closes, and could see shares move 6.9% as a result. The stock rallied nearly 4% in Monday trading. Bernstein Research analyst Laurent Yoon said that Netflix’s mixed second-quarter results have led to “muted investor sentiment” throughout the third quarter and kept shares range bound between $1,150 and $1,250. “We remain generally positive on the upcoming print and full-year outlook, though an overhang persists around Netflix’s need to further diversify its content portfolio,” Yoon wrote in a Monday note to clients. His $1,390 price target on dominant streaming platform suggests the stock can gain about 12.6% from its last close of $1,199.36 per share. Tesla, which has lagged the market with a less than 10% year-to-date advance, is also likely to react to earnings. Shares of the electric vehicle maker and robotics company, could swing 7.1% in either direction after reporting results on Wednesday. Ahead of the report, Wedbush reiterated an outperform rating on Tesla and said Elon Musk’s flagship company “will report its FY3Q25 earnings with incremental positivity around this quarter’s results with the deliveries beat led by some pull-forward EV demand (U.S. tax credit ending) and a relative bounce back in China sales.” Tesla revenue in the second quarter weakened for a second straight three-month period, as sales continued to suffer from increased EV competition. In the third quarter just ended, Tesla is expected to post a year-over-year earnings decline of more than 20%, according to FactSet. TSLA 1Y mountain Tesla stock performance over the past year. General Motors, Intel and semiconductor equipment maker Lam Research , and air carriers American Airlines and Southwest Airlines are also likely to see wide swings based on what the options market is saying. Intel has an expected move of 10.1% in either direction — one of the largest in the screen — on the back of its report due Thursday. Shares of Intel have nearly doubled in 2025, soaring 65% in just the past three months, after the Trump administration took a 10% stake in the chipmaker in August and Nvidia said in mid-September it will invest $5 billion in Intel in a deal to co-develop data center and PC chips. Although momentum has been strong leading up to the earnings report, Intel shares declined after its last three earnings releases, including an 8% drop following its second-quarter print.
Netflix has been largely left behind by the rest of the market this summer, yet Wall Street believes that the streaming giant has what it takes to rev higher again. The stock is up a mere 2.8% over the past three months, while the S & P 500 is up 7% in that time. Alphabet , which owns YouTube, has soared 38% in that time. This underperformance may seem counterintuitive, considering that Netflix just had its biggest hit in “KPop Demon Hunters” over the summer. In August, the movie marked Netflix’s first No. 1 box-office title ever . Sell-side analysts and investors think the stock will soon get out of it summer doldrums. “For a company and a stock that has done so well over five or 10 years, the question is, is it over? And I think what we’ll see is the company continues to execute and grow,” said Ken Leon, CFRA director of equity research. Leon currently has a strong buy rating on the stock. NFLX YTD mountain NFLX YTD chart Left behind, but why? Several factors may have conspired against the streaming stalwart. For one, investors may have left Netflix behind to chase high-flying artificial intelligence stocks, according to Accuvest Global Advisors portfolio manager Eric Clark. Chipmaker AMD has soared more than 50% over the past three months. Intel is up a whopping 65%. Meta Platforms and Nvidia have gained 3.7% and 6.8%, respectively, also outperforming Netflix. “Right now, it’s just a good time to remind yourself that this is a really good business with really good scale that still has good growth opportunities,” Clark told CNBC, calling Netflix a “staple of life.” “The market isn’t rewarding that kind of thing right now, but it will. It always does.” Uncertainty around the company’s subscription numbers may also be keeping the stock in check. Netflix this year stopped disclosing quarterly subscriber numbers, a move by the company to force investors to judge it by other metrics such as revenue and time spent on the platform. Still, this change could be “bringing a little bit more anxiety” leading into the quarterly reports, said Paul Meeks, head of technology research at Freedom Capital Markets. He also noted some on the Street may be worried that the recently merged Paramount Skydance could pose a meaningful threat, potentially weighing Netflix down this summer. “Maybe, after all these years, we’re going to get a legacy media company that can actually compete with Netflix — but I’ll believe it when I see it,” Meeks said to CNBC. Looking ahead, investors and analysts pointed to several positive drivers for the stock, including the company’s upcoming third-quarter earnings report. Content is king Netflix is set to post earnings Tuesday after the bell. Analysts from UBS, Wells Fargo, Bernstein and KeyBanc Capital Markets all reiterated their positive stances on the stock heading into the print, pointing to a strong content slate as a catalyst to further drive subscriber retention and engagement. All four of those firms have buy or overweight-equivalent ratings on the stock. The buyside is just as bullish. The company’s content pipeline “should result in strong subscriber metrics, accelerating revenue growth and expanding operating margins,” Nancy Tengler, CEO and CIO of Laffer Tengler Investments, said to CNBC over email. Meeks of Freedom Capital described this pattern of strong content driving more subscribers and, in turn, more revenue as a “virtuous cycle” for the company. CFRA’s Leon also applauded Netflix’s history of strong revenue growth, widening margins, free cash flow generation and cost discipline as successful factors in supporting its high valuation. But one of the key growth opportunities for Netflix going forward comes from live events — specifically sports. This could include streaming NFL, NBA and MLB games, among others. The Athletic reported late last month that Netflix would stream the New York Yankees against the San Francisco Giants on opening day of the 2026 season next year. Netflix also set a streaming record last year with its slate of Christmas Day NFL games. “The sports market is huge, and people are dying for a video streaming alternative to ESPN,” Meeks said. “ESPN with their brands, they’ll be the lead — but there’s a big, big opportunity for Netflix to get big into live sports, and they’ll do it.” Wells Fargo analyst Steven Cahall noted last week that the NFL could be Netflix’s next big boon. He said the company could pull away some Sunday afternoon games from CBS and Fox “to create a new national streaming window. … This could yield another $3bn in annual NFL media rights fees, and could also be the sort of package that NFLX is saving room for.” Advertising revenue will be another big growth driver for Netflix, with Tengler pointing to the streamer’s recently inked brand and marketing partnership with AB InBev as evidence of the company’s future prospects. Meeks added that Netflix’s lower-cost subscription tier that includes advertisements has helped cement its status as an ad-supported company, rather than one totally dependent on subscriber fees. From a competitive standpoint, Leon said that Netflix appears to be holding its own against other video streamers. With Disney+ having recently raised its prices, Netflix’s base offering is now 50% cheaper, Tengler said, although she expects Netflix to in turn raise its subscription fees next year. Meeks and Leon also respectively nodded at Netflix’s crackdown on password sharing and its growing podcast business as other potential tailwinds. Accuvest’s Clark added that while Netflix is by no means a traditional AI play, the stock could “absolutely” be considered an AI beneficiary. Already, the company has been using AI in its content creation and to help boost user engagement and personalization with its massive catalogue, he said. Where to from here? How Netflix stock reacts to its third-quarter earnings release remains to be seen. But Meeks said that if shares of Netflix continue to stagnate — or weaken — it will be a better buy for his clients. A “decent place to buy” the stock would be around the $1,150 mark, Meeks said. This would be approximately 4% below where the stock closed on Friday at $1,199.36. But should the price go below $1,107 — Netflix’s 200-day moving average — Meeks said that he’d “probably buy it with both hands.” “The last time the stock went below the 200-day support was 2022, and it was only briefly,” he noted. NFLX 5Y mountain NFLX 5Y chart Over the next 12 months, Leon believes that shares of Netflix could reach $1,485, signifying an upside of 24% ahead. Clark’s price target of between $1,500 and $1,600 implies even greater gains going forward, with the higher end of his range corresponding to a 33% rally. ( Learn the best 2026 strategies from inside the NYSE with Josh Brown and others at CNBC PRO Live. Tickets and info here . )
Brazil’s Petrobras has been given permission to drill for oil near the mouth of the Amazon River, casting a shadow over the country’s green ambitions as it prepares to host UN climate talks.
Luiz Inacio Lula da Silva, the president, has come under fire from conservationists who argue his oil expansion plans clash with his image as a global leader on climate change.
Brazil will host Cop30 climate talks in the Amazon city of Belem next month.
Petrobras said drilling in the Foz de Amazonas region will begin immediately and will last for five months, after its five-year battle to get permission to explore the area.
“Petrobras met all the requirements established by (environmental watchdog) Ibama, fully complying with the environmental licensing process,” the oil giant said in a statement sent to AFP.
“We hope to obtain excellent results from this research and prove the existence of oil in the Brazilian portion of this new global energy frontier,” said Magda Chambriard, president of Petrobras.
The company will drill an exploratory well at an offshore site that lies 500km (310 miles) from the mouth of the Amazon River at a depth of more than 2,800 meters (9,200ft).
The drilling of Block 59 – which is 160 km from the coastline – has been a passion project for Lula, who insists oil revenues will help fund Brazil’s climate transition.
Environmentalists have raised alarm about drilling for oil off the coast of the world’s largest tropical rainforest, a biodiverse area that is home to several Indigenous communities.
Brazil’s Climate Observatory NGO said civil society organizations would go to court to fight the decision, based on “illegalities and technical flaws” in the licensing process.
“The approval sabotages the Cop and goes against the role of climate leader claimed by President Luiz Inacio Lula da Silva on the international stage,” said the Climate Observatory.
“The decision is disastrous from an environmental, climate, and sociobiodiversity perspective.”
Foz de Amazonas is part of a promising new offshore oil frontier, with nearby Guyana emerging as a major oil producer in less than a decade following large offshore discoveries.
Ibama denied Petrobras an exploration license in 2023, citing inadequate plans to protect wildlife in case of an oil spill.
As Petrobras appealed, pressure rose from Lula who said earlier this year that Ibama was a government agency acting as if it was “against the government”.
In February, an opinion signed by 29 Ibama technical staff and seen by AFP said the recommendation remained to “deny the environmental license”, highlighting the risk of “massive biodiversity loss in a highly sensitive marine ecosystem”.
However, in May, Rodrigo Agostinho overruled the opinion and allowed Petrobras to go ahead with an oil spill accident response drill that was considered the last step before the license is granted.
In September, Ibama approved the pre-operational environmental assessment, despite Petrobras failing to demonstrate it can “reliably protect fauna in the event of an oil spill.”
Ibama said a new fauna simulation would take place “after the license is issued.”
Ibama’s technical staff noted in February that drilling conditions were very challenging in the Foz de Amazonas basin, prone to intense storms and strong ocean currents.
