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The addition of ipilimumab (Yervoy) to nivolumab (Opdivo) continued to demonstrate clinically meaningful progression-free survival (PFS) improvement over nivolumab monotherapy with no new safety signals observed among patients with microsatellite instability-high (MSI-H) or mismatch repair–deficient (dMMR) metastatic colorectal cancer (mCRC), according to new data from the phase 3 CheckMate 8HW trial (NCT04008030) shared during the 2025 ESMO Congress.¹

At a data cutoff date of April 30, 2025, and a median follow-up of 50.1 months (range, 24.7-67.3), nivolumab plus ipilimumab (n = 171) led to a median progression-free survival (PFS) that was not reached (NR; 95% CI, 55.2-not estimable [NE]) vs 60.8 months (95% CI, 32.8-NE) with nivolumab monotherapy (n = 170; HR, 0.69; 95% CI, 0.48-0.99; P = .0413). However, the prespecified threshold for statistical significance was not met (P < .0383).

The PFS data are consistent with those observed in the first line across all randomized patients by local testing (HR, 0.75; 95% CI, 0.56-1.01). “We believe that the consistency of the benefit is strongly supporting a clinically relevant improvement with the combination over the monotherapy,” Sara Lonardi, MD, chief of Oncology 3 Unit at Veneto Institute of Oncology (IOV) – IRCCS, explained in a presentation of the data.

In an invited discussion of the presentation, Sharlene Gill MD, MPH, MBA, FASCO, professor of medicine at the University of British Columbia, questioned whether the prespecified threshold for statistical significance not being met mattered. “The answer may lie in your perspective.…This is a secondary end point analysis,” she said. “When we look at the clinical magnitude of benefit-a median PFS not yet reached after 50.1 months of follow-up, 13% improvement in 3-year PFS, and a 10% improvement in 4-year PFS-I think we all agree that this is very clinically meaningful.”

How Was the CheckMate 8HW Trial Conducted?

The multicenter, open-label CheckMate 8HW trial included patients with histologically confirmed unresectable or metastatic CRC, who had MSI-H or dMMR status per local testing, no prior treatment with immunotherapy, and an ECOG performance status of 0 or 1. Patients were randomly assigned in a 2:2:1 ratio to receive nivolumab monotherapy (n = 353), nivolumab plus ipilimumab (n = 354), or investigator’s choice of modified folinic acid plus fluorouracil and oxaliplatin (mFOLFOX6) or folinic acid plus fluorouracil and irinotecan (FOLFIRI) with or without bevacizumab (Avastin) or cetuximab (Erbitux; n = 132).²

Patients in the monotherapy arm received nivolumab at 240 mg every 2 weeks for 6 doses, followed by 480 mg every 4 weeks (Q4W) thereafter. In the combination arm, patients received nivolumab at 240 mg plus ipilimumab at 1 mg/kg every 3 weeks for 4 doses, followed by nivolumab at 480 mg Q4W. Treatment continued until disease progression, intolerable toxicity, withdrawn consent, or maximum treatment duration of 2 years was reached. Stratification factors included previous lines of treatment (0 vs 1 vs ≥2) and primary tumor location (right vs left).

The dual primary end points of the trial were PFS per blinded independent central review (BICR) for nivolumab plus ipilimumab vs chemotherapy in the first-line setting and PFS by BICR for nivolumab plus ipilimumab vs nivolumab monotherapy across all lines of treatment. Secondary end points in those with MSI-H/dMMR status included PFS per BICR for the combination vs monotherapy in the first line, objective response rate (ORR) by BICR for the combination vs monotherapy in the first line, overall survival (OS) of the combination vs monotherapy across all lines, and ORR by BICR for the combination vs monotherapy across all lines. Safety was also examined.

What Data Were Previously Reported From CheckMate 8HW?

At a data cutoff date of August 28, 2024, and a median follow-up of 47.0 months (interquartile range, 38.4-53.2), the combination regimen met its co-primary end points among patients with centrally confirmed MSI-H/dMMR mCRC, providing superior PFS compared with chemotherapy in the frontline setting (HR, 0.21; 95% CI, 0.13-0.35; P < .0001) and across all lines of therapy (HR, 0.62; 95% CI, 0.48-0.81; P = .0003).²

In April 2025, the FDA approved the combination of nivolumab and ipilimumab for the treatment of adult and pediatric patients at least 12 years of age with MSI-H or dMMR unresectable mCRC.³ The agency also converted the accelerated approval of nivolumab monotherapy to a regular approval for the treatment of adult and pediatric patients at least 12 years of age with MSI-H or dMMR mCRC who have progressed after fluoropyrimidine, oxaliplatin, and irinotecan. Results from the trial also led to approval of the regimen on a global scale.

At the congress, Lonardi shared results from a preplanned analysis of the final PFS for the combination vs nivolumab alone, as well as the first interim analysis of OS across all lines of therapy.¹

What Additional Efficacy Data Were Observed in CheckMate 8HW?

In the combination arm, the ORR was 73% (95% CI, 65%-79%) vs 61% (95% CI, 53%-79%) in the nivolumab monotherapy arm. Best overall responses in both groups included complete responses (CRs; 35% vs 31%, respectively), partial responses (37% vs 31%), and stable disease (12% vs 19%); progressive disease rates were 11% and 16%, respectively.

“You can see a higher rate of CR and a lower rate of progressive disease,” Lonardi said. “These data are consistent with those observed in all of the randomized first-line patients [identified] per local testing.” The ORRs for those patients were 66% (95% CI, 59%-72%) and 54% (95% CI, 47%-61%), respectively.

The median time to response with the combination was 2.8 months (range, 1.2-38.6) vs 2.7 months (range, 1.2-29.5) with nivolumab monotherapy, and the median duration of response was not reached in either arm.

When looking at OS across all lines in centrally confirmed patients, OS was not reached in either the combination arm (n = 296) or the nivolumab monotherapy arm (n = 286). However, descriptive analyses indicated that OS favored the combination regimen across all lines, with a HR of 0.61 (95% CI, 0.45-0.83). “This is the first time that we have data on OS coming from a randomized trial for a checkpoint inhibitor combination in the setting of MSI-H CRC,” Lonardi noted. With approximately 69% of expected events observed, however, OS data remain immature, she added.

Across all lines of patients, PFS benefit with the combination therapy over the monotherapy was confirmed, with a median PFS that has not yet been reached (95% CI, NE-NE) compared with 44.3 months (95% CI, 22.1-NE; HR, 0.62; 95% CI, 0.48-0.80).

What Was the Safety Profile of Nivolumab Plus Ipilimumab?

Lonardi noted that a higher amount of treatment-related adverse effects (TRAEs) was observed with the addition of ipilimumab; however, globally, the combination regimen was well tolerated with no more than 3% of patients experiencing grade 3/4 toxicity. Moreover, no additional deaths were observed after a longer follow-up for both the combination and monotherapy regimens.

The most common any-grade TRAEs reported in 10% of patients or more across the combination therapy and monotherapy groups included pruritus (24% vs 19%, respectively), diarrhea (21% vs 19%), hypothyroidism (16% vs 11%), asthenia (14% vs 12%), fatigue (13% vs 9%), rash (12% vs 10%), adrenal insufficiency (10% vs 5%), increased alanine aminotransferase level (10% vs 8%), arthralgia (9% vs 6%), and hyperthyroidism (9% vs 6%).

What Questions Remain Regarding Nivolumab Plus Ipilimumab in This mCRC Population?

In her invited discussion, Gill noted that some outstanding questions remain, including:

1. Is there any contribution of chemotherapy in the first-line setting?
2. Is there a proportion of patients who may benefit from PD-1 inhibition alone?
3. Is there are immune-mediated biomarkers that can predict who may benefit from combination therapy vs nivolumab monotherapy?

“This ongoing work is needed to help inform assignment [of therapy],” she said. Lonardi concluded: “These new results in the first line further support [nivolumab plus ipilimumab] as the standard-of-care option in MSI-H/dMMR metastatic CRC.”

References

1. Lonardi S, Lenz HJ, Elez Fernandez E, et al. Nivolumab plus ipilimumab vs nivolumab monotherapy for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): New results from CheckMate 8HW. Presented at: 2025 ESMO Congress; October 17-21, 2025; Berlin, Germany. Abstract LBA29.
2. A combination of nivolumab plus ipilimumab prolongs PFS versus nivolumab alone across all treatment lines in patients with MSI-high or dMMR mCRC. News release. ESMO. February 5, 2025. Accessed October 20, 2025. https://www.esmo.org/oncology-news/a-combination-of-nivolumab-plus-ipilimumab-prolongs-pfs-versus-nivolumab-alone-across-all-treatment-lines-in-patients-with-msi-high-or-dmmr-mcrc
3. FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer. FDA. April 8, 2025. Accessed: October 20, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer

Antiretroviral therapy (ART) regimens dolutegravir plus lamivudine (DTG/3TC) and bictegravir plus emtricitabine and tenofovir alafenamide (BIC/FTC/TAF) demonstrate comparable long-term effectiveness and tolerability in older patients with HIV who are virologically suppressed prior to switching therapy, according to study results presented at IDWeek 2025, held from October 19 to 22, in Atlanta, Georgia.

Researchers conducted a retrospective, real-world chart review across 7 countries to evaluate the effectiveness of DTG/3TC compared with BIC/FTC/TAF in adults aged 50 years and older. Eligible patients were virologically suppressed at baseline and had at least 24 weeks of follow-up after switching to either ART regimen. The index date was defined as the initiation of DTG/3TC or BIC/FTC/TAF.

The analysis included 1144 patients enrolled from the United States (n=326), China (n=221), Spain (n=189), Germany (n=140), France (n=113), South Korea (n=100), and Taiwan (n=55).

Among patients in the DTG/3TC (n=593) and BIC/FTC/TAF (n=551) cohorts, 24.6% and 18.7% were older than 65 years, 32.9% and 34.0% had at least 3 comorbidities, 74.5% and 69.7% were prescribed at least 1 non-ART comedication, and 6.2% and 7.7% had prior virologic failure.

During total follow-up durations of 1463.3 and 1481.9 person-years for the DTG/3TC and BIC/FTC/TAF cohorts, respectively, the incidence rate of virologic failure was identical at 0.07 (95% CI, 0.00-0.14) per 100 person-years, with a single case observed in each group. Approximately 25% of patients had follow-up of 240 weeks or longer. No cases of treatment-emergent resistance were reported in either cohort.

These findings suggest that switching to either the 2-drug or 3-drug ART regimen can maintain durable viral suppression in older, virologically suppressed patients with HIV who often face complex comorbidities and polypharmacy concerns.

Study limitations include the retrospective design and potential variability in regional treatment practices.

The researchers concluded, “In older, virologically suppressed PLHIV [people living with HIV] with age-related comorbidities and comedications, switching to either two-drug DTG/3TC or three-drug BIC/FTC/TAF maintained long-term viral suppression without resistance.”

Disclosure: Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

By Hibah Khaja, PharmD

References:

Fraysse J, Kuretski J, Letang E, et al. The Global REGAL cohort: A retrospective real-world study of the effectiveness and tolerability of the antiretroviral treatment regimens DTG/3TC compared to BIC/FTC/TAF in older persons living with HIV. Presented at: IDWeek 2025; October 19-22; Atlanta, Georgia. Poster 357.

 

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The combination HIV treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; Biktarvy, Gilead) continues to be effective and well-tolerated five years after starting the regimen, according to new data from the BICSTaR trial presented at EACS 2025, in Paris (abstract MeP05.3).

Positive quality-of-life measures also were reported by study participants five years out.

“The five-year outcomes presented at EACS 2025 are consistent with the results observed from multiple phase 3 clinical trials evaluating the treatment responses of people with HIV on Biktarvy,” Gilead spokesperson Brian Plummer told Infectious Disease Special Edition. “In the group of BICSTaR study participants with 5 years of real-world follow-up who were enrolled in Canada, France, and Germany, Biktarvy continued to demonstrate sustained viral suppression, a favorable safety and tolerability profile, and a high barrier to resistance. These benefits were seen in both treatment-naive and treatment-experienced people with HIV who have a high burden of comorbidities.”

A large portion of the study population had comorbidities: 63.6% of treatment-naive participants and 84.1% of treatment-experienced participants. Even so, at five years, 97.9% (47/48) of treatment-naive and 96.8% (306/316) of -experienced participants were virologically suppressed, and in both groups, the median CD4+ cell count and CD4+/CD8+ ratio increased from baseline.

Maintaining Quality of Life

Using the HIV Symptom Index (HIV-SI) and the Short Form Health Survey mental and physical component summary scores (M/PCS) and the HIV Treatment Satisfaction Questionnaire (HIVTSQ), the investigators found the quality-of-life measures remained steady through the study period. At five years, HIV-SI overall bothersome symptom count stayed low. MCS and PCS scores improved from baseline; however, treatment experienced participants saw a small decrease in PCS scores. Finally, HIVTSQ scores were high.

The investigators also reported that changes in metabolic and renal parameters were small.

Low Rates of Adverse Events

Drug-related adverse events occurred in 18.9% (25/132) of naive participants and 14.6% (101/691) of experienced participants, which correlated with regimen discontinuation in 5.3% and 7.7%, respectively. However, the investigators did not find any treatment-emergent resistance.

“The results underscore the importance of patient-reported outcomes as a person-centered approach to HIV research and can help us to better understand the impact on health-related quality of life and specifically, mental health status of people with HIV,” Mr. Plummer told IDSE. “This could help inform treatment strategies for these groups.”

By Meaghan Lee Callaghan

[Mr. Plummer and several of the study investigators are employees of Gilead, the maker of Biktarvy.]

 

Adjuvant treatment with alectinib (Alecensa) elicited a 4-year overall survival (OS) rate of 98.4% for patients with resected, ALK-positive, early stage non–small cell lung cancer (NSCLC), according to an updated analysis of the phase 3 ALINA study (NCT03456076) presented at the 2025 ESMO Congress.

At a median of 48 months of follow-up in the alectinib arm (n = 130) and 47.4 months in the chemotherapy arm (n = 127), the 4-year OS rate was 92.4% in the comparator chemotherapy group; however, 81.7% of patients in this arm had received a subsequent ALK inhibitor after recurrence, including 58.3% who received alectinib. The hazard ratio for OS between the 2 arms was 0.40 (95% CI, 0.12-1.32). The 4-year disease-free survival (DFS) rate was 75.5% with alectinib compared with 47.0% with chemotherapy, and the median DFS was not evaluable (NE; 95% CI, NE-NE) vs 41.4 months (95% CI, 30.6-NE), representing a 65% reduction in the risk of disease recurrence or death (HR, 0.35; 95% CI, 0.23-0.54).

“This slide may give you impression that you are in the wrong room. No, this is not a breast cancer session,” lead investigator Rafal Dziadziuszko, MD, PhD, from the Medical University of Gdansk in Poland, joked when showing the slide for OS. “This is a lung cancer session, which we hoped for, for so many years. This is due to the activity of alectinib, and also activity of ALK inhibitors in post-chemotherapy setting in those patients who relapsed.”

How was the ALINA study designed?

In the ALINA study, patients were randomly assigned 1:1 to receive adjuvant alectinib or platinum-based chemotherapy following the surgical resection of their ALK-positive NSCLC. Alectinib was administered twice daily at 600 mg for 2 years, and chemotherapy was given every 3 weeks for 4 cycles.

Investigator-assessed DFS in the intention-to-treat population (comprising patients with stage IB to IIIA disease), as well as the subgroup of patients with stage II to IIIA disease, served as the primary end point. Central nervous system (CNS) DFS and OS were secondary end points.

Baseline patient characteristics were balanced between the arms, with patients being slightly younger than in other studies of lung cancer. In the alectinib group, 79% of patients were below the age of 65, and 65% were never smokers. The ECOG performance status was 0 (55%) and 1 (45%), and the most common stage at diagnosis was III (53%). N2 status was seen in nearly half of patients (49%), and most had nonsquamous histology (95%). Lobectomy was the most utilized surgical procedure (97%).

Following recurrence, 24 of 31 patients in the alectinib arm (77.4%) and 55 of 60 in the chemotherapy arm (91.7%) received a subsequent therapy. For the chemotherapy group, 81.7% of these treatments were ALK inhibitors, with 61.3% of patients receiving a subsequent ALK inhibitor in the alectinib arm. For alectinib, 29% of patients received subsequent chemotherapy. Radiotherapy was used for 25.8% of those in the alectinib arm following recurrence and for 16.7% in the chemotherapy arm.

What additional data were reported in the long-term ALINA analysis?

For patients specifically with stage II through IIIA disease, the DFS rate at 4 years was 74.5% with alectinib compared with 46.3% with chemotherapy; the median DFS was NE (95% CI, 59.6-NE) and 41.4 months (95% CI, 30.6-67.2), respectively. (HR, 0.36; 95% CI, 0.23-0.56). DFS favored alectinib across all subgroups, including for stages, nodal status, and race, Dziadziuszko noted.

The CNS DFS was also improved with alectinib in the ITT population, with a 63% reduction in the risk of this event occurring with the ALK inhibitor (HR, 0.37; 95% CI. 0.19-0.74). The 4-year CNS DFS rate was 90.4% with alectinib compared with 76.1% with chemotherapy.

“This is an important end point, since ALK-positive disease has a predominance for brain dissemination,” said Dziadziuszko.

Adverse effects were similar to prior assessments of the study, said Dziadziuszko. In the label, the most common adverse reactions were hepatotoxicity, constipation, myalgia, COVID-19, fatigue, rash, and cough.²

“Alectinib continues to demonstrate a robust and durable disease-free survival benefit over chemotherapy, with an HR that is consistently below 0.40, and also benefiting the reduction of risk of CNS recurrence,” Marcello Tiseo, MD, PhD, Department of Medicine and Surgery at the University of Parma in Italy, said during a discussion of the results. “OS data are still immature, but the magnitude and durability of DFS improvement, coupled with a well-tolerated safety profile, reinforce alectinib as a standard of care for resected ALK-positive NSCLC.”

In reference to the OS data, Tiseo proposed more work should be done to examine the duration of therapy, as many of the progression events occurred only after treatment was stopped at 2 years. “The 4-year OS [rate] of [98.4]% and in particular the trend toward improvement in OS despite [most] patients receiving a TKI at recurrence suggests the possibility of curing these patients,” he said.

Based on an earlier assessment of the ALINA trial, the FDA approved adjuvant alectinib for patients with ALK-positive NSCLC in April 2024.² This approval was made under the FDA’s Project Orbis initiative, the Real-Time Oncology Review program, and Assessment Aid, each designed to help expedite impactful treatments for patients. The approval was granted 1 month ahead of schedule.

References

1. Dziadziuszko R, Solomon BJ, Wu Y-L, et al. Updated results from the phase III ALINA study of adjuvant alectinib vs chemotherapy (chemo) in patients (pts) with early-stage ALK+ non-small cell lung cancer (NSCLC). Presented at: 2025 ESMO Congress; October 17-21, 2025; Berlin, Germany. Abstract 1787MO.
2. FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer. FDA. April 18, 2024. Accessed October 20, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-alectinib-adjuvant-treatment-alk-positive-non-small-cell-lung-cancer

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

1. 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.
2. 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

Introduction

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.

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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 ).

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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 ).

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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.

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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).

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.