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ISSN: 2766-2276
2025 July 09;6(7):868-875. doi: 10.37871/jbres2140.
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open access journal Opinion

Cracks in the Evidence: Why Studies from COURAGE to ISCHEMIA Failed to Show Benefit of Stenting PCI

Dasaad Mulijono1-3*

1Department of Cardiology, Bethsaida Hospital, Tangerang, Indonesia
2Indonesian College of Lifestyle Medicine, Indonesia
3Department of Cardiology, Faculty of Medicine, Prima University, Medan, Indonesia
*Corresponding authors: Dasaad Mulijono, Department of Cardiology, Bethsaida Hospital, Indoesia E-mail:

Received: 26 June 2025 | Accepted: 05 July 2025 | Published: 09 July 2025
How to cite this article: Mulijono D. Cracks in the Evidence: Why Studies from COURAGE to ISCHEMIA Failed to Show Benefit of Stenting PCI. J Biomed Res Environ Sci. 2025 Jul 09; 6(7): 868-875. doi: 10.37871/jbres2140, Article ID: jbres1757
Copyright:© 2025 Mulijono D, istributed under Creative Commons CC-BY 4.0.
Keywords
  • PCI
  • Chronic coronary syndrome
  • Optimal medical therapy
  • Vulnerable plaque
  • Incomplete revascularization
  • Stent thrombosis
  • Restenosis
  • Drug-coated balloon technology
  • Indonesian healthcare

Percutaneous Coronary Intervention (PCI) with stenting remains widely utilized for managing Chronic Coronary Syndrome (CCS). However, landmark clinical trials such as COURAGE and ISCHEMIA have repeatedly shown no significant advantage of PCI with stenting over Optimal Medical Therapy (OMT). This review critically analyses methodological limitations, including overlooked Vulnerable Plaques (VPs), Incomplete Revascularization (IR), inherent procedural risks, long-term stent complications, and the consistent lack of mortality benefits. Furthermore, unique challenges in translating these international trial results into the Indonesian healthcare context, such as medication adherence issues, quality disparities in interventional practice, and distinct medico-legal pressures, are discussed. Bethsaida Hospital in Indonesia, led by Prof. Dasaad Mulijono, has successfully addressed these limitations through a pioneering integrated approach combining PCI utilizing Drug-Coated Balloon (DCB) technology, rigorous OMT, and a Whole-Food Plant-Based Diet (WFPBD), resulting in exceptional outcomes, including markedly reduced rates of target lesion revascularization (2%), virtually no myocardial infarctions or PCI-related mortalities, and effective management of VPs. Recognizing these limitations and contextual factors is crucial for informed, individualized CCS treatment decisions. If leading Indonesian cardiology centres can replicate and sustain these strategies, stenting PCI in CCS may be justified.

CCS is a significant global health issue typically managed through PCI with stenting, primarily for symptom relief and ischemia reduction [1-5]. Major trials, including COURAGE and ISCHEMIA, have consistently indicated no survival advantage for PCI over OMT. This article critically reviews these findings, identifies key limitations, and contextualizes implications for Indonesia.

Pivotal studies have reshaped CCS management guidelines. COURAGE [6] demonstrated no mortality or Myocardial Infarction (MI) benefit from adding PCI to OMT. BARI 2D [7] found no superiority of routine revascularization over intensive medical therapy in diabetic patients. FAME 2 [8] showed fewer urgent revascularizations but no significant impact on mortality or MI. ORBITA [9] highlighted minimal symptom improvement over placebo, while ISCHEMIA [10] conclusively supported initial OMT over invasive strategies.

Trial Year Population / Focus Key Finding
COURAGE 2007 CCS patients PCI + OMT showed no added benefit in mortality or MI vs. OMT alone.
BARI 2D 2009 Diabetics with CAD Routine revascularization no better than intensive OMT.
FAME 2 2012 FFR-positive lesions PCI reduced urgent revascularizations, but no mortality/MI benefit.
ORBITA 2017 Stable angina PCI showed minimal symptom improvement over placebo.
ISCHEMIA 2019 Moderate-severe ischemia OMT first strategy favored over invasive, no survival benefit from early PCI.
Missed factors in landmark CCS trials

Missed VPs: PCI targets angiographically significant stenoses, overlooking non-obstructive but rupture-prone plaques [11-14]. Such VPs significantly influence future events, making systemic plaque stabilization via OMT a superior approach.

IR: Diffuse multivessel disease frequently prevents Complete Revascularization (CR) with PCI, resulting in residual ischemia. Coronary Artery Bypass Grafting (CABG) often achieves superior outcomes through more CR [15-23].

Procedural risks: PCI is associated with periprocedural Myocardial Infarction (MI), bleeding from antiplatelet agents, contrast-induced nephropathy, and procedural mortality, potentially negating the clinical benefits. Operator expertise and institutional quality have a significant impact on outcomes, particularly in complex cases [24-30].

Long-term stent complications: Complications, including stent thrombosis, restenosis, lesion or vessel failure, and bleeding, significantly reduce the long-term advantages of PCI. These risks depend heavily on procedural quality, operator skill, and institutional standards [24-30].

Absence of mortality benefit: Cumulatively, overlooked VPs, IR, procedural complications, and stent-related issues consistently eliminate survival advantages, positioning PCI primarily for symptomatic relief [31-33] (Table 1).

Table 1: Missed factors in landmark CCS trials.
Issue Impact on PCI Outcomes Clinical Implication
Vulnerable plaques PCI neglects non-obstructive, vulnerable plaques Prioritize OMT for systemic plaque stabilization
Incomplete revascularization Residual ischemia persists, limiting PCI benefits Consider CABG or meticulous PCI planning
Procedural complications Complications offset clinical advantages Emphasize patient selection, procedural skill, and the centre of excellence for complex cases
Long-term stent risks Persistent complications reduce long-term benefits Continue advances in stent technology, DCB, and meticulous medical therapy
No mortality benefit Combined factors neutralize PCI benefit Emphasize PCI for symptom relief, strongly support OMT

Recognizing these limitations, OMT should remain foundational in CCS management. PCI should be considered selectively based on symptom burden, ischemia severity, patient preferences, procedural expertise, and safety considerations.

Future research should incorporate advanced imaging techniques, such as IVUS, OCT, and CCTA, to identify and manage VPs [34-38]. Improvements in CR, procedural safety, and innovations like DCBs [39-48] and enhanced stent technologies are essential. The utilization of artificial intelligence and robotic technology is promising, particularly in managing challenging and complex cases [49-57].

Challenges of applying ccs guidelines in Indonesia

Applying CCS guidelines in Indonesia encounters significant difficulties, resulting in markedly different outcomes. International trials assume high adherence to OMT, which contrasts sharply with Indonesian realities, where medication discontinuation is standard, disproportionately favouring PCI in practice.

Quality disparities in Indonesian interventional cardiology, notably between well-resourced private hospitals and resource-constrained public institutions, significantly affect procedural outcomes. Additionally, substantial medico-legal pressures in Indonesia often lead physicians to adopt invasive strategies to mitigate legal risk, even when these strategies are contrary to guidelines (Figure 1).

Figure 1: Barriers Contributing to the Treatment Gap.
Why PCI outperforms suboptimal therapy in Indonesia

Real-world replication of trials like COURAGE and ISCHEMIA in Indonesia would differ notably due to systemic constraints [58-60].

Treatment gap

Comprehensive OMT, including lifestyle interventions and intensive follow-up, is rarely consistently achieved, particularly in rural or resource-limited areas.

Medication access and adherence

Essential medications, such as high-dose statins, ACE inhibitors, ARBs, beta blockers, and antiplatelet agents, are often in short supply. Financial and educational barriers severely impede medication adherence, undermining OMT effectiveness.

Cultural and educational barriers

Aggressive medical management and lifestyle modifications are often undervalued. PCI’s immediate symptom relief and tangible angiographic improvements more readily gain patient trust, enhancing compliance.

Healthcare infrastructure constraints

Nationwide, structured cardiovascular prevention programs remain inconsistent, resulting in an increased reliance on PCI for immediate symptomatic relief and psychological benefits.

Failure to rigorously implement OMT significantly elevates cardiovascular risk, realistically increasing the likelihood of adverse cardiovascular events by approximately 300 – 400%. Historical data and observational studies consistently demonstrate superior clinical outcomes in patients receiving strict medical management, thereby underscoring the essential role of comprehensive therapeutic strategies.

According to guideline recommendations, OMT extends beyond pharmacological interventions, which include antianginal agents (such as beta-blockers, calcium channel blockers, and nitrates), antiplatelet medications, and lipid-lowering therapies. It emphasizes the importance of lifestyle modifications and meticulous management of cardiovascular risk factors, which are regularly overlooked in Indonesia.

Given these constraints, an integrated approach combining PCI with robust OMT represents the most practical strategy. Addressing gaps in medication availability, adherence, cultural perceptions, and infrastructure improvements is urgently required for meaningful patient outcomes.

At Bethsaida Hospital, we have successfully integrated PCI (utilizing DCB technology) with OMT and a WFPBD strategy, resulting in exceptional clinical outcomes. Our centre has achieved low target lesion revascularization rates, nearly zero myocardial infarctions post-PCI, zero PCI-related mortality, and the lowest restenosis rate nationwide at 2%. Additionally, no patients have experienced myocardial infarction or death due to misdiagnosed VPs or deferred PCI interventions.

Despite widespread use, PCI with conventional stenting consistently fails to demonstrate mortality benefits over OMT in CCS patients due to inherent limitations such as overlooked VPs, IR, procedural risks, and chronic stent complications. Addressing these factors requires careful consideration of Indonesian-specific challenges such as medication adherence, healthcare quality disparities, and medico-legal pressures. The pioneering approach at Bethsaida Hospital - integrating PCI with DCB technology, rigorous OMT, and WFPBD strategies - illustrates a viable model for overcoming these issues and achieving superior clinical outcomes. Ultimately, PCI utilizing advanced technologies like DCB, alongside OMT and dietary interventions, holds significant promise for enhancing CCS management in Indonesia and similar contexts.

D.M.; Conceptualization, writing, review, and editing.

Funding

This research received no external funding.

Institutional Review Board Statement

Not applicable.

Informed Consent Statement

Not applicable.

Data Availability Statement

Data are contained within the article.

Conflict of Interest

The authors declare no conflict of interest.

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