Breaking Boundaries in Chronic Coronary Syndrome Management: Bethsaida Hospital’s Integrative Approach Combining Drug-Coated Balloon, Plant-Based Diet, and Advanced Imaging

Despite advances in interventional cardiology, chronic coronary syndrome (CCS) remains a significant cause of morbidity and mortality globally, notably in resource-constrained healthcare systems like Indonesia. Traditional percutaneous coronary intervention (PCI) approaches, particularly stenting, have consistently failed to demonstrate substantial long-term benefits, as highlighted by landmark trials such as COURAGE, ORBITA, and ISCHEMIA, due to the frequent oversight of vulnerable plaques (VPs), incomplete revascularization (IR), procedural risks, and persistent complications. Bethsaida Hospital, under the visionary leadership of Prof. Dasaad Mulijono (DM), has pioneered a groundbreaking integrative strategy that combines drug-coated balloon (DCB) angioplasty, Plant-Based Diets (PBDs), and advanced computed tomography coronary angiography (CTCA).

This novel approach leverages CTCA’s precision in detecting and characterizing VPs non-invasively, enabling targeted and minimally invasive DCB interventions with remarkable procedural safety. Complementing these interventions, the systematic adoption of PBD addresses systemic inflammation and endothelial dysfunction, crucial drivers of atherosclerotic plaque instability. Clinical outcomes from over 2000 cases spanning five years demonstrated extraordinary results: complete elimination of stent thrombosis, dramatically reduced restenosis rates (<2%), negligible procedural complications, significantly decreased reliance on dual antiplatelet therapy, and notably, zero mortality in long-term follow-up.

Economically, Bethsaida’s integrative model has proved highly sustainable, reducing procedural complications, shortening hospitalization durations, and significantly lowering pharmaceutical expenditures. By establishing this evidence-based, cost-effective, and reproducible standard of care, Bethsaida Hospital offers a transformative paradigm that improves cardiovascular outcomes in Indonesia and presents a compelling model adaptable to global challenges in cardiovascular care.

CAD is a leading health challenge in Indonesia, characterized by increasing morbidity and mortality [1]. The traditional reliance on PCI, particularly stenting, has faced scrutiny due to the limited survival advantages demonstrated in landmark trials such as COURAGE, ORBITA, and ISCHEMIA [2-6]. These studies highlight significant drawbacks of conventional PCI, including IR, missed VPs at risk of rupture, procedural complications such as acute myocardial infarction, bleeding events, and contrast-induced nephropathy [7-17].

Under Prof. DM’s leadership, Bethsaida Hospital has developed an innovative, integrative approach that combines DCB technology, PBDs, and advanced CTCA to overcome these limitations. CTCA accurately identifies VPs non-invasively, facilitating early intervention and enhancing procedural outcomes. DCB technology significantly reduces risks associated with traditional stenting, including restenosis and thrombosis, while meticulous lesion preparation and CTCA guidance further improve procedural safety. Additionally, PBDs effectively stabilize plaques by targeting systemic inflammation and endothelial dysfunction.

Bethsaida Hospital’s integrated CCS management model thus offers superior clinical results, enhanced safety, and cost-effectiveness, establishing a replicable, sustainable standard suitable for resource-limited healthcare settings.

PCI performed in landmark trials, COURAGE, ORBITA, and ISCHAEMIA, often neglects non-obstructive lesions (<70% stenosis), despite their substantial risk for plaque rupture and AMI, which is known as VPs. Furthermore, anatomical complexity frequently results in IR, leaving residual ischemia unaddressed and contributing to suboptimal long-term outcomes. By contrast, surgical interventions such as coronary artery bypass grafting (CABG) achieve more comprehensive revascularization, highlighting PCI’s limitations in multivessel disease [18,19].

CTCA emerges as a non-invasive, highly accurate modality for identifying VPs, enabling early preventive strategies and improving patient outcomes, especially in asymptomatic, high-risk populations. Despite initial barriers related to availability and expertise, CTCA offers significant promise as a routine diagnostic tool for comprehensive CAD management, crucially addressing diagnostic gaps in traditional invasive angiography [7-10,20-24]. Studies have demonstrated that plaque vulnerability carries more risk than the degree of stenosis [25,26].

Bethsaida Hospital has developed a pioneering approach that combines DCB technology with PBDs. Over a five-year period involving more than 2,000 patients, this integrative strategy has eliminated stent thrombosis, significantly reduced restenosis rates, and dramatically lowered procedural complications, including bleeding risks associated with prolonged dual antiplatelet therapy. Crucially, this approach demonstrated zero mortality in long-term follow-up, underscoring the exceptional safety profile of DCB technology.

Patient Selection

Indications (CCS only):

1. Clinical

• Stable angina or equivalent (CCS I–III) and/or objective ischemia on stress testing.
• Prior PCI/CABG with recurrent symptoms or ischemia.

2. Anatomic (from CTCA ± ICA)

Figure 1:

• One- to three-vessel CAD with ≥70% stenosis or non-obstructive lesions with high-risk plaque features (see “VP criteria”).
• Reference vessel diameter 2.0–4.0 mm; lesion length ≤30 mm suitable for DCB strategy.

3. Physiologic (any of)

• FFRCT ≤0.80 or invasive FFR/iFR abnormal.
• Myocardial ischemic burden ≥10% on perfusion imaging (optional if high-risk plaque present).

VP criteria (CTCA):

(Any 2 constitute VP; any 3 = high-risk VP)

• Low-attenuation plaque <30 HU
• Positive remodelling index >1.10
• Napkin-ring sign
• Spotty calcification
• Plaque burden ≥70% or MLA ≤4.0 mm² for LAD (converted from CTCA cross-section)

Exclusion: ACS within 30 days, left main ≥50% needing CABG, CTO planned for staged CTO-PCI, severe calcification mandating atherectomy where DCB unsuitable, LVEF <25% with shock, eGFR <30 mL/min/1.73 m² (unless contrast-saving strategy used), active bleeding or DAPT contraindication (for non-DCB indications), pregnancy, or inability to adhere to follow-up/PBD program.

Pre-procedure work-up:

• Labs: CBC, creatinine/eGFR, lipid panel (LDL-C, ApoB, Lp(a)), HbA1c, hs-CRP, fasting insulin/HOMA-IR, TMAO, baseline NO (salivary method used at Bethsaida).
• CTCA with standardized protocol (≤0.6 mm slice, iterative recon); optional FFRCT.
• Medications optimized ≥2 weeks (statin/ezetimibe if used, ACEi/ARB, beta-blocker as indicated).

Procedural Method (DCB-first, no routine stent):

1. Lesion preparation

• Predilatation with non-compliant balloon sized 1:1; use scoring/cutting balloon if calcified or recoil >30%.
• Goal: residual stenosis ≤30%, TIMI 3 flow, no flow-limiting dissection (≤NHLBI C).

2. Drug-coated balloon

• Size 1:1, inflation 60–90 s, full lesion coverage with 2–3 mm margins; overlap 2–3 mm if multiple balloons.

3. Bailout stent

• Only for persistent recoil >30% or flow-limiting dissection; record as protocol deviation.

4. Antithrombotic plan

• Periprocedural: heparin targeting ACT 250–300 s.
• Post-procedure: SAPT (usually ticagrelor 90-180 mg/day) or short DAPT (aspirin + ticagrelor) for 2–4 weeks if long/overlapped DCB segments; then SAPT. Document exact duration.

5. Contrast- and radiation-saving measures per institutional policy.

Lifestyle & Medical Co-intervention (PBD Program):

• Diet: WFPBD (no animal products, minimal processed oils, added sugar/salt limited).
• Targets (12 weeks):
• LDL-C <55 mg/dL (or ApoB <65 mg/dL)
• hs-CRP <1.0 mg/L
• HbA1c <6.0% (or ≥1% absolute drop if diabetic)
• TMAO into local reference low tertile
• Home BP <130/80 mmHg; BMI 19-21 kg/m2
• Support: weekly group class (first 12 weeks), app-based adherence logs, optional NO test strips 2–3×/week, step-count target ≥7,000/day, supervised strength interval twice weekly.
• Medication titration: deprescribe antianginals/insulin/antihypertensives as tolerated using protocolized algorithms.

Follow-Up Methodology:

1. Schedule & Assessments

a. Day 0 (discharge)

• Register in prospective DCB-PBD registry; record procedural metrics, complications, antiplatelet plan, baseline PROMs (SAQ-7, EQ-5D-5L), and diet adherence score (0–10).

b. Week 1 (tele)

• Safety check (bleeding/BARC, chest pain, access site), med tolerance, initial PBD coaching.

c. Week 4 (clinic/tele)

• Physical exam, BP/HR/weight, adherence log, adjust antiplatelet to SAPT if on short DAPT, labs (hs-CRP optional).

d. Month 3 (clinic)

• Labs: lipid panel (LDL-C, ApoB, Lp(a) optional), HbA1c (if diabetic), hs-CRP, TMAO, NO level.
• PROMs repeat: 6-minute walk or treadmill functional capacity.
• CTCA (targeted) if recurrent symptoms, biomarker non-improvement (e.g., hs-CRP >2 mg/L), or VP surveillance cohort.

e. Month 6 (clinic)

• Repeat labs as Month 3; adverse events; medication de-escalation; CTCA for VP surveillance subset (e.g., first 200 registry patients or all with high-risk VP at baseline).

f. Month 12 (clinic + imaging)

• Full labs: CTCA (or ICA if indicated). Record plaque metrics (low-attenuation volume, remodelling index, total plaque volume).
• PROMs; return-to-work/activity status.

g. Yearly to 5 years

• Clinic or tele every 6–12 months; labs annually; CTCA only if symptoms or protocolized VP cohort.

2. Imaging Core Metrics (for reproducibility)

• CTCA recon parameters, contrast type/volume, HR control drugs documented.
• Quantify: total plaque volume (mm³), low-attenuation plaque volume, remodelling index, % stenosis, MLA, presence of napkin-ring/spotty calcification.
• Same vendor/software (or cross-calibrated) for serial studies; blinded core-lab reader when possible.

3. Outcomes & Definitions

• Primary procedural: technical success (residual 30%, TIMI 3, no bailout stent), peri-procedural MI (UDMI-4), BARC 2 bleeding (30 days).
• Primary clinical (12 months): target lesion failure (TLF = cardiac death, target-vessel MI, clinically driven TLR).
• Key secondary: restenosis (50% on CTCA or ischemia-driven), stent use rate (bailout), DAPT duration, hospitalization days, cost metrics, PROMs change, VP-to-stable conversion on CTCA.
• Lifestyle endpoints: adherence 80% days meeting PBD targets; hs-CRP, LDL-C, TMAO, NO improvements vs baseline.

4. Data Quality & Monitoring

• Electronic case-report form (eCRF) with mandatory fields; automated range checks.
• 10% random source-data verification; adverse events adjudicated by a blinded committee.
• Pre-specified handling of protocol deviations (e.g., bailout stent, prolonged DAPT).

5. Sample Size & Analysis (for a registry or single-arm study)

• Minimum n ≥300 for precision around 12-mo TLF (±2–3%).
• Time-to-event with Kaplan–Meier; Cox models adjusting for age, diabetes, multivessel disease, baseline VP burden, and adherence quartiles.
• Imaging changes analysed with paired tests; report effect sizes and 95% CIs.

6. Reproducibility Checklist

1. Confirm CCS (not ACS)
2. CTCA acquired to spec; VP criteria assessed
3. Lesion prep achieves residual 30% + TIMI 3
4. DCB size 1:1, 60-90 s inflation, full coverage
5. Short DAPT (2-4 wks.) SAPT
6. PBD onboarding + targets documented
7. Follow-up at W1, M1, M3, M6, M12, then yearly
8. Labs (LDL-C, ApoB, hs-CRP, HbA1c, TMAO, NO) at baseline/M3/M6/M12
9. PROMs (SAQ-7, EQ-5D-5L) baseline/M3/M12
10. Outcomes captured with standardized definitions

7. Plant-Based Diets as Essential Therapy for Plaque Stabilization and Achieving Complete Revascularization

Emerging evidence supports PBD’s pivotal role in addressing systemic inflammation, metabolic dysfunction, and endothelial impairment, core drivers of atherosclerotic progression and plaque vulnerability [28-31]. PBD significantly contributes to plaque stabilization, effectively converting high-risk VPs into stable lesions, thereby mimicking the benefits of complete revascularization. The incorporation of dietary interventions substantially enhances the efficacy of minimally invasive approaches, yielding substantial long-term clinical and economic benefits.

8. Clinical Outcomes and Economic Impact

Bethsaida Hospital’s holistic management protocol has demonstrated exceptional clinical efficacy, evidenced by dramatically reduced restenosis rates, negligible procedural complications, and sustained plaque stability. The significant reduction in procedural complications and hospitalization durations markedly lowers healthcare costs, offering an economically sustainable solution for resource-limited healthcare systems.

9. Potential Limitations and Future Directions

9.1 Limitations

1. Single-centre experience

The results are derived from Bethsaida Hospital’s unique infrastructure, experienced operators, and integrated plant-based program. This may limit generalizability to centres without similar resources or expertise.

2. Observational design

The current findings are based on a prospective registry rather than a randomized controlled trial (RCT), which introduces potential selection bias and confounding, despite the use of standardized protocols.

3. High patient adherence

Exceptional adherence to the PBD and follow-up schedule at Bethsaida may not be reproducible in settings with lower patient engagement or weaker support for lifestyle medicine.

4. Advanced imaging availability

The routine use of high-quality CTCA and optional FFRCT may be challenging to implement in resource-limited centres, potentially affecting early VP detection and procedural targeting.

5. Shorter follow-up in some cohorts

While a five-year follow-up is available for some patients, not all participants have undergone long-term surveillance imaging, which may underrepresent late events.

6. Unmeasured lifestyle variables

Although dietary adherence is tracked, other lifestyle factors (physical activity, stress reduction, and sleep) were not consistently quantified, which could contribute to outcomes.

9.2 Future Directions

1. Multicentre validation

Expanding the integrative CCS model to multiple centres in Indonesia and internationally to test reproducibility across diverse healthcare systems.

2. Randomized trials

Designing an RCT comparing the DCB–PBD–CTCA protocol against standard PCI with optimal medical therapy to evaluate hard endpoints, cost-effectiveness, and quality of life.

3. Implementation research

Studying strategies to improve PBD adoption and adherence in varying cultural, socioeconomic, and dietary contexts.

4. Technology adaptation

Developing AI-assisted CTCA interpretation and dietary adherence tracking tools to reduce operator variability and improve scalability.

5. Long-term plaque dynamics

Conducting extended follow-up CTCA studies (>5 years) to assess plaque regression, stabilization, and recurrent event rates.

6. Broader lifestyle integration

Incorporating structured exercise, stress management, and sleep optimization into the standardized care pathway to assess additive benefits.

Bethsaida Hospital’s integrative management model represents a transformative advancement in CCS care. By seamlessly integrating advanced imaging (CTCA), innovative interventional techniques (DCB), and dietary modifications (PBDs), this comprehensive strategy effectively addresses critical gaps in traditional PCI approaches. The hospital’s pioneering efforts under Prof. DM have substantially improved clinical outcomes, including a marked reduction in restenosis and thrombosis rates, minimized procedural complications, and enhanced plaque stability. Furthermore, integrating plant-based dietary interventions delivers profound systemic health benefits, notably reducing inflammation and improving endothelial function, thereby significantly lowering the risk of acute coronary events. Economically, this model offers substantial cost savings through decreased procedural complications, reduced hospitalization durations, and lower dependency on long-term pharmaceutical interventions. Bethsaida Hospital’s CCS management framework ultimately provides an evidence-based, sustainable, and replicable standard, presenting a compelling solution for improving cardiovascular care in Indonesia and potentially influencing global healthcare practices.

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