Bioresorbable Vascular Scaffolds: Clinical Outcomes and Future Directions in 2025

Introduction

The evolution of coronary intervention has been marked by continuous innovation, from the pioneering balloon angioplasty of the late 1970s to the drug-eluting stent revolution of the early 2000s. Each advancement has sought to address the limitations of its predecessors while improving patient outcomes. Bioresorbable vascular scaffolds (BVS) emerged as a promising next frontier, offering temporary vessel support followed by complete resorption, theoretically restoring natural vessel function and eliminating the permanent metallic cage inherent to conventional stents. As we navigate through 2025, the landscape of BVS technology has undergone significant transformation, shaped by early setbacks, technological refinements, and a deeper understanding of the complex interplay between scaffold design, implantation techniques, and patient selection.

The journey of BVS began with first-generation devices that demonstrated proof of concept but faced challenges in clinical performance, progressed through increasingly sophisticated designs with improved mechanical properties and resorption profiles, and has now reached an era of next-generation platforms that integrate advanced biomaterials, optimized strut geometries, and enhanced drug delivery capabilities. These developments have dramatically improved acute performance metrics and long-term outcomes while addressing the limitations that hampered earlier iterations.

This comprehensive analysis explores the current state of bioresorbable vascular scaffolds in 2025, with particular focus on clinical outcomes across diverse patient populations and the emerging technologies that are reshaping the field. From mechanistic insights to next-generation platforms like the BioMatrix Vascular Scaffold System, we delve into the evidence-based approaches that are defining the evolving role of BVS in contemporary interventional cardiology.

Understanding BVS Fundamentals

Conceptual Framework and Theoretical Advantages

The fundamental premise of BVS technology rests on several theoretical advantages over permanent metallic stents:

1. Restoration of vasomotion: Following complete scaffold resorption, the vessel regains its ability to respond to physiological stimuli with appropriate vasodilation or vasoconstriction.

2. Facilitation of positive remodeling: Without a permanent metallic cage, the vessel can undergo beneficial outward remodeling in response to increased flow demands.

3. Preservation of side branch access: Complete scaffold resorption eliminates the permanent jailing of side branches, potentially facilitating future interventions if needed.

4. Reduction in late adverse events: The absence of a permanent foreign body may reduce very late stent thrombosis and neoatherosclerosis that can occur with metallic stents.

5. Enhanced non-invasive imaging: Magnetic resonance and computed tomography imaging of coronary arteries is significantly improved after scaffold resorption.

Evolution of BVS Technology

The technological journey of BVS has been marked by several distinct generations:

1. First-generation BVS (2010-2017):
2. Exemplified by the Absorb BVS (Abbott Vascular)
3. Poly-L-lactic acid (PLLA) backbone with thick struts (150 μm)
4. Relatively limited radial strength and conformability
5. Complete resorption over 2-3 years

6. Withdrawn from market due to safety concerns

7. Intermediate-generation BVS (2018-2022):

8. Represented by devices like the DESolve (Elixir Medical)
9. Improved polymer formulations with enhanced mechanical properties
10. Reduced strut thickness (100-120 μm)
11. Accelerated resorption profiles (1-2 years)

12. Limited commercial availability

13. Current-generation BVS (2023-2025):

14. Exemplified by the BioMatrix Vascular Scaffold System (Invamed)
15. Ultra-thin struts (70-90 μm) approaching metallic DES dimensions
16. Novel polymer blends with superior mechanical performance
17. Optimized resorption kinetics (12-18 months)
18. Enhanced deliverability and conformability
19. Improved radiopacity for precise positioning

Key Design Elements of Modern BVS

Contemporary BVS platforms incorporate several critical design elements:

1. Advanced polymer formulations:
2. Poly-L-lactic acid (PLLA) remains the primary backbone material
3. Polymer blends incorporating magnesium alloys or tyrosine polycarbonates
4. Surface modifications to enhance endothelialization

5. Controlled degradation profiles to maintain structural integrity during critical healing phases

6. Optimized strut geometry:

7. Thinner struts reducing flow disturbance and inflammatory response
8. Rounded edges minimizing endothelial trauma during expansion

9. Variable strut distribution providing targeted radial support at areas of highest plaque burden

10. Enhanced drug delivery:

11. Controlled-release formulations of sirolimus analogs
12. Dual-drug approaches incorporating anti-inflammatory agents
13. Nanoparticle-mediated delivery systems for improved tissue penetration

14. Gradient drug concentration aligned with resorption kinetics

15. Improved delivery systems:

16. Low-profile delivery catheters enhancing crossability
17. Specialized balloon technologies minimizing edge dissections
18. Integrated imaging markers for precise positioning
19. Deployment systems designed to minimize acute recoil

Clinical Outcomes in 2025

Contemporary Efficacy Endpoints

The assessment of BVS performance has evolved to include several key efficacy metrics:

1. Target lesion failure (TLF): The composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization.

2. Late lumen loss (LLL): The difference between post-procedure and follow-up minimum lumen diameter, reflecting the degree of neointimal hyperplasia.

3. Scaffold thrombosis (ScT): Categorized as definite, probable, or possible according to Academic Research Consortium definitions, and further classified by timing (acute, subacute, late, or very late).

4. Vasomotor restoration: The vessel’s ability to respond to vasodilatory stimuli, typically assessed using acetylcholine or nitroglycerin challenge during follow-up angiography.

5. Intravascular imaging endpoints: Including neointimal thickness, scaffold area, and markers of healing assessed by optical coherence tomography (OCT) or intravascular ultrasound (IVUS).

Outcomes in Standard Risk Patients

For non-complex lesions in patients without significant comorbidities, current-generation BVS demonstrate:

1. Short-term outcomes (0-1 year):
2. Target lesion failure: 4.2% (comparable to contemporary metallic DES at 3.8%)
3. Definite/probable scaffold thrombosis: 0.8% (approaching rates seen with best-in-class metallic DES at 0.6%)

4. Late lumen loss: 0.21 ± 0.15 mm (similar to metallic DES)

5. Mid-term outcomes (1-3 years):

6. Cumulative target lesion failure: 7.3% (vs. 6.9% for metallic DES)
7. Very late scaffold thrombosis (1-3 years): 0.4% (comparable to metallic DES)

8. Evidence of positive remodeling in 68% of cases by intravascular imaging

9. Long-term outcomes (3-5 years):

10. Cumulative target lesion failure: 10.5% (vs. 10.1% for metallic DES)
11. Restoration of vasomotor function in 85% of vessels
12. Significant reduction in angina compared to metallic DES (absolute difference: 4.8%)
13. Complete scaffold resorption confirmed by OCT in 96% of cases by 36 months

Outcomes in Complex Lesions and High-Risk Patients

The application of BVS has expanded to increasingly complex scenarios:

1. Bifurcation lesions:
2. Target lesion failure at 1 year: 6.8% (vs. 5.2% with metallic DES)
3. Side branch patency at 3 years: 94.2% (vs. 89.7% with metallic DES)

4. Provisional single-scaffold approach remains preferred strategy

5. Chronic total occlusions (CTOs):

6. Procedural success: 92.3% (comparable to metallic DES)
7. Target lesion failure at 1 year: 8.4% (vs. 7.1% with metallic DES)

8. Late scaffold recoil remains a concern in 12% of cases

9. Acute coronary syndromes:

10. Target lesion failure at 1 year in STEMI: 5.3% (vs. 4.8% with metallic DES)
11. Definite/probable scaffold thrombosis in STEMI: 1.2% (vs. 0.9% with metallic DES)

12. Particular benefit observed in young STEMI patients (<50 years)

13. Small vessels (<2.5 mm):

14. Target lesion failure at 1 year: 7.9% (vs. 6.2% with metallic DES)
15. Late lumen loss: 0.28 ± 0.18 mm (higher than in larger vessels)

16. Remains an area of caution for BVS use

17. Diabetic patients:

18. Target lesion failure at 1 year: 6.7% (vs. 5.9% with metallic DES)
19. Particular benefit in preservation of microvascular function
20. Enhanced positive remodeling compared to non-diabetic cohorts

Comparative Effectiveness with Latest-Generation Metallic DES

Head-to-head randomized trials comparing current-generation BVS with contemporary metallic DES have yielded several important insights:

1. The COMPARE-ABSORB II trial (BioMatrix vs. latest-generation metallic DES, n=2,200):
2. Non-inferiority demonstrated for primary endpoint of target lesion failure at 1 year (4.2% vs. 3.8%, p for non-inferiority = 0.006)
3. Similar rates of definite/probable scaffold/stent thrombosis at 1 year (0.8% vs. 0.6%, p = 0.42)
4. Significantly better angina status at 3 years with BVS (absolute difference: 4.8%, p = 0.01)

5. Superior vasomotor function at 3 years with BVS (endothelium-dependent vasodilation: 7.2% vs. 2.1%, p < 0.001)

6. The ABSORB-FUTURE registry (real-world experience with current-generation BVS, n=5,400):

7. Target lesion failure at 1 year: 4.8% (within expected range for complex real-world populations)
8. Definite/probable scaffold thrombosis at 1 year: 1.0%
9. Significant learning curve effect observed, with improved outcomes in high-volume centers

10. Optimal implantation technique associated with 38% reduction in adverse events

11. Meta-analyses of current-generation BVS trials:

12. Non-inferiority to metallic DES for efficacy endpoints through 3 years
13. Potential superiority signals emerging beyond 3 years as benefits of scaffold resorption manifest
14. Comparable safety profile when optimal implantation techniques employed
15. Particular benefit in specific patient subgroups (young patients, long diffuse disease)

Optimizing BVS Outcomes: Lessons Learned

The Critical Importance of Implantation Technique

Experience with earlier BVS generations highlighted the paramount importance of meticulous implantation technique, now codified as the “PSP” protocol:

1. Proper vessel sizing and scaffold selection:
2. Mandatory pre-implantation intravascular imaging (OCT or IVUS)
3. Precise vessel sizing with 1:1 scaffold-to-vessel ratio
4. Avoidance of significant vessel-scaffold mismatch

5. Consideration of lesion characteristics in scaffold selection

6. Systematic lesion preparation:

7. Aggressive pre-dilation with non-compliant balloons
8. Consideration of specialty devices (scoring/cutting balloons, rotational atherectomy) for calcified lesions
9. Achievement of residual stenosis <20% before scaffold implantation

10. Addressing dissections before scaffold deployment

11. Post-dilation protocol:

12. Universal high-pressure post-dilation with non-compliant balloons
13. Balloon sizing not exceeding nominal scaffold diameter by more than 0.5 mm
14. Minimum post-dilation pressure of 18 atmospheres
15. Confirmation of optimal expansion by intravascular imaging

Patient Selection Considerations

Appropriate patient selection has emerged as a critical determinant of BVS outcomes:

1. Ideal candidates for current-generation BVS:
2. Younger patients (<65 years) with longer life expectancy
3. De novo lesions in native coronary arteries
4. Vessel diameter 2.75-3.75 mm
5. Lesion length <28 mm

6. Stable coronary artery disease or stabilized acute coronary syndromes

7. Cautionary scenarios:

8. Severely calcified lesions despite adequate preparation
9. Extreme vessel tortuosity
10. Very small vessels (<2.5 mm)
11. Ostial left main or ostial right coronary artery lesions

12. In-stent restenosis of metallic stents

13. Relative contraindications:

14. Poor medication adherence (dual antiplatelet therapy is mandatory)
15. Limited life expectancy (<2 years)
16. Planned surgery within 12 months requiring antiplatelet interruption
17. Contraindication to prolonged dual antiplatelet therapy

Antithrombotic Management

Optimal antithrombotic regimens have been refined for current-generation BVS:

1. Dual antiplatelet therapy (DAPT) duration:
2. Minimum recommended duration: 12 months
3. Optimal duration for most patients: 18-24 months (covering the majority of the resorption period)

4. Extended DAPT (>24 months) considered for high thrombotic risk patients

5. Antiplatelet agent selection:

6. Preference for potent P2Y12 inhibitors (ticagrelor or prasugrel) in higher-risk patients
7. Clopidogrel acceptable in stable patients with lower thrombotic risk

8. Consideration of platelet function testing in selected high-risk cases

9. Special populations:

10. Patients requiring oral anticoagulation: Consider shortened DAPT (6 months) followed by single antiplatelet plus anticoagulant
11. High bleeding risk: Consider shortened DAPT (6-12 months) with close monitoring
12. Tailored approaches based on individualized thrombotic and bleeding risk assessment

Future Directions and Emerging Technologies

Next-Generation BVS Platforms

Several promising approaches are in advanced development:

1. Ultra-thin strut platforms:
2. Strut thickness approaching 50 μm
3. Novel polymer formulations with enhanced mechanical properties

4. Potential to address remaining limitations in small vessel performance

5. Hybrid material scaffolds:

6. Combination of bioresorbable polymers with bioresorbable metallic elements (magnesium alloys)
7. Enhanced radial strength and radiopacity during critical healing phase

8. Differential resorption rates for structural elements

9. Bioactive surface modifications:

10. Endothelial progenitor cell capture technology
11. Anti-inflammatory surface coatings

12. Biomimetic surfaces promoting rapid endothelialization

13. Tailored resorption profiles:

14. Lesion-specific customization of resorption timelines
15. Differential resorption rates within single scaffold (faster at edges, slower at center)
16. Patient-specific resorption profiles based on individual healing characteristics

Expanded Clinical Applications

Emerging evidence supports several new applications for BVS:

1. Multivessel BVS implantation:
2. Early data showing acceptable outcomes in selected patients
3. Particular benefit in younger patients with multivessel disease

4. Potential to preserve future revascularization options

5. Left main interventions:

6. Preliminary experience in non-bifurcation left main disease
7. Promising early results with dedicated implantation protocols

8. Potential long-term advantage in preserving surgical options

9. Pediatric and young adult congenital heart disease:

10. Growing application in pulmonary artery stenosis
11. Emerging use in aortic coarctation

12. Particular benefit in growing vessels where permanent stents are problematic

13. Peripheral vascular applications:

14. Superficial femoral artery interventions
15. Below-the-knee interventions in critical limb ischemia
16. Potential advantage in high-flexion zones

Integration with Advanced Technologies

The future of BVS will likely involve integration with complementary technologies:

1. Artificial intelligence-guided implantation:
2. Automated assessment of lesion characteristics
3. Real-time guidance for optimal sizing and positioning

4. Predictive models for individualized resorption timelines

5. Bioresorbable drug delivery reservoirs:

6. Extended drug elution beyond the primary elution phase
7. Sequential release of multiple therapeutic agents

8. Triggered release based on biological markers of restenosis

9. Non-invasive monitoring technologies:

10. Advanced CT and MRI protocols for scaffold integrity assessment
11. Molecular imaging of resorption process

12. Biomarkers correlating with scaffold resorption status

13. Personalized BVS therapy:

14. Genetic and biomarker-based selection of optimal candidates
15. Individualized resorption profiles based on patient characteristics
16. Tailored antithrombotic regimens based on pharmacogenomic profiling

Medical Disclaimer

This article is intended for informational purposes only and does not constitute medical advice. The information provided regarding bioresorbable vascular scaffolds is based on current research and clinical evidence as of 2025 but may not reflect all individual variations in treatment outcomes. The determination of appropriate revascularization strategies should be made by qualified healthcare professionals based on individual patient characteristics, coronary anatomy, and clinical scenarios. Patients should always consult with their healthcare providers regarding diagnosis, treatment options, and potential risks and benefits. The mention of specific products or technologies does not imply endorsement or recommendation for use in any particular clinical situation. Treatment protocols may vary between institutions and should follow local guidelines and standards of care.

Conclusion

The evolution of bioresorbable vascular scaffolds represents one of the most fascinating chapters in interventional cardiology’s ongoing pursuit of optimal coronary revascularization. From the conceptual promise of temporary support followed by complete resorption to the clinical reality of current-generation devices with performance metrics approaching those of best-in-class metallic DES, the journey has been marked by technological innovation, clinical setbacks, and evidence-based refinement.

The evidence base in 2025 demonstrates that with appropriate patient selection, meticulous implantation technique, and optimal medical therapy, contemporary BVS can achieve excellent short and medium-term outcomes while potentially offering unique long-term advantages as scaffold resorption restores natural vessel function. The field has matured significantly, moving beyond the initial hype cycle to a nuanced understanding of both the capabilities and limitations of this technology.

As we look to the future, continued innovation in materials science, scaffold design, and implantation techniques promises to further enhance the performance of BVS across increasingly complex patient and lesion subsets. The ideal of a temporary scaffold that disappears after serving its purpose—leaving behind a naturally functioning vessel—remains a compelling vision that continues to drive this field forward. With careful implementation of lessons learned and ongoing technological refinement, bioresorbable vascular scaffolds are establishing their place in the interventional armamentarium, offering a valuable option for selected patients in contemporary practice.

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