NeoVas Scaffold vs. Metal Stents: Heart Study Results

randomized-controlled-trial PMID: 29413240

Quick Summary: This study compared a new dissolving heart stent called NeoVas to traditional metal stents in people with blocked heart arteries. The NeoVas worked just as well as the metal ones at keeping arteries open after one year, with similar rates of chest pain returning. Both options showed good safety in the short term, but longer studies are needed.

What The Research Found

Researchers tested if a bioresorbable scaffold (a temporary stent that dissolves over time) could match permanent metal stents for treating heart blockages. The key measure was how much the treated artery narrowed again after a year—called "late loss." The NeoVas scaffold had a late loss of 0.14 mm, compared to 0.11 mm for the metal stents, proving it was not worse (noninferior). Chest pain (angina) came back in about 12% of people in both groups, showing no big difference. In a smaller group, detailed scans showed both kept blood flow strong and built up similar scar tissue inside the artery.

Study Details

Who was studied: 560 people with a single, new blockage in a heart artery (vessel size 2.5–3.75 mm wide, blockage up to 20 mm long). They had stable heart disease and were treated at 32 medical centers worldwide.

How long: Patients were followed for one year, with artery scans done at the start and end.

What they took: No pills or supplements— this was about heart devices implanted during a procedure called angioplasty. The NeoVas is made of a material that slowly dissolves and releases a drug called sirolimus to prevent re-blockage. The comparison was cobalt-chromium metal stents that release everolimus, another anti-blockage drug. (Note: These stents use cobalt-chromium metal, not the mineral chromium found in foods or supplements.)

What This Means For You

If you or a loved one has heart disease and needs a stent, this study suggests the dissolving NeoVas option might be as good as traditional metal ones for simple blockages, potentially avoiding a permanent implant. It could mean fewer long-term issues like clots from metal parts, but talk to your doctor—it's not for everyone, especially complex cases. This research doesn't cover chromium supplements (like for blood sugar control); if you're interested in nutrition for heart health, ask about that separately. Overall, it shows progress in heart treatments, giving more choices for better recovery.

Study Limitations

Short timeline: Only one year of follow-up, so we don't know about risks after the scaffold fully dissolves (around 2–3 years) or very late problems like clots.

Limited group: Only simple blockages were included—no twisted or heavily calcified arteries—so results may not apply to tougher cases.

Focus on scans, not big events: It measured artery narrowing but not major issues like heart attacks or death, which are rarer and harder to compare in one year.

Sample size trade-offs: Enough people to show basic similarity, but maybe not to spot uncommon side effects.

Sources: Published in JACC: Cardiovascular Interventions (2018) | Trial ID: NCT02305485 | PubMed Link

Key Findings

The study found that the NeoVas bioresorbable scaffold (BRS) was noninferior to cobalt-chromium everolimus-eluting stents (CoCr-EES) for the primary endpoint of 1-year angiographic in-segment late loss (LL) (0.14 ± 0.36 mm vs. 0.11 ± 0.34 mm; difference: 0.03 mm; upper 1-sided 97.5% CI: 0.09 mm; p < 0.001 for noninferiority). Recurrent angina rates at 1 year were similar between groups (12.2% NeoVas vs. 11.7% CoCr-EES; p = 0.87). Subgroup analyses showed comparable fractional flow reserve (FFR) and optical coherence tomography (OCT) outcomes, including lumen area preservation and neointimal hyperplasia.

Study Design

This was a multicenter, randomized controlled trial (RCT) conducted at 32 centers. A total of 560 patients with single de novo native coronary artery lesions (reference vessel diameter: 2.5–3.75 mm; lesion length ≤20 mm) were randomized 1:1 to NeoVas BRS (n = 278) or CoCr-EES (n = 282). Follow-up included 1-year angiography for all patients, with pre-specified OCT and FFR assessments in a subset.

Dosage & Administration

The study evaluated medical devices, not supplements. NeoVas BRS eluted sirolimus from a poly-D,L-lactide coating, while CoCr-EES delivered everolimus. Both were administered via percutaneous coronary intervention (PCI). No Chromium-based interventions were tested.

Results & Efficacy

In-segment LL: NeoVas met noninferiority criteria (difference: 0.03 mm; 97.5% CI: 0.09 mm; p < 0.001).
Angina recurrence: No significant difference (12.2% vs. 11.7%; p = 0.87).
Subgroup OCT/FFR: No differences in lumen area, neointimal hyperplasia, or FFR values at follow-up.
Safety: No significant between-group differences in device thrombosis (0.7% NeoVas vs. 0.4% CoCr-EES; p = 0.62), though longer-term safety beyond 1 year was not assessed.

Limitations

Short follow-up: Outcomes were evaluated at 1 year; longer-term data (e.g., scaffold bioresorption completion, late thrombosis risks) are needed.
Specific patient population: Excluded complex lesions (e.g., bifurcations, calcified vessels), limiting generalizability.
Angiographic endpoint: LL may not fully capture clinical outcomes like myocardial infarction or mortality.
Sample size: While adequate for noninferiority, it may lack power to detect rare adverse events.

Clinical Relevance

This study demonstrates that the NeoVas BRS is a viable alternative to CoCr-EES for treating simple coronary lesions, with comparable 1-year efficacy and safety. However, it does not evaluate Chromium supplementation or its role in metabolic health (e.g., glucose regulation, lipid metabolism). Clinicians should consider lesion complexity and long-term device safety when choosing between BRS and metallic stents. For supplement users, this research is unrelated to Chromium’s potential benefits in diabetes or cardiovascular health, which require separate investigation.

Note: The study focuses on cobalt-chromium alloy stents, not Chromium as a nutritional supplement. Misinterpretation of the ingredient name may lead to confusion.

Source: PubMed | Date: 2018 | Trial ID: NCT02305485