Randomized Clinical Trial Comparing Bare-Metal Stents Plus Colchicine Versus Drug-Eluting Stents for Preventing Adverse Cardiac Outcomes: Three-Year Follow-Up Results of the ORal Colchicine in Argentina (ORCA) Trial

Q: What are the key findings of this study?

Bare-metal stents plus 3 months of oral colchicine resulted in similar 3-year major cardiovascular events rates compared to new-generation drug-eluting stents at lower cumulative cost.

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Coronary artery disease undergoing percutaneous coronary intervention (76% acute coronary syndromes) (n=410). Intervention: Bare-metal stents plus oral colchicine (BMS-CO) vs. New-generation drug-eluting stents (DES2G) alone without colchicine. Primary outcome: Major adverse cardiac and cerebrovascular events (MACEs: composite of all-cause death, procedural and non-procedural myocardial infarction, cerebrovascular accident, or ischemia-driven target-vessel revascularization) at 3 years (HR 0.78, 95% CI 0.47-1.30, p=0.39).

Q: What does this research mean for the field?

Bare-metal stents combined with three months of oral colchicine provide comparable three-year MACE rates to drug-eluting stents at a significantly lower cumulative cost. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Alfredo M. Rodriguez–Granillo; Juan Mieres; Carlos Fernández‐Pereira; Camila Correa Sadouet; José Milei; Sandra Swieszkowski; Pablo Stutzbach; Omar Santaera; Pedro Wainer; Juan M. Rokos; C Sosa Gallardo; Roberto Cristodulo-Cortez; Ricardo Pérez de la Hoz; Adnan Kastrati; Alfredo E. Rodríguez

doi:10.3390/jcm14092871

April 22, 2025Journal of Clinical MedicineOpen Access

Randomized Clinical Trial Comparing Bare-Metal Stents Plus Colchicine Versus Drug-Eluting Stents for Preventing Adverse Cardiac Outcomes: Three-Year Follow-Up Results of the ORal Colchicine in Argentina (ORCA) Trial

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Key result

BMS plus colchicine matches DES for 3-year major cardiovascular events at lower cost.

HR 0.78
95% CI 0.47-1.30
P=0.39
n=410

Figures

Why the study?

Bare-metal stents are considered safer but less effective than drug-eluting stents in patients with coronary artery disease, and oral colchicine may compensate for this limitation, prompting a comparison of the cost-effectiveness of these two PCI strategies.

Does bare-metal stent implantation plus 3 months of oral colchicine achieve non-inferior major adverse cardiac and cerebrovascular events and lower cumulative costs compared to second-generation drug-eluting stents in patients undergoing percutaneous coronary intervention?

Key Points

To assess the clinical outcomes and cost-effectiveness of bare-metal stents combined with oral colchicine compared to second-generation drug-eluting stents in patients undergoing percutaneous coronary intervention.
Multicenter, open-label randomized controlled trial (NCT04382443) conducted at 3 centers in Argentina and Bolivia enrolling 410 patients between March 2020 and April 2022.
Patients were randomized 1:1 to bare-metal stents plus oral colchicine (0.5 mg twice daily for 3 months; n=205) or second-generation drug-eluting stents (n=205).
The primary endpoint was a composite of major adverse cardiac and cerebrovascular events (death, myocardial infarction, stroke, or target vessel revascularization) and cumulative treatment costs over a median follow-up of 36.8 months.
The cumulative incidence of major adverse cardiac and cerebrovascular events was 12.7% in the BMS-CO group and 15.6% in the DES2G group (p = 0.39), with no significant differences in individual components.
Cumulative healthcare costs were significantly lower with BMS-CO than with DES2G (USD 4826.4 ± 2512 vs. USD 5708 ± 3637, p < 0.001).
Study medication was discontinued by 5% of patients in the BMS-CO group.

Study Design

Type

RCT (n=410)

Blinding

Open-label with blinded event adjudication

Randomization

1:1 randomization in blocks of 10 using sealed envelopes

Multicenter

Yes

Structured PICO

Does bare-metal stent implantation plus 3 months of oral colchicine achieve non-inferior major adverse cardiac and cerebrovascular events and lower cumulative costs compared to second-generation drug-eluting stents in patients undergoing percutaneous coronary intervention?

P

Population

410 patients with coronary artery disease (76% acute coronary syndromes, 45% multivessel disease) undergoing PCI across 3 centers in Argentina and Bolivia, followed for a median of 36.8 months.

I

Intervention

Percutaneous coronary intervention (PCI) with bare-metal stents (BMS) followed by oral colchicine 0.5 mg twice daily (1 mg total daily dose) for 3 months, plus statins and dual antiplatelet therapy (DAPT: P2Y12 inhibitor [clopidogrel 75 mg daily, prasugrel 10 mg daily, or ticagrelor 90 mg twice daily] plus aspirin 100 mg daily; given for 30 days in chronic coronary syndrome [CCS] and 6 months in ACS, followed by aspirin 100 mg daily for 1 year).

C

Comparator

Percutaneous coronary intervention (PCI) with second-generation drug-eluting stents (DES2G) without adjunctive colchicine, plus statins and dual antiplatelet therapy (DAPT: P2Y12 inhibitor [clopidogrel 75 mg daily, prasugrel 10 mg daily, or ticagrelor 90 mg twice daily] plus aspirin 100 mg daily, mostly continued for 12 months though shorter duration was allowed based on local clinical practice).

O

Outcome

Composite of (1) Major adverse cardiac and cerebrovascular events (MACEs), defined as all-cause death, procedural and non-procedural myocardial infarction (MI), cerebrovascular accident (CVA)/stroke, or ischemia-driven target-vessel revascularization (TVR), and (2) cumulative costs of each treatment strategy, assessed at a median follow-up of 36.8 months (3 years) and blindly adjudicated by an independent clinical events committee.composite

Main Result

Hazard Ratio: 0.78 (95% CI 0.47–1.3)

Absolute Event Rate: 12.7% vs 15.6%

p-value: p=0.39

In patients undergoing PCI (predominantly for ACS), bare-metal stents plus 3 months of oral colchicine resulted in lower 3-year cumulative costs and similar MACE rates compared to second-generation drug-eluting stents, though the trial was underpowered to definitively establish clinical equivalence.

Limitations

Sample size was underpowered to detect differences in clinical endpoints (powered only for cost-saving differences).
Colchicine was administered only in the bare-metal stent arm and not in the drug-eluting stent arm.
Open-label study design (though clinical events underwent blinded adjudication).
Only 14.7% of screened patients were randomized, and low angiographic risk scores limit extrapolation to more complex lesion subsets.
Low number of patients (189) with baseline and 30-day CRP samples due to lack of sponsorship and budget limitations.
Sample size is underpowered to detect differences in clinical endpoints and lack of statistical significance in terms of non-inferiority between BMS and DES
Low number of patients with baseline and 30-day CRP samples (189 patients) due to the study's non-sponsored nature and local Medicare budget limitations
Colchicine was given in the BMS arm only and not in the DES2G arm
Open-label (unblinded) study design
Only 14.7% of screened patients were randomized, with a high proportion of ACS/STEMI and low angiographic risk scores, limiting extrapolation to more complex lesion subsets or clinical scenarios

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Answers are grounded in this paper and cite their sources.

Implication

May support BMS plus colchicine as lower-cost PCI option with similar MACE; leaves definitive noninferiority open due to underpowering.

Abstract

Background: In patients with coronary artery disease, bare-metal stents (BMS) are considered a safer but less effective treatment than drug-eluting stents (DES). Oral colchicine therapy may compensate for this limitation of BMS. This randomized trial compared the cost-effectiveness of two different revascularization strategies during percutaneous coronary intervention (PCI). Methods: Between March 2020 and April 2022, 410 patients were randomly treated with PCI with BMS plus colchicine (BMS-CO: 205 patients) or DES (205 patients) The patients in the BMS-CO group received 0.5 mg oral doses of colchicine for 3 months. The primary endpoint was major adverse cardiac and cerebrovascular events (MACEs), defined as the composite of death, myocardial infarction, stroke, or target vessel revascularization (TVR), and the costs of each treatment strategy. The secondary endpoints included the individual components of MACEs. Results: No significant differences were observed in baseline characteristics, and 76% of the patients presented with acute coronary syndromes. The median follow-up period was 36.8 months. Five percent of the patients in the BMS-CO group discontinued study medication. The cumulative incidence of MACEs was not significantly different, with 12.7% in the BMS-CO group and 15.6% in the DES2G group (p = 0.39) as well individual components of the clinical endpoint. The cumulative costs were lower in the BMS-CO group than in the DES2G group (USD 4826.4 ± 2512 vs. USD 5708 ± 3637, p < 0.001). Conclusions: In the 3 years, the DES strategy failed to be cost-saving compared to BMS-CO. However, due to the small sample size, the equivalence in clinical outcomes with both strategies can occur by chance (NCT04382443).

Discussion

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Cite This Study

Rodriguez–Granillo et al. (2025) conducted an RCT in Coronary artery disease undergoing percutaneous coronary intervention (76% acute coronary syndromes) (n=410). Bare-metal stents plus oral colchicine (BMS-CO) vs. New-generation drug-eluting stents (DES2G) alone without colchicine was evaluated on Major adverse cardiac and cerebrovascular events (MACEs: composite of all-cause death, procedural and non-procedural myocardial infarction, cerebrovascular accident, or ischemia-driven target-vessel revascularization) at 3 years (HR 0.78, 95% CI 0.47-1.30, p=0.39). Bare-metal stents plus 3 months of oral colchicine resulted in similar 3-year major cardiovascular events rates compared to new-generation drug-eluting stents at lower cumulative cost.

synapsesocial.com/papers/6a914fa78fe5092890463408 https://doi.org/10.3390/jcm14092871

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Randomized Clinical Trial Comparing Bare-Metal Stents Plus Colchicine Versus Drug-Eluting Stents for Preventing Adverse Cardiac Outcomes: Three-Year Follow-Up Results of the ORal Colchicine in Argentina (ORCA) Trial

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Randomized Clinical Trial Comparing Bare-Metal Stents Plus Colchicine Versus Drug-Eluting Stents for Preventing Adverse Cardiac Outcomes: Three-Year Follow-Up Results of the ORal Colchicine in Argentina (ORCA) Trial

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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