One-year outcomes with the Alex Plus drug-eluting coronary stent in routine clinical practice: the RESALP (r-EPIC 01) registry

Q: What are the key findings of this study?

The Alex Plus sirolimus-eluting stent demonstrated a 3.1% (95% CI 1.6-4.6) target lesion revascularization rate and a 3.5% (95% CI 2.0-5.0) target vessel failure rate at 1 year in routine practice.

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Coronary artery disease (acute coronary syndrome, stable angina, or silent ischemia) (n=547). Intervention: Alex Plus sirolimus-eluting biodegradable-polymer cobalt-chromium coronary stent. Primary outcome: Target lesion revascularization (TLR) involving the study stent at 1 year (co-primary with target vessel failure [TVF] at 3.5%, 95% CI 2.0-5.0) (95% CI 1.6-4.6).

Q: What does this research mean for the field?

The Alex Plus biodegradable-polymer sirolimus-eluting stent achieves low 1-year rates of target lesion revascularization (3.1%) and target vessel failure (3.5%) with a favorable safety profile in routine clinical practice. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

Alfonso Miguel Torres Bosco; Luis Antonio Íñigo-García; Tamara García-Camarero; José Ramón Rumoroso Cuevas; Eduard Bosch Peligero; Roberto Sáez Moreno; Pablo Luengo-Mondéjar; Juan José De la Cruz Troca; Natalia Bolívar Herrera; Olga Sanz Vázquez; Marta Pombo Jiménez; Juan Francisco Muñoz Bellido; María Mercedes Sanz Sánchez; and Fermín Sáinz Laso; Alejandro D. Sánchez-Espino

doi:10.24875/recice.m26000618

October 26, 2026REC interventional cardiology (English Edition)Open Access

One-year outcomes with the Alex Plus drug-eluting coronary stent in routine clinical practice: the RESALP (r-EPIC 01) registry

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Key result

Alex Plus sirolimus-eluting stent shows ~3% 1-year target lesion revascularization in routine practice.

95% CI 1.6-4.6
n=547

Why the study?

Postmarketing clinical data for the Alex Plus cobalt-chromium sirolimus-eluting stent with a biodegradable polymer remain limited. This study evaluated its 1-year safety and clinical efficacy in routine clinical practice.

What are the 1-year safety and clinical efficacy outcomes (target lesion revascularization and target vessel failure) of the Alex Plus biodegradable-polymer sirolimus-eluting stent in patients undergoing PCI in routine clinical practice?

Key Points

Evaluate the 1-year safety and clinical efficacy of the Alex Plus sirolimus-eluting stent with a biodegradable polymer in routine clinical practice.
Prospective, multicenter, observational registry conducted in Spain among patients undergoing percutaneous coronary intervention for acute coronary syndrome, stable angina, or silent ischemia.
Included 589 enrolled patients requiring implantation of at least 1 Alex Plus stent, with 547 patients (92.9%) completing 1-year follow-up analysis.
At 1 year, target lesion revascularization involving the study stent was 3.1% (95% CI, 1.6-4.6), target vessel failure was 3.5% (95% CI, 2.0-5.0), and study-stent thrombosis occurred in 0.7% (95% CI, 0.0-1.4).
Cumulative 1-year major adverse cardiovascular and cerebrovascular events reached 12.1% (95% CI, 9.4-14.8), all-cause mortality was 4.0% (95% CI, 2.4-5.6), myocardial infarction was 2.0% (95% CI, 0.8-3.2), and stroke was 1.5% (95% CI, 0.5-2.5).
Renal dysfunction (creatinine ≥ 1.5 mg/dL) independently predicted death (OR, 8.87; 95% CI, 3.33-23.63; P < .001) and MACCE (OR, 3.52; 95% CI, 1.59-7.77; P < .001).

Study Design

Type

Observational (n=547)

Blinding

Open-label

Multicenter

Yes

Structured PICO

What are the 1-year safety and clinical efficacy outcomes (target lesion revascularization and target vessel failure) of the Alex Plus biodegradable-polymer sirolimus-eluting stent in patients undergoing PCI in routine clinical practice?

P

Population

547 patients (mean age 65.7 years, 22.5% female) undergoing percutaneous coronary intervention primarily for acute coronary syndrome (67%), stable angina, or silent ischemia at 8 Spanish hospitals, excluding those with cardiogenic shock or life expectancy <1 year, followed for 1 year.

E

Exposure

Implantation of at least 1 Alex Plus stent (a third-generation cobalt-chromium sirolimus-eluting coronary stent with a 5-μm biodegradable polyglycolic-co-lactic acid polymer releasing sirolimus at 1 µg/mm²; total 722 Alex Plus stents implanted out of 1006 total stents) during PCI, with additional DES or balloons permitted per routine clinical practice, followed by dual antiplatelet therapy (aspirin 99.5%, ticagrelor 65%, clopidogrel 30%, prasugrel 5%).

O

Outcome

Target lesion revascularization (TLR) involving the study stent and target vessel failure (TVF, defined as TLR plus acute myocardial infarction involving the vessel treated with the study stent) at 1 year, analyzed on a per-patient basis and adjudicated directly by investigators.composite

In a real-world Spanish multicenter registry, the biodegradable-polymer sirolimus-eluting Alex Plus stent demonstrated low 1-year rates of target lesion revascularization (3.1%), target vessel failure (3.5%), and stent thrombosis (0.7%), comparable to other contemporary drug-eluting stents.

Limitations

Observational design with no control group
Operators were permitted to implant other stents at their discretion, introducing potential patient- and lesion-selection biases
Absence of an external independent event review and adjudication committee
Greater lesion complexity among lesions selected for non-study stents (more calcification, bifurcations, and B2 lesions) may have favored the Alex Plus results
Predefined exclusion criteria (e.g., cardiogenic shock, out-of-hospital cardiac arrest) precluded a true unrestricted all-comers sample
Freedom for operators to implant other stents at their discretion, introducing potential patient- and lesion-selection biases
Absence of an external event review and adjudication committee
Post-revascularization troponin monitoring was not mandated by protocol

Implication

Supports Alex Plus consideration in routine PCI; leaves open randomized trials to confirm comparative effectiveness.

Abstract

Introduction and objectives:The Alex Plus stent is a cobalt-chromium sirolimus-eluting stent with a biodegradable polymer for which postmarketing clinical data remain limited.This study aimed to evaluate the 1-year safety and clinical efficacy of this Alex Plus stent in routine clinical practice.Methods: This prospective, multicenter, observational registry was conducted in Spain.Eligible patients were referred for percutaneous coronary intervention (PCI) due to stable angina, acute coronary syndrome with or without ST-segment elevation, or silent ischemia.Implantation of at least 1 Alex Plus stent was required, although the use of additional devices was permitted according to routine clinical practice.The primary endpoints were target lesion revascularization (TLR) of of lesions treated with the study stent and target vessel failure (TVF) at 1 year.Secondary endpoints included major adverse cardiovascular and cerebrovascular events (MACCE).Results: 589 patients were enrolled; 547 (92.9%) were analyzed.Mean age was 65.7 ± 11.1 years.22.5% were women.Overall, 1006 stents were implanted, including 722 Alex Plus (71.8%).Acute coronary syndrome was the indication in 67%.In-hospital MACCE was 1.65%.At one-year, target lesion revascularization and target vessel failure were 3.1% and 3.5%, respectively; stent thrombosis occurred in 0.7%.Mortality was 4%, myocardial infarction 2%, stroke 1.5%, and overall MACCE 12.1%.Renal dysfunction strongly predicted mortality and MACCE, while disease extent and number of treated vessels and stents were associated with adverse events.Conclusions: In real-world clinical practice, the Alex Plus stent demonstrated low rates of revascularization and thrombosis at one-year, with a safety and efficacy profile comparable to that of other contemporary DES.

Discussion

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Cite This Study

Bosco et al. (2026) conducted an observational in Coronary artery disease (acute coronary syndrome, stable angina, or silent ischemia) (n=547). Alex Plus sirolimus-eluting biodegradable-polymer cobalt-chromium coronary stent was evaluated on Target lesion revascularization (TLR) involving the study stent at 1 year (co-primary with target vessel failure [TVF] at 3.5%, 95% CI 2.0-5.0) (95% CI 1.6-4.6). The Alex Plus sirolimus-eluting stent demonstrated a 3.1% (95% CI 1.6-4.6) target lesion revascularization rate and a 3.5% (95% CI 2.0-5.0) target vessel failure rate at 1 year in routine practice.

synapsesocial.com/papers/6ae28f09cbadf70daf6c4415 https://doi.org/10.24875/recice.m26000618

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One-year outcomes with the Alex Plus drug-eluting coronary stent in routine clinical practice: the RESALP (r-EPIC 01) registry

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

One-year outcomes with the Alex Plus drug-eluting coronary stent in routine clinical practice: the RESALP (r-EPIC 01) registry

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

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