Drug-Eluting Balloons Versus Stents for Coronary In-Stent Restenosis: Six-Month Clinical and Angiographic Outcomes

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Coronary In-Stent Restenosis (n=200). Intervention: Drug-eluting balloon (DEB) angioplasty vs. Repeat drug-eluting stent (DES) implantation. Primary outcome: Major adverse cardiac events (MACE), defined as the composite of target vessel revascularization, myocardial infarction, and all-cause death (p=0.042).

Q: What does this research mean for the field?

Drug-eluting balloon angioplasty is associated with a significantly lower six-month rate of major adverse cardiac events compared to repeat drug-eluting stent implantation for coronary in-stent restenosis, though this difference likely reflects baseline risk disparities rather than a device-specific effect. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Raad Najim; Intisar Yusif; Mohammed Noaman

doi:10.32894/kjms.2026.170766.1334

January 1, 2026Open Access

Drug-Eluting Balloons Versus Stents for Coronary In-Stent Restenosis: Six-Month Clinical and Angiographic Outcomes

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Key result

DEB linked to ~45% lower six-month MACE vs repeat DES, though likely reflecting baseline differences.

P=0.042
n=200

Why the study?

DEB angioplasty and repeat DES implantation are established options for coronary in-stent restenosis, but comparative real-world data from Iraq are limited.

Does drug-eluting balloon angioplasty reduce major adverse cardiac events compared to repeat drug-eluting stent implantation in adults with coronary in-stent restenosis?

Key Points

To compare baseline characteristics and six-month clinical and angiographic outcomes of patients with coronary in-stent restenosis treated with drug-eluting balloon angioplasty versus repeat drug-eluting stent implantation.
Prospective observational study of 200 adults with angiographically confirmed in-stent restenosis treated in routine clinical practice in Kirkuk, Iraq, between November 2023 and November 2024 (100 received drug-eluting balloons and 100 received repeat drug-eluting stents).
Six-month clinical outcomes were documented in all 200 patients (intent-to-treat), and follow-up angiography was performed in 78 drug-eluting balloon and 79 repeat drug-eluting stent patients to evaluate late lumen loss, minimal lumen diameter, and binary restenosis.
Angiographic parameters at six months showed minimal lumen diameter of 2.12 ± 0.45 mm for balloons versus 2.15 ± 0.42 mm for stents (P = 0.715), median late lumen loss of 0.38 mm versus 0.39 mm (P = 0.798), and binary restenosis of 10.3% (8/78) versus 15.2% (12/79; P = 0.474).
Target lesion revascularization occurred in 8.0% of balloon-treated patients versus 9.0% of stent-treated patients (P = 0.999), but target vessel revascularization was significantly higher in the stent group (25.0% vs. 13.0%; P = 0.047), primarily driven by non-target lesion events (16.0% vs. 5.0%; P = 0.011).
Major adverse cardiac events were significantly higher with repeat stents than balloons (29.0% vs. 16.0%; P = 0.042), whereas myocardial infarction was 3.0% in each group (P = 0.999) and all-cause death was 2.0% versus 1.0% (P = 0.999).

Study Design

Type

Observational (n=200)

Multicenter

No

Structured PICO

Does drug-eluting balloon angioplasty reduce major adverse cardiac events compared to repeat drug-eluting stent implantation in adults with coronary in-stent restenosis?

P

Population

200 adult patients with angiographically confirmed coronary in-stent restenosis treated with either drug-eluting balloon angioplasty or repeat drug-eluting stent implantation, followed for six months.

E

Exposure

Drug-eluting balloon (DEB) angioplasty (n=100) selected during routine clinical care.

C

Comparator

Repeat drug-eluting stent (DES) implantation (n=100) selected during routine clinical care.

O

Outcome

Major adverse cardiac events (MACE), defined as the composite of target vessel revascularization, myocardial infarction, and all-cause death at six months.composite

Main Result

Absolute Event Rate: 16% vs 29%

p-value: p=0.042

In a real-world observational cohort, drug-eluting balloons and repeat drug-eluting stents showed comparable six-month angiographic outcomes and target lesion revascularization rates for coronary in-stent restenosis.

Limitations

Single-center observational study without random treatment allocation
Significant baseline differences between groups (e.g., insulin-dependent diabetes, family history of CAD)
No formal sample size calculation or propensity-score adjustment
Six-month follow-up angiography was not mandatory for all patients
Intracoronary imaging was not routinely used
Unavailable data on some pharmacological and procedural variables such as antiplatelet therapy and balloon sizing
Baseline differences between the DEB and DES groups may have influenced the observed differences
No formal sample size calculation or propensity-score adjustment was performed
Six-month angiography was not mandatory for all patients
Some pharmacological and procedural variables were unavailable

Implication

Similar outcomes with DEB versus repeat DES in this Iraqi cohort; leaves open optimal ISR strategy pending randomized data.

Abstract

Background: In-stent restenosis (ISR) remains an important complication of percutaneous coronary intervention. Drug-eluting balloon (DEB) angioplasty and repeat drug-eluting stent (DES) implantation are established treatment options, but comparative real-world data from Iraq are limited. This study aimed to compare baseline characteristics and six-month clinical and angiographic outcomes of patients with coronary ISR treated with DEB versus repeat DESimplantation.Methods: This prospective observational study included 200 adults with angiographically confirmed ISR treated in Kirkuk, Iraq, between November 2023 and November 2024. One hundred patients underwent DEB angioplasty and 100 underwent repeat DES implantation in routine practice. Clinical outcome data at six months were available for all patients, and follow-up angiography was performed in 78 DEB-treated and 79 DES-treated patients. The primaryclinical outcome was major adverse cardiac events (MACE), defined as the composite of target vessel revascularization, myocardial infarction, and all-cause death.Results: DES-treated patients had a longer median time to restenosis and a higher prevalence of insulin-dependent diabetes mellitus and family history of coronary artery disease, whereas hypertension was more common in the DEB group. At six months, minimal lumen diameter, late lumen loss, binary restenosis, and target lesion revascularization were comparable between groups. However, TVR and MACE were significantly higher in the DES group. Myocardial infarctions were infrequent and similar in both groups.Conclusion: DEB and repeat DES showed comparable six-month angiographic outcomes and target lesion revascularization rates. Higher TVR and MACE rates in the DES group may reflect baseline risk differences rather than a device-specific effect.

Discussion

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Cite This Study

Najim et al. (2026) conducted an observational in Coronary In-Stent Restenosis (n=200). Drug-eluting balloon (DEB) angioplasty vs. Repeat drug-eluting stent (DES) implantation was evaluated on Major adverse cardiac events (MACE), defined as the composite of target vessel revascularization, myocardial infarction, and all-cause death (p=0.042). Drug-eluting balloon angioplasty was associated with a significantly lower six-month rate of major adverse cardiac events compared to repeat drug-eluting stent implantation (16.0% vs 29.0%, p=0.042), though this likely reflects baseline risk differences.

synapsesocial.com/papers/6a31570faf7cf7f8256b3d39 https://doi.org/10.32894/kjms.2026.170766.1334

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Drug-Eluting Balloons Versus Stents for Coronary In-Stent Restenosis: Six-Month Clinical and Angiographic Outcomes

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Drug-Eluting Balloons Versus Stents for Coronary In-Stent Restenosis: Six-Month Clinical and Angiographic Outcomes

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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