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A Comparison of a Drug Coated Balloon With Drug Eluting Stent Strategy for Treating Coronary Bifurcation Lesions
Natasha Corballis1,2, Ioannis Merinopoulos1,2, U Bhalraam2
1Department of Medicine, University of East Anglia, Norwich, UK.
Insights
Drug-coated balloons (DCB) offer a safe alternative for treating coronary bifurcation lesions (CBL), showing fewer adverse events compared to drug-eluting stents (DES). Further randomized controlled trials are needed to confirm these findings.
Area of Science:
- Cardiology
- Interventional Cardiology
- Vascular Medicine
Background:
- Coronary bifurcation lesions (CBL) present complex treatment challenges.
- Higher rates of adverse cardiovascular events are linked to anatomical and procedural complexity in CBL management.
Purpose of the Study:
- To compare procedural outcomes of drug-coated balloon (DCB) monotherapy versus second-generation drug-eluting stents (DES) for de novo CBL treatment.
- Evaluate the safety and efficacy of DCB-only approach in complex coronary interventions.
Main Methods:
- Retrospective analysis of patients with CBL treated with either DCB-only or DES-only strategies (2015-2019).
- Comparison of a bifurcation-oriented composite endpoint (BOCE) including cardiovascular death, target bifurcation-related myocardial infarction (TB-MI), and clinically driven target bifurcation revascularization (TBR).
- Propensity score-matched analysis of 2052 patients (1026 per arm) with a median follow-up of 3.6 years.
Main Results:
- The DCB group exhibited higher lesion complexity.
- Propensity-matched analysis revealed significantly fewer events in the DCB group (9.9%) compared to the DES group (14.0%) (HR: 1.39, p=0.01).
- This difference was primarily driven by lower rates of target bifurcation revascularization (TBR) (5.0% vs. 8.9%) and target bifurcation-related myocardial infarction (TB-MI) (1.6% vs. 3.0%) in the DCB arm.
Conclusions:
- DCB-only treatment is a safe alternative for coronary bifurcation lesions, based on this retrospective analysis.
- The findings suggest a potential benefit of DCB over DES in reducing adverse events for CBL.
- A well-designed randomized controlled trial (RCT) is warranted to validate these results.
Background:
The treatment of coronary bifurcation lesions (CBL) remains complex and associated with a higher rate of long-term adverse cardiovascular events due to anatomical and procedural complexity.
Aims:
We compared procedural outcomes between a drug coated balloon (DCB) only approach and a 2nd generation drug eluting stent (DES) for treating de novo CBLs.
Methods:
We retrospectively identified all patients with CBL treated with either a DCB only or DES only strategy, including all coronary bifurcations and compared a bifurcation-oriented composite endpoint (BOCE) of cardiovascular death, target bifurcation-related myocardial infarction (TB-MI), and clinically driven target bifurcation revascularization (TBR) using nationally obtained clinical outcome measures from 2015 to 2019. A propensity score matched analysis was undertaken.
Results:
Of 2113 patients, 1030 patients were treated with a DCB and 1083 with a DES. There was higher lesion complexity in the DCB group, and propensity score-matched analysis was utilized. This included a total of 2052 patients (1026 in each arm). The median age was 68 (59-75), and all clinical presentations were included. The median follow-up time was 3.6 (2.5-4.8) years with 501 (48.8%) patients having follow-up available at 5 years. Propensity matched analysis showed a significant increase in events (14.0% vs. 9.9% respectively) (HR: 1.39 [1.08-1.79], p = 0.01) when using DES compared to DCB, driven predominantly by an increase in TBR (8.9% vs. 5.0%) (HR: 1.79 [1.27-2.50], p ≤ 0.001) and TB-MI (3.0% vs. 1.6%) (HR: 1.92 [1.05-3.57], p 0.03).
Conclusions:
The use of DCB-only in a coronary bifurcation is a safe alternative in treating CBL, within the limitations of a retrospective single center analysis. An appropriately designed RCT is now required.
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