Drug-eluting balloons and drug-eluting stents in the treatment of small vessel coronary artery disease: a systematic review and metanalysis of long-term clinical and angiographic outcomes

Abstract

Introduction Coronary artery disease is a leading cause of mortality and morbidity worldwide. For those undergoing PCI, there are 20–30% with disease of the small coronary arteries on presentation [1]. Small coronary artery disease asserts a significant risk factor for adverse events. It is often diffuse and multi-vessel on presentation and confers higher rates of major adverse cardiac events, (MACE) and target lesion failure after intervention [2,3]. Best practice guidelines on the management of SvCAD interventions remain limited. Drug-eluting balloons are a novel therapy, which has shown promise in treating in-stent restenosis (ISR), however their use in small coronary arteries when compared to drug-eluting stents remains unclear. Purpose This systematic review and meta-analysis compare long-term outcomes (>1 year), of drug-eluting balloons (DEB), vs. drug-eluting stents (DES), in the treatment of small coronary artery disease (<3mm). Methods A systematic review was completed within PRISMA guidelines. The primary outcome was non-inferiority of DEB Vs. DES in major adverse cardiac events (MACE). Secondary outcomes include all-cause mortality, MI, vessel thrombosis, major bleeding and target vessel revascularization at one, two and three years follow-up. Two independent reviewers extracted data. All outcomes used the Mantel-Haenszel and Random effect model. Odds ratios (OR), were presented with a 95% confidence interval (CI). Result Of 4661 articles, four RCTs were included (1414 patients). DEB demonstrated reduced rates of non-fatal MI at one year, OR 0.44 (95% CI 0.2, 0.94) and Basket-2 small reported a significant reduction in two-year bleeding rates OR 0.3 (95% CI 0.1, 0.91). DEBs were non-inferior to DES for all other outcomes. Conclusion Long duration follow-up of DEB and DES use in small coronary arteries demonstrates DEB to be non-inferior to DES in all outcomes across all years of follow-up. There was a significant reduction in rates of non-fatal MI at one year in the DEB arm and a reduction in major bleeding episodes at two years in the Basket Small 2 trial. These data highlight the potential utility and long-term safety of novel DEBs in small coronary artery disease revascularization. Funding Acknowledgement Type of funding sources: None.

Comparison of Small Blood Vessels Diameter with Intravascular Ultrasound and Coronary Angiography for Guidance of Percutaneous Coronary Intervention

“…Small vessel coronary artery disease (SvCAD) is a significant risk factor for MACE in PCI; Currently there is no standardized vascular diameter to define small vessel disease, different thresholds of maximum lumen size have been described, that range from 2.25 to 3.0 mm (about 0.12 in). This lack of consensus causes heterogeneity both in the results of clinical studies and consequently discrepancies in the appropriate therapeutic approach [15]. SvCAD is often diffuse, and revascularization should only be performed in patients with confirmed ischemia and in hemodynamically significant lesions based on functional assessment [16].…”