Journal of Clinical Trials
Open Access

Abstract

Drug-Eluting vs. Bare-Metal Stents: Is it a Matter of Vessel Size?

Mohamed Mehdi Boussaada, Majed Hassine, Mejdi Ben Messaoud, Marouane Mahjoub, Zohra Dridi and Fethi Betbout

Background: Although drug-eluting stents (DES) for percutaneous coronary intervention have dramatically reduced the incidence of in-stent restenosis, their deployment for large-size coronary lesions is still controversial because of problems such as prolonged dual antiplatelet therapy, late in-stent thrombosis and costs.
Aim: This study sought to evaluate the safety and effectiveness of drug-eluting stents (DES) compared to baremetal stents (BMS) for patients with large coronary vessels ≥ 3.5 mm.
Methods: This is a retrospective case-control comparative study conducted in the cardiology A department of the university hospital Fattouma Bourguiba in Monastir. A total of 77 consecutive patients (80 lesions) who underwent, between October 2003 and March 2014, successfully DES implantation were compared to 73 consecutive patients (84 lesions) who were treated with BMS in large coronary vessels ≥ 3.5 mm.
Results: The average age in our population was 59.7 ± 11.3 years with a male majority without any significant difference between the two groups. The DES group contained significantly more patients with diabetes (67.5% vs. 38.1%; p<0.0001) and a history of coronary heart disease (40% vs. 16.7%; p=0.001). The BMS group had significantly more procedures in the aftermath of MI (18.8% vs. 40.5%; p=0.002) including more primary angioplasty (6.7% against 47.1%; p=0.006). About two-thirds of the study patients had multi-vessel disease with equal distribution in both groups. The average duration of dual antiplatelet therapy was significantly prolonged in the DES group: 13.01 ± 8.31 months vs. 7.59 ± 8.19 months; p<0.0001. A mean follow of 27.87 ± 14.82 months was obtained. At 12 months, DES led to a significant reduction in the combined rate of major cardiac events by about 70% (OR=0.32; 95% CI: 0.119 to 0.858; p=0.019) without allowing a significant reduction in the rates of in-stent restenosis, in-stent thrombosis, target vessel revascularization or non-combined major cardiac events. During longterm follow-up, the benefit of DES in terms of MACE was maintained by allowing a 60% reduction in the combined rate of major cardiac events (OR=0.406; 95% CI: 0.172 to 0.955; p=0.035). Multivariate analysis identified the BMS as an independent predictor of major cardiac events and death. However, the type of stent does not appear as a factor influencing the ISR and target lesion revascularization rates.
Conclusion: The results of our study demonstrate a clear clinical benefit of drug-eluting stents during angioplasty of large coronary arteries in reducing major cardiac events and death without having any effect on in-stent restenosis, in-stent thrombosis nor target lesion revascularization.