Objective: One of the drug-eluting stents that have been introduced into clinical practice is the paclitaxel-eluting stent (PES). Several randomised, controlled clinical trials have already been conducted to evaluate the safety and efficacy of this stent, but data regarding clinical practice are still lacking. The aim of this study was to evaluate the safety and efficacy of PESs in a 'real-world' population.
Methods: Two hundred and seventy-three patients with a high cardiovascular risk profile and complex coronary lesions were treated with PESs. Each patient was categorised using the following parameters: cardiovascular risk factors, clinical history, clinical presentation, angiographic pattern, and procedural characteristics. Primary endpoints were major adverse cardiac events (cardiovascular death, coronary artery bypass grafting, myocardial infarction, stroke, target vessel revascularisation, target lesion revascularisation, and remote revascularisation).
Results: A low rate of intraprocedural and periprocedural complications was observed. During the clinical follow-up period (mean 10.5 +/- 4.2 months), 78% of patients were event-free. Twenty-six patients (9.8%) underwent target vessel revascularisation, but only 11 of them (4.2%) had target lesion revascularisation. Seven patients (2.7%) had myocardial infarction, and cardiac death occurred in two patients (0.76%). Only one case (0.37%) of subacute stent thrombosis and one case of late stent thrombosis were observed.
Conclusions: The present study demonstrates that the use of PESs is safe and effective also in patients with a high cardiovascular risk profile and complex coronary lesions.