Multicenter Registry to Evaluate the Efficacy of the NIROYAL Stent
Multicenter Registry to Evaluate the Efficacy of the NIROYAL Stent
The purpose of this registry was to document the safety and efficacy of elective deployment of the NIROYAL stent (Boston Scientific SCIMED, Maple Grove, Minnesota) in coronary arteries. This was a prospective, multi-center international registry. NIROYAL stents (9, 16, 25 and 32 mm-long) were manually crimped onto coronary balloons and deployed in de novo or restenotic lesions in 165 male and female patients with angina pectoris and a reference vessel diameter of 2.0-4.5 mm.
Stent deployment was successful in 98.8% of the lesions. Mean percent diameter stenosis decreased from 83.5 ± 10.8% to 2.7 ± 6.2% after intervention. The interventional procedure of the treatment site was successful in 97.6% of patients. At six-month clinical follow-up, 88.5% had event-free survival [i.e., did not experience a major adverse cardiac event (MACE)] and 95.2% had no anginal symptoms. Furthermore, 87.3% of the patients were free of target vessel failure (defined as a composite of acute procedural failure, target vessel revascularization, myocardial infarction or death at six months). Only three MACE were observed within the first 30 days after stent implantation. A low left ventricular ejection fraction and the percentage stenosis pre-procedure were identified as statistically significant (p < 0.05) predictive factors for MACE.
The incidences of MACE and target vessel failure after six months follow-up were lower than that seen in other studies, and target lesion revascularization rates were low.
Insufficient perfusion of cardiac tissue often results from narrowing or stenosis of coronary arteries due to the presence of atheromatous plaques and/or vasospasm. Acute changes in the plaques may cause unstable angina, myocardial infarction (MI) and sudden death. Percutaneous transluminal coronary angioplasty (PTCA) has become a therapeutic alternative to surgery in treating many different types of coronary lesions. However, approximately 30-40% of lesions treated with PTCA result in restenosis within 3-6 months. Additionally, the vessel being dilatated may become occluded, which may result in myocardial infarction (3-4% of patients).
Coronary stenting has been shown to be an effective treatment for coronary stenosis, and for restoring coronary flow after coronary dissection and abrupt vessel closure. Randomized clinical trials have shown that there is a significant reduction in restenosis, reduced need for target lesion revascularization (TLR), and an improved rate of procedural success for stents compared to PTCA in the treatment of native de novo coronary artery lesions. For treatment of native restenotic lesions, randomized comparative trials have shown a significant reduction in the restenosis rate compared to balloon angioplasty. However, the overall incidence of major adverse cardiac events (MACE) at six-month follow-up is reported to be approximately 14-18%.
Since gold has a better visibility than stainless steel during fluoroscopy, it was felt that a gold stent would be easier to implant at the exact location of the target lesion. The NIROYAL gold stent was manufactured for this reason. This registry examined the effectiveness and safety of the NIROYAL gold stent in the elective treatment of coronary artery disease from the time of implantation up to six months post-implantation.
The purpose of this registry was to document the safety and efficacy of elective deployment of the NIROYAL stent (Boston Scientific SCIMED, Maple Grove, Minnesota) in coronary arteries. This was a prospective, multi-center international registry. NIROYAL stents (9, 16, 25 and 32 mm-long) were manually crimped onto coronary balloons and deployed in de novo or restenotic lesions in 165 male and female patients with angina pectoris and a reference vessel diameter of 2.0-4.5 mm.
Stent deployment was successful in 98.8% of the lesions. Mean percent diameter stenosis decreased from 83.5 ± 10.8% to 2.7 ± 6.2% after intervention. The interventional procedure of the treatment site was successful in 97.6% of patients. At six-month clinical follow-up, 88.5% had event-free survival [i.e., did not experience a major adverse cardiac event (MACE)] and 95.2% had no anginal symptoms. Furthermore, 87.3% of the patients were free of target vessel failure (defined as a composite of acute procedural failure, target vessel revascularization, myocardial infarction or death at six months). Only three MACE were observed within the first 30 days after stent implantation. A low left ventricular ejection fraction and the percentage stenosis pre-procedure were identified as statistically significant (p < 0.05) predictive factors for MACE.
The incidences of MACE and target vessel failure after six months follow-up were lower than that seen in other studies, and target lesion revascularization rates were low.
Insufficient perfusion of cardiac tissue often results from narrowing or stenosis of coronary arteries due to the presence of atheromatous plaques and/or vasospasm. Acute changes in the plaques may cause unstable angina, myocardial infarction (MI) and sudden death. Percutaneous transluminal coronary angioplasty (PTCA) has become a therapeutic alternative to surgery in treating many different types of coronary lesions. However, approximately 30-40% of lesions treated with PTCA result in restenosis within 3-6 months. Additionally, the vessel being dilatated may become occluded, which may result in myocardial infarction (3-4% of patients).
Coronary stenting has been shown to be an effective treatment for coronary stenosis, and for restoring coronary flow after coronary dissection and abrupt vessel closure. Randomized clinical trials have shown that there is a significant reduction in restenosis, reduced need for target lesion revascularization (TLR), and an improved rate of procedural success for stents compared to PTCA in the treatment of native de novo coronary artery lesions. For treatment of native restenotic lesions, randomized comparative trials have shown a significant reduction in the restenosis rate compared to balloon angioplasty. However, the overall incidence of major adverse cardiac events (MACE) at six-month follow-up is reported to be approximately 14-18%.
Since gold has a better visibility than stainless steel during fluoroscopy, it was felt that a gold stent would be easier to implant at the exact location of the target lesion. The NIROYAL gold stent was manufactured for this reason. This registry examined the effectiveness and safety of the NIROYAL gold stent in the elective treatment of coronary artery disease from the time of implantation up to six months post-implantation.
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