Bioresorbable Vascular Scaffolds in Acute STEMI
Aims: Bioresorbable vascular scaffolds (BVSs) have been studied in chronic coronary artery disease, but not in acute ST-segment elevation myocardial infarction (STEMI). This prospective multicentre study analysed the feasibility and safety of BVS implantation during primary percutaneous coronary intervention (p-PCI) in STEMI.
Methods and results: Bioresorbable vascular scaffold implantation became the default strategy for all consecutive STEMI patients between 15 December 2012 and 30 August 2013. A total of 142 patients underwent p-PCI; 41 of them (28.9%) fulfilled the inclusion/exclusion criteria for BVS implantation. The BVS device success was 98%, thrombolysis in myocardial infarction 3 flow was restored in 95% of patients, and acute scaffold recoil was 9.7%. An optical coherence tomography (OCT) substudy (21 patients) demonstrated excellent procedural results with only a 1.1% rate of scaffold strut malapposition. Edge dissections were present in a 38% of patients, but were small and clinically silent. Reference vessel diameter measured by quantitative coronary angiography was significantly lower than that measured by OCT by 0.29 (±0.56) mm, P = 0.028. Clinical outcomes were compared between BVS group and Control group; the latter was formed by patients who had implanted metallic stent and were in Killip Class I or II. Combined clinical endpoint was defined as death, myocardial infarction, or target vessel revascularization. Event-free survival was the same in both groups; 95% for BVS and 93% for Control group, P = 0.674.
Conclusion: Bioresorbable vascular scaffold implantation in acute STEMI is feasible and safe. The procedural results evaluated by angiography and OCT are excellent. The early clinical results are encouraging.
Everolimus-eluting stents have been shown to have favourable outcomes superior to the first generation of drug-eluting stents (DES), to be comparable with other second-generation DES and to be associated with a very low risk of stent thrombosis. Despite these excellent outcomes achieved with the modern DES, cardiologists and researchers continue their search for a fully bioresorbable stent. The first-in-human drug-eluting fully bioresorbable vascular scaffold (BVS) was implanted in 2006 in New Zealand. Since then, BVSs have been shown to be safe and effective in chronic stable coronary artery disease. The BVS use has not yet been systematically investigated in the highly thrombogenic setting of acute myocardial infarction with ST-segment elevation myocardial infarction (STEMI). The potential advantages of implanting BVS ( vs. other DES) in STEMI may be related to the fact that STEMI patients are frequently younger, have less extensive coronary artery disease (compared with non-STE acute coronary syndromes) and may live many years after successful primary percutaneous coronary intervention (p-PCI) and thus derive the benefit of not having a permanent rigid metallic structure in their coronary arteries.
The aim of this prospective multicentre open-labelled study was to analyse the feasibility and safety of BVS implanted during p-PCI. Besides describing the performance of BVS in acute STEMI and the outcomes of STEMI patients with BVS implantation, the study was also focused on the practical question—what proportion of consecutive STEMI patients are suitable candidates for the Absorb BVS implantation? The study is planned for 3 years, with a clinical follow-up plus CT coronary angiography after 1 year and invasive coronary angiography with optical coherence tomography (OCT) after 3 years. This study presents the procedural angiographic plus imaging results and early (up to 6 months) clinical outcomes.
Abstract and Introduction
Abstract
Aims: Bioresorbable vascular scaffolds (BVSs) have been studied in chronic coronary artery disease, but not in acute ST-segment elevation myocardial infarction (STEMI). This prospective multicentre study analysed the feasibility and safety of BVS implantation during primary percutaneous coronary intervention (p-PCI) in STEMI.
Methods and results: Bioresorbable vascular scaffold implantation became the default strategy for all consecutive STEMI patients between 15 December 2012 and 30 August 2013. A total of 142 patients underwent p-PCI; 41 of them (28.9%) fulfilled the inclusion/exclusion criteria for BVS implantation. The BVS device success was 98%, thrombolysis in myocardial infarction 3 flow was restored in 95% of patients, and acute scaffold recoil was 9.7%. An optical coherence tomography (OCT) substudy (21 patients) demonstrated excellent procedural results with only a 1.1% rate of scaffold strut malapposition. Edge dissections were present in a 38% of patients, but were small and clinically silent. Reference vessel diameter measured by quantitative coronary angiography was significantly lower than that measured by OCT by 0.29 (±0.56) mm, P = 0.028. Clinical outcomes were compared between BVS group and Control group; the latter was formed by patients who had implanted metallic stent and were in Killip Class I or II. Combined clinical endpoint was defined as death, myocardial infarction, or target vessel revascularization. Event-free survival was the same in both groups; 95% for BVS and 93% for Control group, P = 0.674.
Conclusion: Bioresorbable vascular scaffold implantation in acute STEMI is feasible and safe. The procedural results evaluated by angiography and OCT are excellent. The early clinical results are encouraging.
Introduction
Everolimus-eluting stents have been shown to have favourable outcomes superior to the first generation of drug-eluting stents (DES), to be comparable with other second-generation DES and to be associated with a very low risk of stent thrombosis. Despite these excellent outcomes achieved with the modern DES, cardiologists and researchers continue their search for a fully bioresorbable stent. The first-in-human drug-eluting fully bioresorbable vascular scaffold (BVS) was implanted in 2006 in New Zealand. Since then, BVSs have been shown to be safe and effective in chronic stable coronary artery disease. The BVS use has not yet been systematically investigated in the highly thrombogenic setting of acute myocardial infarction with ST-segment elevation myocardial infarction (STEMI). The potential advantages of implanting BVS ( vs. other DES) in STEMI may be related to the fact that STEMI patients are frequently younger, have less extensive coronary artery disease (compared with non-STE acute coronary syndromes) and may live many years after successful primary percutaneous coronary intervention (p-PCI) and thus derive the benefit of not having a permanent rigid metallic structure in their coronary arteries.
The aim of this prospective multicentre open-labelled study was to analyse the feasibility and safety of BVS implanted during p-PCI. Besides describing the performance of BVS in acute STEMI and the outcomes of STEMI patients with BVS implantation, the study was also focused on the practical question—what proportion of consecutive STEMI patients are suitable candidates for the Absorb BVS implantation? The study is planned for 3 years, with a clinical follow-up plus CT coronary angiography after 1 year and invasive coronary angiography with optical coherence tomography (OCT) after 3 years. This study presents the procedural angiographic plus imaging results and early (up to 6 months) clinical outcomes.
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