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TCTAP A-002 Bioresorbable Vascular Scaffold in Real World Practice: Single Center Experiences
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 69, NO. 16, SUPPL S, 2017
ABSTRACTS
LBCT (TCTAP A-001 TO TCTAP A-006) TCTAP A-001 Thirty-day Clinical Outcomes Following Bioresorbable Vascular Scaffold Implantation in Patients Presenting with Acute Coronary Syndromes Versus Stable Coronary Artery Disease: Results from the Italian RAI Registry Elisabetta Moscarella,1 Attilio Varricchio,2 Alfonso Ielasi,3 Bernardo Cortese,4 Maria Carmen De Angelis,5 Bruno Loi,6 Giuseppe Tarantini,7 Francesco Pisano,8 Alessandro Durante,9 Michela Facchin,10 Alessandro Colombo,11 Luciano Moretti,12 Gabriele Tumminello,13 Paolo Calabrò,14 Donatella Corrado,15 Giuseppe Steffenino16 1 Second University of Naples AO Dei Colli, Italy; 2Monaldi Hospital, Naples, Italy; 3Bolognini Hospital Seriate, Italy; 4Fatebenefratelli Hospital, Milan, Italy; 5Ospedale Santa Maria della Pieta Nola, Italy; 6 Department of Cardiovascular Sciences, “Brotzu” Hospital, Cagliari, Italy; 7Department of Cardiac, Thoracic and Vascular Sciences, University Hospital of Padua, Padua, Italy; 8Division of Cardiology, “Parini” Regional Hospital, Aosta, Italy; 9Division of Cardiology, “Valduce” Hospital, Como, Italy; 10Division of Cardiology, “Riuniti Hospital Padova Sud”, Monselice (PD), Italy; 11Division of Cardiology, ASST Fatebenefratelli-Sacco, “Sacco” Hospital, Milan, Italy; 12 Division of Cardiology, “Mazzoni” Hospital, Ascoli Piceno, Italy; 13 Division of Cardiology, “Cardinal Massaia” Hospital, Asti, Italy; 14 Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero “Monaldi”, Italy; 15Istituto di Ricerche Farmacologiche Mario Negri”, Milan, Italy; 16S.Croce e Carle Hospital, Cuneo, Italy BACKGROUND Bioresorbable vascular scaffold (BVS) technology represents a revolutionary concept in interventional cardiology. It appears an attractive alternative to metallic drug-eluting stents and its use is rapidly extending even to complex lesions. However concerns have been raised to an increased risk of scaffold thrombosis (ST) that may be related to procedural factors as well as to patients’ characteristics. Acute coronary syndrome (ACS) has shown to increase the risk of drug eluting stent (DES) thrombosis and to date, data on PCI with BVS implantation in patients presenting with acute coronary syndromes (ACS) are still limited. We aimed to investigate the 30 months clinical outcome following BVS implantation in ACS versus stable coronary artery disease (CAD) patients. METHODS RAI (Clinical Trials. gov Identifier: NCT02298413) is an Italian, prospective, multicentre registry not funded by the manufacturer, whose aim is to investigate BVS performance through a 5-year follow-up of all consecutive patients who have undergone successful implantation of 1 or more BVS indifferent lesions subsets. Co-primary end-points were target lesion revascularization (TLR) and BVS definite/probable thrombosis. Secondary endpoint was the occurrence of device-oriented cardiac events (DOCE) including cardiac death, target lesion revascularization and target vessel myocardial infarction. The registry involved 23 centers, was started in October 2012 and the last patient was enrolled in December 2015. Here we report a 30-day clinical comparison between BVS use in ACS versus stable CAD patients. RESULTS Among the 1505 consecutive patients enrolled, 59.5% presented with ACS, of whom 36.5% were ST-elevation myocardial
S1
infarctions, while 40.5% with stable angina. Age, male gender and hypertension were more frequent in the stable CAD group; while smoking and history of previous MI were more frequent in the ACS group. All lesions were pre-dilated and no differences between ACS and stable CAD groups were noted in terms of TIMI 3 final flow (98.3 vs 97.9%; p¼0.5). Intracoronary imaging with Optical Coherence Tomography use didn’t differ between groups (5.8% vs 6.4%; p¼0.6), while Intravascular Ultrasound use was less frequent in ACS patients (5.2% vs 8.1%; p¼0.01). The periprocedural use of Bivalirudin and Glycoprotein IIb/IIIa Inhibitors was more frequent in the ACS group (3.5% vs 1.6%; p¼0.01 and 11.9% vs 2.9%; p0.001 respectively). At 30 days, no differences were found in terms of TLR (0.6% vs 0.7%; p¼0.8), definite/probable BVS thrombosis in (0.9% vs 0.7%, p¼0.6) and DOCE (0.8% vs 1.3%, p¼0.3) between ACS and stable CAD groups respectively. CONCLUSION Our data from a real-world population of consecutive patients suggest that the use of BVS in patients presenting with ACS is associated with good clinical outcome at short-term follow-up compared to stable CAD patients.
TCTAP A-002 Bioresorbable Vascular Scaffold in Real World Practice: Single Center Experiences Yi-Chih Wang,1 Jing-Yi Jhang,1 Cho-Kai Wu,1 Jen-Kuang Lee,1 Chia-Ti Tsai,1 Lian-Yu Lin,1 Ching-Chang Huang,1 Chih-Fan Yeh,1 Ying-Hsien Chen,1 Mao-Shin Lin,1 Yen-Hung Lin,1 Po-Yuan Chang,1 Paul Hsien-Li Kao,1 Chii-Ming Lee,1 Fu-Tien Chiang,1 Juey-Jen Hwang1 1 National Taiwan University Hospital, Taiwan BACKGROUND The procedural features, efficacy, and safety of using bioresorbable vascular scaffold (BVS) in the real world cases were necessary to be tested. METHODS We evaluated the procedural data from 369 patients (pts) receiving a total of 581 BVS implantation for their 426 coronary lesions in National Taiwan University Hospital between March 2014 and June 2016. Their ischemia-driven target lesion revascularization (TLR), target vessel failure (TVF: cardiac death, myocardial infarction, TLR), and definite/probable scaffold thrombosis were assessed at 30 days, 6 months, and 12 months. RESULTS The mean age of the whole pts was 60 12 (29-91) years with male preponderance (87%). Twenty-nine percent of pts were diabetic, and seventy-six percent had multivessel disease. BVS were implanted in 19 % of pts during acute coronary syndrome. Sixty-five percent of lesions were classified as type B2/C, and the LAD was the mostly treated vessel (50%). A wide lesion subtypes such as chronic total occlusion (8%), bifurcation (19%), intrastent restenosis (3%), and diffuse (overlapped by 2 BVS with each S18 mm, 30%) lesions were included. Intravascular ultrasound and optical coherence tomography were used in 27% and 9% of cases, respectively. To facilitate the BVS delivery, buddy wire technique and mother-and-child catheters were necessary for a total of 8% of the lesions. Post-dilatation by noncompliance balloons was done in more than 99% of the procedures. Besides the successful 369 cases, BVS was failed to be delivered in another 6 cases (1.6%). At follow-up, the rate of TLR/TVF at 30-days, 6-months, and 12-months were 0.3/0.3%, 1.1/1.4%, and 1.7/2.3%, respectively. There was no scaffold thrombosis during the follow-up period. CONCLUSION BVS implantation was feasible with great 1-year efficacy and safety for real-world pts with a wide spectrum of clinical features and lesion complexity. Special techniques or devices could be crucial for scaffold delivery in a substantial proportion of cases. Even though, the rate of scaffold delivery failure remained to be noticeable.
ABSTRACTS
LBCT (TCTAP A-001 TO TCTAP A-006) TCTAP A-001 Thirty-day Clinical Outcomes Following Bioresorbable Vascular Scaffold Implantation in Patients Presenting with Acute Coronary Syndromes Versus Stable Coronary Artery Disease: Results from the Italian RAI Registry Elisabetta Moscarella,1 Attilio Varricchio,2 Alfonso Ielasi,3 Bernardo Cortese,4 Maria Carmen De Angelis,5 Bruno Loi,6 Giuseppe Tarantini,7 Francesco Pisano,8 Alessandro Durante,9 Michela Facchin,10 Alessandro Colombo,11 Luciano Moretti,12 Gabriele Tumminello,13 Paolo Calabrò,14 Donatella Corrado,15 Giuseppe Steffenino16 1 Second University of Naples AO Dei Colli, Italy; 2Monaldi Hospital, Naples, Italy; 3Bolognini Hospital Seriate, Italy; 4Fatebenefratelli Hospital, Milan, Italy; 5Ospedale Santa Maria della Pieta Nola, Italy; 6 Department of Cardiovascular Sciences, “Brotzu” Hospital, Cagliari, Italy; 7Department of Cardiac, Thoracic and Vascular Sciences, University Hospital of Padua, Padua, Italy; 8Division of Cardiology, “Parini” Regional Hospital, Aosta, Italy; 9Division of Cardiology, “Valduce” Hospital, Como, Italy; 10Division of Cardiology, “Riuniti Hospital Padova Sud”, Monselice (PD), Italy; 11Division of Cardiology, ASST Fatebenefratelli-Sacco, “Sacco” Hospital, Milan, Italy; 12 Division of Cardiology, “Mazzoni” Hospital, Ascoli Piceno, Italy; 13 Division of Cardiology, “Cardinal Massaia” Hospital, Asti, Italy; 14 Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero “Monaldi”, Italy; 15Istituto di Ricerche Farmacologiche Mario Negri”, Milan, Italy; 16S.Croce e Carle Hospital, Cuneo, Italy BACKGROUND Bioresorbable vascular scaffold (BVS) technology represents a revolutionary concept in interventional cardiology. It appears an attractive alternative to metallic drug-eluting stents and its use is rapidly extending even to complex lesions. However concerns have been raised to an increased risk of scaffold thrombosis (ST) that may be related to procedural factors as well as to patients’ characteristics. Acute coronary syndrome (ACS) has shown to increase the risk of drug eluting stent (DES) thrombosis and to date, data on PCI with BVS implantation in patients presenting with acute coronary syndromes (ACS) are still limited. We aimed to investigate the 30 months clinical outcome following BVS implantation in ACS versus stable coronary artery disease (CAD) patients. METHODS RAI (Clinical Trials. gov Identifier: NCT02298413) is an Italian, prospective, multicentre registry not funded by the manufacturer, whose aim is to investigate BVS performance through a 5-year follow-up of all consecutive patients who have undergone successful implantation of 1 or more BVS indifferent lesions subsets. Co-primary end-points were target lesion revascularization (TLR) and BVS definite/probable thrombosis. Secondary endpoint was the occurrence of device-oriented cardiac events (DOCE) including cardiac death, target lesion revascularization and target vessel myocardial infarction. The registry involved 23 centers, was started in October 2012 and the last patient was enrolled in December 2015. Here we report a 30-day clinical comparison between BVS use in ACS versus stable CAD patients. RESULTS Among the 1505 consecutive patients enrolled, 59.5% presented with ACS, of whom 36.5% were ST-elevation myocardial
S1
infarctions, while 40.5% with stable angina. Age, male gender and hypertension were more frequent in the stable CAD group; while smoking and history of previous MI were more frequent in the ACS group. All lesions were pre-dilated and no differences between ACS and stable CAD groups were noted in terms of TIMI 3 final flow (98.3 vs 97.9%; p¼0.5). Intracoronary imaging with Optical Coherence Tomography use didn’t differ between groups (5.8% vs 6.4%; p¼0.6), while Intravascular Ultrasound use was less frequent in ACS patients (5.2% vs 8.1%; p¼0.01). The periprocedural use of Bivalirudin and Glycoprotein IIb/IIIa Inhibitors was more frequent in the ACS group (3.5% vs 1.6%; p¼0.01 and 11.9% vs 2.9%; p0.001 respectively). At 30 days, no differences were found in terms of TLR (0.6% vs 0.7%; p¼0.8), definite/probable BVS thrombosis in (0.9% vs 0.7%, p¼0.6) and DOCE (0.8% vs 1.3%, p¼0.3) between ACS and stable CAD groups respectively. CONCLUSION Our data from a real-world population of consecutive patients suggest that the use of BVS in patients presenting with ACS is associated with good clinical outcome at short-term follow-up compared to stable CAD patients.
TCTAP A-002 Bioresorbable Vascular Scaffold in Real World Practice: Single Center Experiences Yi-Chih Wang,1 Jing-Yi Jhang,1 Cho-Kai Wu,1 Jen-Kuang Lee,1 Chia-Ti Tsai,1 Lian-Yu Lin,1 Ching-Chang Huang,1 Chih-Fan Yeh,1 Ying-Hsien Chen,1 Mao-Shin Lin,1 Yen-Hung Lin,1 Po-Yuan Chang,1 Paul Hsien-Li Kao,1 Chii-Ming Lee,1 Fu-Tien Chiang,1 Juey-Jen Hwang1 1 National Taiwan University Hospital, Taiwan BACKGROUND The procedural features, efficacy, and safety of using bioresorbable vascular scaffold (BVS) in the real world cases were necessary to be tested. METHODS We evaluated the procedural data from 369 patients (pts) receiving a total of 581 BVS implantation for their 426 coronary lesions in National Taiwan University Hospital between March 2014 and June 2016. Their ischemia-driven target lesion revascularization (TLR), target vessel failure (TVF: cardiac death, myocardial infarction, TLR), and definite/probable scaffold thrombosis were assessed at 30 days, 6 months, and 12 months. RESULTS The mean age of the whole pts was 60 12 (29-91) years with male preponderance (87%). Twenty-nine percent of pts were diabetic, and seventy-six percent had multivessel disease. BVS were implanted in 19 % of pts during acute coronary syndrome. Sixty-five percent of lesions were classified as type B2/C, and the LAD was the mostly treated vessel (50%). A wide lesion subtypes such as chronic total occlusion (8%), bifurcation (19%), intrastent restenosis (3%), and diffuse (overlapped by 2 BVS with each S18 mm, 30%) lesions were included. Intravascular ultrasound and optical coherence tomography were used in 27% and 9% of cases, respectively. To facilitate the BVS delivery, buddy wire technique and mother-and-child catheters were necessary for a total of 8% of the lesions. Post-dilatation by noncompliance balloons was done in more than 99% of the procedures. Besides the successful 369 cases, BVS was failed to be delivered in another 6 cases (1.6%). At follow-up, the rate of TLR/TVF at 30-days, 6-months, and 12-months were 0.3/0.3%, 1.1/1.4%, and 1.7/2.3%, respectively. There was no scaffold thrombosis during the follow-up period. CONCLUSION BVS implantation was feasible with great 1-year efficacy and safety for real-world pts with a wide spectrum of clinical features and lesion complexity. Special techniques or devices could be crucial for scaffold delivery in a substantial proportion of cases. Even though, the rate of scaffold delivery failure remained to be noticeable.