NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

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1 NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE INTERVENTIONAL PROCEDURES PROGRAMME Interventional procedure overview of bioresorbable stent implantation for treating coronary artery disease In coronary artery disease the arteries supplying blood to the heart muscle become narrowed when fatty material (plaque) builds up in the artery walls. It can cause angina (chest pain on exertion) and heart attacks. The narrowings can be treated by inserting stents to widen the arteries. Unlike permanent metal stents, bioresorbable stents dissolve over time, reducing the risk of complications. Introduction The National Institute for Health and Care Excellence (NICE) has prepared this interventional procedure (IP) overview to help members of the Interventional Procedures Advisory Committee (IPAC) make recommendations about the safety and efficacy of an interventional procedure. It is based on a rapid review of the medical literature and specialist opinion. It should not be regarded as a definitive assessment of the procedure. Date prepared This IP overview was prepared in November Procedure name Bioresorbable stent implantation for treating coronary artery disease Specialist societies British Cardiovascular Intervention Society (BCIS) British Cardiovascular Society (BCS). IP overview: bioresorbable stent implantation for treating coronary artery disease 1 of 48

2 Description Indications and current treatment Coronary artery disease is narrowing (stenosis) of the coronary arteries caused by deposition of atherosclerotic plaque. This reduces blood flow to the heart muscle and is usually progressive. Symptoms of coronary artery disease typically include angina chest pain that is exacerbated by exertion. A critical reduction of the blood supply to the heart may result in myocardial infarction or death. The symptoms and health risks associated with a stenosed artery may be treated medically, by modifying risk factors (for example, smoking, hyperlipidaemia, obesity and hyperglycaemia) and by drug treatment (for example, beta-adrenergic blockers, nitrates, calcium-channel blockers, antiplatelet agents and statins). If medical management fails or is inappropriate, the usual options are surgical coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (usually with insertion of a bare metal or drug-eluting stent). Stents are inserted with a view to maintaining the patency of coronary arteries after balloon dilatation. What the procedure involves Bioresorbable stents are designed to be absorbed by the body over time. The aim is to reduce the risk of late complications such as thrombosis that may occur after the use of metal stents, and to reduce the need for long-term antiplatelet drugs, with their risk of bleeding complications. The procedure is usually done under local anaesthesia with fluoroscopic image guidance. The target coronary artery stenosis is dilated, using a percutaneous approach (typically balloon angioplasty over a guide wire via the femoral or radial artery). A bioresorbable stent mounted on a balloon catheter is then passed over the guide wire into the relevant segment of the artery. The stent is expanded by inflation of the balloon within it. The balloon is then deflated and removed with the guide wire. The stent is left in place to act as a scaffold holding the vessel open. Additional imaging, such as intravascular ultrasound and optical coherence tomography, is sometimes used to guide the procedure to optimise positioning and deployment of the stent in the target coronary artery. Bioresorbable stents are absorbed over time (for example, over 2 years). Some bioresorbable stents are also drug-eluting, with a view to reducing the risk of restenosis. Dual antiplatelet agents (for example, aspirin and clopidogrel) are usually prescribed for at least 6 months following the procedure. IP overview: bioresorbable stent implantation for treating coronary artery disease 2 of 48

3 Literature review Rapid review of literature The medical literature was searched to identify studies and reviews relevant to bioresorbable stent implantation for treating coronary artery disease. Searches were conducted of the following databases, covering the period from their commencement to 25 September 2013: MEDLINE, PREMEDLINE, EMBASE, Cochrane Library and other databases. Trial registries and the Internet were also searched. No language restriction was applied to the searches (see appendix C for details of search strategy). Relevant published studies identified during consultation or resolution that are published after this date may also be considered for inclusion. The following selection criteria (table 1) were applied to the abstracts identified by the literature search. Where selection criteria could not be determined from the abstracts the full paper was retrieved. Table 1 Inclusion criteria for identification of relevant studies Characteristic Publication type Patient Intervention/test Outcome Language Criteria Clinical studies were included. Emphasis was placed on identifying good quality studies. Abstracts were excluded where no clinical outcomes were reported, or where the paper was a review, editorial, or a laboratory or animal study. Conference abstracts were also excluded because of the difficulty of appraising study methodology, unless they reported specific adverse events that were not available in the published literature. Patients with coronary artery disease Bioresorbable stent implantation. Articles were retrieved if the abstract contained information relevant to the safety and/or efficacy. Non-English-language articles were excluded unless they were thought to add substantively to the English-language evidence base. List of studies included in the overview This overview is based on 1375 patients from 8 case series and 2 comparative case series and 1 conference abstract. One case series is reported as part of a post-hoc analysis. Other studies that were considered to be relevant to the procedure but were not included in the main extraction table (table 2) have been listed in appendix A. IP overview: bioresorbable stent implantation for treating coronary artery disease 3 of 48

4 Table 2 Summary of key efficacy and safety findings on bioresorbable stent implantation for treating coronary artery disease Abbreviations used: ACC, American College of Cardiology; ACS, acute coronary syndrome; AHA, American Heart Association; AMS, absorbable metallic stent; ARC, Academic Research Consortium; BVS, bioresorbable vascular scaffold; CABG, coronary artery bypass grafting; CK-MB, creatine kinase myocardial band; COPD, chronic obstructive pulmonary disease; DES, drug-eluting stent; DS, diameter stenosis; ID, ischaemia-driven; IHD, ischaemic heart disease; IVUS, intravascular ultrasound; LCA, left coronary artery; LCx, left circumflex artery; MACE, major adverse cardiac event; MI, myocardial infarction; PCI, percutaneous intervention; PLLA, Poly-l-Lactic-Acid; QCA, quantitative coronary angiography; RCA, right coronary artery; RVD, reference vessel diameter; TIMI, thrombolysis in myocardial infarction; TLR, target lesion revascularisation; TVR, target vessel revascularisation Study details Key efficacy findings Key safety findings Comments Onuma (2014) 1, Dudek (2012) 2, Onuma (2010) 3 Case series (ABSORB cohort A) Denmark, Netherlands, New Zealand, Poland Recruitment period: March July 2006 Study population: people with single de novo native coronary artery lesion. AHA/ACC lesion class: 60% B1, 40% B2 n = 30 Age: mean 62 years Sex: 60% (18/30) male Patient selection criteria: 18 or older with stable, unstable or silent ischaemia, lesion in native coronary artery 3.0 mm diameter, < than 8 mm in length for the 12 mm stent, or < 14 mm in length for the 18 mm stent (received by 2), and DS >50% and <100% with a TIMI flow grade of >1. Technique: ABSORB BVS 1.0 everolimuseluting PLLA polymer stent (Abbott Vascular) was implanted. Cypher sirolimus-eluting stent (Cordis USA) was used for additional stenting. Patients received aspirin 75 mg daily for study duration and clopidogrel 75 mg daily for a Number of patients analysed: 30 Device success (successful delivery and deployment of the stent at the intended target lesion with attainment of a final residual stenosis of <50% of the target lesion): 94% (29/31 stent implantation attempts in 30 patients). Procedure success (as for device success, with any adjunctive device without the occurrence of ischaemia related major adverse clinical events up to 7 days after the index procedure) : 100% (30/30) Bailout stenting (not regarded as a device failure): 7% (2/30) (in 1 patient device dislodged but was retrieved and a new device implanted; in 1 patient a device was implanted in a non-target lesion and a DES implanted in target lesion). Major Adverse Cardiac Events (MACE) 1 6 months (n=30) 4 years (n=29) Ischemia driven-mace (%)* 3.3 (1/30) 3.4 (1/29) Cardiac death (%) 0 0 Myocardial Infarction (MI) (%) Q-wave MI 0 0 Non-Q-wave MI (procedure related) 3.3 (1/30)^ 3.4 (1/29) (elevation of CK levels 2 x the upper limit of normal with elevated CK-MB) Ischaemia-driven TLR (%) (PCI/CABG at 0 0 target lesion associated with i) positive functional ischaemia study or ii) ischaemic symptoms and angiographic minimal lumen DS 50% or iii) DS 70%) Stent thrombosis 0 0 *defined by ARC as composite of cardiac death, myocardial infarction or Follow-up issues: 1 patient withdrew consent at 6 months follow-up and 2 patients died from non-cardiac causes (1 due to duodenal perforation at 760 days; 1 due to Hodgkin s disease at 888 days). Study follow-up now complete. Study design issues: All MACE events were adjudicated by an independent Clinical Events Committee and patient safety was monitored by a Data Safety Monitoring Board. 13.3% (4/30) of patients received a non-bvs stent in addition to the study device. These patients were included in the analysis of clinical Study population issues: Target vessel: LAD 47%, LCx 30%, RCA 23%. IP overview: bioresorbable stent implantation for treating coronary artery disease 4 of 48

5 Abbreviations used: ACC, American College of Cardiology; ACS, acute coronary syndrome; AHA, American Heart Association; AMS, absorbable metallic stent; ARC, Academic Research Consortium; BVS, bioresorbable vascular scaffold; CABG, coronary artery bypass grafting; CK-MB, creatine kinase myocardial band; COPD, chronic obstructive pulmonary disease; DES, drug-eluting stent; DS, diameter stenosis; ID, ischaemia-driven; IHD, ischaemic heart disease; IVUS, intravascular ultrasound; LCA, left coronary artery; LCx, left circumflex artery; MACE, major adverse cardiac event; MI, myocardial infarction; PCI, percutaneous intervention; PLLA, Poly-l-Lactic-Acid; QCA, quantitative coronary angiography; RCA, right coronary artery; RVD, reference vessel diameter; TIMI, thrombolysis in myocardial infarction; TLR, target lesion revascularisation; TVR, target vessel revascularisation Study details Key efficacy findings Key safety findings Comments minimum of 6 months. Follow-up: 5 years (median 1862 days) Conflict of interest/source of funding: Study sponsored and undertaken by Abbott Vascular. 2 authors are members of Abbott Vascular advisory board and 3 are employees. ischemia-driven target lesion revascularisation. ^ MI related to the treatment of a non-flow-limiting stenosis (QCA diameter stenosis 42%) at 46 days post procedure 1. Patient underwent TLR with DES. Additional non-ischaemia-driven target vessel revascularisation (TVR) for lesions with DS <50% 2 : 6.9% (2/29) Any TVR (including TLR above) 10.3% (3/29). 1 patient with BVS (in distal LCA) had angina at 106 days; a subtotal occlusion due to coronary spasms was found and treated with intracoronary nitrates and a metallic DES 5 mm proximal to the BVS (non-target lesion). Presented with recurrent angina at 5 years; day 1870: patent scaffolded segment (DS 35%) and stenosed branch treated with metallic EES (ID TVR) 1 patient with BVS in LAD had stable angina class II. On day 85 angiography disclosed moderate non-significant stenosis in the LAD. This was treated with a DES proximal to the patent BVS. Antiplatelet therapy 1,2 At 1 year, 52% (15/29) were on dual antiplatelet therapy, at 2 years all but 1 patient had discontinued clopidogrel and at 4 years, clopidogrel therapy had been discontinued in all patients. At 5 years, clopidogrel was discontinued in all but 1 patient (restarted due to repeat PCI in non-target lesion of intermediate branch while scaffolded segment patent). IP overview: bioresorbable stent implantation for treating coronary artery disease 5 of 48

6 Abbreviations used: ACC, American College of Cardiology; ACS, acute coronary syndrome; AHA, American Heart Association; AMS, absorbable metallic stent; ARC, Academic Research Consortium; BVS, bioresorbable vascular scaffold; CABG, coronary artery bypass grafting; CK-MB, creatine kinase myocardial band; COPD, chronic obstructive pulmonary disease; DES, drug-eluting stent; DS, diameter stenosis; ID, ischaemia-driven; IHD, ischaemic heart disease; IVUS, intravascular ultrasound; LCA, left coronary artery; LCx, left circumflex artery; MACE, major adverse cardiac event; MI, myocardial infarction; PCI, percutaneous intervention; PLLA, Poly-l-Lactic-Acid; QCA, quantitative coronary angiography; RCA, right coronary artery; RVD, reference vessel diameter; TIMI, thrombolysis in myocardial infarction; TLR, target lesion revascularisation; TVR, target vessel revascularisation Study details Key efficacy findings Key safety findings Comments Serruys, ; Ormiston, Serruys Number of patients analysed: 101 (45 B1; 56 B2) Adverse events at 2 Follow-up issues: and 3 years Case series (ABSORB cohort B) New Zealand, Netherlands, Belgium, Poland, Denmark, France, Switzerland, Australia. Recruitment period: Not reported. Study population: Patients with a maximum of 2 de novo native coronary artery lesions in 2 major epicardial vessels. AHA/ACC lesion class: 1% A, 55% B1, 40% B2 and 4% C. n = 101 (45 B1 3 ; 56 B2; 57 stents 4 ) Age: mean 62 years Sex: 72% (73/101) male Patient selection criteria: Lesions in a coronary artery with 3.0 mm diameter and 14 mm length, diameter stenosis 50% and <100%, and a TIMI flow grade of >1. Technique: Second generation ABSORB BVS 1.1 (Abbott Vascular) everolimus eluting PLLA polymer stent implanted. Post-dilation done with balloon shorter than the implanted stent at operator discretion. Bailout stenting done with Xience V. clopidogrel 75 mg daily for a minimum of 6 months. Aspirin continued lifelong. Follow-up: 2 years Conflict of interest/source of funding: Sponsored Device success (successful delivery and deployment of the stent at the intended target lesion with attainment of a final residual stenosis of <50% of the target lesion): 100% in cohorts 1 and 2 Procedural success (as for device success, with any adjunctive device without the occurrence of ID-MACE during the hospital stay with a maximum of the first 7 days after index procedure): 100% in cohort 1 and 2 Bailout stenting in cohorts B1 and B2: bailout stenting for edge dissection or insufficient coverage of the lesion: 6% (6/101) of patients. Pooled clinical results of cohorts B1 and B2 at 3 years (n=100) MACE (cardiac death, MI or ID-TLR) 10 Cardiac death 0 Any MI (mainly non Q-wave = (elevation of CK levels 2 x the upper limit of normal with elevated CK-MB) (1) Transient occlusion of vessel because of incomplete coverage of the dissection by the bioresorbable stent. Bailout stenting done using a metallic DES (in cohort B1). (2) Peri-procedural dissection occurred after pre-dilation. Symptoms resolved with medical therapy and at follow-up the vessel was widely patent (in cohort B2). (3) On day 43 angiography for chest pain showed iatrogenic intra-scaffold thrombus. Treated with an aspiration extraction device, multiple doses of IV heparin and a non-id TVR. At follow-up the vessel was widely patent (in cohort B1). Ischaemia-driven TLR (PCI/CABG at target lesion associated with i) positive functional ischaemia study or ii) ischaemic symptoms and angiographic minimal lumen DS 50% or iii) DS 70%) (1) distal lesion between 1 and 2 years,treated by a CABG day 439 and developed unstable angina treated with a Promus Element covering the distal part of the scaffold (2) restenosis on day 567 (presented with unstable angina on day 564), Xience V stent, no restenosis at 3 years 3 (3/100) 6 (6/100) Deaths 0 Scaffold thrombosis (definite/pro bable) % (n) 0 Cohort B1: 6- and 24- month follow-up. Cohort B2 planned follow-up at 12 and 36 months. One patient withdrew consent for follow-up by 3 years but vital status available through referring physician Study design issues: All events were adjudicated by an independent clinical event committee. In total, additional metallic DES were implanted in 3 lesions. The comparative data reported is presented as hypothesis-generating only. Study population issues: Target vessel: LAD 43%, LCx 24%, RCA 34% Other issues: Bailout stenting was not considered a device failure. IP overview: bioresorbable stent implantation for treating coronary artery disease 6 of 48

7 Abbreviations used: ACC, American College of Cardiology; ACS, acute coronary syndrome; AHA, American Heart Association; AMS, absorbable metallic stent; ARC, Academic Research Consortium; BVS, bioresorbable vascular scaffold; CABG, coronary artery bypass grafting; CK-MB, creatine kinase myocardial band; COPD, chronic obstructive pulmonary disease; DES, drug-eluting stent; DS, diameter stenosis; ID, ischaemia-driven; IHD, ischaemic heart disease; IVUS, intravascular ultrasound; LCA, left coronary artery; LCx, left circumflex artery; MACE, major adverse cardiac event; MI, myocardial infarction; PCI, percutaneous intervention; PLLA, Poly-l-Lactic-Acid; QCA, quantitative coronary angiography; RCA, right coronary artery; RVD, reference vessel diameter; TIMI, thrombolysis in myocardial infarction; TLR, target lesion revascularisation; TVR, target vessel revascularisation Study details Key efficacy findings Key safety findings Comments by Abbott Vascular. Guest editor received institutional research grants from several device and pharmaceutical companies including manufacturer. Several authors are employees and the other authors report no conflicts of interest. 3) Patient had dynamic stenosis due to myocardial bridge. Recurrent angina at 2 months (DS 85%), Xience V stent implanted in previously treated LAD. (4) Severe exertional angina at 12 months had restenosis in the scaffold segment (5) Iatrogenic proximal edge stenosis (64%) at 6 months due to deep engagement of catheter at index procedure (6) Recurrent angina 12 months due to proximal edge restenosis (7) Recurrent stable angina and day 833 coronary angiography showed mid-lad scaffold restenosis, treated with Xience V stent Further non-id TLR (1-3 years) * 1 patient had persistent incomplete strut apposition on OCT without ischaemia. * 1 patient had new stenosis in proximal LAD without binary restenosis in scaffold on day 722 Comparative data (survival analysis) reported When compared with 227 patients receiving single device with identical length and diameter in the SPIRIT I, II and III trials of EES. At 1123 days: Cumulative events: 9.9% vs 11.4% Hazard ratio: ; p = ) Antiplatelet therapy Dual antiplatelet therapy was received by 97% (98/101) at 6 months, 81.2% (82/101) at 12 months, 24.0% (24/101) at 24 months and 21.6% at 36 months follow-up. Time for complete absorption estimated to be approximately 2 years. Authors report that myocardial bridging should be a contraindication for treatment with a bioresorbable scaffold. 2 patients with a myocardial bridge were included in Cohort B2; 1 had ID-TLR at 3 months and 1 was asymptomatic but had aggravation of late loss from 1-3 years. Transient total occlusion triggered by intracoronary acetylcholine and relieved by intracoronary nitrate. IP overview: bioresorbable stent implantation for treating coronary artery disease 7 of 48

8 Abbreviations used: ACC, American College of Cardiology; ACS, acute coronary syndrome; AHA, American Heart Association; AMS, absorbable metallic stent; ARC, Academic Research Consortium; BVS, bioresorbable vascular scaffold; CABG, coronary artery bypass grafting; CK-MB, creatine kinase myocardial band; COPD, chronic obstructive pulmonary disease; DES, drug-eluting stent; DS, diameter stenosis; ID, ischaemia-driven; IHD, ischaemic heart disease; IVUS, intravascular ultrasound; LCA, left coronary artery; LCx, left circumflex artery; MACE, major adverse cardiac event; MI, myocardial infarction; PCI, percutaneous intervention; PLLA, Poly-l-Lactic-Acid; QCA, quantitative coronary angiography; RCA, right coronary artery; RVD, reference vessel diameter; TIMI, thrombolysis in myocardial infarction; TLR, target lesion revascularisation; TVR, target vessel revascularisation Study details Key efficacy findings Key safety findings Comments Nishio (2012) 7 Number of patients analysed: 50 Adverse events Follow-up issues: Case series Japan (single centre) Recruitment period: September 1998 and April 2000 Study population: With stable IHD with a lesion that could be treated by implantation of the Igaki-Tamai stent. AHA/ACC lesion class: 25% B1, 57% B2, 18% C. n=50 patients (63 lesions; 84 stents; 57 procedures) Age: mean 61 years Sex: 88% (44/50) male Patient selection criteria: For prevention of restenosis in a de novo lesion, restenosis of a major coronary artery after plain balloon angioplasty, and suboptimal results after plain balloon angioplasty and elective selection. Technique: lesions dilated by an optimally sized balloon or debulked by directional (n=14) or rotational atherectomy (n=2). The Igaki-Tamai stent (non-drug-eluting PLLA polymer) (Kyoto Medical Planning Company) deployed by balloon inflation through heated contrasts of 80 degrees. Stent size decided by IVUS, and multiple stentings performed, depending on lesion length. Postdilatation performed if Procedural and angiographic success*: 100% (*residual stenosis <50% with TIMI grade 3). Survival rates (Kaplan-Meier event-free analysis) (n=50) At 10-year follow-up Free from all-cause death 87 (77-97) Free from cardiac death 98 (94-100) Free from MACE* 50 (36-64) % (95% Confidence Interval) *included cardiac death, non-cardiac death, non-fatal MI, TLR and TVR. Cumulative TLR and TVR rates per patient Cumulative rates TLR per patient: % (95%CI) At 1 and 3 years 16 (6-26) 16 (6-26) TVR per patient: % (95% CI) At 5 years 18 (7-29) 22 (11-33) At 10 years 28 (15-40) 38 (24-52) Cumulative rates of MACE** during 10 year follow-up (n=50) Cardiac deaths (at 57 months) Non-cardiac death (stroke-2, lung cancer-2, COPD-1, pneumonia-1) Scaffold thrombosis^ (Subacute) Scaffold thrombosis (very late at 10 years)^^ In-hospital % (n) Long-Term % (n) Total % (n) 0 2 (1/50) 2 (1/50) 0 12 (6/50) 12 (6/50) 2 (1/50) 0 2 (1/50) 0 2 (1/50) 2 (1/50) Lesion-related MI 2 (1/50) 2 (1/50) 4 (2/50) Non-fatal non-lesion related 0 4 (2/50) 4 (2/50) Sub-acute scaffold thrombosis occurred in 1 patient on postoperative day 5 (due to cessation of antiplatelet therapy after acute haemorrhagic gastric ulcer). The patient suffered a non-fatal lesion-related MI (despite PCI). High follow-up: 100% at 4 years, 98% at 7 years and 96% at 10 years (2 patients lost to follow-up). Study design issues: Prospective observational study. Unclear how patients were recruited. Small sample size. Primary purpose was to assess the long-term safety of Igaki-Tamai stents. No clinical events committee or independent core laboratories. Clinical data obtained by either telephone interviews or medical record review. 10-year clinical follow-up was not planned at the beginning of study. Stents did not disappear by 6 months therefore all patients underwent angiography at 1 and/or 2 years and then as clinically indicated. Scaffold thrombosis was considered even if the implanted stent was completely biodegraded IP overview: bioresorbable stent implantation for treating coronary artery disease 8 of 48

9 Abbreviations used: ACC, American College of Cardiology; ACS, acute coronary syndrome; AHA, American Heart Association; AMS, absorbable metallic stent; ARC, Academic Research Consortium; BVS, bioresorbable vascular scaffold; CABG, coronary artery bypass grafting; CK-MB, creatine kinase myocardial band; COPD, chronic obstructive pulmonary disease; DES, drug-eluting stent; DS, diameter stenosis; ID, ischaemia-driven; IHD, ischaemic heart disease; IVUS, intravascular ultrasound; LCA, left coronary artery; LCx, left circumflex artery; MACE, major adverse cardiac event; MI, myocardial infarction; PCI, percutaneous intervention; PLLA, Poly-l-Lactic-Acid; QCA, quantitative coronary angiography; RCA, right coronary artery; RVD, reference vessel diameter; TIMI, thrombolysis in myocardial infarction; TLR, target lesion revascularisation; TVR, target vessel revascularisation Study details Key efficacy findings Key safety findings Comments needed. Patients received aspirin for at least 6 months and ticlodipine for 1 month. Follow-up: mean 121 months Conflict of interest/source of funding: Dr Igaki is the developer of this stent and Kyoto Medical Planning Company has commercialised the technology. The data were analysed independently from Dr Igaki. The other authors report no conflicts. MI TLR * 2 (1/50) 26 (13/50) 28 (14/50) TVR* 2 (1/50) 40 (20/50) 42 (21/50) * requiring PCI but not CABG ** MACE included cardiac death, non-cardiac death, non-fatal MI, TLR and TVR ^ further details reported under safety section. ^^ Very late scaffold thrombosis (at 10 years): occurred in 1 patient admitted with ACS. Angiography revealed a massive thrombus within the DES implanted for a lesion proximal to the bioresorbable stent and a smaller amount in the lesion where the 2 bioresorbable stents had been implanted before. After thrombus aspiration, IVUS showed residual thrombus in DES and balloon angioplasty was needed for this lesion. This occurred in the same patient who had sub-acute scaffold thrombosis and suffered a non-fatal MI. Other: and thrombus was observed in the scaffolded lesion. The study reported that stent struts mostly disappeared within 3 years. Technology to implant these stents (such as delivery systems, use of normal contrast media) has evolved over time. Antiplatelet therapy Dual antiplatelet therapy was 36% (18/48) at 1 month, 30% (15/48) at 2-3 months, 20% (10/48) at 4-12 months, and 10% (5/48) at months. It was restarted in 4 patients within 3 years due to additional metallic stents or cerebral infarction. IP overview: bioresorbable stent implantation for treating coronary artery disease 9 of 48

10 Abbreviations used: ACC, American College of Cardiology; ACS, acute coronary syndrome; AHA, American Heart Association; AMS, absorbable metallic stent; ARC, Academic Research Consortium; BVS, bioresorbable vascular scaffold; CABG, coronary artery bypass grafting; CK-MB, creatine kinase myocardial band; COPD, chronic obstructive pulmonary disease; DES, drug-eluting stent; DS, diameter stenosis; ID, ischaemia-driven; IHD, ischaemic heart disease; IVUS, intravascular ultrasound; LCA, left coronary artery; LCx, left circumflex artery; MACE, major adverse cardiac event; MI, myocardial infarction; PCI, percutaneous intervention; PLLA, Poly-l-Lactic-Acid; QCA, quantitative coronary angiography; RCA, right coronary artery; RVD, reference vessel diameter; TIMI, thrombolysis in myocardial infarction; TLR, target lesion revascularisation; TVR, target vessel revascularisation Study details Key efficacy findings Key safety findings Comments Erbel, : PROGRESS-AMS Case series (multicentre-8) USA, Germany, UK, Belgium, Switzerland, the Netherlands and Australia. Recruitment period: Not reported Study population: Patients with single de novo lesions in a native coronary artery. AHA/ACC lesion class: 49.2% A, 42.8% B1, 7.9% B2 n=63 (71 stents) Age: Mean 61.3 years Sex: 70% (44/63) male Patient selection criteria: Symptomatic IHD or silent ischaemia, a discrete de novo lesion in a coronary artery with a RVD 3.0mm-3.5mm, lesion length 13 mm with DS 50-99%. Technique: first-generation absorbable magnesium alloy paclitaxel-eluting stents (AMS) (BIOTRONIK) mm in length and mm in diameter were implanted. Post-dilatation done if the final internal segment diameter was not visually RVD. A second absorbable metal stent was placed for proximal or distal dissection. 75 mg/100 mg aspirin and 75 mg clopidogrel daily for at least 4 months and use of glycoprotein IIb/IIIa inhibitors was left to the operator s discretion. Follow-up: 12 months Conflict of interest/source of funding: sponsored by Biotronik, several authors acted as consultants for Biotronik. Data collection by an independent institution. Number of patients analysed: 63 Procedural success (attainment of <50% final residual DS of target segment using PCI without in-hospital MACE) and device success (procedure success plus index stent deployed in the target lesion): 100% Clinical performance Hospital stay % (n- 63) 4 months % (n=63) MACE* (15/63) Death, MI, stent thrombosis 4-12 months % (n=60) 12 month cumulative % (n=60) 3.3 (2/60) 26.7 (16/60) Total TLR 1.6 (1/63) 39.7 (25/63) PCI TLR 1.6 (1/63) 38.1 (24/63) 5.0 (3/60) 45.0 (27/60) 5.0 (3/60) 43.3 (26/60) CABG TLR 0 (0) 1.6 (1/63) 0 (0) 1.7 (1/60) Ischaemicdriven TLR^ 0 (0) 23.8 (15/63) Total TVR 1.6 (1/63) 39.7 (25/63) PCI TVR 1.6 (1/636) 38.1 (24/63) 3.3 (2/60) 26.7 (16/60) 5.0 (3/60) 45 (27/60) 5.0 (3/60) 43.3 (26/60) CABG TVR 0 (0) 1.6 (1/63) 0 (0) 1.7 (1/60) Ischaemic driven TVR 0 (0) 23.8 (15/63) * defined as cardiac death, Q-wave MI, TLR 3.3 (2/60) 26.7 (16/60) ^ defined as repeat PCI of target lesion or bypass surgery of target vessel, in patients with a positive function, or angina symptoms, or in lesion DS of 50-70%.Q-wave MI: new pathological Q waves in 2+ contiguous leads with raised post-procedure CK or CK-MB. Follow-up issues: At 4 months, angina status of 2 patients was not available and another patient withdrew from study before the 12 months. Clinical event data was unavailable at 12 months for 5% (3/63) patients. Study design issues: Primary endpoints were cardiac death, non-fatal MI or clinically driven TLR at 4 months. All serious events and all predefined major adverse cardiac events were reviewed by an independent Clinical Event Committee and Data Safety Monitoring Board. Study population issues: Target vessels: LAD 34.9%, Circumflex 28.6%, RCA 36.5% IP overview: bioresorbable stent implantation for treating coronary artery disease 10 of 48

11 Abbreviations used: ACC, American College of Cardiology; ACS, acute coronary syndrome; AHA, American Heart Association; AMS, absorbable metallic stent; ARC, Academic Research Consortium; BVS, bioresorbable vascular scaffold; CABG, coronary artery bypass grafting; CK-MB, creatine kinase myocardial band; COPD, chronic obstructive pulmonary disease; DES, drug-eluting stent; DS, diameter stenosis; ID, ischaemia-driven; IHD, ischaemic heart disease; IVUS, intravascular ultrasound; LCA, left coronary artery; LCx, left circumflex artery; MACE, major adverse cardiac event; MI, myocardial infarction; PCI, percutaneous intervention; PLLA, Poly-l-Lactic-Acid; QCA, quantitative coronary angiography; RCA, right coronary artery; RVD, reference vessel diameter; TIMI, thrombolysis in myocardial infarction; TLR, target lesion revascularisation; TVR, target vessel revascularisation Study details Key efficacy findings Key safety findings Comments Ishibashi (2014) 9 Number of patients analysed: 450 Case series (Absorb extend) Netherlands, Belgium, Australia, Brazil Recruitment period: Study population: patients with up to 2 de novo native coronary artery lesions permitted if each lesion is located in a different epicardial vessel. n = 450 Age: Not reported. Sex: Not reported. Patient selection criteria: > 18 years, target lesions in a major epicardial vessel or side branch with stenosis of 50% and <100% and a TIMI flow grade of 1, diameter mm and length 28 mm. Technique: Absorb everolimus-eluting PLLA bioresorbable vascular scaffold (BVS) system (Abbott Vascular, Santa Clara, CA, USA) implanted. Post-dilation carried out according to operator discretion and with balloons fitting within the boundaries of the scaffold/stent. Follow-up: 12 months Conflict of interest/source of funding: None. % (n) Ischaemia-driven MACE 4.2 (19/4 50) Target vessel failure 4.7 (21/4 50) n (%) Device failure 1.5 (7/450) Scaffold dislodgement a, 0.7 (3/450) 1) At site of calcification during repeated attempts. 2 overlapping EES used to crush device against vessel wall and 1 EES deployed to target lesion. Uneventful follow-up. 2) During procedure; GooseNeck snare retrieval failed and device pushed into previous metallic stent in LAD. Balloon inflated to crush device and EES deployed at target lesion. At 5 months: severe proximal LAD and LCx stenosis noted referred for surgical treatment. 3) During repeated attempts to deploy device inside GuideLiner guidewire used. EES deployed at target lesion. Sudden death at home at 3 months (adjudicated as possible stent thrombosis). Subacute scaffold thrombosis 1) Non-STEMI at 6 days treated with thrombolysis. Thrombotic lesion at site of 2 overlapping scaffolds. EES implanted to cover lesion and overlapping segment of 0.4 (2/450) Study population issues: The ABSORB EXTEND study aimed to recruit 800 patients. This paper reports on the first 450 patients enrolled. Lesions: mean lesion length: 11.6 mm; type B2/C ACC/AHA lesions: 38.6%; calcification: 13.2%. Other issues: Previous paper on ABSORB EXTEND trial also reported in Table 2. IP overview: bioresorbable stent implantation for treating coronary artery disease 11 of 48

12 Abbreviations used: ACC, American College of Cardiology; ACS, acute coronary syndrome; AHA, American Heart Association; AMS, absorbable metallic stent; ARC, Academic Research Consortium; BVS, bioresorbable vascular scaffold; CABG, coronary artery bypass grafting; CK-MB, creatine kinase myocardial band; COPD, chronic obstructive pulmonary disease; DES, drug-eluting stent; DS, diameter stenosis; ID, ischaemia-driven; IHD, ischaemic heart disease; IVUS, intravascular ultrasound; LCA, left coronary artery; LCx, left circumflex artery; MACE, major adverse cardiac event; MI, myocardial infarction; PCI, percutaneous intervention; PLLA, Poly-l-Lactic-Acid; QCA, quantitative coronary angiography; RCA, right coronary artery; RVD, reference vessel diameter; TIMI, thrombolysis in myocardial infarction; TLR, target lesion revascularisation; TVR, target vessel revascularisation Study details Key efficacy findings Key safety findings Comments scaffolds. 2) on day 27: patient stopped taking DAPT. Two days later had non-stemi treated by thrombolysis. DAPT restarted and follow-up uneventful. Late scaffold thrombosis 1) On day 75: acute anterior STEMI thrombotic occlusion of LAD proximal to scaffold. Treated with primary PCI with manual thrombectomy and balloon dilatation. Patient reported taking DAPT - 150mg daily dose of clopidogrel and follow-up uneventful. 2) On day 239 following a bee sting, acute anterior STEMI whilst on DAPT. Total occlusion of LAD proximal to device. Treated with manual thrombectomy and EES deployed. 0.4 (2/450) a All occurred in the LCx and 2 were observed after reinsertion of the same device. IP overview: bioresorbable stent implantation for treating coronary artery disease 12 of 48

13 Abbreviations used: ACC, American College of Cardiology; ACS, acute coronary syndrome; AHA, American Heart Association; AMS, absorbable metallic stent; ARC, Academic Research Consortium; BVS, bioresorbable vascular scaffold; CABG, coronary artery bypass grafting; CK-MB, creatine kinase myocardial band; COPD, chronic obstructive pulmonary disease; DES, drug-eluting stent; DS, diameter stenosis; ID, ischaemia-driven; IHD, ischaemic heart disease; IVUS, intravascular ultrasound; LCA, left coronary artery; LCx, left circumflex artery; MACE, major adverse cardiac event; MI, myocardial infarction; PCI, percutaneous intervention; PLLA, Poly-l-Lactic-Acid; QCA, quantitative coronary angiography; RCA, right coronary artery; RVD, reference vessel diameter; TIMI, thrombolysis in myocardial infarction; TLR, target lesion revascularisation; TVR, target vessel revascularisation Study details Key efficacy findings Key safety findings Comments Kajiya T (2013) 10 Number of patients analysed: 11 Adverse events Follow-up issues: Case series Singapore Recruitment period: October 2012 April 2013 Study population: Primary percutaneous coronary intervention (PCI) in patients with ST elevation myocardial infarction (STEMI). n=11 Age: mean 49.5 years Sex: 81.8% (9/11) male Patient selection criteria: patients with appropriate insurance and financial means. Technique: ABSORB BVS 1.1 (Abbott Vascular) was used. Primary PCI performed with intent for BVS using a 6Fr guide catheter with initial thrombus aspiration. Dual antiplatelet therapy was started at presentation to the emergency department as per institution protocol. Transradial approach used in 90.9% of cases. Follow-up: Median 53 days Conflict of interest/source of funding: None. Procedure success (n=11) Primary PCI was performed in all patients with 100% procedure success and thromboaspiration. Post-dilatation was reported in 90.9% (10/11) patients. MACE* and Left Ventricular Ejection Fraction (LVEF) during 1-month follow-up LVEF post PCI (%) 50.6+/-17.5 MACE rate (%) 9.1 (1/11) TVR 0 MI 0 *defined as cardiac death, myocardial infarction, and target vessel revascularisation Death (not BVS related): 1 patient collapsed and admitted with cardiogenic shock, PCI performed but despite inotropic support and therapeutic hypothermia, patient died after procedure. No acute or subacute stent thrombosis at short term follow-up. Follow-up at routine clinic visits after 1 month and by telephone consultations. Short follow-up. Study design issues: The aim of the study was to assess the impact of the BVS in the setting of primary PCI in patients with STEMI. There was no specified study protocol. Very small sample size. Study population issues: Target vessel: LAD 63.6% (n=7), LCx 18.2% (n=2), RCA 18.2% (n=2). Other issues: Patients considered for implantation were generally younger and the procedure was performed by operators with prior experience in its use. IP overview: bioresorbable stent implantation for treating coronary artery disease 13 of 48

14 Abbreviations used: ACC, American College of Cardiology; ACS, acute coronary syndrome; AHA, American Heart Association; AMS, absorbable metallic stent; ARC, Academic Research Consortium; BVS, bioresorbable vascular scaffold; CABG, coronary artery bypass grafting; CK-MB, creatine kinase myocardial band; COPD, chronic obstructive pulmonary disease; DES, drug-eluting stent; DS, diameter stenosis; ID, ischaemia-driven; IHD, ischaemic heart disease; IVUS, intravascular ultrasound; LCA, left coronary artery; LCx, left circumflex artery; MACE, major adverse cardiac event; MI, myocardial infarction; PCI, percutaneous intervention; PLLA, Poly-l-Lactic-Acid; QCA, quantitative coronary angiography; RCA, right coronary artery; RVD, reference vessel diameter; TIMI, thrombolysis in myocardial infarction; TLR, target lesion revascularisation; TVR, target vessel revascularisation Study details Key efficacy findings Key safety findings Comments Muramatsu (2013) 11 Number of patients analysed: 672 (435 BVS vs 237 DES) Follow-up issues: Post-hoc analysis of 3 case series: ABSORB EXTEND (with SPIRIT First and II trial as historical controls) Netherlands, Belgium, Australia, Brazil Recruitment period: January 2010 January 2012 for ABSORB study. Study population: ABSORB EXTEND: patients with 1 or 2 de novo lesions in different native coronary arteries (ACC/AHA: A 2.6%, B1 59.2%, B2 34.8%, C 3.5%). SPIRIT first: Patients with 1 de novo lesion, SPIRIT II: patients with 1 or 2 lesions in different major epicardial vessels (ACC/AHA: A 0.8%, 23.5%, B2 63.8%, C 11.9%) n=719 (469 ABSORB BVS vs 250 XIENCE V DES) Age: Mean 61.4 years (BVS) vs 62.2 years (DES) Sex: 75.2% male (BVS) vs 70.0% male (DES). Patient selection criteria: ABSORB EXTEND older than 18 years, target lesions in a major epicardial vessel or side branch with a visually estimated stenosis of 50% and <100% and a TIMI flow grade of 1, diameter mm and length 28 mm, SPIRIT first: lesions 3.0 mm diameter that could be covered by an 18 mm stent, SPIRIT II vessels mm diameter and 28 mm lesion length. Bailout stenting Occurred in 1.6% (7/435) BVS patients and 2.5% (6/237) DES patients due to edge dissection. Incidence of post-procedural MI^ ABSORB BVS n=424 DES n=219 p value CK-MB elevation % CK-MB elevation % >1xULN* >2xULN >3xULN >4xULN ^ MI was an increase in the creatine kinase level to more than twice the upper limit of the normal accompanied by an increased level of CK-MB * ULN=upper limit of normal. Differences in median post-procedural cardiac enzymes [BVS (n=238) vs DES (n=122)] There was no statistically significant difference in the peak level of cardiac troponin rises between the 2 treatment groups (median 0.05 micrograms/l vs 0.04, p=0.14). 92.8% (435/469) patients in the BVS group and 94.8% (237/250) in the DES group were included in the analysis. Study design issues: The aim was to investigate the incidence and clinical sequelae of small side branch occlusion (SBO), a contributing factor to the development of periprocedural MI after PCI. This primarily focussed on post-hoc angiographic assessment (not presented here). This study is a nonrandomised comparison of 2 different study populations. All clinical outcomes were adjudicated by an independent clinical events committee. Mandatory CK-MB assessment if CK was greater than the upper limit of normal; mandatory CK and CK-MB if troponin level elevated. In-hospital and 30-day clinical events were not reported separately for IP overview: bioresorbable stent implantation for treating coronary artery disease 14 of 48

15 Abbreviations used: ACC, American College of Cardiology; ACS, acute coronary syndrome; AHA, American Heart Association; AMS, absorbable metallic stent; ARC, Academic Research Consortium; BVS, bioresorbable vascular scaffold; CABG, coronary artery bypass grafting; CK-MB, creatine kinase myocardial band; COPD, chronic obstructive pulmonary disease; DES, drug-eluting stent; DS, diameter stenosis; ID, ischaemia-driven; IHD, ischaemic heart disease; IVUS, intravascular ultrasound; LCA, left coronary artery; LCx, left circumflex artery; MACE, major adverse cardiac event; MI, myocardial infarction; PCI, percutaneous intervention; PLLA, Poly-l-Lactic-Acid; QCA, quantitative coronary angiography; RCA, right coronary artery; RVD, reference vessel diameter; TIMI, thrombolysis in myocardial infarction; TLR, target lesion revascularisation; TVR, target vessel revascularisation Study details Key efficacy findings Key safety findings Comments Technique: Lesions treated with standard interventional techniques with mandatory predilation and stents (DES or BVS) implanted at a pressure not exceeding the burst pressure rate. Post-dilation carried out according to operator discretion and with balloons fitting within the boundaries of the scaffold/stent. the 2 treatment groups. Study population issues: Significant differences in baseline characteristics. Follow-up: 30 days Conflict of interest/source of funding: Sponsored and funded by Abbott Vascular. Two authors are employees and one author has served on advisory board and received minor honoraria. Other authors report no other conflicts. IP overview: bioresorbable stent implantation for treating coronary artery disease 15 of 48

16 Abbreviations used: ACC, American College of Cardiology; ACS, acute coronary syndrome; AHA, American Heart Association; AMS, absorbable metallic stent; ARC, Academic Research Consortium; BVS, bioresorbable vascular scaffold; CABG, coronary artery bypass grafting; CK-MB, creatine kinase myocardial band; COPD, chronic obstructive pulmonary disease; DES, drug-eluting stent; DS, diameter stenosis; ID, ischaemia-driven; IHD, ischaemic heart disease; IVUS, intravascular ultrasound; LCA, left coronary artery; LCx, left circumflex artery; MACE, major adverse cardiac event; MI, myocardial infarction; PCI, percutaneous intervention; PLLA, Poly-l-Lactic-Acid; QCA, quantitative coronary angiography; RCA, right coronary artery; RVD, reference vessel diameter; TIMI, thrombolysis in myocardial infarction; TLR, target lesion revascularisation; TVR, target vessel revascularisation Study details Key efficacy findings Key safety findings Comments Kočka (2014) 12 Number of patients analysed: 41 vs 57 Bailout stenting for Follow-up issues: Comparative case series Czech Republic Device success (defined as delivery and deployment of BVS at target edge dissection (multicentre) lesion with final residual stenosis 20% by visual estimation; bailout performed in 3 stenting not considered as a device failure): 98% (40/41). patients. Recruitment period: Study population: Patients with STEMI. Control group: patients who had metallic/drug eluting stents implanted and were in Killip Class I or II who were ineligible for BVS. n = 98 (41 (49 BVS) vs. 57 controls: metallic/drug-eluting stents) Age: BVS mean 58.9 years (63.8 years control) Sex: BVS 77.5% (31/41) male vs 75.4% (43/49) control Patient selection criteria: STEMI <24 hours from symptom onset with signed written informed consent. Maximal lesion length 24 mm. Exclusion criteria (clinical): Killip III-IV class (high likelihood of death within BVS resorption time), any other disease with probable prognosis <3 years; indication for oral anticoagulation; contraindication to or high likelihood of noncompliance to prolonged DAPT. Technique: ABSORB BVS 1.1 (Abbott Vascular, USA) implanted, mostly femoral access but radial access in 8 patients. Bailout stenting of edge dissection performed with study device if deemed safe. Stent sizing based on visual assessment. Intracoronary nitrates given to all normotensive patients, all patients received heparin; DAPT recommended for 12 months. Follow-up: Up to 6 months In 1 patient with LCx occlusion, BVS could not pass through angulated LCx take-off; bare metal stent implanted. Clinical performance Combined clinical endpoint (defined as death, MI or TVR) Event-free survival* Sub-acute scaffold thrombosis Myocardial infarction BVS % (n) Controls % (n) p 5 (2/40) 7 (4/57) 95% 93% (1/40) (on day 13 in patient with 2 BVS in LAD; 3 days after stopping DAPT, treated with repeat PCI with balloon dilatation only. Further course uneventful). 2.5 (1/41) (3 BVS in LAD; planned staged PCI at 5 weeks had MI due to side branch occlusion; reportedly unrelated to 0 2 (1/57) (with PCI in LAD; had NSTEMI with lesion in LCx). previous BVS) Deaths 0 2 (1/57) (due to cardiogenic shock on day 2) TVR (2/57) Scaffold thrombosis and deaths (see Key efficacy findings ) 100% follow-up in BVS group vs. 96.5% in control group (2 temporary visitors from abroad not reached). 40 BVS vs 57 control patients were available for follow-up at discharge; 36 vs 48 at one month; 17/25 at 6 months. Study design issues Prospective study Results reported as per treatment analysis (one patient with device failure analysed as part of control). Study population issues: Of the 142 patients undergoing emergency primary PCI: 28.9% (41/142) with STEMI had BVS implanted. 32% (45/142) were not included in comparative analysis (as 24 patients had Killip III-IV and 21 had no stent implantation). Significant differences in baseline characteristics between groups include: RCA infarct (22.5% BVS vs. 47.3% control) and diabetes mellitus (2.5% BVS vs. 24.6% control). IP overview: bioresorbable stent implantation for treating coronary artery disease 16 of 48

17 Abbreviations used: ACC, American College of Cardiology; ACS, acute coronary syndrome; AHA, American Heart Association; AMS, absorbable metallic stent; ARC, Academic Research Consortium; BVS, bioresorbable vascular scaffold; CABG, coronary artery bypass grafting; CK-MB, creatine kinase myocardial band; COPD, chronic obstructive pulmonary disease; DES, drug-eluting stent; DS, diameter stenosis; ID, ischaemia-driven; IHD, ischaemic heart disease; IVUS, intravascular ultrasound; LCA, left coronary artery; LCx, left circumflex artery; MACE, major adverse cardiac event; MI, myocardial infarction; PCI, percutaneous intervention; PLLA, Poly-l-Lactic-Acid; QCA, quantitative coronary angiography; RCA, right coronary artery; RVD, reference vessel diameter; TIMI, thrombolysis in myocardial infarction; TLR, target lesion revascularisation; TVR, target vessel revascularisation Study details Key efficacy findings Key safety findings Comments Conflict of interest/source of funding: Cost of BVS and publication funded from project no. PRVOUK P35, at Charles University, Prague. Two authors received honoraria from Abbott Vascular. (unstable angina and stent restenosis; treated with surgical revascularisation) *on Kaplan Meier event curves for a composite endpoint of cardiac death, any MI and TVR. Other issues: Angiography and OCT results not presented here. IP overview: bioresorbable stent implantation for treating coronary artery disease 17 of 48

18 Abbreviations used: ACC, American College of Cardiology; ACS, acute coronary syndrome; AHA, American Heart Association; AMS, absorbable metallic stent; ARC, Academic Research Consortium; BVS, bioresorbable vascular scaffold; CABG, coronary artery bypass grafting; CK-MB, creatine kinase myocardial band; COPD, chronic obstructive pulmonary disease; DES, drug-eluting stent; DS, diameter stenosis; ID, ischaemia-driven; IHD, ischaemic heart disease; IVUS, intravascular ultrasound; LCA, left coronary artery; LCx, left circumflex artery; MACE, major adverse cardiac event; MI, myocardial infarction; PCI, percutaneous intervention; PLLA, Poly-l-Lactic-Acid; QCA, quantitative coronary angiography; RCA, right coronary artery; RVD, reference vessel diameter; TIMI, thrombolysis in myocardial infarction; TLR, target lesion revascularisation; TVR, target vessel revascularisation Study details Key efficacy findings Key safety findings Comments Gori (2013) 13 Number of patients analysed: 253 (BVS 150 (194 lesions) vs DES 103 Follow-up issues: (129 lesions) Comparative case series Country of study: Germany. Recruitment period: Study population: Patients with an acute coronary syndrome (unstable angina :acute onset, typical angina leading to emergency department admission and ECG changes suggestive of ischaemia, NSTEMI or STEMI) n = 253 (BVS 150 (194 lesions) vs DES 103 (129 lesions) Age: BVS mean 61.7 vs. DES mean 62.0 years Sex: BVS 73% (110/150) vs. DES 70% (72/103) male Patient selection criteria: de novo lesions in a native coronary artery with an RVD compatible with the use of a 2.5, 3.0 or 3.5 mm BVS (between May and September 2012 only mm BVS were available). Exclusions: LCA lesions, lesions involving a side branch >2 mm in diameter, calcified lesions preventing effective predilation (residual stenosis >60% of the lumen after angioplasty) as well as in-stent restenosis/thrombosis lesions. Technique: ABSORB BVS vs Xience Prime EES a drug-eluting stent (Abbott Vascular, USA). Standard interventional techniques used with mandatory predilatation. Final interventional strategy and use of GP IIb/IIIa inhibitors postdilatation was left to operator s discretion. Thrombectomy used for all thrombotic vessel occlusion. Heparin given, Aspirin 100mg and clopidogrel/prasugrel/ticagrelor prescribed in all Procedure success BVS % (n) DES % (n) Procedural success 98.7 (148/150)* 100 (103/103) * 2 failures treated with DES but not included in reported DES group here. Clinical outcomes In-hospital BVS % (n) Death 0.7% (1/150) ^1 Non-fatal MI 2.1% (3/150) ^3 DES % (n) 1% (1/103) ^2 1% (1/103) 30 days p BVS % (n) 1 1.4% (2/150) ^ % (6/150 )^ 6 Non-TLR % (10/150 ) Hospital stay, days Cumulative MACE incidence (death, nonfatal MI or reintervention) 4.9± ±2.6 DES % (n) 2.9% (3/103) ^5 3.9% (4/103) ^7 6.9% (7/103) % (16/150 )^8 15.5% (16/103 )^9 p >0.8 ^1-Post-MI ventricular septum defect with heart failure. An additional STEMI patient, not included in the database due to receiving mixed BVS/DES revascularisation) died to cardiogenic shock. ^2 -Post-MI cardiogenic shock ^3-2 due to acute in-bvs thrombosis Definite instent/scaffold thrombosis In-hospital BVS % (n) 1.4 (2/1 50)* DES % (n) 1 (1/10 3) p * 1 occurred at 15 minutes postimplantation and 1 at 3 days. Definite instent/scaffold thrombosis at 30 days BVS % (n) 2.0 (3/15 0)** DES % (n) 1.9% (2/10 3) p 1 **incomplete expansion of the device on OCT evident in 2/3. 3/3 had emergency coronary angiography; treated with IIb/IIIa antagonists, heparin, thrombectomy and angioplasty with Clinical follow-up included records of repeat interventions and rehospitalisations obtained through hospital s electronic clinical database. Study design issues: Data from consecutive patients treated with EES during same time period used for comparison. Device choice mainly based on scaffold availability at implantation. All deaths deemed cardiac unless proven otherwise. Study population issues: BVS group had lower prevalence of hypercholesterolaemia (30% vs. 49%; p=0.002); higher prevalence of total occlusion (48% vs. 28%; p=0.001). Procedural differences BVS group: balloon diameter larger (2.7vs 2.54 mm; p= 0.001); pressure higher (13.8 versus 13 atmospheres; p = ); IP overview: bioresorbable stent implantation for treating coronary artery disease 18 of 48