FANTOM II Trial: safety and performance study of the fantom sirolimus-eluting bioresorbable coronary scaffold: first report: final 5-year clinical outcomes

BACKGROUND The primary objective of the FANTOM II study was to evaluate the safety and performance of native coronary artery stent ing using the Fantom sirolimus-eluting bioresorbable coronary scaf fold (Tyrocore, Reva Medical LLC) by assessing the incidence of major adverse cardiac events (MACE) and late lumen loss. The Fantom scaffold is a fully resorbable scaffold, which is composed mainly of an iodinated, polycarbonate copolymer of tyrosine ana logs. Fantom is completely radiopaque and is composed of thin struts (125 microns) that facilitate device delivery and precise target-lesion treatment. METHODS The FANTOM II study is a prospective multicenter trial that enrolled 240 patients with single de novo coronary stenosis with reference vessel diameter 2.5 to 3.5 mm diameter and lesion length 20 mm. MACE through 48 months of follow-up were assessed. Angiographic follow-up was performed in consecutive patient cohorts at 6 months (n » 117) and 9 months (n » 123). Additional angiographic and optical coherence tomography serial imaging has been performed in a subset of patients at 24 months. RESULTS Acute delivery success, acute technical success, acute procedural success, and clinical procedural success rates as defined in the clinical protocol were 97.9% (235 of 240), 95.8% (230 of 240), 99.1% (228 of 230) and 99.6% (227 of 228), respectively. The mean in-stent late lumen loss at 6 months and 9 months were 0.25 0.40 mm and 0.33 0.36 mm, respectively, and in-segment binary restenosis occurred in 2.0% and 7.6% of patients respec tively. Patient follow-up is now complete through the planned 60- month endpoint. Adjudication of all events is in process and final clinical outcomes through 60 months will be reported for the first time at the Transcatheter Cardiovascular Therapeutics (TCT) conference. CONCLUSION The Fantom sirolimus-eluting bioresorbable coronary scaffold demonstrated favorable safety and effectiveness perfor mance at 5 years of follow-up. Longer-term follow-up in real-world clinical post-market evaluations is ongoing to examine the late out comes with this novel device.

FANTOM II long lesion study: initial safety and performance study of the fantom sirolimus-eluting bioresorbable coronary scaffold in long lesionsdfirst report: 2-year outcomes

BACKGROUND The primary objective of the FANTOM II Long Lesion study was to evaluate the safety and performance of native coronary artery stenting of lesions 20 mm in length using 1 or more Fantom sirolimus-eluting bioresorbable coronary scaffolds. Fantom is a fully resorbable scaffold, manufactured from TyroCore, which is composed mainly of an iodinated, polycarbonate copolymer of tyrosine analogs. Fantom is completely radiopaque, enabling multiple scaffolds to be placed in a precise edge-to-edge configuration, allowing complete coverage of longer target lesions. METHODS The FANTOM II Long Lesion study is a prospective, multicenter trial that enrolled 33 patients with de novo coronary stenosis with reference vessel diameters between 2.5 and 3.5 mm and lesion lengths 20 mm. In this study, all lesions were predilated using a 1:1 noncompliant balloon and then subsequently assessed to determine vessel diameter and lesion length. Once sizing was com plete, between 1 and 3 scaffolds were selected to enable complete target lesion coverage. RESULTS In this study, acute technical success, acute procedural success, and clinical procedural success rates as defined in the clinical protocol were 100% (33 of 33) in all cases. Angiographic imaging re sults from for all patients through 6 months of follow-up as well as major adverse cardiac events, target lesion failure, and scaffold thrombosis through 24 months of follow-up will be available in August and reported for the first time at the TCT conference. CONCLUSION As in the Fantom II trial, which was used as a basis for obtaining Conformité Européenne Mark approval, the Fantom siroli mus-eluting bioresorbable coronary scaffold demonstrated favorable initial acute safety in this first cohort of patients with more complex lesions. Longer term follow-up through 5 years is ongoing to examine late outcomes with this novel device.

FANTOM II Trial: safety and performance study of the fantom sirolimus-eluting bioresorbable coronary scaffolddfirst report: 4-year clinical outcomes

BACKGROUND The primary objective of the FANTOM II (Safety and Performance Study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold) was to evaluate the safety and performance of native coronary artery stenting using the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold by assessing the incidence of major adverse cardiac events and late lumen loss. The Fantom scaffold is a fully resorbable scaffold (Tyrocore, REVA Medical) that is composed mainly of an iodinated, polycarbonate copolymer of tyrosine analogs. Fantom is completely radiopaque and is composed of thin struts (125 mm) that facilitate device delivery and precise target lesion treatment. METHODS The FANTOM II study is a prospective, multicenter trial that enrolled 240 patients with single de novo coronary stenosis with reference vessel diameter 2.5 to 3.5 mm and lesion length 20 mm. Major adverse cardiac events through 48-month follow-up were assessed. Angiographic follow-up was performed in consecutive pa tient cohorts at 6 months (n » 117) and 9 months (n » 123). Additional angiographic and optical coherence tomography serial imaging has been performed in a subset of patients at 24 months. RESULTS Acute delivery success, acute technical success, acute pro cedural success, and clinical procedural success rates as defined in the clinical protocol were 97.9% (235 of 240), 95.8% (230 of 240), 99.1% (228 of 230), and 99.6% (227 of 228), respectively. The mean in-stent late lumen loss at 6 months and 9 months were 0.25 0.40 mm and 0.33 0.36 mm, respectively, and in-segment binary restenosis occurred in 2.0% and 7.6% of patients, respectively. Patient follow-up is now complete through 48 months. Adjudication of all events is in process, and final clinical outcomes through 48 months will be re ported for the first time at the Transcatheter Cardiovascular Thera peutics 2020 annual meeting. CONCLUSION The Fantom sirolimus-eluting bioresorbable coronary scaffold demonstrated favorable safety and effectiveness perfor mance at 4 years of follow-up. Longer-term follow-up through 5 years is ongoing to examine the late outcomes with this novel device.

Long-Term serial functional evaluation after implantation of the fantom sirolimus-eluting bioresorbable coronary scaffold: the FANTOM II study

BACKGROUND: The Fantom sirolimus-eluting bioresorbable coronary scaffold (BRS) (REVA Medical, San Diego, California) was previously studied with angiographic late lumen loss at 6, 9, and 24 months with clinical events being followed through 36 months. However, a functional evaluation has not previously been performed. The aim of this study was to assess serial functional changes after percutaneous coronary intervention (PCI) with the Fantom BRS implantation. METHODS: The FANTOM II trial was a prospective, multicenter, single-arm study that enrolled 240 patients with stable coronary artery disease or unstable angina and single de novo native coronary lesions, of which 235 patients received the Fantom BRS and are included in the present analysis. Serial quantitative flow ratio (QFR) analysis was performed in an independent core laboratory at baseline, after PCI, and at 6- or 9-month and 24-month follow-up. RESULTS: QFR was analyzable in 178 patients at baseline, 185 post-PCI, 178 at 6- or 9-month follow-up, and 31 at 24-month follow-up. At baseline, 59 patients (33.1%) had QFR >0.80, whereas 12 (6.5%) at post-PCI, 13 (7.3%) at 6- or 9-month followup, and 3 (9.7%) at 24-month follow-up had QFR _0.80. In the paired analyses, QFR was significantly increased from baseline to post-PCI (0.73 _ 0.12 vs. 0.94 _ 0.07; p < 0.001), while it decreased from post-PCI to 6- or 9-month follow-up (0.94 _ 0.07 vs. 0.92 _ 0.08; p < 0.001) and from 6- or 9-month to 24-month follow-up (0.93 _ 0.07 vs. 0.91 _ 0.09; p » 0.03). CONCLUSION: Serial angiographic analysis showed significant increase in QFR values between baseline and post-PCI. A slight decrease was observed in QFR values with the Fantom BRS over 24 months. (AU)

Clinical and angiographic outcomes with a novel radiopaque sirolimus-eluting bioresorbable vascular scaffold

BACKGROUND A novel bioresorbable scaffold, the sirolimus-eluting Fantom, incorporates a radiopaque polymer, struts with a thickness of 125 microm, and a crossing profile of 1.35 mm. The purpose of this study was to evaluate the 9-month angiographic and 12-month clinical outcomes of the FANTOM scaffold in a larger patient population. METHODS and RESULTS The FANTOM II study (Safety & Performance Study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold - First Report on Initial 24 Month Outcomes) was a prospective, multicenter trial which enrolled 240 patients with single de novo coronary stenosis with reference vessel diameter 2.5 to 3.5 mm diameter and lesion length

Mechanical performance and healing patterns of the novel sirolimus-eluting bioresorbable Fantom scaffold: 6-month and 9-month follow-up by optical coherence tomography in the FANTOM II study

OBJECTIVES: We aimed to evaluate the mechanical properties and healing patterns 6 and 9 months after implantation of the sirolimus-eluting Phantom bioresorbable scaffold (BRS). BACKGROUND: The Phantom BRS (Reva Medical, San Diego, USA) has differentiating properties including radiopacity, strut thickness of 125 µm, high expansion capacity and has demonstrated favorable mid-term clinical and angiographic outcomes. METHODS AND RESULTS: FANTOM II was a prospective, single arm study with implantation of the Phantom BRS in 240 patients with stable angina pectoris. Guidance by optical coherence tomography (OCT) was encouraged and was repeated at 6-month (cohort A) or 9-month follow-up (cohort B). Matched baseline and follow-up OCT recordings were available in 152 patients. In-scaffold mean lumen area in cohort A was 6.8±1.7 mm2 and 5.7±1.4 mm2 at baseline and follow-up (p<0.0001) and was 7.2±1.6 mm2 and 5.6±1.4 mm2 in cohort B (p<0.0001). Mean scaffold area remained stable from 7.1±1.5 mm2 at baseline to 7.2±1.4 mm2 at 6 months (p=0.12), and from 7.4±1.5 mm2 to 7.3±1.4 mm2 at 9 months. Strut malposition was median 0.8 (IQR 0.0;3.5)% and 1.8 (IQR 0.3;6.0)% at baseline and was 0.0 (IQR 0.0;0.0)% in both groups at 6-month and 9-month follow-up. Strut tissue coverage was 98.1 (IQR 95.9;99.4)% at 6 months and 98.9 (IQR 98.3;100.0)% at 9 months. CONCLUSIONS: The novel Phantom BRS had favorable healing patterns at 6-month and 9-month follow-up as malposition was effectively resolved and strut coverage was almost complete. The scaffold remained stable through follow-up with no signs of systematic late recoil. (AU)

Risk and timing of clinical events according to diabetic status of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting stent: 2-year results from a propensity score matched comparison of ABSORB EXTEND and SPIRIT trials

OBJECTIVES: to compare the occurrence of clinical events in diabetics treated with the Absorb bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular, Santa Clara, CA) versus everolimus-eluting metal stents (EES; XIENCE V; Abbott Vascular, Santa Clara, CA) BACKGROUND: There are limited data dedicated to clinical outcomes of diabetic patients treated with bioresorbable scaffolds (BRS) at 2-year horizon. METHODS:The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program (SPIRIT II, SPIRIT III and SPIRIT IV trials) were used for comparison by applying propensity score matching using 29 different variables. The primary endpoint was ischemia driven major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ischemia driven target lesion revascularization (ID-TLR). RESULTS: After 2 years, the ID-MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the Xience group (P = 0.40). There was no difference for MACE components or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; P = 0.69). The occurrence of MACE was not different for both diabetic status (insulin- and non-insulin-requiring diabetes) in all time points up to the 2-year follow-up for the Absorb and Xience groups...

Serial assessment of strut coverage of biodegradable polymer drug-eluting stent at 1, 2, and 3 months after stent implantation by optical frequency domain imaging: the DISCOVERY 1TO3 study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months

BACKGROUND: To assess the vessel-healing pattern of Ultimaster drug-eluting stent using optical frequency domain imaging. Our hypothesis is that biodegradable polymer-based drug-eluting technology allows complete very early strut coverage.METHODS AND RESULTS: The DISCOVERY 1TO3 study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months) is a prospective, single-arm, multicenter study. A total of 60 patients with multivessel disease requiring staged procedure at 1 month were treated with Ultimaster. Optical frequency domain imaging was acquired at baseline, 1, 2, and 3 months. The primary end point is optical frequency domain imaging-assessed strut coverage at 3 months. Mean age of patients was 67.2±9.9 years, and 73.3% were male, and 36.7% presented with acute coronary syndrome. A total of 132 lesions were treated, with average 1.4 lesions per patient treated at baseline and 1.1 lesions treated at 1 month. Strut coverage at 3 months of single implanted stents (n=71, primary end point) was 95.2±5.2% and of combined single and overlapped stents was 95.4±4.9%. Strut coverage of combined single and overlapped stents at 1 (n=49) and 2 months (n=38) was 85.1±12.7% and 87.9±10.8%, respectively...

Two-year outcomes of high bleeding risk patients after polymer-free drug-coated stents

BACKGROUND: A 1-year follow-up, polymer-free metallic stent coated with biolimus-A9 followed by 1-month dual antiplatelet therapy is safer and more effective than a bare-metal stent (BMS) for patients with high risk of bleeding. OBJECTIVES: This study analyzed 2-year outcomes to determine whether these benefits are maintained. METHODS: In a prospective, multicenter, double-blind trial, we randomized 2,466 high bleeding risk patients to receive a drug-coated stent (DCS) or a BMS followed by 1-month dual antiplatelet therapy. The primary safety endpoint was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization. RESULTS:At 2 years, the primary safety endpoint had occurred in 147 DCS and 180 BMS patients (15.3%) (hazard ratio: 0.80; 95% confidence interval: 0.64 to 0.99; p = 0.039). Clinically driven target lesion revascularization occurred for 77 DCS and 136 BMS patients (12.0%) (hazard ratio: 0.54; 95% confidence interval: 0.41 to 0.72; p < 0.0001). Major bleeding occurred in 8.9% of DCS and 9.2% of BMS patients (p = 0.95), and a coronary thrombotic event (myocardial infarction and/or stent thrombosis) occurred in 8.2% of DCS and 10.6% of BMS patients (p = 0.045)...

6-Month clinical and angiographic outcomes of a novel radiopaquesirolimus-eluting bioresorbable vascular scaffold

The purpose of this study was to evaluate the outcomes of the novel Fantom coronary bioresorbable scaffold at 6 months. The Fantom sirolimus-eluting bioresorbable scaffold incorporates a unique proprietary iodinated, polycarbonate copolymer of tyrosine analogs that is radiopaque, with thin struts (125 mm) that facilitate device delivery and precise target lesion treatment. The 6-month outcomes and performance of the Fantom scaffold were evaluated in 117 patients with single de novo native coronary artery lesions of length #20 mm and reference vessel diameter 2.5 to 3.5 mm. The primary angiographic endpoint was mean late lumen loss at 6 months measured by quantitative coronary angiography. Procedural outcomes were categorized as short-term technical success, short-term procedural success, and clinical procedural success. The primary clinical endpoint was major adverse cardiac events at 6 months, the composite of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization (TLR). Short-term technical success, short-term procedural success, and clinical procedural success were achieved in 96.6%, 99.1%, and 99.1% of patients, respectively. Mean 6-month in-stent late lumen loss was 0.25 0.40 mm (n » 100). Binary restenosis was present in 2 patients (2.0%). Major adverse cardiac events within 6 months occurred in 3 patients (2.6%), including no deaths, 2 MIs, and 2 TLRs (1 patient had both an MI and TLR). Scaffold thrombosis occurred in 1 patient (0.9%). The clinical results from 117 patients enrolled in cohort A of the multicenter FANTOM II (Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold) study demonstrate favorable 6-month outcomes of this novel device in the treatment of noncomplex coronary artery disease.

Polymer-free drug-coated coronary stents in patients at high beeding Risk

BACKGROUND:Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month.METHODS:In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization.RESULTS:We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated-stent group and in 154 patients (12.9%) in the bare-metal-stent group (risk difference, -3.6 percentage points; 95% confidence interval [CI], -6.1 to -1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P<0.001 for noninferiority and P=0.005 for superiority). During the same time period, clinically driven target-lesion revascularization was needed in 59 patients (5.1%) in the drug-coated-stent group and in 113 patients (9.8%) in the bare-metal-stent group (risk difference, -4.8 percentage points; 95% CI, -6.9 to -2.6; hazard ratio, 0.50; 95% CI, 0.37 to 0.69; P<0.001)...