Scanning Electron Microscopic Assessment of Stent Coating Integrity in Jailed Wire Technique for Bifurcation Treatment.

OBJECTIVES: To assess the impact of different guidewires on stent coating integrity in jailed wire technique (JWT) for bifurcation treatment. BACKGROUND: JWT is commonly adopted to protect side branch in provisional one-stent strategy for coronary bifurcation lesions. However, this technique may cause defects in stent coatings. The degree of coating damage caused by different types of jailed wires remains unknown. METHODS: A fluid model with a bifurcation was established to mimic the condition in vivo. One-stent strategy was performed with three types of guidewire (nonpolymer-jacketed wire, intermediate polymer-jacketed wire, and full polymer-jacketed wire) tested for JWT. Scanning electron microscopy (SEM) was used to evaluate stent coating integrity and wire structure. The degrees of coating defects were recorded as no, slight, moderate, and severe defects. RESULTS: A total of 27 samples were tested. Analyses of SEM images showed a significant difference in the degree of coating damage among the three types of wire after the procedure of JWT (P < 0.001). Nonpolymer-jacketed wire could inevitably cause a severe defect in stent coatings, while full polymer-jacketed wire caused the least coating damages. Besides, there were varying degrees of coil deformation in nonpolymer-jacketed wires, while no surface damage or jacket shearing was observed in full polymer-jacketed wires. CONCLUSIONS: Although nonpolymer-jacketed wire has long been recommended for JWT, our bench-side study suggests that full polymer-jacketed wire may be a better choice. Further clinical studies are needed to confirm our findings.

First-in-man study of a thinner-strut sirolimus-eluting bioresorbable scaffold (FUTURE-I): Three-year clinical and imaging outcomes.

OBJECTIVES: The FUTURE-I study aimed to assess preliminary safety and effectiveness with the long-term clinical and imaging follow-up for the Firesorb (MicroPort, Shanghai, China), a thinner-strut sirolimus-eluting bioresorbable scaffold (BRS). BACKGROUND: First-generation BRS has been associated with unexpected device-related adverse outcomes at long-term follow-up. METHODS: In this prospective, open-label, first-in-man study, patients with single de novo lesions in native coronary arteries were randomized 2:1 into two cohorts after successful Firesorb implantation: cohort 1 (n = 30) underwent multimodality imaging assessment at 6 and 24 months; and cohort 2 (n = 15) at 12 and 36 months. All patients underwent clinical follow-up at 1, 6, and 12 months and annually up to 5 years. RESULTS: Between January and March 2016, 45 patients were enrolled. At 3-year follow-up, one patient had experienced target lesion failure and none scaffold thrombosis. In-scaffold minimal lumen diameter decreased significantly from 6-month to 2-year (2.53 ± 0.24 mm vs. 2.27 ± 0.37 mm, p = .0003), and only numerically from 1-year to 3-year follow-up (2.48 ± 0.28 mm vs. 2.22 ± 0.13 mm, p = .08). By optical coherence tomography, neointimal strut coverage at 3-year follow-up was 99.8%, and very low rate of late scaffold discontinuity was observed, only in one patient on two cross sections with three malapposed struts. CONCLUSIONS: At 3-year follow-up of the FUTURE-I study, implantation of the thinner-strut Firesorb BRS appeared preliminary feasible and effective in the treatment of patients with noncomplex coronary lesions.

Two-year follow-up of a randomized multicenter study comparing a drug-coated balloon with a drug-eluting stent in native small coronary vessels: The RESTORE Small Vessel Disease China trial.

OBJECTIVES: To report the clinical outcomes of the RESTORE drug-coated balloon (DCB; Cardionovum, Bonn, Germany) for treatment of de novo small vessel disease (SVD) beyond 1 year. BACKGROUND: Previous reports have demonstrated the noninferiority of the RESTORE DCB to the RESOLUTE Integrity drug-eluting stent (DES; Medtronic, Minneapolis, Minnesota) in terms of 9-month in-segment percent diameter stenosis. METHODS: In the prospective, multicenter, noninferiority RESTORE SVD China trial, 230 patients with visually-estimated reference vessel diameter (RVD) ≥2.25 and ≤2.75 mm were randomized to DCB or DES in a 1:1 ratio stratified by diabetes and number of lesions treated. Furthermore, 32 patients with RVD ≥2.00 and <2.25 mm were enrolled in a nested very small vessel (VSV) registry. Clinical follow-up were performed at 2 years to evaluate target lesion failure (TLF) in both groups and the VSV cohort. RESULTS: Overall, 256 (97.7%) patients (115 and 109 in the DCB and DES groups, respectively, and 32 in the VSV cohort) completed 2 years of follow-up. There was no significant difference in TLF between the DCB and DES groups (5.2 vs. 3.7%, p = .75). Target lesion revascularization was acceptable at 1 month, 1 year, and 2 years, and did not differ significantly with DCB from that in the DES group (0.9 vs. 0%, p = 1.0, 4.4 vs. 2.6%, p = .72, 5.2 vs. 2.8%, p = .50, respectively). CONCLUSIONS: Compared to the second-generation DES, the RESTORE DCB did not increase the risk of clinical outcomes. Late catch-up phenomen requiring revascularization was not significant in this study.

Biodegradable polymer drug-eluting stents versus second-generation drug-eluting stents in patients with and without diabetes mellitus: a single-center study.

BACKGROUND: To improve outcomes in patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention remain an unmet clinical need. The study aimed to evaluate the efficacy and safety of G2-DESs and BP-DESs in patients with and without DM in a single center in China. METHODS: A total of 7666 consecutive patients who exclusively had G2-DES or BP-DES implantation throughout 2013 in our center were studied. The primary efficacy endpoint was any target lesion revascularization (TLR), whereas the primary safety endpoint was a composite of death or myocardial infarction (MI) at 2-year follow-up. RESULTS: G2-DESs had a similar occurrence of death, non-fatal MI, TLR, stroke, and stent thrombosis compared with BP-DESs in patients with DM (all P > 0.05). The incidence of TVR and TLR was lower for G2-DESs than for BP-DESs in patients without DM (3.2% vs. 5.1%, P = 0.002; 2.2% vs. 4.5%, P < 0.001, respectively). Kaplan-Meier analysis also showed better TVR- and TLR-free survival rates for G2-DESs than for BP-DESs in patients without DM. Multivariate analysis showed that a BP-DES was an independent risk factor for TLR (hazard ratio 1.963, 95% confidence interval 1.390-2.772, P < 0.001) in patients without DM, which was not predictive of other components of major adverse cardiac events (P > 0.05). CONCLUSIONS: G2-DESs have better efficacy, represented by a reduced risk of TLR, and similar safety compared with BP-DESs in patients without DM. G2-DESs have similar efficacy and safety compared with BP-DESs in patients with DM at 2-year follow-up.

Comparison of two biodegradable-polymer-based sirolimus-eluting stents with varying elution and absorption kinetics in patients with acute myocardial infarction: A subgroup analysis of the PANDA III trial.

BACKGROUND: Implantation of early-generation metallic drug-eluting stents (DES) in patients with acute myocardial infarction (AMI) is associated with poor vessel wall healing. Use of biodegradable polymer (BP) DES might improve safety outcomes; however, the impact of varying drug elution and polymer absorption kinetics of BP-DES on clinical outcomes in the AMI population is unknown. METHODS: This subgroup analysis of the randomized PANDA III trial included 732 patients (366 in each group) presenting with recent (<1 month) AMI. Primary endpoint was 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (MI), or ischemia-driven target lesion revascularization. Secondary endpoints included a patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization; individual TLF and PoCE components; and definite/probable stent thrombosis (ST). RESULTS: There were no significant differences between-groups in baseline clinical, angiographic, or procedural characteristics other than the proportion of post-dilatation, which was performed more frequently with the BuMA stent (53.9% vs. 44.5%; P = 0.004). After 1 year, compared to Excel SES implantation in patients with AMI, BuMA was associated with similar incidences of TLF and PoCE (5.5% vs. 8.3%, P = 0.14; 8.8% vs. 9.9%, P = 0.61, respectively) but lower incidences of MI (2.5% vs. 6.1%, P = 0.02), target vessel MI (2.2% vs. 5.8%, P = 0.01), and definite/probable ST (0.3% vs. 2.2%, P = 0.04). CONCLUSIONS: BuMA SES, with faster drug elution rate and polymer absorption kinetics, might improve safety outcomes compared to Excel SES in the high-risk AMI population. © 2017 Wiley Periodicals, Inc.

Comparison of Drug-Coated Balloon and Drug-Eluting Stent for the Treatment of Small Vessel Disease (from the Dissolve SVD Randomized Trial).

The Dissolve drug-coated balloons (DCBs) is a new-generation DCB coated with paclitaxel of balloon surface, with midchain triglyceride excipient. Although the use of DCBs is a promising technique, little is known about the the clinical efficacy of the novel Dissolve DCB in coronary small vessel disease. This study was a prospective, randomized, multicenter, noninferiority trial comparing the Dissolve DCB with the Resolute drug-eluting stent (DES) in patients with a reference vessel diameter ≥2.25 and ≤2.75 mm. Patients with a reference vessel diameter ≥2.00 and <2.25 mm were enrolled in the very small vessel registry. The angiographic and clinical follow-up were planned at 9 months and 1 year in all patients, respectively. The primary end point was 9-month in-segment percentage diameter stenosis. A total of 247 patients with small vessel disease from 10 Chinese sites were included (Dissolve DCB, n = 118; Resolute DES, n = 129); 30 patients were treated with the DCB in the very small vessel cohort. The 9-month in-segment percentage diameter stenosis was 31.2 ± 2.0% with Dissolve DCB versus 26.1 ± 2.1% with Resolute DES; the 1-sided 97.5% upper confidence limit of the difference was 10.3% (p for noninferiority = 0.0002). At 12 months, the DCB and DES groups were associated with similar rates of target lesion failure (8.5% vs 6.1%, p = 0.28) and major adverse cardiac and cerebrovascular events (20.9% vs 13.6%, p = 0.12). In conclusion, the Dissolve DCB was noninferior to the Resolute DES for the primary end point of 9-month in-segment percentage diameter stenosis in this multicenter, head-to-head, randomized trial (a safety and efficacy study of Dissolve In Treatment Of Coronary Small Vessel Disease; NCT03376646).

A Randomized Comparison of 2 Different Drug-Coated Balloons for In-Stent Restenosis.

BACKGROUND: Although use of drug-coated balloons (DCB) is a promising technique, little is known about the clinical efficacy of the Dissolve DCB in drug-eluting stent (DES) in-stent restenosis (ISR). OBJECTIVES: This study sought to evaluate the efficacy and safety of the Dissolve DCB in patients with DES ISR. METHODS: This was a prospective, multicenter, randomized, noninferiority trial comparing Dissolve DCB with SeQuent Please DCB in patients with DES ISR. Angiographic and clinical follow-up was planned at 9 months in all patients. The primary endpoint was 9-month in-segment late loss. RESULTS: A total of 260 patients with ISR from 10 Chinese sites were included (Dissolve DCB, n = 128; SeQuent Please DCB, n = 132). Nine-month in-segment late loss was 0.50 ± 0.06 mm with Dissolve DCB vs 0.47 ± 0.07 mm with SeQuent Please DCB; the 1-sided 97.5% upper confidence limit of the difference was 0.18 mm (P for noninferiority = 0.03). Rates of target lesion failure and binary restenosis were numerical higher in the Dissolve DCB cohort compared with the SeQuent Please DCB cohort at 9 months (17.5% vs 10.7%; P = 0.12; 23.4% vs 16.4%; P = 0.19, respectively). At 9 months, major adverse cardiac and cerebrovascular events occurred in 36 patients (28.3%) vs 30 patients (22.9%) in the Dissolve DCB and SeQuent Please DCB groups, respectively. CONCLUSIONS: In this head-to-head randomized trial, the Dissolve DCB was noninferior to the SeQuent Please DCB for 9-month in-segment late loss. However, Dissolve DCB with its numerical increase in target lesion failure and binary restenosis warrants assessment in larger clinical trials (A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-Stent Restenosis; NCT03373695).

Immediate and long-term outcomes of drug-eluting stent implantation for unprotected left main coronary artery disease: comparison with bare-metal stent implantation.

BACKGROUND: The efficacy and safety of drug-eluting stent (DES) implantation for unprotected left main coronary artery (LMCA) disease remain to be established in different clinical settings. METHODS: Elective DES implantation for unprotected LMCA stenosis was performed in 220 patients at the Fu Wai Hospital, China, from April 2003 to February 2006. Data derived from the latter group were compared with those derived from 224 patients treated with bare-metal stents (BMSs) before March 2003 in a Chinese registry of unprotected LMCA stenting. RESULTS: Compared with the historical BMS control group, the DES group had more multivessel disease and underwent more bifurcation stenting. The inhospital major adverse cardiac events were significantly higher in the DES than in the BMS recipients (4.1% vs 0.9%, P = .030) because of more complex lesions and procedures in the DES group. During the 15-month mean follow-up period, cumulative cardiac death (0.5% vs 4.9%, P = .004), target-vessel revascularization (5.9% vs 11.6%, P = .034), and major adverse cardiac event (9.5% vs 16.5%, P = .029) rates were significantly lower in the DES than in the BMS group. There was no significant difference in clinical efficacy between sirolimus- and paclitaxel-eluting stents. Angiographic follow-up was performed in 46.4% of DES and 45.7% of BMS recipients, respectively; and the binary restenosis rate was significantly lower in the DES versus the BMS control group (16.7% vs 31.4%, P = .014). CONCLUSIONS: Based on this comparison with a historical control, DES implantation for unprotected LMCA appears safe in selected patients and might be more effective in preventing major adverse cardiac events compared with BMS implantation over a mean follow-up period of 15 months.

Sirolimus-eluting cobalt-chromium stents: two-year clinical results from first-in-man study on the Firebird 2 stent.

BACKGROUND: Drug-eluting stents (DES) have been shown to significantly reduce clinical events and angiographic restenosis in the treatment of coronary artery disease (CAD). This study was conducted to assess the long-term efficacy and safety of the polymer-based sirolimus-eluting cobalt-chromium Firebird 2 stents in the treatment of patients with CAD. METHODS: This first-in-man study using the Firebird 2 stent is a prospective, historically-controlled multicenter clinical study, which enrolled 67 patients with CAD who were treated with the sirolimus-eluting cobalt-chromium stent (Firebird 2, Microport Shanghai, Firebird 2 group), compared to another 49 patients treated with a bare cobalt alloy stent (Driver, Medtronic, control group). Continued 2-year clinical follow-up was performed after getting the initial 6-month angiographic and 1-year clinical follow-up. The incidence of major adverse cardiac events (MACE) including cardiac death, reinfarction and target lesion revascularization (TLR) and stent thrombosis were compared between the two groups. RESULTS: All patients in the Firebird 2 group (100.0%) and 48 patients in the control group (98.0%) completed the 2-year clinical follow-up. At the 1-year follow-up the use of the Firebird 2 stent was highly effective, resulting in a significant 94% decrease of TLR (26.5% in the control group and 1.5% in the Firebird 2 group, P<0.0001). A significant difference in TLR was maintained at 2-year follow-up, Firebird 2 group 1.5% and the control group 31.3% (P<0.0001). Between 1- and 2-year post-stenting, no more TLR occurred in the Firebird 2 group compared with two cases in the control group (P>0.05). There was a 1.5% incidence of MACE at 1- and 2-year follow-up in the Firebird 2 group, compared with 26.5% and 33.3% in the control group, respectively (all P<0.0001). The cumulative 1- and 2-year MACE free survival rates were 98.5% in the Firebird 2 group vs 73.5% and 66.7% in the control group (log rank P<0.0001). No case of stent thrombosis occurred during 2-year follow-up in the Firebird 2 group, compared with one case that suffered a definite stent thrombosis in the control group at 19-month post-stenting: this patient presented with unstable angina pectoris and was treated by balloon angioplasty. CONCLUSIONS: Compared with the bare cobalt alloy stent, the Firebird 2 sirolimus-eluting cobalt-chromium stent is safe and effective in treating patients with CAD. The use of this stent was associated with a sustained clinical benefit and significantly lower rate of TLR and MACE up to 2 years post-stenting.

Comparison between two biodegradable polymer-based sirolimus-eluting stents with differing drug elution and polymer absorption kinetics: two-year clinical outcomes of the PANDA III trial.

AIMS: In the PANDA III trial, the novel poly-lactide-co-glycolide polymer-based BuMA sirolimus-eluting stent (SES) was non-inferior to the polylactide polymer-based Excel SES for the primary endpoint of one-year target lesion failure (TLF), with a lower incidence of stent thrombosis. We sought to investigate whether the effectiveness profile of BuMA SES, with more rapid drug elution and polymer absorption kinetics, would persist at two years. METHODS AND RESULTS: A total of 2,348 patients (mean age, 61.2±10.6 years; 24.3% diabetics; 31.2% with acute myocardial infarction within one month) were randomly assigned to receive either BuMA SES (n=1,174) or Excel SES (n=1,174) in the "all-comer" PANDA III trial. Two-year clinical follow-up was available for 2,262 (96.3%) patients. The incidence of TLF and the patient-oriented composite endpoint (PoCE) was low and similar between the BuMA and Excel groups (7.4% vs. 6.9%, p=0.67, and 13.1% vs. 10.9%, p=0.11, respectively). The rate of any revascularisation was significantly higher with the BuMA SES (6.8% vs. 4.6%, p=0.03). Definite and probable thrombosis occurred in 0.7% and 1.4% of patients in the BuMA and Excel groups, respectively (p=0.10). CONCLUSIONS: Two-year rates of TLF and PoCE events were low and similar between the two biodegradable polymer-based SES.

Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease: The RESTORE SVD China Randomized Trial.

OBJECTIVES: The aim of this study was to evaluate the angiographic efficacy and clinical outcomes of the Restore paclitaxel-coated balloon in a randomized trial designed to enable its approval with an indication for small-vessel disease (SVD). BACKGROUND: Higher rates of restenosis and stent thrombosis limit the effectiveness of drug-eluting stent (DES) treatment of SVD. Whether a drug-coated balloon (DCB)-only strategy is effective in de novo SVD is not yet established. METHODS: In the noninferiority RESTORE SVD China trial, eligible patients with reference vessel diameter ≥2.25 and ≤2.75 mm were randomized to the Restore DCB or the RESOLUTE Integrity DES in a 1:1 ratio stratified by diabetes and number of lesions treated. Patients with RVD ≥2.00 and <2.25 mm were enrolled in a nested very small vessel registry. Angiographic and clinical follow-up were planned at 9 months and 1 year, respectively, in all patients. The study was powered for the primary endpoint of 9-month in-segment percentage diameter stenosis. RESULTS: Between August 2016 and June 2017, a total of 230 subjects at 12 sites were randomized to the DCB group (n = 116) or DES group (n = 114); 32 patients were treated with the DCB in the very small vessel cohort. Nine-month in-segment percentage diameter stenosis was 29.6 ± 2.0% with the DCB versus 24.1 ± 2.0% with the DES; the 1-sided 97.5% upper confidence limit of the difference was 10.9%, achieving noninferiority of the DCB compared with the DES (p for noninferiority < 0.001). The DCB and DES had comparable 1-year rates of target lesion failure (4.4% vs. 2.6%, p = 0.72). CONCLUSIONS: In this multicenter randomized trial, the Restore DCB was noninferior to the RESOLUTE DES for 9-month in-segment percentage diameter stenosis. (Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease; NCT02946307).

A comparison of clinical and angiographic outcomes after Excel bioabsorbable polymer versus Firebird durable polymer rapamycin-eluting stent for the treatment of coronary artery disease in a "real world" setting: six-month follow-up results.

BACKGROUND: Several clinical trials have shown that rapamycin-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention (PCI). The Firebird stent and the Excel stent (coated with bioabsorbable polymer) are two different types of rapamycin-eluting stents made in China, both have been recently approved for clinical use in China by State Food and Drug Administration. However, it is unclear whether there are differences in safety and efficacy between the two types of stents in daily practice. METHODS: In the month of June 2006, a total of 190 consecutive patients were treated exclusively with Firebird stents (n = 93, Firebird group) or Excel stents (n = 97, Excel group) in our center and were included in this study. The frequency of major adverse cardiac events (MACE, a composite of death, myocardial infarction or target lesion revascularization), binary restenosis, and late lumen loss and stent thrombosis during a six-month follow-up period were compared between the two groups. RESULTS: Patient and lesion characteristics were comparable between the groups. Major adverse cardiac event rates were low in hospital and at 6 months (2.1% in the Excel group and 0% in the Firebird group, P > 0.05). The 6-month angiographic in-stent restenosis rate was 0% in both groups, with an associated late loss of (0.15 +/- 0.21) mm versus (0.14 +/- 0.20) mm (P = 0.858) and the in-segment restenosis rate was also 0% for the Excel group and the Firebird group. There was no definite stent thrombosis identified in either group during the six-month follow-up period and only one patient in the Excel group had probable stent thrombosis in hospital. CONCLUSIONS: Results from this mid-term, single-center study showed that both of the Firebird and the Excel rapamycin eluting stent had similar effects on reducing the incidence of MACE and the risk of restenosis (both in-stent and in-segment binary restenosis) after PCI in daily practice.

Comparison of long-term in-stent vascular response between abluminal groove-filled biodegradable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent: 3-year OCT follow-up from the TARGET I trial.

The study sought to compare long-term optical coherence tomography (OCT)-based in-stent vascular response between the abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES) and the durable polymer everolimus-eluting stent (EES) in the TARGET I trial. The TARGET I trial was a prospective, multicenter, randomized clinical trial which enrolled 458 patients with single de novo lesions treated by abluminal groove-filled biodegradable polymer SES and EES. A subset of 43 patients underwent angiography and OCT examinations at 3 years. All OCT images were analyzed at 0.4 mm intervals. A similar increase in angiographic late lumen loss was observed in SES and EES (from 0.05 ± 0.05 vs. 0.05 ± 0.05 mm [p = 0.84] at 9 months to 0.25 ± 0.37 vs. 0.26 ± 0.19 mm [p = 0.99] at 3 years, respectively), without significant differences at 3 years in mean neointimal thickness of stent struts (SES: 0.13 ± 0.02 mm vs. EES: 0.13 ± 0.02 mm, p = 0.80); mean percentage of covered struts (SES: 99.2 % vs. EES: 99.3 %, p = 0.53), or malapposed strut rates (SES: 0.08 % vs. EES: 0.06 %, p = 0.15). The OCT-based in-stent vascular response evaluation found similar vascular healing for the two studied devices, indicating that the luminal loss in EES from 9 months to 3 years cannot be imputed on its coated biocompatible polymer.

First report of a novel abluminal groove filled biodegradable polymer rapamycin-eluting stent in de novo coronary artery disease: results of the first in man FIREHAWK trial.

BACKGROUND: Durable polymers used for first-generation drug-eluting stents (DES) potentially contribute to persistent inflammation and late DES thrombosis. We report the first in human experience with the rapamycin-eluting biodegradable polymer coated cobalt-chromium FIREHAWK stent with abluminal groove. METHODS: A total of 21 patients with stable or unstable angina, or prior myocardial infarction, with single de novo native coronary stenoses < 30 mm in length in vessel sizes ranging from 2.25 to 4.0 mm were enrolled. The primary endpoint was major adverse cardiac events (MACE) at 30 days defined as the composite of cardiac death, myocardial infarction (Q and non-Q), or ischemia-driven target lesion revascularization. Secondary endpoints include device, lesion, and clinical success rates, 4-month in-stent late lumen loss by quantitative coronary angiography (QCA), proportion of uncovered or malapposed stent struts by optical coherence tomograpphy (OCT) at 4 months, and MACE at 4, 12, 24 and 36-month follow-up. RESULTS: Device success was 95.7%, lesion and clinical success was 100.0%. There were no MACE events at 30 days. One patient died of non-cardiac hemorrhagic stroke 5 days after index procedure. At 4 months, in-stent late loss was (0.13 ± 0.18) mm, and complete strut coverage was 96.2% by OCT with 0.1% strut malapposition. At 4-month follow-up there was no additional MACE events, and a single target vessel (non-target lesion) revascularization. CONCLUSIONS: The FIREHAWK abluminal groove biodegradable polymer rapamycin-eluting stent demonstrated feasibility, safety and efficacy in this first in human experience. OCT findings indicated excellent stent strut coverage 4 months after implantation. Larger studies are required to confirm whether the early FIREHAWK stent results translate into longer term restenosis and thrombosis benefits.