SYNERGY-Everolimus-Eluting Stent With a Bioabsorbable Polymer in ST-Elevation Myocardial Infarction: CLEAR SYNERGY OASIS-9 Registry.

Our objective was to evaluate the clinical effectiveness of the SYNERGY stent (Boston Scientific Corporation, Marlborough, Massachusetts) in patients with ST-elevation myocardial infarction (STEMI). The only drug-eluting stent approved for treatment of STEMI by the Food and Drug Administration is the Taxus stent (Boston Scientific) which is no longer commercially available, so further data are needed. The CLEAR (Colchicine and spironolactone in patients with myocardial infarction) SYNERGY stent registry was embedded into a larger randomized trial of patients with STEMI (n = 7,000), comparing colchicine versus placebo and spironolactone versus placebo. The primary outcome for the SYNERGY stent registry is major adverse cardiac events (MACE) as defined by cardiovascular death, recurrent MI, or unplanned ischemia-driven target vessel revascularization within 12 months. We estimated a MACE rate of 6.3% at 12 months after primary percutaneous coronary intervention for STEMI based on the Thrombectomy vs percutaneous coronary intervention alone in STEMI (TOTAL) trial. Success was defined as upper bound of confidence interval (CI) to be less than the performance goal of 9.45%. Overall, 733 patients were enrolled from 8 countries with a mean age 60 years, 19.4% diabetes mellitus, 41.3% anterior MI, and median door-to-balloon time of 72 minutes. The MACE rate was 4.8% (95% CI 3.2 to 6.3%) at 12 months which met the success criteria against performance goal of 9.45%. The rates of cardiovascular death, recurrent MI, or target vessel revascularization were 2.7%, 1.9%, 1.0%, respectively. The rates of acute definite stent thrombosis were 0.3%, subacute 0.4%, late 0.4%, and cumulative stent thrombosis of 1.1% at 12 months. In conclusion, the SYNERGY stent in STEMI performed well and was successful compared with the performance goal based on previous trials.

Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy.

BACKGROUND: Nonadherence to antiplatelet therapy after percutaneous coronary intervention (PCI) is common, even in clinical trials. OBJECTIVES: The purpose of this study was to investigate the impact of nonadherence to study protocol regimens in the MASTER DAPT (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen) trial. METHODS: At 1-month after PCI, 4,579 high bleeding risk patients were randomized to single antiplatelet therapy (SAPT) for 11 months (or 5 months in patients on oral anticoagulation [OAC]) or dual antiplatelet therapy (DAPT) for ≥2 months followed by SAPT. Coprimary outcomes included net adverse clinical events (NACE), major adverse cardiac and cerebral events (MACE), and major or clinically relevant nonmajor bleeding (MCB) at 335 days. Inverse probability-of-censoring weights were used to correct for nonadherence Academic Research Consortium type 2 or 3. RESULTS: In total, 464 (20.2%) patients in the abbreviated-treatment and 214 (9.4%) in the standard-treatment groups incurred nonadherence Academic Research Consortium type 2 or 3. At inverse probability-of-censoring weights analyses, NACE (HR: 1.01; 95% CI: 0.88-1.27) or MACE (HR: 1.07; 95% CI: 0.83-1.40) did not differ, and MCB was lower with abbreviated compared with standard treatment (HR: 0.51; 95% CI: 0.60-0.73) consistently across OAC subgroups; among OAC patients, SAPT discontinuation 6 months after PCI was associated with similar MACE and lower MCB (HR: 0.47; 95% CI: 0.22-0.99) compared with SAPT continuation. CONCLUSIONS: In the MASTER DAPT adherent population, 1-month compared with ≥3-month DAPT was associated with similar NACE or MACE and lower MCB. Among OAC patients, SAPT discontinuation after 6 months was associated with similar MACE and lower MCB than SAPT continuation (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).

Abbreviated Antiplatelet Therapy After Coronary Stenting in Patients With Myocardial Infarction at High Bleeding Risk.

BACKGROUND: The optimal duration of antiplatelet therapy (APT) after coronary stenting in patients at high bleeding risk (HBR) presenting with an acute coronary syndrome remains unclear. OBJECTIVES: The objective of this study was to investigate the safety and efficacy of an abbreviated APT regimen after coronary stenting in an HBR population presenting with acute or recent myocardial infarction. METHODS: In the MASTER DAPT trial, 4,579 patients at HBR were randomized after 1 month of dual APT (DAPT) to abbreviated (DAPT stopped and 11 months single APT or 5 months in patients with oral anticoagulants) or nonabbreviated APT (DAPT for minimum 3 months) strategies. Randomization was stratified by acute or recent myocardial infarction at index procedure. Coprimary outcomes at 335 days after randomization were net adverse clinical outcomes events (NACE); major adverse cardiac and cerebral events (MACCE); and type 2, 3, or 5 Bleeding Academic Research Consortium bleeding. RESULTS: NACE and MACCE did not differ with abbreviated vs nonabbreviated APT regimens in patients with an acute or recent myocardial infarction (n = 1,780; HR: 0.83; 95% CI: 0.61-1.12 and HR: 0.86; 95% CI: 0.62-1.19, respectively) or without an acute or recent myocardial infarction (n = 2,799; HR: 1.03; 95% CI: 0.77-1.38 and HR: 1.13; 95% CI: 0.80-1.59; Pinteraction = 0.31 and 0.25, respectively). Bleeding Academic Research Consortium 2, 3, or 5 bleeding was significantly reduced in patients with or without an acute or recent myocardial infarction (HR: 0.65; 95% CI: 0.46-0.91 and HR: 0.71; 95% CI: 0.54-0.92; Pinteraction = 0.72) with abbreviated APT. CONCLUSIONS: A 1-month DAPT strategy in patients with HBR presenting with an acute or recent myocardial infarction results in similar NACE and MACCE rates and reduces bleedings compared with a nonabbreviated DAPT strategy. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).

Proximal Left Anterior Descending Artery Treatment Using a Bioresorbable Polymer Coating Sirolimus-Eluting Stent: Real-World Outcomes From the Multicenter Prospective e-Ultimaster Registry.

Background Guidelines recommend heart team discussion and coronary artery bypass graft consideration in patients with proximal left anterior descending (LAD) artery stenosis. Evidence suggests that outcomes of proximal LAD angioplasty might not differ from treatment of nonproximal LAD locations. We aim to determine clinical outcomes of patients undergoing percutaneous coronary intervention in the proximal LAD segment in comparison with nonproximal LAD angioplasty, using a thin-strut drug-eluting stent. Methods and Results In this analysis of the e-Ultimaster registry, patients undergoing angioplasty in the proximal LAD territory were compared with those treated in nonproximal LAD locations. Multivariate analysis and propensity score were used to adjust for differences among the groups. The primary outcome was target lesion failure: a composite of cardiac death, target-lesion-related myocardial infarction, and/or clinically driven target lesion revascularization at 1-year follow-up. Of the 17 805 patients (mean age, 64.2±11; 76% male), 5452 (30.6%) underwent proximal LAD and 12 353 (69.4%) nonproximal LAD percutaneous coronary intervention. Patients in the proximal LAD group had more multivessel disease (48.7% versus 43.5%; P<0.001) and 2-fold more bifurcations lesions (18.8% versus 9.2%; P<0.0001). After propensity-weighted adjustment, target lesion failure did not differ between the groups (3.3% versus 2.9%; P=0.17 for proximal LAD versus nonproximal LAD angioplasty, respectively). In multivariate analysis, proximal LAD treatment was not an independent predictor of target lesion failure (odds ratio, 1.07; 95% CI, 0.88-1.31; P=0.48). Conclusions At 1-year follow-up, patients had similar clinical outcomes independent of stenting location, questioning whether proximal LAD treatment should be regarded differently from stenting in any other coronary artery territory.

Randomised evaluation of a novel biodegradable polymer-based sirolimus-eluting stent in ST-segment elevation myocardial infarction: the MASTER study.

AIMS: The MASTER study was designed to compare the performance of a new biodegradable polymer sirolimus-eluting stent (BP-SES) with a bare metal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI). METHODS AND RESULTS: The study was a prospective, randomised (3:1), controlled, single-blind multicentre trial that enrolled 500 STEMI patients within 24 hours of symptom onset during 2013-2015. Three hundred and seventy-five patients were treated with BP-SES and 125 with BMS. One hundred and four (104) randomised patients underwent angiographic follow-up at six months. The primary clinical endpoint was target vessel failure (TVF), defined as cardiac death, MI not clearly attributable to a non-target vessel, or clinically driven target vessel revascularisation (TVR) at 12 months. The primary angiographic endpoint was in-stent late lumen loss (LLL) at six months in the angiographic cohort. The major secondary endpoint for safety was a composite of all-cause death, recurrent MI, unplanned infarct-related artery revascularisation, stroke, definite stent thrombosis (ST) or major bleeding at one month. At 12 months, TVF had occurred in 6.1% of BP-SES and 14.4% of BMS patients (pnon-inferiority=0.0004), mainly driven by a higher rate of repeat revascularisation in BMS patients. The safety endpoint occurred in 3.5% of BP-SES and 7.2% of BMS patients (p=0.127). In-stent LLL demonstrated the superiority (p=0.0125) of BP-SES (0.09±0.43 mm) over BMS (0.79±0.67 mm). CONCLUSIONS: The study showed clinical non-inferiority and angiographic superiority of BP-SES versus a comparator BMS, suggesting that this novel DES may be a potential treatment option in STEMI.

Randomised comparison of a biodegradable polymer ultra-thin sirolimus-eluting stent versus a durable polymer everolimus-eluting stent in patients with de novo native coronary artery lesions: the meriT-V trial.

AIMS: The aim of this study was to evaluate the safety and efficacy of the BioMime sirolimus-eluting coronary stent (SES) compared to the XIENCE family of everolimus-eluting coronary stents (EES) in the treatment of patients with de novo native coronary artery lesions. METHODS AND RESULTS: The meriT-V is a prospective, multicentre, randomised, open-label, active-controlled, non-inferiority trial. A total of 256 patients with up to two de novo native coronary artery lesions were enrolled and randomly assigned (2:1) to BioMime SES or XIENCE EES. BioMime SES was non-inferior to XIENCE EES for the primary endpoint of in-stent late lumen loss (0.15±0.27 mm vs. 0.15±0.29 mm; difference: -0.006 mm; 95% confidence interval: -0.085 to 0.072; p=0.87; p for non-inferiority <0.0001) at nine-month follow-up. The major adverse cardiac events rate was numerically lower in the BioMime SES group (2.98% vs. 7.14%; p=0.13), driven by a statistically significant lower risk of any myocardial infarction (0.60% vs. 4.76%; p=0.03), when compared with the XIENCE EES group. There was no difference in target vessel myocardial infarction (p=0.62) between the groups. There was no definite or probable stent thrombosis in either group. CONCLUSIONS: In the treatment of de novo native coronary artery lesions, the biodegradable polymer ultra-thin SES (BioMime) was non-inferior to a durable polymer EES (XIENCE) at nine-month follow-up. Further studies powered for clinical endpoints are needed.

First Bioresorbable Vascular Scaffold Implantation in Patients with Acute Coronary Syndrome in the Republic of Macedonia.

BACKGROUND: The term acute coronary syndrome (ACS) refers to any group of clinical symptoms compatible with acute myocardial ischemia. These high-risk manifestations of coronary atherosclerosis are important causes of the use of emergency medical care and hospitalization. We evaluated the feasibility and the acute performance of the everolimus-eluting bioresorbable vascular scaffolds (BVS) for the treatment of patients presenting with ACS. METHODS AND RESULTS: The present investigation was a prospective, single-centre study. Clinical outcomes were reported at the 30-day, 6-month, 1 year and 2 years follow-up. The procedural success was 100.0%. After the BVS implantation a TIMI flow 3 was achieved in all 15 patients and the postprocedure percentage diameter stenosis was 16.4 ± 8.6%. No patients had angiographically visible residual thrombus at the end of the procedure. Optical coherence tomography (OCT) analysis was performed in 8 patients (53.3%) and showed that the post-procedure mean lumen area was 7.86 ± 1.81 mm(2), minimum lumen area 5.51 ± 1.58 mm(2). At the 30-day, 6-month, 1 year (15 patients) and 2 years follow-up (5 patients) target-lesion failure rate was 0%. Non-target vessel revascularization and target vessel myocardial infarction were not reported. No cases of cardiac death or scaffold thrombosis were observed. CONCLUSION: BVS implantation in patients presenting with ACS appeared feasible, with high rate of final TIMI-flow 3 and good scaffold apposition.

Safety of Slender 5Fr Transradial Approach for Carotid Artery Stenting With a Novel Nitinol Double-Layer Micromesh Stent.

We aimed to evaluate the feasibility and safety of performing percutaneous carotid stent implantation with a newly designed double-layer stent using transradial slender 5Fr techniques. We recruited 10 consecutive patients who underwent percutaneous carotid stenting using nitinol double-layer micromesh (Roadsaver) stents. Mean age of patients was 66 years. Seven patients had ≥2 high-risk criteria according to SAPPHIRE classification. Indication was neurologic symptoms in 7 and severe lesion without symptoms in 3 cases. Type 2 aortic arch was present in 8 patients and type 1 in 2 patients. Access was right radial artery in 9 cases and right ulnar artery in 1 case. Right carotid artery was stented in 4 cases and left carotid artery in 6 cases. Embolic protection device (EPD) was used in 6 cases. Nine stents were successfully delivered using 5Fr destination sheath (n = 7) or shuttle sheath (n = 2), and 1 was implanted using Mo-Ma 8Fr proximal EPD. Procedural success was obtained in all cases with only 1 case of temporary vasospasm due to distal EPD. Total procedural time was 21 minutes (13 to 30 minutes) with filter time of 5 ± 1 minutes. Fluoroscopy time was 8 minutes (5 to 12 minutes) and contrast volume was 150 ml (100 to 200 ml). Hospital stay was 1 ± 1 day with 4 patients discharged on the same day of the procedure. Using right transradial approach and slender 5Fr techniques, this new double-layer micromesh stent can be implanted in left and right carotid arteries with promising results.