Short-term dual antiplatelet therapy in diabetic patients admitted for acute coronary syndrome treated with a new-generation drug-eluting stent.

BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) in patients with diabetes mellitus (DM) admitted with acute coronary syndrome (ACS) and treated with a drug-eluting stent (DES) remains unclear. This is a prespecified sub-study from the Randomised Evaluation of short-term DUal antiplatelet therapy in patients with acute Coronary syndromE treated with a new generation DES (REDUCE) trial that was designed to determine the efficacy and safety of short-term versus standard 12 months DAPT in diabetic patients with ACS undergoing percutaneous coronary intervention (PCI) using the COMBO stent. METHODS: In this study we included ACS diabetic patients enroled in the REDUCE trial treated with the COMBO stent and randomly assigned to either 3 or 12 months of DAPT. The primary study endpoint was the composite of all-cause mortality, myocardial infarction (MI), stent thrombosis (ST), stroke, target vessel revascularisation (TVR), and bleeding complications at 12 and 24 months follow-up. RESULTS: A total of 307 diabetic patients were included, of which 162 (52.8%) in the 3 months DAPT group and 145 (47.2%) in the 12 months DAPT group. Patient characteristics, PCI success, and number of stents used were similar in the 3 and 12 months DAPT groups. Occurrence of the primary study endpoint at 12 and 24 months follow-up was comparable between the two groups (3.1 vs. 3.5%, p = 0.865, and 15.8 vs. 14.9%, p = 0.824, respectively). Moreover, the prevalence of the specific clinical outcome parameters (all-cause mortality), MI, ST, stroke, TVR, and bleeding was similar in both study groups. CONCLUSIONS: This sub-analysis shows similar clinical outcomes following 3 months DAPT as compared to 12 months DAPT in diabetic patients undergoing PCI for ACS using the COMBO stent. These results suggest that, even in this particular subset of patients, short duration of DAPT might be considered safe. Future larger studies are warranted to provide more precise estimations in terms of safety and efficacy of short term DAPT in these high-risk patients.

BIOSOLVE-IV-registry: Safety and performance of the Magmaris scaffold: 12-month outcomes of the first cohort of 1,075 patients.

OBJECTIVES: We aimed to assess the safety and performance of the Magmaris sirolimus-eluting bioresorbable magnesium scaffold in a large patient population. BACKGROUND: Magmaris has shown good outcomes in small-sized controlled trials, but further data are needed to confirm its usability, safety, and performance. METHODS: BIOSOLVE-IV is an international, single arm, multicenter registry including patients with a maximum of two single de novo lesions. Follow-up is scheduled up to 5 years; the primary outcome is target lesion failure (TLF) at 12 months. RESULTS: A total of 1,075 patients with 1,121 lesions were enrolled. Mean patient age was 61.3 ± 10.5 years and 19.2% (n = 206) presented with non-ST-elevation myocardial infarction (NSTEMI). Lesions were 3.2 ± 0.3 mm in diameter and 14.9 ± 4.2 mm long; 5.1% (n = 57) were bifurcation lesions. Device success was 97.3% (n = 1,129) and procedure success 98.9% (n = 1,063). The Kaplan-Meier estimate of TLF at 12 months was 4.3% [95% confidence interval, CI: 3.2, 5.7] consisting of 3.9% target lesion revascularizations, 0.2% cardiac death, and 1.1% target-vessel myocardial infarction. Definite/probable scaffold thrombosis occurred in five patients (0.5% [95% CI: 0.2, 1.1]), thereof four after early discontinuation of antiplatelet/anticoagulation therapy. CONCLUSION: BIOSOLVE-IV confirms the safety and performance of the Magmaris scaffold in a large population with excellent device and procedure success and a very good safety profile up to 12 months in a low-risk population.

How to set up regional STEMI networks: a "Stent - Save a life!" initiative.

Clinical guidelines recommend the development of ST-elevation myocardial infarction (STEMI) networks at community, regional and/or national level to ideally offer primary coronary angioplasty, or at least the best available STEMI care to all patients. However, there is a discrepancy between this clinical recommendation and daily practice, with no coordinated care for STEMI patients in many regions of the world. While this can be a consequence of lack of resources, in reality it is more frequently a lack of organisational power. In this paper, the Stent - Save a Life! Initiative (www.stentsavealife.com) proposes a practical methodology to set up a STEMI network effectively in any region of the world with existing resources, and to develop the STEMI network continuously once it has been established.

Effect of Procedural Technique on Cardiovascular Outcomes Following Second-Generation Drug-Eluting Resorbable Magnesium Scaffold Implantation.

BACKGROUND: This study sought to assess target lesion failure (TLF) and clinically driven target lesion revascularization (CD-TLR) through 1 year following second-generation drug-eluting magnesium scaffold (Magmaris) implantation using a dedicated technique (so-called "4 P's" strategy). METHODS AND RESULTS: The 4 P's strategy stands for: correct patient selection, proper scaffold sizing, pre-dilatation (<20% residual stenosis), post-dilatation. All the patient and lesion characteristics, preparation, and sizing of the device were compared in patients with TLF and CD-TLR through 1-year follow-up. We analyzed 315 patients for this study. At 1 year, there were 14 TLFs and 10 CD-TLRs. The TLF rates were 7.7%, 4.9%, and 4.1%; while the CD-TLR rates were 7.7%, 2.5%, and 3.2% in the undersized, properly sized, and oversized vessel groups, correspondingly. Diameter stenosis (DS) after pre-dilatation in patients with TLF and CD-TLR was significantly greater than in those without TLF and CD-TLR. In patients with a properly sized scaffold, DS after pre-dilatation was similar in patients with and without TLF and CD-TLR. However, in patients with non-properly sized scaffolds, greater post-balloon DS was observed in patients with TLF and CD-TLR. CONCLUSIONS: Improper sizing and poor lesion preparation before Magmaris implantation appear to be related to TLF during 1-year follow-up.

Asia Pacific TAVI registry (an APSIC initiative): initial report of early outcomes: Asia Pacific TAVI registry.

AIMS: The aim of the study was to report the clinical experience, 30-day mortality and acute outcomes of patients undergoing transcatheter aortic valve implantation (TAVI) in the Asia Pacific region. METHODS AND RESULTS: The Asia Pacific TAVI registry is an international, multicentre, prospective, observational registry managed under the auspices of the Asian Pacific Society of Interventional Cardiology (APSIC). Patients undergoing TAVI in seven centres from Hong Kong, Japan, Philippines, Singapore and Taiwan, treated with TAVI devices for severe symptomatic aortic stenosis, were assessed. This first review presents the acute results and 30-day mortality. A multivariable analysis was also performed to identify independent predictors of early all-cause mortality. The enrolment was from 2009 to 2017 and a total of 1,125 patients were recruited. The 30-day mortality rate was 2.5%. Baseline logistic EuroSCORE more than 16 was independently associated with a 2.8-times increased risk of 30-day all-cause mortality (p=0.016). Post-procedural stroke (HR 4.9, p=0.008) was also associated with increased mortality. CONCLUSIONS: This initial report of the Asia Pacific TAVI registry demonstrated good acute success and low 30-day mortality. The preprocedural logistic EuroSCORE and post-procedural stroke incidence were strongly associated with acute mortality. Further attempts to reduce post-procedural stroke should be explored.

Sex differences in patients undergoing transcatheter aortic valve replacement in Asia.

OBJECTIVES: Transcatheter aortic valve replacement (TAVR) is increasingly performed. Physically small Asians have smaller aortic root and peripheral vessel anatomy. The influence of gender of Asian patients undergoing TAVR is unknown and may affect outcomes. The aim of this study was to assess sex differences in Asian patients undergoing TAVR. METHODS: Patients undergoing TAVR from eight countries were enrolled. In this retrospective analysis, we examined differences in characteristics, 30-day clinical outcomes and 1-year survival between female and male Asian patients. RESULTS: Eight hundred and seventy-three patients (54.4% women) were included. Women were older, smaller and had less coronary artery and lung disease but tended to have higher logistic EuroSCOREs. Smaller prostheses were used more often in women. Major vascular complications occurred more frequently in women (5.5% vs 1.8%, p<0.01); however, 30-day stroke and mortality (women vs men: 1.5% vs 1.6%, p=0.95% and 4.3% vs 3.4%, p=0.48) were similar. Functional status improvement was significant and comparable between the sexes. Conduction disturbance and permanent pacemaker requirements (11.2% vs 9.0%, p=0.52) were also similar as was 1-year survival (women vs men: 85.6% vs 88.2%, p=0.25). The only predictors of 30-day mortality were major vascular injury in women and age in men. CONCLUSIONS: Asian women had significantly smaller stature and anatomy with some differences in clinical profiles. Despite more frequent major vascular complications, women had similar 30-day stroke or mortality rates. Functional status improvement was significant and comparable between the sexes. Conduction disturbance and permanent pacemaker requirements were similar as was 1-year survival.

No-reflow is an independent predictor of death and myocardial infarction after percutaneous coronary intervention.

BACKGROUND: No-reflow occurring during percutaneous coronary intervention (PCI) has been associated with poor inhospital outcomes. The objectives of this analysis were to evaluate the occurrence of no-reflow as an independent predictor of adverse events and to determine whether treatment with intracoronary vasodilator therapy affected clinical outcomes. METHODS: We prospectively collected data from 4264 consecutive patients undergoing PCI, identifying those with no-reflow, and analyzed their treatments and clinical outcomes. RESULTS: No-reflow was identified in 135 of 4264 patients (3.2%). Baseline demographics were comparable, but patients with no-reflow were more likely to have acute myocardial infarction, unstable angina, and cardiogenic shock and to have undergone saphenous vein graft interventions. No-reflow was highly predictive of postprocedural myocardial infarction (17.7% vs 3.5% in patients without no-reflow, P <.001) and death (7.4% vs 2.0%, P <.001) and remained a strong independent predictor of death or myocardial infarction after multivariate analysis (odds ratio 3.6, P <.001). The administration of intracoronary verapamil, sodium nitroprusside, or both was not associated with a reduction in the rate of death or myocardial infarction (adjusted odds ratio of death or myocardial infarction 1.04, P =.945 for nitroprusside; and adjusted odds ratio of death or myocardial infarction 0.94, P =.91 for verapamil), despite an improvement in angiographic flow rates for patients treated with sodium nitroprusside. CONCLUSIONS: No-reflow is a strong independent predictor of inhospital mortality and postprocedural myocardial infarction. Administration of verapamil or sodium nitroprusside was not associated with improved inhospital outcomes in patients with no-reflow, although anterograde flow rates were improved in patients treated with sodium nitroprusside.