Very Long-Term Clinical Outcomes After Direct Stenting in Patients Presenting With ST-Segment Elevation Myocardial Infarction.

BACKGROUND/PURPOSE: Direct Stenting (DS) could be associated with reduced distal embolization and improved reperfusion in patients with ST-segment elevation myocardial infarction (STEMI). However, the impact of DS on long-term outcomes remains unclear, therefore we evaluated the impact of DS on very long-term clinical outcome in STEMI. METHODS/MATERIALS: Between April 2002 and December 2004, patients presenting with STEMI undergoing percutaneous coronary intervention were investigated. The study population was divided into two groups: DS and conventional stenting (CS) and stratified according to initial TIMI flow. Major adverse cardiac events (MACE) were assessed at 10 years and all-cause mortality at 15 years. Cox proportional hazards models were used. When the proportional hazards assumption was not satisfied, landmark analysis at mid-term (2 years) was performed. RESULTS: A total of 812 consecutive patients were evaluated, 6 patients were excluded due to inadequate angiographic images, 450 (55.8%) underwent DS and 356 (44.2%) CS. At 15 years follow-up, DS was associated with a reduction in all-cause mortality (DS 35.0% vs. CS 45.3%, aHR 0.74, 95% CI 0.58-0.93, p = 0.010). The landmark analysis at 2 years identifies reduced 2-year MACE in DS compared with CS (6.8% vs.14%, aHR 0.67, 95% CI 0.49-0.93, p = 0.015) and beyond 2 years no significant differences were found between the groups (27.4% vs. 29.3%, aHR 1.00, 95% CI 0.74-1.36, p = 0.999). In patients with baseline TIMI 0-1, DS was associated with lower 10-year MACE and 15-year mortality compared with CS (aHR0.71, 95%CI 0.55-0.92, p = 0.010 and aHR0.65, 95%CI 0.50-0.84, p = 0.001, respectively). CONCLUSIONS: DS was associated with reduced 15-year all-cause mortality and reduced mid-term MACE rate in patients with STEMI. Clinical events reduction associated with DS was particularly relevant in patients with initial TIMI flow 0-1.

Comparison of direct stenting with conventional strategy on myocardial impairments in ST-segment elevation myocardial infarction: a cardiac magnetic resonance imaging study.

Direct stenting (DS) without pre-dilatation of the culprit lesion might improve myocardial perfusion and prognosis in patients undergoing percutaneous coronary intervention for ST-elevation myocardial infarction (STEMI); however, some studies report conflicting results. We investigated whether DS provides incremental myocardial benefits over conventional stenting (CS) in STEMI patients based on cardiac magnetic resonance imaging (CMR) measures. Reperfused patients who underwent CMR examinations within 1 week of STEMI onset were selected from a multicenter CMR registry of STEMI (NCT: 03768453). Patients were stratified into either a DS or CS group. Each group comprised 137 patients after 1:1 propensity score matching. Major adverse events (MACEs), including death, myocardial re-infarction, re-admission for heart failure, and stroke were noted during a median period of 44 months (interquartile range 32-58 months). DS was associated with larger (p = 0.007) and shorter (p = 0.005) stent sizes than CS. DS and CS achieved comparable angiographic TIMI-3 flow grades (p = 0.86) and myocardial blush grades (p = 0.70). There were no group differences regarding the incidence of CMR manifestations of microvascular dysfunction, including microvascular obstruction (MVO) (p = 0.89) and intramyocardial hemorrhage (p = 0.47), the extent of MVO (p = 0.21), infarction size (p = 0.83), or left ventricular ejection fraction (p = 0.57). Kaplan-Meier analysis revealed similar risks of MACEs (log rank p = 0.909), which occurred in 23.4% of DS and 26.3% of CS patients (p = 0.576). DS did not show any incremental benefits over CS on myocardial impairments as evaluated using CMR.Clinical Trial Registration: Clinicaltrials.gov, NCT: 03768453.

Endovascular Treatment of Large or Giant Non-saccular Vertebrobasilar Aneurysms: Pipeline Embolization Devices Versus Conventional Stents.

BACKGROUND: Endovascular treatment of large or giant non-saccular vertebrobasilar aneurysms (VBAs) by conventional stents is difficult and has unsatisfactory outcomes. OBJECT: This study was performed to retrospectively analyze the safety and efficacy of a flow diverter in treating large and giant non-saccular VBAs. METHODS: We identified 78 patients with 83 large or giant non-saccular VBAs who accepted endovascular treatment with a pipeline embolization device (PED) or conventional stent from January 2014 to June 2018. The technical details of the procedure, procedure-associated complications, angiographic outcomes, and clinical outcomes were evaluated. RESULTS: Forty-two patients (53.8%, 42/78) with 44 aneurysms (53.0%, 44/83) underwent endovascular treatment with PEDs. Thirty-six patients (46.2%, 36/78) with 39 aneurysms (47.0%, 39/83) underwent endovascular treatment with conventional stents. The complication rate of PED group and conventional stent group was 7.1% (3/42) and 5.6% (2/36), respectively (odds ratio, 0.765; 95% confidence interval, 0.121-4.851; P = 0.776). During a median follow-up time of 28.8 months, the complete occlusion rate in the PED group and conventional stent group was 90.2% (37/41) and 70.3% (26/37), respectively (odds ratio, 3.913; 95% confidence interval, 1.122-13.652; P = 0.032). CONCLUSION: Endovascular treatment with a PED is a promising and safe modality for large and giant non-saccular VBAs, and the complication rate is acceptable, compared with conventional endovascular treatment.

Impact of direct stenting on clinical outcomes for small vessel coronary artery disease in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction.

INTRODUCTION: Direct stenting (DS) is associated with improved markers of reperfusion during primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI). However, data evaluating its impact in small vessel coronary artery disease (CAD) are lacking. AIM: To compare DS and conventional stenting (CS) for small vessel CAD on clinical outcomes of patients with STEMI undergoing PPCI. MATERIAL AND METHODS: A cohort of 616 STEMI patients treated with DS (202 patients) or CS (414 patients) in small vessel (≤ 2.75 mm) lesions was retrospectively analyzed. The primary endpoint was to compare the occurrence of major adverse cardiac events (MACE) between groups during 2-year follow-up. The secondary end points included in-hospital target lesion revascularization (TLR) and in-hospital death. RESULTS: The primary end-point, MACEs, occurred in 9.2% in the DS group and 12.3% in the CS group (p > 0.05). The rates of TLR, myocardial infarction (MI) and target vessel revascularization (TVR) were not significantly different between groups (p > 0.05). The stent thrombosis (ST) rate was significantly lower in the DS group (1.0% vs. 4.2%, p = 0.04) at 2 years. However, DS was not found to be an independent predictor of ST in multivariate analysis. There were no significant differences in in-hospital rates of death and TLR. The DS compared to CS resulted in greater rates of postprocedural TIMI grade 3 flow, and lower risk of edge dissection. The procedure time, radiation exposure and contrast administration were found to be significantly lower in the DS group. CONCLUSIONS: In selected patients with STEMI undergoing PPCI for small vessel CAD, DS is not only safe and feasible but also reduces ST rates, contrast load, and procedural and radiation exposure time.

Comparing Direct Stenting With Conventional Stenting in Patients With Acute Coronary Syndromes: A Meta-Analysis of 12 Clinical Trials.

Our aim was to compare direct stenting (DS) with conventional stenting (CS) in patients with acute coronary syndrome (ACS). We searched PubMed, EMBASE, and ISI web of science for eligible studies. Primary end point was major adverse cardiac events (MACEs) in short term. Secondary end points were 1-year mortality and after-procedural no-reflow phenomenon. Twelve trials in 8998 patients were included. The odds ratios (ORs) were pooled using the Mantel-Haenszel fixed effect model. Short-term MACEs were significantly reduced in the DS arm in contrast to the CS (5.00% vs 8.08%, DS vs CS, respectively, OR [95% confidence interval] = 0.61 [0.46-0.80], P = .0004). One-year mortality and after-procedural no-reflow phenomenon were significantly lower in the DS group. No heterogeneity was observed through I(2) test (Phet = .81, .89, and .77 for each end point, respectively). This meta-analysis demonstrated that in selected patients with ACS, DS is not only safe and feasible but also reduces short-term and 1-year mortality as well as the occurrence of after-procedural no-reflow phenomenon.