Off-Hours Presentation, Door-to-Balloon Time, and Clinical Outcomes in Patients Referred for Primary Percutaneous Coronary Intervention.

OBJECTIVES: Presentation with ST-segment-elevation myocardial infarction (STEMI) during off-hours may impact timely reperfusion and clinical outcomes. We investigated the association between off-hours presentation, door-to-balloon time, and in-hospital mortality in patients with STEMI referred for primary percutaneous coronary intervention (PCI). METHODS: We included consecutive patients referred for primary PCI at the University of Ottawa Heart Institute between July 2004 and December 2017. The off-hours group included patients presenting on weekends, statutory holidays, or between 18:00 to 07:59 hours on weekdays. The on-hours group included patients presenting between 08:00 and 17:59 hours on weekdays. The primary clinical outcome was the adjusted in-hospital mortality. The primary quality-of-care indicator was door-to-balloon time. RESULTS: A total of 5132 patients were included, with 3152 (61.4%) in the off-hours group and 1980 (38.6%) in the on-hours group. The median door-to-balloon time was longer in the off-hours group compared with the on-hours group (102 minutes vs 77 minutes; P<.001), while the median onset-to-door time was similar (P=.40). There was no difference in the rates of in-hospital mortality (3.5% vs 3.0%; P=.32) or in the adjusted mortality (odds ratio, 1.2; 95% confidence interval, 0.8-1.8; P=.44) between off-hours and on-hours groups. However, door-to-balloon time was an independent predictor of in-hospital mortality (P<.01) and off-hours presentation was an independent predictor of longer door-to-balloon time (P<.001), with an excess of 22.1 minutes. CONCLUSION: Patients treated with primary PCI during off-hours had longer door-to-balloon times. Treatment during off-hours was an independent predictor of longer door-to-balloon time and longer door-to-balloon times were associated with higher mortality.

Transradial Angiography and Intervention in Acute Coronary Syndromes.

Considerable evidence supports transradial angiography and intervention in patients with acute coronary syndrome, with an emphasis on decreasing major bleeding and access site vascular complications. Patients undergoing invasive treatment are at greatest risk of bleeding and have the most to gain. The radial advantage has consistently been shown to translate into reduced mortality in pooled data analyses. The benefits of transradial access have been demonstrated across the acute coronary syndrome spectrum and in both sexes. A radial-first strategy should be the default approach and continuous efforts should be made to increase operator expertise of transradial access in these patients.

Periprocedural Bivalirudin Versus Unfractionated Heparin During Percutaneous Coronary Intervention Following Fibrinolysis for ST-Segment Elevation Myocardial Infarction.

BACKGROUND: A pharmacoinvasive strategy for ST-segment elevation myocardial infarction (STEMI) management combines the use of fibrinolysis with the routine transfer to coronary angiography, with percutaneous coronary intervention (PCI) if needed. This method reduces the risk of major adverse cardiovascular event (MACE) compared with fibrinolysis alone; however, it is associated with higher bleeding risk. We sought to assess the bivalirudin compared with unfractionated heparin (UFH) used during PCI as part of a pharmacoinvasive strategy. METHODS: We identified consecutive patients referred to the University of Ottawa Heart Institute between April 2009 and May 2011 as part of a pharmacoinvasive strategy for STEMI. The primary efficacy outcome was MACE, defined as a composite of death, reinfarction, or stroke during index hospitalization. The primary safety outcome was TIMI bleeding. RESULTS: We identified 200 patients meeting inclusion criteria: 123 patients (61.5%) in the bivalirudin group and 77 patients (37.5%) in the UFH group. Median fibrinolysis to balloon time was 324 minutes in the bivalirudin group and 226 minutes in the UFH group (P<.001). Initial TIMI grade 3 flow was higher in the bivalirudin group vs the UFH group, but there was no difference in the rates post PCI. MACE rates were 4.9% vs 7.8% (P=.40) and TIMI bleeding rates were 7.3% vs 11.7% (P=.29) in patients treated with bivalirudin vs UFH, respectively. CONCLUSION: The periprocedural use of bivalirudin vs UFH was associated with similar rates of MACE and bleeding. Given the expense of bivalirudin and lack of demonstrable clinical superiority, UFH remains the first-line periprocedural anticoagulant in a pharmacoinvasive strategy.

Ultrasound Guidance in Femoral Artery Catheterization: A Systematic Review and a Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: During percutaneous cardiac procedures, the use of radial access is growing, but femoral access remains needed for large-bore, high-risk procedures. Methods are needed to make femoral access safer. In this systematic review and meta-analysis of randomized-controlled trials (RCTs), we assess whether ultrasound guidance is associated with a decreased risk of vascular complications during femoral artery catheterization. METHODS: Medline, Embase, and Cochrane Central were searched from inception to April 2018. RCTs assessing the use of ultrasound among adult patients undergoing a femoral artery catheterization were included. The primary outcome was vascular-access related complications. Secondary outcomes included major and minor vascular access bleeding, success rate, venipuncture, number of attempts, and successful placement into the common femoral artery. RESULTS: Five RCTs (n = 1553) met the inclusion criteria, with two trials using blinded outcome assessment. Ultrasound use was associated with a reduction in the rate of vascular-access related complications (1.9% vs 4.3%; odds ratio [OR], 0.44; 95% confidence interval [CI], 0.24-0.81; P<.01). This was primarily driven by a reduction in local hematomas; once hematomas were excluded, the association was no longer significant (0.6% vs 1.7%; OR, 0.39; 95% CI, 0.15-1.07; P=.07). There was no significant reduction in major bleeding (0.3% vs 1.3%; OR, 0.28; 95% CI, 0.07-0.1.16; P=.08) or minor bleeding (1.4% vs 2.8%; OR, 0.50; 95% CI, 0.24-1.05; P=.07). CONCLUSIONS: Ultrasound guidance during femoral artery catheterization is associated with a decreased risk of vascular complications, primarily driven by a reduction in local hematomas. Larger trials are needed to determine the effect of ultrasound on major bleeding and vascular complications (excluding hematomas).

A meta-analysis of randomized controlled trials to compare long-term clinical outcomes of bioabsorbable polymer and durable polymer drug-eluting stents.

AIMS: The durable polymer (DP) of a drug-eluting stent (DES) serves no function once drug elution is complete. To ascertain the benefits of bioabsorbable polymer (BP) over DP-DESs requires a longer follow-up period, to overcome the time taken for polymer absorption. The primary aim of this meta-analysis was to compare the safety and efficacy of BP-DES with the DP-DES over mid (2 years) to long-term (3-5 years) follow-up. METHODS AND RESULTS: A thorough computer-based search was performed using Ovid MEDLINE, EMBASE, Google Scholar, and PubMed databases. We only included randomized controlled studies comparing clinical outcomes between BP-DESs and DP-DESs. Only studies where data were available for a minimum of 2 years were included. A separate analysis of 2-year outcomes and 3- to 5-year outcomes were conducted. Data from 6 and 8 studies were included in 3- to 5-year and 2-year follow-up, respectively. There were no differences between stent groups in cardiac mortality, stent thrombosis (ST), target lesion revascularization, target vessel failure, and reinfarction rates for either 2-year or 3- to 5-year follow-up. Subgroup analysis according to strut thickness (<100 µm, >100 µm) of BP-DES demonstrated similar results. The analyses of ST and very late ST favoured BP-DESs but did not reach statistically significant level. CONCLUSION: There were no differences in clinical outcomes between BP-DESs and DP-DESs over mid- and long-term follow-up.

Transcatheter Aortic Valve Implantation in Intermediate Surgical Risk Patients With Severe Aortic Stenosis: A Systematic Review and Meta-Analysis.

BACKGROUND: Recent data from randomised and observational studies have reported non-inferior outcomes for transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR) in intermediate-risk patients. We performed a systematic review to evaluate the mortality of TAVI compared to SAVR in intermediate-risk patients. METHODS: A comprehensive search of four major databases (Embase, Ovid MEDLINE, PubMed, and Google Scholar) was performed from their inception to 29 April 2016. We included original research studies reporting data on TAVI and SAVR in intermediate-risk patients. We compared the outcomes of TAVI to SAVR. RESULTS: A total of 2,375 and 2,377 intermediate-risk patients underwent TAVI and SAVR respectively. The 30-day all-cause (p=0.07), 30-day cardiac (p=0.53), and 12-month all-cause mortality (p=0.34) was similar between the two groups. However, TAVI through transfemoral access had a significantly lower mortality than SAVR (OR 0.58, p=0.006). The incidence of ≥moderate aortic incompetence (p<0.00001) and pacemaker implantation (p<0.0001) was higher in the TAVI group. CONCLUSIONS: In the intermediate-risk patients, the 30-day and 12-month mortality are similar between TAVI and SAVR. Increased operator experience and improved device technology have led to a significant reduction in mortality in intermediate-risk patients undergoing TAVI.

Safety and Efficacy of a Pharmacoinvasive Strategy in ST-Segment Elevation Myocardial Infarction: A Patient Population Study Comparing a Pharmacoinvasive Strategy With a Primary Percutaneous Coronary Intervention Strategy Within a Regional System.

OBJECTIVES: This study investigated the safety and efficacy of a pharmacoinvasive strategy compared with a primary percutaneous coronary intervention (PCI) strategy for ST-segment elevation myocardial infarction (STEMI) in the context of a real-world system. BACKGROUND: Primary PCI continues to be the optimal reperfusion therapy; however, in areas where PCI centers are not readily available, a pharmacoinvasive strategy has been proposed. METHODS: The University of Ottawa Heart Institute regional STEMI system provides a primary PCI strategy for patients presenting within a 90-km radius from the PCI center, and a pharmacoinvasive strategy for patients outside this limit. We included all confirmed STEMI patients between April 2009 and May 2011. The primary efficacy outcome was a composite of mortality, reinfarction, or stroke and the primary safety outcome was major bleeding. RESULTS: We identified 236 and 980 consecutive patients enrolled in pharmacoinvasive and primary PCI strategies, respectively. The median door-to-needle time was 31 min in the pharmacoinvasive group and the median door-to-balloon time was 95 min in the primary PCI group. In a multivariable model, there was no significant difference in the primary efficacy outcome (odds ratio: 1.54; p = 0.21); however, the propensity for more bleeding with a pharmacoinvasive strategy approached statistical significance (odds ratio: 2.02; p = 0.08). CONCLUSIONS: Within the context of a STEMI system, a pharmacoinvasive strategy was associated with similar rates of the composite of mortality, reinfarction, or stroke as compared with a primary PCI strategy; however, there was a propensity for more bleeding with a pharmacoinvasive strategy.