Systematic review and meta-analysis of intravascular temperature management vs. surface cooling in comatose patients resuscitated from cardiac arrest.

OBJECTIVE: To systematically review the effectiveness and safety of intravascular temperature management (IVTM) vs. surface cooling methods (SCM) for induced hypothermia (IH). METHODS: Systematic review and meta-analysis. English-language PubMed, Embase and the Cochrane Database of Systematic Reviews were searched on May 27, 2019. The quality of included observational studies was graded using the Newcastle-Ottawa Quality Assessment tool. The quality of included randomized trials was evaluated using the Cochrane Collaboration's risk of bias tool. Random effects modeling was used to calculate risk differences for each outcome. Statistical heterogeneity and publication bias were assessed using standard methods. ELIGIBILITY: Observational or randomized studies comparing survival and/or neurologic outcomes in adults aged 18 years or greater resuscitated from out-of-hospital cardiac arrest receiving IH via IVTM vs. SCM were eligible for inclusion. RESULTS: In total, 12 studies met inclusion criteria. These enrolled 1573 patients who received IVTM; and 4008 who received SCM. Survival was 55.0% in the IVTM group and 51.2% in the SCM group [pooled risk difference 2% (95% CI -1%, 5%)]. Good neurological outcome was achieved in 40.9% in the IVTM and 29.5% in the surface group [pooled risk difference 5% (95% CI 2%, 8%)]. There was a 6% (95% CI 11%, 2%) lower risk of arrhythmia with use of IVTM and 15% (95% CI 22%, 7%) decreased risk of overcooling with use of IVTM vs. SCM. There was no significant difference in other evaluated adverse events between groups. CONCLUSIONS: IVTM was associated with improved neurological outcomes vs. SCM among survivors resuscitated following cardiac arrest. These results may have implications for care of patients in the emergency department and intensive care settings after resuscitation from cardiac arrest.

Age-associated outcomes after survived out-of-hospital cardiac arrest and subsequent target temperature management.

BACKGROUND: The registry of the German Society of Intensive Care and Emergency Medicine was founded to analyze outcome of modern post-resuscitation care. METHODS: A total of 902 patients were analyzed in this retrospective, multicenter, and population-based observational trial on individuals suffering from out-of-hospital cardiac arrest. All patients had return of spontaneous circulation (ROSC) and received TTM after admitted to an intensive care unit. Outcome was focused on age and analyzed by creating 4 subgroups (<65, 65-74, 75-84, ≥85 years). Twenty-eight day and 180-day survival and a favorable neurological outcome according to the Cerebral Performance Category scale were evaluated as clinical endpoints. RESULTS: At 28-day and 180-day follow-up, 44.8% and 53.4% of all patients had died, respectively. The evaluation of survival rate by age category revealed a higher mortality, but not an unfavorable neurological prognosis with increasing age. In multiple stepwise regressions, age, time to ROSC, bystander resuscitation, and cardiac cause of cardiac arrest were associated with increased chance of 180-day survival and, in addition, bystander resuscitation, time of hypoxia, and a defibrillation performed by emergency medical service were associated with a favorable neurological outcome at 180-day follow-up. CONCLUSION: Increasing age was associated with a higher mortality, but not with an unfavorable neurological outcome. The majority of survivors had a favorable neurologic outcome 6 months after cardiac arrest.

Invasive versus non-invasive cooling after in- and out-of-hospital cardiac arrest: a randomized trial.

INTRODUCTION: Mild induced hypothermia (MIH) is indicated for comatose survivors of sudden cardiac arrest (SCA) to improve clinical outcome. In this study, we compared the efficacy of two different cooling devices for temperature management in SCA survivors. METHODS: Between April 2008 and August 2009, 80 patients after survived in-hospital (IHCA) and out-of-hospital cardiac arrest (OHCA) were included in this prospective, randomized, single center study. Hypothermia was induced after randomization by either invasive Coolgard(®) cooling or non-invasive ArcticSun(®) surface cooling at 33.0 °C core body temperature for 24 h followed by active rewarming. The primary endpoint was defined as the efficacy of both cooling systems, measured by neuron-specific enolase (NSE) levels as a surrogate parameter for brain damage. Secondary efficacy endpoints were the clinical and neurological outcome, time to start of cooling and reaching the target temperature, target temperature-maintenance and hypothermia-associated complications. RESULTS: NSE at 72 h did not differ significantly between the 2 groups with 16.5 ng/ml, interquartile range 11.8-46.5 in surface-cooled patients versus 19.0 ng/ml, interquartile range 11.0-42.0 in invasive-cooled patients, p = 0.99. Neurological and clinical outcome was similar in both groups. Target temperature of 33.0 °C was maintained more stable in the invasive group (33.0 versus 32.7 °C, p < 0.001). Bleeding complications were more frequent with invasive cooling (n = 17 [43.6 %] versus n = 7 [17.9 %]; p = 0.03). CONCLUSION: Invasive cooling has advantages with respect to temperature management over surface cooling; however, did not result in different outcome as measured by NSE release in SCA survivors. Bleeding complications were more frequently encountered by invasive cooling.

Stent thrombosis up to 3 years after stenting for ST-segment elevation myocardial infarction versus for stable angina--comparison of the effects of drug-eluting versus bare-metal stents.

BACKGROUND: The long-term safety of drug-eluting stents (DES) for the treatment of ST-segment elevation myocardial infarction (STEMI) is unclear and may differ from that in stable angina (stable) patients as noted in autopsy studies. METHODS: To assess this problem, 210 consecutive STEMI and 323 stable patients, randomized 2:1 to DES versus bare-metal stents (BMS), were followed up for 3 years for definite/probable stent thrombosis (ST) and cardiac death/myocardial infarction. Events occurring during the initial 6 months were separated from later events. RESULTS: The 3-year rate of ST was 8.1% in STEMI vs 3.4% in stable patients (P = .02), with corresponding rates of 9.4% vs 2.9% (P = .01) for DES and of 5.6% vs 4.3% (P = .71) for BMS patients, respectively. This difference appeared only after 6 months: 4.6% in STEMI vs 1.7% in stable patients (P = .05) and in DES-treated patients (6.2% vs 2.0%, P = .05). Results of ST were paralleled by findings of clinical events, although here differences were less pronounced, but also seen only late after stenting. Thus, in STEMI patients, late events occurred more frequently after DES vs BMS implantation (11.6% vs 3.0%, P = .04), compared to results in stable patients (DES 6.4%, BMS 1.9%, P = .08). CONCLUSIONS: In this pilot study, we observed an increased rate of late ST and a trend to more related clinical events in patients after stenting for STEMI vs for stable angina, particularly if treated with DES. This may explain outcome differences between results of pivotal trials in stable patients vs those of "real-world" patients.

Short and long-term benefits of sirolimus-eluting stent in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials.

BACKGROUND: Recent concerns have emerged on the potential higher risk of stent thrombosis after DES implantation, that might be even more pronounced among STEMI patients. The aim of the current study was to perform a meta-analysis to evaluate the benefits and safety of Sirolimus-Eluting Stent (SES) as compared to BMS in patients undergoing primary angioplasty for STEMI. METHODS: The literature was scanned by formal searches of electronic databases (MEDLINE and CENTRAL). We examined all completed randomized trials of DES for STEMI. The following keywords were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, stenting, DES, sirolimus-eluting stent (SES), Cypher. Information on study design, type of stent, inclusion and exclusion criteria, primary endpoint, number of patients, angiographic and clinical outcome, were extracted by two investigators. Disagreements were resolved by consensus. RESULTS: A total of 9 trials were included in the meta-analysis, involving 2,769 patients (1389 or 50.2% randomized to DES and 1,380 or 49.8% randomized to BMS). At 12 months follow-up, SES was associated with a significant reduction in TVR (4.9% vs. 13.6%, p < 0.0001), with a trend in benefits in mortality (2.9% vs. 4.2%, p = 0.08) and reinfarction (3.0% vs. 4.3%, p = 0.06), without any significant difference in stent thrombosis (1.9% vs. 2.5%, p = 0.36). Safety and efficacy of DES were confirmed at 2-3 years follow-up (data available from 4 trials including 569 patients). CONCLUSIONS: This meta-analysis shows that among selected STEMI patients undergoing primary angioplasty, SES as compared to BMS is safe and associated with a significant reduction in TVR at 1 and 2-3 years follow-up.

Efficacy and safety of drug-eluting stents in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials.

BACKGROUND: Recent concerns have emerged on the potential higher risk of stent thrombosis after DES implantation, that might be even more pronounced among STEMI patients. Thus, the aim of the current study was to perform a meta-analysis to evaluate the benefits and safety of DES as compared to BMS in patients undergoing primary angioplasty for STEMI. METHODS: The literature was scanned by formal searches of electronic databases (MEDLINE and CENTRAL). We examined all completed randomized trials of DES for STEMI. The following key words were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, stenting, DES, sirolimus-eluting stent (SES), Cypher, paclitaxel-eluting stent (PES), Taxus. Information on study design, type of stent, inclusion and exclusion criteria, primary endpoint, number of patients, angiographic and clinical outcome, were extracted by two investigators. Disagreements were resolved by consensus. RESULTS: A total of 11 trials were included in the meta-analysis, involving 3605 patients (1888 or 52.3% randomized to DES and 1719 or 47.7% randomized to BMS). At 12 months follow-up, no significant difference was observed in mortality (4.1% vs 4.4%, OR [95% CI]=0.91 [0.66-1.27], p=0.59, reinfarction (3.1% vs 3.4%, OR [95% CI]=0.85 [0.58, 1.23], p=0.38 or stent thrombosis (1.6% vs 2.2%, OR [95% CI]=0.76 [0.47, 1.23], p=0.22), whereas DES were associated with a significant reduction in TVR (5.0% vs 12.6%, OR [95% CI]=0.36 [0.28, 0.47], p<0.0001). Safety and efficacy of DES were confirmed at 18 to 24 months follow-up (data available from 4 trials including 1178 patients). CONCLUSIONS: This meta-analysis shows that among selected STEMI patients undergoing primary angioplasty, SES and PES, as compared to BMS, are safe and associated with a significant reduction in TVR at 1 and 2 years follow-up.

Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction.

AIMS: To compare the efficacy and safety of drug-eluting stents vs. bare-metal stents in patients with acute ST-segment elevation myocardial infarction. METHODS AND RESULTS: We performed a meta-analysis of eight randomized trials comparing drug-eluting stents (sirolimus-eluting or paclitaxel-eluting stents) with bare-metal stents in 2786 patients with acute ST-segment elevation myocardial infarction. All patients were followed up for a mean of 12.0-24.2 months. Individual data were available for seven trials with 2476 patients. The primary efficacy endpoint was the need for reintervention (target lesion revascularization). The primary safety endpoint was stent thrombosis. Other outcomes of interest were death and recurrent myocardial infarction. Drug-eluting stents significantly reduced the risk of reintervention, hazard ratio of 0.38 (95% CI, 0.29-0.50), P < 0.001. The overall risk of stent thrombosis: hazard ratio of 0.80 (95% CI, 0.46-1.39), P = 0.43; death: hazard ratio of 0.76 (95% CI, 0.53-1.10), P = 0.14; and recurrent myocardial infarction: hazard ratio of 0.72 (95% CI, 0.48-1.08, P = 0.11) was not significantly different for patients receiving drug-eluting stents vs. bare-metal stents. CONCLUSION: The use of drug-eluting stents in patients with acute ST-segment elevation myocardial infarction is safe and improves clinical outcomes by reducing the risk of reintervention compared with bare-metal stents.