Dataset Information

Randomized trial of primary PCI with or without routine manual thrombectomy.

ABSTRACT: BACKGROUND:During primary percutaneous coronary intervention (PCI), manual thrombectomy may reduce distal embolization and thus improve microvascular perfusion. Small trials have suggested that thrombectomy improves surrogate and clinical outcomes, but a larger trial has reported conflicting results. METHODS:We randomly assigned 10,732 patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI to a strategy of routine upfront manual thrombectomy versus PCI alone. The primary outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within 180 days. The key safety outcome was stroke within 30 days. RESULTS:The primary outcome occurred in 347 of 5033 patients (6.9%) in the thrombectomy group versus 351 of 5030 patients (7.0%) in the PCI-alone group (hazard ratio in the thrombectomy group, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P=0.86). The rates of cardiovascular death (3.1% with thrombectomy vs. 3.5% with PCI alone; hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P=0.34) and the primary outcome plus stent thrombosis or target-vessel revascularization (9.9% vs. 9.8%; hazard ratio, 1.00; 95% CI, 0.89 to 1.14; P=0.95) were also similar. Stroke within 30 days occurred in 33 patients (0.7%) in the thrombectomy group versus 16 patients (0.3%) in the PCI-alone group (hazard ratio, 2.06; 95% CI, 1.13 to 3.75; P=0.02). CONCLUSIONS:In patients with STEMI who were undergoing primary PCI, routine manual thrombectomy, as compared with PCI alone, did not reduce the risk of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA class IV heart failure within 180 days but was associated with an increased rate of stroke within 30 days. (Funded by Medtronic and the Canadian Institutes of Health Research; TOTAL ClinicalTrials.gov number, NCT01149044.).

SUBMITTER: Jolly SS

PROVIDER: S-EPMC4995102 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomized trial of primary PCI with or without routine manual thrombectomy.

Jolly Sanjit S SS Cairns John A JA Yusuf Salim S Meeks Brandi B Pogue Janice J Rokoss Michael J MJ Kedev Sasko S Thabane Lehana L Stankovic Goran G Moreno Raul R Gershlick Anthony A Chowdhary Saqib S Lavi Shahar S Niemelä Kari K Steg Philippe Gabriel PG Bernat Ivo I Xu Yawei Y Cantor Warren J WJ Overgaard Christopher B CB Naber Christoph K CK Cheema Asim N AN Welsh Robert C RC Bertrand Olivier F OF Avezum Alvaro A Bhindi Ravinay R Pancholy Samir S Rao Sunil V SV Natarajan Madhu K MK ten Berg Jurriën M JM Shestakovska Olga O Gao Peggy P Widimsky Petr P Džavík Vladimír V

The New England journal of medicine 20150316 15

<h4>Background</h4>During primary percutaneous coronary intervention (PCI), manual thrombectomy may reduce distal embolization and thus improve microvascular perfusion. Small trials have suggested that thrombectomy improves surrogate and clinical outcomes, but a larger trial has reported conflicting results.<h4>Methods</h4>We randomly assigned 10,732 patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI to a strategy of routine upfront manual thrombectomy versus ...[more]

PMID: 25853743

Similar Datasets

Project description:BackgroundMigraine is a highly prevalent neurological disorder. It is the third most prevalent disorder and the seventh highest cause of disability worldwide. Acupuncture may be a viable prophylactic treatment option for frequent or uncontrolled migraine. Clinical studies comparing acupuncture and placebo acupuncture have not reached a consistent conclusion in confirming whether acupuncture is effective in migraine prophylaxis. The effect of acupuncture mainly depends on acupoints and needles operation. We found that the design of the placebo acupuncture in previous studies included shallow needling at sham acupoints, non-penetrating needling at sham acupoints, and needling at inactive acupuncture points to achieve the inert effect of control group, but the non-penetrating needling at true acupoints was ignored. This randomized controlled trial aims to use true acupoints for non-penetrating acupuncture as control to evaluate the efficacy of manual acupuncture for the prophylaxis of migraine without aura (MWoA).Methods/designThis is a single-blinded, randomized, controlled, prospective, multi-center trial with two parallel treatment groups. A total of 198 eligible patients with MWoA will be randomly divided into two groups (1:1 allocation ratio). The intervention group will receive manual acupuncture and the control group will receive placebo acupuncture (non-penetrating). Patients will receive three acupuncture treatment sessions per week for 4 consecutive weeks. All patients will then receive a 12-week follow-up.DiscussionIn this study, we are evaluating the efficacy and safety of manual acupuncture in the prophylaxis of MWoA. The placebo control is using non-penetrating needling verum acupoints. It is essential to determine an appropriate control method to ensure the methodological quality of a randomized controlled trial.Trial registrationThe trial has been registered in the Chinese Clinical Trial Registry (approval no. ChiCTR2000032308 ) in April 2020.

Project description:BackgroundComplete revascularization may improve outcomes compared with an infarct-related artery (IRA)-only strategy in patients being treated with primary percutaneous coronary intervention (PPCI) who have multivessel disease presenting with ST-segment elevation myocardial infarction (STEMI). However, there is concern that non-IRA PCI may cause additional non-IRA myocardial infarction (MI).ObjectivesThis study sought to determine whether in-hospital complete revascularization was associated with increased total infarct size compared with an IRA-only strategy.MethodsThis multicenter prospective, randomized, open-label, blinded endpoint clinical trial evaluated STEMI patients with multivessel disease having PPCI within 12 h of symptom onset. Patients were randomized to either IRA-only PCI or complete in-hospital revascularization. Contrast-enhanced cardiovascular magnetic resonance (CMR) was performed following PPCI (median day 3) and stress CMR at 9 months. The pre-specified primary endpoint was infarct size on pre-discharge CMR. The study had 80% power to detect a 4% difference in infarct size with 100 patients per group.ResultsOf the 296 patients in the main trial, 205 participated in the CMR substudy, and 203 patients (98 complete revascularization and 105 IRA-only) completed the pre-discharge CMR. The groups were well-matched. Total infarct size (median, interquartile range) was similar to IRA-only revascularization: 13.5% (6.2% to 21.9%) versus complete revascularization, 12.6% (7.2% to 22.6%) of left ventricular mass, p = 0.57 (95% confidence interval for difference in geometric means 0.82 to 1.41). The complete revascularization group had an increase in non-IRA MI on the pre-discharge CMR (22 of 98 vs. 11 of 105, p = 0.02). There was no difference in total infarct size or ischemic burden between treatment groups at follow-up CMR.ConclusionsMultivessel PCI in the setting of STEMI leads to a small increase in CMR-detected non-IRA MI, but total infarct size was not significantly different from an IRA-only revascularization strategy. (Complete Versus Lesion-Only Primary PCI Pilot Study [CvLPRIT]; ISRCTN70913605).

Project description:BACKGROUND:An estimated 8.2 million adults in the United States live with co-occurring mental health and substance use disorders. Although the benefits of integrated treatment services for persons with co-occurring disorders has been well-established, gaps in access to integrated care persist. Implementation research can address this gap. We evaluated if the Network for the Improvement of Addiction Treatment (NIATx) implementation strategy was effective in increasing integrated services capacity among organizations treating persons with co-occurring disorders. METHODS:This study employed a cluster randomized waitlist control group design. Forty-nine addiction treatment organizations from the State of Washington were randomized into one of two study arms: (1) NIATx strategy (active implementation strategy), or (2) waitlist (control). The primary outcome was a standardized organizational measure of integrated service capability: the Dual Diagnosis in Addiction Treatment (DDCAT) Index. Intent-to-treat analyses and per-protocol analyses were conducted to address the following questions: (1) Is NIATx effective in increasing integrated service capacity? and (2) Are there differences in organizations that actually use NIATx per-protocol versus those that do not? RESULTS:From baseline to one-year post active implementation, both the NIATx strategy and waitlist arms demonstrated improvements over time in DDCAT Index total and DDCAT dimension scores. In intent-to-treat analyses, a moderate but statistically significant difference in improvement between study arms was seen only in the Program Milieu dimension (p =?0.020, Cohen's d?=?0.54). In per-protocol analyses, moderate-to-large effects in Program Milieu (p =?0.002, Cohen's d?=?0.91) and Continuity of Care (p =?0.026, Cohen's d?=?0.63) dimensions, and in total DDCAT Index (p =?0.046, Cohen's d?=?0.51) were found. CONCLUSIONS:Overall, organizations in both study arms improved DDCAT Index scores over time. Organizations in the NIATx strategy arm with full adherence to the NIATx protocol had significantly greater improvements in the primary outcome measure of integrated service capacity for persons with co-occurring disorders. TRAIL REGISTRATION:ClinicalTrials.gov, NCT03007940 . Retrospectively registered January 2017.

Project description:ImportanceWhether intravenous thrombolysis is needed in combination with mechanical thrombectomy in patients with acute large vessel occlusion stroke is unclear.ObjectiveTo examine whether mechanical thrombectomy alone is noninferior to combined intravenous thrombolysis plus mechanical thrombectomy for favorable poststroke outcome.Design, setting, and participantsInvestigator-initiated, multicenter, randomized, open-label, noninferiority clinical trial in 204 patients with acute ischemic stroke due to large vessel occlusion enrolled at 23 hospital networks in Japan from January 1, 2017, to July 31, 2019, with final follow-up on October 31, 2019.InterventionsPatients were randomly assigned to mechanical thrombectomy alone (n = 101) or combined intravenous thrombolysis (alteplase at a 0.6-mg/kg dose) plus mechanical thrombectomy (n = 103).Main outcomes and measuresThe primary efficacy end point was a favorable outcome defined as a modified Rankin Scale score (range, 0 [no symptoms] to 6 [death]) of 0 to 2 at 90 days, with a noninferiority margin odds ratio of 0.74, assessed using a 1-sided significance threshold of .025 (97.5% CI). There were 7 prespecified secondary efficacy end points, including mortality by day 90. There were 4 prespecified safety end points, including any intracerebral hemorrhage and symptomatic intracerebral hemorrhage within 36 hours.ResultsAmong 204 patients (median age, 74 years; 62.7% men; median National Institutes of Health Stroke Scale score, 18), all patients completed the trial. Favorable outcome occurred in 60 patients (59.4%) in the mechanical thrombectomy alone group and 59 patients (57.3%) in the combined intravenous thrombolysis plus mechanical thrombectomy group, with no significant between-group difference (difference, 2.1% [1-sided 97.5% CI, -11.4% to ∞]; odds ratio, 1.09 [1-sided 97.5% CI, 0.63 to ∞]; P = .18 for noninferiority). Among the 7 secondary efficacy end points and 4 safety end points, 10 were not significantly different, including mortality at 90 days (8 [7.9%] vs 9 [8.7%]; difference, -0.8% [95% CI, -9.5% to 7.8%]; odds ratio, 0.90 [95% CI, 0.33 to 2.43]; P > .99). Any intracerebral hemorrhage was observed less frequently in the mechanical thrombectomy alone group than in the combined group (34 [33.7%] vs 52 [50.5%]; difference, -16.8% [95% CI, -32.1% to -1.6%]; odds ratio, 0.50 [95% CI, 0.28 to 0.88]; P = .02). Symptomatic intracerebral hemorrhage was not significantly different between groups (6 [5.9%] vs 8 [7.7%]; difference, -1.8% [95% CI, -9.7% to 6.1%]; odds ratio, 0.75 [95% CI, 0.25 to 2.24]; P = .78).Conclusions and relevanceAmong patients with acute large vessel occlusion stroke, mechanical thrombectomy alone, compared with combined intravenous thrombolysis plus mechanical thrombectomy, failed to demonstrate noninferiority regarding favorable functional outcome. However, the wide confidence intervals around the effect estimate also did not allow a conclusion of inferiority.Trial registrationumin.ac.jp/ctr Identifier: UMIN000021488.

Dataset Information

Randomized trial of primary PCI with or without routine manual thrombectomy.

Publications

Randomized trial of primary PCI with or without routine manual thrombectomy.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure