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Bo Lagerqvist - One of the best experts on this subject based on the ideXlab platform.

  • clinical impact of direct stenting and interaction with Thrombus Aspiration in patients with st segment elevation myocardial infarction undergoing percutaneous coronary intervention thrombectomy trialists collaboration
    European Heart Journal, 2018
    Co-Authors: Karim D Mahmoud, Sanjit S Jolly, Stefan James, Vladimir Džavik, John A Cairns, Goran K Olivecrona, Henrik Renlund, Bo Lagerqvist, Ashraf Alazzoni, Sasko Kedev
    Abstract:

    Aims Preliminary studies suggest that direct stenting (DS) during percutaneous coronary intervention (PCI) may reduce microvascular obstruction and improve clinical outcome. Thrombus Aspiration may facilitate DS. We assessed the impact of DS on clinical outcome and myocardial reperfusion and its interaction with Thrombus Aspiration among ST-segment elevation myocardial infarction (STEMI) patients undergoing PCI. Methods and results Patient-level data from the three largest randomized trials on routine manual Thrombus Aspiration vs. PCI only were merged. A 1:1 propensity matched population was created to compare DS and conventional stenting. Synergy between DS and Thrombus Aspiration was assessed with interaction P-values in the final models. In the unmatched population (n= 17 329), 32% underwent DS and 68% underwent conventional stenting. Direct stenting rates were higher in patients randomized to Thrombus Aspiration as compared with PCI only (41% vs. 22%; P < 0.001). Patients undergoing DS required less contrast (162mL vs. 172mL; P< 0.001) and had shorter fluoroscopy time (11.1min vs. 13.3 min; P< 0.001). After propensity matching (n= 10 944), no significant differences were seen between DS and conventional stenting with respect to 30-day cardiovascular death [1.7% vs. 1.9%; hazard ratio 0.88, 95% confidence interval (CI) 0.55-1.41; P=0.60; Pinteraction = 0.96) and 30-day stroke or transient ischaemic attack (0.6% vs. 0.4%; odds ratio 1.02; 95% CI 0.14-7.54; P=0.99; Pinteraction = 0.81). One-year results were similar. No significant differences were seen in electrocardiographic and angiographic myocardial reperfusion measures. Conclusion Direct stenting rates were higher in patients randomized to Thrombus Aspiration. Clinical outcomes and myocardial reperfusion measures did not differ significantly between DS and conventional stenting and there was no interaction with Thrombus Aspiration. (Less)

  • Thrombus Aspiration in st segment elevation myocardial infarction an individual patient meta analysis thrombectomy trialists collaboration
    Circulation, 2017
    Co-Authors: Sanjit S Jolly, Karim D Mahmoud, Stefan James, Vladimir Džavik, John A Cairns, Salim Yusuf, Goran K Olivecrona, Henrik Renlund, Felix Zijlstra, Bo Lagerqvist
    Abstract:

    BACKGROUND: Thrombus Aspiration during percutaneous coronary intervention (PCI) for the treatment of ST-segment-elevation myocardial infarction (STEMI) has been widely used; however, recent trials have questioned its value and safety. In this meta-analysis, we, the trial investigators, aimed to pool the individual patient data from these trials to determine the benefits and risks of Thrombus Aspiration during PCI in patients with ST-segment-elevation myocardial infarction. METHODS: Included were large (n≥1000), randomized, controlled trials comparing manual thrombectomy and PCI alone in patients with ST-segment-elevation myocardial infarction. Individual patient data were provided by the leadership of each trial. The prespecified primary efficacy outcome was cardiovascular mortality within 30 days, and the primary safety outcome was stroke or transient ischemic attack within 30 days. RESULTS: The 3 eligible randomized trials (TAPAS [Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction], TASTE [Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia], and TOTAL [Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI]) enrolled 19 047 patients, of whom 18 306 underwent PCI and were included in the primary analysis. Cardiovascular death at 30 days occurred in 221 of 9155 patients (2.4%) randomized to Thrombus Aspiration and 262 of 9151 (2.9%) randomized to PCI alone (hazard ratio, 0.84; 95% confidence interval, 0.70-1.01; P=0.06). Stroke or transient ischemic attack occurred in 66 (0.8%) randomized to Thrombus Aspiration and 46 (0.5%) randomized to PCI alone (odds ratio, 1.43; 95% confidence interval, 0.98-2.10; P=0.06). There were no significant differences in recurrent myocardial infarction, stent thrombosis, heart failure, or target vessel revascularization. In the subgroup with high Thrombus burden (TIMI [Thrombolysis in Myocardial Infarction] Thrombus grade ≥3), Thrombus Aspiration was associated with fewer cardiovascular deaths (170 [2.5%] versus 205 [3.1%]; hazard ratio, 0.80; 95% confidence interval, 0.65-0.98; P=0.03) and with more strokes or transient ischemic attacks (55 [0.9%] versus 34 [0.5%]; odds ratio, 1.56; 95% confidence interval, 1.02-2.42, P=0.04). However, the interaction P values were 0.32 and 0.34, respectively. CONCLUSIONS: Routine Thrombus Aspiration during PCI for ST-segment-elevation myocardial infarction did not improve clinical outcomes. In the high Thrombus burden group, the trends toward reduced cardiovascular death and increased stroke or transient ischemic attack provide a rationale for future trials of improved Thrombus Aspiration technologies in this high-risk subgroup. CLINICAL TRIAL REGISTRATION: URLs: http://www.ClinicalTrials.gov http://www.crd.york.ac.uk/prospero/. Unique identifiers: NCT02552407 and CRD42015025936.

  • Thrombus Aspiration in st segment elevation myocardial infarctionclinical perspective
    Circulation, 2017
    Co-Authors: Sanjit S Jolly, Karim D Mahmoud, Felix Zijlstra, Stefan James, Vladimir Džavik, John A Cairns, Salim Yusuf, Goran K Olivecrona, Henrik Renlund, Bo Lagerqvist
    Abstract:

    Background: Thrombus Aspiration during percutaneous coronary intervention (PCI) for the treatment of ST-segment–elevation myocardial infarction (STEMI) has been widely used; however, recent trials have questioned its value and safety. In this meta-analysis, we, the trial investigators, aimed to pool the individual patient data from these trials to determine the benefits and risks of Thrombus Aspiration during PCI in patients with ST-segment–elevation myocardial infarction. Methods: Included were large (n≥1000), randomized, controlled trials comparing manual thrombectomy and PCI alone in patients with ST-segment–elevation myocardial infarction. Individual patient data were provided by the leadership of each trial. The prespecified primary efficacy outcome was cardiovascular mortality within 30 days, and the primary safety outcome was stroke or transient ischemic attack within 30 days. Results: The 3 eligible randomized trials (TAPAS [Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction], TASTE [Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia], and TOTAL [Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI]) enrolled 19 047 patients, of whom 18 306 underwent PCI and were included in the primary analysis. Cardiovascular death at 30 days occurred in 221 of 9155 patients (2.4%) randomized to Thrombus Aspiration and 262 of 9151 (2.9%) randomized to PCI alone (hazard ratio, 0.84; 95% confidence interval, 0.70–1.01; P =0.06). Stroke or transient ischemic attack occurred in 66 (0.8%) randomized to Thrombus Aspiration and 46 (0.5%) randomized to PCI alone (odds ratio, 1.43; 95% confidence interval, 0.98–2.10; P =0.06). There were no significant differences in recurrent myocardial infarction, stent thrombosis, heart failure, or target vessel revascularization. In the subgroup with high Thrombus burden (TIMI [Thrombolysis in Myocardial Infarction] Thrombus grade ≥3), Thrombus Aspiration was associated with fewer cardiovascular deaths (170 [2.5%] versus 205 [3.1%]; hazard ratio, 0.80; 95% confidence interval, 0.65–0.98; P =0.03) and with more strokes or transient ischemic attacks (55 [0.9%] versus 34 [0.5%]; odds ratio, 1.56; 95% confidence interval, 1.02–2.42, P =0.04). However, the interaction P values were 0.32 and 0.34, respectively. Conclusions: Routine Thrombus Aspiration during PCI for ST-segment–elevation myocardial infarction did not improve clinical outcomes. In the high Thrombus burden group, the trends toward reduced cardiovascular death and increased stroke or transient ischemic attack provide a rationale for future trials of improved Thrombus Aspiration technologies in this high-risk subgroup. Clinical Trial Registration: URLs: . Unique identifiers: [NCT02552407][1] and CRD42015025936. # Clinical Perspective {#article-title-14} [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02552407&atom=%2Fcirculationaha%2F135%2F2%2F143.atom

  • Thrombus Aspiration in st segment elevation myocardial infarctionclinical perspective an individual patient meta analysis thrombectomy trialists collaboration
    Circulation, 2017
    Co-Authors: Sanjit S Jolly, Karim D Mahmoud, Stefan James, Vladimir Džavik, John A Cairns, Salim Yusuf, Goran K Olivecrona, Henrik Renlund, Felix Zijlstra, Bo Lagerqvist
    Abstract:

    Background: Thrombus Aspiration during percutaneous coronary intervention (PCI) for the treatment of ST-segment–elevation myocardial infarction (STEMI) has been widely used; however, recent trials have questioned its value and safety. In this meta-analysis, we, the trial investigators, aimed to pool the individual patient data from these trials to determine the benefits and risks of Thrombus Aspiration during PCI in patients with ST-segment–elevation myocardial infarction. Methods: Included were large (n≥1000), randomized, controlled trials comparing manual thrombectomy and PCI alone in patients with ST-segment–elevation myocardial infarction. Individual patient data were provided by the leadership of each trial. The prespecified primary efficacy outcome was cardiovascular mortality within 30 days, and the primary safety outcome was stroke or transient ischemic attack within 30 days. Results: The 3 eligible randomized trials (TAPAS [Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction], TASTE [Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia], and TOTAL [Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI]) enrolled 19 047 patients, of whom 18 306 underwent PCI and were included in the primary analysis. Cardiovascular death at 30 days occurred in 221 of 9155 patients (2.4%) randomized to Thrombus Aspiration and 262 of 9151 (2.9%) randomized to PCI alone (hazard ratio, 0.84; 95% confidence interval, 0.70–1.01; P =0.06). Stroke or transient ischemic attack occurred in 66 (0.8%) randomized to Thrombus Aspiration and 46 (0.5%) randomized to PCI alone (odds ratio, 1.43; 95% confidence interval, 0.98–2.10; P =0.06). There were no significant differences in recurrent myocardial infarction, stent thrombosis, heart failure, or target vessel revascularization. In the subgroup with high Thrombus burden (TIMI [Thrombolysis in Myocardial Infarction] Thrombus grade ≥3), Thrombus Aspiration was associated with fewer cardiovascular deaths (170 [2.5%] versus 205 [3.1%]; hazard ratio, 0.80; 95% confidence interval, 0.65–0.98; P =0.03) and with more strokes or transient ischemic attacks (55 [0.9%] versus 34 [0.5%]; odds ratio, 1.56; 95% confidence interval, 1.02–2.42, P =0.04). However, the interaction P values were 0.32 and 0.34, respectively. Conclusions: Routine Thrombus Aspiration during PCI for ST-segment–elevation myocardial infarction did not improve clinical outcomes. In the high Thrombus burden group, the trends toward reduced cardiovascular death and increased stroke or transient ischemic attack provide a rationale for future trials of improved Thrombus Aspiration technologies in this high-risk subgroup. Clinical Trial Registration: URLs: http://www.ClinicalTrials.govhttp://www.crd.york.ac.uk/prospero/. Unique identifiers: NCT02552407 and CRD42015025936.

  • Thrombus Aspiration in st elevation myocardial infarction an individual patient meta analysis
    Circulation, 2017
    Co-Authors: Sanjit S Jolly, Karim D Mahmoud, Felix Zijlstra, Stefan James, Vladimir Džavik, John A Cairns, Salim Yusuf, Goran K Olivecrona, Henrik Renlund, Bo Lagerqvist
    Abstract:

    BACKGROUND—: Thrombus Aspiration during percutaneous coronary intervention (PCI) for the treatment of ST elevation myocardial infarction (STEMI) has been widely used; however, recent trials have questioned its value and safety. In this meta-analysis, we, the trial investigators, aimed to pool the individual patient data from these trials to determine the benefits and risks of Thrombus Aspiration during PCI in patients with STEMI. METHODS—: Included were large (N≥1000) randomized controlled trials comparing manual thrombectomy vs. PCI alone in patients with STEMI. Individual patient data was provided by the leadership of each trial. The pre-specified primary efficacy outcome was cardiovascular (CV) mortality within 30 days and the primary safety outcome was stroke or transient ischemic attack (TIA) within 30 days. RESULTS—: The 3 eligible randomized trials (TAPAS, TASTE and TOTAL) enrolled 19,047 patients, of whom 18,306 underwent PCI and were included in the primary analysis. CV death at 30 days occurred in 221 (2.4%) of 9155 patients randomized to Thrombus Aspiration and 262 (2.9%) of 9151 randomized to PCI alone (hazard ratio (HR) 0.84; 95% CI 0.70-1.01, p=0.06). Stroke or TIA occurred in 66 (0.8%) randomized to Thrombus Aspiration and 46 (0.5%) randomized to PCI alone (odds ratio [OR] 1.43 95% CI 0.98-2.1, p=0.06). There were no significant differences in recurrent myocardial infarction, stent thrombosis, heart failure or target vessel revascularization. In the subgroup with high Thrombus burden (TIMI Thrombus grade ≥3) Thrombus Aspiration was associated with less CV death (170 [2.5%] vs. 205 [3.1%] HR 0.80; 95% CI 0.65-0.98, p =0.03), and with more stroke or TIA (55 [0.9%] vs. 34 [0.5%] OR 1.56; 95% CI 1.02-2.42, p=0.04). However, the interaction p-values were 0.32 and 0.34, respectively. CONCLUSIONS—: Routine Thrombus Aspiration during STEMI PCI did not improve clinical outcomes. In the high Thrombus burden subgroup the trends toward reduced CV death and increased stroke or TIA provide a rationale for future trials of improved Thrombus Aspiration technologies in this high-risk subgroup. CLINICAL TRIAL REGISTRATION—: ClinicalTrials.gov identifier NCT02552407, PROSPERO CRD42015025936 (Less)

Sanjit S Jolly - One of the best experts on this subject based on the ideXlab platform.

  • Thrombus Aspiration in patients with high Thrombus burden in the total trial
    Journal of the American College of Cardiology, 2018
    Co-Authors: Sanjit S Jolly, John A Cairns, Shahar Lavi, Warren J Cantor, Ivo Bernat, Asim N Cheema, Raul Moreno, Sasko Kedev, Goran Stankovic
    Abstract:

    Abstract Background Routine Thrombus Aspiration in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) does not improve clinical outcomes. However, there is remaining uncertainty about the potential benefit in those patients with high Thrombus burden, where there is a biological rationale for greater benefit. Objectives The purpose of this study was to evaluate the benefit of Thrombus Aspiration among STEMI patients with high Thrombus burden. Methods TOTAL (ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI) was a randomized trial of routine manual thrombectomy versus PCI alone in patients with STEMI (n = 10,732). High Thrombus burden (Thrombolysis In Myocardial Infarction Thrombus grade ≥3) was a pre-specified subgroup. Results The primary outcome of cardiovascular (CV) death, MI, cardiogenic shock, or heart failure was not different at 1 year with Thrombus Aspiration in patients with high Thrombus burden (8.1% vs. 8.3% Thrombus Aspiration; hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.84 to 1.13) or low Thrombus burden (6.0% vs. 5.0% Thrombus Aspiration; HR: 1.22; 95% CI: 0.73 to 2.05; interaction p = 0.41). However, among patients with high Thrombus burden, stroke at 30 days was more frequent with Thrombus Aspiration (31 [0.7%] Thrombus Aspiration vs. 16 [0.4%] PCI alone, HR: 1.90; 95% CI: 1.04 to 3.48). In the high Thrombus burden group, Thrombus Aspiration did not significantly improve CV mortality at 30 days (HR: 0.78; 95% CI: 0.61 to 1.01; p = 0.06) and at 1 year (HR: 0.88; 95% CI: 0.72 to 1.09; p = 0.25). Irrespective of treatment assignment, high Thrombus burden was an independent predictor of death (HR: 1.78; 95% CI: 1.05 to 3.01). Conclusions In patients with high Thrombus burden, routine Thrombus Aspiration did not improve outcomes at 1 year and was associated with an increased rate of stroke. High Thrombus burden is still an important predictor of outcome in STEMI. (A Trial of routine Aspiration ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI [TOTAL]; NCT01149044)

  • clinical impact of direct stenting and interaction with Thrombus Aspiration in patients with st segment elevation myocardial infarction undergoing percutaneous coronary intervention thrombectomy trialists collaboration
    European Heart Journal, 2018
    Co-Authors: Karim D Mahmoud, Sanjit S Jolly, Stefan James, Vladimir Džavik, John A Cairns, Goran K Olivecrona, Henrik Renlund, Bo Lagerqvist, Ashraf Alazzoni, Sasko Kedev
    Abstract:

    Aims Preliminary studies suggest that direct stenting (DS) during percutaneous coronary intervention (PCI) may reduce microvascular obstruction and improve clinical outcome. Thrombus Aspiration may facilitate DS. We assessed the impact of DS on clinical outcome and myocardial reperfusion and its interaction with Thrombus Aspiration among ST-segment elevation myocardial infarction (STEMI) patients undergoing PCI. Methods and results Patient-level data from the three largest randomized trials on routine manual Thrombus Aspiration vs. PCI only were merged. A 1:1 propensity matched population was created to compare DS and conventional stenting. Synergy between DS and Thrombus Aspiration was assessed with interaction P-values in the final models. In the unmatched population (n= 17 329), 32% underwent DS and 68% underwent conventional stenting. Direct stenting rates were higher in patients randomized to Thrombus Aspiration as compared with PCI only (41% vs. 22%; P < 0.001). Patients undergoing DS required less contrast (162mL vs. 172mL; P< 0.001) and had shorter fluoroscopy time (11.1min vs. 13.3 min; P< 0.001). After propensity matching (n= 10 944), no significant differences were seen between DS and conventional stenting with respect to 30-day cardiovascular death [1.7% vs. 1.9%; hazard ratio 0.88, 95% confidence interval (CI) 0.55-1.41; P=0.60; Pinteraction = 0.96) and 30-day stroke or transient ischaemic attack (0.6% vs. 0.4%; odds ratio 1.02; 95% CI 0.14-7.54; P=0.99; Pinteraction = 0.81). One-year results were similar. No significant differences were seen in electrocardiographic and angiographic myocardial reperfusion measures. Conclusion Direct stenting rates were higher in patients randomized to Thrombus Aspiration. Clinical outcomes and myocardial reperfusion measures did not differ significantly between DS and conventional stenting and there was no interaction with Thrombus Aspiration. (Less)

  • response by jolly et al to letters regarding article Thrombus Aspiration in st segment elevation myocardial infarction an individual patient meta analysis thrombectomy trialists collaboration
    Circulation, 2017
    Co-Authors: Sanjit S Jolly, Stefan James, Vladimir Džavik, John A Cairns, Ole Frobert
    Abstract:

    Karamasis and colleagues describe their own registry of patients with ST-segment–elevation myocardial infarction undergoing Thrombus Aspiration in whom they performed serial ECGs and showed worsening in ST-segment elevation in 13.5% of cases after the first wire passage, in 19.7% of cases after Thrombus Aspiration, and in 12.5% of cases at the end of the procedure. Thus, >50% ST-segment resolution occurred in 15.2% after wire passage, in 21.8% after Thrombus Aspiration, and in 44.3% at the end of the procedure.1 However, without a control group for comparison, one should be cautious about the interpretation of these results. Thrombus Aspiration devices may cause transient reductions in flow after Thrombus Aspiration, which may be related to disruption of culprit plaque or distal embolization. Although we agree that Thrombus Aspiration can in some cases “effectively remove Thrombus and …

  • Thrombus Aspiration in st segment elevation myocardial infarctionclinical perspective
    Circulation, 2017
    Co-Authors: Sanjit S Jolly, Karim D Mahmoud, Felix Zijlstra, Stefan James, Vladimir Džavik, John A Cairns, Salim Yusuf, Goran K Olivecrona, Henrik Renlund, Bo Lagerqvist
    Abstract:

    Background: Thrombus Aspiration during percutaneous coronary intervention (PCI) for the treatment of ST-segment–elevation myocardial infarction (STEMI) has been widely used; however, recent trials have questioned its value and safety. In this meta-analysis, we, the trial investigators, aimed to pool the individual patient data from these trials to determine the benefits and risks of Thrombus Aspiration during PCI in patients with ST-segment–elevation myocardial infarction. Methods: Included were large (n≥1000), randomized, controlled trials comparing manual thrombectomy and PCI alone in patients with ST-segment–elevation myocardial infarction. Individual patient data were provided by the leadership of each trial. The prespecified primary efficacy outcome was cardiovascular mortality within 30 days, and the primary safety outcome was stroke or transient ischemic attack within 30 days. Results: The 3 eligible randomized trials (TAPAS [Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction], TASTE [Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia], and TOTAL [Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI]) enrolled 19 047 patients, of whom 18 306 underwent PCI and were included in the primary analysis. Cardiovascular death at 30 days occurred in 221 of 9155 patients (2.4%) randomized to Thrombus Aspiration and 262 of 9151 (2.9%) randomized to PCI alone (hazard ratio, 0.84; 95% confidence interval, 0.70–1.01; P =0.06). Stroke or transient ischemic attack occurred in 66 (0.8%) randomized to Thrombus Aspiration and 46 (0.5%) randomized to PCI alone (odds ratio, 1.43; 95% confidence interval, 0.98–2.10; P =0.06). There were no significant differences in recurrent myocardial infarction, stent thrombosis, heart failure, or target vessel revascularization. In the subgroup with high Thrombus burden (TIMI [Thrombolysis in Myocardial Infarction] Thrombus grade ≥3), Thrombus Aspiration was associated with fewer cardiovascular deaths (170 [2.5%] versus 205 [3.1%]; hazard ratio, 0.80; 95% confidence interval, 0.65–0.98; P =0.03) and with more strokes or transient ischemic attacks (55 [0.9%] versus 34 [0.5%]; odds ratio, 1.56; 95% confidence interval, 1.02–2.42, P =0.04). However, the interaction P values were 0.32 and 0.34, respectively. Conclusions: Routine Thrombus Aspiration during PCI for ST-segment–elevation myocardial infarction did not improve clinical outcomes. In the high Thrombus burden group, the trends toward reduced cardiovascular death and increased stroke or transient ischemic attack provide a rationale for future trials of improved Thrombus Aspiration technologies in this high-risk subgroup. Clinical Trial Registration: URLs: . Unique identifiers: [NCT02552407][1] and CRD42015025936. # Clinical Perspective {#article-title-14} [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02552407&atom=%2Fcirculationaha%2F135%2F2%2F143.atom

  • Thrombus Aspiration in st segment elevation myocardial infarction an individual patient meta analysis thrombectomy trialists collaboration
    Circulation, 2017
    Co-Authors: Sanjit S Jolly, Karim D Mahmoud, Stefan James, Vladimir Džavik, John A Cairns, Salim Yusuf, Goran K Olivecrona, Henrik Renlund, Felix Zijlstra, Bo Lagerqvist
    Abstract:

    BACKGROUND: Thrombus Aspiration during percutaneous coronary intervention (PCI) for the treatment of ST-segment-elevation myocardial infarction (STEMI) has been widely used; however, recent trials have questioned its value and safety. In this meta-analysis, we, the trial investigators, aimed to pool the individual patient data from these trials to determine the benefits and risks of Thrombus Aspiration during PCI in patients with ST-segment-elevation myocardial infarction. METHODS: Included were large (n≥1000), randomized, controlled trials comparing manual thrombectomy and PCI alone in patients with ST-segment-elevation myocardial infarction. Individual patient data were provided by the leadership of each trial. The prespecified primary efficacy outcome was cardiovascular mortality within 30 days, and the primary safety outcome was stroke or transient ischemic attack within 30 days. RESULTS: The 3 eligible randomized trials (TAPAS [Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction], TASTE [Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia], and TOTAL [Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI]) enrolled 19 047 patients, of whom 18 306 underwent PCI and were included in the primary analysis. Cardiovascular death at 30 days occurred in 221 of 9155 patients (2.4%) randomized to Thrombus Aspiration and 262 of 9151 (2.9%) randomized to PCI alone (hazard ratio, 0.84; 95% confidence interval, 0.70-1.01; P=0.06). Stroke or transient ischemic attack occurred in 66 (0.8%) randomized to Thrombus Aspiration and 46 (0.5%) randomized to PCI alone (odds ratio, 1.43; 95% confidence interval, 0.98-2.10; P=0.06). There were no significant differences in recurrent myocardial infarction, stent thrombosis, heart failure, or target vessel revascularization. In the subgroup with high Thrombus burden (TIMI [Thrombolysis in Myocardial Infarction] Thrombus grade ≥3), Thrombus Aspiration was associated with fewer cardiovascular deaths (170 [2.5%] versus 205 [3.1%]; hazard ratio, 0.80; 95% confidence interval, 0.65-0.98; P=0.03) and with more strokes or transient ischemic attacks (55 [0.9%] versus 34 [0.5%]; odds ratio, 1.56; 95% confidence interval, 1.02-2.42, P=0.04). However, the interaction P values were 0.32 and 0.34, respectively. CONCLUSIONS: Routine Thrombus Aspiration during PCI for ST-segment-elevation myocardial infarction did not improve clinical outcomes. In the high Thrombus burden group, the trends toward reduced cardiovascular death and increased stroke or transient ischemic attack provide a rationale for future trials of improved Thrombus Aspiration technologies in this high-risk subgroup. CLINICAL TRIAL REGISTRATION: URLs: http://www.ClinicalTrials.gov http://www.crd.york.ac.uk/prospero/. Unique identifiers: NCT02552407 and CRD42015025936.

Ole Frobert - One of the best experts on this subject based on the ideXlab platform.

  • response by jolly et al to letters regarding article Thrombus Aspiration in st segment elevation myocardial infarction an individual patient meta analysis thrombectomy trialists collaboration
    Circulation, 2017
    Co-Authors: Sanjit S Jolly, Stefan James, Vladimir Džavik, John A Cairns, Ole Frobert
    Abstract:

    Karamasis and colleagues describe their own registry of patients with ST-segment–elevation myocardial infarction undergoing Thrombus Aspiration in whom they performed serial ECGs and showed worsening in ST-segment elevation in 13.5% of cases after the first wire passage, in 19.7% of cases after Thrombus Aspiration, and in 12.5% of cases at the end of the procedure. Thus, >50% ST-segment resolution occurred in 15.2% after wire passage, in 21.8% after Thrombus Aspiration, and in 44.3% at the end of the procedure.1 However, without a control group for comparison, one should be cautious about the interpretation of these results. Thrombus Aspiration devices may cause transient reductions in flow after Thrombus Aspiration, which may be related to disruption of culprit plaque or distal embolization. Although we agree that Thrombus Aspiration can in some cases “effectively remove Thrombus and …

  • impact of Thrombus Aspiration during st elevation myocardial infarction a six month composite endpoint and risk of stroke analyses of the taste trial
    BMC Cardiovascular Disorders, 2016
    Co-Authors: Goran K Olivecrona, Bo Lagerqvist, Ole Frobert, Thorarinn Gudnason, Michael Maeng, Truls Ramunddal, Jan Haupt, Thomas Kellerth, Jason Stewart, Giovanna Sarno
    Abstract:

    Routine Thrombus Aspiration during primary percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) did not reduce the primary composite endpoint in the “A Randomised Trial of Routine Aspiration ThrOmbecTomy With PCI Versus PCI ALone in Patients With STEMI Undergoing Primary PCI” (TOTAL) trial. We aimed to analyse a similar endpoint in “The Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia” (TASTE) trial up to 180 days. In TASTE, 7244 patients with STEMI were randomised to Thrombus Aspiration followed by PCI or to PCI alone. We analysed the quadruple composite endpoint of cardiovascular death, cardiogenic shock, rehospitalisation for myocardial infarction, or new hospitalisation for heart failure. Furthermore, an extended net-benefit composite endpoint including stent thrombosis, target vessel revascularization or stroke within 180 days was analysed. The primary quadruple composite endpoint occurred in 8.7 % (316 of 3621) in the Thrombus Aspiration group compared to 9.3 % (338 of 3623) in the PCI alone group (hazard ratio (HR), 0.93; 95 % confidence interval (CI); 0.80 - 1.09, P = 0.36) and the extended net-benefit composite endpoint in 12.0 % (436) vs. 13.2 % (479) (HR, 0.90; 95 % CI; 0.79 - 1.03, P = 0.12). Stroke within 30 days occurred in 0.7 % (27) vs. 0.7 % (24) (HR, 0.89; 95 % CI; 0.51–1.54, P = 0.68). A large and an extended composite endpoint analysis from the TASTE trial did not demonstrate any clinical benefit of routine Thrombus Aspiration during PCI in patients with STEMI. There was no evidence of an increased risk of stroke with Thrombus Aspiration.

  • Thrombus Aspiration in patients with large anterior myocardial infarction a Thrombus Aspiration in st elevation myocardial infarction in scandinavia trial substudy
    American Heart Journal, 2016
    Co-Authors: Fredrik Calais, Stefan James, Bo Lagerqvist, Jerzy Leppert, Ole Frobert
    Abstract:

    Background The TASTE trial did not demonstrate clinical benefit of Thrombus Aspiration (TA). High-risk patients might benefit from TA. Methods The TASTE trial was a multicenter, randomized, control ...

  • tct 3 Thrombus Aspiration in patients with large anterior myocardial infarction a taste trial substudy
    Journal of the American College of Cardiology, 2015
    Co-Authors: Fredrik Calais, Stefan James, Bo Lagerqvist, Jerzy Leppert, Ole Frobert
    Abstract:

    Thrombus Aspiration in patients with large anterior myocardial infarction : a TASTE trial substudy

  • st elevation myocardial infarction Thrombus Aspiration and different invasive strategies a taste trial substudy
    Journal of the American Heart Association, 2015
    Co-Authors: Ole Frobert, Stefan James, Fredrik Calais, Bo Lagerqvist
    Abstract:

    Background-—The clinical effect of Thrombus Aspiration in ST-elevation myocardial infarction may depend on the type of Aspiration catheter and stenting technique. Methods and Results-—The multicenter, prospective, randomized, open-label trial Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia (TASTE) did not demonstrate a clinical benefit of Thrombus Aspiration compared to percutaneous coronary intervention alone. We assessed the effect of type of Aspiration device, stent type, direct stenting, and postdilatation on outcomes at 1 year. There was no difference in all-cause mortality, between the 3 most frequently used Aspiration catheters (Eliminate [Terumo] 5.4%, Export [Medtronic] 5.0%, Pronto [Vascular Solutions] 4.5%) in patients randomized to Thrombus Aspiration. There was no difference in mortality between directly stented patients randomized to Thrombus Aspiration compared to patients randomized to percutaneous coronary intervention only (risk ratio 1.08, 95% CI 0.70 to 1.67, P=0.73). Similarly, there was no difference in mortality between the 2 randomized groups for patients receiving drug-eluting stents (risk ratio 0.89, 95% CI 0.63 to 1.26, P=0.50) or for those treated with postdilation (risk ratio 0.72, 95% CI 0.49 to 1.07, P=0.11). Furthermore, there was no difference in rehospitalization for myocardial infarction or stent thrombosis between the randomized arms in any of the subgroups. Conclusions-—In patients with ST-elevation myocardial infarction randomized to Thrombus Aspiration, the type of Aspiration catheter did not affect outcome. Stent type, direct stenting, or postdilation did not affect outcome irrespective of treatment with Thrombus Aspiration and percutaneous coronary intervention or percutaneous coronary intervention alone.

Stefan James - One of the best experts on this subject based on the ideXlab platform.

  • clinical impact of direct stenting and interaction with Thrombus Aspiration in patients with st segment elevation myocardial infarction undergoing percutaneous coronary intervention thrombectomy trialists collaboration
    European Heart Journal, 2018
    Co-Authors: Karim D Mahmoud, Sanjit S Jolly, Stefan James, Vladimir Džavik, John A Cairns, Goran K Olivecrona, Henrik Renlund, Bo Lagerqvist, Ashraf Alazzoni, Sasko Kedev
    Abstract:

    Aims Preliminary studies suggest that direct stenting (DS) during percutaneous coronary intervention (PCI) may reduce microvascular obstruction and improve clinical outcome. Thrombus Aspiration may facilitate DS. We assessed the impact of DS on clinical outcome and myocardial reperfusion and its interaction with Thrombus Aspiration among ST-segment elevation myocardial infarction (STEMI) patients undergoing PCI. Methods and results Patient-level data from the three largest randomized trials on routine manual Thrombus Aspiration vs. PCI only were merged. A 1:1 propensity matched population was created to compare DS and conventional stenting. Synergy between DS and Thrombus Aspiration was assessed with interaction P-values in the final models. In the unmatched population (n= 17 329), 32% underwent DS and 68% underwent conventional stenting. Direct stenting rates were higher in patients randomized to Thrombus Aspiration as compared with PCI only (41% vs. 22%; P < 0.001). Patients undergoing DS required less contrast (162mL vs. 172mL; P< 0.001) and had shorter fluoroscopy time (11.1min vs. 13.3 min; P< 0.001). After propensity matching (n= 10 944), no significant differences were seen between DS and conventional stenting with respect to 30-day cardiovascular death [1.7% vs. 1.9%; hazard ratio 0.88, 95% confidence interval (CI) 0.55-1.41; P=0.60; Pinteraction = 0.96) and 30-day stroke or transient ischaemic attack (0.6% vs. 0.4%; odds ratio 1.02; 95% CI 0.14-7.54; P=0.99; Pinteraction = 0.81). One-year results were similar. No significant differences were seen in electrocardiographic and angiographic myocardial reperfusion measures. Conclusion Direct stenting rates were higher in patients randomized to Thrombus Aspiration. Clinical outcomes and myocardial reperfusion measures did not differ significantly between DS and conventional stenting and there was no interaction with Thrombus Aspiration. (Less)

  • response by jolly et al to letters regarding article Thrombus Aspiration in st segment elevation myocardial infarction an individual patient meta analysis thrombectomy trialists collaboration
    Circulation, 2017
    Co-Authors: Sanjit S Jolly, Stefan James, Vladimir Džavik, John A Cairns, Ole Frobert
    Abstract:

    Karamasis and colleagues describe their own registry of patients with ST-segment–elevation myocardial infarction undergoing Thrombus Aspiration in whom they performed serial ECGs and showed worsening in ST-segment elevation in 13.5% of cases after the first wire passage, in 19.7% of cases after Thrombus Aspiration, and in 12.5% of cases at the end of the procedure. Thus, >50% ST-segment resolution occurred in 15.2% after wire passage, in 21.8% after Thrombus Aspiration, and in 44.3% at the end of the procedure.1 However, without a control group for comparison, one should be cautious about the interpretation of these results. Thrombus Aspiration devices may cause transient reductions in flow after Thrombus Aspiration, which may be related to disruption of culprit plaque or distal embolization. Although we agree that Thrombus Aspiration can in some cases “effectively remove Thrombus and …

  • Thrombus Aspiration in st segment elevation myocardial infarctionclinical perspective
    Circulation, 2017
    Co-Authors: Sanjit S Jolly, Karim D Mahmoud, Felix Zijlstra, Stefan James, Vladimir Džavik, John A Cairns, Salim Yusuf, Goran K Olivecrona, Henrik Renlund, Bo Lagerqvist
    Abstract:

    Background: Thrombus Aspiration during percutaneous coronary intervention (PCI) for the treatment of ST-segment–elevation myocardial infarction (STEMI) has been widely used; however, recent trials have questioned its value and safety. In this meta-analysis, we, the trial investigators, aimed to pool the individual patient data from these trials to determine the benefits and risks of Thrombus Aspiration during PCI in patients with ST-segment–elevation myocardial infarction. Methods: Included were large (n≥1000), randomized, controlled trials comparing manual thrombectomy and PCI alone in patients with ST-segment–elevation myocardial infarction. Individual patient data were provided by the leadership of each trial. The prespecified primary efficacy outcome was cardiovascular mortality within 30 days, and the primary safety outcome was stroke or transient ischemic attack within 30 days. Results: The 3 eligible randomized trials (TAPAS [Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction], TASTE [Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia], and TOTAL [Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI]) enrolled 19 047 patients, of whom 18 306 underwent PCI and were included in the primary analysis. Cardiovascular death at 30 days occurred in 221 of 9155 patients (2.4%) randomized to Thrombus Aspiration and 262 of 9151 (2.9%) randomized to PCI alone (hazard ratio, 0.84; 95% confidence interval, 0.70–1.01; P =0.06). Stroke or transient ischemic attack occurred in 66 (0.8%) randomized to Thrombus Aspiration and 46 (0.5%) randomized to PCI alone (odds ratio, 1.43; 95% confidence interval, 0.98–2.10; P =0.06). There were no significant differences in recurrent myocardial infarction, stent thrombosis, heart failure, or target vessel revascularization. In the subgroup with high Thrombus burden (TIMI [Thrombolysis in Myocardial Infarction] Thrombus grade ≥3), Thrombus Aspiration was associated with fewer cardiovascular deaths (170 [2.5%] versus 205 [3.1%]; hazard ratio, 0.80; 95% confidence interval, 0.65–0.98; P =0.03) and with more strokes or transient ischemic attacks (55 [0.9%] versus 34 [0.5%]; odds ratio, 1.56; 95% confidence interval, 1.02–2.42, P =0.04). However, the interaction P values were 0.32 and 0.34, respectively. Conclusions: Routine Thrombus Aspiration during PCI for ST-segment–elevation myocardial infarction did not improve clinical outcomes. In the high Thrombus burden group, the trends toward reduced cardiovascular death and increased stroke or transient ischemic attack provide a rationale for future trials of improved Thrombus Aspiration technologies in this high-risk subgroup. Clinical Trial Registration: URLs: . Unique identifiers: [NCT02552407][1] and CRD42015025936. # Clinical Perspective {#article-title-14} [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02552407&atom=%2Fcirculationaha%2F135%2F2%2F143.atom

  • Thrombus Aspiration in st segment elevation myocardial infarction an individual patient meta analysis thrombectomy trialists collaboration
    Circulation, 2017
    Co-Authors: Sanjit S Jolly, Karim D Mahmoud, Stefan James, Vladimir Džavik, John A Cairns, Salim Yusuf, Goran K Olivecrona, Henrik Renlund, Felix Zijlstra, Bo Lagerqvist
    Abstract:

    BACKGROUND: Thrombus Aspiration during percutaneous coronary intervention (PCI) for the treatment of ST-segment-elevation myocardial infarction (STEMI) has been widely used; however, recent trials have questioned its value and safety. In this meta-analysis, we, the trial investigators, aimed to pool the individual patient data from these trials to determine the benefits and risks of Thrombus Aspiration during PCI in patients with ST-segment-elevation myocardial infarction. METHODS: Included were large (n≥1000), randomized, controlled trials comparing manual thrombectomy and PCI alone in patients with ST-segment-elevation myocardial infarction. Individual patient data were provided by the leadership of each trial. The prespecified primary efficacy outcome was cardiovascular mortality within 30 days, and the primary safety outcome was stroke or transient ischemic attack within 30 days. RESULTS: The 3 eligible randomized trials (TAPAS [Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction], TASTE [Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia], and TOTAL [Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI]) enrolled 19 047 patients, of whom 18 306 underwent PCI and were included in the primary analysis. Cardiovascular death at 30 days occurred in 221 of 9155 patients (2.4%) randomized to Thrombus Aspiration and 262 of 9151 (2.9%) randomized to PCI alone (hazard ratio, 0.84; 95% confidence interval, 0.70-1.01; P=0.06). Stroke or transient ischemic attack occurred in 66 (0.8%) randomized to Thrombus Aspiration and 46 (0.5%) randomized to PCI alone (odds ratio, 1.43; 95% confidence interval, 0.98-2.10; P=0.06). There were no significant differences in recurrent myocardial infarction, stent thrombosis, heart failure, or target vessel revascularization. In the subgroup with high Thrombus burden (TIMI [Thrombolysis in Myocardial Infarction] Thrombus grade ≥3), Thrombus Aspiration was associated with fewer cardiovascular deaths (170 [2.5%] versus 205 [3.1%]; hazard ratio, 0.80; 95% confidence interval, 0.65-0.98; P=0.03) and with more strokes or transient ischemic attacks (55 [0.9%] versus 34 [0.5%]; odds ratio, 1.56; 95% confidence interval, 1.02-2.42, P=0.04). However, the interaction P values were 0.32 and 0.34, respectively. CONCLUSIONS: Routine Thrombus Aspiration during PCI for ST-segment-elevation myocardial infarction did not improve clinical outcomes. In the high Thrombus burden group, the trends toward reduced cardiovascular death and increased stroke or transient ischemic attack provide a rationale for future trials of improved Thrombus Aspiration technologies in this high-risk subgroup. CLINICAL TRIAL REGISTRATION: URLs: http://www.ClinicalTrials.gov http://www.crd.york.ac.uk/prospero/. Unique identifiers: NCT02552407 and CRD42015025936.

  • Thrombus Aspiration in st segment elevation myocardial infarctionclinical perspective an individual patient meta analysis thrombectomy trialists collaboration
    Circulation, 2017
    Co-Authors: Sanjit S Jolly, Karim D Mahmoud, Stefan James, Vladimir Džavik, John A Cairns, Salim Yusuf, Goran K Olivecrona, Henrik Renlund, Felix Zijlstra, Bo Lagerqvist
    Abstract:

    Background: Thrombus Aspiration during percutaneous coronary intervention (PCI) for the treatment of ST-segment–elevation myocardial infarction (STEMI) has been widely used; however, recent trials have questioned its value and safety. In this meta-analysis, we, the trial investigators, aimed to pool the individual patient data from these trials to determine the benefits and risks of Thrombus Aspiration during PCI in patients with ST-segment–elevation myocardial infarction. Methods: Included were large (n≥1000), randomized, controlled trials comparing manual thrombectomy and PCI alone in patients with ST-segment–elevation myocardial infarction. Individual patient data were provided by the leadership of each trial. The prespecified primary efficacy outcome was cardiovascular mortality within 30 days, and the primary safety outcome was stroke or transient ischemic attack within 30 days. Results: The 3 eligible randomized trials (TAPAS [Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction], TASTE [Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia], and TOTAL [Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI]) enrolled 19 047 patients, of whom 18 306 underwent PCI and were included in the primary analysis. Cardiovascular death at 30 days occurred in 221 of 9155 patients (2.4%) randomized to Thrombus Aspiration and 262 of 9151 (2.9%) randomized to PCI alone (hazard ratio, 0.84; 95% confidence interval, 0.70–1.01; P =0.06). Stroke or transient ischemic attack occurred in 66 (0.8%) randomized to Thrombus Aspiration and 46 (0.5%) randomized to PCI alone (odds ratio, 1.43; 95% confidence interval, 0.98–2.10; P =0.06). There were no significant differences in recurrent myocardial infarction, stent thrombosis, heart failure, or target vessel revascularization. In the subgroup with high Thrombus burden (TIMI [Thrombolysis in Myocardial Infarction] Thrombus grade ≥3), Thrombus Aspiration was associated with fewer cardiovascular deaths (170 [2.5%] versus 205 [3.1%]; hazard ratio, 0.80; 95% confidence interval, 0.65–0.98; P =0.03) and with more strokes or transient ischemic attacks (55 [0.9%] versus 34 [0.5%]; odds ratio, 1.56; 95% confidence interval, 1.02–2.42, P =0.04). However, the interaction P values were 0.32 and 0.34, respectively. Conclusions: Routine Thrombus Aspiration during PCI for ST-segment–elevation myocardial infarction did not improve clinical outcomes. In the high Thrombus burden group, the trends toward reduced cardiovascular death and increased stroke or transient ischemic attack provide a rationale for future trials of improved Thrombus Aspiration technologies in this high-risk subgroup. Clinical Trial Registration: URLs: http://www.ClinicalTrials.govhttp://www.crd.york.ac.uk/prospero/. Unique identifiers: NCT02552407 and CRD42015025936.

Goran K Olivecrona - One of the best experts on this subject based on the ideXlab platform.

  • clinical impact of direct stenting and interaction with Thrombus Aspiration in patients with st segment elevation myocardial infarction undergoing percutaneous coronary intervention thrombectomy trialists collaboration
    European Heart Journal, 2018
    Co-Authors: Karim D Mahmoud, Sanjit S Jolly, Stefan James, Vladimir Džavik, John A Cairns, Goran K Olivecrona, Henrik Renlund, Bo Lagerqvist, Ashraf Alazzoni, Sasko Kedev
    Abstract:

    Aims Preliminary studies suggest that direct stenting (DS) during percutaneous coronary intervention (PCI) may reduce microvascular obstruction and improve clinical outcome. Thrombus Aspiration may facilitate DS. We assessed the impact of DS on clinical outcome and myocardial reperfusion and its interaction with Thrombus Aspiration among ST-segment elevation myocardial infarction (STEMI) patients undergoing PCI. Methods and results Patient-level data from the three largest randomized trials on routine manual Thrombus Aspiration vs. PCI only were merged. A 1:1 propensity matched population was created to compare DS and conventional stenting. Synergy between DS and Thrombus Aspiration was assessed with interaction P-values in the final models. In the unmatched population (n= 17 329), 32% underwent DS and 68% underwent conventional stenting. Direct stenting rates were higher in patients randomized to Thrombus Aspiration as compared with PCI only (41% vs. 22%; P < 0.001). Patients undergoing DS required less contrast (162mL vs. 172mL; P< 0.001) and had shorter fluoroscopy time (11.1min vs. 13.3 min; P< 0.001). After propensity matching (n= 10 944), no significant differences were seen between DS and conventional stenting with respect to 30-day cardiovascular death [1.7% vs. 1.9%; hazard ratio 0.88, 95% confidence interval (CI) 0.55-1.41; P=0.60; Pinteraction = 0.96) and 30-day stroke or transient ischaemic attack (0.6% vs. 0.4%; odds ratio 1.02; 95% CI 0.14-7.54; P=0.99; Pinteraction = 0.81). One-year results were similar. No significant differences were seen in electrocardiographic and angiographic myocardial reperfusion measures. Conclusion Direct stenting rates were higher in patients randomized to Thrombus Aspiration. Clinical outcomes and myocardial reperfusion measures did not differ significantly between DS and conventional stenting and there was no interaction with Thrombus Aspiration. (Less)

  • Thrombus Aspiration in st segment elevation myocardial infarctionclinical perspective
    Circulation, 2017
    Co-Authors: Sanjit S Jolly, Karim D Mahmoud, Felix Zijlstra, Stefan James, Vladimir Džavik, John A Cairns, Salim Yusuf, Goran K Olivecrona, Henrik Renlund, Bo Lagerqvist
    Abstract:

    Background: Thrombus Aspiration during percutaneous coronary intervention (PCI) for the treatment of ST-segment–elevation myocardial infarction (STEMI) has been widely used; however, recent trials have questioned its value and safety. In this meta-analysis, we, the trial investigators, aimed to pool the individual patient data from these trials to determine the benefits and risks of Thrombus Aspiration during PCI in patients with ST-segment–elevation myocardial infarction. Methods: Included were large (n≥1000), randomized, controlled trials comparing manual thrombectomy and PCI alone in patients with ST-segment–elevation myocardial infarction. Individual patient data were provided by the leadership of each trial. The prespecified primary efficacy outcome was cardiovascular mortality within 30 days, and the primary safety outcome was stroke or transient ischemic attack within 30 days. Results: The 3 eligible randomized trials (TAPAS [Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction], TASTE [Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia], and TOTAL [Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI]) enrolled 19 047 patients, of whom 18 306 underwent PCI and were included in the primary analysis. Cardiovascular death at 30 days occurred in 221 of 9155 patients (2.4%) randomized to Thrombus Aspiration and 262 of 9151 (2.9%) randomized to PCI alone (hazard ratio, 0.84; 95% confidence interval, 0.70–1.01; P =0.06). Stroke or transient ischemic attack occurred in 66 (0.8%) randomized to Thrombus Aspiration and 46 (0.5%) randomized to PCI alone (odds ratio, 1.43; 95% confidence interval, 0.98–2.10; P =0.06). There were no significant differences in recurrent myocardial infarction, stent thrombosis, heart failure, or target vessel revascularization. In the subgroup with high Thrombus burden (TIMI [Thrombolysis in Myocardial Infarction] Thrombus grade ≥3), Thrombus Aspiration was associated with fewer cardiovascular deaths (170 [2.5%] versus 205 [3.1%]; hazard ratio, 0.80; 95% confidence interval, 0.65–0.98; P =0.03) and with more strokes or transient ischemic attacks (55 [0.9%] versus 34 [0.5%]; odds ratio, 1.56; 95% confidence interval, 1.02–2.42, P =0.04). However, the interaction P values were 0.32 and 0.34, respectively. Conclusions: Routine Thrombus Aspiration during PCI for ST-segment–elevation myocardial infarction did not improve clinical outcomes. In the high Thrombus burden group, the trends toward reduced cardiovascular death and increased stroke or transient ischemic attack provide a rationale for future trials of improved Thrombus Aspiration technologies in this high-risk subgroup. Clinical Trial Registration: URLs: . Unique identifiers: [NCT02552407][1] and CRD42015025936. # Clinical Perspective {#article-title-14} [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02552407&atom=%2Fcirculationaha%2F135%2F2%2F143.atom

  • Thrombus Aspiration in st segment elevation myocardial infarction an individual patient meta analysis thrombectomy trialists collaboration
    Circulation, 2017
    Co-Authors: Sanjit S Jolly, Karim D Mahmoud, Stefan James, Vladimir Džavik, John A Cairns, Salim Yusuf, Goran K Olivecrona, Henrik Renlund, Felix Zijlstra, Bo Lagerqvist
    Abstract:

    BACKGROUND: Thrombus Aspiration during percutaneous coronary intervention (PCI) for the treatment of ST-segment-elevation myocardial infarction (STEMI) has been widely used; however, recent trials have questioned its value and safety. In this meta-analysis, we, the trial investigators, aimed to pool the individual patient data from these trials to determine the benefits and risks of Thrombus Aspiration during PCI in patients with ST-segment-elevation myocardial infarction. METHODS: Included were large (n≥1000), randomized, controlled trials comparing manual thrombectomy and PCI alone in patients with ST-segment-elevation myocardial infarction. Individual patient data were provided by the leadership of each trial. The prespecified primary efficacy outcome was cardiovascular mortality within 30 days, and the primary safety outcome was stroke or transient ischemic attack within 30 days. RESULTS: The 3 eligible randomized trials (TAPAS [Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction], TASTE [Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia], and TOTAL [Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI]) enrolled 19 047 patients, of whom 18 306 underwent PCI and were included in the primary analysis. Cardiovascular death at 30 days occurred in 221 of 9155 patients (2.4%) randomized to Thrombus Aspiration and 262 of 9151 (2.9%) randomized to PCI alone (hazard ratio, 0.84; 95% confidence interval, 0.70-1.01; P=0.06). Stroke or transient ischemic attack occurred in 66 (0.8%) randomized to Thrombus Aspiration and 46 (0.5%) randomized to PCI alone (odds ratio, 1.43; 95% confidence interval, 0.98-2.10; P=0.06). There were no significant differences in recurrent myocardial infarction, stent thrombosis, heart failure, or target vessel revascularization. In the subgroup with high Thrombus burden (TIMI [Thrombolysis in Myocardial Infarction] Thrombus grade ≥3), Thrombus Aspiration was associated with fewer cardiovascular deaths (170 [2.5%] versus 205 [3.1%]; hazard ratio, 0.80; 95% confidence interval, 0.65-0.98; P=0.03) and with more strokes or transient ischemic attacks (55 [0.9%] versus 34 [0.5%]; odds ratio, 1.56; 95% confidence interval, 1.02-2.42, P=0.04). However, the interaction P values were 0.32 and 0.34, respectively. CONCLUSIONS: Routine Thrombus Aspiration during PCI for ST-segment-elevation myocardial infarction did not improve clinical outcomes. In the high Thrombus burden group, the trends toward reduced cardiovascular death and increased stroke or transient ischemic attack provide a rationale for future trials of improved Thrombus Aspiration technologies in this high-risk subgroup. CLINICAL TRIAL REGISTRATION: URLs: http://www.ClinicalTrials.gov http://www.crd.york.ac.uk/prospero/. Unique identifiers: NCT02552407 and CRD42015025936.

  • Thrombus Aspiration in st segment elevation myocardial infarctionclinical perspective an individual patient meta analysis thrombectomy trialists collaboration
    Circulation, 2017
    Co-Authors: Sanjit S Jolly, Karim D Mahmoud, Stefan James, Vladimir Džavik, John A Cairns, Salim Yusuf, Goran K Olivecrona, Henrik Renlund, Felix Zijlstra, Bo Lagerqvist
    Abstract:

    Background: Thrombus Aspiration during percutaneous coronary intervention (PCI) for the treatment of ST-segment–elevation myocardial infarction (STEMI) has been widely used; however, recent trials have questioned its value and safety. In this meta-analysis, we, the trial investigators, aimed to pool the individual patient data from these trials to determine the benefits and risks of Thrombus Aspiration during PCI in patients with ST-segment–elevation myocardial infarction. Methods: Included were large (n≥1000), randomized, controlled trials comparing manual thrombectomy and PCI alone in patients with ST-segment–elevation myocardial infarction. Individual patient data were provided by the leadership of each trial. The prespecified primary efficacy outcome was cardiovascular mortality within 30 days, and the primary safety outcome was stroke or transient ischemic attack within 30 days. Results: The 3 eligible randomized trials (TAPAS [Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction], TASTE [Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia], and TOTAL [Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI]) enrolled 19 047 patients, of whom 18 306 underwent PCI and were included in the primary analysis. Cardiovascular death at 30 days occurred in 221 of 9155 patients (2.4%) randomized to Thrombus Aspiration and 262 of 9151 (2.9%) randomized to PCI alone (hazard ratio, 0.84; 95% confidence interval, 0.70–1.01; P =0.06). Stroke or transient ischemic attack occurred in 66 (0.8%) randomized to Thrombus Aspiration and 46 (0.5%) randomized to PCI alone (odds ratio, 1.43; 95% confidence interval, 0.98–2.10; P =0.06). There were no significant differences in recurrent myocardial infarction, stent thrombosis, heart failure, or target vessel revascularization. In the subgroup with high Thrombus burden (TIMI [Thrombolysis in Myocardial Infarction] Thrombus grade ≥3), Thrombus Aspiration was associated with fewer cardiovascular deaths (170 [2.5%] versus 205 [3.1%]; hazard ratio, 0.80; 95% confidence interval, 0.65–0.98; P =0.03) and with more strokes or transient ischemic attacks (55 [0.9%] versus 34 [0.5%]; odds ratio, 1.56; 95% confidence interval, 1.02–2.42, P =0.04). However, the interaction P values were 0.32 and 0.34, respectively. Conclusions: Routine Thrombus Aspiration during PCI for ST-segment–elevation myocardial infarction did not improve clinical outcomes. In the high Thrombus burden group, the trends toward reduced cardiovascular death and increased stroke or transient ischemic attack provide a rationale for future trials of improved Thrombus Aspiration technologies in this high-risk subgroup. Clinical Trial Registration: URLs: http://www.ClinicalTrials.govhttp://www.crd.york.ac.uk/prospero/. Unique identifiers: NCT02552407 and CRD42015025936.

  • Thrombus Aspiration in st elevation myocardial infarction an individual patient meta analysis
    Circulation, 2017
    Co-Authors: Sanjit S Jolly, Karim D Mahmoud, Felix Zijlstra, Stefan James, Vladimir Džavik, John A Cairns, Salim Yusuf, Goran K Olivecrona, Henrik Renlund, Bo Lagerqvist
    Abstract:

    BACKGROUND—: Thrombus Aspiration during percutaneous coronary intervention (PCI) for the treatment of ST elevation myocardial infarction (STEMI) has been widely used; however, recent trials have questioned its value and safety. In this meta-analysis, we, the trial investigators, aimed to pool the individual patient data from these trials to determine the benefits and risks of Thrombus Aspiration during PCI in patients with STEMI. METHODS—: Included were large (N≥1000) randomized controlled trials comparing manual thrombectomy vs. PCI alone in patients with STEMI. Individual patient data was provided by the leadership of each trial. The pre-specified primary efficacy outcome was cardiovascular (CV) mortality within 30 days and the primary safety outcome was stroke or transient ischemic attack (TIA) within 30 days. RESULTS—: The 3 eligible randomized trials (TAPAS, TASTE and TOTAL) enrolled 19,047 patients, of whom 18,306 underwent PCI and were included in the primary analysis. CV death at 30 days occurred in 221 (2.4%) of 9155 patients randomized to Thrombus Aspiration and 262 (2.9%) of 9151 randomized to PCI alone (hazard ratio (HR) 0.84; 95% CI 0.70-1.01, p=0.06). Stroke or TIA occurred in 66 (0.8%) randomized to Thrombus Aspiration and 46 (0.5%) randomized to PCI alone (odds ratio [OR] 1.43 95% CI 0.98-2.1, p=0.06). There were no significant differences in recurrent myocardial infarction, stent thrombosis, heart failure or target vessel revascularization. In the subgroup with high Thrombus burden (TIMI Thrombus grade ≥3) Thrombus Aspiration was associated with less CV death (170 [2.5%] vs. 205 [3.1%] HR 0.80; 95% CI 0.65-0.98, p =0.03), and with more stroke or TIA (55 [0.9%] vs. 34 [0.5%] OR 1.56; 95% CI 1.02-2.42, p=0.04). However, the interaction p-values were 0.32 and 0.34, respectively. CONCLUSIONS—: Routine Thrombus Aspiration during STEMI PCI did not improve clinical outcomes. In the high Thrombus burden subgroup the trends toward reduced CV death and increased stroke or TIA provide a rationale for future trials of improved Thrombus Aspiration technologies in this high-risk subgroup. CLINICAL TRIAL REGISTRATION—: ClinicalTrials.gov identifier NCT02552407, PROSPERO CRD42015025936 (Less)