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Stavros K Kakkos - One of the best experts on this subject based on the ideXlab platform.

  • percutaneous Rheolytic Thrombectomy for thrombosed autogenous fistulae and prosthetic arteriovenous grafts outcome after aggressive surveillance and endovascular management
    Journal of Endovascular Therapy, 2008
    Co-Authors: Stavros K Kakkos, Georges K Haddad, Joseph A Haddad, Martha M Scully
    Abstract:

    PURPOSE: To study the outcome of Rheolytic Thrombectomy for hemodialysis access occlusion. METHODS: A prospective study was conducted of 187 patients (88 men; median age 63 years, range 21-89) with end-stage renal disease treated with the AngioJet Rheolytic Thrombectomy catheter followed by angioplasty (+/- stenting) of the culprit lesions in 285 episodes of arteriovenous graft (n = 261) or fistula (n = 24) thrombosis. Clinical success was defined as at least one successful subsequent hemodialysis session. Graft monitoring and surveillance included clinical and hemodialysis parameters, respectively, to detect a failing/failed access. RESULTS: Rheolytic Thrombectomy had a technical (immediate) success rate of 98.2% and a clinical success rate of 95.1%. Technical and clinical success for patients presenting within 2 days of the thrombosis was 99.6% and 96.6%, respectively, compared to 91.8% (p = 0.003, odds ratio 20.8) and 87.8% (p = 0.019, odds ratio 4) for later presentation. The number of stenoses that was managed (median, interquartile range) was significantly higher in grafts (4, 3-4) compared to fistulae (2, 2-3; p<0.001) and in accesses that had been treated for dysfunction or thrombosis in the past (4, 3-4) compared to accesses that had not (3, 3-4; p = 0.07). During follow-up, 95 (36.6%) accesses had no further thrombotic events, 23 (9%) accesses became dysfunctional and were treated with endovascular techniques, 137 (52.3%) developed recurrent thrombosis for which Rheolytic Thrombectomy was attempted, and 30 (11.5%) were abandoned or removed for infection. Functional assisted primary patency at 1, 6, 12, and 18 months was 72.4%, 45.1%, 30.3%, and 22.4%, respectively. Reintervention and venous outflow stenosis were associated with better and worse outcomes, respectively; multivariate analysis identified patient age, central vein stenosis, and stenting as additional independent predictors of improved patency. CONCLUSION: Rheolytic Thrombectomy is a highly successful procedure, with acceptable long-term assisted primary patency. Early referral for Thrombectomy should be encouraged.

  • equivalent secondary patency rates of upper extremity vectra vascular access grafts and transposed brachial basilic fistulas with aggressive access surveillance and endovascular treatment
    Journal of Vascular Surgery, 2008
    Co-Authors: Stavros K Kakkos, Georges K Haddad, Joseph A Haddad, Martha M Scully, Daniel J Reddy, Timothy J Nypaver, Tanja Andrzejewski, Donna L Schmid
    Abstract:

    Objectives The 2006 update of the DOQI guidelines has stated that in patients with end-stage renal disease, autogenous radial-cephalic, or brachial-cephalic fistulas are the preferred access modalities, followed by transposed brachial-basilic (TBB) fistulas and prosthetic arteriovenous (AV) grafts. AV grafts are in general least preferred; however, there is very limited data comparing directly the last two modalities. The aim of the present study is to compare outcomes of the TBB fistula and the Vectra Vascular Access Graft. Methods Seventy-six patients had a prosthetic brachial-axillary Vectra graft placed, while in 41 patients brachial-basilic upper arm transposition was performed. Graft surveillance to detect a failing/failed access was followed by endovascular treatment, Rheolytic Thrombectomy (AngioJet, Possis Medical), and/or angioplasty ± stenting of the responsible anatomical lesion(s). Results Use of Vectra grafts and TBB fistulas started after a median (interquartile range) of 14 (7-30) and 70 (52-102) days, respectively ( P P = .032); total number of isolated angioplasty sessions, performed for failing graft or fistula was 31 and 45, respectively ( P = .004). Although primary patency of the two access modalities was equivalent, primary assisted patency was significantly reduced in Vectra grafts (70% at 12 months and 58% at 18 months), compared with TBB fistulas (82% at 12 months and 78% at 18 months, P = .033); however, as a result of endovascular intervention, secondary patency rates at 12 months (87% vs 88%) and 18 months (87% vs 83%) were equivalent ( P = .91). Presence of arterial anastomosis stenosis treated with angioplasty at any stage had a significant negative predictive value on secondary patency rates at 12 and 18 months which were 61%, compared with 96% for Vectra grafts that had any intra-graft, venous outflow, draining or central vein stenosis treated with angioplasty at any stage ( P = .010). Conclusions Aggressive graft surveillance and endovascular treatment methods can yield equivalent long-term secondary patency rates between Vectra graft and TBB fistulas. The advantage of earlier use of Vectra graft must be balanced against the need for more frequent secondary interventions and the risk of graft infection.

  • results of aggressive graft surveillance and endovascular treatment on secondary patency rates of vectra vascular access grafts
    Journal of Vascular Surgery, 2007
    Co-Authors: Stavros K Kakkos, Georges K Haddad, Roger K Haddad, Daniel J Reddy, Timothy J Nypaver, Alexander D Shepard
    Abstract:

    Objective The aim of the present study was to determine the effect of an aggressive graft surveillance and endovascular treatment protocol on secondary patency rates of a polyetherurethaneurea vascular access graft, specially designed to provide early access and rapid hemostasis. Methods One hundred and ninety Vectra Vascular Access Grafts (C. R. Bard, Inc, Murray Hill, NJ) were placed in 176 patients (78 females and 98 males, mean age 61.7 years). There were 41 forearm grafts, 145 upper arm grafts and four thigh grafts. Graft surveillance was performed by using clinical and hemodialysis parameters to detect a failing/failed graft and followed by endovascular treatment, Rheolytic Thrombectomy (AngioJet, Possis Medical Inc, Minneapolis, Minn) and/or angioplasty ± stenting of the anatomical lesion (arterial anastomosis, graft, venous outflow, draining or central veins). Results Hemodialysis started after a median of 15.5 days, as soon as from the day of the operation in some cases. Bleeding complications occurred in six patients (3.2%), venous hypertension in seven (3.7%), steal syndrome in two (1.1%), neurological complications in two (1.1%), while late infection (range 2.7-14.6 months) was seen in six patients (3.2%). Thrombectomy and angioplasty (median number of sessions 1, interquartile range 1-2) was performed in 43 grafts. Isolated angioplasty, not associated with thrombosis (median number of sessions 1, interquartile range 1-2), was performed in 50 grafts. These interventions increased primary assisted patency from 69% and 63% at 12 and 18 months, respectively to a secondary patency rate of 86%. Taking into account grafts removed for late infection, functional secondary patency rate dropped to 83% and 81%, at 12 and 18 months, respectively. Arterial anastomosis angioplasty was performed more frequently in thrombosed grafts (28.6%) than failing grafts (6.7%), P P = .007) and 90.9% for grafts that had any intra-graft, venous outflow, or draining or central vein stenosis treated with angioplasty at any stage ( P = .002). Multivariate analysis identified the presence of arterial anastomosis stenosis as the single predictor of secondary patency (relative risk 0.247, P = .002). Conclusions Aggressive graft surveillance and endovascular treatment increases significantly secondary patency rates of Vectra Vascular Access Grafts. Longer follow-up will determine the effectiveness of this policy. The role of inflow stenosis on graft longevity and alternative treatment options warrant further investigation.

David Antoniucci - One of the best experts on this subject based on the ideXlab platform.

  • comparison of manual thrombus aspiration with Rheolytic Thrombectomy in acute myocardial infarction
    Circulation-cardiovascular Interventions, 2013
    Co-Authors: Guido Parodi, Angela Migliorini, Renato Valenti, Akiko Maehara, Ruben Vergara, Nazario Carrabba, Gary S Mintz, David Antoniucci
    Abstract:

    Background—Manual thrombus aspiration (MTA) is completely ineffective in 30% of cases, and the high profiles of the catheters prevent their use in tortuous and calcified vessels. The Rheolytic Thrombectomy (RT) device has the potential for improved thrombus removal in acute myocardial infarction as compared with MTA. No data exist on the comparison between the 2 techniques. Methods and Results—Randomized study, including 80 acute myocardial infarction patients allocated to RT or MTA before infarct artery stenting. Primary end point of this study is residual thrombus burden by optical coherence tomography. Secondary end points are (1) residual thrombolysis in myocardial infarction thrombus grade; (2) postintervention thrombolysis in myocardial infarction flow and myocardial blush; (3) early ST-segment resolution; (4) percentage of malapposed stent struts at 6 months; (5) 6-month restenosis; and (6) 6-month major adverse cardiovascular events. All but 1 patient had residual thrombus after manual aspiration ...

  • comparison of angiojet Rheolytic Thrombectomy before direct infarct artery stenting with direct stenting alone in patients with acute myocardial infarction the jetstent trial
    Journal of the American College of Cardiology, 2010
    Co-Authors: Angela Migliorini, Guido Parodi, Renato Valenti, Amerigo Stabile, Alfredo E Rodriguez, Caterina Gandolfo, Alfredo Rodriguez M Granillo, Franzjosef Neumann, Antonio Colombo, David Antoniucci
    Abstract:

    Objectives The aim of this study was to determine whether Rheolytic Thrombectomy (RT) before direct infarct artery stenting as compared with direct stenting (DS) alone results in improved myocardial reperfusion and clinical outcome in patients with acute myocardial infarction. Background The routine removal of thrombus before infarct artery stenting is still a matter of debate. Methods This is a multicenter, international, randomized, 2-arm, prospective study. Eligible patients were patients with acute myocardial infarction, angiographic evidence of thrombus grade 3 to 5, and a reference vessel diameter ≥2.5 mm. Coprimary end points were early ST-segment resolution and 99m Tc-sestamibi infarct size. An α value = 0.05 achieved by both coprimary surrogate end points or an α value = 0.025 for a single primary surrogate end point would be considered evidence of statistical significance. Other surrogate end points were Thrombolysis In Myocardial Infarction (TIMI) flow grade 3, corrected TIMI frame count, and TIMI grade 3 blush. Clinical end points were a composite of major adverse cardiovascular events at 1, 6, and 12 months. Results From December 2005 to September 2009, 501 patients were randomly allocated to RT before DS or to DS alone. The ST-segment resolution was more frequent in the RT arm as compared with the DS alone arm: 85.8% and 78.8%, respectively (p = 0.043), while no difference between groups were revealed in the other surrogate end points. The 6-month major adverse cardiovascular events rate was 11.2% in the Thrombectomy arm and 19.4% in the DS alone arm (p = 0.011). The 1-year event-free survival rates were 85.2 ± 2.3% for the RT arm, and 75.0 ± 3.1% for the DS alone arm (p = 0.009). Conclusions Although the primary efficacy end points were not met, the results of this study support the use of RT before infarct artery stenting in patients with acute myocardial infarction and evidence of coronary thrombus. (AngioJet Rheolytic Thrombectomy Before Direct Infarct Artery Stenting in Patients Undergoing Primary PCI for Acute Myocardial Infarction [JETSTENT]; NCT00275990 )

  • comparison of Rheolytic Thrombectomy before direct infarct artery stenting versus direct stenting alone in patients undergoing percutaneous coronary intervention for acute myocardial infarction
    American Journal of Cardiology, 2004
    Co-Authors: David Antoniucci, Gentian Memisha, Guido Parodi, Angela Migliorini, Renato Valenti, Giovanni M Santoro, Roberto Sciagrà
    Abstract:

    This randomized trial compared Rheolytic Thrombectomy before direct infarct artery stenting with direct infarct artery stenting alone in 100 patients with a first acute myocardial infarction (AMI). The primary end point of the study was early ST-segment elevation resolution, and the secondary end points were corrected Thrombolysis In Myocardial Infarction (TIMI) frame count, infarct size, and 1-month clinical outcome. The primary end point rates were 90% in the Thrombectomy group and 72% in the placebo group (p = 0.022). Randomization to Thrombectomy was independently related to the primary end point (odds ratio 3.56, p = 0.032). The corrected Thrombolysis In Myocaridal Infarctions (TIMI) frame count was lower in the Thrombectomy group (18.2 ± 7.7 vs 22.5 ± 11.0, p = 0.032), and infarct size was smaller in the Thrombectomy group (13.0 ± 11.6% vs 21.2 ± 18.0%, p = 0.010). At 1 month, there were no major adverse cardiac events. Rheolytic Thrombectomy before routine direct infarct-related artery (IRA) stenting is highly feasible and provides more effective myocardial reperfusion in patients undergoing percutaneous coronary intervention for AMI.

Georges K Haddad - One of the best experts on this subject based on the ideXlab platform.

  • percutaneous Rheolytic Thrombectomy for thrombosed autogenous fistulae and prosthetic arteriovenous grafts outcome after aggressive surveillance and endovascular management
    Journal of Endovascular Therapy, 2008
    Co-Authors: Stavros K Kakkos, Georges K Haddad, Joseph A Haddad, Martha M Scully
    Abstract:

    PURPOSE: To study the outcome of Rheolytic Thrombectomy for hemodialysis access occlusion. METHODS: A prospective study was conducted of 187 patients (88 men; median age 63 years, range 21-89) with end-stage renal disease treated with the AngioJet Rheolytic Thrombectomy catheter followed by angioplasty (+/- stenting) of the culprit lesions in 285 episodes of arteriovenous graft (n = 261) or fistula (n = 24) thrombosis. Clinical success was defined as at least one successful subsequent hemodialysis session. Graft monitoring and surveillance included clinical and hemodialysis parameters, respectively, to detect a failing/failed access. RESULTS: Rheolytic Thrombectomy had a technical (immediate) success rate of 98.2% and a clinical success rate of 95.1%. Technical and clinical success for patients presenting within 2 days of the thrombosis was 99.6% and 96.6%, respectively, compared to 91.8% (p = 0.003, odds ratio 20.8) and 87.8% (p = 0.019, odds ratio 4) for later presentation. The number of stenoses that was managed (median, interquartile range) was significantly higher in grafts (4, 3-4) compared to fistulae (2, 2-3; p<0.001) and in accesses that had been treated for dysfunction or thrombosis in the past (4, 3-4) compared to accesses that had not (3, 3-4; p = 0.07). During follow-up, 95 (36.6%) accesses had no further thrombotic events, 23 (9%) accesses became dysfunctional and were treated with endovascular techniques, 137 (52.3%) developed recurrent thrombosis for which Rheolytic Thrombectomy was attempted, and 30 (11.5%) were abandoned or removed for infection. Functional assisted primary patency at 1, 6, 12, and 18 months was 72.4%, 45.1%, 30.3%, and 22.4%, respectively. Reintervention and venous outflow stenosis were associated with better and worse outcomes, respectively; multivariate analysis identified patient age, central vein stenosis, and stenting as additional independent predictors of improved patency. CONCLUSION: Rheolytic Thrombectomy is a highly successful procedure, with acceptable long-term assisted primary patency. Early referral for Thrombectomy should be encouraged.

  • equivalent secondary patency rates of upper extremity vectra vascular access grafts and transposed brachial basilic fistulas with aggressive access surveillance and endovascular treatment
    Journal of Vascular Surgery, 2008
    Co-Authors: Stavros K Kakkos, Georges K Haddad, Joseph A Haddad, Martha M Scully, Daniel J Reddy, Timothy J Nypaver, Tanja Andrzejewski, Donna L Schmid
    Abstract:

    Objectives The 2006 update of the DOQI guidelines has stated that in patients with end-stage renal disease, autogenous radial-cephalic, or brachial-cephalic fistulas are the preferred access modalities, followed by transposed brachial-basilic (TBB) fistulas and prosthetic arteriovenous (AV) grafts. AV grafts are in general least preferred; however, there is very limited data comparing directly the last two modalities. The aim of the present study is to compare outcomes of the TBB fistula and the Vectra Vascular Access Graft. Methods Seventy-six patients had a prosthetic brachial-axillary Vectra graft placed, while in 41 patients brachial-basilic upper arm transposition was performed. Graft surveillance to detect a failing/failed access was followed by endovascular treatment, Rheolytic Thrombectomy (AngioJet, Possis Medical), and/or angioplasty ± stenting of the responsible anatomical lesion(s). Results Use of Vectra grafts and TBB fistulas started after a median (interquartile range) of 14 (7-30) and 70 (52-102) days, respectively ( P P = .032); total number of isolated angioplasty sessions, performed for failing graft or fistula was 31 and 45, respectively ( P = .004). Although primary patency of the two access modalities was equivalent, primary assisted patency was significantly reduced in Vectra grafts (70% at 12 months and 58% at 18 months), compared with TBB fistulas (82% at 12 months and 78% at 18 months, P = .033); however, as a result of endovascular intervention, secondary patency rates at 12 months (87% vs 88%) and 18 months (87% vs 83%) were equivalent ( P = .91). Presence of arterial anastomosis stenosis treated with angioplasty at any stage had a significant negative predictive value on secondary patency rates at 12 and 18 months which were 61%, compared with 96% for Vectra grafts that had any intra-graft, venous outflow, draining or central vein stenosis treated with angioplasty at any stage ( P = .010). Conclusions Aggressive graft surveillance and endovascular treatment methods can yield equivalent long-term secondary patency rates between Vectra graft and TBB fistulas. The advantage of earlier use of Vectra graft must be balanced against the need for more frequent secondary interventions and the risk of graft infection.

  • results of aggressive graft surveillance and endovascular treatment on secondary patency rates of vectra vascular access grafts
    Journal of Vascular Surgery, 2007
    Co-Authors: Stavros K Kakkos, Georges K Haddad, Roger K Haddad, Daniel J Reddy, Timothy J Nypaver, Alexander D Shepard
    Abstract:

    Objective The aim of the present study was to determine the effect of an aggressive graft surveillance and endovascular treatment protocol on secondary patency rates of a polyetherurethaneurea vascular access graft, specially designed to provide early access and rapid hemostasis. Methods One hundred and ninety Vectra Vascular Access Grafts (C. R. Bard, Inc, Murray Hill, NJ) were placed in 176 patients (78 females and 98 males, mean age 61.7 years). There were 41 forearm grafts, 145 upper arm grafts and four thigh grafts. Graft surveillance was performed by using clinical and hemodialysis parameters to detect a failing/failed graft and followed by endovascular treatment, Rheolytic Thrombectomy (AngioJet, Possis Medical Inc, Minneapolis, Minn) and/or angioplasty ± stenting of the anatomical lesion (arterial anastomosis, graft, venous outflow, draining or central veins). Results Hemodialysis started after a median of 15.5 days, as soon as from the day of the operation in some cases. Bleeding complications occurred in six patients (3.2%), venous hypertension in seven (3.7%), steal syndrome in two (1.1%), neurological complications in two (1.1%), while late infection (range 2.7-14.6 months) was seen in six patients (3.2%). Thrombectomy and angioplasty (median number of sessions 1, interquartile range 1-2) was performed in 43 grafts. Isolated angioplasty, not associated with thrombosis (median number of sessions 1, interquartile range 1-2), was performed in 50 grafts. These interventions increased primary assisted patency from 69% and 63% at 12 and 18 months, respectively to a secondary patency rate of 86%. Taking into account grafts removed for late infection, functional secondary patency rate dropped to 83% and 81%, at 12 and 18 months, respectively. Arterial anastomosis angioplasty was performed more frequently in thrombosed grafts (28.6%) than failing grafts (6.7%), P P = .007) and 90.9% for grafts that had any intra-graft, venous outflow, or draining or central vein stenosis treated with angioplasty at any stage ( P = .002). Multivariate analysis identified the presence of arterial anastomosis stenosis as the single predictor of secondary patency (relative risk 0.247, P = .002). Conclusions Aggressive graft surveillance and endovascular treatment increases significantly secondary patency rates of Vectra Vascular Access Grafts. Longer follow-up will determine the effectiveness of this policy. The role of inflow stenosis on graft longevity and alternative treatment options warrant further investigation.

Donna L Schmid - One of the best experts on this subject based on the ideXlab platform.

  • equivalent secondary patency rates of upper extremity vectra vascular access grafts and transposed brachial basilic fistulas with aggressive access surveillance and endovascular treatment
    Journal of Vascular Surgery, 2008
    Co-Authors: Stavros K Kakkos, Georges K Haddad, Joseph A Haddad, Martha M Scully, Daniel J Reddy, Timothy J Nypaver, Tanja Andrzejewski, Donna L Schmid
    Abstract:

    Objectives The 2006 update of the DOQI guidelines has stated that in patients with end-stage renal disease, autogenous radial-cephalic, or brachial-cephalic fistulas are the preferred access modalities, followed by transposed brachial-basilic (TBB) fistulas and prosthetic arteriovenous (AV) grafts. AV grafts are in general least preferred; however, there is very limited data comparing directly the last two modalities. The aim of the present study is to compare outcomes of the TBB fistula and the Vectra Vascular Access Graft. Methods Seventy-six patients had a prosthetic brachial-axillary Vectra graft placed, while in 41 patients brachial-basilic upper arm transposition was performed. Graft surveillance to detect a failing/failed access was followed by endovascular treatment, Rheolytic Thrombectomy (AngioJet, Possis Medical), and/or angioplasty ± stenting of the responsible anatomical lesion(s). Results Use of Vectra grafts and TBB fistulas started after a median (interquartile range) of 14 (7-30) and 70 (52-102) days, respectively ( P P = .032); total number of isolated angioplasty sessions, performed for failing graft or fistula was 31 and 45, respectively ( P = .004). Although primary patency of the two access modalities was equivalent, primary assisted patency was significantly reduced in Vectra grafts (70% at 12 months and 58% at 18 months), compared with TBB fistulas (82% at 12 months and 78% at 18 months, P = .033); however, as a result of endovascular intervention, secondary patency rates at 12 months (87% vs 88%) and 18 months (87% vs 83%) were equivalent ( P = .91). Presence of arterial anastomosis stenosis treated with angioplasty at any stage had a significant negative predictive value on secondary patency rates at 12 and 18 months which were 61%, compared with 96% for Vectra grafts that had any intra-graft, venous outflow, draining or central vein stenosis treated with angioplasty at any stage ( P = .010). Conclusions Aggressive graft surveillance and endovascular treatment methods can yield equivalent long-term secondary patency rates between Vectra graft and TBB fistulas. The advantage of earlier use of Vectra graft must be balanced against the need for more frequent secondary interventions and the risk of graft infection.

Angela Migliorini - One of the best experts on this subject based on the ideXlab platform.

  • comparison of manual thrombus aspiration with Rheolytic Thrombectomy in acute myocardial infarction
    Circulation-cardiovascular Interventions, 2013
    Co-Authors: Guido Parodi, Angela Migliorini, Renato Valenti, Akiko Maehara, Ruben Vergara, Nazario Carrabba, Gary S Mintz, David Antoniucci
    Abstract:

    Background—Manual thrombus aspiration (MTA) is completely ineffective in 30% of cases, and the high profiles of the catheters prevent their use in tortuous and calcified vessels. The Rheolytic Thrombectomy (RT) device has the potential for improved thrombus removal in acute myocardial infarction as compared with MTA. No data exist on the comparison between the 2 techniques. Methods and Results—Randomized study, including 80 acute myocardial infarction patients allocated to RT or MTA before infarct artery stenting. Primary end point of this study is residual thrombus burden by optical coherence tomography. Secondary end points are (1) residual thrombolysis in myocardial infarction thrombus grade; (2) postintervention thrombolysis in myocardial infarction flow and myocardial blush; (3) early ST-segment resolution; (4) percentage of malapposed stent struts at 6 months; (5) 6-month restenosis; and (6) 6-month major adverse cardiovascular events. All but 1 patient had residual thrombus after manual aspiration ...

  • comparison of angiojet Rheolytic Thrombectomy before direct infarct artery stenting with direct stenting alone in patients with acute myocardial infarction the jetstent trial
    Journal of the American College of Cardiology, 2010
    Co-Authors: Angela Migliorini, Guido Parodi, Renato Valenti, Amerigo Stabile, Alfredo E Rodriguez, Caterina Gandolfo, Alfredo Rodriguez M Granillo, Franzjosef Neumann, Antonio Colombo, David Antoniucci
    Abstract:

    Objectives The aim of this study was to determine whether Rheolytic Thrombectomy (RT) before direct infarct artery stenting as compared with direct stenting (DS) alone results in improved myocardial reperfusion and clinical outcome in patients with acute myocardial infarction. Background The routine removal of thrombus before infarct artery stenting is still a matter of debate. Methods This is a multicenter, international, randomized, 2-arm, prospective study. Eligible patients were patients with acute myocardial infarction, angiographic evidence of thrombus grade 3 to 5, and a reference vessel diameter ≥2.5 mm. Coprimary end points were early ST-segment resolution and 99m Tc-sestamibi infarct size. An α value = 0.05 achieved by both coprimary surrogate end points or an α value = 0.025 for a single primary surrogate end point would be considered evidence of statistical significance. Other surrogate end points were Thrombolysis In Myocardial Infarction (TIMI) flow grade 3, corrected TIMI frame count, and TIMI grade 3 blush. Clinical end points were a composite of major adverse cardiovascular events at 1, 6, and 12 months. Results From December 2005 to September 2009, 501 patients were randomly allocated to RT before DS or to DS alone. The ST-segment resolution was more frequent in the RT arm as compared with the DS alone arm: 85.8% and 78.8%, respectively (p = 0.043), while no difference between groups were revealed in the other surrogate end points. The 6-month major adverse cardiovascular events rate was 11.2% in the Thrombectomy arm and 19.4% in the DS alone arm (p = 0.011). The 1-year event-free survival rates were 85.2 ± 2.3% for the RT arm, and 75.0 ± 3.1% for the DS alone arm (p = 0.009). Conclusions Although the primary efficacy end points were not met, the results of this study support the use of RT before infarct artery stenting in patients with acute myocardial infarction and evidence of coronary thrombus. (AngioJet Rheolytic Thrombectomy Before Direct Infarct Artery Stenting in Patients Undergoing Primary PCI for Acute Myocardial Infarction [JETSTENT]; NCT00275990 )

  • comparison of Rheolytic Thrombectomy before direct infarct artery stenting versus direct stenting alone in patients undergoing percutaneous coronary intervention for acute myocardial infarction
    American Journal of Cardiology, 2004
    Co-Authors: David Antoniucci, Gentian Memisha, Guido Parodi, Angela Migliorini, Renato Valenti, Giovanni M Santoro, Roberto Sciagrà
    Abstract:

    This randomized trial compared Rheolytic Thrombectomy before direct infarct artery stenting with direct infarct artery stenting alone in 100 patients with a first acute myocardial infarction (AMI). The primary end point of the study was early ST-segment elevation resolution, and the secondary end points were corrected Thrombolysis In Myocardial Infarction (TIMI) frame count, infarct size, and 1-month clinical outcome. The primary end point rates were 90% in the Thrombectomy group and 72% in the placebo group (p = 0.022). Randomization to Thrombectomy was independently related to the primary end point (odds ratio 3.56, p = 0.032). The corrected Thrombolysis In Myocaridal Infarctions (TIMI) frame count was lower in the Thrombectomy group (18.2 ± 7.7 vs 22.5 ± 11.0, p = 0.032), and infarct size was smaller in the Thrombectomy group (13.0 ± 11.6% vs 21.2 ± 18.0%, p = 0.010). At 1 month, there were no major adverse cardiac events. Rheolytic Thrombectomy before routine direct infarct-related artery (IRA) stenting is highly feasible and provides more effective myocardial reperfusion in patients undergoing percutaneous coronary intervention for AMI.