Feature | Thrombectomy Devices | October 20, 2015

Routine Thrombus Aspiration Shows No Late Benefit in STEMI Patients

Outcomes from pair of clinical studies presented at TCT 2015

thrombus aspiration, STEMI patients, TCT 2015, TOTAL study

October 20, 2015 — A pair of studies presented at the 27th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium showed no late benefit of thrombus aspiration during percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI).

The TOTAL study was a prospective, randomized, investigator-initiated trial of routine manual thrombectomy with PCI versus PCI alone in patients with STEMI within 12 hours of symptom onset. The study enrolled 10,732 eligible patients from 87 hospitals in 20 countries. Using a 1:1 randomization, patients were assigned to thrombectomy followed by PCI (n=5,372) or to PCI alone (n=5,360). After excluding patients who did not undergo PCI in each group (337 in the PCI and thrombectomy group and 331 in the PCI alone group), the final study population was comprised of 10,064 patients (5,035 thrombectomy and 5,029 PCI alone).

The primary outcome (a composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock or class IV heart failure) at one year occurred in 395 (8 percent) of 5,035 patients in the thrombectomy group compared with 394 (8 percent) of 5,029 in the PCI alone group (hazard ratio [HR] 1.00 [95 percent CI 0.87–1.15], p=0.99). Cardiovascular death at one year occurred in 179 (4 percent) of the thrombectomy group and in 192 (4 percent) in the PCI alone group (HR 0.93 [95 percent CI 0.76–1.14], p=0.48). Recurrent myocardial infarction, cardiogenic shock or heart failure at one year were similar between the groups, as were all-cause death, stent thrombosis, definite stent thrombosis, target vessel revascularization and major bleeding.

The key safety outcome of the study, stroke within one year, occurred in 60 patients (1.2 percent) in the thrombectomy group compared with 36 (0.7 percent) in the PCI alone group (HR 1.66 [95 percent CI 1.10–2.51], p=0.015).

“Routine thrombus aspiration during PCI for STEMI did not reduce cardiovascular death, myocardial infarction, shock or heart failure after one year compared with PCI alone,” said lead investigator Sanjit S. Jolly, M.D., MSc. Jolly is an interventional cardiologist at Hamilton Health Sciences and an associate professor at McMaster University in Hamilton, Canada.

“A strategy of routine thrombus aspiration may be associated with an increased rate of stroke. The TOTAL trial is the largest trial of thrombus aspiration with significantly more power to detect differences in which stroke was a prespecified safety outcome. As a result, thrombus aspiration can no longer be recommended as a routine strategy in STEMI.”

The second trial was designed as a prospective, randomized, controlled, single-blind, single-center study. Patients with subacute STEMI presenting between 12 and 48 hours after symptom onset were randomized in a 1:1 ratio to manual thrombus aspiration (n=70) or standard PCI alone (n=74). The primary endpoint was the extent of microvascular obstruction (MVO) assessed by cardiac magnetic resonance imaging (CMR) one to four days after randomization. Secondary endpoints included measures of CMR (infarct size, myocardial salvage, left ventricular ejection fraction and volumes), angiography (TIMI flow post-PCI and myocardial blush grade post-PCI), enzymatic infarct size (high-sensitivity troponin T after 24 and 48 hours) and clinical outcomes after 30 days.

The extent of MVO was not significantly different between patients assigned to thrombus aspiration and PCI alone (2.5 ± 4 percent vs.3.1 ± 4.4 percent, p=.47, respectively). There were also no significant differences in infarct size, left ventricular ejection fraction, or angiographic and clinical endpoints between groups.

“In patients with subacute STEMI, routine manual thrombus aspiration before PCI failed to show a significant reduction in the primary endpoint of microvascular obstruction assessed by cardiac magnetic imaging compared to conventional PCI alone,” said lead investigator Steffen Desch, M.D. Desch is a professor at the University of Schleswig-Holstein, Campus Lübeck in Lübeck, Germany.

“This finding is further supported by a lack of benefit in angiographic, enzymatic, and clinical secondary endpoints.”

For more information: www.tctconference.com

Related Content

Biotronik Studies Demonstrate Efficacy of Minimizing Metal Burden in SFA Therapy
News | Stents Bare Metal| September 22, 2017
Physicians demonstrated that reducing metal burden in superficial femoral artery (SFA) therapy could effectively reduce...
Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Overlay Init