Mechanical Thrombectomy Versus Anticoagulation Alone in Intermediate-High Risk PE
Rachel RosovskyStavros KonstantinidesIdo WeinbergSuhail DohadZachary RosolJakub StępniewskiJohn M. MoriartySahil A. ParikhAndrew HoldenRichard N. ChannickBraedon McDonaldKhanjan NagarshethY MatusovR. LooksteinAhmed AlBadriMohamed Faher AlmahmoudSameer AroraBülent ArslanSteve AttanasioKeith H. BenzulyV. BishayPaul BoiteauPaul BoucherBrendan BuckleyMichael CampbellChad ChristophersonYashasvi ChughF. ColladoFrank CorriganMichael CutticaShani DahanLaura DavidsonAlex DavidovichDavid DexterMihaela Ioana DregoescTammer El-AiniMahir ElderFakhir ElmasriRukshan FernandoA. FischmanJames FlahertyBrian FreezeOren FriedmanJennifer FungSiddharth GandhiKirema Garcia-ReyesM. Kurt GordonP GuichardScott HamiltonFrank HaoEric HergetYasin HussainElias IliadisF ItalianoNatalia JaworskaKamil JonasKevin JonesMinhaj KhajaHussein KiliddarGrzegorz KopećAndreas KramerHolger KuehneGautam KumarMatthew C. LangstonBRIAN LAWLERMarysa LeyaKevin LiuWojciech MagońAziz MarzougAlan MatsumotoYuri MatusovMichael McDanielShay McGuinnessStephen MerrileesBushra MinaSanjay MisraPeter MonteleoneNicolas J. MouawadRuben MylvaganamJean PannetonKen ParharJong ParkGaurav ParmarJonathan PasseriRahul PatelMarloe PrinceM. RanadeAnimesh RathoreLisa RauschertRehan RiazWillie RobinsonRajesh SachdevaRobert SalazarDaniel SchimmelJeffrey SchusslerMatthew SebastianJanet ShapiroAbdul SheikhDan ShiloAlexander Sidor
Key result
CAVT with anticoagulation improves 90-day 6-minute walk distance by ~111 meters over anticoagulation alone.
- n=100
Why the study?
Reperfusion strategies for intermediate-high risk PE have not been evaluated in randomized trials against anticoagulation alone using patient-centered outcomes.
Does computer-assisted vacuum thrombectomy with anticoagulation improve RV/LV ratio change and functional outcomes in patients with acute intermediate-high risk PE compared to anticoagulation alone?
Key Points
- To determine whether computer-assisted vacuum thrombectomy combined with anticoagulation improves functional capacity, quality of life, and safety over 90 days compared with anticoagulation alone in acute intermediate-high risk pulmonary embolism.
- Multicenter randomized trial (STORM-PE; NCT05684796) across 22 international sites enrolling 100 intermediate-high risk pulmonary embolism patients randomized 1:1 to computer-assisted vacuum thrombectomy (CAVT) plus anticoagulation or anticoagulation alone.
- Evaluated the 48-hour right-ventricular-to-left-ventricular ratio change as the primary endpoint, alongside 7-day major adverse events and 90-day functional and quality of life metrics.
- CAVT patients achieved a significantly greater 6-minute walk distance at 90 days compared with anticoagulation alone (478.7 ± 159.5 m vs 368.0 ± 127.8 m, P = 0.003).
- Significantly more patients in the CAVT group attained NYHA Functional Class I status at 90 days than in the anticoagulation group (97.4% [37/38] vs 75.6% [34/45], P = 0.005).
- No significant differences occurred between arms in all-cause mortality, pulmonary embolism-related mortality, or symptomatic recurrence within 90 days, with comparable dyspnea and quality-of-life scores.
Study Design
Type
RCT (n=100)
Randomization
1:1
Multicenter
Yes
Structured PICO
Does computer-assisted vacuum thrombectomy with anticoagulation improve RV/LV ratio change and functional outcomes in patients with acute intermediate-high risk PE compared to anticoagulation alone?
P
Population
100 patients with acute intermediate-high risk pulmonary embolism randomized to mechanical thrombectomy with anticoagulation versus anticoagulation alone, followed for 90 days.
I
Intervention
Computer-assisted vacuum thrombectomy (CAVT) with anticoagulation
C
Comparator
Anticoagulation alone
O
Outcome
Right-ventricular-to-left-ventricular (RV/LV) ratio change at 48 hourssurrogate
In patients with acute intermediate-high risk PE, computer-assisted vacuum thrombectomy combined with anticoagulation safely improved 90-day functional outcomes, including 6-minute walk distance and NYHA Functional Class, compared to anticoagulation alone.
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“What's particularly compelling is that a significantly greater portion of patients treated with CAVT achieved normalisation of RV/LV ratio within 48 hours—a critical indicator of right heart recovery—without an increase in complications. These findings represent a meaningful advancement in optimising early interventions in patients with intermediate-high-risk PE, and we look forward to exploring how changes in RV/LV ratio correlate with other clinical and functional outcomes.”
“Earlier and more uniform physiologic recovery and stabilization of right-heart function at 48 hours, and also at 7 days, appears to be translating to greater functional status and greater functional capacity in the endovascular group, and this certainly creates a greater level of confidence amongst the vascular community that this is a therapy that should likely be offered to patients in a more uniform matter.”
“The field of interventional therapies for acute PE has really expanded rapidly in the last 10 years, but there has not been a randomized controlled trial evaluating any minimally invasive therapy since 2013, so many of us in the interventional space felt that there was a need to establish core data to move the field forward, and that's what STORM-PE was about. We found the addition of the thrombectomy procedure in a statistically significant way dramatically reduced the strain on the right heart as compared to anticoagulation alone.”
Implication
May support vacuum thrombectomy for functional recovery in intermediate-high risk PE; leaves open larger trials confirming mortality benefit.
Abstract
BACKGROUND: Up to 50% of pulmonary embolism (PE) survivors experience long-term functional limitations and reduced quality of life (QoL). Reperfusion strategies can rapidly relieve right-ventricular (RV) dysfunction and prevent clinical deterioration or hemodynamic collapse; however, these approaches have never been evaluated in a randomized trial against anticoagulation alone using patient-centered outcomes. OBJECTIVES: This study sought to evaluate whether mechanical thrombectomy with anticoagulation improves functional, QoL, and safety outcomes compared with anticoagulation alone in patients with acute intermediate-high risk PE over 90 days. METHODS: STORM-PE enrolled 100 PE patients randomized 1:1 to computer-assisted vacuum thrombectomy (CAVT) with anticoagulation or anticoagulation alone across 22 international sites, with RV-to-left-ventricular (RV/LV) ratio change at 48 hours as the primary endpoint. Secondary endpoints included major adverse events within 7 days, functional and QoL outcomes, mortality, and symptomatic PE recurrence through 90 days. RESULTS: For all patients, median time from randomization to last follow-up visit was 91.0 days [Q1-Q3: 80.5-100.0]. At 90 days, 66.0% (31/47) of CAVT and 64.2% (34/53) of anticoagulation patients completed the 6-min walk test. The CAVT arm exhibited a longer 6-min walk distance compared with anticoagulation alone (478.7 ± 159.5 m vs 368.0 ± 127.8 m, P = 0.003). More CAVT than anticoagulation patients were NYHA Functional Class I (97.4% [37/38] vs 75.6% [34/45], P = 0.005) at 90 days. Dyspnea and QoL scores were comparable between groups, with no differences between arms for all-cause mortality, PE-related mortality, and symptomatic PE recurrence within 90 days. CONCLUSIONS: In STORM-PE, CAVT with anticoagulation resulted in improved functional outcomes at 90 days compared with anticoagulation alone, with equivalent safety rates. This trial supports CAVT as an effective and safe reperfusion strategy for intermediate-high risk PE. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov Unique Identifier: NCT05684796.
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Cite This Study
Rosovsky et al. (2026) conducted an RCT in acute intermediate-high risk pulmonary embolism (n=100). Computer-assisted vacuum thrombectomy (CAVT) with anticoagulation vs. Anticoagulation alone was evaluated on RV-to-left-ventricular (RV/LV) ratio change at 48 hours. Computer-assisted vacuum thrombectomy with anticoagulation improved 90-day 6-minute walk distance compared with anticoagulation alone (478.7m vs 368.0m, P=0.003).