Effects on Mortality and Major Bleeding of Radial Versus Femoral Artery Access for Coronary Angiography or Percutaneous Coronary Intervention: Meta-Analysis of Individual Patient Data From 7 Multicenter Randomized Clinical Trials.

BACKGROUND: In some randomized clinical trials, transradial access (TRA) compared with transfemoral access (TFA) was associated with lower mortality in patients with coronary artery disease undergoing invasive management. We analyzed the effects of TRA versus TFA across multicenter randomized clinical trials and whether these associations are modified by patient or procedural characteristics. METHODS: We performed an individual patient data meta-analysis of multicenter randomized clinical trials comparing TRA with TFA among patients undergoing coronary angiography with or without percutaneous coronary intervention. The primary outcome was all-cause mortality and the co-primary outcome was major bleeding at 30 days. The primary analysis was conducted by 1-stage mixed-effects models on the basis of the intention-to-treat cohort. The effect of access site on mortality and major bleeding was assessed further by multivariable analysis. The relationship among access site, bleeding, and mortality was investigated by natural effect model mediation analysis with multivariable adjustment. RESULTS: A total of 21 600 patients (10 775 TRA, 10 825 TFA) from 7 randomized clinical trials were included. The median age was 63.9 years, 31.9% were women, 95% presented with acute coronary syndrome, and 75.2% underwent percutaneous coronary intervention. All-cause mortality (1.6% versus 2.1%; hazard ratio, 0.77 [95% CI, 0.63-0.95]; P=0.012) and major bleeding (1.5% versus 2.7%; odds ratio, 0.55 [95% CI, 0.45-0.67]; P<0.001) were lower with TRA. Subgroup analyses for mortality showed consistent results, except for baseline hemoglobin level (Pinteraction=0.003), indicating that the benefit of TRA was substantial in patients with moderate or severe anemia, whereas it was not significant in patients with milder or no baseline anemia. After adjustment, TRA remained associated with 24% and 51% relative risk reduction of all-cause mortality and major bleeding, respectively. A mediation analysis showed that the benefit of TRA on mortality was only partially driven by major bleeding prevention and ancillary mechanisms are required to fully explain the causal association. CONCLUSIONS: TRA is associated with lower all-cause mortality and major bleeding at 30 days compared with TFA. The effect on mortality was driven by patients with anemia. The reduction in major bleeding only partially explains the mortality benefit. REGISTRATION: URL: https://www.crd.york.ac.uk/prospero; Unique identifier: CRD42018109664.

Distal Versus Conventional Radial Access for Coronary Angiography and Intervention: The DISCO RADIAL Trial.

BACKGROUND: Currently, transradial access (TRA) is the recommended access for coronary procedures because of increased safety, with radial artery occlusion (RAO) being its most frequent complication, which will increasingly affect patients undergoing multiple procedures during their lifetimes. Recently, distal radial access (DRA) has emerged as a promising alternative access to minimize RAO risk. A large-scale, international, randomized trial comparing RAO with TRA and DRA is lacking. OBJECTIVES: The aim of this study was to assess the superiority of DRA compared with conventional TRA with respect to forearm RAO. METHODS: DISCO RADIAL (Distal vs Conventional Radial Access) was an international, multicenter, randomized controlled trial in which patients with indications for percutaneous coronary procedure using a 6-F Slender sheath were randomized to DRA or TRA with systematic implementation of best practices to reduce RAO. The primary endpoint was the incidence of forearm RAO assessed by vascular ultrasound at discharge. Secondary endpoints include crossover, hemostasis time, and access site-related complications. RESULTS: Overall, 657 patients underwent TRA, and 650 patients underwent DRA. Forearm RAO did not differ between groups (0.91% vs 0.31%; P = 0.29). Patent hemostasis was achieved in 94.4% of TRA patients. Crossover rates were higher with DRA (3.5% vs 7.4%; P = 0.002), and median hemostasis time was shorter (180 vs 153 minutes; P < 0.001). Radial artery spasm occurred more with DRA (2.7% vs 5.4%; P = 0.015). Overall bleeding events and vascular complications did not differ between groups. CONCLUSIONS: With the implementation of a rigorous hemostasis protocol, DRA and TRA have equally low RAO rates. DRA is associated with a higher crossover rate but a shorter hemostasis time.

Prognostic Role of Residual Thrombus Burden Following Thrombectomy: Insights From the TOTAL Trial.

BACKGROUND: It is unclear whether more effective forms of thrombus removal than current aspiration catheters would lead to improved outcomes. We sought to evaluate the prognostic role of residual thrombus burden (rTB), after manual thrombectomy, in patients undergoing primary percutaneous coronary intervention with routine manual thrombectomy in the TOTAL trial (Thrombectomy Versus PCI Alone). METHODS: This is a single-arm analysis of patients from the TOTAL trial who underwent routine manual aspiration thrombectomy. The rTB was quantified by an angiographic core laboratory using the Thrombolysis in Myocardial Infarction criteria and validated using existing optical coherent tomography data. Large rTB was defined as grade ≥3. The primary outcome was death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or new or worsening heart failure within 180 days. RESULTS: Of 5033 patients randomized to routine thrombectomy, 2869 patients had quantifiable rTB (1014 [35%] had large rTB). Patients with large rTB were more likely to have hypertension, previous percutaneous coronary intervention, myocardial infarction, or Killip class III on presentation but less likely to have Killip class I. The primary outcome occurred more frequently in patients with large rTB, even after adjustment for known risk predictors (8.6% versus 4.6%; adjusted hazard ratio, 1.83 [95% CI, 1.34-2.48]). These patients also had a higher risk of cardiovascular death (adjusted hazard ratio, 1.83 [95% CI, 1.13-2.95]), cardiogenic shock (adjusted hazard ratio, 2.02 [95% CI, 1.08-3.76]), and heart failure (adjusted hazard ratio, 1.74 [95% CI, 1.02-2.96]) but not myocardial infarction or stroke. CONCLUSIONS: Large rTB is a common finding in primary percutaneous coronary intervention and is associated with increased risk of adverse cardiovascular outcomes, including cardiovascular death. Future technologies offering better thrombus removal than current devices may decrease or even eliminate the risk associated with rTB. This, potentially, can turn into a strategic option to be studied in clinical trials. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01149044.

Distal radial access and postprocedural ultrasound evaluation of proximal and distal radial artery.

The aim of this study was to evaluate the patency of the proximal and distal radial artery after coronary procedures performed via the distal radial artery (DRA). Ultrasound (US) as the most reliable method was used to diagnose radial artery occlusions (RAO). We evaluated 115 patients who underwent catheterization via distal radial access (dTRA). Following the procedure and after successful hemostasis (80 ± 36 min), arterial patency and diameter at conventional transradial access (cTRA) and distal puncture sites (either in the anatomical snuffbox or the dorsal distal RA) were assessed. No RAO were found in the proximal or distal RA and there were no significant other complications. The mean diameter of the radial artery at conventional puncture site was 2.86 ± 0.49 mm and at distal puncture site 2.31 ± 0.47 mm (p < 0.001). Postprocedural compression time of dTRA was very short. In conclusion distal radial access was associated with the absence of early arterial occlusion, significant local bleeding and other relevant complications.

Distal versus conventional radial access for coronary angiography and intervention: Design and rationale of DISCO RADIAL study.

BACKGROUND: Transradial access (TRA) has become the default access method for coronary diagnostic and interventional procedures. As compared to transfemoral access, TRA has been shown to be safer, cost-effective and more patient-friendly. Radial artery occlusion (RAO) represents the most frequent complication of TRA, and precludes future coronary procedures through the radial artery, the use of the radial artery as a conduit for coronary artery bypass grafting or as arteriovenous fistula for patients on hemodialysis. Recently, distal radial access (DRA) has emerged as a promising alternative to TRA, yielding potential for minimizing the risk of RAO. However, an international multicenter randomized comparison between DRA, and conventional TRA with respect to the rate of RAO is still lacking. TRIAL DESIGN: DISCO RADIAL is a prospective, multicenter, open-label, randomized, controlled, superiority trial. A total of 1300 eligible patients will be randomly allocated to undergo coronary angiography and/or percutaneous coronary intervention (PCI) through DRA or TRA using the 6 Fr Glidesheath Slender sheath introducer. Extended experience with both TRA and DRA is required for operators' eligibility and optimal evidence-based best practice to reduce RAO systematically implemented by protocol. The primary endpoint is the incidence of forearm RAO assessed by vascular ultrasound at discharge. Several important secondary endpoints will also be assessed, including access-site cross-over, hemostasis time, and access-site related complications. SUMMARY: The DISCO RADIAL trial will provide the first large-scale multicenter randomized evidence comparing DRA to TRA in patients scheduled for coronary angiography or PCI with respect to the incidence of RAO at discharge.

A Randomized Trial Comparing Short versus Prolonged Hemostasis with Rescue Recanalization by Ipsilateral Ulnar Artery Compression: Impact on Radial Artery Occlusion-The RESCUE-RAO Trial.

BACKGROUND: Despite the enormous benefits of radial access, this route is associated with a risk of radial artery occlusion (RAO). OBJECTIVE: We compared the incidence of RAO in patients undergoing transradial coronary angiography and intervention after short versus prolonged hemostasis protocol. Also we assessed the efficacy of rescue 1-hour ipsilateral ulnar artery compression if RAO was observed after hemostasis. Material and Methods. Patients referred for elective transradial coronary procedures were eligible. After 6 F radial sheath removal, patients were randomized to short (3 hours) (n = 495) or prolonged (8 hours) (n = 503) hemostasis and a simple bandage was placed over the puncture site. After hemostasis was completed, oximetry plethysmography was used to assess the patency of the radial artery. RESULTS: One thousand patients were randomized. Baseline characteristics were similar between both groups with average age 61.4 ± 9.4 years (71% male) and PCI performed on half of the patients. The RAO rate immediately after hemostasis was 3.2% in the short hemostasis group and 10.1% in the prolonged group (p < 0.001). Rescue recanalization was successful only in the short group in 56.2% (11/19); at hospital discharge, RAO rates were 1.4% in the short group and 10.1% in the prolonged group (p < 0.001). CONCLUSION: Shorter hemostasis was associated with significantly less RAO compared to prolonged hemostasis. Rescue radial artery recanalization was effective in > 50%, but only in the short hemostasis group.

Post-procedural radial artery occlusion and patency detection using duplex ultrasound vs. the reverse Barbeau test.

The transradial approach is recommended as a first choice in coronary catheterizations and interventions, for among other reasons, the reduction in the number of local complications. A head-to-head comparison of the reverse Barbeau test (RBT) and duplex ultrasonography (DUSG) for the detection of post-procedural radial artery patency and occlusion has not yet been evaluated. In 500 patients from our same-day discharge program (age 65 ± 9.4 years, 148 women), radial artery patency and occlusion, compression time, haematomas, and other local complications were evaluated. Radial artery patency was confirmed in 495 patients (99.0%), and complete radial artery occlusion (RAO) was detected in 2 (0.4%) patients using both methods. In 3 patients (0.6%), the RBT was negative, while incomplete RAO was detected by DUSG. Superficial haematomas (˃ 5 but ≤10 cm) were found in 27 (5.4%) patients. There were no other local complications. Detection of radial artery patency and occlusion using the RBT and DUSG was comparable. The incidence of RAO in our study was extremely low. Thanks to its simplicity, the RBT has the potential to be used as the first method of detection of radial occlusion after coronary catheterizations.

Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper.

Transradial access (TRA) is increasingly used worldwide for percutaneous interventional procedures and associated with lower bleeding and vascular complications than transfemoral artery access. Radial artery occlusion (RAO) is the most frequent post-procedural complication of TRA, restricting the use of the same radial artery for future procedures and as a conduit for coronary artery bypass graft. The authors review recent advances in the prevention of RAO following percutaneous TRA diagnostic or interventional procedures. Based on the available data, the authors provide easily applicable and effective recommendations to prevent periprocedural RAO and maximize the chances of access in case of repeat catheterization or coronary artery bypass grafting surgery.

Radial Versus Femoral Approach in Women Undergoing Coronary Angiography: A Meta-Analysis of Randomized Controlled Trials.

OBJECTIVES: We sought to compare outcomes with radial vs femoral approach in female patients undergoing coronary angiography. BACKGROUND: Women undergoing cardiac procedures have increased risk of bleeding and vascular complications, but are under-represented in randomized clinical trials (RCTs) involving coronary angiography. METHODS: We performed a meta-analysis of RCTs comparing outcomes in women undergoing angiography with radial vs femoral approaches. The primary outcome was non-coronary artery bypass graft (CABG) related bleeding at 30 days. Secondary outcomes included major adverse cardiovascular or cerebrovascular events (MACCE; a composite of death, stroke or myocardial infarction), vascular complications, procedure duration, and access-site crossover. RESULTS: Four studies (n = 6041 female patients) met the inclusion criteria. In female patients undergoing coronary angiography, radial access decreased non-CABG related bleeding (odds ratio [OR], 0.56; 95% confidence interval [CI], 0.44-0.72; P<.001), MACCE (OR, 0.73; 95% CI, 0.58-0.93; P=.01), vascular complications (OR, 0.49; 95% CI, 0.32-0.75; P<.001) with no significant difference in procedure time (mean difference, 0.04; 95% CI, -0.97 to 0.89; P=.93). There was an increase in access-site crossover using the radial approach (OR, 2.86; 95% CI, 2.24-3.63; P<.001). Patients undergoing radial approach were more likely to prefer radial access for the next procedure (OR, 6.96; 95% CI, 5.70-8.50; P<.001). CONCLUSIONS: In female patients undergoing coronary angiography or intervention, the radial approach is associated with decreased bleeding, MACCE, and vascular complications. These data suggest that radial access should be the preferred approach for women.

Thrombus Aspiration in Patients With High Thrombus Burden in the TOTAL Trial.

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).

Impact of sheath size and hemostasis time on radial artery patency after transradial coronary angiography and intervention in Japanese and non-Japanese patients: A substudy from RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT) randomized multicenter trial.

BACKGROUND: During transradial (TR) access, it remains unclear whether differences in baseline patients characteristics and hemostasis care impact the rate of radial artery occlusion (RAO). We sought to compare the rate of RAO after TR access with the 6 French(Fr) Glidesheath Slender (GSS6Fr, Terumo, Japan) or a standard 5 Fr sheath in Japanese and non-Japanese patients. METHODS AND RESULTS: The Radial Artery Patency and Bleeding, Efficacy, Adverse evenT (RAP and BEAT) trial randomized 1,836 patients undergoing TR coronary angiography and/or interventions to receive the GSS6Fr or the standard 5 Fr Glidesheath (GS5Fr, Terumo, Japan). Out of this study population, 1,087 were Japanese patients and 751 non-Japanese patients. The overall incidence of RAO was significantly higher in Japanese patients (3.6% vs. 1.2%, P = 0.002). Use of GSS6Fr was associated with higher rates of RAO than GS5Fr in Japanese patients (5% vs. 2.2%, P = 0.02) and with similar RAO rates in non-Japanese patients (1.3 vs. 1.1%, P = 1). The mean hemostasis time was significantly longer in Japanese patients (378 ± 253 vs. 159 ± 136 min, P < 0.001) and more Japanese patients had a hemostasis time of more than 6 hr (16.2% vs. 4.9%, P < 0.0001). Longer hemostasis time was an independent predictor of RAO (OR per additional hour 1.070, 95% CI 1.008-1.136, P = 0.03). CONCLUSIONS: Use of GSS6Fr was associated with a higher rate of RAO than a standard 5 Fr sheath in Japanese patients but not in non-Japanese patients. Whether improvement in post-procedural care and reduced hemostasis time could impact the incidence of RAO in Japanese patients should be further assessed.

Comparison of a new slender 6 Fr sheath with a standard 5 Fr sheath for transradial coronary angiography and intervention: RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT), a randomised multicentre trial.

AIMS: The 6 Fr Glidesheath Slender (GSS6Fr) is a recently developed thin-walled radial sheath with an outer diameter (OD) that is smaller than the OD of standard 6 Fr sheaths. The purpose of this trial was to clarify whether the use of this new slender sheath would result in similar rates of RAO to a standard 5 Fr sheath in unselected patients undergoing transradial (TR) coronary angiography and/or intervention, and to assess the relative importance of sheath size and haemostasis protocol on the rate of RAO. METHODS AND RESULTS: We conducted a randomised, multicentre, non-inferiority trial comparing the GSS6Fr against the standard GS5Fr in patients undergoing TR coronary angiography and/or intervention. Patients in each group were subsequently randomised to undergo patent haemostasis or the institutional haemostasis protocol. The primary endpoint was the occurrence of RAO at discharge. A total of 1,926 patients were randomised in 12 centres. The incidence of RAO was 3.47% with GSS6Fr compared with 1.74% with GS5Fr (risk difference 1.73%, 95% CI: 0.51-2.95%; pnon-inferiority=0.150). Patients randomised to patent haemostasis had a similar rate of RAO compared with institutional haemostasis (2.61% vs. 2.61%, p=1). There was no difference with regard to all secondary endpoints, including vascular access-site complications, local bleeding and spasm. CONCLUSIONS: In this large multicentre randomised trial, the GSS6Fr was associated with a low event rate for the primary endpoint (RAO), although non-inferiority to the GS5Fr was not met, due to a lower than expected rate of RAO in the GS5Fr group. As compared to institutional haemostasis, the use of patent haemostasis was not associated with a reduced rate of RAO.

Prevention of Radial Artery Occlusion After Transradial Catheterization: The PROPHET-II Randomized Trial.

OBJECTIVES: The study sought to evaluate whether prophylactic ipsilateral ulnar artery compression during radial artery hemostasis could reduce the risk of radial artery occlusion (RAO). BACKGROUND: RAO after transradial access (TRA) is a structural complication of TRA. It limits future ipsilateral TRA and may cause transient pain. Maintaining radial artery flow during hemostasis reduces the incidence of acute RAO. Ipsilateral ulnar compression increases radial artery flow and could impact the incidence of RAO. METHODS: Three thousand patients undergoing diagnostic cardiac catheterization using TRA were randomized to receive either standard patent hemostasis protocol (Group I) or prophylactic ipsilateral ulnar compression in addition to patent hemostasis (Group II). Using plethysmography, radial artery patency was evaluated at the time of removal of the compression device as well as 24 h and 30 days after the procedure. The primary study endpoint was 30-day RAO. RESULTS: The primary endpoint, 30-day RAO, was significantly reduced in patients with patent hemostasis and prophylactic ulnar compression compared with standard patent hemostasis (0.9% vs. 3.0%; p = 0.0001). Baseline patient and procedural characteristics were similar between the 2 groups. RAO was significantly reduced by prophylactic ulnar compression at all time intervals (p < 0.0001). CONCLUSIONS: Prophylactic ipsilateral ulnar compression during radial artery hemostasis is an effective, simple, and inexpensive technique that lowers the risk of RAO after TRA.

Access-site bleeding and radial artery occlusion in transradial primary percutaneous coronary intervention: influence of adjunctive antiplatelet therapy.

BACKGROUND: The aim of this study was to evaluate access-site complications in patients with ST-segment elevation myocardial infarction treated with a transradial primary percutaneous coronary intervention relative to three different P2Y12 platelet inhibitors. PATIENTS AND METHODS: We enrolled 334 consecutive patients (76.9% men, age: 59.4±9.1 years) treated by one of the following: clopidogrel (n=118), prasugrel (n=102), and ticagrelor (n=114). The use of the IIb/IIIa inhibitor, abciximab, was left to the operators' discretion. The time needed to achieve patent hemostasis, compression time, and local complications were analyzed. RESULTS: The baseline characteristics were similar in all three P2Y12 platelet inhibitor groups. Abciximab was used in 72 (21.6%) patients. Administration of abciximab was associated with a higher incidence of grade II and III hematomas (23.6 vs. 5.0%, P<0.0001, and 5.6 vs. 1.1%, P=0.041, respectively). Among different platelet P2Y12 receptor inhibitor groups, the incidences of hematomas grade II and III were similar in patients who did (P≥0.14) and did not (P≥0.31) receive abciximab. There were no grade IV or V hematomas in any of the groups. Patent hemostasis was achieved faster (24.5±13.4 vs. 43.5±30.0 min, P<0.0001) and compression time was shorter (113.2±53.6 vs. 217.8±115.5 min, P<0.0001) when abciximab was not used. Radial artery occlusion occurred in one (0.3%) patient. CONCLUSION: After transradial primary percutaneous coronary intervention, early patent hemostasis and short artery compression times were associated with a higher incidence of local hematomas. The incidence of hematomas was dependent on the use of abciximab, but unrelated to the type of P2Y12 inhibitor used. All hematomas were without clinical consequences.

Radial Artery Occlusion After Transradial Interventions: A Systematic Review and Meta-Analysis.

BACKGROUND: Radial artery occlusion (RAO) may occur posttransradial intervention and limits the radial artery as a future access site, thus precluding its use as an arterial conduit. In this study, we investigate the incidence and factors influencing the RAO in the current literature. METHODS AND RESULTS: We searched MEDLINE and EMBASE for studies of RAO in transradial access. Relevant studies were identified and data were extracted. Data were synthesized by meta-analysis, quantitative pooling, graphical representation, or by narrative synthesis. A total of 66 studies with 31 345 participants were included in the analysis. Incident RAO ranged between <1% and 33% and varied with timing of assessment of radial artery patency (incidence of RAO within 24 hours was 7.7%, which decreased to 5.5% at >1 week follow-up). The most efficacious measure in reducing RAO was higher dose of heparin, because lower doses of heparin were associated with increased RAO (risk ratio 0.36, 95% CI 0.17-0.76), whereas shorter compression times also reduced RAO (risk ratio 0.28, 95% CI 0.05-1.50). Several factors were found to be associated with RAO including age, sex, sheath size, and diameter of radial artery, but these factors were not consistent across all studies. CONCLUSIONS: RAO is a common complication of transradial access. Maintenance of radial patency should be an integral part of all procedures undertaken through the radial approach. High-dose heparin along with shorter compression times and patent hemostasis is recommended in reducing RAO.

Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial.

BACKGROUND: Two large trials have reported contradictory results at 1 year after thrombus aspiration in ST elevation myocardial infarction (STEMI). In a 1-year follow-up of the largest randomised trial of thrombus aspiration, we aimed to clarify the longer-term benefits, to help guide clinical practice. METHODS: The trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI (TOTAL) was a prospective, randomised, investigator-initiated trial of routine manual thrombectomy versus percutaneous coronary intervention (PCI) alone in 10,732 patients with STEMI. Eligible adult patients (aged ≥18 years) from 87 hospitals in 20 countries were enrolled and randomly assigned (1:1) within 12 h of symptom onset to receive routine manual thrombectomy with PCI or PCI alone. Permuted block randomisation (with variable block size) was done by a 24 h computerised central system, and was stratified by centre. Participants and investigators were not masked to treatment assignment. The trial did not show a difference at 180 days in the primary outcome of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure. However, the results showed improvements in the surrogate outcomes of ST segment resolution and distal embolisation, but whether or not this finding would translate into a longer term benefit remained unclear. In this longer-term follow-up of the TOTAL study, we report the results on the primary outcome (cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure) and secondary outcomes at 1 year. Analyses of the primary outcome were by modified intention to treat and only included patients who underwent index PCI. This trial is registered with ClinicalTrials.gov, number NCT01149044. FINDINGS: Between Aug 5, 2010, and July 25, 2014, 10,732 eligible patients were enrolled and randomly assigned to thrombectomy followed by PCI (n=5372) or to PCI alone (n=5360). After exclusions of 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 comprised 10,064 patients (5035 thrombectomy and 5029 PCI alone). The primary outcome at 1 year occurred in 395 (8%) of 5035 patients in the thrombectomy group compared with 394 (8%) of 5029 in the PCI alone group (hazard ratio [HR] 1·00 [95% CI 0·87-1·15], p=0·99). Cardiovascular death within 1 year occurred in 179 (4%) of the thrombectomy group and in 192 (4%) of 5029 in the PCI alone group (HR 0·93 [95% CI 0·76-1·14], p=0·48). The key safety outcome, stroke within 1 year, occurred in 60 patients (1·2%) in the thrombectomy group compared with 36 (0·7%) in the PCI alone group (HR 1·66 [95% CI 1·10-2·51], p=0·015). INTERPRETATION: Routine thrombus aspiration during PCI for STEMI did not reduce longer-term clinical outcomes and might be associated with an increase in stroke. As a result, thrombus aspiration can no longer be recommended as a routine strategy in STEMI. FUNDING: Canadian Institutes of Health Research, Canadian Network and Centre for Trials Internationally, and Medtronic Inc.

Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial

BackgroundTwo large trials have reported contradictory results at 1 year after thrombus aspiration in ST elevation myocardial infarction (STEMI). In a 1-year follow-up of the largest randomised trial of thrombus aspiration, we aimed to clarify the longer-term benefits, to help guide clinical practice.MethodsThe trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI (TOTAL) was a prospective, randomised, investigator-initiated trial of routine manual thrombectomy versus percutaneous coronary intervention (PCI) alone in 10 732 patients with STEMI. Eligible adult patients (aged ≥18 years) from 87 hospitals in 20 countries were enrolled and randomly assigned (1:1) within 12 h of symptom onset to receive routine manual thrombectomy with PCI or PCI alone. Permuted block randomisation (with variable block size) was done by a 24 h computerised central system, and was stratified by centre. Participants and investigators were not masked to treatment assignment. The trial did not show a difference at 180 days in the primary outcome of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure. However, the results showed improvements in the surrogate outcomes of ST segment resolution and distal embolisation, but whether or not this finding would translate into a longer term benefit remained unclear...