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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 P interaction =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.

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.

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.

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.The aim of this study was to assess the superiority of DRA compared with conventional TRA with respect to forearm RAO.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.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.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.

Toto odborne stanovisko reprezentuje nazor výse uvedených odborných spolecnosti a bylo vytvořene v souladu s vědeckými a lekařskými poznatky dostupnými v době připravy publikace. Cilem tohoto dokumentu je pomahat lekařům při volbě nejlepsiho diagnostickeho a lecebneho postupu pro každeho pacienta s daným onemocněnim, přicemž je posuzovan jak vliv na klinicke výsledky, tak poměr přinosu a rizika daneho postupu. Definitivni rozhodnuti týkajici se konkretniho pacienta vsak musi ucinit osetřujici lekař po konzultaci s pacientem a tento dokument v žadnem připadě nenahrazuje individualni odpovědnost každeho lekaře. Obsah tohoto dokumentu byl publikovan pouze pro nekomercni a edukacni ucely.

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.

Highlights •RAO remains the most frequent post-procedural complication of transradial access, restricting the use of the same radial artery for future procedures, as a conduit for coronary artery bypass grafting or for arteriovenous fistula creation in patients requiring hemodialysis. •The real-world reported incidence of RAO remains high, with wide variability in the uptake of RAO prevention strategies. •The paper reviews the main recent advances in the field of RAO prevention and provides a series of expert recommendations to prevent RAO. •This consensus document is meant to provide guidance to increase the adoption of simple and effective methods to achieve an institutional rate of RAO

ný clanek představuje přistup Ceske asociace intervencni kardiologie k invazivni lecbě srdecnich onemocněni během koronavirove pandemie. Primarni angioplastika zůstava metodou volby pro lecbu pacientů s infarktem myokardu s elevacemi useku ST (STEMI) i pro nemocne s infarktem myokardu be elevaci useku ST (NSTEMI) a trvajici ischemii, bez ohledu na znalost přitomnosti koronaviru u těchto pacientů v době výkonu. Ostatni nemocni, kteři potřebuji katetrizacni lecbu srdecni nemoci, by měli být vysetřeni alespoň 48 hodin před přijetim do zdravotnickeho zařizeni na přitomnost COVID-19. Přiznivý průběh pandemie v Ceske republice umožňuje v soucasnosti katetrizacnim laboratořim postupný navrat k obvykle urovni kvality a dostupnosti invazivni lecby. © 2020, CKS.

Standardni radialni přistup z praveho ci leveho zapěsti se stal dominantni přistupovou cestou ke koronarnim katetrizacim a intervencim s doporucenim IA dle poslednich guidelines Evropske kardiologicke spolecnosti pro revaskularizaci myokardu z roku 2018. Od te doby bylo publikovano několik clanků o možnosti provadět intervencni výkony na koronarnich tepnach z tzv. distalniho radialniho přistupu. Tento clanek popisuje nase prvni zkusenosti s timto novým přistupem.

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.

Postprocedural radial artery occlusion (RAO) can be minimized mainly by slender less invasive approach, adequate anticoagulation and optimal postprocedural care which should be started immediately after transradial procedure in catheterization laboratory. With simple hemostasis protocol described in this chapter the risk of early RAO can be reduced below 1%.

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)

Cil: Cilem prace bylo porovnat dva kompresni prostředky po transradialni koronarni katetrizaci a intervenci.Metody: Z konsekutivně zařazených 280 pacientů, katetrizovaných a intervenovaných (n = 74) v programu jednodenni hospitalizace, jich mělo 140 komprimovano radialni tepnu po výkonu pomoci kompresniho prostředku TR Band (TB) a 140 pomoci prostředku Seal-One (SO). Hodnotili jsme dobu potřebnou k dosaženi perfuzni hemostazy, celkovou dobu komprese a lokalni komplikace.Výsledky: Perfuzni hemostaza v TB skupině byla dosažena za 17,5 ± 10,3 min, ve skupině SO za 21,4 ± 10,5 min (p = NS). Celkova doba komprese radialni tepny dosahovala ve skupině TB 90,7 ± 38,4 min a ve skupině SO 64,0 ± 26,5 min (p < 0,001). Výskyt hematomů ≥ 5 cm byl v obou skupinach stejný (6,4 % vs. 6,4 %, p = NS), výskyt hematomů nad 10 cm byl ve skupině TB 0,7 % a ve skupině SO 1,4 % (p = NS). V obou skupinach nebyly prokazany žadný uzavěr radialni tepny ani dalsi lokalni komplikace při propustěni.Zavěr: Komprese radialni tepny pomoci prostředků TR Band a Seal-One je spojena s casným dosaženim perfuzni hemostazy a kratkou celkovou dobou komprese. Průměrna doba komprese prostředkem Seal-One byla v nasi studii kratsi. Komprese radialni tepny po výkonu nebyla spojena s výskytem uzavěru radialni tepny při propustěni ani dalsimi lokalnimi komplikacemi kromě nizkeho výskytu klinicky nezavažných hematomů.

We sought to compare outcomes with radial vs femoral approach in female patients undergoing coronary angiography.Women undergoing cardiac procedures have increased risk of bleeding and vascular complications, but are under-represented in randomized clinical trials (RCTs) involving coronary angiography.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.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).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.

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 Conclusions Prophylactic ipsilateral ulnar compression during radial artery hemostasis is an effective, simple, and inexpensive technique that lowers the risk of RAO after TRA.

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

2Zdravotnicka zachranna služba Plzeňskeho kraje 3ARO Mulacovy nemocnice, Plzeň Přednemocnicni předleceni STEMI pacientů P2Y12 inhibitory zůstava i v r. 2016 stale kontroverzni otazkou. Na podzim roku 2012 vypracovala Zachranna zdravotnicka služba (ZZS) Plzeňskeho kraje ve spolupraci s Kardiologickým odd. FN Plzeň metodický list na zakladě doporucených postupů ESC pro diagnostiku a lecbu STEMI pacientů z r. 2012. V obdobi 2013–2014 bylo v Plzeňskem kraji ve vozech ZZS předleceno P2Y12 inhibitory teměř 50 % nemocných. Nejcastěji podaným P2Y12 inhibitorem byl ticagrelor.

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.

The primary outcome occurred in 347 of 5033 patients (6.9%) in the thrombectomy group versus 351 of 5030 patients (7.0%) in the PCI-alone group (hazard ratio in the thrombectomy group, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P = 0.86). The rates of cardiovascular death (3.1% with thrombectomy vs. 3.5% with PCI alone; hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P = 0.34) and the primary outcome plus stent thrombosis or target-vessel revascularization (9.9% vs. 9.8%; hazard ratio, 1.00; 95% CI, 0.89 to 1.14; P = 0.95) were also similar. Stroke within 30 days occurred in 33 patients (0.7%) in the thrombectomy group versus 16 patients (0.3%) in the PCI-alone group (hazard ratio, 2.06; 95% CI, 1.13 to 3.75; P = 0.02). Conclusions In patients with STEMI who were undergoing primary PCI, routine manual thrombectomy, as compared with PCI alone, did not reduce the risk of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA class IV heart failure within 180 days but was associated with an increased rate of stroke within 30 days. (Funded by Medtronic and the Canadian Institutes of Health Research; TOTAL ClinicalTrials.gov number, NCT01149044.)

Item does not contain fulltext 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.

Objectives This study sought to compare radial and femoral approaches in patients presenting with ST-segment elevation myocardial infarction (STEMI) and undergoing primary percutaneous coronary intervention (PCI) by high-volume operators experienced in both access sites. Background The exact clinical benefit of the radial compared to the femoral approach remains controversial. Methods STEMI-RADIAL (ST Elevation Myocardial Infarction treated by RADIAL or femoral approach) was a randomized, multicenter trial. A total of 707 patients referred for STEMI

The incidence of ST elevation myocardial infarction (STEMI) is around 66 STEMI per 100 000 of population/year, with 6–12% hospital mortality in unselected patients [1] . Modern treatment strategies for STEMI are based on immediate antithrombotic treatment and primary percutaneous coronary intervention (PCI) with stent implantation. Therapy with a combination of two or even three more potent antiplatelet and anticoagulant agents reduces both short-term and long-term ischemic risk, morbidity and mortality; on the other hand it is associated with higher risks of bleeding. The first part of this review is focused on the pathogenesis of thrombi in STEMI patients and antithrombotic drugs currently used to treat STEMI patients. In the second part we discuss several factors that can affect bleeding risks including the choice of access site for coronary angiography, prevention and treatment of bleeding in STEMI patients. Finding a balance which minimizes both thrombotic and bleeding risk is crucial, although, it can be difficult and further randomized studies directed at finding this balance are needed.

Objectives This study sought to evaluate outcomes of same-day discharge (SDD) following percutaneous coronary intervention (PCI) versus overnight hospitalization (ON). Background Although there are data on the safety and feasibility of SDD after PCI, ON continues to be prevalent. Methods The Cochrane search strategy was used to search the PubMed database, EMBASE, and the Cochrane Library for relevant literature. Thirteen studies (5 randomized and 8 observational) of SDD after uncomplicated PCI versus ON met inclusion criteria. Data were pooled using a random effects model, and reported as odds ratios (OR) with their 95% confidence intervals (CI). The primary outcomes were incidence of total complications, major adverse cardiovascular events (MACE), and rehospitalization within 30 days after PCI. Results A total of 13 studies, involving 111,830 patients were pooled. There was significant variation in the definition of outcomes across studies. For total complications, the strategy of SDD compared with ON after PCI had an estimated OR of 1.20 (95% CI: 0.82 to 1.74) in randomized and 0.67 (95% CI: 0.27 to 1.66) in observational studies. Similar results were found for MACE (randomized, OR: 0.99, 95% CI: 0.45 to 2.18; observational, OR: 0.59, 95% CI: 0.06 to 5.57) and rehospitalizations (randomized, OR: 1.10, 95% CI: 0.70 to 1.74; observational, OR: 0.62, 95% CI: 0.10 to 3.98) at 30 days post PCI. Conclusions There is considerable heterogeneity across published studies comparing SDD with ON. This, coupled with the low event rate and wide corresponding CIs, suggest that an adequately powered multicenter randomized trial comparing SDD with ON would require a very large sample size (>17,000). Until such a trial is completed, SDD after uncomplicated PCI seems a reasonable approach in selected patients.

The study sought to evaluate whether prophylactic ipsilateral ulnar artery compression during radial artery hemostasis could reduce the risk of radial artery occlusion (RAO).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.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.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).Prophylactic ipsilateral ulnar compression during radial artery hemostasis is an effective, simple, and inexpensive technique that lowers the risk of RAO after TRA.

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 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 .

Summary 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.

With femoral access, bivalirudin decreases risks of major bleeding after percutaneous coronary intervention (PCI) and provides better net clinical benefit compared to unfractionated heparin (UFH) plus planned glycoprotein IIb/IIIa inhibitors. Whether this benefit exists compared to UFH monotherapy is less clear. We performed a systematic review and meta-analysis to compare outcomes in patients undergoing transfemoral PCI with UFH or bivalirudin. Randomized trials (n = 3) and observational studies (n = 13) comparing bivalirudin to UFH monotherapy were reviewed. Primary outcomes were 30-day rates of major adverse cardiovascular events (MACEs) including death, myocardial infarction (MI), urgent revascularization, as well as all-cause mortality, MI, major bleeding, and blood transfusion. We collected data from 16 studies involving 32,492 patients undergoing PCI. Most observational studies were performed in the United States, whereas all randomized trials were done in Europe. Compared to UFH monotherapy, bivalirudin was associated with similar risk of MACEs (odds ratios [OR] 0.92, 95% confidence interval [CI] 0.75 to 1.12), a substantial 45% relative decrease in major bleeding (OR 0.55, 95% CI 0.43 to 0.72), and a trend in the decrease of transfusion (OR 0.87, 95% CI 0.70 to 1.08). A decrease in mortality was seen in observational studies (OR 0.62, 95% CI 0.45 to 0.85) but remained inconclusive in randomized trials (OR 0.63, 95% CI 0.20 to 2.01). MI rate was similar with the 2 anticoagulants. In conclusion, in patients undergoing transfemoral PCI, the benefit of bivalirudin over UFH monotherapy is driven by a significant decrease in major bleeding with similar rates of MACE. As PCI practice moves toward other bleeding-avoidance strategies such as the radial approach, future studies should focus on the interaction between anticoagulant strategy and access-site choice.

We greatly appreciate the letter by Dr. Koutouzis and colleagues and their interest in our study [(1)][1]. As rightly pointed out by the authors, the ULTRA (ULnar Artery Transient Compression Facilitating Radial Artery Patent Hemostasis) study [(2)][2] and PROPHET-II Trial (PROPhylactic

Cil: Zhodnotit využiti a indikace intraaortalni balonkove kontrapulsace (IABK) v kardiologicke intenzivni peci, charakteristiku a klinický výsledek lecených pacientů.Metodika: Retrospektivni analýza pacientů hospitalizovaných na kardiologicke jednotce intenzivni pece lecených IABK od 1. 1. 2005 do 31. 12. 2008.Výsledky: Intraaortalni balonkovou kontrapulsaci jsme použili u 67 pacientů. Nejcastějsi indikaci byl kardiogenni sok u pacientů s infarktem myokardu s elevacemi useku ST (STEMI) (61 %), dale kardiogenni sok u pacientů bez elevaci useku ST (NSTEMI) (21 %) a kardio-genni sok jine etiologie (9 %). V 9 % byla IABK použita jako podpora před vysoce rizikovou perkutanni koronarni intervenci. Průměrna doba lecby IABK byla 50 hodin (maximum 240 hodin). Vsichni pacienti podstoupili koronarografii. Komplikace lecby IABK jsme zaznamenali u 13 % pacientů. Padesat pět pacientů mělo kardiogenni sok při infarktu myokardu (IM). Průměrný věk u teto skupiny byl 67 ± 9 let (76 % mužů). U pacientů s IM a kardiogennim sokem byla v 73 % provedena primarni perkutanni koronarni intervence (PCI), 22 % pacientů bylo indikovano k urgentnimu CABG. V době zahajeni IABK bylo 94 % nemocných na katecholaminove podpoře, 80 % pacientů na invazivni mechanicke ventilaci.Nemocnicni mortalita pacientů s IM a kardiogennim sokem v nasem souboru byla 50 %, jednorocni mortalita 55 %.Zavěr: Na nasem pracovisti je IABK soucasti komplexni pece o pacienty s těžsimi formami kardiogenniho soku předevsim při akutnim infarktu myokardu. Nemocnicni mortalita pacientů s akutnim infarktem myokardu v kardiogennim soku v nasem souboru je srovnatelna s literarnimi udaji.

Výhody radialniho přistupu u koronarnich intervenci prokazaly v poslednich letech cetne studie. V tomto přehledu jsou zdůrazněny přednosti a limity transradialniho přistupu u koronarnich i nekoronarnich katetrizaci a intervenci.

Background The benefit of transradial access (TRA) in patients with cardiogenic shock (CS) is uncertain. We sought to determine the benefits of TRA in patients with CS undergoing coronary angiography/intervention. Methods MEDLINE, Embase, Cochrane Central, and electronic databases were searched for studies that assessed the following: (1) patients with CS who underwent percutaneous coronary intervention (PCI) and (2) the association between choice of arterial access, 30-day all-cause mortality, and 30-day major adverse cardiac and cerebral events (MACCEs) using random-effects model. Results From 3,652 retrieved citations, 8 studies involving 8,131 patients with CS undergoing PCI (via TRA: 2,321 patients, via TFA: 5,810 patients) were included. Transradial access was associated with significantly reduced risk for all-cause mortality (unadjusted: risk ratio [RR] 0.60, 95% CI 0.52-0.71, P I 2 = 29%, 8 included studies; adjusted: RR 0.55, 95% CI 0.46-0.65, P I 2 = 0%, 6 included studies) and MACCE (unadjusted: RR 0.68, 95% CI 0.63-0.73, P I 2 = 0%, 6 included studies; adjusted: RR 0.63, 95% CI 0.52-0.75, P I 2 = 0%, 4 included studies) at 30 days when compared with TFA. Conclusions Transradial access is associated with reduced mortality and MACCE at 30 days in patients with CS undergoing PCI. Considering the possible influence of selection bias on the effect estimate in our analysis, randomized controlled trials are needed to better assess this association.

Assessment of the treatment procedures and their results is increasingly important in current medicine. The emphasis is put on an effective use of the health technologies (HTA). Unlike randomised studies, which involve strictly selected groups of patients who meet inclusion and exclusion criterias, the multicentre clinical registries provide a real-life picture of the treatment safety and effectiveness. Well prepared registries involve both research database and a friendly user interface enabling collection of parametric and easily analyzable data. Although there are some technological aspects aiming to ensure a maximum quality of entered data, cooperation with the users and data managers is essential. Such a registry, otherwise meaningful, must provide answers to previously defined medical hypotheses. Regular feedback to users (so called benchmarking or reporting) is considered to be of key importance. The Czech TAVI Registry (CTR) is a good example of reaching all of the above defined criterias. This registry contains data of approximately 95 % of all transcatheter aortic valve implantations (TAVI) performed in the Czech Republic. It is based on a general system aimed at the design of clinical trials, namely the TrialDB2 (a database system for clinical registries developed by the Institute of Biostatistics and Analyses at the Masaryk University (IBA MU). CTR has been run as an English-language version under the auspices of the Czech Society of Cardiology and represents one of the top-quality registries maintained by IBA MU. This paper presents the currently available database systems and some reports from this particular registry.

We read with great interest and concern the paper by Le May et al. [(1)][1] regarding the role of radial approach in patients with acute coronary syndrome (ACS). Our concerns are due to their inappropriate interpretation of clinical trial data and spurious arguments against radial access that runs

Despite the extensive armamentarium of antihypertensive medication available, the control of hypertension remains poor. Therefore any possibilities of non-pharmacological treatment of resistant hypertension are welcome. Recently, close attention was paid to renal denervation. Present work summarizes the scientific reports and clinical trials related to this topic published so far and addresses the unanswered questions. Moreover, it also contains brief summary of authors own experience with the method.

The adoption of transradial coronary angiography and coronary intervention is growing because of emerging data on its potential advantages over the femoral approach. As the adoption of radial procedures increases, it is important to understand the remaining challenges of both the technique and its implementation. In this review, we discuss four important issues related to transradial procedures--radial access site bleeding, radial artery injury and occlusion, radiation exposure, and implementation of a successful transradial primary percutaneous coronary intervention (PCI) programme. Although the radial artery is superficial and haemostasis can be achieved readily, access site bleeding can occur that, if left unchecked, can lead to forearm haematoma and, rarely, to compartment syndrome. Radial artery injury and occlusion are consequences of radial access, and randomized trials show that use of smaller diameter sheaths, adequate anticoagulation, and post-procedure 'patent' haemostasis reduce the risk of occlusion. The published literature demonstrates an association between transradial procedures and increased radiation exposure; therefore, reduction of radiation dosing during transradial procedures should be a priority for operators and catheterization laboratories. The potential reduction in mortality seen with transradial primary PCI must be balanced against the clinical imperative of timely reperfusion. Operators and catheterization laboratories should not begin a transradial primary PCI programme until sufficient radial experience has been gained in the elective setting. In addition, a protocol for femoral bailout should be considered to maintain door-to-reperfusion metrics.

Background Although radial approach is increasingly used in percutaneous coronary interventions (PCIs) including in acute myocardial infarction (MI), patients with cardiogenic shock have been excluded from comparisons with femoral approach. The aim of our study was to compare clinical outcomes in patients undergoing primary PCI with cardiogenic shock by radial and femoral approach. Methods and Results From 2,663 patients presenting with ST-elevation MI in 2 large volume radial centers, we identified 197 patients (7.4%) with signs of cardiogenic shock immediately before undergoing primary PCI. Radial approach was used in 55% of cases when at least 1 radial artery was weakly palpable, either spontaneously or after intravenous noradrenaline bolus. Patients in the radial group were older (69 ± 12 vs 64 ± 12 years, P = .010), had less diabetes (13% vs 26%, P = .028), and required less often intubation prior PCI (42% vs 66%, P = .0006) or intraaortic balloon pump (36% vs 55%, P = .0096). Mortality at 1 year was 44% in the radial group and 64% in the femoral group ( P = .0044). Independent predictors of late mortality included radial approach (hazard ratio [HR] 0.65, 95% CI 0.42-0.98, P = .041), the use of glycoprotein IIb-IIIa receptor inhibitors (HR 0.63, 95% CI 0.40-0.96, P = .032), baseline creatinine ≥110 μmol/L (HR 3.34, 95% CI 2.20-5.12, P 200 mg/dL (HR 2.02, 95% CI 1.34-3.11, P = .0008), and age >65 years (HR 1.80, 95% CI 1.18-2.79, P = .006). Conclusion Radial approach was safe and feasible in more than half of the patients with ST-elevation MI and cardiogenic shock treated by primary PCI. After adjustment for baseline and procedural characteristics, radial approach remained associated with better survival. However, prognosis of patients undergoing primary PCI in cardiogenic shock remains poor.

This study sought to evaluate outcomes of same-day discharge (SDD) following percutaneous coronary intervention (PCI) versus overnight hospitalization (ON).Although there are data on the safety and feasibility of SDD after PCI, ON continues to be prevalent.The Cochrane search strategy was used to search the PubMed database, EMBASE, and the Cochrane Library for relevant literature. Thirteen studies (5 randomized and 8 observational) of SDD after uncomplicated PCI versus ON met inclusion criteria. Data were pooled using a random effects model, and reported as odds ratios (OR) with their 95% confidence intervals (CI). The primary outcomes were incidence of total complications, major adverse cardiovascular events (MACE), and rehospitalization within 30 days after PCI.A total of 13 studies, involving 111,830 patients were pooled. There was significant variation in the definition of outcomes across studies. For total complications, the strategy of SDD compared with ON after PCI had an estimated OR of 1.20 (95% CI: 0.82 to 1.74) in randomized and 0.67 (95% CI: 0.27 to 1.66) in observational studies. Similar results were found for MACE (randomized, OR: 0.99, 95% CI: 0.45 to 2.18; observational, OR: 0.59, 95% CI: 0.06 to 5.57) and rehospitalizations (randomized, OR: 1.10, 95% CI: 0.70 to 1.74; observational, OR: 0.62, 95% CI: 0.10 to 3.98) at 30 days post PCI.There is considerable heterogeneity across published studies comparing SDD with ON. This, coupled with the low event rate and wide corresponding CIs, suggest that an adequately powered multicenter randomized trial comparing SDD with ON would require a very large sample size (17,000). Until such a trial is completed, SDD after uncomplicated PCI seems a reasonable approach in selected patients.

We are pleased to address Dr. Lee’s comments on the results of the STEMI-RADIAL (ST Elevation Myocardial Infarction treated by RADIAL or femoral approach) trial published in the Journal [(1)][1]. First, this letter has already been published twice with almost identical content [(2,3)][2]. Second

We read with great interest the paper by Brayton et al. [(1)][1]. This paper is nearly identical to our recent publication in JACC: Cardiovascular Interventions [(2)][2]. It is interesting that 2 similar papers using the same data would be published in the JACC family of journals just a few