Heparins crossover in percutaneous coronary interventions: a real issue with increasing rate of transradial procedures?

AIMS: Current guidelines give a class III recommendation to the intraprocedural use of unfractionated heparin (UFH) in patients pretreated with enoxaparin. The aim of our study was to evaluate bleeding complications in patients who underwent percutaneous coronary interventions (PCIs) performed using intraprocedural crossover of heparin therapy. METHODS: We retrospectively evaluated all PCIs performed at two Italian hospitals since January 2011 to December 2013. After a propensity-matched analysis, patients were divided into two groups (with a ratio 1 : 2) according to intraprocedural crossover of heparins (from enoxaparin to UFH) (Group 1) or intraprocedural UFH alone (Group 2). The primary end-point was a haemoglobin drop of at least 3 g/dl within 48 h after the procedure. RESULTS: During the 3 years analysed, 3224 patients underwent PCI, and after the propensity analysis, 309 patients were considered eligible for our study: 104 patients in Group 1 (69 ±â€Š12 years, 78% men) and 205 patients in Group 2 (69 ±â€Š13 years, 80% men, P = NS). There were no significant differences between the two groups for BMI, periprocedural use of antiplatelet therapy, baseline haemoglobin haematocrit or platelets levels. The primary end-point did not differ between the two groups (2.9% in Group 1 and 3.4% in Group 2, P = 0.550). Also, nadir of haematocrit or haemoglobin levels did not differ between the two groups. Finally, in hospital, major adverse cardio-cerebrovascular events did not differ between the two groups (1.9% in Group 1 and 3.9% in Group 2, P = 0.50). CONCLUSION: In this retrospective analysis of a large PCI database, the 'heparins crossover' during PCI was not associated with increased bleeding risk.

Closed versus open cell stent for high-risk percutaneous coronary interventions in ST-elevation acute myocardial infarction: the Closed versus Open Cells stent for High risk percutaneous coronary Interventions in ST-Elevation acute myocardial infarction (COCHISE) pilot study.

BACKGROUND: Stent deployment may be associated with distal embolization and slow flow in coronary thrombotic lesions. There are no data on the risk of distal thrombus embolization according to the stent design. The aim was to evaluate coronary flow after percutaneous coronary interventions (PCI) in acute myocardial infarction according to the employed stent (closed versus open cell design). METHODS: From March 2010 to December 2011, 223 consecutive patients with acute ST-elevation myocardial infarction were randomized to primary PCI either with an open cell (112 patients, 88 men) or with a closed cell stent design (111 patients, 92 men). The primary endpoint was the corrected TIMI frame count (cTFC) after the procedure. RESULTS: There were no significant differences in procedural success nor in-stent deployment in the 2 groups. At baseline, there were no significant differences in cTFC between the 2 groups (70 ± 37 and 67 ± 39, P = .65, respectively). After the procedure, the open cell group showed significantly higher cTFC compared to the closed cell group (18 ± 11 and 15 ± 5, P = .003 respectively). This difference was associated with a significant lower rate of TIMI 3 flow (87% and 95%, P = .037) and myocardial blush grade 3 (65% and 87%, P = .001) in the open compared to the closed cell group. There were 2 cases of death in the open cell and 1 case in the closed cell group. CONCLUSIONS: The use of a closed cell stent design rather than an open cell during PCI for acute ST-elevation myocardial infarction is associated with better coronary angiographic flow after PCI.

Cardiac magnetic resonance detection of left ventricular thrombus in acute myocardial infarction.

INTRODUCTION: Left ventricular thrombosis (LVT) is a possible complication of acute myocardial infarction. Aim of our study was to evaluate incidence and clinical characteristics of patients with LVT after ST elevation myocardial infarction (STEMI) using contrast- enhanced magnetic resonance (CMR). METHODS AND RESULTS: In a prospective cohort of 36 consecutive patients with STEMI acutely reperfused with primary percutaneous coronary intervention, CMR was performed within one week. LVT was found in 7 patients (19%), and was located in left ventricle apex or adherent to antero-septum. Compared to the rest of population patients with LVT have lower ejection fraction (38 ± 7% versus 51 ± 6%, P = 0.009), larger left ventricle end systolic volume (95.8 ± 19 ml versus 68.9 ± 19 ml, P = 0.02), higher time to reperfusion (9.3 ± 7.2 versus 5 ± 3.6, P = 0.03) and left anterior descending artery was constantly involved (100% versus 41 %, P = 0.06). In 5 cases the LVT was also detected by echocardiography, however, in 2 cases it was missed. CONCLUSIONS: The incidence of LVT after STEMI is not negligible and was accurately detected by CMR. Localization of myocardial infarction, time to reperfusion, ejection fraction and left ventricle end systolic volume are the most important predictors of left ventricle thrombus formation.

Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study.

OBJECTIVES: The purpose of this study was to assess whether transradial access for ST-segment elevation acute coronary syndrome undergoing early invasive treatment is associated with better outcome compared with conventional transfemoral access. BACKGROUND: In patients with acute coronary syndrome, bleeding is a significant predictor of worse outcome. Access site complications represent a significant source of bleeding for those patients undergoing revascularization, especially when femoral access is used. METHODS: The RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) was a multicenter, randomized, parallel-group study. Between January 2009 and July 2011, 1,001 acute ST-segment elevation acute coronary syndrome patients undergoing primary/rescue percutaneous coronary intervention were randomized to the radial (500) or femoral (501) approach at 4 high-volume centers. The primary endpoint was the 30-day rate of net adverse clinical events (NACEs), defined as a composite of cardiac death, stroke, myocardial infarction, target lesion revascularization, and bleeding). Individual components of NACEs and length of hospital stay were secondary endpoints. RESULTS: The primary endpoint of 30-day NACEs occurred in 68 patients (13.6%) in the radial arm and 105 patients (21.0%) in the femoral arm (p = 0.003). In particular, compared with femoral, radial access was associated with significantly lower rates of cardiac mortality (5.2% vs. 9.2%, p = 0.020), bleeding (7.8% vs. 12.2%, p = 0.026), and shorter hospital stay (5 days first to third quartile range, 4 to 7 days] vs. 6 [range, 5 to 8 days]; p = 0.03). CONCLUSIONS: Radial access in patients with ST-segment elevation acute coronary syndrome is associated with significant clinical benefits, in terms of both lower morbidity and cardiac mortality. Thus, it should become the recommended approach in these patients, provided adequate operator and center expertise is present. (Radial Versus Femoral Investigation in ST Elevation Acute Coronary Syndrome [RIFLE-STEACS]; NCT01420614).

Impact of vascular approach (transradial vs. transfemoral) on the efficacy of thrombus aspiration in acute myocardial infarction patients.

BACKGROUND: Manual thrombus aspiration improves the efficacy of percutaneous coronary interventions (PCIs) in ST-elevation acute myocardial infarction (STEMI). The transradial approach (TRA) is an emerging vascular approach for PCI but is associated with specific technical requirements. As data on the combination of thrombus aspiration and TRA are scarce, we sought to assess the feasibility of TRA manual thrombus aspiration in STEMI patients. METHODS: All consecutive patients treated with manual thrombectomy for acute STEMI in three Italian hospitals were considered. Patients were divided according to the vascular approach into two groups: TRA and transfemoral (TFA). Two primary end points were defined: thrombectomy feasibility (ability to cross the occlusion with the device) and thrombectomy efficacy (absolute thrombus score reduction after device crossing). RESULTS: From January 2008 to December 2009, 303 patients were included: 151 patients (63±13 years) were treated through TFA, and 152 patients (61±12 years, P=.25) were treated through TRA. There were no significant differences in thrombectomy feasibility (75% in the TRA compared to 74.8% in the TFA group, P=.97) or in thrombectomy efficacy (2.6±.8 for TRA and 2.9±2 for TFA, P=.15). In both groups, there was a significant reduction in thrombus score after manual thrombus aspiration. Angiographically evident distal embolization after device crossing was low and observed in seven cases (5%) either for TFA and TRA (P=.99). CONCLUSIONS: The present study suggests that, in the setting of acute STEMI, manual thrombus aspiration through TRA is feasible, and its efficacy is comparable to the TFA.

Transradial percutaneous coronary interventions using sheathless guiding catheters: a multicenter registry.

BACKGROUND: Transradial approach (TRA) for percutaneous coronary interventions (PCIs) is a common alternative to transfemoral approach associated with lower complications. However, a limitation of TRA is the use of large caliber guiding catheters due to the small size of the radial artery. The sheathless guiding catheter system that is in diameter 1-2 French (Fr) smaller than the corresponding introducer sheath may overcome these difficulties. METHODS: From January 2010 through December 2010 in 5 Italian high-volume hospitals, 213 consecutive patients who underwent TRA-PCIs using the sheathless Eaucath guiding catheter system because of small radial artery caliber (Group 1) or undergoing bifurcation PCIs (Group 2) were enrolled in this registry. In patients of Group 1 (n = 79), a 6.5-Fr sheathless guiding catheter was employed, whereas in patients of Group 2 (n = 134) a 7.5 Fr was used. RESULTS: Among the 213 patients enrolled, 270 vessels were treated for 316 lesions. No procedures required conversion to a conventional guiding catheter system. There were significantly more female patients in Group 1, and they were, older, shorter, and thinner than patients in Group 2. No cases of major vascular complications were observed in either groups. During procedures, adjunctive devices employed included intravascular ultrasound, thrombectomy catheters, and distal protection systems. CONCLUSIONS: The use of the sheathless guiding catheter system is feasible for TRA-PCIs in case of small radial artery caliber or intended coronary bifurcation intervention.

Evaluation of the "learning curve" for left and right radial approach during percutaneous coronary procedures.

The transradial approach for percutaneous coronary procedures may be effectively performed through the right radial approach (RRA) or left radial approach (LRA) after an appropriate "learning curve." However, studies evaluating the "learning curve" for RRA and LRA are lacking. In the Transradial Approach (Left vs Right) and Procedural Times During Percutaneous Coronary Procedures (TALENT) study, which randomized 1,540 patients to the RRA or LRA, transradial procedures were performed by either seniors or fellows. Diagnostic procedures performed by fellows were divided into 3 stages: 0 to 100 procedures (stage 1), 101 to 200 procedures (stage 2), and >200 procedures (sage 3). The primary end point of the study was fluoroscopy time during the 3 stages. Six fellows performed 532 procedures, 260 through the RRA and 272 through the LRA. During the training period, fellows showed a progressive significant reduction in fluoroscopy time for the LRA over the 3 stages (stage 1: 258 seconds, interquartile range [IQR] 138 to 377; stage 2: 198 seconds, IQR 126.5 to 375; stage 3: 142 seconds, IQR 95 to 325; p = 0.003), whereas for the RRA, only a slight and nonsignificant reduction in fluoroscopy time was observed (stage 1: 271 seconds, IQR 186 to 364; stage 2: 240 seconds, IQR 156 to 395; stage 3: 218.5 seconds, IQR 145.5 to 300.5; p = 0.20). Cannulation time was progressively reduced over the time for the 2 radial approaches: during stage 1, <40% of procedures required ≤3 minutes for radial cannulation, whereas at stage 3, radial cannulation time was ≤3 minutes in >60% of procedures (p <0.0001). In conclusion, the LRA is associated with a shorter learning curve compared to the RRA.

The PREHAMI (PREsillion™ in high-risk acute myocardial infarction) registry: in-hospital and long-term outcomes.

OBJECTIVES: To evaluate the efficacy of the new Cobalt-Chromium (Co-Cr) Presillion™ stent for the treatment of high-risk acute myocardial infarction (MI) patients. BACKGROUND: Percutaneous coronary intervention (PCI) with stent represents the gold standard treatment for acute MI. METHODS AND RESULTS: We enrolled patients with high-risk acute MI (either ST-segment elevation MI or non-ST-segment elevation MI) treated with PCI using a new Co-Cr bare metal stent with closed cells design and limited balloon compliance. We considered high-risk features as one of the following: age ≥ 70 years, ejection fraction ≤ 35%, glomerular filtration rate ≤ 60 mL/min, diabetes mellitus, rescue PCI, or chronic atrial fibrillation or other conditions requiring long-term oral anticoagulation therapy. Primary outcome of the study was rate of major adverse cardiac events (MACE) defined as all-cause death, new MI, and target-vessel revascularization. A total of 129 consecutive patients were enrolled (69 ± 11 years, 74% men): 71 (55%) patients with ST-segment elevation MI and 58 (45%) patients with non-ST-segment elevation MI. A total of 153 vessels (169 lesions and 179 stents) were treated. The device success rate was high (98.8%). In-hospital MACE rate was 5.4% mainly because of death associated with the acute MI. At 1-year follow-up, the MACE rate was 17.3%, with 11% all-cause death (7.9% of cardiac origin), 0.6% of stent thrombosis, and 4.6% target-vessel revascularization. CONCLUSIONS: The use of the Co-Cr Presillion stent in patients with high-risk acute MI treated invasively seems to be safe and efficacious with optimal deliverability and good long-term outcomes and represents a good option in the treatment of these patients.

Transradial approach (left vs right) and procedural times during percutaneous coronary procedures: TALENT study.

BACKGROUND: most of the studies assessing transradial approach for coronary angiography (CA) have been performed through right radial approach (RRA). Our aim was to evaluate the safety and efficacy of left radial approach (LRA) compared with RRA for coronary procedures. METHODS: from January 2009 to December 2009, in 2 hospitals, 1,540 patients were randomized to RRA (770 patients) or LRA (770 patients) for percutaneous coronary procedures. The primary end point was fluoroscopy time for CA and for percutaneous coronary intervention (PCI) evaluated independently. Prespecified subgroup analyses according to patient age and operator experience were planned. RESULTS: in 1,467 patients (732 RRA and 735 LRA), a CA (diagnostic group) was performed, and in 688 (344 each for RRA and LRA), a PCI. In the diagnostic group, LRA was associated with significantly lower fluoroscopy time (149 seconds, interquartile range [IQR] 95-270 seconds) and dose area product fluoroscopy (10.7 Gy cm(2), IQR 6-20.5 Gy cm(2)) compared with the RRA (168 seconds, IQR 110-277 seconds, P = .0025 and 12.1 Gy cm(2), IQR 7-23.8 Gy cm(2), P = .004, respectively). In the PCI group, there were no significant differences in fluoroscopy time (614 seconds, IQR 367-1,087 seconds for LRA and 695 seconds, IQR 415-1,235 seconds, P = .087 for RRA) and dose area product fluoroscopy (53.7 Gy cm(2), IQR 29-101 Gy cm(2) for LRA and 63.1 Gy cm(2), IQR 31-119 Gy cm(2), P = .17 for RRA). According to subgroup analyses, the differences between LRA and RRA were confined to older patients (≥ 70 years old) and to operators in training. CONCLUSIONS: left radial approach for coronary diagnostic procedures is associated with lower fluoroscopy time and radiation dose adsorbed by patients compared with the RRA, particularly in older patients and for operators in training.

Comparison of immediate vs early invasive strategy in patients with first acute non-ST-elevation myocardial infarction.

BACKGROUND: The best timing for coronary angiography (immediate vs early) in patients with acute non-ST-elevation myocardial infarction (NSTEMI) is controversial. HYPOTHESIS: Evaluate in NSTEMI patients the effects of an immediate compared to an early invasive strategy on microvascular damage, myocardial perfusion, and infarct size. METHODS: We randomized 54 consecutive patients with first episode of NSTEMI: 27 patients (22 males, age 58.8 ± 9.4 years, group A) underwent immediate (≤6 hours) percutaneous coronary intervention (PCI) with a double bolus of eptifibatide, and 27 patients (24 males, age 59.7 ± 9.8 years, P = 0.72, group B) underwent early (7-72 hours) PCI with upstream eptifibatide. Microvascular damage was evaluated at predischarge by myocardial contrast echocardiography, and the contrast defect length was calculated. RESULTS: There were no significant differences in pre-PCI myocardial blush grade (MBG) (41% MBG 0 or 1 in group A vs 37% MBG 0 or 1 in group B, P = 0.78), in post-PCI MBG (7.4% MBG 0 or 1 in both groups, P = 1.00), and in contrast defect length (4.5% in group A vs 2.8% in group B, P = 0.56). However, group A showed a significant reduction in creatine kinase myocardial band isoenzyme peak (26 ± 26 ng/mL in group A vs 69 ± 79 ng/mL in group B, P = 0.01) and in troponin T peak (0.84 ± 1.2 ng/mL in group A vs 1.8 ± 2.1 ng/mL in group B, P = 0.048). CONCLUSIONS: In patients with NSTEMI treated with eptifibatide, immediate PCI is associated with less increase in myonecrosis markers compared with PCI within 72 hours. There were no significant differences in myocardial perfusion between the 2 strategies.

Impact of chronic aspirin and statin therapy on presentation of patients with acute myocardial infarction and impaired renal function.

Chronic use of aspirin and statins has been associated with reduced risk of subsequent myocardial infarction (MI). However, in patients with chronic kidney disease (CKD), the cardioprotective role of aspirin and statins seems to be reduced. To evaluate the impact of chronic aspirin and statin use on clinical presentation of acute MI according to renal function, the authors retrospectively analyzed 595 consecutive patients admitted to our hospital for acute MI. Renal function was normal in 404 patients and impaired in 191. Patients on therapy (113 patients) were less likely to have ST-segment elevation MI (STEMI) compared with patients not treated (36% vs 53%, respectively, P=.0002). These results have been confirmed in the population of patients with CKD (48% of STEMI in patients receiving chronic therapy and 67% in patients without therapy,P=.01). Multivariate analysis in the group of patients with CKD showed that use of aspirin or statins was an independent predictor of a decreased probability of STEMI (odds ratio, 0.5; 95% confidence interval, 0.2-1.0,P=.05). The authors' results suggest that in a community-based sample of patients with acute MI, chronic aspirin and statin therapy has a cardioprotective role that is evident also in patients with CKD.

Endovascular treatment of a giant superior mesenteric artery pseudoaneurysm using a nitinol stent-graft.

A 68-year-old woman presenting with gastrointestinal bleeding (hematocrit 19.3%) and in a critical clinical condition (American Society of Anesthesiologists grade 4) from a giant superior mesenteric artery pseudoaneurysm (196.0 x 131.4 mm) underwent emergency endovascular treatment. The arterial tear supplying the pseudoaneurysm was excluded using a 5.0 mm diameter and 31 mm long monorail expanded polytetrafluoroethylene (ePTFE)-covered self-expanding nitinol stent. Within 6 days of the procedure, a gradual increase in hemoglobin levels and a prompt improvement in the clinical condition were observed. Multislice CT angiograms performed immediately, 5 days, 30 days and 3 months after the procedure confirmed the complete exclusion of the pseudoaneurysm.