Ernesto Lioy

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).

Radial Versus Femoral Randomized Investigation in ST Elevation Acute Coronary Syndrome: the RIFLE STEACS 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).

In-Stent Neointimal Proliferation Correlates With the Amount of Residual Plaque Burden Outside the Stent: An Intravascular Ultrasound Study

BACKGROUND The aim of this study was to evaluate the relationship between residual plaque burden after coronary stent implantation and the development of late in-stent neointimal proliferation. METHODS AND RESULTS Between January 1996 and May 1997, 50 patients underwent intravascular ultrasound (IVUS) interrogation at 6+/-1.2 months after coronary stent implantation in native coronary arteries. IVUS images were acquired with a motorized pullback, and cross-sectional measurements were performed within the stents at 1-mm intervals. The following measurements were obtained: (1) lumen area (LA), (2) stent area (SA), (3) area delimited by the external elastic membrane (EEMA), (4) percent neointimal area calculated as (SA-LA/SA)x100, and (5) percent residual plaque area calculated as (EEMA-SA)/EEMAx100. Volume measurements within the stented segments were calculated by applying Simpsons rule. In the pooled data analysis of 876 cross sections, linear regression showed a significant positive correlation between percent residual plaque area and percent neointimal area (r=0.50, y= 45.03+0.29x, P<0.01). There was significant incremental increase in mean percent neointimal area for stepwise increase in percent residual plaque area. Mean percent neointimal area was 16.3+/-10.3% for lesions with a percent residual plaque area of <50% and 27.7+/-11% for lesions with a percent residual plaque area of >/=50% (P<0.001). The volumetric analysis showed that the percent residual plaque volume was significantly greater in restenotic lesions compared with nonrestenotic lesions (58.7+/-4.3% versus 51.4+/-5.7%, respectively; P<0.01). CONCLUSIONS Late in-stent neointimal proliferation has a direct correlation with the amount of residual plaque burden after coronary stent implantation, supporting the hypothesis that plaque removal before stent implantation may reduce restenosis.

Arterial access-site-related outcomes of patients undergoing invasive coronary procedures for acute coronary syndromes (from the ComPaRison of Early Invasive and Conservative Treatment in Patients With Non-ST-ElevatiOn Acute Coronary Syndromes [PRESTO-ACS] Vascular Substudy).

Transradial access (TRA) decreased bleeding after coronary interventions compared with femoral access (FA). However, no large study focused on arterial access-related outcomes in patients with acute coronary syndromes, although procedure-related bleeding significantly impaired prognosis. The aim was to evaluate access site-related outcomes of patients who underwent an invasive coronary procedure in the PRESTO-ACS Study. The cumulative primary study end point was death or reinfarction during hospitalization and at 1-year follow-up. Secondary end points were in-hospital bleeding and a net clinical outcome (combination of the primary end point and bleeding). Of 1,170 patients studied, 863 underwent a percutaneous coronary procedure using FA, and 307, using TRA. Compared with FA, TRA was associated with higher glycoprotein IIb/IIIa inhibitor use (52% vs 34%; p <0.0001). The in-hospital primary end point was similar between TRA (2.6%) and FA (2.9%; p = 0.79). However, TRA was associated with a significant decrease in bleeding (0.7% vs 2.4%; p = 0.05) and a nonsignificant decrease in net clinical outcome (3.3% vs 4.6%; p = 0.30). At 1-year follow-up, the TRA group had a statistically significant decrease in death or reinfarction (4.9% vs 8.3%; p = 0.05), bleeding (0.7% vs 2.7%; p = 0.03), and net clinical outcome (5.5% vs 9.9%; p = 0.02). In conclusion, in patients with non-ST-elevation acute coronary syndromes, use of TRA was associated with lower bleeding complications and identified patients with better long-term outcomes.

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.

Efficacy of ivabradine administration in patients affected by inappropriate sinus tachycardia

BACKGROUND Inappropriate sinus tachycardia (IST) is characterized by an elevated heart rate (HR) at rest and an exaggerated HR response to physical activity or emotional stress. Beta-blockers and calcium channel blockers are the first-line therapy but sometimes are poorly tolerated due to side effects. OBJECTIVE The purpose of this study was to evaluate the efficacy and safety of ivabradine, a selective inhibitor of the I(f) current of the sinoatrial node, in patients affected by IST. METHODS Eighteen consecutive symptomatic patients (2 men and 16 women; mean age 45 +/- 15 years) affected by IST were enrolled in the study. Every patient underwent resting ECG, 24-hour Holter ECG, and exercise ECG at baseline and at 3-month and 6-month follow-up. RESULTS Sixteen patients (14 women; mean age 41 +/- 14 years) completed the study. Holter ECG assessment showed a significant reduction of medium HR (P <.001) and maximal HR (P <.001, basal vs 3-6 months; P = .02, 3 vs 6 months). Minimal HR slightly decreased at 3 months and then stabilized (P = .49, 3 vs 6 months) despite an increased drug dose. Stress test showed a significant decrease at rest (P <.001) and maximal HR (P <.05), suggesting an increased tolerance to physical stress, which was confirmed by a progressive increase of maximal load reached (>100 W) during stress test at 3 months (75%) and 6 months (85%). One patient was excluded because of phosphenes despite dose lowering, and another patient did not complete the protocol. CONCLUSION Ivabradine could represent an effective and safe alternative to calcium channel blockers and beta-blockers for treatment of IST.

Transradial access compared with femoral puncture closure devices in percutaneous coronary procedures

BACKGROUND Transradial access (RA) is associated with less complications and is preferred by patients. Vascular closure devices (VCDs) may improve discomfort and may reduce complications associated with transfemoral access. Aim was to evaluate complications and discomfort associated with percutaneous coronary procedures employing RA or VCDs. METHODS We enrolled 1492 consecutive patients who underwent percutaneous coronary procedures with RA (604 procedures), femoral approach with manual compression (MC) (276 procedures), or with either Angioseal (311 procedures) or Starclose (301 procedures) closure device. Discomfort was assessed using procedure-specific questions. Major vascular complications were evaluated during hospitalization. RESULTS RA significantly reduced major complications (0.7%) compared to either the MC (2.9%, p=0.03) or the VCDs (Starclose 2.7%, Angioseal 3.9%, p=0.003). There were no significant differences in major complications between MC and either the Angioseal or the Starclose. At multivariate analysis the RA was predictor of reduced complications (OR 0.26, 95% CI 0.08-0.85, p=0.03 vs MC, and OR 0.19, 95% CI 0.07-0.57, p=0.003 vs VCDs). The RA was associated with a significant reduction in procedural discomfort with 44.2% of patients referring no discomfort (p<0.0001). Starclose and Angioseal were better tolerated than MC (27.8%, 29.3% and 8.9% patients respectively without discomfort, p<0.0001). CONCLUSIONS RA is associated with a significant reduction in major vascular complications compared to femoral approach even if two different VCDs are employed. VCDs are better tolerated than MC but the RA was associated with the lowest discomfort.

Operator Radiation Exposure During Percutaneous Coronary Procedures Through the Left or Right Radial Approach The TALENT Dosimetric Substudy

Background— Transradial percutaneous coronary procedures may be effectively performed through the right radial approach (RRA) or the left radial approach (LRA), but data on radiation dose absorbed by operators comparing the two approaches are lacking. The aim of the present study was to evaluate radiation dose absorbed by operators during coronary procedures through the RRA and LRA. Methods and Results— Three operators were equipped with 5 different dosimeters (left wrist, shoulder, thorax outside the lead apron, thorax under the lead apron, and thyroid) during RRA or LRA for coronary procedures. Each month, the dosimeters were analyzed to determine the radiation dose absorbed. From February to December 2009, 390 patients were randomly assigned to the RRA (185 patients; age, 66±11 years) or the LRA (185 patients; age, 66±11 years). There were no significant differences in fluoroscopy time (for RRA, 369 seconds; interquartile range, 134 to 857 seconds; for LRA, 362 seconds; interquartile range, 142 to 885 seconds; P=0.58) between the 2 groups. There were no significant differences in monthly radiation dose at the thorax (0.85±0.46 mSv for RRA and 1.12±0.78 mSv for LRA, P=0.33), at the thyroid (0.36±0.2 mSv for RRA and 0.34±0.3 mSv for LRA, P=0.87), and at the shoulder (0.73±0.44 mSv for RRA and 0.94±0.42 mSv for LRA, P=0.27). The dose at the wrist was significantly higher for the RRA (2.44±1.12 mSv) compared with the LRA (1±0.8 mSv, P=0.002). In both radial approaches, the thoracic radiation dose under the lead apron was undetectable. Conclusions— Compared with RRA, LRA for coronary procedures is associated with similar radiation dose for operators at the body, shoulder, or thyroid level, with a possible significant advantage at the wrist. The cumulative radiation dose for both approaches is well under to the annual dose-equivalent limit. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00282646.

Real-world outcome of coronary bifurcation lesions in the drug-eluting stent era: Results from the 4,314-patient Italian Society of Invasive Cardiology (SICI-GISE) Italian Multicenter Registry on Bifurcations (I-BIGIS)

BACKGROUND Drug-eluting stents (DESs) introduction has somewhat renewed the issues of strategy and stenting technique for treatment of bifurcation lesions. In particular, concerns remain on extensive use of DESs, especially in the side branch, and on time of dual antiplatelet therapy (DAT) discontinuation, reflecting lack of pertinent long-term data. This study aimed to evaluate clinical safety and efficacy of different strategies for bifurcations treatment in a large observational real-world registry. METHODS A multicenter, retrospective Italian study of consecutive patients undergoing bifurcation percutaneous coronary intervention between January 2002 and December 2006 was performed. The primary end point was the long-term rate of major adverse cardiac events (MACEs). The role of DAT length on outcome was also analyzed. RESULTS A total of 4,314 patients (4,487 lesions) were enrolled at 22 independent centers. In-hospital procedural success rate was 98.7%. After median follow-up of 24 months, MACEs occurred in 17.7%, with cardiac death in 3.4%, myocardial infarction in 4.0%, target lesion revascularization in 13.2%, and stent thrombosis in 2.9%. Extensive multivariable analysis showed that MACEs were independently predicted by age, diabetes, renal failure, systolic dysfunction, multivessel disease, myocardial infarction at admission, restenotic lesion, bare-metal stent implantation, complex stenting strategy, and short duration of DAT. CONCLUSIONS This large study based on current clinical practice in an unselected patient population presenting with bifurcation disease and submitted to percutaneous coronary intervention demonstrated favorable long-term clinical results in this challenging patient setting, especially when DESs, simple stenting strategy, and DAT for at least 6 months are used.

Catheter Ablation of Right Atrial Ganglionated Plexi in Patients with Vagal Paroxysmal Atrial Fibrillation

Background— Catheter ablation of ganglionated plexi (GP) in the left atrium has been proposed in different subgroup of patients with atrial fibrillation (AF). Anatomic studies found a high prevalence of GP in the posterior surface of the right atrium (RA). Experimental data suggested the potential role of right atrial GP in the AF initiation and maintenance. The aim of our study was to assess the efficacy of GP ablation in RA in patients with vagal AF. Methods and Results— Thirty-four patients without structural heart diseases were randomly assigned for a selective ablation procedure targeted on the elimination of vagal reflex evoked by high frequency stimulation or an extensive approach at anatomic sites of GP. All patients underwent Holter ECG and heart rate variability evaluation at baseline and at 3, 6, 12, and 18 months of follow-up. At a mean follow-up of 19.7±5.2 months, AF recurred in 5 of 17 patients with anatomic ablation and in 13 of 17 patients with a selective approach (P=0.01). No patient had major complications. After ablation, heart rate variability parameters showed a significant parasympathetic (and sympathetic) denervation in the first 6 months, which was more prominent in patients with anatomic GP ablation and in those without AF recurrence. Conclusions— This study demonstrates that in a selected population of vagal paroxysmal AF, the anatomic ablation of GPs in the RA is effective in about 70% of patients. These results confirm that atrial vagal denervation can abolish AF, as suggested by experimental and clinical data.