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.
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 cm2 , IQR 6-20.5 Gy cm2 ) compared with the RRA (168 seconds, IQR 110-277 seconds, P = .0025 and 12.1 Gy cm2 , IQR 7-23.8 Gy cm2 , 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 cm2 , IQR 29-101 Gy cm2 for LRA and 63.1 Gy cm2 , IQR 31-119 Gy cm2 , 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.
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.
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.
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.
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.
Ivabradine could represent an effective and safe alternative to calcium channel blockers and beta-blockers for treatment of IST.
Background The role of intraaortic balloon pump (IABP) during percutaneous coronary intervention (PCI) in high-risk acute patients remains debated. Device-related complications and the more complex ...patient management could explain such lack of clinical benefit. We aimed to assess the impact of transradial versus transfemoral access for PCI requiring IABP support on vascular complications and clinical outcome. Methods We retrospectively analyzed 321 consecutive patients receiving IABP support during transfemoral (n = 209) or transradial (n = 112) PCI. Thirty-day net adverse clinical events (NACEs) (composite of postprocedural bleeding, cardiac death, myocardial infarction, target lesion revascularization, and stroke) were the primary end point, with access-related bleeding and hospital stay as secondary end points. Results Cardiogenic shock and hemodynamic instability were the most common indications for IABP support. Cumulative 30-day NACE rate was 50.2%, whereas an access site–related bleeding occurred in 14.3%. Patients undergoing transfemoral PCI had a higher unadjusted rate of NACEs when compared with the transradial group (57.4% vs 36.6%, P < .01), mainly due more access-related bleedings (18.7% vs 6.3%, P < .01). Such increased risk of NACEs was confirmed after propensity score adjustment (hazard ratio 0.57 0.4-0.9, P = .007), whereas hospital stay appeared comparable in the 2 groups. Conclusions In this observational registry, high-risk patients undergoing PCI and requiring IABP support appeared to have fewer NACEs if transradial access was used instead of transfemoral, mainly due to fewer access-related bleedings. Given the inherent limitations of this retrospective work, including the inability to adjust for unknown confounders, further controlled studies are warranted to confirm or refute these findings.
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.
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.
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 )
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.
Stent thrombosis is a severe complication associated with percutaneous coronary interventions (PCIs). The optimal treatment strategy of this complication is not well known, although emergency PCI in ...hospitals with 24 h facilities for urgent coronary angiography is still considered the best solution. The present report descibes four cases of subacute and late stent thrombosis treated with systemic thrombolysis due to the unavailability of the catheterization laboratory. All patients had a very short symptom-to-treatment time (median of 50 min) and were successfully treated with tenecteplase. The subsequent coronary angiography confirmed complete resolution of the thrombosis and the patients were discharged without further PCIs performed.