OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions.

BACKGROUND: Imaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain. METHODS: We conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years. RESULTS: We assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P = 0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group. CONCLUSIONS: Among patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.).

Radial versus femoral access site for percutaneous coronary intervention in patients suffering acute myocardial infarction : A randomized prospective multicenter trial.

BACKGROUND: Transradial access (TRA) in percutaneous coronary intervention (PCI) is a widely used standard technique with lower complication rates compared to transfemoral access (TFA). The aim of this study was to evaluate the impact of TRA versus TFA for PCI on clinically significant vascular access complications in the setting of acute myocardial infarction (AMI). METHODS: This multicenter study randomly assigned 250 patients in a 1:1 fashion (TRA vs. TFA) admitted with or without ST-segment elevation AMI undergoing immediate PCI. The primary endpoint was defined as the occurrence of hematoma, pseudo-aneurysm or local bleeding at the access site requiring any further intervention and/or prolonged hospital stay. Radiation exposure to the patient and operator was also investigated. RESULTS: In the study cohort (N = 250 patients, mean age 62 ± 12.7 years, 76% males) 5 patients (2%) achieved the primary endpoint without a significant difference between groups, 4 out of 125 (3.2%) in the TFA group and 1 out of 125 (0.8%) in the TRA group (p = 0.17). Access site hematoma was significantly more frequent in the TFA group compared to the TRA group (24.8% vs. 8.8%, respectively; p < 0.0007). Local bleeding was only seen in the TFA group (3.2% vs. 0%, p = 0.04). Time intervals from admission to catheter laboratory to first balloon inflation were longer in the TRA compared to the TFA group (34 ± 17 min vs 29.5 ± 13 min, respectively; p = 0.018). Radiation exposure to the patient and operator was identical. CONCLUSION: The use of TRA was accompanied by lower rates of access site complications; however, the need for subsequent treatment or prolonged hospital stays was not observed using either of the two access approaches.

[Transcatheter aortic valve replacement: when should it be used in aortic stenosis?]. / Kathetergestützter Aortenklappenersatz: eine neue therapeutische Option der Aortenklappenstenose?

30% of patients with significant aortic stenosis are not considered for operative aortic valve replacement because of the high perioperative risk. An alternative catheter based option for these patients is the transcatheter aortic valve replacement (TAVI). In general, there are two approaches for TAVI: transfemoral and transapical. Transfemoral aortic valve replacement is performed by transcatheter replacement of an aortic valve via the femoral arteries. Transapical valve replacement is achieved by transcatheter implantation via the fifth intercostal space. The most common complications are vessel injuries, bleeding complications, new onset of AV-block, development of paravalvular insufficiency, acute kidney injury, stroke and TIA. The first long-term observations suggest positive results. First clinical trials in a high-risk population show a promising outcome. Therefore TAVI offers a reasonable therapy option for patients with high perioperative risk. Further long-term clinical trials are still pending.

Rehospitalization rates after transcatheter aortic valve implantation.

AIMS: Comorbidities pose a major challenge to screening, selection and follow-up of transcatheter aortic valve implantation (TAVI) patients as well as to the procedure itself. The aim of the present study was to assess cardiac and non-cardiac readmission rates besides clinical endpoint data in the first 50 patients of a single center TAVI programme. METHODS AND RESULTS: TAVI was performed using the transfemoral CoreValve system. Procedural success rate was 94%; intraprocedural mortality was 2%. 82% of the patients remained free of a combined safety endpoint at 30 days, and 76.1% remained free of a combined efficacy endpoint at six months (modified criteria of the Valve Academic Research Consortium). At six months, among all surviving patients, 10.3% had experienced readmissions for cardiac causes, and 43.6% had experienced readmissions for non-cardiac causes. Causes of non-cardiac readmissions showed a wide distribution over various medical disciplines, reflecting the high rate of comorbidities. Beyond six months until a predefined reference date (mean follow up 9.9 months), the probability of hospitalization fell by half (1.54 vs. 0.74 hospital days per patient per month), driven by a decrease of non-cardiac readmissions. Karnofsky score before and after TAVI yielded a significant and sustained improvement of performance status, as assessed retrospectively at reference date. CONCLUSION: The findings of the present study suggest that the high prevalence of comorbidities in high-risk TAVI patients results in a high rate of non-cardiac rehospitalizations during the first 6 months of follow-up. Despite this fact, improvement of global everyday performance following TAVI as perceived by the patients seems to be substantial.

2-year results of the AUTAX (Austrian Multivessel TAXUS-Stent) registry beyond the SYNTAX (synergy between percutaneous coronary intervention with TAXUS and cardiac surgery) study.

OBJECTIVES: The multicenter AUTAX (Austrian Multivessel TAXUS-Stent) registry investigated the 2-year clinical/angiographic outcomes of patients with multivessel coronary artery disease after implantation of TAXUS Express stents (Boston Scientific, Natick, Massachusetts), in a "real-world" setting. BACKGROUND: The AUTAX registry included patients with 2- or 3-vessel disease, with/without previous percutaneous coronary intervention (PCI) and concomitant surgery. METHODS: Patients (n = 441, 64 +/- 12 years, 78% men) (n = 1,080 lesions) with possible complete revascularization by PCI were prospectively included. Median clinical follow-up was 753 (quartiles 728 to 775) days after PCI in 95.7%, with control angiography of 78% at 6 months. The primary end point was the composite of major adverse cardiac (nonfatal acute myocardial infarction [AMI], all-cause mortality, target lesion revascularization [TLR]) and cerebrovascular events (MACCE). Potential risk factor effects on 2-year MACCE were evaluated using Cox regression. RESULTS: Complete revascularization was successful in 90.5%, with left main PCI of 6.8%. Rates of acute, subacute, and late stent thrombosis were 0.7%, 0.5%, and 0.5%. Two-year follow-up identified AMI (1.4%), death (3.6%), stroke (0.2%), and TLR (13.1%), for a composite MACCE of 18.3%. The binary restenosis rate was 10.8%. The median of cumulative SYNTAX score was 23.0 (range 12.0 to 56.5). The SYNTAX score did not predict TLR or MACCE, due to lack of scoring of restenotic or bypass stenoses (29.8%). Age (hazard ratio [HR]: 1.03, p = 0.019) and acute coronary syndrome (HR: 2.1, p = 0.001) were significant predictors of 2-year MACCE. Incomplete revascularization predicted death or AMI (HR: 3.84, p = 0.002). CONCLUSIONS: With the aim of complete revascularization, TAXUS stent implantations can be safe for patients with multivessel disease. The AUTAX registry including patients with post-PCI lesions provides additional information to the SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) study. (Austrian Multivessel TAXUS-Stent Registry; NCT00738686).

Small vessel stenting with cobalt-chromium stents (Arthos Pico) in a real world setting.

BACKGROUND: In current clinical practice, 35-67% of significant coronary artery lesions are located in small (<3.0 mm) vessels, a setting with poor short- and long-term results after percutaneous coronary interventions. OBJECTIVES: The aim of the present Arthos Pico Austria Multicenter Registry is to demonstrate the safety and efficacy of the Arthos Pico (cobalt-chromium alloy) stent implantation in small coronary arteries in a real world setting. METHODS: Two hundred and three patients (mean age, 67+/-12 years; 63% male) were included in the Registry; 199 patients (98%) were controlled clinically (including noninvasive stress tests) 6 and 12 months after stent implantation. Clinically driven angiographic controls were performed in 37 patients (18.2%) at mean 6 months after stenting. The primary endpoint of the study was the 6-month rate of major adverse cardiac events (as target vessel revascularization, all cause death, and acute myocardial infarction), the secondary endpoints were the intervention complications, and the occurrence of acute and subacute stent thrombosis. RESULTS: The procedural success was 99%. The rates of acute and subacute stent thrombosis were 0.5 and 1.5%, respectively. During the 6-month clinical follow-up, primary endpoint events (major adverse cardiac events) were recorded in 13% of the clinically controlled patients: four patients (2%) with acute myocardial infarction; 12 patients (6%) with target vessel revascularization; and 10 patients died (5%), resulting in an event-free survival rate of 87%. Between the 6- and 12-month follow-up, additional target vessel revascularization was performed in three patients, acute myocardial infarction and death occurred in one patient each, respectively. Thus, the 12-month major adverse cardiac event-free survival rate was 85%. Patients who died had older age (76+/-7 years) and a high proportion of type C lesions (50%) at the initial angiography. Multivariate analysis revealed older age (P=0.026) and type C lesions (P=0.016) as significant predictors for all causes of death. CONCLUSION: In conclusion, stenting of small arteries with Arthos Pico is safe and effective in the prevention of major adverse cardiac events during 6- and 12-month follow-up.