Comparison of novel 6.5 Fr sheathless guiding catheters versus 5 Fr guiding catheters for transradial coronary intervention.

AIMS: To assess the safety and efficacy of a novel sheathless (SH) 6.5 Fr (French) hydrophilic-coated guiding catheter (GC) compared to the standard 5 Fr GCs in transradial coronary interventions (TRI). METHODS AND RESULTS: Patients undergoing TRI with 6.5 Fr SH or 5 Fr GCs were included. Baseline characteristics and in-hospital outcomes were recorded. Primary endpoints were procedural success and presence of radial pulse at discharge. Secondary endpoints were successful GC support, in-hospital adverse events, access-site complications, procedural duration and contrast load. There were 269 patients with 146 procedures in each group. The SH GC group had more non-ST elevation MI, in-stent restenosis, high-risk and bifurcation lesions. Procedural success in both arms was 95.2%. One patient in each group (0.7%) experienced radial artery occlusion (RAO) after TRI, without clinical sequelae. One access-site haematoma and one minor stroke occurred in the 5 Fr group (none in the SH group, both p=ns). Mean procedure time (52±21 vs. 45±21 minutes, p=0.004) and contrast load (160±45 ml vs. 140±45 ml, p=0.003) were greater in the SH group. CONCLUSIONS: Both 6.5 Fr SH GCs and 5 Fr GCs achieved high procedural TRI success with low RAO rates. The SH GC eliminated the disadvantages of the 5 Fr GC whilst maintaining the advantage of low RAO rates, and may become the GC of choice in TRI.

Three-year experience of primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction in a hospital without on-site cardiac surgery.

INTRODUCTION: Primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) in hospitals without on-site cardiac surgery capability, despite receiving only a class IIb recommendation in the ACC/AHA practice guidelines, can be performed effectively and safely. We reviewed the fi rst 3 years of our experience. MATERIALS AND METHODS: This is a retrospective single centre review of all patients receiving primary PCI for STEMI between 2003 and 2005. Demographic, procedural and outcome data were analysed. RESULTS: There were 259 patients who underwent primary PCI. The mean age was 55.3 +/- 12.3 years. Median door-to-balloon time was 97.5 minutes and 45.2% and 52.9% had anterior and inferior STEMI, respectively. The majority of patients presented with Killip class I (87.6%); however, 5.8% were in Killip class IV. Single vessel disease was found in 47.1%. Angiographic PCI success (defined as residual stenosis <50% with TIMI 3 fl ow) was achieved in 89.1%. Usage of stents, distal protection and aspiration devices were 97.2%, 27.8% and 34.1 %, respectively; 9.3% required intra-aortic balloon pump insertion. No patients required transfer for emergency coronary bypass surgery as a result of PCI complications. Post-PCI ST resolution >50% was achieved in 80.6%. The mean post-infarct left ventricular ejection fraction was 44.1%. In-hospital, 30-day, 6-month and 1-year mortality rates were 2%, 2.8%, 4.0% and 4.8%, respectively. Clinically driven target lesion revascularisation rate was 2.8% at 1 year. CONCLUSIONS: Our results are comparable to those from on-site surgical centres. This supports the feasibility and safety of primary PCI in cardiac centres without on-site cardiac surgery.

Use of Taxus polymer-coated paclitaxel-eluting stents for treatment of in-stent restenosis in real world patients: results of clinical and angiographic follow-up at six months in a single-center registry.

OBJECTIVE: To evaluate the safety and efficacy of Taxus paclitaxel-eluting stents in a real world group of unselected patients with coronary in-stent restenosis (ISR) lesions. METHODS: This is a prospective single-center registry of a consecutive series of 94 patients with 104 ISR lesions, without previous brachytherapy, over a period of 1 year. Quantitative coronary angiographic analyses were performed at baseline and at 6-month angiographic follow-up. Clinical follow-up were obtained at 6 months. RESULTS: Pre-intervention mean reference vessel diameter was 2.62 +/- 0.50 mm and mean lesion length was 13.95 +/- 6.78 mm. Baseline ISR patterns were mostly either Type I focal (32.7%) or Type II diffuse intrastent (48.1%). At 6-month angiographic follow-up, the in-stent and in-segment binary restenosis was 3.8% (4/105) and 7.6% (8/105) respectively, and the in-stent and in-segment late loss was 0.30 +/- 0.50 mm and 0.57 +/- 0.54 mm, respectively. Seven of these eight restenosed lesions had a diffuse or proliferative ISR pattern prior to intervention. Lesions that restenosed had longer mean stent length per lesion (37.3 mm vs. 22.5 mm in nonrestenosed group; P = 0.001) and more likely to have had a pattern of total occlusion pre-intervention (25.0% vs. 3.1% in nonrestenosed group; P = 0.046). At 6-month clinical follow-up, the MACE rate was 8.5% and target lesion revascularization rate was 7.4%. There was no death but subacute stent thrombosis occurred in 1 patient (1.1%) at 3 days after intervention. CONCLUSIONS: Paclitaxel-eluting Taxus stent for the treatment of ISR effectively suppresses recurrent neointimal proliferation, and was safe and efficacious at 6-month follow-up.

High-frequency mechanical vibration to recanalize chronic total occlusions after failure to cross with conventional guidewires.

BACKGROUND: Crossing chronic total occlusions (CTO) of coronary arteries continues to challenge interventional cardiologists. A clinical study was undertaken in four European centers to examine the feasibility of using the new CROSSER system that utilizes high-frequency mechanical vibration to penetrate atherosclerotic plaque material to cross CTOs in patients where conventional guidewire techniques had failed. The objective of the study was to determine whether the CROSSER system could safely cross such CTOs. PATIENTS AND METHODS: A total of 55 CTO lesions in 53 patients were treated in two clinical phases: (1) Phase 1 feasibility study (30 CTOs), with a primary focus on device safety; and (2) Phase 2 pivotal study (25 CTOs) using an improved version of the device, with a primary focus on effectiveness. RESULTS: The primary endpoint of device efficacy and the secondary endpoint of clinical success were both 76% (19 of 25) in the pivotal study phase. No major adverse cardiac events of death, Q-wave myocardial infarction or target lesion revascularization (by either coronary artery bypass graft surgery or percutaneous coronary intervention) were observed through 30-day follow up. No coronary perforation or pericardial tamponade occurred. CONCLUSIONS: The CROSSER system is a safe device that can cross many occlusions after a conventional guidewire failure. With additional refinement and improvements to the device, this success rate could be further increased.

Prospective non-randomized multi-centre evaluation of the non-polymer based ACHIEVE Paclitaxel Eluting Coronary Stent System in treatment of lesions with high risk of revascularization due to restenosis: the DELIVER II study.

BACKGROUND: The ACHIEVE Paclitaxel Eluting Coronary Stent System (CSS) is a non-polymeric paclitaxel coated stent loaded with a dose density of 3.0 microg/mm2 stent surface area. DELIVER II set out to evaluate the use of this stent in the treatment of patients with coronary lesions with a higher risk of revascularization including chronic total or sub-total occlusion, small vessel, bifurcated, and long lesions, multivessel disease, and restenotic lesions. METHODS: DELIVER II was a prospective, non-randomized, single-arm, multi-centre study. A total of 1531 patients with 1986 lesions were enrolled at 86 sites worldwide. The primary endpoint was target lesion revascularization (TLR) rate at six months follow-up. The lesion subsets were comprised of 28.5% restenotic lesions, 16.5% chronic total or subtotal occlusions, 29.0% bifurcation lesions, 37.4% small vessels and 16.6% long lesions. RESULTS: The Target Lesion Revascularization (TLR) rate (intent-to-treat) at 180 days was 8.2% (156/1909). The MACE rate for the overall per-protocol population was 3.6% (47/1310) at 30 days, 13.0% (167/1287) at 180 days, and in a sub-set of 500 patients, 20.5% (84/409) at 365 days. Multivariable logistic regression analysis identified that the factors leading to higher risk of revascularization were left anterior descending artery lesions, restenotic lesions, the post-procedural minimum luminal diameter, total stent length and number of diseased vessels. CONCLUSION: DELIVER II demonstrated comparatively low rates of TLR and MACE for the ACHIEVE Paclitaxel Eluting CSS in high risk patients. In addition, this registry helped to identify risk factors leading to an increased risk of revascularization in difficult-to-treat patient groups.