Real-World Experience of Coronary Intravascular Lithotripsy in an Asian Population: A Retrospective, Observational, Single-Center, All-Comers Registry.

OBJECTIVES: To assess the clinical and angiographic outcomes of coronary intravascular lithotripsy (IVL) use in an all-comers population with moderate-to-severely calcified coronary lesions. BACKGROUND: IVL has been shown to modify coronary calcific plaques with minimal vascular complications. METHODS: This was a retrospective, observational study of patients treated with IVL. The primary endpoint was in-hospital major adverse cardiovascular event (MACE), which included cardiac death, myocardial infarction (MI), and target-vessel revascularization (TVR). Secondary endpoints were clinical success (stent expansion with <30% in-stent residual stenosis and no in-hospital MACE) and angiographic success. RESULTS: Between August 2019 and December 2019, a total of 50 calcified lesions were treated in 45 patients using the Shockwave C2 IVL catheter (Shockwave Medical). They were further studied in 3 treatment subgroups: (1) primary IVL group with de novo lesions (n = 23 lesions); (2) secondary IVL group in which non-compliant balloon dilation failed (n = 15 lesions); and (3) tertiary IVL group with IVL to underexpanded stents (n = 12 lesions). The mean diameter stenosis of calcified lesions was 63.2 ± 10.2% at baseline, and decreased to 33.5 ± 10.9% immediately post IVL (P<.001) and 15 ± 7.1% post stenting (P<.001). Mean minimal lumen diameter was 1.1 ± 0.3 mm at baseline, and increased to 1.90 ± 0.5 mm post IVL (P<.001) and 2.80 ± 0.50 mm post stenting (P<.001). In-hospital and 30-day MACE occurred in 3 and 4 patients, respectively. Overall, clinical success and angiographic success were achieved in 90% and 94% of cases, respectively. CONCLUSIONS: IVL appears to be a safe, effective, and feasible strategy for calcium modification in an all-comers cohort with high success rate, minimal procedural complications, and low MACE rates.

Feasibility of transradial coronary angiography and intervention using a single Ikari left guiding catheter for ST elevation myocardial infarction.

BACKGROUND: Transradial coronary intervention (TRI) has been widely adopted in ST elevation myocardial infarction (STEMI) patients but there is limited literature on the use of a single catheter for both diagnostic angiography and intervention. We aim to evaluate the feasibility and outcomes of TRI with a single Ikari left (IL) guiding catheter in STEMI patients. METHODS: This is a retrospective study of 362 consecutive STEMI patients from August 2007 to December 2008. We assessed the feasibility of TRI with a single IL and compared this strategy with conventional transfemoral intervention (TFI) on the following outcomes: (1) door to perfusion time, (2) total procedural duration, (3) total fluoroscopy duration, and (4) major adverse cardiac events (MACE) by intention to treat analysis. RESULTS: TRI was attempted in 185 patients. There were no failed radial cannulations. Overall success rate of primary TRI with a single IL was 96.9% and there were only 2 failures that required conversion to TFI. Compared to TFI, TRI with IL tended to a shorter median door to perfusion time, 90 (IQR 76.0 - 119.5) versus 98 (IQR 80.8 - 120.5) minutes (P = 0.07) and a shorter median procedure duration of 34 (IQR 27.0 - 45.0) versus 37 (IQR 28.0 - 49.3) minutes (P = 0.06). The median fluoroscopy duration was longer in the TRI group. MACE were comparable between the 2 groups. CONCLUSION: In experienced centers, TRI with a single IL catheter for STEMI is a feasible and effective approach and outcomes are comparable to conventional TFI.

Prasugrel versus clopidogrel in Asian patients with acute coronary syndromes: design and rationale of a multi-dose, pharmacodynamic, phase 3 clinical trial.

BACKGROUND: Prasugrel is a third generation thienopyridine that is more potent, rapid in onset, and consistent in inhibition of platelets than clopidogrel. However, early prasugrel dose-ranging studies and the subsequent phase 3 TRITON-TIMI 38 trial were conducted primarily in Caucasian populations. OBJECTIVES: The current clinical study is designed to confirm superior inhibition of platelet aggregation with prasugrel versus clopidogrel in the treatment of Asian subjects with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). RESEARCH DESIGN AND METHODS: This is a phase 3, randomized, double-blind, multi-dose, four-arm parallel, multinational clinical trial. East and Southeast Asian patients (N = 715) with moderate- to high-risk ACS undergoing PCI will be randomized to one of three prasugrel dosing regimens (60 mg LD/10 mg MD; 30 mg LD/7.5 mg MD; 30 mg LD/5 mg MD) or clopidogrel (300 mg LD/75 mg MD) for 90 days. MAIN OUTCOME MEASURES: The primary endpoint is inhibition of platelet aggregation measured by the point-of-care Accumetrics VerifyNow P2Y12 device, and the primary analysis will be performed in a hierarchical manner for descending doses of prasugrel. Additional key endpoints include major adverse cardiovascular events, non-coronary artery bypass-graft (CABG) surgery-related TIMI bleeding, and genetic analyses of cytochrome P450 polymorphisms. CONCLUSIONS: This study is a phase 3, multi-dose, pharmacodynamic comparison of prasugrel versus clopidogrel in Asian patients with ACS undergoing PCI. It is the first study designed to investigate prasugrel therapy specifically in Asian ACS subjects, and will inform which doses of prasugrel are effective and safe for patients of Asian ethnicity.

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.