Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: 12-month results from the TARGET II trial / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>In the TARGET I randomized controlled trial, the novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent FIREHAWK proved non-inferior to the everolimus-eluting stent in nine-month in-stent late loss in single de novo coronary lesions. This study was aimed at evaluating clinical safety and effectiveness of FIREHAWK in a moderately complex population (including patients with small vessels, long lesions and multi-vessels), and at validating the ability of the SYNTAX score (SS) to predict clinical outcomes in patients treated with this latest generation drug-eluting stent.</p><p><b>METHODS</b>TARGET II was a prospective, multicenter, single-arm study with primary outcome of 12-month target lesion failure (TLF), including cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (TLR). Stent thrombosis was defined according to the Academic Research Consortium (ARC) definition. Patients were grouped by tertiles of SS (≤6, >6 to ≤12, and >12). All patients were exclusively treated with the FIREHAWK stent and were followed up at 1, 6, and 12 months, and annually thereafter up to five years.</p><p><b>RESULTS</b>A total of 730 patients were included in this registry study. The 12-month incidence of TLF was 4.4% and the incidence of TLF components were, cardiac death 0.5%, TV-MI 3.2%, and TLR 2.2%. One definite/probable stent thrombosis was observed at 12-month follow-up. Mean SS was 10.87±6.87. Patients in the SS >12 tertile had significantly higher TLF (P = 0.02) and TLR (P < 0.01) rates than those in lower SS groups. In COX proportional-hazards regression analyses, TLF incidence was strongly related to lesion length (long lesion vs. non-long lesion patients; HR 3.416, 95% CI, 1.622-7.195), but unrelated to diabetic, small vessel, and multivessel subgroups.</p><p><b>CONCLUSIONS</b>The low TLF incidence in this study indicates that FIREHAWK is safe and effective in the treatment of moderately complex coronary disease. SS is also able to predict adverse clinical outcomes in FIREHAWK treated patients.</p>

Efficacy and safety of FIREHAWK® abluminal groove filled biodegradable polymer sirolimus-eluting stents for the treatment of long coronary lesions: nine-month angiographic and one-year clinical results from TARGET I trial long cohort / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Previous studies indicated that long coronary lesions are one of the key predictors of drug-eluting stent (DES) failure. The purpose of this study was to evaluate the efficacy and the safety of the long length FIREHAWK(®) stent in long coronary artery disease.</p><p><b>METHODS</b>The long cohort of TARGET I was a prospective, multicenter, single arm trial. It was planned to enroll 50 patients undergoing percutaneous coronary intervention (PCI) for the treatment of de novo long lesions in a native coronary artery. The major inclusion criteria of the trial was that patients were intended to undergo the treatment of a long target lesion(s) with diameter stenosis ≥ 70% and reference vessel diameter 2.5 mm to 4.0 mm by visual estimate, that needed to be covered by at least one 33 mm or 38 mm stent or multiple long stents overlapped. The angiographic follow-up was planned at 9-month and the clinical follow-up will be up to 5 years. The primary end point was in-stent late lumen loss at 9-month.</p><p><b>RESULTS</b>Fifty patients (mean age (57.6 ± 10.2) years) with 59 de novo long lesions (reference vessel diameter (2.85 ± 0.44) mm, lesion length (35.2 ± 9.4) mm, and stent length (41.8 ± 11.3) mm) were enrolled. The angiographic follow-up rate was 92% at 9-month. The in-stent late loss was (0.16 ± 0.16) mm. Proximal edge, distal edge and in-segment late loss (mm) were 0.21 ± 0.35, 0.03 ± 0.33, and 0.07 ± 0.26, respectively. No in-segment binary restenosis was observed. At 1-year no death, Q wave myocardial infarction (MI), or stent thrombosis occurred. Non-Q-wave MI occurred in two patients (4%) due to procedural complications.</p><p><b>CONCLUSIONS</b>Treatment of long coronary lesions with the FIREHAWK(®) stent is able to produce similar results as observed in the FIREHAWK(®) FIM clinical trial. Based on this result, we are confident in the treatment prospect of the FIREHAWK(®) for long coronary lesions.</p>

First report of a novel abluminal groove filled biodegradable polymer rapamycin-eluting stent in de novo coronary artery disease: results of the first in man FIREHAWK trial / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Durable polymers used for first-generation drug-eluting stents (DES) potentially contribute to persistent inflammation and late DES thrombosis. We report the first in human experience with the rapamycin-eluting biodegradable polymer coated cobalt-chromium FIREHAWK stent with abluminal groove.</p><p><b>METHODS</b>A total of 21 patients with stable or unstable angina, or prior myocardial infarction, with single de novo native coronary stenoses < 30 mm in length in vessel sizes ranging from 2.25 to 4.0 mm were enrolled. The primary endpoint was major adverse cardiac events (MACE) at 30 days defined as the composite of cardiac death, myocardial infarction (Q and non-Q), or ischemia-driven target lesion revascularization. Secondary endpoints include device, lesion, and clinical success rates, 4-month in-stent late lumen loss by quantitative coronary angiography (QCA), proportion of uncovered or malapposed stent struts by optical coherence tomograpphy (OCT) at 4 months, and MACE at 4, 12, 24 and 36-month follow-up.</p><p><b>RESULTS</b>Device success was 95.7%, lesion and clinical success was 100.0%. There were no MACE events at 30 days. One patient died of non-cardiac hemorrhagic stroke 5 days after index procedure. At 4 months, in-stent late loss was (0.13 ± 0.18) mm, and complete strut coverage was 96.2% by OCT with 0.1% strut malapposition. At 4-month follow-up there was no additional MACE events, and a single target vessel (non-target lesion) revascularization.</p><p><b>CONCLUSIONS</b>The FIREHAWK abluminal groove biodegradable polymer rapamycin-eluting stent demonstrated feasibility, safety and efficacy in this first in human experience. OCT findings indicated excellent stent strut coverage 4 months after implantation. Larger studies are required to confirm whether the early FIREHAWK stent results translate into longer term restenosis and thrombosis benefits.</p>

Stenting of Unprotected Left Main Coronary Artery Stenosis without Anticogulation: Immediate and Late Outcomes

BACKGROUND: Recently, several reports regarding the protected and/or unprotected left main stenting suggested the possibility of percutaneous intervention for this prohibited area. We intented to evaluate immediate and long-term outcomes after elective stenting of unprotected left main coronary artery in selected patients. METHOD: Forty eight consecutive patients with unprotected left main coronary artery stenosis and normal left ventricular function were treated with stents implantation. The poststent antithrombotic regimen were aspirin, ticlopidine with warfarin in 14 pateints or without warfarin in 34 patients. The stents for left main coronary artery stenosis were Palmaz-Schatz stent in 25, NIR stent in 8, Multi-link stent in 3, Cordis stent in 7, Palmaz stent in 2, Gianturco-Roubin stent II in 2, and Microstent in 1 patient. Intravascular ultrasound was performed in selected patients before predilation and after stenting at late stage of this study. RESULTS: The procedural success rate was 100%. Regardless of anticoagulation, the in hospital complication including stent thrombosis, myocardial infarction, emergency bypass surgery and death did not occur. Six-months follow-up angiography was performed in 31 patients(82%) of 38 eligible patients. The angiographic restenosis occurred in 7 patients(22%) who subsequently underwent elective coronary bypass surgery in 5 patients and rotational atherectomy/balloon angioplasty in 2 patients. The target lesion revascularization rate was 18%. One death(3%) occurred 2 days after elective coronary bypass surgery during follow-up period. CONCLUSION: Stenting of unprotected left main coronary artery stenosis might be a safe and effective alternative to bypass surgery in carefully selected patients with normal left ventricular function. However, further clinical study should be needed for the late outcomes with larger numbers of patients.

"Late Clinical Outcomes of Cordis Tantalum Coronary Stenting without Anticoagulation : Validation of Angiographic Measurement and In-stent Restenosis by Intravascular Ultrasound"

BACKGROUND: The Cordis coronary stent is a flexible, balloon expandable, radiopaque tantalum stent. Previous reports have shown excellent initial clinical outcomes. To our knowledge, there is no report of the long-term clinical outcomes. The intensely radiopaque tantalum may interfere with the angiographic assessment. We intended to evaluate long-term clinical and angiographic restenosis rates after successful implantation of the Cordis tantalum coronary stent. METHOD: Two hundred and eighty-five consecutive patients with 300 lesions were treated with 366 Cordis stents. An angiographic follow-up substudy was performed in 190 lesions ; 6 month follow-up angiograms were available in 167(88%). At follow-up, intravascular ultrasound(IVUS) was performed to (1) determine the pattern of restenosis and (2) to validate the quantitative coronary angiographic(QCA) caliper measurements. RESULTS: IVUS and QCA caliper measurement of minimal luminal diameter correlated reliably (r=0.767, p<0.001). The QCA analysis detected diffuse in-stent restenosis more reliably than focal in-stent restenosis(p<0.01). The overall angiographic restenosis rate was 19%, The factors affecting angiographic restenosis were post-stent minimum lumen diameter, type C lesion, and reference vessel size. CONCLUSION: We concluded 1) The angiographic restenosis rate of Cordis stent was comparable to that of other slotted-tube stent. 2) The QCA caliper method is reliable for the assessment of Cordis in-stent restenosis, especially in the detection of diffuse in-stent restenosis. However, QCA may miss focal in-stent restenosis only detectable by IVUS

The Effects of Excimer Laser Coronary Angioplasty in Calcified Lesions : Investigation with Intravascular Ultrasound

BACKGROUND: Coronary artery target lesion calcification may be an important determinant of the arterial response to catheter therapy for coronary arterial disease. The excimer laser coronary angioplasty(ELCA) has been reported to be a promising treatment for complex coronary artery disease. However, the effects of ELCA is not well known against the calcified target lesion. METHODS: To assess the arterial and plaque remodeling in calcified lesions after excimer laser coronary angioplasty, we used a comprehensive intravascular ultrasound(IVUS) imaging system(25MHz rotation transducer, 3.9 Fr monorail imaging sheath, motorized transducer pull back at 0.5mm/sec and quantification) to study 23 patients(1 left main, 10 LAD, 4 LCX, 6 RCA, 2 SVG) before and immediately after ELCA(the AIS 308nm XeCl excimer laser, pulse width >200nsec, pulse frequency 20Hz, energy density 35-65mJ/mm2). Paired before and after ELCA image slices were analysed ; and extermal elastic membrane, lumen, plaque+media(P+M) and calcium cross-sectional area(CSA) measured; and their differences after ELCA calculated. RESULTS: The IVUS results about the therapeutic effects of ELCA showed the enlargement of lumen CSA from 1.5+/-0.4 to 3.2+/-0.9mm2(p<0.001) and decreased of P+M CSA from 14.6+/-3.8 to 13.4+/-3.6mm2(p<0.001) without arterial expansion. The decrease of calcium CSA from 1.8+/-0.7 to 1.5+/-0.6mm2(p<0.001) and the formation of small, superficial fissures within the calcified plaque(15/23 lesions) were noted. The number of small fissures correlate with the calcium CSA significantly(r=0.61, p<0.001). CONCLUSION: The plaque and calcium ablation is the main effects of ELCA in calcified lesion, and the calcium ablation and fissure formation after ELCA may contribute to decrease the dissection and improve the success after ajunctive PTCA.