Site‐Specific Antithrombotic Therapy: 24‐Month Outcomes of the Randomized DESyne BDS Plus Trial Using a Novel Triple‐Drug Eluting Coronary Implant With Two Anticoagulants and Sirolimus

Two-Year Clinical, Angiographic, and Intravascular Ultrasound Follow-Up of the XIENCE V Everolimus-Eluting Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions: The SPIRIT II Trial

We evaluated the safety and efficacy of the novel dual-therapy sirolimus-eluting and endothelial progenitor cell (EPC) capture COMBO stent. (Very) late stent thrombosis (ST) and neo-atherosclerosis limit the performance of drug-eluting stents. The capture of EPCs accelerates stent re-endothelialization, thereby potentially decreasing the risk of restenosis and ST. In total, 440 patients with de novo lesions in native coronary arteries were randomized (1:1) to either receive the COMBO stent (n = 220) or Nano polymer-free sirolimus-eluting stent (n = 220). The primary endpoint was the 9-month angiographic in-segment late lumen loss (LLL). Secondary endpoints included target lesion failure (TLF), a patient-oriented composite endpoint (PoCE), and ST. At 9 months, the COMBO in-segment LLL (0.29 ± 0.46 mm) was non-inferior to that of the Nano comparator stent (0.31 ± 0.44 mm; pnon-inferiority < .0001). Clinical outcomes were also similar between the COMBO and Nano stents, with TLF rates of 9.3% and 7.9% (p = .61) at 12 months, and 9.4% and 8.0% (p = .62) at 24 months, respectively. The PoCE rate was 14.8% and 10.6% (p = .19) at 12 months, and 16.0% and 11.3% (p = .16) at 24 months, respectively. Ischemia-driven target lesion revascularization rates were 6.0% and 3.7% (p = .26) at 12 months, and 6.2% and 3.8% (p = .26) at 24 months, respectively. No case of ST occurred in either group. The RECOVERY trial has shown the COMBO stent was effective, meeting the primary non-inferiority angiographic endpoint, and safe, with an overall low rate of clinical events in both stent groups, including no ST for up to 2 years.

TCT-647 Value Of High-Density Lipoprotein Cholesterol In Predicting Future Cardiovascular Events Of Patients With Low-Density Lipoprotein Cholesterol At The Time Of Percutaneous Coronary Intervention

First Report of the Resolute Onyx 2.0-mm Zotarolimus-Eluting Stent for the Treatment of Coronary Lesions With Very Small Reference Vessel Diameter

The study sought to evaluate the safety and efficacy of FIREHAWK, a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES) for treating patients with single de novo coronary lesions compared with the durable polymer everolimus-eluting stent (EES) XIENCE V. A total of 458 patients with single de novo native coronary lesions ≤24 mm in length and a coronary artery ≥2.25 to ≤4.0 mm in diameter were enrolled in the TARGET I study, a prospective, randomised, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) at nine-month follow-up. The secondary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, target vessel myocardial infarction (TVMI), or ischaemia-driven target lesion revascularisation (iTLR). Patients were centrally randomised to treatment with either biodegradable polymer SES (n=227) or durable polymer EES (n=231). The nine-month in-stent LLL of the biodegradable polymer SES was comparable to the EES group (0.13 ± 0.24 mm vs. 0.13 ± 0.18 mm, p=0.94; difference and 95% confidence interval 0.00 [-0.04, 0.04] mm; p for non-inferiority <0.0001). Cardiac death (0.4% vs. 0.0%), TVMI (1.3% vs. 1.7%), iTLR (0.4% vs. 0.4%) and TLF (2.2% vs. 2.2%) were similar between the biodegradable polymer SES and durable polymer EES groups at 12-month follow-up (all p>0.05). No definite/probable stent thrombosis was observed in both of these groups. In the multicentre TARGET I trial, the novel abluminal groove-filled biodegradable polymer SES FIREHAWK was non-inferior to the durable polymer EES XIENCE V with respect to the primary endpoint of in-stent LLL at nine months for treating patients with single de novo coronary lesions. The incidences of clinical endpoints were low in both of the stents at 12-month follow-up. (ClinicalTrials.gov identifier: NCT01196819).

The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes

Final 5-year outcomes of the Epic02 - RANGO study: A real-world registry of the durable fluoroacrylate polymer-based sirolimus-eluting Angiolite® stent.

Background In recent years, drug-coated balloons (DCB) have established themselves as another tool in the arsenal of interventional cardiology devices for the treatment of in-stent restenosis (ISR) lesion. Aims The study was designed to compare the biolimus DCB to the paclitaxel-coated SeQuent PleaseTM DCB. Method This was a prospective, non-inferiority, randomized, multicenter, study conducted at 20 centers in 6 countries. The primary endpoint was in-segment % diameter stenosis (%DS) at six months. The study was powered to enrol 201 patients in at 2:1 randomization to either the biolimus DCB (BCB) or the SeQuent PleaseTM DCB (SQP). Key secondary endpoints included, late-lumen loss, binary restenosis, and target lesion failure (TLF) and myocardial infarction at 1 year. Results A total of 202 patients were randomised with 135 in the BCB group and 67 in the SQP group. Mean patient age was 68.9 ± 9.9 years in the BCB group compared to 68.2 ± 10.5 years in the SQP group. At 6 months, %DS was 41.8 ± 21.3 in the BCB group compared to 31.4 ± 17.7 in the SQP group (95% confidence for the difference: 3.5-16.9, p-value for non-inferiority 0.32). At 12 months, TLF was 23.74%, in the BCB group vs 17.07% in the control group, hazard ratio (HR) of 1.44 [95% CI: 0.72-2.88], p=0.28. There were more clinically driven revascularization in the BCB group (21.61%) compared to SQP (15.61%) [HR: 1.46, 95% CI: 0.71-3.01], p=0.29. More myocardial infarction were observed in the SQP group (BCB: 7.59% vs SQP: 3.77%, [HR: 0.48, 95% CI: 0.14-1.68], p=0.24)(see Figure). Conclusions In ISR patients, the REFORM study was not able to demonstrate non-inferioirity of the biolimus DCB compared to the SeQuent Please DCB.

Angiography and Optical Coherence Tomography Assessment of the Drug-Coated Balloon ESSENTIAL for the Treatment of In-Stent Restenosis

3-Year Outcomes of the DKCRUSH-V Trial Comparing DK Crush With Provisional Stenting for Left Main Bifurcation Lesions

In this second part of the article, we will complete the review of drug-eluting stent technologies (Table 1) and discuss methodological and technical aspects of drug-eluting stents. View this table: TABLE 1. Drug-Eluting Stent Platforms Under Investigation ### Biological Agents (Continued) #### (1) Stents Eluting Antiproliferative Agents A number of antineoplastic medications have been considered for the prevention of restenosis. Paclitaxel and its derivatives have been the most investigated compounds of this group. ##### (a) Paclitaxel-Eluting Stents Paclitaxel (Taxol; Bristol-Myers Squibb) is a microtubule-stabilizing agent with potent antitumor activity.1 Many different platforms that use polymer coating or surface modifications to adhere paclitaxel onto the stents have been utilized over the past 2 years. ###### Preclinical Data Unlike other antimitotic agents, paclitaxel shifts the cytoskeleton equilibrium toward assembly, leading to reduced vascular cell proliferation, migration, and signal transduction.2 Paclitaxel is highly lipophilic, resulting in a rapid cellular uptake and a long-lasting effect in the cell.3 NIR stents (Boston Scientific Corp) coated with poly(lactide-co-Σ-caprolactone) copolymer and paclitaxel (200 μg/stent) were placed in porcine coronary arteries. Paclitaxel-eluting stents showed a marked reduction in neointimal and medial cell proliferation at all time points (7, 28, 56, and 180 days).4 However, arteries treated with paclitaxel showed incomplete healing, late persistence of a large number of macrophages, and fibrin deposition. Similar findings were observed with a stent platform coated with cross-linked biodegradable polymer (chondroitin sulfate and gelatin) and 42.0, 20.2, 8.6, or 1.5 μg of paclitaxel in rabbit iliac arteries.5 These studies indicate the need for a more controlled drug release of paclitaxel due to the narrow toxic-therapeutic window and high hydrophobic character of this compound. ###### Clinical Data: De Novo Lesions The QuaDS drug-eluting stent (Quanam Medical Corp) was the first drug-eluting stent implanted in human coronary arteries. This slotted tube stent has 50% of its surface area covered by multiple nonbiodegradable polyacrylate sleeves that release 7-hexanoyltaxol (called QP2 or taxane). Approximately 800 μg of the …

Data about the long-term performance of new-generation ultrathin-strut drug-eluting stents (DES) in challenging coronary lesions, such as left main (LM), bifurcation, and chronic total occlusion (CTO) lesions are scant. The international multicenter retrospective observational ULTRA study included consecutive patients treated from September 2016 to August 2021 with ultrathin-strut (<70 µm) DES in challenging de novo lesions. Primary endpoint was target lesion failure (TLF): composite of cardiac death, target-lesion revascularization (TLR), target-vessel myocardial infarction (TVMI), or definite stent thrombosis (ST). Secondary endpoints included all-cause death, acute myocardial infarction (AMI), target vessel revascularization, and TLF components. TLF predictors were assessed with Cox multivariable analysis. Of 1801 patients (age: 66.6 ± 11.2 years; male: 1410 [78.3%]), 170 (9.4%) experienced TLF during follow-up of 3.1 ± 1.4 years. In patients with LM, CTO, and bifurcation lesions, TLF rates were 13.5%, 9.9%, and 8.9%, respectively. Overall, 160 (8.9%) patients died (74 [4.1%]from cardiac causes). AMI and TVMI rates were 6.0% and 3.2%, respectively. ST occurred in 11 (1.1%) patients while 77 (4.3%) underwent TLR. Multivariable analysis identified the following predictors of TLF: age, STEMI with cardiogenic shock, impaired left ventricular ejection fraction, diabetes, and renal dysfunction. Among the procedural variables, total stent length increased TLF risk (HR: 1.01, 95%CI: 1-1.02 per mm increase), while intracoronary imaging reduced the risk substantially (HR: 0.35, 95%CI: 0.12-0.82). Ultrathin-strut DES showed high efficacy and satisfactory safety, even in patients with challenging coronary lesions. Yet, despite using contemporary gold-standard DES, the association persisted between established patient- and procedure-related features of risk and impaired 3-year clinical outcome.

Objective: To compare the long term safety and efficacy of the novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent(Firehawk stent) and permanent polymer coating everolimus eluting stent(Xience V stent) for the treatment of coronary de novo lesions. Methods: This prospective, multi-center, non-inferiority, randomized control trial(TARGETⅠ trial) was performed between August 2010 and April 2011, a total of 460 patients with primary, de novo, single vessel and single coronary lesion from 16 medical centers were enrolled. The diameter stenosis of target lesion was ≥70%, and lesion length was≤24 mm. The patients were randomly assigned to treatment with Firehawk stent (Firehawk stent group) or Xience V stent (Xience V stent group) groups by a web-based allocation system and was stratified by center. The late lumen loss after 9 months, target lesion failure (TLF) which was a composite of cardiac death, target vessel myocardial infarction, or ischemia driven target lesion revascularization, patient-oriented composite endpoint (PoCE) which was a composite of all cause death, all cause myocardial infarction, or any revascularization, and stent thrombosis after 5 years were compared between the two groups. Results: (1) There were 2 patients without stent implantation dropped out of this trial. There were 227 patients in Firehawk stent group, and 231 patients in Xience V stent group. The baseline characteristics were similar between the two groups(all P>0.05). (2) The 9 months late lumen loss in Firehawk stent group was non-inferior to that in Xience V stent group ((0.13±0.24)mm vs. (0.13±0.18)mm, P=0.94). (3) A total of 442 (96.5%) patients completed 5 years clinical follow-up. There were no significant differences on 5-year TLF rate (6.0%(13/217) vs. 6.7% (15/225), P=0.77) and PoCE rate (12.0%(26/217) vs. 17.8% (40/225), P=0.09) between the Firehawk stent group and Xience V stent group. (4) Kaplan-Meier analysis showed that TLF rates between 1-5 years were similar in Firehawk stent group and Xience V stent group (5.7% and 6.6% respectively, HR=0.88, 95%CI 0.42-1.84, P=0.72). Land-Mark analysis showed that TLF rates bewteen 1-5 years were similar in Firehawk stent group and Xience V stent group (3.6% and 4.4% respectively, HR=0.83, 95%CI 0.34-2.00, P=0.67). Kaplan-Meier analysis showed that PoCE rates between 1-5 years were also similar in Firehawk stent group and Xience V stent group (11.4% and 17.3% respectively, HR=0.64, 95%CI 0.39-1.04, P=0.07). Land-Mark analysis showed that PoCE rates after 5 years were similar in Firehawk stent group and Xience V stent group (8.4% and 10.0% respectively, HR=0.66, 95%CI 0.40-1.10, P=0.11). (5) No stent thrombosis was documented in Firehawk stent group during the 5 years follow-up period, and there was 1 case of stent thrombosis in Xience V stent group after 3 years of stent implantation. Conclusion: TARGETⅠ trial results of 5 years follow up indicate the novel Firehawk stent have a durable safety and efficacy profile which is comparable to the Xience V stent in treating patients with single de novo coronary lesion. Clinical Trial Registration North American Clinical Trial Registration Center, NCT01196819.

Although several studies have shown positive outcomes after the use of drug-coated balloons (DCB) for in-stent restenosis (ISR), data on randomised controlled trials versus latest-generation drug-eluting stents (DES) are limited. Therefore, in this randomised trial, we sought to evaluate whether a butyryl-tri-hexyl citrate (BTHC)-based paclitaxel DCB is non-inferior to a biodegradable polymer sirolimus-eluting stent (BP-SES) therapy in patients with ISR in either a bare metal stent (BMS) or DES. A total of 229 patients with ISR in BMS or DES from 13 German centres and one Latvian centre were 2:1 randomly allocated to DCB (n=157) or DES (n=72). The primary efficacy endpoint was defined as in-stent late lumen loss (LLL) at six months, and the primary safety endpoint was target lesion failure (TLF) at 12 months. LLL in the DCB arm was 0.03±0.40 mm compared to 0.20±0.70 mm in the DES arm (p=0.40). DCB proved to be non-inferior to DES (Δ = -0.17±0.52 mm, 97.5% CI -∞; -0.01]; p<0.0001). At 12 months, Kaplan-Meier TLF estimates were 16.7% in the DCB arm and 14.2% in the DES arm (p=0.65) and remained similar at 18 months (DCB versus DES: 17.4% versus 19.5%, p=0.88). In patients with DES or BMS ISR, treatment with a paclitaxel DCB showed similar LLL at six months and TLF rates up to 18 months compared to a second-generation sirolimus DES.

Prospective study to evaluate safety and efficacy of Zotarolimus Eluting Stent (PSEZES) in patients with long coronary artery lesions