In-segment Late Lumen Loss Research Articles

Abstract 4136442: Efficacy and Safety of Paclitaxel-coated balloons versus Uncoated balloons in the Management of Coronary in-stent restenosis: a Meta Analysis of Randomized Controlled Trials

Introduction: Coronary in-stent restenosis (ISR) remains challenging despite stent technology advancements. Paclitaxel-coated balloons (PCB) offer a promising non-implant approach to deliver antiproliferative agents directly to the vessel wall. This meta-analysis aims to evaluate the comparative effectiveness of PCB versus uncoated balloons (UCB) in managing coronary ISR to address emerging safety concerns. Methodology: Medline, Scopus and Embase were searched until April 2024 for randomized controlled trials (RCTs) comparing PCB versus UCB in patients undergoing coronary ISR. Primary outcomes were in-segment late lumen loss (LLL), binary restenosis, target lesion revascularization (TLR), major adverse cardiac events (MACE), and mortality. Secondary outcomes included in-stent LLL, in-stent binary restenosis, myocardial infarction (MI), cardiac death, target vessel MI, and target vessel revascularization (TVR). Results: This meta-analysis includes seven RCTs with 1,408 patients (PCB = 864, UCB = 544). PCB significantly reduced in-segment LLL (MD= -0.50, 95% CI [-0.67, -0.33]; P < 0.00001), in-segment binary restenosis (RR= 0.25, 95% CI [0.14, 0.45]; P < 0.00001), target lesion revascularization (RR= 0.43, 95% CI [0.32, 0.58]; P < 0.00001), mortality (RR=0.56, 95% CI [0.39, 0.80]; P=0.001), and MACE (RR= 0.36, 95% CI [0.25, 0.51]; P < 0.00001). PCB also significantly decreased in-stent LLL (MD= -0.52, 95% CI [-0.72, -0.32]; P < 0.00001), in-stent binary restenosis (RR = 0.19, 95% CI [0.11, 0.35]; P < 0.00001), and TVR (RR = 0.45, 95% CI [0.29, 0.70]; P = 0.0003). PCB showed a short-term reduction in MACE and target lesion revascularization at 6 months, 1 year and 3 years of followup. No difference was observed in MI, cardiac death, or target vessel MI. Conclusion: In patients with coronary ISR, PCB are associated with reduced in-segment LLL, in-segment binary restenosis events, target lesion revascularization, mortality, MACE, in-stent LLL, in-stent binary restenosis and target vessel revascularization.

A randomised trial of sirolimus- versus paclitaxel-coated balloons for de novo coronary lesions.

Paclitaxel-coated balloons (PCB) are a viable alternative to drug-eluting stents in the treatment of de novo coronary lesions. Whether sirolimus represents an alternative to paclitaxel for drug-coated balloons remains elusive. This randomised, controlled, multicentre, non-inferiority trial investigated a novel sirolimus-coated balloon (SCB) with a crystalline coating versus a PCB in de novo coronary lesions. To compare a novel SCB with a clinically proven PCB, 70 patients with de novo coronary lesions were enrolled at 4 centres in Germany and Switzerland. The primary endpoint was non-inferiority regarding angiographic late lumen loss (LLL) at 6 months, with a predefined margin of δ=0.35 mm. Secondary endpoints included procedural success, major adverse cardiac events, and individual clinical endpoints. Quantitative coronary angiography revealed no differences in baseline parameters. At 6 months, in-segment LLL was 0.04±0.39 mm in the PCB group versus 0.11±0.37 mm in the SCB group (non-significant), respectively. The mean difference between SCB and PCB was 0.07 mm (95% confidence interval: -0.12 to 0.26). Non-inferiority at the predefined margin of 0.35 was shown. Clinical event rates up to 12 months were not different between the groups (3 target lesion revascularisations in the PCB group versus 2 in the SCB group, no myocardial infarctions, no deaths). The novel SCB showed similar angiographic outcomes in the treatment of de novo coronary disease as compared with a clinically proven PCB (ClinicalTrials.gov: NCT03908450).

Clinical safety and performance of the world's thinnest-strut Evermine50 everolimus-eluting stent: a 24-month follow-up of the Evermine 50 EES - 1 study.

Ultrathin-strut stents are considered the future of percutaneous coronary intervention for treating coronary artery disease (CAD). These drug-eluting stents with biodegradable-polymer technology have the potential to improve clinical outcomes in CAD patients. This study aimed to evaluate the safety and performance of newer-generation ultrathin-strut (50 µm) Evermine50 everolimus-eluting stents (EES) in patients with single or multiple long lesions. This is a prospective, single-arm, multicentre study conducted in India that enrolled 118 patients with de novo coronary lesions. The endpoints were defined based on the major adverse cardiac events (MACE; composite of cardiac death, myocardial infarction [MI] and clinically driven target lesion revascularisation) up to 24-month follow-up. A subset of patients (n=21) underwent angiographic follow-up for a mean follow-up period of 12 mon. A total of 138 lesions were successfully treated in 118 patients, the majority of whom were males (80.51%). The average stent length and diameter deployed were 26.02±9.24 mm and 2.97±0.36 mm, respectively. The results exhibited low MACE at 24-month follow-up (0.87%) with no stent thrombosis and 1 death (0.87%, which was cardiac). The core lab angiographic assessment showed in-segment and in-device late lumen loss of 0.12±0.31 mm and 0.17±0.31 mm, respectively, at a mean follow-up of 12 months, with clinically acceptable outcomes. The Evermine50 EES showed satisfactory primary clinical as well as angiographic outcomes, reaffirming the safety and performance of the world's thinnest-strut stent by exhibiting low rates of MACE at 24-month follow-up with an absence of any stent thrombosis and MI. Clinical Trials Registry-India (CTRI) number: CTRI/2017/02/007781.

Biolimus-coated versus paclitaxel-coated balloons for coronary in-stent restenosis (BIO ASCEND ISR): a randomised, non-inferiority trial.

The treatment of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation remains challenging in current clinical practice. The study was conducted to investigate a novel biolimus-coated balloon (BCB) for the treatment of coronary DES-ISR compared with the best-investigated paclitaxel-coated balloon (PCB). This was a prospective, multicentre, randomised, non-inferiority trial comparing a novel BCB with a clinically proven PCB for coronary DES-ISR. The primary endpoint was in-segment late lumen loss (LLL) at 9 months assessed by an independent core laboratory. Baseline and follow-up optical coherence tomography were performed in a prespecified subgroup of patients. A total of 280 patients at 17 centres were randomised to treatment with a BCB (n=140) versus a PCB (n=140). At 9 months, LLL in the BCB group was 0.23±0.37 mm compared to 0.25±0.35 mm in the PCB group; the mean difference between the groups was -0.02 (95% confidence interval [CI]: -0.12 to 0.07) mm; p-value for non-inferiority<0.0001. Similar clinical outcomes were also observed for both groups at 12 months. In the optical coherence tomography substudy, the neointimal area at 9 months was 2.32±1.04 mm2 in the BCB group compared to 2.37±0.93 mm2 in the PCB group; the mean difference between the groups was -0.09 (95% CI: -0.94 to 0.76) mm2; p=non-significant. This head-to-head comparison of a novel BCB shows similar angiographic outcomes in the treatment of coronary DES-ISR compared with a clinically proven PCB. (ClinicalTrials.gov: NCT04733443).

Intravascular Ultrasound vs Angiography-Guided Drug-Coated Balloon Angioplasty: The ULTIMATE Ⅲ Trial

BackgroundDrug-coated balloon (DCB) angioplasty seems a safe and effective option for specific de novo coronary lesions. However, the beneficial effect of intravascular ultrasound (IVUS)-guided DCB angioplasty in de novo lesions remains uncertain. ObjectivesThis study aimed to assess the benefits of IVUS guidance over angiography guidance during DCB angioplasty in de novo coronary lesions. MethodsA total of 260 patients with high bleeding risk who had a de novo coronary lesion (reference vessel diameter 2.0-4.0 mm, and lesion length ≤15 mm) were randomly assigned to either an IVUS-guided or an angioplasty-guided DCB angioplasty group. The primary endpoint was in-segment late lumen loss (LLL) at 7 months after procedure. The secondary endpoint was target vessel failure at 6 months. ResultsA total of 2 patients in the angiography-guided group and 7 patients in the IVUS-guided group underwent bailout stent implantation (P = 0.172). The primary endpoint of 7-month LLL was 0.03 ± 0.52 mm with angiography guidance vs −0.10 ± 0.34 mm with IVUS guidance (mean difference 0.14 mm; 95% CI: 0.02-0.26; P = 0.025). IVUS guidance was also associated with a larger 7-month minimal lumen diameter (2.06 ± 0.62 mm vs 1.75 ± 0.63 mm; P < 0.001) and a smaller diameter stenosis (28.15% ± 13.88% vs 35.83% ± 17.69%; P = 0.001) compared with angiography guidance. Five target vessel failures occurred at 6 months, with 4 (3.1%) in the angiography-guided group and 1 (0.8%) in the IVUS-guided group (P = 0.370). ConclusionsThis study demonstrated that IVUS-guided DCB angioplasty is associated with a lower LLL in patients with a de novo coronary lesion compared with angiography guidance. (Intravascular Ultrasound Versus Angiography Guided Drug-Coated Balloon [ULTIMATE-III]; NCT04255043)

Sirolimus-eluting iron bioresorbable scaffold versus cobalt-chromium everolimus-eluting stents in patients with coronary artery disease: Rationale and design of the IRONMAN-II trial

BackgroundThe previous first-in-human study established the preliminary safety and effectiveness of the novel thin-strut iron bioresorbable scaffold (IBS). The current study aims to directly compare the imaging and physiological efficacy, and clinical outcomes of IBS with contemporary metallic drug-eluting stents (DES). MethodsA total of 518 patients were randomly allocated to treatment with IBS (257 patients) or metallic DES (261 patients) from 36 centers in China. The study is powered to test noninferiority of the IBS compared with the metallic everolimus-eluting stent in terms of the primary endpoint of in-segment late lumen loss at 2 years, and major secondary endpoints including 2-year quantitative flow ratio and cross-sectional mean flow area measured by optical coherence tomography (OCT) (limited to the OCT subgroup, 25 patients in each group). ConclusionThis will be the first powered randomized trial investigating the safety and efficacy of the novel thin-strut IBS compared to a contemporary metallic DES. The findings will provide valuable evidence for future research of this kind and the application of metallic bioresorbable scaffolds.

Is There an Advantage of Ultrathin-Strut Drug-Eluting Stents over Second- and Third-Generation Drug-Eluting Stents?

In patients undergoing percutaneous coronary intervention, the second-generation drug-eluting stents (DES) are considered the gold standard of care for revascularization. By reducing neointimal hyperplasia, drug-eluting coronary stents decrease the need for repeat revascularizations compared with conventional coronary stents without an antiproliferative drug coating. It is important to note that early-generation DESs were associated with an increased risk of very late stent thrombosis, most likely due to delayed endothelialization or a delayed hypersensitivity reaction to the polymer. Studies have shown a lower risk of very late stent thrombosis with developing second-generation DESs with biocompatible and biodegradable polymers or without polymers altogether. In addition, research has indicated that thinner struts are associated with a reduced risk of intrastent restenosis and angiographic and clinical results. A DES with ultrathin struts (strut thickness of 70 µm) is more flexible, facilitates better tracking, and is more crossable than a conventional second-generation DES. The question is whether ultrathin eluting drug stents suit all kinds of lesions. Several authors have reported that improved coverage with less thrombus protrusion reduced the risk of distal embolization in patients with ST-elevation myocardial infarction (STEMI). Others have described that an ultrathin stent might recoil due to low radial strength. This could lead to residual stenosis and repeated revascularization of the artery. In CTO patients, the ultrathin stent failed to prove non-inferiority regarding in-segment late lumen loss and showed statistically higher rates of restenosis. Ultrathin-strut DESs with biodegradable polymers have limitations when treating calcified (or ostial) lesions and CTOs. However, they also possess certain advantages regarding deliverability (tight stenosis, tortuous lesions, high angulation, etc.), ease of use in bifurcation lesions, better endothelialization and vascular healing, and reducing stent thrombosis risk. In light of this, ultrathin-strut stents present a promising alternative to existing DESs of the second and third generation. The aims of the study are to compare ultrathin eluting stents with second- and third-generation conventional stents regarding procedural performance and outcomes based on different lesion types and specific populations.

Comparing the efficacy and safety of two different drug-coated balloons in in-stent restenosis: Two-year clinical outcomes of the RESTORE ISR China randomized trial

BackgroundThis head-to-head, multicenter, randomized trial investigated the safety and efficacy of Restore (Cardionovum, Bonn, Germany) drug-coated balloon (DCB) angioplasty in an Asian patient population with coronary drug-eluting stent in-stent restenosis (DES-ISR). MethodsA total of 240 patients with coronary DES-ISR were treated with Restore DCB or with SeQuent® Please (Braun, Melsungen, Germany) DCB. This trial used nine-month in-segment late lumen loss (LL) as the primary endpoint. Secondary endpoints included two-year clinical event rates. ResultsPatient, lesion, and procedural characteristics in both treatment groups were similar. Nine-month in-segment LL was 0.38 ± 0.50 mm with Restore vs. 0.35 ± 0.47 mm with SeQuent® Please (p for non-inferiority = 0.02). The two-year follow-up rates were 95.8 % (115/120) in the Restore group and 94.2 % (113/120) in the SeQuent® Please group. Both groups had similar one- and two-year target lesion failure (TLF) rates (13.3 % vs. 12.6 %; p = 0.87 at one year, 14.8 % vs. 15.0 %; p = 1.0 at two years). Moreover, the all-cause mortality and myocardial infarction rates were 0 and 3.5 % (4/120) in the Restore group and 0.9 % (1/120) and 3.5 % (4/120) in the SeQuent® Please group, respectively. Additional analyzing of vessel quantitative flow ratio (QFR) did also show noninferior outcomes for one explicit treatment bunch. ConclusionsThe two-year follow-up indicated sustained long-term clinical safety and efficacy for both devices on the basis of QFR value.

Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions.

Paclitaxel-coated balloons (PCBs) are a preferred treatment option for coronary in-stent restenosis. To date, data from randomized trials of alternative drug coatings are lacking. The aim of the randomized Malaysian and German-Swiss randomized trials was to investigate a novel sirolimus-coated balloon (SCB) compared with a PCB in in-stent restenosis. One hundred one patients with drug-eluting stent in-stent restenosis were enrolled in 2 identical randomized trials comparing the novel SCB (SeQuent SCB, 4 μg/mm²) with the clinically proven PCB (SeQuent Please, 3 μg/mm²). Primary end point was angiographic late lumen loss at 6 months. Secondary end points included procedural success, major adverse cardiac events, and individual clinical end points such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.25±0.57 mm in the PCB group versus 0.26±0.60 mm in the SCB group. Mean difference between SCB and PCB was 0.01 (95% CI, -0.23 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. Clinical events up to 12 months did not differ between the groups. This first-in man comparison of a novel SCB with a crystalline coating showed similar angiographic and clinical outcomes in the treatment of coronary drug-eluting stent in-stent restenosis compared with PCB. URL: https://www. gov; Unique identifier: NCT02996318, NCT03242096.

Comparison of Different Types of Drug-Eluting Stents for De Novo Long Coronary Artery Lesions.

Outcomes of percutaneous coronary intervention for diffuse long lesions remain relatively unfavorable. Prior clinical trials investigated the relative efficacy and safety of different types of drug-eluting stents (DES) in long lesions. This study sought to compare the relative performance of different types of DES for de novo long (≥25mm) coronary artery lesions. Using a pooled analysis of individual data of 1,450 patients from 3 randomized clinical trials, we compared angiographic and clinical outcomes of 5 different types of DES: 224 patients with cobalt-chromium everolimus-eluting stents (EES), 255 with platinum-chromium EES, 250 with Resolute zotarolimus-eluting stents, 245 with biodegradable polymer biolimus-eluting stents, and 476 with first-generation sirolimus-eluting stents (SES). The primary endpoint was in-segment late lumen loss at 9months. The primary endpoint was not significantly different between 4 second-generation DES and 1 first-generation SES (0.17 ± 0.41mm in cobalt-chromium EES; 0.11 ± 0.37 in platinum-chromium EES: 0.14 ± 0.38 in Resolute zotarolimus-eluting stents; 0.14 ± 0.38 in biodegradable polymer biolimus-eluting stents; or 0.10 ± 0.37 in SES, respectively, overall P = 0.38). Also, there were no significant between-group differences with respect to death, myocardial infarction, target-vessel revascularization, or stent thrombosis at 12months. In the multiple treatment propensity-score analysis, the risk of angiographic and clinical outcomes was also similar among several types of DES. In this patient-level pooled analysis, several second-generation DES showed similar angiographic and clinical outcomes in patients with de novo long coronary lesions. (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III [LONG-DES-III]; NCT01078038; Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV [LONG-DES-IV]; NCT01186094; and Everolimus-eluting [PROMUS-ELEMENT] vs. Biolimus A9-Eluting [NOBORI] Stents for Long-Coronary Lesions [LONG-DES-V]; NCT01186120).

Biolimus-Coated Balloon in Small-Vessel Coronary Artery Disease: The BIO-RISE CHINA Study.

Drug-coated balloons are a safe and effective option for patients undergoing percutaneous coronary intervention, but prior randomized studies have exclusively used paclitaxel-coated devices. The aim of this study was to assess for the first time the safety and efficacy of a novel biolimus-coated balloon (BCB) in patients with small-vessel coronary disease. In a prospective trial conducted at 10 centers in China, 212 patients with small-vessel native coronary disease (reference vessel diameter 2.0-2.75mm, lesion length≤25mm) were randomized to receive a BCB or an uncoated balloon. The primary endpoint was in-segment late lumen loss at 9months. In the per-protocol population, angiographic late lumen loss at 9months was 0.16 ± 0.29mm in the BCB group vs 0.30 ± 0.35mm with the plain balloon (P=0.001). Late luminal enlargement (positive remodeling) occurred in 29.7% of patients in the BCB group vs 9.8% of patients with plain balloons (P=0.007). In the full analysis set population, after 12months, target lesion failure rates were 6.7% in the BCB group vs 13.9% with the plain balloon (HR: 0.47; 95%CI: 0.19-1.16), and rates of the patient-oriented clinical outcome were 14.3% with the BCB vs 21.8% with the plain balloon (HR: 0.64; 95%CI: 0.33-1.24). In this first-in-human study, a novel BCB showed superior efficacy to plain balloon angioplasty in patients with small-vessel coronary disease undergoing percutaneous coronary intervention. Positive vascular remodeling was more frequent, and there was a trend toward improved clinical outcomes. (A Randomized Trial of a Biolimus-Coated Balloon Versus POBA in Small Vessel Coronary Artery Disease [Brave]; NCT03769623).

A prospective, multicentre first-in-man study of the polymer-free ultrathin-strut BIOrapid stent (BIOVITESSE).

Polymer-free drug-coated stents aim to avoid the inflammatory potential of durable polymers, thereby improving the long-term safety profile, and allowing a shorter duration of dual antiplatelet therapy. The BIOVITESSE study was conducted to assess the safety and clinical performance of the BIOrapid polymer-free coronary stent system coated with a novel highly lipophilic sirolimus derivate. BIOVITESSE was a prospective, multicentre, first-in-man study that enrolled subjects with de novo coronary lesions in two cohorts of 33 patients each. The primary endpoint of the first cohort was strut coverage at one month as assessed by optical coherence tomography. The primary endpoint of the second cohort was late lumen loss at nine-month follow-up. Patients were on average 63 years old (range: 42-87) and 12% had diabetes. The 66 patients had 70 lesions with an average lesion length of 12.5±5.4 mm. Predilatation was performed in 91.4% and post-dilatation in 87.1% lesions; device success was obtained in 97.4%. At one month, 95.2±5.6% (95% CI: 93.2-97.2) of struts were covered and at nine months, in-stent late lumen loss was 0.31±0.30 mm (95% CI: 0.20-0.42) and in-segment late lumen loss was 0.20±0.29 mm. Two target lesion failures occurred (3.1%): one at day 1 (to cover an asymptomatic stent edge dissection), and one at day 288 post-procedure for restenosis. No stent thrombosis was reported during the 12-month study duration. The BIOrapid stent system exhibited an excellent safety profile, high strut coverage at one-month, and moderate angiographic efficacy according to the late lumen loss at nine-month angiographic follow-up.

Treatment of Coronary De Novo Lesions by a Sirolimus- or Paclitaxel-Coated Balloon

The aim of this randomized controlled trial was to investigate a novel sirolimus-coated balloon (SCB) compared with the best investigated paclitaxel-coated balloon (PCB). There is increasing clinical evidence for the treatment of coronary de novo disease using drug-coated balloons. However, it is unclear whether paclitaxel remains the drug of choice or if sirolimus is an alternative, in analogy to drug-eluting stents. Seventy patients with coronary de novo lesions were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, B. Braun Melsungen; 4μg/mm2) with a PCB (SeQuent Please, B. Braun Melsungen; 3μg/mm2). The primary endpoint was angiographic late lumen loss (LLL) at 6months. Secondary endpoints included major adverse cardiovascular events and individual clinical endpoints such as cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. Quantitative coronary angiography revealed no differences in baseline parameters. After 6months, in-segment LLL was 0.01 ± 0.33mm in the PCB group versus 0.10 ± 0.32mm in the SCB group. The mean difference between SCB and PCB was 0.08 (95%CI:-0.07 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. However, negative LLL was more frequent in the PCB group (60% of lesions vs 32% in the SCB group; P=0.019). Major adverse cardiovascular events up to 12months also did not differ between the groups. This first-in-human comparison of a novel SCB with a crystalline coating showed similar angiographic outcomes in the treatment of coronary de novo disease compared with a clinically proven PCB. However, late luminal enlargement was more frequently observed after PCB treatment. (Treatment of Coronary De-Novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia [SCBDNMAL]; NCT04017364).

Comparison of 2 Different Paclitaxel-Coated Balloons in CoronaryIn-Stent Restenosis: A Randomized Controlled Trial.

Drug-coated balloons (DCBs) offer an effective treatment for in-stent restenosis (ISR). The Genoss DCB is a novel paclitaxel-coated balloon with a shellac plus vitamin E excipient that enhances drug delivery to the target lesion, minimizing restenosis. This study aimed to investigate the angiographic efficacy, clinical safety, and effectiveness of the novel shellac plus vitamin E-based DCB in a randomized controlled trial designed to enable regulatory approval of this new device in South Korea. This noninferiority trial randomized patients experiencing their first ISR to the novel shellac plus vitamin E-based DCB or the reference SeQuent Please iopromide-based DCB in a 1:1 ratio. All patients underwent planned angiographic and clinical follow-up at 6months. The study was powered for the primary endpoint of 6months in-segment late lumen loss (LLL). A total of 82 patients from 7 centers were randomized to either the novel shellac plus vitamin E-based DCB group (n=41) or the reference iopromide-based DCB group (n=41). The 6-month in-segment LLL was 0.15 ± 0.43mm with the novel DCB compared with 0.24 ± 0.39mm with the reference device. The 1-sided 97.5% upper confidence limit of the difference was 0.13mm, lower than the noninferiority limit of 0.29mm, achieving noninferiority (P for noninferiority=0.001). Major cardiovascular events were comparable between 2 groups at 6months (7.7% for the novel DCB vs 10.3% for the reference DCB; P = 0.692). In this multicenter, head-to-head comparison randomized trial, the novel shellac plus vitamin E-based DCB showed a comparable result to the reference iopromide-based device for the primary endpoint of 6-month in-segment LLL for the treatment of coronary ISR. (Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please in Korean Patient With Coronary In-stent Restenosis; NCT04405063).

High-speed rotational atherectomy in coronary artery calcification: The randomized ROTAXUS and PREPARE-CALC trials.

The clinical outcomes of high-speed rotational atherectomy (RA) to optimize target lesion preparation in coronary artery calcification (CAC) have been examined in several trials. This study was conducted to evaluate the safety and efficacy of RA for CAC. Patient data were pooled from ROTAXUS and PREPARE-CALC. The primary endpoint was the in-stent late lumen loss and major adverse cardiac events at 9 months. Secondary endpoints included in-segment late lumen loss, binary restenosis, strategy success, procedural duration, and contrast amount. Four hundred and forty patients were enrolled from Germany in this study, 220 patients were randomized to the RA group and 220 patients were randomized to the Control group. Despite similar baseline characteristics, significantly more patients in the Control group were crossover (14.1% vs. 2.3%, p < 0.0001), resulting in higher strategy success in the RA group (95.0% vs. 82.3%, p < 0.0001). At 9 months, in-stent late lumen loss was higher in the RA group (0.34 ± 0.52 mm vs. 0.24 ± 0.47 mm, p = 0.03) and procedural duration was longer in the RA group (76.3 ± 41.8 min vs. 67.0 ± 38.8 min, p = 0.02). major adverse cardiac events (17.8% vs. 25.2%, p = 0.06), in-segment late lumen loss (0.28 ± 0.66 mm vs. 0.17 ± 0.55 mm, p = 0.05), binary restenosis (7.3% vs. 8.2%, p = 0.71 in-stent; 7.7% vs. 9.0%, p = 0.62 in-segment), and contrast amount (215.5 ± 112.5 ml vs. 203.7 ± 96.5 ml, p = 0.24) were similar in both groups. Lesion preparation with upfront RA before drug-eluting stent implantation is feasible in CAC, is more strategy successful, and is associated with excessive in-stent late lumen loss and excellent clinical outcomes at 9 months although longer procedural duration.

Osstem Cardiotec Centum Stent Versus Xience Alpine Stent for De Novo Coronary Artery Lesion: A Multicenter, Randomized, Parallel-Designed, Single Blind Test.

To compare the safety and efficacy of a new everolimus-eluting stent with an abluminal-coated biodegradable polymer (Osstem Cardiotec Centum) with those of the Xience Alpine stent (Xience). This randomized, prospective, multicenter, parallel-designed, single-blind trial was conducted among patients with myocardial ischemia undergoing percutaneous coronary intervention (PCI) from 21st September 2018 until 3rd July 2020. The primary efficacy endpoint was in-segment late lumen loss (LLL) at 270 days after the procedure and the primary safety endpoints were major adverse cardiac events (MACE), composite of cardiac death, myocardial infarction, and target lesion revascularization. We enrolled 121 patients and analyzed 113 patients who finished 270 days of follow-up for the primary efficacy endpoint. The mean age of the participants was 66.8 years. As for the primary efficacy endpoint, LLL of the Osstem Cardiotec Centum group was 0.09±0.13 mm and that of the Xience group was 0.12±0.14 mm (upper limit of 1-sided 95% confidence interval, 0.02; p for non-inferiority, 0.0084). This result demonstrates the non-inferiority of the Osstem Cardiotec Centum. As for the primary safety endpoint, MACE occurred in one patient (1.59% of the Xience group). Meanwhile, no MACE occurred in the Osstem Cardiotec Centum group. The Osstem Cardiotec Centum is non-inferior to the Xience Alpine® stent and is confirmed to be safe. It could be safely and effectively applied to patients with coronary artery disease undergoing PCI.

Nine-month angiographic and 2-year clinical outcomes of the RECOVERY trial: A randomized study of the biodegradable polymer sirolimus-eluting COMBO dual-therapy stent versus a polymer-free sirolimus-eluting stent in Chinese patients.

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.

A First-in-Man Clinical Evaluation of Sirolimus and Ascorbic Acid-Eluting Stent Systems: a Multicenter, Subject-Blinded, Randomized Study.

This clinical trial was conducted to evaluate the safety and efficacy of D+Storm™ drug-eluting stent (DES) and BioMatrix Flex™ DES. This study was a multicenter, subject-single-blind, randomized, and confirmed comparative clinical trial. According to the inclusion criteria, those diagnosed with stable angina, unstable angina, silent ischemia, or non-ST-segment myocardial infarction were selected among patients with coronary artery stenosis as subjects. Among the subjects with 50% stenosis on coronary angiography, the experiment was performed on those who had a lesion with reference vessel 2.5-4.0 mm in diameter and ≤40 mm in length. The primary endpoint was an in-segment late loss and the secondary endpoints were in-stent late lumen loss, stent malapposition, the incidence of mortality, myocardial infarction, reoperation, and stent thrombosis at 36 weeks. 57 patients in the D+Storm™ DES group and 55 patients in the BioMatrix Flex™ DES group were enrolled in the study. Fifty-seven patients in the D+Storm™ DES group and Fifty-five patients in the BioMatrix Flex™ DES group were enrolled in the study. An average of in-segment late lumen loss was 0.08±0.13 mm in the D+Storm™ DES group and 0.14±0.32 mm in the BioMatrix Flex™ DES group with no significant difference between the 2 groups (p=0.879). In addition, there was no significant difference in adverse events between D+Storm™ DES and BioMatrix Flex™ DES. This study demonstrated the clinical effectiveness and safety of D+Storm™ DES implantation in patients with coronary artery disease over a 36-week follow-up period.

Drug-Coated balloons vs drug-eluting stents for the treatment of small coronary artery disease: A meta-analysis of randomized trials.

There is conflicting evidence about the effects of drug-coated balloons (DCB) compared with drug-eluting stents (DES) in patients with native small vessel coronary artery disease (CAD). The PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases and main international conference proceedings were searched for randomized controlled trials (RCT) comparing DCB versus DES in patients with native small vessel CAD. Data were pooled by meta-analysis using a random-effects model. The primary endpoint was target vessel revascularization (TVR). Secondary clinical endpoints were: myocardial infarction (MI), target lesion revascularization (TLR), all-cause death, cardiac death, and stent thrombosis or target vessel thrombosis. Secondary angiographic outcomes were: in-segment restenosis, in-segment percentage-diameter stenosis, in-segment late lumen loss, in-segment net luminal gain, and in-segment minimal lumen diameter. Five trials enrolling 1,459 patients were included. Mean clinical follow-up was 10.2months. The use of DCB, compared with DES, was associated with similar risk of TVR (odds ratio [OR]: 0.97; 95% confidence interval [CI] 0.56 to 1.68; p=.92), TLR (OR: 1.74; 95% CI: 0.57 to 5.28; p=.33), all-cause death (OR: 1.03; 95% CI: 0.14 to 7.48; p=.98), with a trend toward a lower risk of MI (OR: 0.49; 95% CI: 0.23 to 1.03; p=.06), and with significant lower risk of vessel thrombosis (OR: 0.12; 95% CI: 0.01 to 0.94; p=.04). DCB use was associated with similar risk of angiographic restenosis (OR: 1.12; 95% CI 0.69 to 1.84; p=.64), comparable late luminal loss (standardized mean difference (SMD): -0.18; 95% CI: -0.39 to 0.03; p=.09), while leading to significant higher percentage diameter stenosis (SMD: 0.27; 95% CI 0.12 to 0.41; p < .01) and smaller minimal luminal diameter (SMD: -0.52; 95% CI: -0.86 to -0.18; p=.003). Compared with DES, the use of DCB for the treatment of native small vessel CAD is associated with similar TVR and restenosis and reduces the risk of vessel thrombosis, although DES implantation yields slightly better angiographic surrogate endpoints.

Drug-coated balloon versus drug-eluting stent for treating de novo coronary lesions in large vessels: ameta-analysis of clinical trials.

Studies examining the efficiency of drug-coated balloon (DCB) compared to drug-eluting stents (DES) for de novo lesions in large vessels have reported inconsistent results. This comprehensive meta-analysis of clinical trials compared the efficacy and safety of DCB and DES for the treatment of de novo coronary lesions. The authors formally searched electronic databases before October 2019 to identify randomized and non-randomized clinical trials (RCTs and non-RCTs, respectively). Clinical trials were eligible for inclusion if they compared DCB with DES in patients with coronary lumen diameters >2.5 mm. Three RCTs and one non-RCT with atotal of 321 patients were included in our meta-analysis (DCB group = 152, DES group = 169). The primary endpoint was in-segment late lumen loss (LLL) with astandardized mean difference (SMD) of -0.07 (95% confidence interval [CI]: -0.31, 0.316; P = 0.548) and the secondary endpoint was target lesion revascularization (TLR) with arisk ratio (RR) of 1.17 (95% CI: 0.46, 2.95; P = 0.746). This meta-analysis indicated that DCB might be non-inferior to DES as evidenced by quantitative coronary angiography (QCA) assessed at 6-9months after percutaneous coronary intervention in patients presenting with coronary artery disease.