Resolute Zotarolimus-eluting Stent Implantation Research Articles

In Vivo Assessment of In-Stent Restenosis After Resolute Zotarolimus-Eluting Stent Implantation: Multimodality Imaging with Directional Coronary Atherectomy.

In Vivo Assessment of In-Stent Restenosis After Resolute Zotarolimus-Eluting Stent Implantation: Multimodality Imaging with Directional Coronary Atherectomy.

Comparison of the 9-Month Intrastent Condition and 30-Month Clinical Outcomes After Resolute Zotarolimus-Eluting Stent Implantation Between Standard-Duration and 1-Month Dual Antiplatelet Therapy Followed by Prasugrel Monotherapy.

Background: In this study we investigated the efficacy and safety of very short duration (1-month) dual antiplatelet therapy (DAPT) followed by prasugrel monotherapy. In particular, we compared intrastent conditions using optical coherence tomography (OCT) after second-generation drug-eluting stent implantation between standard-duration and 1-month DAPT followed by prasugrel monotherapy.Methods and Results: Between May 2015 and February 2018, 120 consecutive patients who underwent elective Resolute zotarolimus-eluting stent implantation were enrolled and divided into those receiving standard-duration or 1-month (1M) DAPT followed by prasugrel monotherapy; 47 patients (n=55 stents) and 46 patients (n=54 stents) in the standard and 1M groups, respectively, completed the protocol. The primary endpoint was the prevalence of abnormal intrastent tissue at the 9-month examination, as observed by OCT. The secondary endpoint was the presence of composite adverse events, including all-cause death, myocardial infarction, stent thrombosis, target lesion and vessel revascularization, and major and minor bleeding. The prevalence of abnormal intrastent tissue was similar between the standard and 1M groups (1.6% vs. 1.5%, respectively; non-inferiority P<0.01). There was a tendency for fewer composite events in the 1M than standard group at the 30-month follow-up examination (28.3% vs. 44.7%, respectively; P=0.41).Conclusions: In conclusion, 1M DAPT followed by prasugrel monotherapy after second-generation drug-eluting stent implantation was not inferior to standard-duration DAPT in terms of intrastent thrombus formation and composite adverse events.

Comparison of the 9-month intra-stent conditions and 2-year clinical outcomes after Resolute zotarolimus-eluting stent implantation between 3-month and standard dual antiplatelet therapy

BackgroundThe use of short-duration dual antiplatelet therapy (DAPT) remains controversial. To investigate efficacy and safety of short-duration DAPT, we performed a detailed comparison of intra-stent conditions by optical coherence tomography (OCT) after second-generation drug-eluting stent implantation with short-term and standard DAPT. Methods and resultsEighty-two consecutive patients with stable angina pectoris who received Resolute zotarolimus-eluting stents (R-ZESs; Medtronic Cardiovascular, Santa Rosa, CA, USA) were enrolled. Patients were assigned to 3-month (3M group: 41 patients) and standard (standard group: 41 patients) DAPT. In the 3M group, clopidogrel was discontinued 3 months after stent implantation. In the standard group, DAPT was maintained until follow-up OCT. At 9 months, neointimal proliferation was significantly larger in the 3M group, but there were no significant between-group differences in the proportion of uncovered and malapposed strut. The prevalence of abnormal intra-stent tissue (AIT) at 9 months was equivalent between groups. A multiple regression analysis revealed malapposition at 9 months as the strongest independent predictor of AIT at 9 months, and the prevalence of AIT was not associated with DAPT duration. Over 2 years, cardiac events were equal between groups; however, major bleeding was higher tendency in the standard group than in the 3M group. ConclusionThis OCT study indicated that reducing DAPT's duration may provide acceptable arterial healing in patients with implanted R-ZESs.

Long-term outcomes after Resolute zotarolimus-eluting stent implantation in patients with ST-segment elevation acute myocardial infarction: insights from the RESOLUTE All Comers Trial and the RESOLUTE Global Clinical Trial Program.

We examined long-term outcomes after implantation of the Resolute zotarolimus-eluting stent (R-ZES) in ST-segment elevation acute myocardial infarction (STEMI) patients. We compared long-term outcomes of STEMI patients undergoing primary angioplasty <12 hours from symptom onset who were randomised to the R-ZES (n=122) or the everolimus-eluting stent (EES, n=158) in the RESOLUTE All Comers Trial after propensity score adjustment. The five-year cumulative incidence of target lesion failure (TLF) was 7.6% versus 10.4% among patients treated with R-ZES versus EES, respectively, (adjusted p=0.304), and comprised clinically driven target lesion revascularisation (TLR, 2.5% versus 2.0%, adjusted p=0.766) and cardiac death/target vessel MI (5.1% versus 9.1%, adjusted p=0.123). The five-year cumulative incidence of stent thrombosis was 0.8% for R-ZES patients versus 1.3% for EES patients (adjusted p=0.868). In the RESOLUTE Global Clinical Trial Program, excluding RESOLUTE All Comers, the three-year cumulative incidence of TLF with R-ZES was 9.8% and comprised 7.0% clinically driven TLR and 4.5% cardiac death/target vessel MI. Patients with STEMI who received R-ZES had excellent long-term clinical outcomes which were similar to those of patients who received EES.

Neointimal coverage of zotarolimus-eluting stent at 1, 2, and 3 months' follow-up: an optical coherence tomography study.

Incomplete neointimal coverage and malapposed struts after stenting are associated with increased risk of stent thrombosis. We aimed to evaluate neointimal coverage early after Resolute zotarolimus-eluting stent (R-ZES) implantation using optical coherence tomography (OCT). A total of 20 patients with de novo native coronary lesions with R-ZES were enrolled. Among these patients, 20 stented lesions in 19 patients were evaluated at 1, 2, and 3 months after R-ZES implantation. The strut apposition and neointimal coverage were evaluated by OCT. Neointimal hyperplasia (NIH) thickness and percentage of covered struts and the proportion of incompletely apposed struts were measured at 1-mm intervals. The mean percentages of covered stent struts were over 85 % within 3 months (88.4 ± 6.3 % at 1 month, 95.5 ± 5.5 % at 2 months, 93.6 ± 3.5 % at 3 months). The percentages of incompletely apposed struts were not significantly different among the groups (4.4 ± 4.2 % at 1 month, 1.9 ± 1.9 % at 2 months, 3.1 ± 2.2 % at 3 months, p = 0.51). Mean NIH thickness (38.9 ± 8.1 μm at 1 month, 70.6 ± 18.8 μm at 2 months, 54.1 ± 5.9 at 3 months, p = 0.0016) was thickest in the 2 months group. Most of all OCT findings within 2 months demonstrated neointimal coverage with low signal intensity. The neointimal coverage of ZES-R was over 85 % within 3 months. These data may support shorter requirement of dual antiplatelet therapy duration with R-ZES.

Balancing ischaemia and bleeding with dual antiplatelet therapy: a resolute endeavour

This editorial refers to ‘Modifying effect of dual antiplatelet therapy on incidence of stent thrombosis according to implanted drug-eluting stent type’[†][1], by E. Camenzind et al. , on page 1932 and ‘Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following Resolute zotarolimus-eluting stent implantation’[‡][2], by S. Silber et al. , on page 1949. The most devastating complication after stent implantation is sudden, thrombotic coronary occlusion, which results in myocardial infarction (MI) in 80–90% of patients and death in 20–30%. Dual antiplatelet therapy (DAPT) with aspirin and an ADP receptor antagonist is the foundation to prevent stent thrombosis (ST).1 Whereas drug-eluting stents (DES) are more effective than bare metal stents (BMS) in preventing restenosis and recurrent ischaemia, DES susceptibility to ST is increased by delayed endothelialization, polymer hypersensitivity, and other mechanisms,2 necessitating prolonged DAPT. Long-term DAPT may have additional benefits by preventing atherothrombotic events in patients with vascular disease.3 However, DAPT increases major bleeding, the occurrence of which is strongly associated with subsequent mortality.4 Striking the right balance between ischaemic and bleeding complications by fine-tuning the potency and duration of DAPT is essential to optimize DES outcomes. First-generation paclitaxel-eluting stents and sirolimus-eluting stents (SES) were approved based on the basis of double-blind randomized trials in which DAPT was used for 3–6 months. Thereafter, reports of late ST resulted in recommendations for DAPT for 1 year or longer, without randomized evidence to support this endorsement. These guidelines have been carried forward to newer generation DES, despite randomized trials demonstrating enhanced safety and effectiveness with these devices compared with their earlier … [1]: #fn-2 [2]: #fn-3

Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation

The optimal duration of dual antiplatelet therapy (DAPT) following the use of new generation drug-eluting stents is unknown. The association between DAPT interruption and the rates of stent thrombosis (ST) and cardiac death/target-vessel myocardial infarction (CD/TVMI) in patients receiving a Resolute zotarolimus-eluting stent (R-ZES) was analysed in 4896 patients from the pooled RESOLUTE clinical programme. Daily acetylsalicylate (ASA) and a thienopyridine for 6-12 months were prescribed. A DAPT interruption was defined as any interruption of ASA and/or a thienopyridine of >1 day; long interruptions were >14 days. Three groups were analysed: no interruption, interruption during the first month, and >1-12 months. There were 1069 (21.83%) patients with a DAPT interruption and 3827 patients with no interruption. Among the 166 patients in the 1-month interruption group, 6 definite/probable ST events occurred (3.61%; all long DAPT interruptions), and among the 903 patients in the >1-12 months (60% occurred between 6 and 12 months) interruption group, 1 ST event occurred (0.11%; 2-day DAPT interruption). Among patients with no DAPT interruption, 32 ST events occurred (0.84%). Rates of CD/TVMI were 6.84% in the 1-month long interruption group, 1.41% in the >1-12 months long interruption group, and 4.08% in patients on continuous DAPT. In a pooled population of patients receiving an R-ZES, DAPT interruptions within 1 month are associated with a high risk of adverse outcomes. Dual antiplatelet therapy interruptions between 1 and 12 months were associated with low rates of ST and adverse cardiac outcomes. Randomized clinical trials are needed to determine whether early temporary or permanent interruption of DAPT is truly safe. ClinicalTrials.gov Identifiers: NCT00617084; NCT00726453; NCT00752128; NCT00927940.

One-Year Outcomes from an All-Comers Chinese Population of Patients Implanted With the Resolute Zotarolimus-Eluting Stent

The RESOLUTE China Registry is a prospective, multicenter, all-comers, observational study of patients in China implanted with the Resolute zotarolimus-eluting stent (R-ZES). R-ZES was commercially available before the enrollment began. All patients suitable for R-ZES implantation according to applicable guidelines were candidates for enrollment at 30 centers and were treated per standard hospital practice. Dual antiplatelet therapy (DAPT) was prescribed for a minimum of 6 months per current European Society of Cardiology guidelines and the device instructions for use. There were 1,800 patients enrolled with a mean age of 61.3 ± 10.9 years, 76% of patients were men, and 61% had complex disease. DAPT use was 94% at 1 year. Target lesion failure (cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization) at 1 year was 3.5% (95% confidence interval 2.7% to 4.5%). The rate of cardiac death was 0.6%, target vessel myocardial infarction 2.3%, and clinically driven target lesion revascularization 0.9%. The 1-year rate of definite or probable stent thrombosis was 0.5% (8 of 1,750); 0.4% (7 of 1,750) occurred early (0 to 30 days) and 1 event occurred late (1 to 12 months). One stent thrombosis occurred in a patient who had an interruption of DAPT within the first month; all other stent thromboses occurred while on DAPT. Outcomes did not differ significantly between monitored and unmonitored patients (difference in target lesion failure, p = 0.264). In conclusion, the RESOLUTE China Registry confirms the safety and effectiveness of R-ZES in a large real-world Chinese population.

Nine‐Month Angiographic and Intravascular Ultrasound Outcomes After Resolute Zotarolimus‐Eluting Stent Implantation for the Treatment of In‐Stent Restenosis

We aimed to evaluate the mid-term outcomes of resolute zotarolimus-eluting stent (R-ZES) implantation for in-stent restenosis (ISR). There has been a paucity of data regarding the effects of new-generation drug-eluting stent to treat ISR. From 2009 to 2010, a total of 98 patients with 98 ISR lesions were prospectively enrolled after R-ZES implantation for the treatment of ISR. Among 98 patients, 73 patients underwent follow-up angiography at 9 months. Serial intravascular ultrasound (IVUS) at both postprocedure and 9 months was evaluated in 55 patients. The overlapped segment of R-ZES was defined as the portion of R-ZES superimposed on previous stent. Late loss and binary restenosis rate were 0.3 ± 0.5 mm and 5.5% at 9 months. On IVUS, the percentage of neointimal volume and maximum percentage of neointimal area were 3.9 ± 6.3% and 17.3 ± 15.5%, respectively. There was no significant change of vessel volume index between postprocedure and 9 months (16.9 ± 4.7 mm³ /mm vs. 17.1 ± 4.6 mm³ /mm, P = 0.251). Late-acquired incomplete stent apposition was observed in 5 (5/55, 9.1%) cases. Compared with nonoverlapped segments of R-ZES, the overlapped did not show larger neointimal volume index (0.3 ± 0.5 mm³ /mm vs. 0.2 ± 0.3 mm³ /mm, P = 0.187) on 9-month IVUS. During follow-up (median, 353 days), repeat target-lesion revascularization was performed in four cases, but there were no death or stent thrombosis. This study suggested that R-ZES implantation for the treatment of ISR was effective up to 9 months and showed favorable vascular responses on serial IVUS assessment.

TCT-210 Clinical Outcomes Following Resolute Zotarolimus-eluting Stent Implantation in Diabetic versus Non-Diabetic Patients Suitable for Percutaneous Coronary Revascularization: Insights From a Multicenter Italian Registry

Diabetes mellitus remains a significant predictor of adverse clinical outcomes after percutaneous coronary intervention (PCI). Outcomes after 2nd generation drug-eluting stent (DES) implantation in diabetics remains ill-defined. Aim of this study was to compare the clinical outcomes of the Resolute

Circulation: Cardiovascular Interventions Editors’ Picks

<i>Circulation: Cardiovascular Interventions</i> Editors’ Picks

TCT-636 Final Three Year Results Following Resolute Zotarolimus-Eluting Stent Implantation in the RESOLUTE International Trial

The RESOLUTE International (R-INT) trial has demonstrated the safety and effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) through 2 years in a real-world population of patients with coronary artery disease requiring percutaneous coronary intervention (PCI). Concerns regarding long-

TCT-232: Impact of Stent Size and Length on Neointimal Hyperplasia After Resolute Zotarolimus-Eluting Stent Implantation: Insights From RESOLUTE Trials

TCT-232: Impact of Stent Size and Length on Neointimal Hyperplasia After Resolute Zotarolimus-Eluting Stent Implantation: Insights From RESOLUTE Trials