Concept: Bare-metal stent
AimsThe purpose of this pre-specified analysis of the PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY (PRODIGY) was to assess device-specific outcomes relative to different duration of dual antiplatelet therapy (DAPT) after Everolimus- (EES), Paclitaxel (PES), Zotarolimus- (ZES-S) eluting, or bare metal stents (BMS).Methods and resultsWe randomized 2013 patients to BMS, ZES-S, PES, or EES implantation. At 30 days, each stent group underwent up to 6 or 24 months clopidogrel therapy. The primary endpoint, which was a composite of death, myocardial infarction, or cerebrovascular accident, did not differ in patients receiving BMS [HR: 0.89 (95%CI: 0.54-1.45)], PES [HR: 0.74 (95%CI: 0.43-1.25)], or EES [HR: 0.63 (95%CI: 0.33-1.21)] implantation across DAPT groups, whereas it was significantly higher in ZES-S patients undergoing long when compared with short-term DAPT therapy (HR: 2.85, P = 0.0018), with positive interaction testing (P-value = 0.004). At the 6-month landmark analysis, heterogeneity across stent types persisted for the primary study endpoint and other secondary clinical outcomes, whereas patients receiving PES showed a significantly higher rate of definite, probable and definite, probable, possible stent thrombosis in the short DAPT regimen. No association in absolute or relative terms was noted between stent potency in inhibiting intimal hyperplasia and greater vulnerability to shorter DAPT therapy.ConclusionOur study suggests that optimal duration of DAPT may be stent-specific and it does not support a clear association between stent potency and vulnerability to shorter DAPT therapy.Trial Registration clinicaltrials.gov Identifier: NCT00611286. http://clinicaltrials.gov/ct2/show/NCT00611286?term=prodigy&rank=2.
Drug-eluting stents (DES) have been in clinical use for nearly a decade; however, the relative short- and long-term efficacy and safety of DES compared with bare-metal stents (BMS) and among the DES types are less well defined.
Aims: To investigate the incidence of cardiac events in octogenarians who underwent percutaneous coronary intervention (PCI) with stenting, as well as to evaluate the efficacy and safety of drug-eluting stents (DES) in this population. Methods and results: The study included 6,129 consecutive patients who underwent PCI with stenting from 2000 to 2005 in our centre, of whom 291 (4.7%) were octogenarians. After adjusting for confounders, age ≥80 years appeared a significant predictor of high mortality at 30 days (adjusted hazard ratio [aHR] 1.92, 95% CI 1.23-3.01), and four years (aHR 2.25, 95% CI 1.77-2.85). No differences were seen with respect to incident myocardial infarction (MI), but target lesion (63.2 vs. 32.6 per 1,000 person-years at one year and 27.9 vs. 16.6 per 1,000 person-years at four years) and vessel (83.1 vs. 52.9 per 1,000 person-years at one year and 37.7 vs. 25.0 per 1,000 person-years at four years) revascularisation rates were lower in octogenarians. When comparing DES with bare metal stents (BMS) in octogenarians, mortality and MI rates were comparable, but there was a significantly lower incidence of target lesion revascularisation at one- (9.5 vs. 0.6 per 1,000 person-years, aHR 0.07, 95% CI 0.01-0.57) and four-year (3.4 vs. 0.7 per 1,000 person-years, aHR 0.16, 95% CI 0.04-0.59) follow-up in patients who received a DES. Conclusions: Octogenarians undergoing PCI with stenting have an increased mortality risk, whereas the rates of repeat revascularisation in octogenarians are lower. This study suggests that the benefit of DES in reducing revascularisation rates is extended to elderly patients.
Current guidelines recommend combining clopidogrel with aspirin for up to 1 year after coronary stenting, but the value of clopidogrel beyond this time is uncertain.
BACKGROUND: THE EFFICACY AND SAFETY OF DRUG-ELUTING STENTS (DES) IN PATIENTS WITH ST-SEGMENTELEVATION MYOCARDIAL INFARCTION (STEMI) IS CONTROVERSIAL. CONSEQUENTLY, DES IMPLANTATION HAS A CLASS IIA INDICATION IN THE AMERICAN COLLEGE OF CARDIOLOGY/AMERICAN HEART ASSOCIATION AND THE EUROPEAN SOCIETY OF CARDIOLOGY STEMI GUIDELINES.METHODS AND RESULTS: PUBMED, EMBASE, AND CENTRAL WERE SEARCHED FOR RANDOMIZED CLINICAL TRIALS, UNTIL MARCH 2013, COMPARING ANY OF THE 5 FOOD AND DRUG ADMINISTRATIONAPPROVED DURABLE STENT AND POLYMER DES (SIROLIMUS ELUTING STENT, PACLITAXEL ELUTING STENT, EVEROLIMUS-ELUTING STENT [EES], ZOTAROLIMUS-ELUTING STENT, AND ZOTAROLIMUS-ELUTING STENT RESOLUTE), AGAINST EACH OTHER OR BARE METAL STENTS (BMS), AND ENROLLING 50 PATIENTS WITH STEMI. EFFICACY (TARGET VESSEL REVASCULARIZATION) AND SAFETY (DEATH, MYOCARDIAL INFARCTION, AND STENT THROMBOSIS) OUTCOMES AT THE LONGEST REPORTED FOLLOW-UP TIMES WERE EVALUATED. TWENTY-EIGHT RANDOMIZED CLINICAL TRIALS WITH 34 068 PATIENT-YEARS OF FOLLOW-UP ON SUBJECTS WITH STEMI FULFILLED THE INCLUSION CRITERIA. WHEN COMPARED WITH BMS (REFERENCE RATE RATIO [RR] OF 1), SIROLIMUS ELUTING STENT (RR, 0.46; 95% CREDIBILITY INTERVAL [CRI], 0.360.56), PACLITAXEL ELUTING STENT (RR, 0.69; 95% CRI, 0.530.87), AND EES (RR, 0.42; 95% CRI, 0.260.62) WERE ASSOCIATED WITH A STATISTICALLY SIGNIFICANT REDUCTION IN RATE OF TARGET VESSEL REVASCULARIZATION, WITH THE POINT ESTIMATE FOR ZOTAROLIMUS-ELUTING STENT RESOLUTE TRENDING IN A SIMILAR DIRECTION. THERE WAS NO INCREASE IN THE RISK OF DEATH, MYOCARDIAL INFARCTION, OR STENT THROMBOSIS WITH ANY DES COMPARED WITH BMS. MOREOVER, EES WAS ASSOCIATED WITH A STATISTICALLY SIGNIFICANT REDUCTION IN THE RATE OF STENT THROMBOSIS WHEN COMPARED WITH SIROLIMUS ELUTING STENT (RR, 0.38; 95% CRI, 0.210.74), PACLITAXEL ELUTING STENT (RR, 0.39; 95% CRI, 0.210.73), AND EVEN BMS (RR, 0.42; 95% CRI, 0.230.76). THERE WAS A 74% PROBABILITY THAT EES HAD THE LOWEST RATE OF ANY STENT THROMBOSIS WHEN COMPARED WITH ALL OTHER STENT TYPES (NO DATA ON ZOTAROLIMUS-ELUTING STENT RESOLUTE). THERE WAS NO INCREASE IN VERY LATE STENT THROMBOSIS WITH EES VERSUS BMS (RR, 0.89; 95% CRI, 0.098.67).CONCLUSIONS: In patients with STEMI, DES versus BMS was associated with substantial decrease in the risk of target vessel revascularization without compromising safety. EES had the added advantage of substantial reduction in the risk of stent thrombosis when compared with first-generation DES and BMS with no increase in very late stent thrombosis.
OBJECTIVES: to assess the endothelial dysfunction (ED) after bare metal stents (BMS) and sirolimus eluting stents (SES) implantation in the same patient, overcoming the confounding role of individual variables. BACKGROUND: SES reduce restenosis rate compared to BMS but cause more ED. ED is a potentially unsafe phenomenon, since it is the first step in the cascade of atherosclerosis. Studies showing more pronounced ED with drug eluting stents than BMS involved different series of patients, making the comparison difficult because endothelial function (EF) is responsive to many risk factors. METHODS: we designed a prospective comparison of 6 months post-deployment EF of SES vs. BMS implanted in the same patient, but in different coronary segments. Forty-eight lesions were randomly assigned on a 1:1 allocation using block sizing of 4 according to a computer-generated sequence (SAS System, Version 9.1) basis to treatment with SES or BMS. The EF was evaluated by measuring vessel diameter variation in the stented segment, before and after selective intracoronary infusion of acetylcholine (iiAch). RESULTS: In eligible patients, the relative magnitudes of major vasoconstriction were 2.6, 2.9, 4.6, and 3.1 at 5 mm proximal and 5, 10 and 20 distal to the stent edge. Overall, a 3.5 fold major distal vasoconstriction after iiAch of SES vs. BMS was calculated. CONCLUSIONS: in the same patients, but treating different coronary segments, SES implantation induces a higher rate of vasoconstriction compared to BMS. The increased vasoconstriction after iiAch is an indicator of ED. © 2013 Wiley Periodicals, Inc.
Background Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month. Methods In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization. Results We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated-stent group and in 154 patients (12.9%) in the bare-metal-stent group (risk difference, -3.6 percentage points; 95% confidence interval [CI], -6.1 to -1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P<0.001 for noninferiority and P=0.005 for superiority). During the same time period, clinically driven target-lesion revascularization was needed in 59 patients (5.1%) in the drug-coated-stent group and in 113 patients (9.8%) in the bare-metal-stent group (risk difference, -4.8 percentage points; 95% CI, -6.9 to -2.6; hazard ratio, 0.50; 95% CI, 0.37 to 0.69; P<0.001). Conclusions Among patients at high risk for bleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1-month course of dual antiplatelet therapy. (Funded by Biosensors Europe; LEADERS FREE ClinicalTrials.gov number, NCT01623180 .).
This study sought to determine whether there is an ideal level of platelet reactivity (PR) to optimize safety and efficacy within the large multicenter ADAPT-DES (Assessment of Dual AntiPlatelet Therapy With Drug-Eluting Stents) study of 8,582 patients receiving successful drug-eluting stent implantation.
A 1-year follow-up, polymer-free metallic stent coated with biolimus-A9 followed by 1-month dual antiplatelet therapy is safer and more effective than a bare-metal stent (BMS) for patients with high risk of bleeding.
Sex-related differences have been noted in cardiovascular anatomy, pathophysiology, and treatment responses, yet we continued to drive evaluation of vascular device development in animal models without consideration of animal sex. We aimed to understand sex-related differences in the vascular responses to stent implantation by analyzing the pooled data of endovascular interventions in 164 Yucatan mini-swine (87 female, 77 male). Bare metal stents (BMS) or drug-eluting stents (DES) were implanted in 212 coronary arteries (63 single BMS implantation, 68 single DES implantation, 33 overlapped BMS implantation, and 48 overlapped DES implantation). Histomorphological parameters were evaluated from vascular specimens at 3-365 days after stent implantation and evaluated values were compared between female and male groups. While neointima formation at all times after implantation was invariant to sex, statistically significant differences between female and male groups were observed in injury, inflammation, adventitial fibrosis, and neointimal fibrin deposition. These differences were observed independently, i.e., for different procedure types and at different follow-up timings. Only subtle temporal sex-related differences were observed in extent and timing of resolution of inflammation and fibrin clearance. These subtle sex-related differences may be increasingly important as interventional devices meld novel materials that erode and innovations in drug delivery. Erodible materials may act differently if inflammation has a different temporal sequence with sex, and drug distribution after balloon or stent delivery might be different if the fibrin clearance speaks to different modes of pharmacokinetics in male and female swine.