Repeat Revascularization After Contemporary Percutaneous Coronary Intervention

Benefit of Long-Term Dual Anti-Platelet Therapy in Patients Treated With Drug-Eluting Stents: From the NHLBI Dynamic Registry

Initial trials comparing stenting with balloon angioplasty demonstrated improved angiographic and clinical outcomes with the former.1–3 The main clinical problem with bare metal stents (BMS) became the development of in-stent restenosis.4–6 Early data suggested that drug-eluting stents (DES) could mitigate, if not abolish, this problem.7–9 Since the approval of DES, these devices have become the predominant stents used in percutaneous coronary interventions, regardless of indication. As of September 2007, the Cypher sirolimus-eluting stent (SES) (Cordis Johnson & Johnson, Miami Lakes, Fla) had been deployed in >3 million patients worldwide,10 and the millionth Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Mass) was implanted as of January 2005.11 Over the past 2 years, numerous reports of very late stent thrombosis (ST) with first-generation DES have surfaced. This highly morbid complication and data suggesting that death and myocardial infarction (MI) may be more common with DES12,13 have altered the focus of trials and registries working to determine optimal DES use. There is a hope that second-generation DES will be less prone to ST as a result of differences in drug, stent design, and polymer. Medtronic, Inc (Minneapolis, Minn) presented safety and efficacy data to a public meeting of the US Food and Drug Administration (FDA) Circulatory System Devices Panel (CSDP) in October 2007 on its Endeavor zotarolimus-eluting stent (ZES), seeking approval for the indication of treating de novo native coronary lesions ≤27 mm with reference vessel diameters of 2.5 to 3.5 mm. The FDA asked the CSDP to determine whether the data presented demonstrated a reasonable level of safety and effectiveness, with clinical benefits clearly outweighing short- and long-term risks of ZES use. Important efficacy end points included ischemia-driven target lesion revascularization (TLR) or target vessel revascularization (TVR); safety end points included death, MI, and ST. The …

Impact of Sex on 3-Year Outcome After Percutaneous Coronary Intervention Using Bare-Metal and Drug-Eluting Stents in Previously Untreated Coronary Artery Disease: Insights From the RESEARCH (Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital) and T-SEARCH (Taxus-Stent Evaluated at Rotterdam Cardiology Hospital) Registries

Mortality After Repeat Revascularization Following PCI or CABG for Left Main Disease: The EXCEL Trial

Large-scale randomized comparison of drug-eluting stents (DES) based on durable polymer versus biodegradable polymer technology is currently insufficient in patients with acute coronary syndrome (ACS). The present study aimed to prove the noninferiority of the durable polymer DES (DP-DES) compared with the biodegradable polymer DES (BP-DES) in such patients. The HOST-REDUCE-POLYTECH-ACS (Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases-Comparison of Reduction of Prasugrel Dose or Polymer Technology in ACS Patients) trial is an investigator-initiated, randomized, open-label, adjudicator-blinded, multicenter, noninferiority trial comparing the efficacy and safety of DP-DES and BP-DES in patients with ACS. The primary end point was a patient-oriented composite outcome (a composite of all-cause death, nonfatal myocardial infarction, and any repeat revascularization) at 12 months. The key secondary end point was device-oriented composite outcome (a composite of cardiac death, target-vessel myocardial infarction, or target lesion revascularization) at 12 months. A total of 3413 patients were randomized to receive the DP-DES (1713 patients) and BP-DES (1700 patients). At 12 months, patient-oriented composite outcome occurred in 5.2% in the DP-DES group and 6.4% in the BP-DES group (absolute risk difference, -1.2%; Pnoninferiority<0.001). The key secondary end point, device-oriented composite outcome, occurred less frequently in the DP-DES group (DP-DES vs BP-DES, 2.6% vs 3.9%; hazard ratio, 0.67 [95% CI, 0.46-0.98]; P=0.038), mostly because of a reduction in target lesion revascularization. The rate of spontaneous nonfatal myocardial infarction and stent thrombosis were extremely low, with no significant difference between the 2 groups (0.6% versus 0.8%; P=0.513 and 0.1% versus 0.4%; P=0.174, respectively). In ACS patients receiving percutaneous coronary intervention, DP-DES was noninferior to BP-DES with regard to patient-oriented composite outcomes at 12 months after index percutaneous coronary intervention. Registration: URL: https://wwwclinicaltrials.gov; Unique identifier: NCT02193971.

Long-term clinical outcomes after percutaneous coronary intervention to treat long lesions in hemodialysis patients in the era of second-generation drug-eluting stents

Although some studies have investigated sex-related outcomes up to 5 years after percutaneous coronary intervention (PCI), analyses at longer follow-up (ie, to 10 years) in large cohorts treated exclusively with drug-eluting stent (DES) platforms are lacking. Therefore, this study aimed to define whether sex-related differences in long-term outcomes after PCI persist both in the DES era and at longer-term follow-up. Individual data of patients treated with DES in 5 randomized controlled trials with 10-year follow-up were pooled. Patients were divided into 2 groups by sex. The analysis of individual participant data was performed using a 1-stage approach by entering a clustering effect by parent study in all univariable and multivariable models focusing on sex. The main outcomes of interest for this analysis included cardiovascular death, myocardial infarction, repeat revascularization, and definite stent thrombosis to 10 years after PCI. Survival was analyzed by the Kaplan-Meier method to estimate the time to first event, and differences between the 2 groups were tested with the log-rank test. Hazard ratios (HRs) and 95% CIs were calculated with a Cox proportional hazards model. Conventional multivariable analyses with adjustment for relevant variables were performed. Among 9700 patients undergoing PCI with DES implantation included in the present analysis, 2296 were women and 7404 were men. Through to 10 years, cardiovascular death occurred in 407 of the 2296 female patients and 1012 of the 7404 male patients (adjusted HR [HRadj], 0.94 [95% CI, 0.80-1.11]). Female sex was associated with a lower risk of repeat revascularization of the target lesion (HRadj, 0.80 [95% CI, 0.74-0.87]), target vessel (HRadj, 0.81 [95% CI, 0.76-0.87]), and nontarget vessels (HRadj, 0.69 [95% CI, 0.62-0.77]). Compared with male patients, female patients displayed an increased risk of myocardial infarction in the first 30 days after PCI with DES (HRadj, 1.65 [95% CI, 1.24-2.19]) but a comparable risk of myocardial infarction thereafter. The risk of definite stent thrombosis was not significantly different between female and male patients (HRadj, 1.14 [95% CI, 0.89-1.47]). Through to 10-year follow-up after PCI with DES, female patients are at increased risk of early myocardial infarction, receive fewer repeat revascularizations, and have no difference in cardiovascular mortality compared with male patients.

Impact of Intravascular Ultrasound on Long-Term Clinical Outcomes in Patients With Acute Myocardial Infarction.

New-generation stents compared with coronary bypass surgery for unprotected left main disease: A word of caution

Introduction: New Generation drug eluting stents (DES) have overcome the limitations of bare metal stents and first generation DES resulting in lower risk of ischemic events in women. Hypothesis: We sought to compare increasing total stent length per patient for 3-yr outcomes in DM and non-DM women after percutaneous coronary intervention (PCI) with new generation DES. Methods: The WIN-DES collaboration is a pooled database of women undergoing PCI with coronary stents in 26 randomized trials. We compared total stent length per patient treated with new generation DES in quartiles (Among DM - Q1: 8-18mm, Q2: 18-24mm, Q3: 24-38mm and Q4: 38+mm; among non-DM Q1: 8-18mm, Q2: 18-24mm, Q3: 24-36mm and Q4: 36+mm). 3-yr outcomes were analyzed in a time to event manner and adjusted using multivariable methods. Major adverse cardiovascular events (MACE) were defined as a composite of death, myocardial infarction (MI) or target lesion revascularization (TLR). Results: The study sample comprised 5403 patients, of which 31.8% (n = 1719) had DM. In both DM and non-DM groups, patients in Q4 had greater prevalence of B2/C type and calcified lesions with smaller stent diameter compared to others. 3-yr MACE increased from Q1-Q4 in DM and non-DM patients, albeit DM patients experienced higher event rates ( Figure ). After multivariable adjustment, findings were unchanged, and increasing stent length remained associated with greater risk of 3-yr MACE in DM (p-trend=0.003) and non-DM (p-trend &lt;0.0001) patients. No interaction was observed between DM status and stent length for any outcomes. Conclusions: Despite the use of new generation DES, increasing total stent length per patient was associated with greater risk of MACE in both DM and non-DM women undergoing PCI. Women with DM experienced worse outcomes, and a greater risk of TLR regardless of total stent length. Meticulous attention to stent optimization and post PCI pharmacotherapy is needed to mitigate long-term adverse outcomes in women.

Advances in percutaneous coronary intervention (PCI) have improved the outcomes of patients with coronary artery diseases. The advent of drug-eluting stents (DES) has dramatically reduced the rate of revascularization. The first-generation DES has yielded the main role of PCI to the second-generation DES; however, many patients had been implanted with the first-generation DES, sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). Therefore, it is of importance to detect the long-term clinical outcomes in patients who underwent PCI with SES or PES. We analyzed data from our PCI cohort who underwent PCI with first-generation DES at Juntendo University Hospital between August 2004 and June 2010. The index procedure was analyzed when patients underwent multiple PCIs. Patients who were implanted with both SES and PES were excluded from this study. The study ended on December 31, 2011. The primary outcome was a composite of all-cause mortality and acute coronary syndrome (ACS). The secondary outcome was the rate of target lesion revascularization (TLR) and stent thrombosis. We analyzed data from 861 consecutive patients who underwent implantation of SES or PES. The median follow-up period was 1671 days (interquartile range 1081 and 2105). Kaplan-Meier curves for the primary endpoint did not significantly differ between the two groups (p = 0.8). The incidence of stent thrombosis was 1.4 and 1.8 per 1,000 person-years in the SES and PES groups, respectively (p = 0.9). The rate of TLR was significantly lower in the SES, than the PES group (12.6 and 38.3 per 1,000 person-years, p = 0.03). The rate of TLR was lower in the group treated with SES than PES, but the primary outcome comprising all-cause mortality and ACS was comparable between the two groups.

Highlights From the Circulation Family of Journals.

Several stent expansion criteria derived from the intravascular ultrasound (IVUS) evaluation have been proposed to predict future clinical outcomes, but optimal stent expansion criteria as a guide during percutaneous coronary intervention (PCI) are still controversial. There are no studies evaluating the utility of stent expansion criteria along with the clinical and procedural factors in predicting target lesion revascularization (TLR) after contemporary IVUS-guided PCI. OPTIVUS-Complex PCI study (Optimal Intravascular Ultrasound Guided Complex Percutaneous Coronary Intervention) multivessel cohort was a prospective multicenter study enrolling 961 patients undergoing multivessel PCI including left anterior descending coronary artery using IVUS with an intention to meet the prespecified criteria for optimal stent expansion. We compared several stent expansion criteria (minimum stent area [MSA], MSA/distal or average reference lumen area, MSA/distal or average reference vessel area, OPTIVUS criteria, IVUS-XPL [Impact of Intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions] criteria, ULTIMATE [Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-Comers" Coronary Lesions] criteria, and modified MUSIC [Multicenter Ultrasound Stenting in Coronaries Study] criteria) as well as clinical, angiographic, and procedural characteristics between lesions with and without TLR. Among 1957 lesions, the cumulative 1-year incidence of lesion-based TLR was 1.6% (30 lesions). Hemodialysis, treatment of proximal left anterior descending coronary artery lesions, calcified lesions, small proximal reference lumen area, and small MSA had univariate associations with TLR, while all of the stent expansion criteria except for MSA were not associated with TLR. The independent risk factors of TLR were calcified lesions (hazard ratio, 2.34 [95% CI, 1.03-5.32]; P=0.04) and small proximal reference lumen area (Tertile 1: hazard ratio, 7.01 [95% CI, 1.45-33.93]; P=0.02; and Tertile 2: hazard ratio, 5.40 [95% CI, 1.17-24.90]; P=0.03). In contemporary IVUS-guided PCI practice, the 1-year incidence of TLR was very low. MSA, but not other stent expansion criteria, had univariate association with TLR. Independent risk factors of TLR were calcified lesions and small proximal reference lumen area, although the findings should be interpreted with caution due to small number of TLR events, limited lesion complexity, and short duration of follow-up.

Objective Diabetes is a negative predictor in coronary artery disease patients. Since the introduction of percutaneous coronary intervention (PCI), PCI has evolved through technological advances in devices, improvements in operators' techniques and the establishment of effective therapeutic protocols. The aim of this study is to examine the changes in the clinical outcomes following PCI in patients with diabetes. Methods We compared the clinical outcomes in patients with diabetes following PCI from 1984 to 2010 at Juntendo University over three eras (plain old balloon angioplasty (POBA)-, bare metal stents (BMS)- and drug-eluting stents (DES)-eras). The primary endpoint was a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and repeat revascularization within 3 years after the index PCI. Results A total of 1,584 patients were examined. The baseline characteristics became unfavorable over time with regard to age, prevalence of hypertension, presentation with acute coronary syndrome and a reduced left ventricular ejection fraction. The administration of aspirin, statins and β-blockers increased over time. The event-free survival rate for the 3-year cardiovascular events was lower in the DES-era. The adjusted relative risk reduction for 3-year cardiovascular events was 46 % in the DES-era compared with the POBA-era. Conclusion The incidence of 3-year cardiovascular events decreased from 1984 to 2010 in patients with diabetes following PCI, despite the higher risk profiles in the DES-era.

Drug-eluting stents (DES) have demonstrated safety and efficacy in clinical outcomes, especially reduced rate of revascularization. However, it remains unknown whether clinical outcomes related to mortality improved after the introduction of DES. We sought to examine clinical outcomes including all-cause mortality, cardiovascular and non-cardiovascular death in pre-DES and DES eras. This was a single-center retrospective study including patients who underwent percutaneous coronary intervention (PCI) from August 1997 and June 2011. Study population was divided into two groups according to the time period of PCI (August 1997 to July 2004; pre-DES era, August 2004 to June 2011; DES era). The primary endpoint was all-cause mortality and secondary endpoints were cardiovascular and non-cardiovascular mortality. These endpoints were evaluated 3 years after PCI. A total of consecutive 3361 patients from our PCI cohort were analyzed. Patients in DES era were more likely to have traditional risk factors and angiographic disadvantages. The incidence of the primary endpoint was comparable between the two groups (p = 0.053). Cardiovascular and non-cardiovascular mortality were also similar between the groups (p = 0.1 and p = 0.2, respectively). Importantly, non-cardiovascular mortality accounted for over 60% of all-cause mortality in both eras. DES era was not associated with 3-year all-cause mortality, whereas DES use was associated with a reduction in 3-year cardiovascular mortality (HR 0.16, 95% CI 0.010-0.9, p = 0.035). All-cause mortality, cardiovascular and non-cardiovascular mortality at three years were comparable between pre-DES and DES era, despite the higher risk profiles of patients in DES era.