Objectives The aim of this study was to determine whether drug-eluting stents (DES) are superior to bare-metal stents (BMS) in octogenarian patients with angina. Background Patients ≥80 years of age ...frequently have complex coronary disease warranting DES but have a higher risk of bleeding from prolonged dual antiplatelet therapy. Methods This multicenter randomized trial was conducted in 22 centers in the United Kingdom and Spain. Patients ≥80 years of age underwent stent placement for angina. The primary endpoint was a 1-year composite of death, myocardial infarction, cerebrovascular accident, target vessel revascularization, or major hemorrhage. Results In total, 800 patients (83.5 ± 3.2 years of age) were randomized to BMS (n = 401) or DES (n = 399) for treatment of stable angina (32%) or acute coronary syndrome (68%). Procedural success did not differ between groups (97.7% for BMS vs. 95.4% for DES; p = 0.07). Thirty-eight percent of patients had ≥2-vessel percutaneous coronary intervention, and 66% underwent complete revascularization. Patients who received BMS had shorter stent implants (24.0 ± 13.4 mm vs. 26.6 ± 14.3 mm; p = 0.01). Rates of dual antiplatelet therapy at 1 year were 32.2% for patients in the BMS group and 94.0% for patients in the DES group. The primary endpoint occurred in 18.7% of patients in the BMS group versus 14.3% of patients in the DES group (p = 0.09). There was no difference in death (7.2% vs. 8.5%; p = 0.50), major hemorrhage (1.7% vs. 2.3%; p = 0.61), or cerebrovascular accident (1.2% vs. 1.5%; p = 0.77). Myocardial infarction (8.7% vs. 4.3%; p = 0.01) and target vessel revascularization (7.0% vs. 2.0%; p = 0.001) occurred more often in patients in the BMS group. Conclusions BMS and DES offer good clinical outcomes in this age group. DES were associated with a lower incidence of myocardial infarction and target vessel revascularization without increased incidence of major hemorrhage. (Xience or Vision Stent–Management of Angina in the Elderly XIMA; ISRCTN92243650 )
Background
Percutaneous coronary intervention (PCI) with drug‐eluting stent (DES) implantation is a widely adopted strategy for the treatment of de novo coronary artery disease. DES implantation ...conveys an inherent risk for short‐ and long‐term complications, including in‐stent restenosis and stent thrombosis. Drug‐coated balloons are emerging as an alternative approach to fulfill the “leaving nothing behind” principle and avoid long‐term DES‐related complications.
Design
TRANSFORM II is an investigator‐initiated, multicenter, noninferiority, randomized clinical trial, testing a sirolimus‐coated balloon (SCB) versus the standard of care for native coronary vessels with a 2–3 mm diameter, in terms of 12‐month target lesion failure (TLF; primary endpoint) and net adverse cardiovascular events (coprimary endpoint). Patients undergoing PCI will be randomized to be treated with either SCB or new‐generation everolimus‐eluting stent and will be followed up clinically for up to 60 months. Assuming a TLF rate of 8% at 12 months with DES, a sample size of 1325 patients was chosen to ensure an 80% power to detect a 1.5% lower incidence in the SCB group with a type I error rate of 0.05. The TRANSFORM II trial is registered on clinicaltrials.gov (identification number NCT04893291). Several substudies, including an optical coherence tomography assessment at 9 months (intracoronary imaging substudy), will investigate the study device in different clinical and lesion settings.
Conclusions
The randomized TRANSFORM II trial will determine whether a novel SCB is noninferior to a current everolimus‐eluting stent when adopted for the treatment of de novo lesions in coronary vessels with a diameter between 2 and 3 mm.
Abstract
This Consensus Document is the first of two reports summarizing the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) on the ...clinical use of intracoronary imaging including intravascular ultrasound (IVUS) and optical coherence tomography (OCT). The first document appraises the role of intracoronary imaging to guide percutaneous coronary interventions (PCIs) in clinical practice. Current evidence regarding the impact of intracoronary imaging guidance on cardiovascular outcomes is summarized, and patients or lesions most likely to derive clinical benefit from an imaging-guided intervention are identified. The relevance of the use of IVUS or OCT prior to PCI for optimizing stent sizing (stent length and diameter) and planning the procedural strategy is discussed. Regarding post-implantation imaging, the consensus group recommends key parameters that characterize an optimal PCI result and provides cut-offs to guide corrective measures and optimize the stenting result. Moreover, routine performance of intracoronary imaging in patients with stent failure (restenosis or stent thrombosis) is recommended. Finally, strengths and limitations of IVUS and OCT for guiding PCI and assessing stent failures and areas that warrant further research are critically discussed.
The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) among patients at high bleeding risk (HBR) is unknown.
The purpose of this analysis was to ...compare 1 vs 3 months of DAPT in HBR patients undergoing drug-eluting stent implantation.
The XIENCE Short DAPT program comprised 3 prospective, multicenter, single-arm studies of HBR patients treated with a short DAPT course followed by aspirin monotherapy after PCI with a cobalt-chromium everolimus-eluting stent. In this exploratory analysis, patients who received 1-month DAPT (XIENCE 28 USA and 28 Global) were compared with those on 3-month DAPT (XIENCE 90) using propensity score stratification. Ischemic and bleeding outcomes were assessed between 1 and 12 months after index PCI.
A total of 3,652 patients were enrolled and 1,392 patients after 1-month DAPT and 1,972 patients after 3-month DAPT were eligible for the analyses. The primary endpoint of all-cause mortality or myocardial infarction was similar between the 2 groups (7.3% vs 7.5%; difference −0.2%; 95% CI: −2.2% to 1.7%; P = 0.41). The key secondary endpoint of BARC (Bleeding Academic Research Consortium) type 2-5 bleeding was lower with 1-month DAPT compared with 3-month DAPT (7.6% vs 10.0%; difference −2.5%; 95% CI: −4.6% to −0.3%; P = 0.012). Major BARC type 3-5 bleeding did not differ at 12 months (3.6% vs 4.7%; difference −1.1%; 95% CI: −2.6% to 0.4%; P = 0.082), but was lower with 1-month DAPT at 90 days (1.0% vs 2.1%; P = 0.015).
Among HBR patients undergoing PCI, 1 month of DAPT, compared with 3 months of DAPT, was associated with similar ischemic outcomes and lower bleeding risk. (XIENCE 90 Study; NCT03218787; XIENCE 28 USA Study; NCT03815175; XIENCE 28 Global Study; NCT03355742)
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Objectives
to test the safety and efficacy of intravascular imaging and specifically optical coherence tomography (OCT) as a diagnostic tool for left main angioplasty and analyze the mid‐term outcome ...accordingly.
Background
Clinical data and international guidelines recommend the use of intravascular imaging ultrasound (IVUS) to guide left main (LM) angioplasty. Despite early experience using OCT in this setting is encouraging, the evidence supporting its use is still limited.
Methods
ROCK II is a multicenter, investigator‐driven, retrospective European study to compare the performance of IVUS and OCT versus angiography in patients undergoing distal‐LM stenting. The primary study endpoint was target‐lesion failure (TLF) including cardiac death, target‐vessel myocardial infarction and target‐lesion revascularization. We designed this study hypothesizing the superiority of intravascular imaging over angiographic guidance alone, and the non‐inferiority of OCT versus IVUS.
Results
A total of 730 patients, 377 with intravascular‐imaging guidance (162 OCT, 215 IVUS) and 353 with angiographic guidance, were analyzed. The one‐year rate of TLF was 21.2% with angiography and 12.7% with intravascular‐imaging (p = 0.039), with no difference between OCT and IVUS (p = 0.26). Intravascular‐imaging was predictor of freedom from TLF (HR 0.46; 95% CI 0.23–0.93: p = 0.03). Propensity‐score matching identified three groups of 100 patients each with no significant differences in baseline characteristics. The one‐year rate of TLF was 16% in the angiographic, 7% in the OCT and 6% in the IVUS group, respectively (p = 0.03 for IVUS or OCT vs. angiography). No between‐group significant differences in the rate of individual components of TLF were found.
Conclusions
Intravascular imaging was superior to angiography for distal LM stenting, with no difference between OCT and IVUS.
This study sought to assess the incidence, predictors, and outcome of drug-eluting stent(DES) thrombosis in real-world clinical practice.
The DES thromboses in randomized trials could not be ...comparable to those observed in clinical practice, frequently including off-label indications.
We designed a large-scale, nonindustry-linked multicentered registry, with 20 centers in Spain. The participant centers provided follow-up data for their patients treated with DES, reporting a detailed standardized form in the event of any angiography-documented DES-associated thrombosis occurring.
Of 23,500 patients treated with DES, definite stent thrombosis(ST) developed in 301: 24 acute, 125 subacute, and 152 late. Of the late, 62 occurred >1 year(very late ST). The cumulative incidence was 2% at 3 years. Antiplatelet treatment had been discontinued in 95 cases(31.6%). No differences in incidences were found among stent types. Independent predictors for subacute ST analyzed in a subgroup of 14,120 cases were diabetes, renal failure, acute coronary syndrome, ST-segment elevation myocardial infarction, stent length, and left anterior descending artery stenting, and for late ST were ST-segment elevation myocardial infarction, stenting in left anterior descending artery, and stent length. Mortality at 1-year follow-up was 16% and ST recurrence 4.6%. Older age, left ventricular ejection fraction <45%, nonrestoration of Thrombolysis In Myocardial Infarction flow grade 3, and additional stenting were independent predictors for mortality.
The cumulative incidence of ST after DES implantation was 2% at 3 years. No differences were found among stent types. Patient profiles differed between early and late ST. Short-term prognosis is poor, especially when restoration of normal flow fails.
Objectives
We sought to investigate the effect of a 15‐min delayed intraprocedural reassessment of paravalvular aortic regurgitation (PVR) after an immediate evaluation of posttranscatheter aortic ...valve replacement (TAVR) on the regurgitation grading and usage of postdilatation.
Background
PVR after TAVR is associated with poor prognosis, but postdilatation may increase the risk of other complications.
Methods
In a prospective cohort of consecutive patients treated with balloon‐expandable valve ES‐3 ultra, the degree of PVR was assessed immediately and 15 min after that first evaluation (excluded severe cases), with the indication of postdilatation based on the delayed assessment. As a control group, the previous consecutive series of patients also treated with the same model of valve prosthesis was used.
Results
A total of 180 patients were included in the prospective study cohort and 152 in the retrospective control group. In the study group, the immediate PVR assessment showed none‐trace 27.5%, mild 52%, moderate 19%, and severe 1.5%, and the delayed re‐evaluation graded PVR as none‐trace 83%, mild 15.6%, and moderate 1.2% (p < 0.001 as compared to immediate). In the control group, the immediate PVR assessment showed none‐trace 33.5%, mild 52%, moderate 13%, and severe 1.5%. The rate of postdilatation was 2.8% in the study group versus 10.5% in the control group (p = 0.006). At discharge, no differences were observed between groups in PVR echocardiographic grading.
Conclusions
A post‐TAVR delayed intraprocedural reassessment of the PVR shows a clearly lower degree of regurgitation as compared to immediate evaluation, which significantly decreased the indication of postdilatation.
Abstract
This consensus document is the second of two reports summarizing the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) on ...the clinical use of intracoronary imaging including intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS)-IVUS. Beyond guidance of stent selection and optimization of deployment, invasive imaging facilitates angiographic interpretation and may guide treatment in acute coronary syndrome. Intravascular imaging can provide additional important diagnostic information when confronted with angiographically ambiguous lesions and allows assessment of plaque morphology enabling identification of vulnerability characteristics. This second document focuses on useful imaging features to identify culprit and vulnerable coronary plaque, which offers the interventional cardiologist guidance on when to adopt an intracoronary imaging-guided approach to the treatment of coronary artery disease and provides an appraisal of intravascular imaging-derived metrics to define the haemodynamic significance of coronary lesions.
New-generation drug-eluting stents (DES) have mostly been investigated in head-to-head non-inferiority trials against early-generation DES and have typically shown similar efficacy and superior ...safety. How the safety profile of new-generation DES compares with that of bare-metal stents (BMS) is less clear.
We did an individual patient data meta-analysis of randomised clinical trials to compare outcomes after implantation of new-generation DES or BMS among patients undergoing percutaneous coronary intervention. The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random-effects meta-analysis and examined at maximum follow-up and a 1-year landmark. Risk estimates are reported as hazard ratios (HRs) with 95% CIs. This study is registered in PROSPERO, number CRD42017060520.
We obtained individual data for 26 616 patients in 20 randomised trials. Mean follow-up was 3·2 (SD 1·8) years. The risk of the primary outcome was reduced in DES recipients compared with BMS recipients (HR 0·84, 95% CI 0·78–0·90, p<0·001) owing to a reduced risk of myocardial infarction (0·79, 0·71–0·88, p<0·001) and a possible slight but non-significant cardiac mortality benefit (0·89, 0·78–1·01, p=0·075). All-cause death was unaffected (HR with DES 0·96, 95% CI 0·88–1·05, p=0·358), but risk was lowered for definite stent thrombosis (0·63, 0·50–0·80, p<0·001) and target-vessel revascularisation (0·55, 0·50–0·60, p<0·001). We saw a time-dependent treatment effect, with DES being associated with lower risk of the primary outcome than BMS up to 1 year after placement. While the effect was maintained in the longer term, there was no further divergence from BMS after 1 year.
The performance of new-generation DES in the first year after implantation means that BMS should no longer be considered the gold standard for safety. Further development of DES technology should target improvements in clinical outcomes beyond 1 year.
Bern University Hospital.
Objectives
To asses mid‐term clinical outcomes of bioresorbable vascular scaffolds (BVS) for the treatment of coronary artery disease in a large‐scale all‐comers population.
Background
Several ...clinical settings are underrepresented in randomized studies investigating BVS against drug‐eluting stents. Whether their results can be translated into the heterogeny patient population seen during daily routine requires further investigation.
Methods
The European ABSORB Consortium comprises the following European registries: GABI‐R, ABSORB UK Registry, ABSORB France, BVS RAI Registry, and REPARA BVS Registry, which all prospectively collected patient‐level data regarding outcomes following unrestricted BVS implantation. The primary endpoint of target lesion failure (TLF) includes cardiac death, target‐vessel myocardial infarction (TVMI) and target‐lesion revascularisation (TLR) at 12 months. The incidence of scaffold thrombosis (ST) according to ARC criteria was also assessed. Multivariable analysis was used to adjust for differences in patient and lesion characteristics.
Results
A total of 10,312 patients (mean age 58.4 ± 11.4 y) underwent BVS implantation during routine practice. The 12‐month follow‐up was complete in 95.5% of patients. At 12 months, the primary endpoint of TLF occurred in 3.6%; its components cardiac death, TVMI and TLR were documented in 1.2%, 1.8%, and 2.6%, respectively. The definite/probable ST rate was 1.7%. Absence of predilatation, discontinuation of DAPT and scaffold diameter below 3 mm were independent predictors of ST.
Conclusions
The EAC demonstrates reasonable real‐world clinical outcome data after BVS implantation. However, the rate of scaffold thrombosis remains high.
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