Showing papers in "Jacc-cardiovascular Interventions in 2013"
TL;DR: Routine lesion preparation using RA did not reduce late lumen loss of DES at 9 months, and Balloon dilation with only provisional rotablation remains the default strategy for complex calcified lesions before DES implantation.
Abstract: Objectives This study sought to determine the effect of rotational atherectomy (RA) on drug-eluting stent (DES) effectiveness. Background DES are frequently used in complex lesions, including calcified stenoses, which may challenge DES delivery, expansion, and effectiveness. RA can adequately modify calcified plaques and facilitate stent delivery and expansion. Its impact on DES effectiveness is widely unknown. Methods The ROTAXUS (Rotational Atherectomy Prior to TAXUS Stent Treatment for Complex Native Coronary Artery Disease) study randomly assigned 240 patients with complex calcified native coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120, standard therapy group). Stenting was performed using a polymer-based slow-release paclitaxel-eluting stent. The primary endpoint was in-stent late lumen loss at 9 months. Secondary endpoints included angiographic and strategy success, binary restenosis, definite stent thrombosis, and major adverse cardiac events at 9 months. Results Despite similar baseline characteristics, significantly more patients in the standard therapy group were crossed over (12.5% vs. 4.2%, p = 0.02), resulting in higher strategy success in the rotablation group (92.5% vs. 83.3%, p = 0.03). At 9 months, in-stent late lumen loss was higher in the rotablation group (0.44 ± 0.58 vs. 0.31 ± 0.52, p = 0.04), despite an initially higher acute lumen gain (1.56 ± 0.43 vs. 1.44 ± 0.49 mm, p = 0.01). In-stent binary restenosis (11.4% vs. 10.6%, p = 0.71), target lesion revascularization (11.7% vs. 12.5%, p = 0.84), definite stent thrombosis (0.8% vs. 0%, p = 1.0), and major adverse cardiac events (24.2% vs. 28.3%, p = 0.46) were similar in both groups. Conclusions Routine lesion preparation using RA did not reduce late lumen loss of DES at 9 months. Balloon dilation with only provisional rotablation remains the default strategy for complex calcified lesions before DES implantation. (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease. A Multicenter, Prospective, Randomized Controlled Trial [ROTAXUS]; NCT00380809)
370 citations
TL;DR: Results from IRAD show that TEVAR is associated with lower mortality over a 5-year period than medical therapy for TBAAD, and further randomized trials with long-term follow-up are needed.
Abstract: Objectives This study sought to evaluate long-term survival in type B aortic dissection patients treated with thoracic endovascular aortic repair (TEVAR) therapy. Background Historical data have supported medical therapy in type B acute aortic dissection (TBAAD) patients. Recent advances in TEVAR appear to improve in-hospital mortality. Methods We examined 1,129 consecutive patients with TBAAD enrolled in IRAD (International Registry of Acute Aortic Dissection) between 1995 and 2012 who received medical (n = 853, 75.6%) or TEVAR (n = 276, 24.4%) therapy. Results Clinical history was similar between groups. TEVAR patients were more likely to present with a pulse deficit (28.3% vs. 13.4%, p Conclusions Results from IRAD show that TEVAR is associated with lower mortality over a 5-year period than medical therapy for TBAAD. Further randomized trials with long-term follow-up are needed.
340 citations
TL;DR: Nonatherosclerotic SCAD predominantly affects women, and most have concomitant FMD, but this requires proof from histology or intracoronary imaging of the affected coronary arteries.
Abstract: Objectives We sought to evaluate the prevalence of fibromuscular dysplasia (FMD) and other predisposing conditions among spontaneous coronary artery dissection (SCAD) patients. Background Spontaneous coronary artery dissection is considered rare. However, we observed many young women with SCAD and concomitant FMD. Methods Spontaneous coronary artery dissection patients were identified prospectively and retrospectively at Vancouver General Hospital over the past 6 years. Coronary angiograms were meticulously reviewed by 2 senior interventional cardiologists. Identified patients were contacted for prospective evaluation at our SCAD clinic, and screening for FMD of renal, iliac, and cerebrovascular arteries was performed with computed tomography angiography or magnetic resonance angiography, if not already screened during the index angiogram. Potential predisposing and precipitating conditions for SCAD were extracted from clinical history. Results We identified 50 patients with nonatherosclerotic SCAD from April 2006 to March 2012. Average age was 51.0 years, and almost all were women (98.0%). All presented with myocardial infarction (MI), 30.0% had ST-segment elevation, and 70.0% had non–ST-segment elevation MI. Only 1 was postpartum, and 2 were involved in intense isometric exercises. Emotional stress was reported in 26.0% before the MI. Twelve percent had >1 dissected coronary artery. Most SCAD patients had FMD of ≥1 noncoronary territory (86.0%): 25 of 43 (58.1%) renal, 21 of 43 (48.8%) iliac, and 20 of 43 (46.5%) cerebrovascular (6 of 43, 14.0% had intracranial aneurysm). Five had incomplete FMD screening. Conclusions Nonatherosclerotic SCAD predominantly affects women, and most have concomitant FMD. We suspect these patients have underlying coronary FMD that predisposed them to SCAD, but this requires proof from histology or intracoronary imaging of the affected coronary arteries.
339 citations
TL;DR: CTO PCI carries low risk for procedural complications despite high success rates, according to a meta-analysis of 65 studies published between 2000 and 2011 reporting procedural complications of CTO PCI.
Abstract: Objectives This study sought to perform a weighted meta-analysis of the complication risk during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Background The safety profile of CTO PCI has received limited study. Methods We conducted a meta-analysis of 65 studies published between 2000 and 2011 reporting procedural complications of CTO PCI. Data on the frequency of death, emergent coronary artery bypass graft surgery, stroke, myocardial infarction, perforation, tamponade, stent thrombosis, major vascular or bleeding events, contrast nephropathy, and radiation skin injury were collected. Results A total of 65 studies with 18,061 patients and 18,941 target CTO vessels were included. Pooled estimates of outcomes were as follows: angiographic success 77% (95% confidence interval [CI]: 74.3% to 79.6%); death 0.2% (95% CI: 0.1% to 0.3%); emergent coronary artery bypass graft surgery 0.1% (95% CI: 0.0% to 0.2%); stroke Conclusions CTO PCI carries low risk for procedural complications despite high success rates.
318 citations
TL;DR: In a large cohort of unselected patients undergoing coronary stenting, compared with BMS, there was a significant excess risk of stent thrombosis at 3 years with G1-DES, driven by an increased risk ofStent thromabosis events beyond 1 year.
Abstract: Objectives This study sought to compare the risk of stent thrombosis among patients treated with bare-metal stents (BMS), first-generation drug-eluting stents (G1-DES), and second-generation drug-eluting stents (G2-DES) for a period of 3 years. Background In patients undergoing coronary stenting, there is a scarcity of long-term follow-up data on cohorts large enough to compare rates of stent thrombosis across the stent generations. Methods A total of 18,334 patients undergoing successful coronary stent implantation from 1998 to 2011 at 2 centers in Munich, Germany, were included in this study. Patients were stratified into 3 groups according to treatment with BMS, G1-DES, and G2-DES. Results The cumulative incidence of definite stent thrombosis at 3 years was 1.5% with BMS, 2.2% with G1-DES, and 1.0% with G2-DES. On multivariate analysis, G1-DES compared with BMS showed a significantly higher risk of stent thrombosis (odds ratio [OR]: 2.05; 95% confidence interval [CI]: 1.47 to 2.86; p Conclusions In a large cohort of unselected patients undergoing coronary stenting, compared with BMS, there was a significant excess risk of stent thrombosis at 3 years with G1-DES, driven by an increased risk of stent thrombosis events beyond 1 year. G2-DES were associated with a similar risk of stent thrombosis compared with BMS.
292 citations
TL;DR: The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes.
Abstract: Objectives This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. Background The LEADERS trial is the first randomized study to evaluate biodegradable polymer–based drug-eluting stents (DES) against durable polymer DES. Methods The LEADERS trial was a 10-center, assessor-blind, noninferiority, “all-comers” trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The primary endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary endpoints included extending the primary endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. Results At 5 years, the BES was noninferior to SES for the primary endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority Conclusions The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220 )
288 citations
TL;DR: Reported cases of coronary obstruction after TAVI occurred more frequently in women, in patients receiving a balloon-expandable valve, and the LCA was the most commonly involved artery.
Abstract: Objectives This study sought to evaluate, through a systematic review of the published data, the main baseline characteristics, management, and clinical outcomes of patients suffering coronary obstruction as a complication of transcatheter aortic valve implantation (TAVI). Background Very few data exist on coronary obstruction after TAVI. Methods Studies published between 2002 and 2012, with regard to coronary obstruction as a complication of TAVI, were identified with a systematic electronic search. Only the studies reporting data on the main baseline and procedural characteristics, management of the complication, and clinical outcomes were analyzed. Results A total of 18 publications describing 24 patients were identified. Most (83%) patients were women, with a mean age of 83 ± 7 years and a mean logistic European System for Cardiac Operative Risk Evaluation score of 25.1 ± 12.0%. Mean left coronary artery (LCA) ostium height and aortic root width were 10.3 ± 1.6 mm and 27.8 ± 2.8 mm, respectively. Most patients (88%) had received a balloon-expandable valve, and coronary obstruction occurred more frequently in the LCA (88%). Percutaneous coronary intervention was attempted in 23 cases (95.8%) and was successful in all but 2 patients (91.3%). At 30-day follow-up, there were no cases of stent thrombosis or repeat revascularization, and the mortality rate was 8.3%. Conclusions Reported cases of coronary obstruction after TAVI occurred more frequently in women, in patients receiving a balloon-expandable valve, and the LCA was the most commonly involved artery. Percutaneous coronary intervention was a feasible and successful treatment in most cases. Continuous efforts should be made to identify the factors associated with this life-threatening complication to implement the appropriate measures for its prevention.
259 citations
TL;DR: A computer model that accurately predicts myocardial fractional flow reserve (FFR) from angiographic images alone, in patients with coronary artery disease, was developed and was reliably predicted without the need for invasive measurements or inducing hyperemia.
Abstract: Objectives The aim of this study was to develop a computer model that accurately predicts myocardial fractional flow reserve (FFR) from angiographic images alone, in patients with coronary artery disease. Background Percutaneous coronary intervention (PCI) guided by FFR is superior to standard assessment alone. FFR-guided PCI results in improved clinical outcomes, a reduction in the number of stents implanted, and reduced cost. Currently FFR is used in few patients. A less invasive FFR would be a valuable tool. Methods Nineteen patients with stable coronary artery disease awaiting elective PCI were studied. They underwent rotational coronary angiography. The FFR was measured, physiologically significant lesions were stented, and angiography and FFR were repeated. Three-dimensional arterial anatomy pre- and post-stenting was reconstructed offline. Generic boundary conditions for computational fluid dynamics analysis were applied. The virtual fractional flow reserve (vFFR) and measured fractional flow reserve (mFFR) values were compared. Results Thirty-five matched anatomical and physiological datasets were obtained: 10 right coronary arteries (RCA) (5 pre- and post-stenting), and 12 left coronary arteries (LCA) (8 pre- and post-stenting). The computational fluid dynamics model predicted which lesions were physiologically significant (FFR 0.80) with accuracy, sensitivity, specificity, positive and negative predictive values of 97%, 86%, 100%, 100%, and 97% respectively. On average, the vFFR values deviated from mFFR by ±0.06 (mean delta = 0.02, SD = 0.08). The vFFR and mFFR were closely correlated (r = 0.84). Conclusions We have developed a model of intracoronary physiology based upon a rotational coronary angiogram. Significant lesions were identified with 97% accuracy. The FFR was reliably predicted without the need for invasive measurements or inducing hyperemia.
242 citations
TL;DR: A model that predicts bleeding complications using an expanded bleeding definition among patients undergoing percutaneous coronary intervention (PCI) provides accurate estimates of post-PCI bleeding risk, thereby better informing clinical decision making and facilitating risk-adjusted provider feedback to support quality improvement.
Abstract: Objectives This study sought to develop a model that predicts bleeding complications using an expanded bleeding definition among patients undergoing percutaneous coronary intervention (PCI) in contemporary clinical practice. Background New knowledge about the importance of periprocedural bleeding combined with techniques to mitigate its occurrence and the inclusion of new data in the updated CathPCI Registry data collection forms encouraged us to develop a new bleeding definition and risk model to improve the monitoring and safety of PCI. Methods Detailed clinical data from 1,043,759 PCI procedures at 1,142 centers from February 2008 through April 2011 participating in the CathPCI Registry were used to identify factors associated with major bleeding complications occurring within 72 h post-PCI. Risk models (full and simplified risk scores) were developed in 80% of the cohort and validated in the remaining 20%. Model discrimination and calibration were assessed in the overall population and among the following pre-specified patient subgroups: females, those older than 70 years of age, those with diabetes mellitus, those with ST-segment elevation myocardial infarction, and those who did not undergo in-hospital coronary artery bypass grafting. Results Using the updated definition, the rate of bleeding was 5.8%. The full model included 31 variables, and the risk score had 10. The full model had similar discriminatory value across pre-specified subgroups and was well calibrated across the PCI risk spectrum. Conclusions The updated bleeding definition identifies important post-PCI bleeding events. Risk models that use this expanded definition provide accurate estimates of post-PCI bleeding risk, thereby better informing clinical decision making and facilitating risk-adjusted provider feedback to support quality improvement.
234 citations
TL;DR: The S3 THV and delivery system might facilitate fully percutaneous implantation in a broader range of patients with the potential for more accurate positioning and less paravalvular regurgitation.
Abstract: Objectives The aim of this study was to demonstrate the first-in-human feasibility and short-term clinical outcomes with a new balloon-expandable transcatheter heart valve (THV). Background The SAPIEN 3 (S3) THV incorporates a paravalvular sealing system, an active 3-dimensional coaxial positioning catheter, and is compatible with a 14-F expandable sheath. Methods The S3 THV was implanted in 15 patients with symptomatic severe aortic stenosis via femoral arterial access. Multidetector computed tomography before and after valve implantation allowed assessment of a novel annular area sizing algorithm. Clinical and echocardiographic data were obtained at baseline, discharge, and 30 days. Results All 15 device implants were successful. Multidetector computed tomography estimated an aortic annular area of 4.9 ± 0.4 cm 2 , predicting 9.7 ± 6.9% THV oversizing. Post-transcatheter aortic valve replacement multidetector computed tomography showed consistently symmetrical and circular THVs. Aortic valve area increased from 0.7 ± 0.2 cm 2 to 1.5 ± 0.2 cm 2 (p Conclusions The S3 THV and delivery system might facilitate fully percutaneous implantation in a broader range of patients with the potential for more accurate positioning and less paravalvular regurgitation.
220 citations
TL;DR: In patients with anterior ST-segment elevation myocardial infarction, RIPC at the time of pPCI reduced enzymatic infarct size and was also associated with an improvement of T2-weighted edema volume and ST- segment resolution >50%.
Abstract: Objectives This study sought to evaluate whether remote ischemic post-conditioning (RIPC) could reduce enzymatic infarct size in patients with anterior ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention (pPCI). Background Myocardial reperfusion injury may attenuate the benefit of pPCI. In animal models, RIPC mitigates myocardial reperfusion injury. Methods One hundred patients with anterior ST-segment elevation myocardial infarction and occluded left anterior descending artery were randomized to pPCI + RIPC (n = 50) or conventional pPCI (n = 50). RIPC consisted of 3 cycles of 5 min/5 min ischemia/reperfusion by cuff inflation/deflation of the lower limb. The primary endpoint was infarct size assessed by the area under the curve of creatinine kinase-myocardial band release (CK-MB). Secondary endpoints included the following: infarct size assessed by cardiac magnetic resonance delayed enhancement volume; T2-weighted edema volume; ST-segment resolution >50%; TIMI (Thrombolysis In Myocardial Infarction) frame count; and myocardial blush grading. Results Four patients (2 RIPC, 2 controls) were excluded due to missing samples of CK-MB. A total of 96 patients were analyzed; median area under the curve CK-MB was 8,814 (interquartile range [IQR]: 5,567 to 11,325) arbitrary units in the RIPC group and 10,065 (IQR: 7,465 to 14,004) arbitrary units in control subjects (relative reduction: 20%, 95% confidence interval: 0.2% to 28.7%; p = 0.043). Seventy-seven patients underwent a cardiac magnetic resonance scan 3 to 5 days after randomization, and 66 patients repeated a second scan after 4 months. T2-weighted edema volume was 37 ± 16 cc in RIPC patients and 47 ± 22 cc in control subjects (p = 0.049). ST-segment resolution >50% was 66% in RIPC and 37% in control subjects (p = 0.015). We observed no significant differences in TIMI frame count, myocardial blush grading, and delayed enhancement volume. Conclusions In patients with anterior ST-segment elevation myocardial infarction, RIPC at the time of pPCI reduced enzymatic infarct size and was also associated with an improvement of T2-weighted edema volume and ST-segment resolution >50%. (Remote Postconditioning in Patients With Acute Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention [PCI] [RemPostCon]; NCT00865722 )
TL;DR: Cumulative all-cause mortality at 30 days and 1 year was similar among propensity-score matched TAVI and SAVR patients at intermediate surgical risk, and effects of treatment on 1-year mortality were similar across all subgroups except for sex.
Abstract: Objectives This study sought to compare all-cause mortality in patients at intermediate surgical risk undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). Background Physicians are selecting “lower” surgical risk patients to undergo TAVI. No clinical data exist about the clinical outcomes of TAVI versus SAVR among intermediate-surgical-risk patients. Methods We prospectively enrolled symptomatic patients with severe aortic stenosis who underwent TAVI or SAVR. Propensity-score matched pairs of TAVI and SAVR patients with Society of Thoracic Surgeons (STS) scores between 3% and 8% made up the study population. Primary endpoint was all-cause mortality at 1 year. Results Between November 2006 and January 2010, 3,666 consecutive patients underwent either TAVI (n = 782) or SAVR (n = 2,884). Four hundred five TAVI patients were matched to 405 SAVR patients. Of matched TAVI patients, 99 (24%) patients had STS scores 8%. Among patients with STS scores between 3% and 8%, 20 (7.8%) versus 18 (7.1%) patients had died up to 30 days (hazard ratio: 1.12, 95% confidence interval: 0.58 to 2.15, p = 0.74) and 42 (16.5%) versus 43 (16.9%) patients had died up to 1 year (hazard ratio: 0.90, 95% confidence interval: 0.57 to 1.42, p = 0.64) after TAVI and SAVR, respectively. Effects of treatment on 1-year mortality were similar across all subgroups except for sex, with some evidence for a beneficial effect of TAVI in women but not in men (test for interaction p = 0.024). Conclusions Cumulative all-cause mortality at 30 days and 1 year was similar among propensity-score matched TAVI and SAVR patients at intermediate surgical risk. (Surgical Replacement and Transcatheter Aortic Valve Implantation [SURTAVI]; NCT01586910 )
TL;DR: The low event rate at 5 years suggests sustained safety after the implantation of a fully bioresorbable Absorb everolimus-eluting scaffold, and noninvasive assessment of the coronary artery with an option of functional assessment could be an alternative to invasive imaging after treatment of coronary narrowing with such a polymeric bioresolved scaffold.
Abstract: Objectives: This study sought to demonstrate the 5-year clinical and functional multislice computed tomography angiographic results after implantation of the fully resorbable everolimus-eluting sca...
TL;DR: In STEMI patients undergoing primary PCI, the radial approach is associated with favorable outcomes and should be the preferred approach for experienced radial operators.
Abstract: Objectives This study sought to determine the safety and efficacy of radial access compared with femoral access for primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). Background Numerous randomized controlled trials, including several new studies, have compared outcomes of these approaches in the context of primary PCI for STEMI patients with inconclusive results. Methods We performed a meta-analysis of randomized controlled trials to compare outcomes in STEMI patients undergoing radial versus femoral access for primary PCI. Primary outcomes were death and major bleeding evaluated at the longest available follow-up. Secondary outcomes included access site bleeding, stroke, and procedure time. Twelve studies (N = 5,055) were included. All trials were conducted in centers experienced with both approaches. Results Compared with femoral approach, radial approach was associated with decreased risk of mortality (2.7% vs. 4.7%; odds ratio [OR]: 0.55, 95% confidence interval [CI]: 0.40 to 0.76; p Conclusions In STEMI patients undergoing primary PCI, the radial approach is associated with favorable outcomes and should be the preferred approach for experienced radial operators.
TL;DR: In this paper, the authors evaluated the long-term safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-ELuting stent (PES) in patients with obstructive coronary artery disease.
Abstract: Objectives This study sought to evaluate the long-term safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in patients with obstructive coronary artery disease. Background The use of EES compared to PES has been shown to result in improved clinical outcomes in patients undergoing PCI. However, there have been concerns regarding the durability of these benefits over longer-term follow-up. Methods SPIRIT III was a prospective, multicenter trial in which 1,002 patients were randomized 2:1 to EES versus PES. Endpoints included ischemia-driven target vessel failure (TVF) (death, myocardial infarction (MI), or ischemia-driven target vessel revascularization [TVR]), the pre-specified primary endpoint), target lesion failure (TLF) (cardiac death, target-vessel MI, or ischemia-driven target lesion revascularization [TLR]), major adverse cardiac events (MACE) (cardiac death, MI, or ischemia-driven TLR), their individual components and stent thrombosis. Results Five-year follow-up was available in 91.9% of patients. Treatment with EES versus PES resulted in lower 5-year Kaplan-Meier rates of TVF (19.3% vs. 24.5%, p = 0.05), TLF (12.7% vs. 19.0%, p = 0.008), and MACE (13.2% vs. 20.7%, p = 0.007). EES also resulted in reduced rates of all-cause death (5.9% vs. 10.1%, p = 0.02), with nonsignificantly different rates of MI, stent thrombosis, and TLR, and no evidence of late catch-up of TLR over time. Conclusions At 5 years after treatment, EES compared to PES resulted in durable benefits in composite safety and efficacy measures as well as all-cause mortality. Additionally, the absolute difference in TLR between devices remained stable over time without deterioration of effect during late follow-up.
TL;DR: Pulmonary Flow Grade score is useful in determining therapeutic efficacy, and PEPSI is highly supportive to reduce the risk of RPE after PTPA using these 2 indexes, PTPA could become a safe and common therapeutic strategy for CTEPH.
Abstract: Objectives: This study sought to identify useful predictors for hemodynamic improvement and risk of reperfusion pulmonary edema (RPE), a major complication of this procedure.Background: Percutaneou...
TL;DR: In this paper, the authors conducted a meta-analysis of the final 3-year results from the international SPIRIT (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronaries Artery Lesions) II, III, and IV clinical trials.
Abstract: Objectives This study sought to investigate whether the everolimus-eluting stent (EES) is superior to the paclitaxel-eluting stent (PES) with respect to long-term individual clinical outcomes. Background Individual studies have indicated a clinical advantage of coronary EES compared with PES with respect to restenosis and the composite endpoint of major adverse cardiac events. However, these trials were not powered for superiority in low-frequency event rates and have reported limited data beyond 1-year follow-up. Methods We conducted a meta-analysis of the final 3-year results from the international SPIRIT (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) II, III, and IV clinical trials. Individual patient data from 4,989 patients who were prospectively randomized to treatment with EES (n = 3,350) or PES (n = 1,639) were pooled for analysis. Results At 3-year follow-up, EES was superior to PES in reducing the following event rates: target lesion failure (8.9% vs. 12.5%, hazard ratio [HR]: 0.71, 95% confidence interval [CI]: 0.59 to 0.85; p = 0.0002), all-cause mortality (3.2% vs 5.1%, HR: 0.65, 95% CI: 0.49 to 0.86; p = 0.003), myocardial infarction (3.2% vs. 5.1%, HR: 0.64, 95% CI: 0.48 to 0.85; p = 0.002), cardiac death or myocardial infarction (4.4% vs. 6.3%, HR: 0.70, 95% CI: 0.54 to 0.90; p = 0.005), ischemia-driven target lesion revascularization (6.0% vs. 8.2%, HR: 0.72, 95% CI: 0.58 to 0.90; p = 0.004), stent thrombosis (0.7% vs. 1.7%, HR: 0.45, 95% CI: 0.26 to 0.78; p = 0.003), and major adverse cardiac events (9.4% vs. 13.0%, HR: 0.71, 95% CI: 0.60 to 0.85; p = 0.0002). No interaction was present between stent type and the 3-year relative rates of target lesion failure across a broad range of subgroups, with the exception of diabetes and vessel (left anterior descending vs. other). Conclusions In this large dataset with 3-year follow-up, coronary implantation of EES compared with PES resulted in reduced rates of all-cause mortality, myocardial infarction, ischemia-driven target lesion revascularization, stent thrombosis, and target lesion failure. Further research is warranted to characterize possible interactions between stent type, diabetes, and vessel.
TL;DR: This review discusses the current safety issues related to U.S. Food and Drug Administration approved atrial septal defect devices and proposes a potential avenue to gather additional safety data including factors, which may be involved in device erosion.
Abstract: This review discusses the current safety issues related to U.S. Food and Drug Administration approved atrial septal defect devices and proposes a potential avenue to gather additional safety data including factors, which may be involved in device erosion.
TL;DR: The present study has demonstrated in vivo that a maxLCBI(4mm) >400, as detected by NIRS, is a signature of plaques causing STEMI.
Abstract: Objectives: This study sought to describe near-infrared spectroscopy (NIRS) findings of culprit lesions in ST-segment elevation myocardial infarction (STEMI).Background: Although autopsy studies de...
TL;DR: Pre-dilation with PEB angioplasty prior to BMS implantation, as compared to PTA + BMS in complex FPA lesions, reduces restenosis and target lesion revascularization at 12-month follow-up.
Abstract: Objectives This study sought to compare paclitaxel-eluting balloon (PEB) with conventional percutaneous transluminal angioplasty (PTA), followed by systematic implantation of a self-expanding nitinol bare-metal stent (BMS) in patients at risk for restenosis. Background PTA is an effective strategy for treating atherosclerosis of the femoropopliteal axis (FPA). Whereas PEB have shown advantage over uncoated balloons in the treatment of simple lesions, it is unknown whether these results are applicable to complex degrees of FPA atheroma. Methods A total of 104 patients (110 FPA lesions in 110 limbs) were randomly assigned to either PEB + BMS or PTA + BMS. The primary endpoint was 12-month binary restenosis. Secondary endpoints were freedom from target lesion revascularization and major amputation. Post hoc subanalyses were performed for the comparison of long (≥100 mm) versus short lesions and true lumen versus subintimal approach. Results Mean lesion length was 94 ± 60 versus 96 ± 69 mm in the PEB + BMS and PTA + BMS groups (p = 0.8), respectively. The primary endpoint occurred in 9 (17%) versus 26 (47.3%) of lesions in the PEB + BMS and PTA + BMS groups (p = 0.008), respectively. A near-significant (p = 0.07) 1-year freedom from target lesion revascularization advantage was observed in the PEB + BMS group. No major amputation occurred. No significant difference was observed according to lesion characteristics or technical approach. Conclusions Pre-dilation with PEB angioplasty prior to BMS implantation, as compared to PTA + BMS in complex FPA lesions, reduces restenosis and target lesion revascularization at 12-month follow-up. Restenosis reduction is maintained irrespective of lesion length and recanalization technique. (Drug Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery [DEBATE-SFA]; NCT01556542)
TL;DR: Clinical acuity is a strong predictor of PCI procedural mortality, whereas the presence of a chronic total occlusion, subacute stent thrombosis, and left main lesion location were significant angiographic predictors.
Abstract: Objectives This study sought to update and validate a contemporary model for inpatient mortality following percutaneous coronary intervention (PCI), including variables indicating high clinical risk. Background Recently, new variables were added to the CathPCI Registry data collection form. This modification allowed us to better characterize the risk of death, including recent cardiac arrest and duration of cardiogenic shock. Methods Data from 1,208,137 PCI procedures performed between July 2009 and June 2011 at 1,252 CathPCI Registry sites were used to develop both a “full” and pre-catheterization PCI in-hospital mortality risk model using logistic regression. To support prospective implementation, a simplified bedside risk score was derived from the pre-catheterization risk model. Model performance was assessed by discrimination and calibration metrics in a separate split sample. Results In-hospital mortality was 1.4%, ranging from 0.2% among elective cases (45.1% of total cases) to 65.9% among patients with shock and recent cardiac arrest (0.2% of total cases). Cardiogenic shock and procedure urgency were the most predictive of inpatient mortality, whereas the presence of a chronic total occlusion, subacute stent thrombosis, and left main lesion location were significant angiographic predictors. The full, pre-catheterization, and bedside risk prediction models performed well in the overall validation sample (C-indexes 0.930, 0.928, 0.925, respectively) and among pre-specified patient subgroups. The model was well calibrated across the risk spectrum, although slightly overestimating risk in the highest risk patients. Conclusions Clinical acuity is a strong predictor of PCI procedural mortality. With inclusion of variables that further characterize clinical stability, the updated CathPCI Registry mortality models remain well-calibrated across the spectrum of PCI risk.
TL;DR: Clinicians should make revascularization decisions based on broadened clinical judgment when a single FFR result falls within this uncertainty zone, particularly between 0.77 and 0.83, when measurement certainty falls to less than 80%.
Abstract: Objectives This study sought to evaluate the effects of fractional flow reserve (FFR) measurement variability on FFR-guided treatment strategy. Background Current appropriateness guidelines recommend the utilization of FFR to guide coronary revascularization based on a fixed cut-off of 0.8. This rigid approach does not take into account the intrinsic biological variability of a single FFR result and the clinical judgment of experienced interventionists. Methods FFR reproducibility data from the landmark Deferral Versus Performance of PTCA in Patients Without Documented Ischemia (DEFER) trial was analyzed (two repeated FFR measurements in the same lesion, 10 min apart) and the standard deviation of the difference (SDD) between repeated measurements was calculated. The measurement certainty (probability that the FFR-guided revascularization strategy will not change if the test is repeated 10 min later) was subsequently established across the whole range of FFR values, from 0.2 to 1. Results Outside the [0.75 to 0.85] FFR range, measurement certainty of a single FFR result is >95%. However, closer to its cut-off, certainty falls to less than 80% within 0.77 to 0.83, reaching a nadir of 50% around 0.8. In clinical practice, that means that each time a single FFR value falls between 0.75 and 0.85, there is a chance that the FFR-derived revascularization recommendation will change if the measurement is repeated 10 min later, with this chance increasing the closer the FFR result is to 0.8. Conclusions A measurement FFR gray-zone is found between 0.75 and 0.85]. Therefore, clinicians should make revascularization decisions based on broadened clinical judgment when a single FFR result falls within this uncertainty zone, particularly between 0.77 and 0.83, when measurement certainty falls to less than 80%.
TL;DR: High rates of stent edge dissections were detected by OCT, usually related to the presence of atherosclerosis at stent edges and to PCI technique, and affected the subsequent management of this complication.
Abstract: Objectives This study sought to investigate the frequency, predictors, and detailed qualitative and quantitative assessment of optical coherence tomography (OCT)-detected stent edge dissections. Its impact on subsequent management and clinical outcomes were also investigated. Background OCT is a high-resolution imaging modality that can lead to more frequent recognition and accurate assessment of vascular injuries during percutaneous coronary intervention (PCI). Methods From September 2010 to June 2011, all patients with OCT post-PCI were enrolled. Edge dissections were defined as disruptions of the arterial lumen surface in both the 5-mm distal and proximal stent edges. Qualitative and quantitative analyses of all edges were performed at 0.2-mm intervals. Results In total, 395 edges (249 lesions in 230 patients) were analyzed. The overall incidence of OCT-detected edge dissection was 37.8%, and most (84%) were not apparent on angiography. Independent predictors for OCT-detected dissections were presence of atherosclerotic plaque at stent edges, calcification angle, minimum fibrous cap thickness, thin-cap fibroatheromas, stent/lumen eccentricity, and vessel overstretching. Mean dissection length measured 2.04 ± 1.60 mm, 96.2% appeared as flaps, and 52.8% extended beyond the intima/atheroma layer. Additional stenting was performed in 22.6% of all dissections, which were longer, had bigger dimensions, and promoted deeper vascular injury. The 12-month major adverse cardiac event rate was similar between patients with (7.95%) and without (5.69%, p = 0.581) dissections. Conclusions High rates of stent edge dissections were detected by OCT, usually related to the presence of atherosclerosis at stent edges and to PCI technique. Detailed OCT assessment of dissection severity was possible and affected the subsequent management of this complication. Non–flow-limiting, small, and superficial dissections left untreated proved benign.
TL;DR: A strategy of routine IVUS for drug-eluting stent implantation in long lesions did not improve the 1-year MACE rates and the IVUS use per operator decision was associated with improved results.
Abstract: Objectives This study sought to assess the impact of intravascular ultrasound (IVUS) guidance on clinical outcomes following drug-eluting stent implantation when treating long lesions. Background The role of IVUS guidance when treating long lesions has been tested during bare-metal stent, but not during drug-eluting stent, implantation. Methods A total of 543 patients treated with stents ≥28 mm in length were randomly assigned to IVUS guidance (n = 269) versus angiography guidance (n = 274). The primary endpoint was a composite of major adverse cardiac events (MACE), including cardiovascular death, myocardial infarction, target vessel revascularization, or stent thrombosis at 1 year following intervention. Results In the intention-to-treat analysis, total stent length was 32.4 mm in the IVUS-guided arm versus 32.3 mm in angiography-guided arm (p = 0.84). Adjunct post-dilation was more frequently performed in the IVUS-guided arm (54.6% vs. 44.5%, p = 0.03); post-intervention minimal lumen diameters were similar (2.55 vs. 2.55 mm, respectively, p = 0.50); and MACE occurred in 12 (4.5%) patients in IVUS-guided arm and in 20 (7.3%) patients in the angiography-guided arm (p = 0.16). However, among the 269 patients assigned to IVUS guidance, IVUS was not used in 13 patients (4.8%); conversely, in 274 patients assigned to angiography alone, 41 patients (15.0%) were treated with IVUS guidance. Therefore, in a per-protocol analysis according to actual IVUS usage, minimum lumen diameter was larger (2.58 vs. 2.51 mm, p = 0.04), and MACE rates were lower: 4.0% in the IVUS-guided arm versus 8.1% in the angiography-guided arm (p = 0.048). Conclusions A strategy of routine IVUS for drug-eluting stent implantation in long lesions did not improve the 1-year MACE rates. The IVUS use per operator decision was associated with improved results. (A New Strategy Regarding Discontinuation of Dual Antiplatelet; NCT01145079 )
TL;DR: FD-OCT generates similar reference lumen dimensions but higher degrees of disease severity and NIH, as well as better detection of malapposition and tissue prolapse compared with IVUS, as an assessment of coronary disease and percutaneous coronary intervention using stents.
Abstract: Objectives: We compared intravascular ultrasound (IVUS) and 2 different generations of optical coherence tomography (OCT)—time-domain OCT (TD-OCT) and frequency-domain OCT (FD-OCT)—for the assessme...
TL;DR: Percutaneous valve-in-valve implantation of the Melody valve in the mitral or tricuspid position for treatment of bioprosthetic valve dysfunction is feasible and can lead to significant symptomatic improvement in carefully selected high-risk patients.
Abstract: Objectives The purpose of this study was to report the results of percutaneous valve-in-valve therapy using the Melody valve (Medtronic, Minneapolis, Minnesota) for patients with degenerated mitral and tricuspid bioprosthetic valves Background Open surgery for replacement of degenerated bioprosthetic valves is associated with morbidity and mortality Methods Nineteen patients (median age 65 years, range 10 to 88 years; 7 males) with degenerated mitral (n = 9) or tricuspid (n = 10) bioprosthetic valves underwent transvenous valve-in-valve implantation of the Melody valve Results In the mitral patients, the mean Society of Thoracic Surgeons mortality score was 133 ± 56% All patients had a prosthetic valve mean diastolic inflow gradient ≥5 mm Hg Moderate or worse regurgitation was present in 7 of 9 mitral and 7 of 10 tricuspid patients Implantation of a Melody valve was successful in all Among the mitral patients, mean diastolic gradient decreased from 123 ± 46 mm Hg to 52 ± 2 mm Hg (p Conclusions Percutaneous valve-in-valve implantation of the Melody valve in the mitral or tricuspid position for treatment of bioprosthetic valve dysfunction is feasible and can lead to significant symptomatic improvement in carefully selected high-risk patients
TL;DR: In this article, the authors focus on the use of platelet function testing and pharmacogenomic testing in order to identify patients who either do not respond to or are at risk of not responding sufficiently to P2Y12 inhibitors.
Abstract: P2Y12 inhibitors are widely used in patients with acute coronary syndromes and in the secondary prevention of thrombotic events in vascular diseases. Within the past few years, several pharmacological, genetic, and clinical limitations of the second-generation thienopyridine clopidogrel have raised major concerns. High on-treatment platelet reactivity, which is common in clopidogrel-treated patients, and its clinical implications led to the development of the more effective platelet P2Y12 inhibitors prasugrel (a third-generation thienopyridine) and ticagrelor (a cyclopentyl-triazolo-pyrimidine). The pharmacokinetics and pharmacodynamics of prasugrel and ticagrelor indicate that they provide more consistent, more rapid, and more potent platelet inhibition than clopidogrel, which translates into improved ischemic outcomes. Nevertheless, higher efficacy, which is reflected by low on-treatment platelet reactivity, increases the risk of major bleeding events. Therefore, cardiologists might be facing a new challenge in the future: to individualize the level of platelet inhibition in order to decrease thrombotic events without increasing bleeding. The current review focuses on the use of platelet function testing and pharmacogenomic testing in order to identify patients who either do not respond to or are at risk of not responding sufficiently to P2Y12 inhibitors. Moreover, this paper discusses randomized trials, which so far have failed to show that tailored antiplatelet therapy improves clinical outcome, and treatment options for patients with high on-treatment platelet reactivity.
TL;DR: The results of this study suggest that in STEMI patients with MVD presenting with CS and CA, MV primary PCI may improve clinical outcome.
Abstract: Objectives This study sought to assess the impact of multivessel (MV) primary percutaneous coronary intervention (PCI) on clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) presenting with cardiogenic shock (CS) and resuscitated cardiac arrest (CA). Background The safety and efficacy of MV primary PCI in patients with STEMI and refractory CS is unknown. Methods We conducted a multicenter prospective observational study of consecutive STEMI patients presenting to 5 French centers. Patients were classified as having single-vessel (SVD) or multivessel (MVD) coronary disease, and underwent culprit-only or MV primary PCI. Baseline characteristics and 6-month survival were compared. Results Among 11,530 STEMI patients, 266 had resuscitated CA and CS. Patients with SVD (36.5%) had increased 6-month survival compared to those with MVD (29.6% vs. 42.3%, p = 0.032). Baseline characteristics were similar in those with MVD undergoing culprit-only (60.9%) or MV (39.1%) primary PCI. However, 6-month survival was significantly greater in patients who underwent MV PCI (43.9% vs. 20.4%, p = 0.0017). This survival advantage was mediated by a reduction in the composite of recurrent CA and death due to shock (p = 0.024) in MV PCI patients. In those with MVD, culprit artery PCI success (hazard ratio [HR]: 0.63; 95% confidence interval [CI]: 0.41 to 0.96, p = 0.030) and MV primary PCI (HR: 0.57; 95% CI: 0.38 to 0.84, p = 0.005) were associated with increased 6-month survival. Conclusions The results of this study suggest that in STEMI patients with MVD presenting with CS and CA, MV primary PCI may improve clinical outcome. Randomized trials are required to verify these results.
TL;DR: The FFR(cor), and, by extension, microcirculatory resistance can be derived without the need for P(w), and this method enables assessment of coronary micro Circulatory status before or without balloon inflation, in the presence of epicardial stenosis.
Abstract: Objectives: This study sought to investigate a novel method to calculate the index of microcirculatory resistance (IMR) in the presence of significant epicardial stenosis without the need for ballo...
TL;DR: Radiation dose as measured by air kerma was nominally higher with radial versus femoral access, but differences were present only in lower-volume centers and operators, suggesting high-volume Centers have the lowest radiation dose irrespective of which access site approach that they use.
Abstract: Objectives The authors sought to compare the radiation dose between radial and femoral access. Background Small trials have shown an increase in the radiation dose with radial compared with femoral access, but many were performed during the operators9 learning curve of radial access. Methods Patients were randomized to radial or femoral access, as a part of the RIVAL (RadIal Vs. femorAL) trial (N = 7,021). Fluoroscopy time was prospectively collected in 5740 patients and radiation dose quantified as air kerma in 1,445 patients and dose-area product (DAP) in 2,255 patients. Results Median fluoroscopy time was higher with radial versus femoral access (9.3 vs. 8.0 min, p Conclusions Radiation dose as measured by air kerma was nominally higher with radial versus femoral access, but differences were present only in lower-volume centers and operators. High-volume centers have the lowest radiation dose irrespective of which access site approach that they use. (A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention (PCI) Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy [RIVAL]; NCT01014273)