Abstract Background Guidelines recommend postponing surgery for at least 6 months after treatment with a drug-eluting stent by percutaneous coronary intervention (DES-PCI). Objectives The goal of ...this study was to evaluate the surgical risk associated with DES-PCI compared with that in nonstented patients without ischemic heart disease (IHD). Methods Between 2005 and 2012, a total of 22,590 patients underwent DES-PCI in western Denmark. By record-linking the Western Denmark Heart Registry and the Danish National Patient Register, we evaluated 4,303 DES-PCI–treated patients with a surgical procedure and compared them with a control group of patients without previous IHD undergoing similar surgical procedures (n = 20,232). Events of interest were myocardial infarction (MI), cardiac death, and all-cause mortality within 30 days after surgery. Results Surgery in DES-PCI–treated patients was associated with an increased risk of MI (1.6% vs. 0.2%; odds ratio OR: 4.82; 95% confidence interval CI: 3.25 to 7.16) and cardiac death (1.0% vs. 0.2%; OR: 5.87; 95% CI: 3.60 to 9.58) but not all-cause mortality (3.1% vs. 2.7%; OR: 1.12; 95% CI: 0.91 to 1.38). When stratified for time from PCI to surgery, only surgery within the first month was associated with a significant increased risk of events. Conclusions Patients requiring surgery within 12 months after DES-PCI had an increased risk of MI and cardiac death compared with patients without IHD. The increased risk was only present within the first month after DES-PCI, suggesting that surgery might be undertaken earlier than currently recommended.
Abstract Objectives The goal of this study was to assess the real-world clinical utility of fractional flow reserve (FFR) derived from coronary computed tomography angiography (FFRCT ) for ...decision-making in patients with stable coronary artery disease (CAD). Background FFRCT has shown promising results in identifying lesion-specific ischemia. The real-world feasibility and influence on the diagnostic work-up of FFRCT testing in patients suspected of having CAD are unknown. Methods We reviewed the complete diagnostic work-up of nonemergent patients referred for coronary computed tomography angiography over a 12-month period at Aarhus University Hospital, Denmark, including all patients with new-onset chest pain with no known CAD and with intermediate-range coronary lesions (lumen reduction, 30% to 70%) referred for FFRCT . The study evaluated the consequences on downstream diagnostic testing, the agreement between FFRCT and invasively measured FFR or instantaneous wave-free ratio (iFR), and the short-term clinical outcome after FFRCT testing. Results Among 1,248 patients referred for computed tomography angiography, 189 patients (mean age 59 years; 59% male) were referred for FFRCT , with a conclusive FFRCT result obtained in 185 (98%). FFRCT was ≤0.80 in 31% of patients and 10% of vessels. After FFRCT testing, invasive angiography was performed in 29%, with FFR measured in 19% and iFR in 1% of patients (with a tendency toward declining FFR-iFR guidance during the study period). FFRCT ≤0.80 correctly classified 73% (27 of 37) of patients and 70% (37 of 53) of vessels using FFR ≤0.80 or iFR ≤0.90 as the reference standard. In patients with FFRCT >0.80 being deferred from invasive coronary angiography, no adverse cardiac events occurred during a median follow-up period of 12 (range 6 to 18 months) months. Conclusions FFRCT testing is feasible in real-world symptomatic patients with intermediate-range stenosis determined by coronary computed tomography angiography. Implementation of FFRCT for clinical decision-making may influence the downstream diagnostic workflow of patients. Patients with an FFRCT value >0.80 being deferred from invasive coronary angiography have a favorable short-term prognosis.
Abstract Objectives This study sought to report the late multimodality imaging and clinical outcomes of the novel poly- l -lactic-acid–based DESolve novolimus-eluting bioresorbable coronary scaffold ...for the treatment of de novo coronary lesions. Background Bioresorbable scaffolds are an alternative to drug-eluting metallic stents and provide temporary vascular scaffolding, which potentially may allow vessel restoration and reduce the risk of future adverse events. Methods Overall, 126 patients were enrolled at 13 international sites between November 2011 and June 2012. The primary endpoint was in-scaffold late lumen loss at 6 months. Major adverse cardiac events, the main safety endpoint, were defined as the composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. All patients underwent angiography at 6 months. Serial intravascular ultrasound and optical coherence tomography were performed in a subset of patients. Results The scaffold device success rate was 97% (n = 122 of 126), and procedural success was 100% (n = 122 of 122). The major adverse cardiac event rate was 3.3% (n = 4 of 122) at 6 months and 7.4% (n = 9 of 122) at 24 months, including 1 probable stent thrombosis within the first month. At 6-month angiographic follow-up, in-scaffold late lumen loss was 0.20 ± 0.32 mm. Paired intravascular ultrasound analysis demonstrated a significant increase in vessel, lumen and scaffold dimensions between post-procedure and 6-month follow-up, and strut-level optical coherence tomography analysis showed full strut coverage in 99 ± 1.7%. Conclusions Our results showed favorable performance of the DESolve scaffold, effective inhibition of neointimal hyperplasia, and for the first time, early luminal and scaffold growth at 6 months with sustained efficacy and safety through 2 years. (Elixir Medical Clinical Evaluation of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System—The DESolve Nx Trial; NCT02086045 )
Stent Thrombosis, Myocardial Infarction, and Death After Drug-Eluting and Bare-Metal Stent Coronary Interventions Lisette Okkels Jensen, Michael Mæng, Anne Kaltoft, Per Thayssen, Hans Henrik Tilsted ...Hansen, Morten Bøttcher, Jens Flensted Lassen, Lars Romer Krussel, Klaus Rasmussen, Knud Nøerregaard Hansen, Lars Pedersen, Søren Paaske Johnsen, Henrik Toft Sørensen, Leif Thuesen We compared rates of stent thrombosis (ST), myocardial infarction (MI), death, and target lesion revascularization after implantation of drug-eluting stents (DES) and bare-metal stents (BMS), with population-based medical databases in Denmark. The DES were implanted in 3,548 patients, and BMS were implanted in 8,847 patients. The risk of definite ST was similar in the 2 groups. Very late definite ST (between 12 and 15 months after implantation) occurred more frequently in patients receiving DES. The MI and mortality were similar in the 2 groups. Target lesion revascularization was reduced by 43% in patients treated with DES.
The mechanisms behind the increased mortality in patients with acute myocardial infarction and co-existing severe mental illness (SMI) compared with non-SMI patients remain unclear. We studied 12,102 ...patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention, of whom 457 had SMI. The primary outcome was major adverse cardiac events (death, myocardial infarction, target vessel revascularization) at 30 days, 1 year, 2 years, and maximum follow-up. Patients with SMI were younger, more often women, had higher prevalence of active smoking and diabetes, and had a longer duration of symptoms than patients without SMI. There were no substantial differences in the in-hospital treatment of patients with and without SMI. Fewer SMI patients were treated with the recommended medications during follow up; however, the absolute differences were modest. Compared with non-SMI patients, the cumulative risks of major adverse cardiac events after 1 year, 2 years, and maximum follow-up were higher among SMI patients hazard ratio 1.27 (1.02 to 1.57), hazard ratio 1.32 (1.09 to 1.60), and hazard ratio 1.43 (1.25 to 1.65), respectively. Even after adjustment for differences in baseline characteristics, the differences in outcome persisted. In conclusion, compared with patients without SMI, primary percutaneous coronary intervention treated patients with SMI had a worse baseline risk profile. No differences in in-hospital treatments were found. Although the absolute differences were small, SMI patients were less likely to receive recommended medical treatment during follow up and they face a worse prognosis, even after adjustment for differences in risk profile. This indicates that SMI per se is likely to have an adverse effect on the prognosis following ST-elevation myocardial infarction.
Diabetes is associated with increased risk of major adverse cardiac events (MACEs) after percutaneous coronary intervention. The purpose of this substudy of the SORT OUT IV trial was to compare ...clinical outcomes in patients with and without diabetes mellitus treated with everolimus-eluting stents (EESs) or sirolimus-eluting stents (SESs). In total 2,774 patients (390 with diabetes, 14.1%) were randomized to stent implantation with EESs (n = 1,390, diabetes in 14.0%) or SESs (n = 1,384, diabetes in 14.2%). Randomization was stratified by presence/absence of diabetes. The primary end point was MACEs, a composite of cardiac death, myocardial infarction, definite stent thrombosis, or target vessel revascularization within 18 months. MACEs were higher in diabetic than in nondiabetic patients (13.1% vs 6.4%, hazard ratio HR 2.08, 95% confidence interval CI 1.51 to 2.86). In diabetic patients, MACEs were seen in 10.3% of those treated with EESs and in 15.8% of those treated with SESs (HR 0.63, 95% CI 0.36 to 1.11). In nondiabetic patients, MACEs occurred in 6.6% of EES-treated and in 6.3% SES-treated patients (HR 1.06, 95% CI 0.77 to 1.46). In diabetics, cardiac death occurred in 3.1% of EES-treated and in 4.6% of SES-treated patients (HR 0.67, 95% CI 0.24 to 1.89), myocardial infarction occurred in 0.5% of EES-treated and in 3.6% of SES-treated patients (HR 0.14, 95% CI 0.02 to 1.16), and clinically driven target lesion revascularization was needed in 3.1% of EES-treated and in 7.7% of SES-treated patients (HR 0.40, 95% CI 0.15 to 1.02). No interaction between diabetes status and type of drug-eluting stent was found for the end points. In conclusion, patients with diabetes have higher MACE rates than nondiabetics. No significant differences in safety or efficacy outcomes after EES or SES implantation were present in nondiabetic or diabetic patients.
Patients with diabetes mellitus (DM) have a worse outcome after percutaneous coronary intervention (PCI) than nondiabetic patients. The purpose of this study was to compare rates of stent thrombosis, ...myocardial infarction (MI), target lesion revascularization (TLR), and death in diabetic and nondiabetic patients treated with primary PCI for ST-segment elevation MI (STEMI) in Western Denmark. From January 2002 through June 2005, 3,655 consecutive patients with STEMI treated with primary PCI and stent implantation (316 patients with DM, 8.6%; 3,339 patients without DM, 91.4%) were recorded in the Western Denmark Heart Registry. All patients were followed for 3 years. Cox regression analysis was used to compute hazard ratios (HRs), controlling for potential confounding. Three-year rates of definite stent thrombosis were 1.6% in the DM group and 1.5% in the non-DM group (adjusted HR 1.15, 95% confidence interval CI 0.50 to 2.67). The rate of MI was 12.3% in the DM group versus 5.6% in the non-DM group (adjusted HR 2.56, 95% CI 1.81 to 3.61). Rates of TLR were 12.1% in the DM group and 8.7% in the non-DM group (adjusted HR 1.55, 95% CI 1.14 to 2.11). All-cause mortality was 23.7% in patients with DM versus 12.7% in patients without DM (adjusted HR 2.03, 95% CI 1.59 to 2.59). In conclusion, stent thrombosis rate was similar in patients with and without DM and STEMI treated with primary PCI, whereas the presence of DM increased the risk of MI, TLR, and death.
Background In patients with ST-segment elevation myocardial infarction (STEMI), timely reperfusion with primary percutaneous coronary intervention (PCI) is the preferred treatment. In primary PCI ...patients with multivessel disease, it is unclear whether culprit vessel PCI only is the preferred treatment. We compared mortality among (1) STEMI patients with single-vessel disease and those with multivessel disease and (2) multivessel disease patients with and without additional revascularization of nonculprit lesions within 2 months after the index PCI. Methods From January 2002 to June 2009, all patients presenting with STEMI and treated with primary PCI were identified from the Western Denmark Heart Registry, which covers a population of 3.0 million. The hazard ratio (HR) for death was estimated using a Cox regression model, controlling for potential confounding. Results The study cohort consisted of 8,822 patients: 4,770 (54.1%) had single-vessel disease and 4,052 (45.9%) had multivessel disease. Overall, 1-year cumulative mortality was 7.6%, and 7-year cumulative mortality was 24.0%. Multivessel disease was associated with higher 7-year mortality (adjusted HR 1.45 95% CI 1.30-1.62, P < .001). Among patients with multivessel disease, lack of additional revascularization beyond the culprit lesion was associated with higher 7-year mortality (adjusted HR 1.50 95% CI 1.25-1.80, P < .001). In patients with multivessel disease who underwent additional revascularization, 7-year mortality (adjusted HR 1.01 95% CI 0.84-1.22, P = .89) was similar compared to patients with single-vessel disease. Conclusion In STEMI patients, multivessel disease was associated with a higher mortality compared to single-vessel disease. In multivessel disease patients, additional revascularization was associated with a higher survival compared with culprit vessel PCI only.
Background Third-generation coronary drug-eluting stents (DES) with biodegradable polymers have been designed to improve safety and efficacy. We designed a large scale registry-based randomized ...clinical trial to compare 2 third-generation DES: a thin strut, cobalt-chromium DES with silicon carbide-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the stainless steel biodegradable polymer biolimus-eluting Nobori stents (N-BES, Nobori; Terumo, Tokyo, Japan) in an all-comer patient population. Design The multicenter SORT OUT VII trial (NCT01879358) randomly assigned 2,530 patients to treatment with biodegradable polymer O-SES or biodegradable polymer N-BES at 3 sites in Western Denmark. Patients were eligible, if they were ≥18 years old; had chronic stable coronary artery disease or acute coronary syndromes; and ≥1 coronary lesion with >50% diameter stenosis, requiring treatment with a DES. The primary end point target lesion failure is a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 12 months. Clinically, driven event detection based on Danish registries will be used. An event rate of 6.5% is assumed in each stent group. With a sample size of 1,157 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level will have 90% power to detect noninferiority of the O-SES compared with the N-BES with a predetermined noninferiority margin of 3.0%. Conclusion The SORT OUT VII trial will determine whether the biodegradable polymers O-SES is noninferior to the N-BES with respect to driven event.
Diabetes is associated with an increased risk of major adverse cardiac events after percutaneous coronary intervention. We compared clinical outcomes in patients with and without diabetes mellitus ...treated with the second-generation Endeavor zotarolimus-eluting stent (ZES) or the first-generation Cypher Select+ sirolimus-eluting stent (SES). We randomized 2,332 patients to treatment with ZESs (n = 1,162, n = 169 diabetics) or SESs (n = 1,170, n = 168 diabetics) and followed them for 18 months. Randomization was stratified by presence/absence of diabetes. The primary end point was major adverse cardiac events defined as a composite of cardiac death, myocardial infarction, or target vessel revascularization. Secondary end points included these individual end points plus all-cause mortality and target lesion revascularization. In diabetic patients, use of ZES compared to SES was associated with an increased risk of major adverse cardiac events (18.3% vs 4.8%, hazard ratio 4.05, 95% confidence interval 1.86 to 8.82), myocardial infarction (4.7% vs 0.6%, hazard ratio 8.09, 95% confidence interval 1.01 to 64.7), target vessel revascularization (14.2% vs 3.0%, hazard ratio 4.99, 95% confidence interval 1.90 to 13.1), and target lesion revascularization (12.4% vs 1.2%, hazard ratio 11.0, 95% confidence interval 2.59 to 47.1). In patients without diabetes differences in absolute risk decrease were smaller but similarly favored SES. In conclusion, implantation of ZESs compared to SESs is associated with a considerable increased risk of adverse events in patients with diabetes at 18-month follow-up.
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