This study has reported 10-year clinical follow-up of patients enrolled in the prospective, randomized LE MANS (Left Main Stenting) trial.
The very long-term outcome after left main stenting in ...comparison with surgical revascularization remains unknown.
In this prospective, multicenter trial, we randomly assigned 105 patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease according to SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score to percutaneous coronary intervention (PCI) with stenting (n = 52) or coronary artery bypass grafting (CABG) (n = 53). Drug-eluting stents were implanted in 35%, whereas arterial grafts to the left anterior descending artery were utilized in 81%. Currently, the mean long-term follow-up was collected at 9.8 ± 1.0 years. Follow up for all-cause mortality is complete, whereas the incidence of major adverse cardiovascular and cerebral events (MACCE) was reported from 90% of patients. Ambulatory follow-up was completed in 46 (43.9%) patients.
At 10 years, there was a trend toward higher ejection fraction in stenting when compared with surgery (54.9 ± 8.3% vs. 49.8 ± 10.3%; p = 0.07). The mortality (21.6% vs. 30.2%; p = 0.41) and MACCE (51.1% vs. 64.4%; p = 0.28) were statistically not different between groups; however, numerically the difference was in favor of stenting. Similarly, there was no difference in the occurrence of myocardial infarction (8.7 vs. 10.4%; p = 0.62), stroke (4.3 vs. 6.3%; p = 0.68), and repeated revascularization rates (26.1% vs. 31.3%; p = 0.64). The probability of very long-term survival up to 14 years was comparable between PCI and CABG (74.2% vs. 67.5%; p = 0.34; hazard ratio: 1.45, 95% confidence interval: 0.67 to 3.13); however, there was a trend toward higher MACCE-free survival in the PCI group (34.7% vs. 22.1%; p = 0.06; hazard ratio: 1.71, 95% confidence interval: 0.97 to 2.99).
In patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease, stenting offers numerically, but statistically nonsignificant, favorable long-term outcome up to 10 years in terms of safety and efficacy outcome measures, therefore, constitutes an alternative therapy for CABG.
Summary Background Incomplete revascularisation is common after percutaneous coronary intervention and is associated with increased mortality and adverse cardiovascular events. We aimed to assess ...whether adjunctive anti-ischaemic pharmacotherapy with ranolazine would improve the prognosis of patients with incomplete revascularisation after percutaneous coronary intervention. Methods We performed this multicentre, randomised, parallel-group, double-blind, placebo-controlled, event-driven trial at 245 centres in 15 countries in Europe, Israel, Russia, and the USA. Patients (aged ≥18 years) with a history of chronic angina with incomplete revascularisation after percutaneous coronary intervention (defined as one or more lesions with ≥50% diameter stenosis in a coronary artery ≥2 mm diameter) were randomly assigned (1:1), via an interactive web-based block randomisation system (block sizes of ten), to receive either twice-daily oral ranolazine 1000 mg or matching placebo. Randomisation was stratified by diabetes history (presence vs absence) and acute coronary syndrome presentation (acute coronary syndrome vs non-acute coronary syndrome). Study investigators, including all research teams, and patients were masked to treatment allocation. The primary endpoint was time to first occurrence of ischaemia-driven revascularisation or ischaemia-driven hospitalisation without revascularisation. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov , number NCT01442038. Findings Between Nov 3, 2011, and May 27, 2013, we randomly assigned 2651 patients to receive ranolazine (n=1332) or placebo (n=1319); 2604 (98%) patients comprised the full analysis set. After a median follow-up of 643 days (IQR 575–758), the composite primary endpoint occurred in 345 (26%) patients assigned to ranolazine and 364 (28%) patients assigned to placebo (hazard ratio 0·95, 95% CI 0·82–1·10; p=0·48). Incidence of ischaemia-driven revascularisation and ischaemia-driven hospitalisation did not differ significantly between groups. 189 (14%) patients in the ranolazine group and 137 (11%) patients in the placebo group discontinued study drug because of an adverse event (p=0·04). Interpretation Ranolazine did not reduce the composite rate of ischaemia-driven revascularisation or hospitalisation without revascularisation in patients with a history of chronic angina who had incomplete revascularisation after percutaneous coronary intervention. Further studies are warranted to establish whether other treatment could be effective in improving the prognosis of high-risk patients in this population. Funding Gilead Sciences, Menarini.
MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation ...of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical effect of MiStent sirolimus-eluting stent compared with a durable polymer drug-eluting stents has not been investigated in a large randomised trial in an all-comer population.
We did a randomised, single-blind, multicentre, phase 3 study (DESSOLVE III) at 20 hospitals in Germany, France, Netherlands, and Poland. Eligible participants were any patients aged at least 18 years who underwent percutaneous coronary intervention in a lesion and had a reference vessel diameter of 2·50–3·75 mm. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting bioresorbable polymer stent (MiStent) or an everolimus-eluting durable polymer stent (Xience). Randomisation was done by local investigators via web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint (DOCE)—cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation—between the groups at 12 months after the procedure assessed by intention-to-treat. A margin of 4·0% was defined for non-inferiority of the MiStent group compared with the Xience group. All participants were included in the safety analyses. This trial is registered with ClinicalTrials.gov, number NCT02385279.
Between March 20, and Dec 3, 2015, we randomly assigned 1398 patients with 2030 lesions; 703 patients with 1037 lesions were assigned to MiStent, of whom 697 received the index procedure, and 695 patients with 993 lesions were asssigned to Xience, of whom 690 received the index procedure. At 12 months, the primary endpoint had occurred in 40 patients (5·8%) in the sirolimus-eluting stent group and in 45 patients (6·5%) in the everolimus-eluting stent group (absolute difference −0·8% 95% CI −3·3 to 1·8, pnon-inferiority=0·0001). Procedural complications occurred in 12 patients (1·7%) in the sirolimus-eluting stent group and ten patients (1·4%) in the everolimus-eluting stent group; no clinical adverse events could be attributed to these dislodgements through a minimum of 12 months of follow-up. The rate of stent thrombosis, a safety indicator, did not differ between groups and was low in both treatment groups.
The sirolimus-eluting bioabsorbable polymer stent was non-inferior to the everolimus-eluting durable polymer stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. MiStent seems a reasonable alternative to other stents in clinical practice.
The European Cardiovascular Research Institute, Micell Technologies (Durham, NC, USA), and Stentys (Paris, France).
A case of a 64‐year‐old patient who was referred to interventional cardiology unit in order to qualify her to mitral valve repair is presented. Transthoracic echocardiography revealed a giant ...inferior wall basal aneurysm of the left ventricle (44 mm × 31 mm, 57 ml) and coronary angiography revealed chronic total occlusion of the proximal right coronary artery. The patient refused surgical treatment and was treated with pharmacotherapy alone. At 1 year follow‐up, clear progression of the disease was observed. Based on this case study, we would cautiously suggest that in similar cases of large inferobasal wall aneurysms causing severe MR, OMT may be insufficient to prevent disease progression, and that early surgical intervention may be preferred.
Acute and Late Outcomes of Unprotected Left Main Stenting in Comparison With Surgical Revascularization Pawel E. Buszman, Stefan R. Kiesz, Andrzej Bochenek, Ewa Peszek-Przybyla, Iwona Szkrobka, ...Marcin Debinski, Bozena Bialkowska, Dariusz Dudek, Agata Gruzka, Aleksander Zurakowski, Krzysztof Milewski, Miroslaw Wilczynski, Lukasz Rzeszutko, Piotr Buszman, Jan Szymszal, Jack L. Martin, Michal Tendera Unprotected left main coronary artery (ULMCA) stenting is the subject of intense investigation as a potential alternative to bypass surgery. We randomly assigned 105 patients with ULMCA stenosis to receive percutaneous coronary intervention (PCI) (52 patients) or coronary artery bypass grafting (CABG) (53 patients). Patients treated with PCI had favorable early outcomes in comparison with the CABG group. At 1 year, the ejection fraction improved significantly only in the PCI group. Target vessel failure was similar in both groups. After more than 2 years, major adverse cardiac and cerebrovascular event-free survival was similar in both groups with a trend toward improved survival after PCI.
The aim of the BIOPAC trial was to determine long-term safety and efficacy of a novel microcrystalline paclitaxel-coated balloon (mcPCB) with a biocompatible polymer as an excipient in the treatment ...of occlusive femoropopliteal lesions. In this first-in-human prospective controlled randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease were randomized to either mcPCB (study group) or POBA (plain old balloon angioplasty) (control group) on a 1:1 basis. Late lumen loss (LLL) at 6 months was the primary endpoint of the study and serious adverse events (SAE: death, amputation, repeated revascularization) were considered a composite secondary endpoint. Routine angiography was scheduled for all study subjects at 6-month follow-up; outpatient appointments were scheduled at 12 and 36 months after intervention. At 6 months, the LLL was 63% lower in the mcPCB group compared to the POBA group (0.52 ± 1.2 vs 1.39 ± 1.1 mm; psup < 0.01). Binary restenosis occurred in 23% vs 52% of patients (p = 0.02). At 3 years, the prevalence of SAE was significantly lower in the mcPCB group (33.3 vs 63.3%; p = 0.02), which mainly resulted from a twofold reduction in target vessel revascularization rate (28.6 vs 59.3%; p = 0.02). The difference in mortality was nonsignificant (7.4 vs 14.3%; p = 0.42). Patients with mcPCB were less symptomatic and less likely to adhere to secondary prevention measures. In this pivotal trial, a novel mcPCB proved superior to POBA concerning LLL at 6-month follow-up, and SAE at 12 months. This result was sustained up to 3 years. There was no difference between groups regarding mortality. ClinicalTrials.gov Identifier: NCT02145065
Background: This multicenter retrospective study with a control group was designed to assess the influence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on the outcomes of ...patients with myocardial infarction (MI). Methods: A total of 129 patients with COVID-19 who were treated for MI were included in this study. The control group comprised 129 comparable patients without SARS-CoV-2 infection. The in-hospital, out-of-hospital, and overall mortality were analyzed. Results: A total of thirty-one (24%) patients died in the study group, and two (1.6%) patients died in the control group (OR = 20.09; CI: 4.69–85.97; p < 0.001). Similar results were observed in all analyzed patient subgroups. Multivariable Cox regression analysis confirmed the significant influence of SARS-CoV-2 infection on in-hospital outcomes (HR: 8.48459; CI: 1.982–36.320; p = 0.004). Subanalysis of the groups with COVID-19 plus ST-elevation MI (STEMI) or non-ST-elevation MI (NSTEMI) revealed comparable mortality rates: 14 (21.12%) patients in the NSTEMI group and 17 (26.98%) patients in the STEMI subgroup died (OR: 1.3; CI: 0.56–3.37; p = 0.45). During out-of-hospital observation, no differences in mortality were observed (OR: 0.77; CI: 0.11–4.07; p = 0.73). Conclusions: SARS-CoV-2 infection affects the in-hospital outcomes of patients with both MI and COVID-19, regardless of MI type (STEMI vs. NSTEMI).
Aims
We aimed to update the logistic clinical SYNTAX score to predict 2 year all‐cause mortality after contemporary percutaneous coronary intervention (PCI).
Methods and results
We analyzed 15,883 ...patients in the GLOBAL LEADERS study who underwent PCI. The logistic clinical SYNTAX model was updated after imputing missing values by refitting the original model (refitted original model) and fitting an extended new model (new model, with, selection based on the Akaike Information Criterion). External validation was performed in 10,100 patients having PCI at Fu Wai hospital.
Chronic obstructive pulmonary disease, prior stroke, current smoker, hemoglobin level, and white blood cell count were identified as additional independent predictors of 2 year all‐cause mortality and included into the new model.
The c‐indexes of the original, refitted original and the new model in the derivation cohort were 0.74 (95% CI 0.72–0.76), 0.75 (95% CI 0.73–0.77), and 0.78 (95% CI 0.76–0.80), respectively. The c‐index of the new model was lower in the validation cohort than in the derivation cohort, but still showed improved discriminative ability of the newly developed model (0.72; 95% CI 0.67–0.77) compared to the refitted original model (0.69; 95% CI 0.64–0.74). The models overestimated the observed 2 year all‐cause mortality of 1.11% in the Chinese external validation cohort by 0.54 percentage points, indicating the need for calibration of the model to the Chinese patient population.
Conclusions
The new model of the logistic clinical SYNTAX score better predicts 2 year all‐cause mortality after PCI than the original model. The new model could guide clinical decision making by risk stratifying patients undergoing PCI.
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