Coronary bifurcation lesions treated with simple or complex stenting: 5-year survival from patient-level pooled analysis of the Nordic Bifurcation Study and the British Bifurcation Coronary Study.

AIMS: Randomized trials of coronary bifurcation stenting have shown better outcomes from a simple (provisional) strategy rather than a complex (planned two-stent) strategy in terms of short-term efficacy and safety. Here, we report the 5-year all-cause mortality based on pooled patient-level data from two large bifurcation coronary stenting trials with similar methodology: the Nordic Bifurcation Study (NORDIC I) and the British Bifurcation Coronary Study: old, new, and evolving strategies (BBC ONE). METHODS AND RESULTS: Both multicentre randomized trials compared simple (provisional T-stenting) vs. complex (culotte, crush, and T-stenting) techniques, using drug-eluting stents. We analysed all-cause death at 5 years. Data were collected from phone follow-up, hospital records, and national mortality tracking. Follow-up was complete for 890 out of 913 patients (97%). Both Simple and Complex groups were similar in terms of patient and lesion characteristics. Five-year mortality was lower among patients who underwent a simple strategy rather than a complex strategy [17 patients (3.8%) vs. 31 patients (7.0%); P = 0.04]. CONCLUSION: For coronary bifurcation lesions, a provisional single-stent approach appears to be associated with lower long-term mortality than a systematic dual stenting technique.

Minute ventilation sensor-driven rate response as a part of cardiac resynchronization therapy optimization in older patients.

BACKGROUND: Chronotropic incompetence (CI) is common among elderly cardiac resynchronization therapy pacemaker (CRT-P) patients on optimal medical therapy. This study aimed to evaluate the impact of optimized rate-adaptive pacing utilizing the minute ventilation (MV) sensor on exercise tolerance. METHODS: In a prospective, multicenter study, older patients (median age 76 years) with a guideline-based indication for CRT were evaluated following CRT-P implantation. If there was no documented CI, requiring clinically rate-responsive pacing, the device was programmed DDD at pre-discharge. At 1 month, a 6-min walk test (6MWT) was conducted. If the maximum heart rate was < 100 bpm or < 80% of the age-predicted maximum, the response was considered CI. Patients with CI were programmed with DDDR. At 3 months post-implant, the 6MWT was repeated in the correct respective programming mode. In addition, heart rate score (HRSc, defined as the percentage of all sensed and paced atrial events in the single tallest 10 bpm histogram bin) was assessed at 1 and 3 months. RESULTS: CI was identified in 46/61 (75%) of patients without prior indication at enrollment. MV sensor-based DDDR mode increased heart rate in CI patients similarly to non-CI patients with intrinsically driven heart rates during 6MWT. Walking distance increased substantially with DDDR (349 ± 132 m vs. 376 ± 128 m at 1 and 3 months, respectively, p < 0.05). Furthermore, DDDR reduced HRSc by 14% (absolute reduction, p < 0.001) in those with more severe CI, i.e., HRSc ≥ 70%. CONCLUSION: Exercise tolerance in older CRT-P patients can be further improved by the utilization of an MV sensor.

The management of patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation: in-hospital-data from the Atrial Fibrillation undergoing Coronary Artery Stenting study.

Current recommendations on the management of patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention with stent (PCI-S) essentially derive from small, single-center, retrospective datasets. To obtain larger and better quality data, we carried out the prospective, multicenter Atrial Fibrillation undergoing Coronary Artery Stenting (AFCAS) study. Therefore, consecutive patients with history of or ongoing AF undergoing PCI-S were enrolled, and occurrence of adverse ischemic and bleeding events recorded during 12 months follow-up. In this article, we report the in-hospital observations. Out of the 963 patients, in the majority of cases (49.1%) AF was permanent. The associated risk of stroke, as defined by a CHADS2 -score ≥2, was in 70% of patients moderate to high. Upon enrollment in the registry, 69.3% of patients were on VKA therapy. Overall occurrence of in-hospital major adverse cardiac events was 4.5% (cardiovascular death 1.9%, urgent revascularization in 1.5%, and stroke/arterial thromboembolism in 0.6%). Bleeding complications occurred in 7.1% of patients, being severe in 2.5%. In a logistic regression analysis, no risk factor was independently associated with bleeding events, whereas Clopidogrel treatment decreased and female gender/treatment with gpIIb/IIIa-antagonists, respectively increased the risk for the combined ischemic endpoint. The majority of AF patients undergoing PCI-S are at high stroke risk, and therefore VKA treatment should not be withdrawn and combined anticoagulant and antiplatelet treatment is warranted. Current management appears largely in accordance with current recommendations, whereby accounting for the limited occurrence of in-hospital adverse ischemic and bleeding events.

Randomized comparison of final kissing balloon dilatation versus no final kissing balloon dilatation in patients with coronary bifurcation lesions treated with main vessel stenting: the Nordic-Baltic Bifurcation Study III.

BACKGROUND: It is unknown whether the preferred 1-stent bifurcation stenting approach with stenting of the main vessel (MV) and optional side branch stenting using drug-eluting stents should be finalized by a kissing balloon dilatation (FKBD). Therefore, we compared strategies of MV stenting with and without FKBD. METHODS AND RESULTS: We randomized 477 patients with a bifurcation lesion to FKBD (n=238) or no FKBD (n=239) after MV stenting. The primary end point was major adverse cardiac events: cardiac death, non-procedure-related index lesion myocardial infarction, target lesion revascularization, or stent thrombosis within 6 months. The 6-month major adverse cardiac event rates were 2.1% and 2.5% (P=1.00) in the FKBD and no-FKBD groups, respectively. Procedure and fluoroscopy times were longer and more contrast media was needed in the FKBD group than in the no-FKBD group. Three hundred twenty-six patients had a quantitative coronary assessment. At 8 months, the rate of binary (re)stenosis in the entire bifurcation lesion (MV and side branch) was 11.0% versus 17.3% (P=0.11), in the MV was 3.1% versus 2.5% (P=0.68), and in the side branch was 7.9% versus 15.4% (P=0.039) in the FKBD versus no-FKBD groups, respectively. In patients with true bifurcation lesions, the side branch restenosis rate was 7.6% versus 20.0% (P=0.024) in the FKBD and no-FKBD groups, respectively. CONCLUSIONS: MV stenting strategies with and without FKBD were associated with similar clinical outcomes. FKBD reduced angiographic side branch (re)stenosis, especially in patients with true bifurcation lesions. The simple no-FKBD procedures resulted in reduced use of contrast media and shorter procedure and fluoroscopy times. Long-term data on stent thrombosis are needed. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00914199.

Heparin bridging vs. uninterrupted oral anticoagulation in patients with Atrial Fibrillation undergoing Coronary Artery Stenting. Results from the AFCAS registry.

BACKGROUND: The anti-thrombotic strategy during coronary stenting is challenging in patients on long-term oral anticoagulation (OAC) because of atrial fibrillation (AF). Uninterrupted OAC (UAC) is increasingly used, but bridging therapy (BT) is still in common use. METHODS AND RESULTS: Management of patients with Atrial Fibrillation undergoing Coronary Artery Stenting (AFCAS) is a prospective multicenter European registry that recruited 963 patients with AF undergoing coronary stenting. To compare the safety of UAC and BT, bleeding complications and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction, target vessel revascularization, stent thrombosis and stroke) were assessed in 290 patients treated with UAC and 161 patients with BT during a 30-day follow-up period. In the BT group, OAC was interrupted for a median of 5 days. Overall bleeding complications tended to be more common in the BT group (18.6% vs. 12.1%, P=0.07), with no significant difference in the rate of major bleeding (2.5% vs. 1.4%) or MACCE (6.2% vs. 3.8%). After adjustment for propensity score, BT was not associated with bleeding complications (odds ratio [OR], 1.38; 95% confidence interval [CI]: 0.77-2.48, P=0.28) or MACCE (OR, 1.16; 95%CI: 0.44-3.05, P=0.76). Periprocedural international normalized ratio was not associated with bleeding or MACCE. CONCLUSIONS: UAC does not increase perioperative complications during coronary stenting and is a simple and cost-effective alternative to conventional heparin bridging.

[Coronary artery disease in women]. / Naisten sepelvaltimotauti.

Although the rate of coronary artery disease mortality has decreased over the last decades, it is still the leading cause of death in Finland. Coronary artery disease appears in women with a delay of ten years as compared with men. For women, diabetes and smoking increase the risk of developing the disease more than for men. Women's coronary arteries are smaller in size, which previously impaired the results of invasive treatment. Treatment outcome with current techniques is equal independently of gender. In spite of this, women in an acute attack of coronary artery disease are less frequently directed to coronary angiography.

Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: the Nordic bifurcation study.

BACKGROUND: The optimal stenting strategy in coronary artery bifurcation lesions is unknown. In the present study, a strategy of stenting both the main vessel and the side branch (MV+SB) was compared with a strategy of stenting the main vessel only, with optional stenting of the side branch (MV), with sirolimus-eluting stents. METHODS AND RESULTS: A total of 413 patients with a bifurcation lesion were randomized. The primary end point was a major adverse cardiac event: cardiac death, myocardial infarction, target-vessel revascularization, or stent thrombosis after 6 months. At 6 months, there were no significant differences in rates of major adverse cardiac events between the groups (MV+SB 3.4%, MV 2.9%; P=NS). In the MV+SB group, there were significantly longer procedure and fluoroscopy times, higher contrast volumes, and higher rates of procedure-related increases in biomarkers of myocardial injury. A total of 307 patients had a quantitative coronary assessment at the index procedure and after 8 months. The combined angiographic end point of diameter stenosis >50% of main vessel and occlusion of the side branch after 8 months was found in 5.3% in the MV group and 5.1% in the MV+SB group (P=NS). CONCLUSIONS: Independent of stenting strategy, excellent clinical and angiographic results were obtained with percutaneous treatment of de novo coronary artery bifurcation lesions with sirolimus-eluting stents. The simple stenting strategy used in the MV group was associated with reduced procedure and fluoroscopy times and lower rates of procedure-related biomarker elevation. Therefore, this strategy can be recommended as the routine bifurcation stenting technique.

Intravascular ultrasound assessment of minimum lumen area and intimal hyperplasia in in-stent restenosis after drug-eluting or bare-metal stent implantation. The Nordic Intravascular Ultrasound Study (NIVUS).

INTRODUCTION: Drug-eluting stents (DES) reduce the risk of restenosis after percutaneous coronary intervention. The aim of the study was to evaluate, by intravascular ultrasound (IVUS), the minimum lumen area site in the stented segment and the distribution of intimal hyperplasia in patients presenting with a DES or bare-metal stent (BMS) in-stent restenosis. METHODS: The "Nordic Intravascular Ultrasound Study (NIVUS)" study was conducted in Nordic and Baltic countries as a prospective multicenter registry. Two hundred nine patients (DES n=121 and BMS n=88) with in-stent restenosis were enrolled. RESULTS: At the minimum lumen area site in the stented segment, the stent area (5.8±2.2mm2 vs. 7.6±2.4mm2, p<0.001) and intimal hyperplasia area (2.6±2.0mm2 vs. 5.0±2.2mm2, p<0.001) were significantly lower in patients treated with DES compared to BMS. The percentage of stents that did not have a minimum stent area of at least 5.0mm2 (under expansion) was higher in DES (58.7% vs. 37.7%, p=0.008) compared to BMS. Intimal hyperplasia covered 55.4±33.3% of the stent length in the DES compared to 90.7±17.4% in the BMS group, p<0.001. Focal in-stent restenosis was more often seen in DES treated patients compared to BMS treated patients (DES n=84 (59.9%) vs. BMS n=15 (17.0%), p<0.001). CONCLUSION: Stent underexpansion was more often seen in DES than BMS in-stent restenosis. DES more often had focal in-stent restenosis with less intimal hyperplasia.

Left atrial appendage occlusion versus standard medical care in patients with atrial fibrillation and intracerebral haemorrhage: a propensity score-matched follow-up study.

AIMS: The aim of this study was to investigate the prognosis in patients with atrial fibrillation (AF) and intracerebral haemorrhage (ICH) having a left atrial appendage occlusion (LAAO) versus patients receiving standard medical therapy. METHODS AND RESULTS: A total of 151 patients from the Nordic countries with AF and previous ICH who underwent LAAO using the AMPLATZER Cardiac Plug or the AMPLATZER AMULET were compared to a propensity score-matched group of 151 patients receiving standard medical therapy. The two groups were matched so that their risks for stroke and bleeding were similar (CHA2DS2-VASc and HAS-BLED scores). The standard care patients were identified from the Danish Stroke Registry among 787 patients with AF and ICH. The primary endpoint was a composite of all-cause mortality, ischaemic stroke and major bleeding. Patients with AF and a prior ICH treated with LAAO had a lower risk of the composite outcome as compared to patients treated with standard medical care (events/1,000 years [95% confidence interval]: 53.3 [44.3-64.1] vs. 366.7 [298.2-450.9]; hazard ratio 0.16 [0.07-0.37]). CONCLUSIONS: LAAO is suggested to be of major clinical benefit in AF patients having sustained an ICH. These results have to be confirmed in a randomised clinical trial.

Heart rate turbulence after atrial premature beats before spontaneous onset of atrial fibrillation.

OBJECTIVES: This study was designed to assess the temporal changes in vagal responses to atrial premature beats before spontaneous onset of atrial fibrillation (AF). BACKGROUND: Enhanced vagal activity plays a major role in the onset and perpetuation of experimental AF, but the role of vagal activation in the onset of clinical AF episodes is not so well established. METHODS: We calculated heart rate turbulence after atrial premature impulses occurring 0 to 60 min before the onset of AF ("prior to AF") and compared it with the hourly means of the other hours of the 24-h electrocardiogram recordings ("non-AF hours") in 39 patients with structural heart disease and 29 patients with lone AF. Traditional heart rate variability measurements and approximate entropy (ApEn) were also analyzed. RESULTS: Turbulence onset (TO) was significantly less negative during the 1 h preceding AF than during the non-AF hours (0.71 +/- 1.76 vs. -0.35 +/- 1.46, p < 0.00001). Less negative TO before AF was observed among both the patients with structural heart disease (1.16 +/- 1.73 vs. 0.07 +/- 1.23; p < 0.0001) and those with lone AF (0.17 +/- 1.67 vs. -0.85 +/- 1.56; p < 0.0001). No significant difference was seen in the turbulence slope between the two periods, and none of the traditional frequency and time domain measurements differentiated between the periods; ApEn was significantly lower before AF than during the non-AF hours (p < 0.01). CONCLUSIONS: Altered heart rate dynamics, suggesting transient enhancement of vagal outflow after premature atrial excitation, are temporally related to spontaneous onset of clinical AF.

Nonlinear heart rate variability in CABG patients and the preconditioning effect.

OBJECTIVE: Heart rate variability (HRV) is the most frequently used noninvasive diagnostic method in the assessment of cardiac autonomic control. The clinical relevance of HRV, especially nonlinear HRV in CPB patients has not been well studied. Short brief myocardial ischemia has been reported to influence HRV. We therefore hypothesis that the protective mechanism of ischemic preconditioning (IP) may involve in cardiac autonomic regulation. METHODS: Eighty-six CABG patients were randomized into a control and an IP group. The IP patients received two periods of 2-min ischemia followed by 3-min reperfusion by aortic cross-clamped. Holter data were collected in 86 CABG patients before and after surgery. Arrhythmias, linear and nonlinear HRV measures were analyzed. RESULTS: All time and frequency domain HRV variables as well as nonlinear indexes of HRV, the short-term (4-11 beats) scaling exponent alpha1, were suppressed significantly after surgery in both study groups. The lower pre- and postoperative exponent alpha1 predict the higher incidence of postoperative AF and worse postoperative outcome. The suppressed exponent alpha1 was attenuated in the IP group as compared to controls (P = 0.008). No other differences were observed in the changes in linear HRV measures between the groups. IP significantly reduced the incidence of postoperative arrhythmias and improved postoperative outcome. CONCLUSIONS: The present findings show that cardiac autonomic regulation is impaired after CABG. Nonlinear HRV exponent alpha1 is a more sensitive measure to predict the postoperative outcome in CABG patients. IP alleviates the extreme autonomic reactions after surgery, suggesting that cardiac autonomic regulation is involved in the IP protective mechanism.

Underuse of evidence-based treatment modalities in diabetic patients with non-ST elevation acute coronary syndrome. A prospective nation wide study on acute coronary syndrome (FINACS).

This study was designed to evaluate how new treatment guidelines of acute coronary syndrome (ACS) without ST elevation have been implemented in clinical practice especially in diabetic patients. A prospective follow-up was performed on 501 consecutive patients with suspected ACS without ST elevation admitted to nine hospitals in Finland between 15 January and 11 March 2001. The study group included 143 (29%) diabetic patients. Their risk profile was more severe than in non-diabetic patients; ST-depression on admission electrocardiography 57 versus 38%; P<0.0001, elevated troponin levels 66 versus 56%; P<0.05. Six months composite incidence of death, new myocardial infarction (MI), refractory angina or readmission for unstable angina was 39% in diabetic patients and 20% in non-diabetic patients (P<0.0001). In spite of this more severe risk profile, glycoprotein (GP) IIb/IIIa receptor antagonists and statins were used with similar frequency in non-diabetic and diabetic patients (15 vs. 19 and 48 vs. 54%, respectively; P=NS for both). In diabetic patients mean delay for in hospital coronary angiography was longer (6.4 vs. 4.2 days, P<0.05) and it was performed less often (32 vs. 45% P<0.05). Our results show that diabetic patients with ACS have higher risk profile and worse outcome than non-diabetic patients. Despite their indisputable benefits in diabetic patients, statins, GP IIb/IIIa receptor antagonists and invasive strategy were underused or often neglected. Further education is needed to change attitudes and to better implement new guidelines into clinical practice.

Performance of bleeding risk-prediction scores in patients with atrial fibrillation undergoing percutaneous coronary intervention.

The hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, and drugs/alcohol (HAS-BLED); anticoagulation and risk factors in atrial fibrillation (ATRIA); modified Outpatient Bleeding Risk Index (mOBRI); and reduction of atherothrombosis for continued health (REACH) schemes are validated bleeding risk-prediction tools, but their predictive performance in patients with AF receiving multiple antithrombotic drugs after percutaneous coronary intervention (PCI) is unknown. We sought to compare the predictive performance of bleeding risk-estimation tools in a cohort of patients with atrial fibrillation (AF) undergoing PCI. Management of patients with AF undergoing coronary artery stenting is a multicenter European prospective registry enrolling patients with AF undergoing PCI. We calculated HAS-BLED, ATRIA, mOBRI, and REACH bleeding risk-prediction scores and assessed the rate of bleeding complications as defined by Bleeding Academic Research Consortium at 12 months follow-up in 929 consecutive patients undergoing PCI. Increasing age, femoral access site, and previous peptic ulcer were independent determinants of bleeding. Low bleeding risk scores as determined by HAS-BLED 0 to 2, ATRIA 0 to 3, mOBRI 0, and REACH 0 to 10 were detected in 23.7%, 73.0%, 7.8%, and 5.7% of patients of the cohort, respectively. No significant differences were detected in the rates of any bleeding or major bleeding events for low versus intermediate/high scores with each risk-prediction tool. In conclusion, the performance of ATRIA, HAS-BLED, mOBRI, and REACH scores in predicting bleeding complications in this high-risk patient subset was useless.

One-year outcome of patients with atrial fibrillation undergoing coronary artery stenting: an analysis of the AFCAS registry.

BACKGROUND: Most evidence regarding the efficacy and safety of the antithrombotic regimens for patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention with stent (PCI-S) derives from small, single-center, retrospective datasets. To obtain further data on this issue, we carried out the prospective, multicenter, observational Management of patients with Atrial Fibrillation undergoing Coronary Artery Stenting (AFCAS) registry (Clinicaltrials.gov identifier NCT00596570). HYPOTHESIS: We hypothesize that the antithrombotic treatment of AF patients undergoing PCI-S is variable and the clinical outcome may vary according to the different regimens. METHODS: Consecutive AF patients undergoing PCI-S at 17 European institutions were included and followed for 1 year. Outcome measures included: (1) major adverse cardiac/cerebrovascular events (MACCE), including all-cause death, myocardial infarction, repeat revascularization, stent thrombosis, or stroke/transient ischemic attack, and (2) bleeding, and were compared according to the antithrombotic regimen adopted. A propensity-score analysis was carried out to adjust for baseline and procedural differences. RESULTS: Out of the 975 patients enrolled, 914 were included in the final analysis. The mean CHADS2 score was 2.2 ± 1.2, and 71% of patients had a CHADS2 score ≥2. Triple therapy (TT) of vitamin K antagonist (VKA), aspirin, and clopidogrel was prescribed to 74% of patients, dual antiplatelet therapy to 18%, and VKA plus clopidogrel to 8%. At 1-year follow-up, no significant differences were found in the occurrence of MACCE and bleeding among the 3 antithrombotic regimens, even when adjusted for propensity score. CONCLUSIONS: In this large, real-world population of AF patients undergoing PCI-S, TT was the antithrombotic regimen most frequently prescribed. Although several limitations need to be acknowledged, in our study the 1-year efficacy and safety of TT, dual antiplatelet therapy, and VKA plus clopidogrel was comparable.

Intravascular ultrasound assessed incomplete stent apposition and stent fracture in stent thrombosis after bare metal versus drug-eluting stent treatment the Nordic Intravascular Ultrasound Study (NIVUS).

BACKGROUND: This prospective multicenter registry used intravascular ultrasound (IVUS) in patients with definite stent thrombosis (ST) to compare rates of incomplete stent apposition (ISA), stent fracture and stent expansion in patients treated with drug-eluting (DES) versus bare metal (BMS) stents. ST is a rare, but potential life threatening event after coronary stent implantation. The etiology seems to be multifactorial. METHODS: 124 patients with definite ST were assessed by IVUS during the acute ST event. The study was conducted in 15 high-volume percutaneous coronary intervention -centers in the Nordic-Baltic countries. RESULTS: In early or late ST there were no differences in ISA between DES and BMS. In very late ST, ISA was a more frequent finding in DES than in BMS (52% vs.16%; p=0.005) and the maximum ISA area was larger in DES compared to BMS (1.1 ± 2.3mm(2) vs. 0.1 ± 0.5mm(2); p=0.004). Further, ISA was more prevalent in sirolimus-eluting than in paclitaxel-eluting stents (58% vs. 37%; p=0.02). Stent fractures were found both in DES (16%) and BMS (24%); p=0.28, and not related to time of stent thrombosis occurrence. For stents with nominal diameters ≥ 2.75 mm, 38% of the DES and 22% of the BMS had a minimum stent area of less than 5mm(2); p=0.14. CONCLUSIONS: Very late stent thrombosis was more prevalent and associated with more extensive ISA in DES than in BMS treated patients. Stent fracture was a common finding in ST after DES and BMS implantation.

Clinical outcome after crush versus culotte stenting of coronary artery bifurcation lesions: the Nordic Stent Technique Study 36-month follow-up results.

OBJECTIVES: The aim of the study was to compare long-term follow-up results of crush versus culotte stent techniques in coronary bifurcation lesions. BACKGROUND: The randomized Nordic Stent Technique Study showed similar 6-month clinical and 8-month angiographic results with the crush and culotte stent techniques of de novo coronary artery bifurcation lesions using sirolimus-eluting stents. Here, we report the 36-month efficacy and safety of the Nordic Stent Technique Study. METHODS: A total of 424 patients with a bifurcation lesion were randomized to stenting of both main vessel and side branch with the crush or the culotte technique and followed for 36 months. Major adverse cardiac events-the composite of cardiac death, myocardial infarction, stent thrombosis, or target vessel revascularization-were the primary endpoint. RESULTS: Follow-up was complete for all patients. At 36 months, the rates of the primary endpoint were 20.6% versus 16.7% (p = 0.32), index lesion restenosis 11.5% versus 6.5% (p = 0.09), and definite stent thrombosis 1.4% versus 4.7% (p = 0.09) in the crush and the culotte groups, respectively. CONCLUSIONS: At 36-month follow-up, the clinical outcomes were similar for patients with coronary bifurcation lesions treated with the culotte or the crush stent technique. (Nordic Bifurcation Study. How to Use Drug Eluting Stents [DES] in Bifurcation Lesions? NCT00376571).

Long-term results after simple versus complex stenting of coronary artery bifurcation lesions: Nordic Bifurcation Study 5-year follow-up results.

OBJECTIVES: This study sought to report the 5-year follow-up results of the Nordic Bifurcation Study. BACKGROUND: Randomized clinical trials with short-term follow-up have indicated that coronary bifurcation lesions may be optimally treated using the optional side branch stenting strategy. METHODS: A total of 413 patients with a coronary bifurcation lesion were randomly assigned to a simple stenting strategy of main vessel (MV) and optional stenting of side branch (SB) or to a complex stenting strategy, namely, stenting of both MV and SB. RESULTS: Five-year clinical follow-up data were available for 404 (98%) patients. The combined safety and efficacy endpoint of cardiac death, non-procedure-related myocardial infarction, and target vessel revascularization were seen in 15.8% in the optional SB stenting group as compared to 21.8% in the MV and SB stenting group (p = 0.15). All-cause death was seen in 5.9% versus 10.4% (p = 0.16) and non-procedure-related myocardial infarction in 4% versus 7.9% (p = 0.09) in the optional SB stenting group versus the MV and SB stenting group, respectively. The rates of target vessel revascularization were 13.4% versus 18.3% (p = 0.14) and the rates of definite stent thrombosis were 3% versus 1.5% (p = 0.31) in the optional SB stenting group versus the MV and SB stenting group, respectively. CONCLUSIONS: At 5-year follow-up in the Nordic Bifurcation Study, the clinical outcomes after simple optional side branch stenting remained at least equal to the more complex strategy of planned stenting of both the main vessel and the side branch.

Comparison of additional versus no additional heparin during therapeutic oral anticoagulation in patients undergoing percutaneous coronary intervention.

Uninterrupted oral anticoagulation (OAC) therapy can be the preferred strategy in patients with atrial fibrillation at moderate to high risk of thromboembolism undergoing percutaneous coronary intervention (PCI). To evaluate the need for additional heparins in addition to therapeutic peri-PCI OAC, we assessed bleeding complications and major adverse cardiac and cerebrovascular events in 414 consecutive patients undergoing PCI during therapeutic (international normalized ratio 2 to 3.5) periprocedural OAC. Patients were divided into those with no (n = 196) and with (n = 218) additional use of periprocedural heparins. No differences in major adverse cardiac and cerebrovascular events (4.1% vs 3.2%, p = 0.79) or major bleeding (1.0% vs 3.7%, p = 0.11) were detected, but access site complications (5.1% vs 11.0%, p = 0.032) were less frequent in those without additional heparins. When adjusted for propensity score, patients with additional heparins had a higher risk of access site complications (odds ratio 2.6, 95% confidence interval 1.1 to 6.1, p = 0.022) without any increased risk of any other adverse event. Analysis of 1-to-1 propensity-matched pairs showed a significantly higher risk of access site complication in patients receiving additional AC (13.1% vs 5.7%, p = 0.049). In conclusion, therapeutic warfarin treatment seems to provide sufficient AC for PCI. Additional heparins are not needed and may increase access site complications.

Long-term safety of drug-eluting stents in patients on warfarin treatment.

BACKGROUND: The safety of drug-eluting stents (DES) in patients on long-term warfarin treatment has been questioned due to high risk of bleeding complications during prolonged triple (aspirin, clopidogrel, and warfarin) antithrombotic therapy. METHODS: We analysed the long-term outcome of 415 consecutive warfarin-treated patients who underwent DES (n = 191) or bare-metal (n = 224) stenting in six hospitals. RESULTS: The mean duration of triple therapy was longer (4.2 ± 3.1 versus 2.1 ± 1.8 months; P < 0.001) in the DES group. The incidence of major adverse cardiovascular and cerebrovascular events was comparable in the DES and bare-metal groups (39.8% versus 42.4%; P = 0.59) during a median follow-up of 3.5 years. Similarly, major bleeding events occurred equally often in both study groups (14.7% versus 12.9%). Six patients in the DES group and seven patients in the bare-metal group suffered stent thrombosis (3.1% versus 3.1%). In the propensity score analyses of 101 matched pairs, the outcome was similar in the two groups. CONCLUSION: Selective use of DES with a short triple therapy seems to be safe in patients with warfarin therapy. The prognosis of this fragile patient population is quite poor, and major bleeding events are common irrespective of stent type.