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1.
Article in English | MEDLINE | ID: mdl-38914900

ABSTRACT

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.

2.
Cardiovasc Revasc Med ; 18(8): 577-582, 2017 Dec.
Article in English | MEDLINE | ID: mdl-29066343

ABSTRACT

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.


Subject(s)
Coronary Restenosis/diagnostic imaging , Coronary Vessels/diagnostic imaging , Drug-Eluting Stents , Metals , Neointima , Percutaneous Coronary Intervention/instrumentation , Stents , Aged , Cell Proliferation , Coronary Restenosis/etiology , Coronary Restenosis/pathology , Coronary Vessels/pathology , Female , Humans , Hyperplasia , Latvia , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Predictive Value of Tests , Prospective Studies , Registries , Risk Factors , Scandinavian and Nordic Countries , Time Factors , Treatment Outcome , Ultrasonography, Interventional
3.
EuroIntervention ; 13(3): 371-378, 2017 Jun 20.
Article in English | MEDLINE | ID: mdl-28485276

ABSTRACT

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.


Subject(s)
Atrial Appendage/surgery , Atrial Fibrillation/therapy , Cerebral Hemorrhage/etiology , Heart Diseases/therapy , Stroke/complications , Aged , Aged, 80 and over , Anticoagulants/therapeutic use , Atrial Fibrillation/complications , Female , Follow-Up Studies , Heart Diseases/complications , Humans , Male , Middle Aged , Propensity Score , Registries , Septal Occluder Device , Stroke/therapy , Treatment Outcome
4.
Eur Heart J ; 37(24): 1923-8, 2016 Jun 21.
Article in English | MEDLINE | ID: mdl-27161619

ABSTRACT

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.


Subject(s)
Stents , Coronary Artery Disease , Humans , Time Factors , Treatment Outcome
5.
Am J Cardiol ; 113(12): 1995-2001, 2014 Jun 15.
Article in English | MEDLINE | ID: mdl-24793675

ABSTRACT

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.


Subject(s)
Angioplasty, Balloon, Coronary/adverse effects , Anticoagulants/adverse effects , Atrial Fibrillation/drug therapy , Coronary Stenosis/therapy , Hemorrhage/chemically induced , Age Factors , Aged , Angioplasty, Balloon, Coronary/methods , Anticoagulants/therapeutic use , Atrial Fibrillation/diagnosis , Atrial Fibrillation/mortality , Cohort Studies , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/mortality , Electrocardiography/methods , Female , Follow-Up Studies , Hemorrhage/epidemiology , Hemorrhage/physiopathology , Hospital Mortality/trends , Humans , Male , Middle Aged , Predictive Value of Tests , Prospective Studies , Radiography , Risk Assessment , Severity of Illness Index , Sex Factors , Survival Rate , Treatment Outcome
6.
Clin Cardiol ; 37(6): 357-64, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24481953

ABSTRACT

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.


Subject(s)
Atrial Fibrillation/diagnosis , Atrial Fibrillation/drug therapy , Coronary Vessels/surgery , Registries/statistics & numerical data , Stents , Aspirin/therapeutic use , Clopidogrel , Female , Fibrinolytic Agents/therapeutic use , Humans , Male , Percutaneous Coronary Intervention/methods , Platelet Aggregation Inhibitors/therapeutic use , Prospective Studies , Ticlopidine/analogs & derivatives , Ticlopidine/therapeutic use , Vitamin K/antagonists & inhibitors
7.
JACC Cardiovasc Interv ; 6(11): 1160-5, 2013 Nov.
Article in English | MEDLINE | ID: mdl-24262616

ABSTRACT

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).


Subject(s)
Cardiovascular Agents/administration & dosage , Coronary Artery Disease/therapy , Drug-Eluting Stents , Percutaneous Coronary Intervention/instrumentation , Percutaneous Coronary Intervention/methods , Sirolimus/administration & dosage , Aged , Coronary Angiography , Coronary Artery Disease/diagnosis , Coronary Artery Disease/mortality , Coronary Restenosis/etiology , Coronary Thrombosis/etiology , Female , Finland , Humans , Latvia , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Prosthesis Design , Risk Factors , Scandinavian and Nordic Countries , Time Factors , Treatment Outcome
8.
Catheter Cardiovasc Interv ; 82(7): E864-70, 2013 Dec 01.
Article in English | MEDLINE | ID: mdl-23765437

ABSTRACT

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.


Subject(s)
Anticoagulants/therapeutic use , Atrial Fibrillation/drug therapy , Coronary Artery Disease/therapy , Percutaneous Coronary Intervention/instrumentation , Stents , Aged , Aged, 80 and over , Anticoagulants/adverse effects , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/mortality , Chi-Square Distribution , Coronary Artery Disease/complications , Coronary Artery Disease/diagnosis , Coronary Artery Disease/mortality , Europe , Female , Guideline Adherence , Hemorrhage/chemically induced , Hospital Mortality , Humans , Logistic Models , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Platelet Aggregation Inhibitors/therapeutic use , Practice Guidelines as Topic , Prospective Studies , Registries , Risk Factors , Sex Factors , Stroke/etiology , Stroke/prevention & control , Thromboembolism/etiology , Thromboembolism/prevention & control , Time Factors , Treatment Outcome
9.
J Am Coll Cardiol ; 62(1): 30-4, 2013 Jul 02.
Article in English | MEDLINE | ID: mdl-23644088

ABSTRACT

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.


Subject(s)
Coronary Artery Disease/epidemiology , Coronary Artery Disease/surgery , Drug-Eluting Stents , Percutaneous Coronary Intervention/trends , Aged , Coronary Artery Disease/diagnosis , Coronary Restenosis/diagnosis , Coronary Restenosis/epidemiology , Coronary Restenosis/prevention & control , Denmark/epidemiology , Female , Finland/epidemiology , Follow-Up Studies , Humans , Latvia/epidemiology , Male , Middle Aged , Norway/epidemiology , Percutaneous Coronary Intervention/instrumentation , Percutaneous Coronary Intervention/methods , Sweden/epidemiology , Time Factors , Treatment Outcome
10.
Int J Cardiol ; 168(2): 1010-6, 2013 Sep 30.
Article in English | MEDLINE | ID: mdl-23164593

ABSTRACT

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.


Subject(s)
Drug-Eluting Stents/adverse effects , Equipment Failure , Metals/adverse effects , Thrombosis/diagnostic imaging , Thrombosis/epidemiology , Ultrasonography, Interventional , Aged , Baltic States/epidemiology , Female , Humans , Male , Middle Aged , Prospective Studies , Registries , Scandinavian and Nordic Countries/epidemiology , Stents/adverse effects , Treatment Outcome , Ultrasonography, Interventional/methods
11.
Am J Cardiol ; 110(1): 30-5, 2012 Jul 01.
Article in English | MEDLINE | ID: mdl-22464216

ABSTRACT

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.


Subject(s)
Angioplasty, Balloon, Coronary , Anticoagulants/administration & dosage , Atrial Fibrillation/complications , Coronary Artery Disease/therapy , Heparin/administration & dosage , Preoperative Care/methods , Thrombosis/prevention & control , Administration, Oral , Aged , Aspirin/administration & dosage , Clopidogrel , Coronary Artery Disease/complications , Drug Therapy, Combination , Female , Fibrinolytic Agents/administration & dosage , Follow-Up Studies , Humans , Injections, Subcutaneous , Male , Platelet Aggregation Inhibitors/administration & dosage , Postoperative Complications/etiology , Postoperative Complications/prevention & control , Prospective Studies , Thrombosis/etiology , Ticlopidine/administration & dosage , Ticlopidine/analogs & derivatives , Time Factors , Treatment Outcome , Warfarin/administration & dosage
12.
Circ J ; 76(6): 1363-8, 2012.
Article in English | MEDLINE | ID: mdl-22447005

ABSTRACT

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.


Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Anticoagulants/administration & dosage , Atrial Fibrillation/drug therapy , Coronary Artery Disease/therapy , Heparin/administration & dosage , Stents , Administration, Oral , Aged , Aged, 80 and over , Angioplasty, Balloon, Coronary/adverse effects , Angioplasty, Balloon, Coronary/mortality , Anticoagulants/adverse effects , Atrial Fibrillation/complications , Atrial Fibrillation/mortality , Coronary Artery Disease/complications , Coronary Artery Disease/mortality , Coronary Thrombosis/etiology , Drug Administration Schedule , Drug Substitution , Europe , Female , Hemorrhage/chemically induced , Heparin/adverse effects , Humans , Logistic Models , Male , Myocardial Infarction/etiology , Odds Ratio , Propensity Score , Prospective Studies , Registries , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
13.
Ann Med ; 44(3): 271-8, 2012 May.
Article in English | MEDLINE | ID: mdl-21208149

ABSTRACT

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.


Subject(s)
Angioplasty, Balloon, Coronary/adverse effects , Anticoagulants/adverse effects , Drug-Eluting Stents/adverse effects , Hemorrhage/chemically induced , Platelet Aggregation Inhibitors/adverse effects , Warfarin/adverse effects , Adult , Aged , Anticoagulants/therapeutic use , Contraindications , Coronary Thrombosis/epidemiology , Coronary Thrombosis/prevention & control , Drug Therapy, Combination , Female , Follow-Up Studies , Humans , Incidence , Kaplan-Meier Estimate , Male , Middle Aged , Platelet Aggregation Inhibitors/administration & dosage , Propensity Score , Stents , Treatment Outcome , Warfarin/therapeutic use
14.
Circulation ; 123(1): 79-86, 2011 Jan 04.
Article in English | MEDLINE | ID: mdl-21173348

ABSTRACT

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.


Subject(s)
Angioplasty, Balloon, Coronary , Coronary Artery Disease/pathology , Coronary Artery Disease/therapy , Drug-Eluting Stents , Aged , Angioplasty, Balloon, Coronary/methods , Coronary Artery Disease/epidemiology , Denmark/epidemiology , Female , Finland/epidemiology , Follow-Up Studies , Humans , Latvia/epidemiology , Male , Middle Aged , Norway/epidemiology , Sweden/epidemiology
15.
Am J Cardiol ; 106(2): 175-9, 2010 Jul 15.
Article in English | MEDLINE | ID: mdl-20598999

ABSTRACT

Long-term oral anticoagulation (OAC) prevents recurrent thrombosis, pulmonary embolism, and stroke, but it also increases bleeding risk. An outpatient bleeding risk index (OBRI) may help to identify patients at high risk of bleeding complications. The aim of this study was to evaluate the predictive value of OBRI in patients with OAC undergoing percutaneous coronary intervention (PCI). In addition, we analyzed the impact of OBRI on treatment choices in this patient group. Four hundred twenty-one patients with OAC underwent PCI at 6 centers in Finland. Complete follow-up was achieved in all patients (median 1,276 days). Sixty-four patients (15%) had a low bleeding risk (OBRI 0), 319 patients (76%) moderate bleeding risk (OBRI 1 to 2), and 38 (9%) high bleeding risk (OBRI 3 to 4). OBRI had no significant effect on periprocedural or long-term antithrombotic medications, choice of access site, or stent type. During follow-up, the incidence of major bleeding increased (p = 0.02) progressively with higher OBRI category (6.3%, 14.1%, and 26.3%, respectively). Similarly, mortality was highest in patients with high OBRI (14.1%, 20.7%, and 39.5%, p = 0.009, respectively), but rates of major adverse cardiovascular and cerebrovascular events were comparable in the OBRI categories. In conclusion, bleeding risk seems not to modify periprocedural or long-term treatment choices in patients after PCI on home warfarin. In contrast, patients with high OBRI often have major bleeding episodes and this simple index seems to be suitable for risk evaluation in this patient group.


Subject(s)
Angioplasty, Balloon, Coronary , Anticoagulants/adverse effects , Hemorrhage/etiology , Aged , Female , Humans , Male , Middle Aged , Predictive Value of Tests , Retrospective Studies , Risk Assessment , Risk Factors , Stents , Time Factors
16.
Thromb Haemost ; 102(6): 1227-33, 2009 Dec.
Article in English | MEDLINE | ID: mdl-19967155

ABSTRACT

The aim of this study was to evaluate the safety of glycoprotein IIb/IIIa inhibitors (GPIs) during percutaneous coronary intervention (PCI) in patients on chronic warfarin therapy due to atrial fibrillation (AF). We analysed all consecutive AF patients (N = 377, mean age 70 years, male 71%) on warfarin therapy referred for PCI in seven centres. Major bleeding, access site complications and major adverse cardiovascular events were recorded during hospitalisation. A total of 111 patients (29%) received periprocedural GPIs with a wide inter-hospital variation in their use (range 3-68%). The use of GPIs increased with the severity of the disease presentation and 49% of patients with ST-elevation myocardial infarction received GPIs. Mean periprocedural international normalised ratio (INR) of patients who received GPIs was 1.89 (range 1.1-3.3). Major bleeding was more common in the patients treated with GPIs (9.0% vs. 1.5%, p = 0.001) than in those without GPIs, but there was no difference in major adverse cardiovascular events between the groups. In multivariable analysis, use of GPIs (odds ratio [OR] 5.1, 95% confidence interval [CI] 1.3-20.6, p = 0.02) and old age (OR 1.2, 95% CI 1.0-1.3, p= 0.02) remained as the only independent predictors of major bleeding. Also after adjusting for propensity score, GPIs remained as a significant predictor of major bleeding (OR 3.8, 95% CI 1.03-14.1, p = 0.045). In the GPI group, major bleeding was not predicted by INR level or warfarin pause. GPIs increase the risk of major bleeding events irrespective of periprocedural INR levels and should be used with caution in this fragile patient group.


Subject(s)
Angioplasty, Balloon , Anticoagulants/therapeutic use , Platelet Membrane Glycoproteins/antagonists & inhibitors , Warfarin/therapeutic use , Aged , Aged, 80 and over , Angioplasty, Balloon/adverse effects , Angioplasty, Balloon, Coronary/adverse effects , Anticoagulants/administration & dosage , Atrial Fibrillation/drug therapy , Drug-Eluting Stents , Female , Hemorrhage/etiology , Hemorrhage/prevention & control , Humans , Male , Middle Aged , Retrospective Studies , Warfarin/administration & dosage
17.
Duodecim ; 125(7): 739-46, 2009.
Article in Finnish | MEDLINE | ID: mdl-19432079

ABSTRACT

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.


Subject(s)
Coronary Disease/mortality , Cause of Death , Coronary Angiography , Coronary Disease/diagnostic imaging , Diabetes Complications/diagnostic imaging , Diabetes Complications/mortality , Female , Finland/epidemiology , Humans , Risk Factors , Sex Factors , Smoking/adverse effects
18.
EuroIntervention ; 4(2): 229-33, 2008 Aug.
Article in English | MEDLINE | ID: mdl-19110788

ABSTRACT

AIMS: The risk of stent thrombosis has been reported to increase with percutaneous coronary intervention (PCI) complexity. The present study reports the pre-specified secondary endpoint of a 14-month stent thrombosis and major adverse cardiac events in patients stented with a simple versus a complex bifurcation technique using sirolimus eluting stents (SES). METHODS AND RESULTS: A total of 413 patients with a coronary bifurcation lesion were randomised to a simple treatment strategy; stenting of main vessel and optional stenting of side branch (MV group), or to a complex stenting strategy; stenting of both main vessel and side branch (MV+SB group). Mortality data were available in all patients and 14-month clinical follow-up data in 395 (96%) of the patients. After 14 months, the rates of definite, probable and possible stent thrombosis (ARC criteria) were 1.0% vs. 0.5%, 1.0% vs. 0% and 0.5% vs. 0% (ns) in the MV and in the MV+SB groups, respectively. Rates of MACE were 9.5% in the MV group and 8.2% in the MV+SB group (ns). Total death was seen in 2.4% vs. 1.0% and non-PCI related myocardial infarction in 2.0% vs. 1.0% in the MV and the MV+SB groups, respectively. CONCLUSIONS: After 14 months, two months after recommended cessation of dual antiplatelet therapy, the rates of stent thrombosis and major adverse cardiac events were low and independent of treatment complexity in patients treated with SES for coronary artery bifurcation lesions.


Subject(s)
Angioplasty, Balloon, Coronary/methods , Coronary Artery Disease/pathology , Coronary Artery Disease/therapy , Coronary Vessels/pathology , Drug-Eluting Stents , Aged , Female , Follow-Up Studies , Humans , Immunosuppressive Agents/administration & dosage , Male , Middle Aged , Platelet Aggregation Inhibitors/therapeutic use , Sirolimus/administration & dosage , Thrombosis/prevention & control , Treatment Outcome
19.
World J Surg ; 32(12): 2643-9, 2008 Dec.
Article in English | MEDLINE | ID: mdl-18850246

ABSTRACT

BACKGROUND: Atrial fibrillation (AF) is the most frequently encountered postoperative arrhythmic complication after coronary artery bypass graft (CABG). There is increasing evidence to support the influence of inflammation in the pathogenesis of AF. The aim of the present study was to investigate the relation of postoperative new AF and systemic inflammatory changes after CABG. METHODS: A total of 113 CABG patients were recruited in the present study. Holter data from 24-hour electrocardiography were collected from 1 day before the operation to postoperative day 2 (POD2). AF was registered as positive if any AF event occurred. Serum cytokine, including interleukin (IL)-6, IL-8, and IL-10 were analyzed before and after surgery. RESULTS: The overall incidences of postoperative AF and sustained AF were 36.3% and 31.9%, respectively. Patients with postoperative AF had longer respiratory treatment, intensive care unit treatment, and inotropic medication periods. Similar concentrations of serum IL-6 were found after surgery in patients with and without AF. The concentrations of serum IL-8 was significantly higher at 2 hours and on POD1 and POD2 in patients with postoperative AF. The concentration of serum IL-10 was significantly higher on POD1 in patients with postoperative AF. CONCLUSIONS: Postoperative AF in CABG patients is associated with a more complicated postoperative outcome. Higher concentrations of serum IL-8 in CABG patients with postoperative AF suggested that an influence of inflammation in the pathogenesis postoperative AF after open heart surgery.


Subject(s)
Atrial Fibrillation/blood , Atrial Fibrillation/etiology , Coronary Artery Bypass/adverse effects , Coronary Artery Disease/blood , Coronary Artery Disease/surgery , Interleukin-8/blood , Aged , Atrial Fibrillation/diagnosis , Cardiopulmonary Bypass , Cohort Studies , Coronary Artery Disease/complications , Female , Humans , Inflammation/complications , Interleukin-10/blood , Male , Middle Aged , Risk Factors
20.
Eur Heart J ; 29(8): 1001-10, 2008 Apr.
Article in English | MEDLINE | ID: mdl-18346963

ABSTRACT

AIMS: Uninterrupted anticoagulation (UAC) is assumed to increase bleeding and access-site complications. A common consensus is to postpone percutaneous coronary interventions (PCI) to reach international normalized ratio (INR) levels < 1.5-1.8. METHODS AND RESULTS: To assess the safety and feasibility of UAC, we analysed retrospectively all consecutive patients (n = 523) on warfarin therapy referred for PCI in four centres with a policy to interrupt anticoagulation (IAC) before PCI and in three centres with a long experience on UAC during PCI. Major bleeding, access-site complications, and major adverse cardiac events (death, myocardial infarction, target vessel revascularization, and stent thrombosis) were recorded during hospitalization. In the IAC group, warfarin was withdrawn for a mean of 3 days prior to PCI (mean INR 1.7). In the UAC group, mean INR value was 2.2. Glycoprotein IIb/IIIa (GP) inhibitors (P < 0.001) and low-molecular-weight heparins (P < 0.001) were more often used in the IAC group. Major bleeding and access-site complications were more common in the IAC group (5.0% vs. 1.2%, P = 0.02 and 11.3% vs. 5.0%, P = 0.01, respectively) than in the UAC group. After adjusting for propensity score, the group difference in access-site complications remained significant [OR (odds ratio) 2.8, 95% CI (confidence interval) 1.3-6.1, P = 0.008], but did not remain significant in major bleeding (OR 3.9, 95% CI 1.0-15.3, P = 0.05). In multivariable analysis, femoral access (OR 9.9, 95% CI 1.3-75.2), use of access-site closure devices (OR 2.1, 95% CI 1.1-4.0), low-molecular-weight heparin (OR 2.7, 95% CI 1.1-6.7) and old age predicted access-site complications, and the use of GP inhibitors (OR 3.0, 95% CI 1.0-9.1) remained as a predictor of major bleeding. CONCLUSION: Our study shows that PCI is a safe procedure during UAC with no excess bleeding complications.


Subject(s)
Angioplasty, Balloon, Coronary/adverse effects , Anticoagulants/therapeutic use , Blood Loss, Surgical/prevention & control , Coronary Disease/therapy , Coronary Thrombosis/prevention & control , Aged , Epidemiologic Methods , Female , Humans , Male , Practice Guidelines as Topic
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