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Biomedical subjects

Harry Suryapranata

Publications and source records attributed to Harry Suryapranata.

69 records · Page 4Linked to original sources
PubMed2003

Randomized comparison between stenting and off-pump bypass surgery in patients referred for angioplasty.

BACKGROUND: Stenting improves cardiac outcome in comparison with balloon angioplasty. Compared with conventional surgery, off-pump bypass surgery on the beating heart without cardiopulmonary bypass may reduce morbidity, hospital stay, and costs. The purpose, therefore, was to compare cardiac outcome, quality of life, and cost-effectiveness 1 year after stenting and after off-pump surgery. METHODS AND RESULTS: Patients referred for angioplasty (n=280) were randomly assigned to stenting (n=138) or off-pump bypass surgery. At 1 year, survival free from stroke, myocardial infarction, and repeat revascularization was 85.5% after stenting and 91.5% after off-pump surgery (relative risk, 0.93; 95% CI, 0.86 to 1.02). Freedom from angina was 78.3% after stenting and 87.0% after off-pump surgery (P=0.06). Quality-adjusted lifetime was 0.82 year after stenting and 0.79 year after off-pump surgery (P=0.09). Hospital stay after the initial procedure was 1.43 and 5.77 days, respectively (P<0.01). Stenting reduced overall costs by 2933 dollars (26.2%) per patient (8276 dollars versus 11 209 dollars; P<0.01). Stenting was more cost-effective in 95% of the bootstrap estimates. CONCLUSIONS: At 1 year, stenting was more cost-effective than off-pump surgery while maintaining comparable cardiac outcome and quality of life. Stenting rather than off-pump surgery, therefore, can be recommended as a first-choice revascularization strategy in selected patients.

Aged↗
PubMed2003

Symptom-onset-to-balloon time and mortality in patients with acute myocardial infarction treated by primary angioplasty.

OBJECTIVES: The aim of the study was to evaluate the relationship between symptom-onset-to-balloon time and one-year mortality in patients with ST-segment elevation myocardial infarction (STEMI) treated by primary angioplasty. BACKGROUND: Despite the prognostic implications demonstrated in patients with STEMI treated with thrombolysis, the impact of time-delay on prognosis in patients undergoing primary angioplasty has yet to be established. METHODS: Our study population consisted of 1,791 patients with STEMI treated by primary angioplasty from 1994 to 2001. All clinical, angiographic and follow-up data were collected. Subanalyses were conducted according to patient risk profile at presentation and preprocedural Thrombolysis In Myocardial Infarction (TIMI) flow. RESULTS: A total of 103 patients (5.8%) had died at one year. Symptom-onset-to-balloon time was significantly associated with the rate of postprocedural TIMI 3 flow (p = 0.012), myocardial blush grade (p = 0.033), and one-year mortality (p = 0.02). A stronger linear association between symptom-onset-to-balloon time and one-year mortality was observed in non-low-risk patients (p = 0.006) and those with preprocedural TIMI flow 0 to 1 (p = 0.013). No relationship was found between door-to-balloon time and mortality. At multivariate analysis, a symptom-onset-to-balloon time >4 h was identified as an independent predictor of one-year mortality (p < 0.05). CONCLUSIONS: This study shows that, in patients with STEMI treated by primary angioplasty, symptom-onset-to-balloon time, but not door-to-balloon time, is related to mortality, particularly in non-low-risk patients and in the absence of preprocedural anterograde flow. Furthermore, a symptom-onset-to-balloon time >4 h was identified as independent predictor of one-year mortality.

Angioplasty, Balloon, Coronary↗
PubMed2003

Glucose-insulin-potassium infusion inpatients treated with primary angioplasty for acute myocardial infarction: the glucose-insulin-potassium study: a randomized trial.

OBJECTIVES: In this study we considered the question of whether adjunction of glucose-insulin-potassium (GIK) infusion to primary coronary transluminal angioplasty (PTCA) is effective in patients with an acute myocardial infarction (MI). BACKGROUND: A combined treatment of early and sustained reperfusion of the infarct-related coronary artery and the metabolic modulation with GIK infusion has been proposed to protect the ischemic myocardium. METHODS: From April 1998 to September 2001, 940 patients with an acute MI and eligible for PTCA were randomly assigned, by open-label, to either a continuous GIK infusion for 8 to 12 h or no infusion. RESULTS: The 30-day mortality was 23 of 476 patients (4.8%) receiving GIK compared with 27 of 464 patients (5.8%) in the control group (relative risk [RR] 0.82, 95% confidence interval [CI] 0.46 to 1.46). In 856 patients (91.1%) without signs of heart failure (HF) (Killip class 1), 30-day mortality was 5 of 426 patients (1.2%) in the GIK group versus 18 of 430 patients (4.2%) in the control group (RR 0.28, 95% CI 0.1 to 0.75). In 84 patients (8.9%) with signs of HF (Killip class > or =2), 30-day mortality was 18 of 50 patients (36%) in the GIK group versus 9 of 34 patients (26.5%) in the control group (RR 1.44, 95% CI 0.65 to 3.22). CONCLUSIONS: Glucose-insulin-potassium infusion as adjunctive therapy to PTCA in acute MI did not result in a significant mortality reduction in all patients. In the subgroup of 856 patients without signs of HF, a significant reduction was seen. The effect of GIK infusion in patients with signs of HF (Killip class > or =2) at admission is uncertain.

Age Factors↗
PubMed2003

Angiographic assessment of reperfusion in acute myocardial infarction by myocardial blush grade.

BACKGROUND: Angiographic successful reperfusion in acute myocardial infarction has been defined as TIMI 3 flow. However, TIMI 3 flow does not always result in effective myocardial reperfusion. Myocardial blush grade (MBG) is an angiographic measure of myocardial perfusion. We hypothesized that optimal angiographic reperfusion is defined by TIMI 3 flow and MBG 2 or 3. METHODS AND RESULTS: In 924 consecutive patients with TIMI 3 flow after angioplasty for acute myocardial infarction, we prospectively studied the value of MBG. End points were death, MACE, enzymatic infarct size, and residual left ventricular ejection fraction. Follow-up was 16+/-11 months. Of the 924 patients, 101 (11%) patients had MBG 0 or 1. Mortality was significantly higher in patients with MBG 0 or 1 compared with patients with MBG 2 or 3 (relative risk, 4.7; 95% CI, 2.3 to 9.5; P<0.001). The combined incidence of MACE was higher in patients with MBG 0 or 1 compared with patients with MBG 2 or 3 (relative risk, 1.8; 95% CI, 1.1 to 2.8; P=0.009). Enzymatic infarct size was larger (1437+/-2388 versus 809+/-1672, P=0.001) and left ventricular ejection fraction was lower (37.7+/-10.6 versus 43.8+/-11.1, P<0.001) in patients with MBG 0 or 1 compared with patients with MBG 2 or 3. CONCLUSIONS: MBG is a strong angiographic predictor of mortality in patients with TIMI 3 flow after primary angioplasty. Enzymatic infarct size is larger and residual left ventricular ejection fraction is lower in patients with MBG 0 or 1 compared with MBG 2 or 3. Angiographic definition of successful reperfusion should include both TIMI 3 flow as well as MBG 2 or 3.

Angioplasty↗
PubMed2003

A comparison of two invasive strategies in patients with non-ST elevation acute coronary syndromes: results of the Early or Late Intervention in unStable Angina (ELISA) pilot study. 2b/3a upstream therapy and acute coronary syndromes.

BACKGROUND: Only few studies specifically addressed the effect of timing of angiography and/or pre-treatment with a glycoprotein 2b/3a receptor blocker in patients with non-ST elevation acute coronary syndromes (ACS) who undergo invasive treatment. METHODS: In a 2-year period, 220 patients with non-ST elevation ACS, were randomized to early angiography without tirofiban pre-treatment (Early strategy) or to delayed angiography after 24-48h pre-treatment with tirofiban (Late strategy). The first 48h after admission, CKmb levels were measured and enzymatic infarct size (LDHQ(48)) was assessed by the area under the LDH release curve. When PCI was performed beyond 48h, CKmb was measured 6 and 12h afterwards. RESULTS: Median time to angiography was 6 (Early) and 50 (Late) hours. PCI was performed in 130 patients (59%). In these patients, a patent (TIMI 2 or 3 flow) culprit vessel was more often present in the Late group compared to the Early group (66% vs 82% p=0.05). In patients with an elevated CKmb (n=96, 44%), LDHQ(48)was significantly lower in patients who underwent angiography after pre-treatment with tirofiban (629+/-503U/L (Early) vs 432+/-441U/L (Late), p=0.02). No difference in clinical outcome between the groups was observed at 30 days follow-up. CONCLUSION: This pilot study showed that a strategy of delayed angiography with concomitant pre-treatment with tirofiban is associated with improved angiographic outcomes and less initial enzyme release, compared to a strategy of immediate angiography without 2b/3a inhibitor pre-treatment. The use of an end point parameter, which assess total enzyme release over a given period of time, might be of special value in patients with non-ST elevation ACS, who undergo very early invasive treatment.

Angina, Unstable↗
PubMed2003

The prognostic importance of heart failure and age in patients treated with primary angioplasty.

BACKGROUND: Effective risk stratification is essential in the management of patients with acute myocardial infarction. Available models have not yet been studied and validated in patients treated with primary angioplasty for acute myocardial infarction. METHODS: The prognostic value of heart failure defined by Killip class and age upon admission and the impact of success and failure of the angioplasty procedure was studied in 1702 consecutive patients treated with primary angioplasty. FINDINGS: The combination of Killip class and age is a strong predictor of 30-day mortality and categorizes patients in subgroups with 30-day mortality risk ranging from 0.5 to 70%. Angioplasty failure results in a high 30-day mortality, in particular in patients with Killip class > or =II and/or age > or =70 years. A large majority of patients (72%), characterized by Killip class I and age <70 years, can be identified with a 0.5% risk of death at 30 days. INTERPRETATION: The presence of heart failure (Killip class) and age predicts 30-day mortality in patients on their way to the catheterization laboratory for primary angioplasty. This simple and effective early risk stratification, in combination with success and failure of the primary angioplasty, can be used to direct subsequent patient management.

Adult↗
PubMed2003

Coronary intervention with a heparin-coated stent and aspirin only.

OBJECTIVES: To determine the safety and efficacy of a post-stenting anti-platelet regimen of aspirin without additional ticlopidine or clopidogrel after successful heparin-coated stent implantation. METHODS: A prospective, non-randomized, multi-center pilot study of patients undergoing percutaneous coronary intervention, including those with acute coronary syndromes and small vessels with one-month clinical follow-up, was undertaken. Patients received a heparin-coated stent and were treated with aspirin only. RESULTS: Over a period of 6 months, a total of 122 patients were recruited in 6 centers. Their mean age was 57.2 10.0 years, 79% were male and 31% had unstable angina. Most (75%) had single-vessel disease, predominantly of the left anterior descending artery (51%), with a mean reference diameter of 2.44 mm 0.44 mm at baseline and 2.48 0.41 mm post stenting. At a 1-month clinical follow-up, no major adverse cardiovascular events (including subacute stent thrombosis) had occurred. Five patients were readmitted to hospital for symptoms unrelated to the interventional procedure. CONCLUSIONS: Heparin-coated stent implantation using an antiplatelet regimen of aspirin only, appears to be safe and feasible. A randomized trial of a larger number of patients appears warranted.

Adult↗
PubMed2002

Influence of prehospital administration of aspirin and heparin on initial patency of the infarct-related artery in patients with acute ST elevation myocardial infarction.

OBJECTIVES: The aim of this study was to investigate the influence of prehospital administration of aspirin and heparin on the initial patency of the infarct-related artery (IRA) in patients with acute myocardial infarction (MI). BACKGROUND: Prehospital diagnosis of acute MI facilitates early pharmacologic intervention on the way to the catheterization laboratory for primary angioplasty. METHODS: We studied the angiographic data and 30-day clinical outcome of 1,702 patients treated with primary angioplasty; 860 received aspirin and heparin before transportation to our hospital and 842 received aspirin and heparin in our hospital. RESULTS: The Thrombolysis In Myocardial Infarction (TIMI) 2 or 3 flow in the IRA was higher in the prehospital treated group (31% vs. 20%, relative risk 0.65, 95% confidence interval 0.55 to 0.78, p < 0.001). Patients with TIMI 2 or 3 flow on the initial angiogram had a higher angioplasty success rate (94% vs. 89%, p < 0.001), a smaller enzymatic infarct size, a higher left ventricular ejection fraction and a lower 30-day mortality (1.6% vs. 3.4%, p = 0.04). CONCLUSIONS: Prehospital administration of aspirin and heparin results in a higher initial patency of the IRA in patients with acute MI.

Angioplasty, Balloon, Coronary↗
PubMed2002

Reperfusion therapy in elderly patients with acute myocardial infarction: a randomized comparison of primary angioplasty and thrombolytic therapy.

OBJECTIVES: This study sought to determine the short- and long-term outcome of primary coronary angioplasty and thrombolytic therapy for acute myocardial infarction (AMI) in patients older than 75 years of age. BACKGROUND: The benefit of reperfusion therapy in elderly patients with AMI is uncertain, although elderly people account for a large proportion of deaths. METHODS: We randomly assigned a total of 87 patients with an AMI who were older than 75 years to treatment with angioplasty or intravenous (IV) streptokinase. Clinical outcome was measured by taking the end points of death and the combination of death, reinfarction or stroke during follow-up. RESULTS: The primary end point, a composite of death, reinfarction or stroke, at 30 days had occurred in 4 (9%) patients in the angioplasty group as compared with 12 (29%) in the thrombolysis group (p = 0.01, relative risk [RR]: 4.3, 95% confidence interval [CI]: 1.2 to 20.0). At one year the corresponding figures were 6 (13%) and 18 (44%), respectively (p = 0.001, RR: 5.2, 95% CI: 1.7 to 18.1). CONCLUSIONS: In this series of patients with AMI who were older than 75 years, primary coronary angioplasty had a significant clinical benefit when compared with IV streptokinase therapy.

Aged↗
PubMed2002

The effect of completeness of revascularization on event-free survival at one year in the ARTS trial.

OBJECTIVES: We sought to assess the relationship between completeness of revascularization and adverse events at one year in the ARTS (Arterial Revascularization Therapies Study) trial. BACKGROUND: There is uncertainty to what extent degree of completeness of revascularization, using up-to-date techniques, influences medium-term outcome. METHODS: After consensus between surgeon and cardiologist regarding the potential for equivalence in the completeness of revascularization, 1,205 patients with multivessel disease were randomly assigned to either bypass surgery or stent implantation. All baseline and procedural angiograms and surgical case-record forms were centrally assessed for completeness of revascularization. RESULTS: Of 1,205 patients randomized, 1,172 underwent the assigned treatment. Complete data for review were available in 1,143 patients (97.5%). Complete revascularization was achieved in 84.1% of the surgically treated patients and 70.5% of the angioplasty patients (p < 0.001). After one year, the stented angioplasty patients with incomplete revascularization showed a significantly lower event-free survival than stented patients with complete revascularization (i.e., freedom from death, myocardial infarction, cerebrovascular accident and repeat revascularization) (69.4% vs. 76.6%; p < 0.05). This difference was due to a higher incidence of subsequent bypass procedures (10.0% vs. 2.0%; p < 0.05). Conversely, at one year, bypass surgery patients with incomplete revascularization showed only a marginally lower event-free survival rate than those with complete revascularization (87.8% vs. 89.9%). CONCLUSIONS: Complete revascularization was more frequently accomplished by bypass surgery than by stent implantation. One year after bypass, there was no significant difference in event-free survival between surgically treated patients with complete revascularization and those with incomplete revascularization, but patients randomized to stenting with incomplete revascularization had a greater need for subsequent bypass surgery.

Aged↗
PubMed2002

A randomized comparison of the value of additional stenting after optimal balloon angioplasty for long coronary lesions: final results of the additional value of NIR stents for treatment of long coronary lesions (ADVANCE) study.

OBJECTIVES: We sought to investigate the clinical benefit of additional stent implantation after achieving an optimal result of balloon angioplasty (BA) in long coronary lesions (>20 mm). BACKGROUND: Long coronary lesions are associated with increased early complications and late restenosis after BA. Stenting improves the early outcome, but stent restenosis is also related to both lesion length and stent length. METHODS: A total of 437 patients with a single native lesion 20 to 50 mm in length were included and underwent BA, using long balloons matched to lesion length and vessel diameter (balloon/artery ratio 1.1) to achieve a diameter stenosis (DS) <30% by on-line quantitative coronary angiography (QCA). "Bail-out stenting" was performed for flow-limiting dissections or >50% DS. Patients in whom an optimal BA result was achieved were randomized to additional stenting (using NIR stents) or no stenting. The primary end point was freedom from major adverse cardiac events (MACE) at nine months, and core laboratory QCA was performed on serial angiograms. RESULTS: Bailout stenting was necessary in 149 patients (34%) and was associated with a significantly increased risk of peri-procedural infarction (p < 0.02). Among the 288 randomized patients, the mean lesion length was 27+/-9 mm, and the vessel diameter was 2.78+/-0.52 mm. The procedural success rate was 90% for the 143 patients assigned to BA alone (control group), as compared with 93% in the 145 patients assigned to additional stenting (stent group), which resulted in a superior early minimal lumen diameter (0.54 mm, p < 0.001) and led to reduced angiographic restenosis (27% vs. 42%, p = 0.022). Freedom from MACE at nine months was 77% in both groups. CONCLUSIONS: A strategy of provisional stenting for long coronary lesions led to bailout stenting in one-third of patients, with a threefold increase in peri-procedural infarction. Additional stenting yielded a lower angiographic restenosis rate, but no reduction in MACE at nine months.

Aged↗
PubMed2000

Clinical and angiographic results with the beStent: the Registry for Optimal beStent Evaluation (ROSE) trial.

BACKGROUND: Although safety and efficacy of the beStent (Medtronic Inc., Santa Rosa, CA, USA) have been described, the long-term angiographic and clinical outcomes have yet to be investigated. The ROSE (Registry for Optimal beStent Evaluation) trial was designed to assess the procedural safety of single 15 mm beStent implantation, and the six-month angiographic and 12-month clinical outcomes of patients treated with this novel coronary stent. METHODS: Patients with angina and a single de novo lesion in a native coronary artery of >/=2.75 mm diameter were included in this multicenter, prospective, observational trial. Clinical follow-up was obtained at one, six and 12 months. Angiography was performed before and after the stent implantation and at six months. The primary end-point included major adverse cardiac events (death, myocardial infarction and target lesion revascularization), major bleeding complications, and thrombotic occlusions at one-month follow-up. Secondary end-points were major cardiac-event-free survival at six- and 12-month follow-up and angiographic restenosis at six months. A total of 120 patients (80% male, mean age 58.6 +/- 10.6 years) with stable (48%) or unstable (44%) angina pectoris were allocated. The target vessel reference diameter pre-procedure was 2.85 +/- 0.52 mm. RESULTS: Minimal lumen diameter pre/post and at follow-up was 0.97 +/- 0.28 mm, 2.53 +/- 0.40 mm and 1.86 +/- 0.63 mm, respectively. Restenosis rate according to the >50% diameter stenosis criterion at six-month follow-up was 21.5%. At 12 months, the event-free survival rate was 75% (no deaths, two Q-wave and seven non-Q-wave infarctions, five bypass surgery interventions and 16 target lesion revascularizations), whilst 87% of the patients were free of angina pectoris. CONCLUSION: Despite the relatively high percentage of small vessels, the outcome of the ROSE trial is comparable to those observed in previous stent trials, indicating that the coronary beStent is safe and effective as a primary device for the treatment of native coronary artery lesions in patients with (un)stable angina pectoris.

Journal Article↗
PubMed1999

Clinical and quantitative angiographic outcomes following elective implantation of the self-expanding Wallstent for longer coronary artery lesions--final results of the Wellstent native study.

BACKGROUND: Implantation of short balloon-expandable stents provides superior clinical and angiographic outcome compared with balloon angioplasty in selected patients. The purpose of the Wellstent study was to evaluate the safety and efficacy of the self-expanding Wallstent combined with aspirin and ticlopidine in patients with stable or unstable angina related to a native coronary lesion up to 45 mm in length. METHODS: 105 patients (111 lesions) with stable (57%) or unstable (43%) angina were included in this prospective multicentre evaluation. Angiography before and after Wallstent implantation and at 6-month follow-up was analysed at the core lab using the CAAS 2 system. The primary end-point was incidence of major adverse cardiac events (MACE) at 30 days. Secondary end-points were angiographic outcome at 6 months and MACE at 6 months and 1 year. RESULTS: Acute procedural success (successful stent implantation with residual stenosis <20%) was achieved in 99%. Mean reference diameter was 3.18 +/- 0.66 mm, minimal luminal diameter was 1.00 +/- 0.50 mm pre- and 2.84 +/- 0.47 mm poststent (diameter stenosis 16 +/- 6%). The mean hospital stay was 2.2 days. At 30 days, 95% of patients were free of MACE. At 6 month and 1 year clinical follow-up, 75% and 71% of patients, respectively, remained free of MACE, the majority of which (19 of 30) were re-interventions at re-angiography. In 90% of eligible patients, MLD at follow-up was 1.65 +/- 0.75 mm (late loss 1.20 +/- 0.66 mm, loss index 0.66), diameter stenosis 42 +/- 15%, with a restenosis rate of 32%. Longer stents were associated with greater luminal loss (P = 0.001) and less-favourable clinical outcome. CONCLUSIONS: Wallstent implantation, combined with aspirin and ticlopidine, achieved excellent acute and 30 day clinical results in a heterogenous high-risk patient group. Clinical outcome at 6 months and 1 year remained good, and most adverse events were re-PTCA during follow-up angiography. The loss index of 0.66 and restenosis rate of 32%, related in part to the use of longer stents, emphasizes the continuing need for effective anti-proliferative therapy.

Journal Article↗
PubMed1999

Cardioprotective effects of adenosine transport inhibition during reversible ischaemia in patients with coronary artery disease.

BACKGROUND: Adenosine plays a major role in protecting ischaemic myocardium and may potentiate ischaemic preconditioning. Nucleosine transport inhibition may enhance these favourable effects. DESIGN: Randomized, double blind, placebo controlled study, to investigate the haemodynamic and cardioprotective effects of nucleoside transport inhibition during ischaemia in patients with coronary artery disease. PATIENTS AND METHODS: Elective left anterior descending (LAD) coronary angioplasty was used to produce reversible ischaemia in 24 patients with stable angina and a single LAD lesion. They were randomized to receive either the nucleoside transport inhibitor draflazine or placebo. The study medication was infused between the 2nd and 3rd balloon inflation. The primary endpoint was ischaemia-induced wall motion abnormalities as measured by left septal echo amplitude, which was plotted against time to produce an area under the curve. RESULTS: No differences were observed in the systemic haemodynamics or the myocardial collateral circulation of the two groups. The ischaemia-induced regional wall motion abnormalities improved significantly after draflazine, while no difference was observed in the placebo group. This improvement was even more pronounced in patients with low caffeine levels compared with those with high caffeine levels. CONCLUSIONS: Draflazine, in the dose and route used, is associated with a significant improvement in regional myocardial function of the ischaemic area, without affecting systemic or collateral circulation, when compared with placebo. This implies that draflazine has a cardio-protective effect in ischaemic myocardium. High caffeine blood levels reduce these effects.

Journal Article↗