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August 2003
L. Gruberg, S. Milo, M. Ben Tzvi, C. Lotan, G. Merin, S. Braun, R. Mohr, D. Tzivoni, D. Bitran and R. Beyar

Background: The Arterial Revascularization Therapies Study was a multicenter, randomized trial designed to compare percutaneous coronary intervention with stenting versus coronary artery bypass graft surgery in 1,205 patients with multivessel coronary artery disease. The most appropriate type of treatment for these patients is still a matter of considerable debate.

Objectives: To evaluate the clinical characteristics of patients enrolled in the ARTS[1] trial in Israel in comparison to those worldwide, and to assess the 1 year outcome in these patients.

Methods: Between April 1997 and June 1998, a total of 1,205 patients with multivessel coronary artery disease, who were considered to be equally treatable with both modalities, were randomized to either stenting (n=600) or CABG[2] (n=605) at 67 centers around the world. In Israel, 53 patients at four participating medical centers underwent randomization to either PCI[3] with stents (n=27) or CABG (n=26).

Results: Clinical and angiographic characteristics were similar in the two groups, except for a significantly higher incidence of diabetic patients in Israel who were randomized to CABG, compared to those worldwide (35% vs. 16%, P = 0.01). Also, there were more patients with unstable angina in Israel (63 vs. 37%, P = 0.006). At 1 year follow-up, overall mortality and cerebrovascular accident rates were similar between the two groups and equivalent to results obtained around the world. There was a significantly higher incidence of myocardial infarction rates in patients randomized to stenting in Israel compared to patients worldwide (7.4 vs. 5.3%, P = 0.01) or to patients randomized to CABG in Israel (7.4 vs. 0%, P = 0.006). Similar to the overall ARTS results, there was a higher incidence of repeat revascularization procedures in patients assigned to the PCI with stenting arm (22.2 vs. 3.8%, P = 0.004) compared to those randomized to CABG, respectively.

Conclusions: The results of this analysis of the Israeli ARTS population indicate that coronary stenting and bypass surgery yield similar findings with regard to mortality and stroke and are comparable to those obtained in the whole study group. Likewise, coronary stenting was associated with an increased incidence of repeat revascularization procedures as compared to CABG. However, patients in Israel randomized to stenting had a higher rate of myocardial infarctions as compared to the overall results and to patients who underwent CABG in Israel. The present analysis provides important data for the safety and efficacy of either stenting or bypass surgery in treating patients with multivessel disease in Israel.

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[1] ARTS = Arterial Revascularization Therapies Study

[2] CABG = coronary artery bypass graft surgery

[3] PCI = percutaneous coronary intervention


June 2003
Winkler and D. Tzivoni

Background: Prior studies have suggested that women are at higher risk for morbidity and mortality during coronary angioplasty, although long-term prognosis is similar after successful procedures.

Objectives: To examine the role of gender in coronary stenting, including immediate procedural success as well as early and late outcomes.

Methods: The study group comprised 560 consecutive patients (119 women and 441 men) who had undergone stenting over a 3 year period.

Results: The indications for coronary stenting were similar among women and men, and stents were successfully deployed at similar rates without complications (92 vs. 90% respectively). Cardiac death or myocardial infarction within 30 days of the procedure was observed in 5% of women and men, whereas none of the women, compared to 1.4% of men, had early revascularization. Bleeding complications occurred in 4% of women and 2% of men. During 10 ± 2.8 months of follow-up, 58% of women and men underwent repeat cardiac catheterization, revealing similar rates of restenosis, 36 vs. 32% respectively. During the study period, 3.3% of women as compared to 0.9% of men had a cardiac death (not significant). Cardiac death or myocardial infarction was observed in 7% of women and 8% of men, and the combined endpoint of death, myocardial infarction or revascularization, was noted in 24% and 26% respectively. Multivariate Cox analyses of the clinical, angiographic and procedural characteristics revealed that multiple stent deployment was the only predictor of major adverse cardiac event among men, whereas none of these characteristics predicted outcome in women.

Conclusion: Coronary stenting is performed with similar success rates among women and men, with similar restenosis rates, as well as early and late major adverse cardiac events.
 

February 2003
N. Horowitz, M. Kapeliovich, R. Beyar and H. Hammerman

Background: Coronary stenting was recently introduced as a primary intervention for acute myocardial infarction. Several randomized controlled studies have shown that stenting may be superior to balloon angioplasty for the treatment of AMI[1]. However, routine stenting may also cause deterioration of coronary flow.

Objective: To analyze the clinical characteristics and the outcome of patients who were treated with stenting for AMI in our center in the recent era of stenting.

Methods: Fifty-five patients with AMI were treated by stent implantation between January 1998 and December 1999. Adverse clinical events were recorded, including death, recurrent infarction, coronary artery bypass grafting, cerebrovascular accident, and target vessel revascularization. In-hospital, 1 month, 6 month and 1 year follow-up was performed in all patients. Repeated coronary angiography was performed according to clinical indications.

Results: Baseline angiographic results showed Thrombolysis in Myocardial Infarction (TIMI) 0 flow in 39 patients (70.9%), TIMI I flow in no patient and TIMI II/III flow in 16 patients (29.1%). TIMI grade 3 flow was achieved in 90.9% of patients at the end of the procedure. In-hospital mortality rate was 5.4% (2.1% in patients without cardiogenic shock). There was no evidence of re-infarction or TVR[2]. The rates of bleeding complication (all of them minor), CVA[3], and CABG[4] were 9.1%, 3.6% and 1.8% respectively. The 6 month mortality rate remained the same. Rates of re-infarction, restenosis, TVR and CABG were 3.6%, 14.5%, 14.5% and 5.4% respectively. The 1 year mortality rate was 7.3%. Restenosis rate was 18% and CABG 7.3%. One year event-free survival was 70.9%.

Conclusions: This study suggests that stenting is a safe and effective mode of therapy in the setting of AMI associated with a high rate of revascularization and a low short and long-term outcome.






[1] AMI = acute myocardial infarction



[2] TVR = target vessel revascularization

[3] cerebrovascular accident



[4] CABG = coronary artery bypass grafting



 
August 2002
Sivan Ekstein, MD, Amir Elami, MD, Gideon Merin, MD, Mervyn S. Gotsman, MD, FACC and Chaim Lotan, MD, FACC

Background: Patients with multivessel coronary artery disease are candidates for either angioplasty and stenting or coronary artery bypass grafting. A prospective randomized study designed to compare the both methods included only a minority of the eligible patients.

Objective: To compare coronary artery bypass grafting to angioplasty plus stenting in patients with multivessel disease who declined randomization to a multicenter study (the ARTS).

Methods: During 1997-98 we prospectively followed 96 consecutive patients who were eligible according to the ARTS criteria but refused randomization. Of these patients, 50 underwent angioplasty + stenting and 46 underwent coronary bypass surgery. We compared the incidence of major adverse cardiac and cerebral events, chest pain recurrence, quality of life and procedural cost during the first 6 months.

Results: All procedures were completed successfully without mortality or cerebral events. The rate of Q-wave myocardial infarction was 2% in the AS[1] group vs. 0% in the CABG[2] group (not significant). Minor complications occurred in 7 patients (14%) in the AS group and in 21 patients (45%) in the CABG group (P < 0.01). At 6 months follow-up the incidence of major cardiac and cerebral events was similar in both groups (11% and 4% in the AS and CABG groups respectively, P=NS). Seventeen patients (36%) in the AS group required repeat revascularization compared to only 3 (7%) in the CABG group (P=0.002). Nevertheless, quality of life was better, hospitalization was shorter and the cost was lower during the first 6 months after angioplasty.

Conclusion: Angioplasty with stenting compared to coronary bypass surgery in patients with multivessel disease resulted in similar short-term major complications. However, 36% of patients undergoing angioplasty may need further revascularization procedures during the first 6 months.


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[1]
AS = angioplasty + stenting

[2] CABG = coronary artery bypass graft

October 1999
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