A randomized trial comparing phosphorylcholine-coated stenting with balloon angioplasty as well as abciximab with placebo for restenosis reduction in small coronary arteries.

OBJECTIVE: The objective of this randomized trial was to assess the antirestenotic effects of phosphorylcholine (PC)-coated stents as well as of abciximab in small coronary arteries when compared with percutaneous transluminal coronary angioplasty (PTCA) and placebo respectively. BACKGROUND: Stent coating with PC has been shown to reduce protein absorption and platelet activation which may reduce the risk of restenosis. Furthermore, on the basis of nondedicated studies abciximab is believed to reduce the risk of restenosis after coronary interventions. METHODS: A total of 502 patients with lesions situated in small coronary arteries (vessel diameter /=50% diameter stenosis) at follow-up; death or myocardial infarction, and target vessel revascularization (TVR), were assessed as secondary end-points. RESULTS: Angiographic restenosis did not differ between patients treated with PC-coated stents or with PTCA (39.0% vs. 34.2%; P = 0.30) and between patients receiving abciximab or placebo (39.3% vs. 34.3%; P = 0.29). Similarly, the need for TVR at 1-year follow-up did not differ between patients receiving PC-coated stents or PTCA (20.2% vs. 20.5%; P = 0.98) as well as between patients treated with abciximab or placebo (18.7% vs. 21.9%; P = 0.44). CONCLUSIONS: PC-coated stents and abciximab failed to reduce the incidence of angiographic restenosis after percutaneous coronary intervention of small coronary arteries. These data strengthen the belief that future studies on prevention of restenosis in small coronary arteries should focus on drug-eluting stents.

A randomized trial comparing the hand-mounted JoStent with the premounted Multi-Link Duet stent in patients with coronary artery disease.

The objective of this multicenter randomized study was to compare the angiographic and clinical results achieved 1 year after coronary placement of two stent models: the hand-mounted JoStent and the premounted Multi-Link Duet stent. We included 505 patients who were randomly assigned to receive either the hand-mounted JoStent (n = 252) or the premounted Multi-Link Duet stent (n = 253). The primary endpoint of the study, late lumen loss, measured 1.12 mm in the JoStent group and 1.17 mm in the Multi-Link Duet group. These values were statistically equivalent (P = 0.02 from the equivalence test). No significant difference was observed in the incidence of restenosis, 24.2% in the JoStent and 25.2% in the Multi-Link Duet stent group, and target vessel revascularization, 13.9% in the JoStent and 15.4% in the Multi-Link Duet patients. In conclusion, the hand-mounted JoStent and the premounted Multi-Link Duet stent enable excellent procedural success rates and equally favorable 1-year angiographic and clinical outcomes.

Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO) trial.

BACKGROUND: Increased thrombogenicity and smooth muscle cell proliferative response induced by the metal struts compromise the advantages of coronary stenting. The objective of this randomized, multicenter study was to assess whether a reduced strut thickness of coronary stents is associated with improved follow-up angiographic and clinical results. METHODS AND RESULTS: A total of 651 patients with coronary lesions situated in native vessels >2.8 mm in diameter were randomly assigned to receive 1 of 2 commercially available stents of comparable design but different thickness: 326 patients to the thin-strut stent (strut thickness of 50 microm) and 325 patients to the thick-strut stent (strut thickness of 140 microm). The primary end point was the angiographic restenosis (>/=50% diameter stenosis at follow-up angiography). Secondary end points were the incidence of reinterventions due to restenosis-induced ischemia and the combined rate of death and myocardial infarctions at 1 year. The incidence of angiographic restenosis was 15.0% in the thin-strut group and 25.8% in the thick-strut group (relative risk, 0.58; 95% CI, 0.39 to 0.87; P=0.003). Clinical restenosis was also significantly reduced, with a reintervention rate of 8.6% among thin-strut patients and 13.8% among thick-strut patients (relative risk, 0.62; 95% CI, 0.39 to 0.99; P=0.03). No difference was observed in the combined 1-year rate of death and myocardial infarction. CONCLUSIONS: The use of a thinner-strut device is associated with a significant reduction of angiographic and clinical restenosis after coronary artery stenting. These findings may have relevant implications for the currently most widely used percutaneous coronary intervention.

A randomized trial comparing stenting with balloon angioplasty in small vessels in patients with symptomatic coronary artery disease. ISAR-SMART Study Investigators. Intracoronary Stenting or Angioplasty for Restenosis Reduction in Small Arteries.

BACKGROUND: More than 30% of the lesions currently treated with interventional approaches are situated in vessels smaller in size than those representing an established indication for stenting. The objective of this randomized trial was to assess whether compared with PTCA, stenting of small coronary vessels is associated with a reduction of restenosis. METHODS AND RESULTS: Patients with symptomatic coronary artery disease with lesions situated in native coronary vessels between 2 and 2.8 mm in size were randomly assigned to be treated with either stenting (n=204) or PTCA (n=200). Adjunct therapy consisted of abciximab, ticlopidine, and aspirin. Repeat angiography at 6-month follow-up was performed in 83% of the patients. The primary end point of the study was the incidence of angiographic restenosis (>/=50% diameter stenosis) at follow-up; adverse clinical events, such as death, myocardial infarction, stroke, or target vessel revascularization, were assessed as secondary end points. After 7 months, there were no significant differences in the infarct-free survival rates between the 2 study groups: 96.6% for stent patients, and 97.0% for PTCA patients (P:=0. 80). Target vessel revascularization was needed in 20.1% of the stent patients and 16.5% of the PTCA patients (P:=0.35). The primary end point of angiographic restenosis was found in 35.7% of the stent patients and 37.4% of the PTCA patients (P:=0.74). The net lumen gain observed at follow-up was identical (0.76+/-0.78 in the stent group versus 0.76+/-0.63 mm in the PTCA group, P:=0.93). CONCLUSIONS: Stenting and PTCA are associated with equally favorable results when used for treating lesions in small coronary vessels.

[Indications spectrum for beta-1-selective adrenergic receptor blockers]. / Indikationsspektrum beta-1-selektiver Adrenorezeptorenblocker.

The major indications for beta receptor blockers include, in addition to arterial hypertension, various clinical manifestations of coronary heart disease. Used as antihypertensive agents, beta receptor blockers bring about regression of myocardial hypertrophy and an improvement in diastolic ventricular function. Anti-anginal effects are utilized in the treatment of symptomatic and asymptomatic myocardial ischemia, as well as for secondary prophylaxis after acute myocardial infarction. A detailed knowledge of the subtypes of adrenoceptors--in particular beta-1 receptors in the case of the heart--led to the development of largely organ-specific antagonists. In contrast to nonspecific beta blockers, beta-1 selective substances, for example, atenolol, have only a mild, clinically non-relevant, effect on glucose and lipid metabolism.

[Anti-ischemic therapy with verapamil. Improving prognosis by secondary prevention after acute myocardial infarct]. / Antiischämische Therapie mit Verapamil. Prognoseverbesserung durch Sekundärprophylaxe nach akutem Myokardinfarkt.

Calcium antagonists reduce myocardial oxygen demand and increase the oxygen supply to the myocardium via a coronary dilating effect. For the treatment of silent myocardial ischämia and of stable and instable angina pectoris, studies with verapamil revealed an anti-ischemic efficacy comparable with that of beta blockers and nitrates. Studies of secondary prophylaxis after acute myocardial infarction reveal a cardioprotective effect of verapamil in terms of a reduction in mortality and re-infarction rates. Calcium antagonists have further organ-protective effects such as a reduction of left ventricular wall hypertrophy and a slowing effect on the progression of arteriosclerotic vascular changes.

[ACE inhibition with cilazapril. Major therapeutic aspects: hypertension and metabolic syndrome]. / ACE-Hemmung mit Cilazapril. Therapieschwerpunkte: Hypertonie und metabolisches Syndrom.

Today, essential hypertension is considered to be genetically closely related to disordered peripheral glucose metabolism, and this situation is described by the term metabolic syndrome. Both diseases--hypertension and type II diabetes--submit the heart and arterial vessels to an unphysiological, chronic stress, which they can compensate only for a certain time. Today, when antihypertensive treatment is indicated, drugs capable of preventing late vascular injury while at the same time having the potency to reverse already existing organic changes, are employed. ACE-inhibitors are presently considered to be the most potent substances that are capable of exerting a positive effect on hypertension-associated changes, while not increasing the individual risk profile in the development of arteriosclerosis. The present paper discusses the new ACE-inhibitor, cilazapril, which can be administered in a practical single dose and develops a profile of action typical of ACE-inhibitors in hypertensives with and without an accompanying metabolic syndrome.