Study Design

Study Design:

Patients Screened: 111
Patients Enrolled: 110
Mean Follow Up: 9 months for the initial study; 6 years for the long-term follow-up
Mean Patient Age: mean 58 years
Female: 15

Patient Populations:

Both absolute (TIMI flow grade 0) and “functional” (TIMI flow grade 1) occlusions were included. Symptomatic patients or those with inducible ischemia in the territory supplied by the occluded artery were included. The patients were required to be suitable candidates for CABG.

Exclusions:

Acute myocardial infarction within 30 days; chest pain at rest within 7 days; contraindication to aspirin or warfarin; total occlusion at a site of a previous PTCA; occlusion <30 days in duration; significant left main disease; vessel <3 mm in diameter or with severe tortuosity; lesion >13 mm or involving a major side branch; evidence after recanalization of diffuse disease, additional stenosis >50% of the lumen diameter in the distal segment following the intervention, or complex dissection.

Primary Endpoints:

Minimum lumen diameter at 9 month angiographic follow-up

Secondary Endpoints:

Binary restenosis at follow-up; major ischemic events (death, myocardial infarction, CABG, repeat angioplasty, target lesion revascularization); symptomatic status at follow-up; hemorrhagic events (intracranial bleeding or complications requiring vascular surgery or blood transfusion)

Drug/Procedures Used:

The target occlusion was treated by conventional PTCA. In case of successful recanalization, defined as restoration of anterograde TIMI grade 2 or 3 flow with a residual stenosis <50% of the lumen diameter, the angiogram was immediately evaluated to establish whether all the angiographic inclusion criteria were met.

Stent Implantation: a standard Palmaz-Schatz stent was manually crimped onto a conventional balloon catheter and deployed with post-dilation. 4-8 hours following sheath removal, warfarin and intravenous heparin infusion were started. Heparin infusion was continued until an INR of 2.5-3.5 was obtained at which point patients were transitioned to warfarin, which was continued for 1 month.

PTCA alone: further balloon dilatations aimed to optimize the angiographic result were allowed. Crossover to stent implantation was allowed in the case of worsening of the residual stenosis to <50% of the lumen diameter.

Concomitant Medications:

Aspirin (150 to 325 mg daily) and a calcium channel blocking agent starting at least 24 h before PTCA. During the procedure, heparin was given to maintain the activated clotting time >250 seconds.