Randomized Trial of Simple Versus Complex Drug-Eluting Stenting for Bifurcation Lesions

Abstract

Background-The optimal strategy for treating coronary bifurcation lesions remains a subject of debate. With bare-metal stents, single-stent approaches appear to be superior to systematic 2-stent strategies. Drug-eluting stents, however, have low rates of restenosis and might offer improved outcomes with complex stenting techniques. Methods and Results-Patients with significant coronary bifurcation lesions were randomized to either a simple or complex stenting strategy with drug-eluting stents. In the simple strategy, the main vessel was stented, followed by optional kissing balloon dilatation/T-stent. In the complex strategy, both vessels were systematically stented (culotte or crush techniques) with mandatory kissing balloon dilatation. Five hundred patients 64Ϯ10 years old were randomized; 77% were male. Eighty-two percent of lesions were true bifurcations (Ͼ50% narrowing in both vessels). In the simple group (nϭ250), 66 patients (26%) had kissing balloons in addition to main-vessel stenting, and 7 (3%) had T stenting. In the complex group (nϭ250), 89% of culotte (nϭ75) and 72% of crush (nϭ169) cases were completed successfully with final kissing balloon inflations. The primary end point (a composite at 9 months of death, myocardial infarction, and target-vessel failure) occurred in 8.0% of the simple group versus 15.2% of the complex group (hazard ratio 2.02, 95% confidence interval 1.17 to 3.47, Pϭ0.009). Myocardial infarction occurred in 3.6% versus 11.2%, respectively (Pϭ0.001), and in-hospital major adverse cardiovascular events occurred in 2.0% versus 8.0% (Pϭ0.002), respectively. Procedure duration and x-ray dose favored the simple approach. Conclusions-When coronary bifurcation lesions are treated, a systematic 2-stent technique results in higher rates of in-hospital and 9-month major adverse cardiovascular events. This difference is largely driven by periprocedural myocardial infarction. Procedure duration is longer, and x-ray dose is higher. The provisional technique should remain the preferred strategy in the majority of cases. Clinical Trial Registration Information-URL: http://www.clinicaltrials.gov. Unique identifier: NCT 00351260.

Importance of the Spasm Provocation Test in Diagnosing and Clarifying the Activity of Vasospastic Angina

“…The immediate angiographic success was 100% in all patients in both groups, the procedural in-hospital success was 100% in all the patients in both groups, no documented ECG changes after intervention during the index hospitalization and no one from either group suffered in-hospital major complications. Results of our study were in agreement with that reported in the BBC trial [11]. Study.…”

“…The use of two stents minimizes lumen loss of one side during expansion of the other vessel [9]. Several studies [10][11][12] have concluded that stenting the main vessel (MV) with provisional stenting (PS) of side branches (SB) is preferable in the great majority of bifurcation lesions. Various techniques with the use of one or two stents have been developed to optimize the treatment of this subset of lesions [1][2][3][13][14][15][16][17][18][19].…”

Six-month clinical outcomes of the Tryton Side Branch Stent for the treatment of bifurcation lesions

“…Thus far, six randomised controlled trials (RCT) have compared the use of two stents versus a single-stent approach in the treatment of BL [15][16][17][18][19][20]. The BBC-ONE trial showed a clinical benefit favouring the single-stent technique, which was mainly driven by a reduction in periprocedural MI, of which clinical consequences are still a matter of debate [21,22].…”

Coronary bifurcation stenting with dedicated Tryton side-branch stent. Early and 6-month results of 40 patients

“…Reduction of restenosis rate by introduction of DES led to the development of many techniques based on the implantation of two or more stents [17]. However, none of them was superior to MB stenting with the use of a single stent and provisional side-branch stenting [18][19][20][21]. Besides, despite significant progress in the stenting of bifurcation lesions multi-stent techniques are related to higher risk of periprocedural complications, mainly non-Q wave myo - cardial infarctions, not to mention the costs [19][20][21].…”